As filed with the Securities and Exchange Commission on May 3, 2013

Registration No. 333-_________

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

Heat Biologics, Inc.

(Exact name of Registrant as specified in its charter)

100 Europa Drive

Chapel Hill, North Carolina 27517

(919) 240-7133

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

Jeffrey Wolf

Chief Executive Officer and

Chairman of the Board of Directors

Heat Biologics, Inc.

100 Europa Drive

Chapel Hill, North Carolina 27517

(919) 240-7133

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Approximate date of commencement of proposed sale to the public:  As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.  þ

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act of 1933, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ¨

If delivery of the prospectus is expected to be made pursuant to Rule 424, check the following box. ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

CALCULATION OF REGISTRATION FEE

(1)

 Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(o) of the Securities Act of 1933, as amended.

(2)

Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.

(3)

Includes shares of common stock the underwriters have the option to purchase to cover over-allotments, if any.

(4)

No fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended.

(5)

Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended. The representative’s warrants are exercisable at a per share exercise price equal to 125% of the public offering price per share. As estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended, the proposed maximum aggregate offering price of the representative’s warrants is $1,031,250, which is equal to 125% of $825,000 (5% of $16,500,000).

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities, nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

        Shares

Common Stock

This is an initial public offering of       shares of common stock by Heat Biologics, Inc. No public market currently exists for our common stock. We anticipate that the initial public offering price per share of our common stock will be between $       and $       per share.

We expect to effect a        -for-       reverse stock split of our outstanding common stock just prior to the date of this prospectus.  We have applied to list our common stock on the NASDAQ Capital Market under the symbol “HEAX.”

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and, as such, may elect to comply with certain reduced public company reporting requirements for future filings.

Investing in our common stock involves risk. See “Risk Factors” beginning on page 9 of this prospectus for a discussion of information that should be considered in connection with an investment in our common stock.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

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We have granted a 45-day option to the underwriters to purchase up to       additional shares of common stock solely to cover over-allotments, if any.

The underwriters expect to deliver the shares against payment therefor on or about                 , 2013.

Sole Book-Running Manager

Aegis Capital Corp

                         , 2013

TABLE OF CONTENTS

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You should rely only on the information contained in this prospectus. Neither we nor the underwriters have authorized anyone to provide you with information different from that contained in this prospectus. We are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of shares of our common stock.

Except where the context requires otherwise, in this prospectus the “Company,” “Heat Biologics,” “Heat,” “we,” “us” and “our” refer to Heat Biologics, Inc., a Delaware corporation formed in June 2008, and, where appropriate, its subsidiaries, Heat Biologics I, Inc., Heat Biologics III, Inc., Heat Biologics IV, Inc. and Heat Biologics GmbH. In June 2012, we divested our 92.5% interest in Heat Biologics II, Inc.  The divestiture resulted in Heat Biologics II, Inc. being classified as discontinued operations in our consolidated financial statements for the years ended December 31, 2012 and 2011.

For investors outside the United States: Neither we nor any of the underwriters have taken any action that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of shares of common stock and the distribution of this prospectus outside of the United States.

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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. This summary is not complete and does not contain all of the information that you should consider before deciding to invest in our securities. We urge you to read this entire prospectus carefully, especially the “Risk Factors” section. Except where the context requires otherwise, in this prospectus the “Company,” “Heat Biologics,” “Heat,” “we,” “us” and “our” refer to Heat Biologics, Inc., a Delaware corporation, and, where appropriate, its subsidiaries, Heat Biologics I, Inc. Heat Biologics III, Inc., Heat Biologics IV, Inc. and Heat Biologics GmbH.  Unless otherwise included, all share amounts and per share amounts in this prospectus have been presented on a pro forma basis as if a reverse stock split of our outstanding shares of common stock at a ratio of    -for-    , that we expect to effect just prior to the date of this prospectus has occurred.

Heat Biologics

Overview 

We are a clinical-stage biopharmaceutical company engaged in the development of novel allogeneic, “off-the-shelf” cellular therapeutic vaccines to combat a wide range of cancers and infectious diseases. Our proprietary ImPACT™ Immune Pan Antigen Cytotoxic Therapy is being designed to deliver live, genetically-modified, irradiated human cells which are reprogrammed to “pump out” a broad spectrum of cancer associated antigens together with a potent immune adjuvant called “gp96” to educate and activate a cancer patient’s immune system to recognize and kill cancerous cells. We intend for our ImPACT cells to secrete an antigen-adjuvant complex that generates anti-cancer immune responses in patients by mobilizing and activating cytotoxic “killer” T cells that target multiple cancer antigens, thus harnessing a patient’s own immune system to fight cancer.  

Unlike “autologous” or “personalized” therapeutic vaccine approaches which require extraction and processing of cancer or blood from each individual patient, our ImPACT therapeutic vaccine uses a common master cell line to mass-produce a single vaccine product applicable to all patients for each particular cancer type. We believe our off-the-shelf, allogenic immunotherapy offers logistical, manufacturing and cost of goods benefits compared to autologous patient-specific approaches.

We have filed an IND to initiate a Phase II clinical trial in non-small cell lung cancer patients (NSCLC) patients with our therapeutic vaccine candidate HS-110, which is derived from a genetically-modified human lung cancer cell line.  We believe that the results of our recently completed Phase I clinical trial in NSCLC demonstrated that our HS-110 is designed to generate anti-cancer immune responses.  Eighteen patients were vaccinated, and 15 of the 18 vaccinated patients completed the first course of three planned courses of therapy.

Based on our evaluation, 11 of 15 patients responded to our therapy with a median survival of 16.5 months for immune responders, versus a median survival of 4.5 months for immune non-responders and the historical control group.  The one-year overall survival rate of patients in our study was 44%, comparing quite favorably with the 5% rate for the historical control group. One of our late-stage lung cancer patients is surviving over four years since starting our therapy and another patient is surviving over three years since starting our therapy. These findings were consistent with multiple pre-clinical published studies on ImPACT therapy.  

We have also developed ImPACT therapeutic vaccines for bladder cancer, breast cancer and ovarian cancer. We plan to initiate a Phase I/II clinical trial for bladder cancer in mid-2013 with HS-410, a genetically-modified bladder cancer cell line. We also plan to initiate a second grant-funded, investigator-sponsored Phase I clinical trial of our ImPACT therapy against NSCLC in the second quarter of 2013.  To date, in excess of $14,000,000 of funding has been awarded to the primary inventor of the technology that we license by the National Institutes of Health (NIH) and through other research and clinical grants, which has been used to further develop our ImPACT technology platform.

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The table below summarizes our current product candidates and their stages of development:

The NIH is also currently fully funding the primary inventor’s study of our HS-HIV product candidate in non-human primates with a therapeutic and prophylactic vaccine for the treatment and prevention of HIV utilizing our ImPACT approach.

ImPACT Therapy—Novel Pan-Antigen Immune Activation

Our ImPACT therapy is a novel technology platform designed to educate and stimulate the immune system to combat specific disease targets, such as cancer cells. ImPACT utilizes live, human-derived, genetically-modified attenuated cells that generate an array of cellular antigens complexed to a secreted immunostimulatory protein called “gp96”, a heat shock protein. The secreted antigen and adjuvant complex are designed to generate a potent immune response to cancer cells by mobilizing and activating a patient’s own killer T cells to recognize and attack a broad array of different tumor antigens with the goal of eliminating cancer cells. In contrast to other vaccine technologies that target only single cancer antigens, ImPACT’s pan-antigen approach is designed to enable the patient to induce and maintain an immune response against a broad array of tumor-specific proteins, by potentially providing a more robust immune response and limiting cancer cells’ ability to evade the immune system. We believe that our clinical and pre-clinical results suggest that ImPACT is designed to generate anti-tumor immune responses capable of targeting and destroying tumors and maintaining remission. We believe our novel, off-the-shelf, live attenuated cell therapy can potentially be used to not only combat a wide range of cancers, but also to treat various infectious diseases, such as hepatitis C, malaria and HIV.  NIH-funded non-human primate studies of ImPACT for HIV, which we believe are encouraging, have been completed.

Recent Developments

In March 2013, we closed the first tranche of our Series B Preferred Stock private placement offering in which we sold an aggregate of 1,891,419 shares of our Series B-1 Preferred Stock for gross proceeds of $5,050,090.  The investors in the offering committed to purchase and we agreed to sell an additional 433,122 shares of our Series B-2 Preferred Stock at a second tranche closing to be held after fulfillment of certain conditions, including receipt of additional grant funding.  In addition, at the second tranche closing, we have agreed to issue to each investor a warrant exercisable for two shares of Series B-1 Preferred Stock for each share of Series B-2 Preferred Stock purchased by them at the second tranche closing.  All shares of the Series B Preferred Stock automatically convert into shares of our common stock upon the consummation of a firm commitment underwritten public offering resulting in aggregate net cash proceeds to us of at least $15,000,000.

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Strengths and Competitive Advantages

We believe that the following are key investment attributes of our company:

·

We believe our ImPACT technology combines broad antigen targeting complexed with a potent immune adjuvant. We believe ImPACT has already been shown to activate the immune system against a wide variety of antigens by eliciting a significant cytotoxic T cell immune response as measured by extensive pre-clinical and clinical immunological testing.  The activated immune response generated by our ImPACT Therapy may be useful in treating wide range of cancers and infectious diseases.

·

We have filed an IND to initiate a Phase II clinical trial in NSCLC patients with our therapeutic vaccine candidate HS-110, which is derived from a genetically-modified human lung cancer cell line. We expect to initiate Phase I/II clinical trials for bladder cancer with our second product candidate, HS-410, in mid-2013.

·

The National Institute of Health (NIH) and other organizations have provided significant funding to the primary inventor of the technology that we license for both our pre-clinical and clinical studies.

·

Our proprietary technology platform, ImPACT, is being applied to develop multiple therapeutic vaccines against a wide range of cancers and infectious diseases. We believe we have many opportunities to generate positive results and to gain FDA approval, which lowers our dependence on any one drug in order to generate returns.  

·

We believe our therapeutic vaccines are easier and less expensive to manufacture than autologous vaccines because our therapeutic vaccines do not require the harvesting of blood and/or cancer cells from each patient in order to manufacture a course of treatment. We believe this is highly advantageous because it can bring the logistics, manufacturing, cost and distribution of our therapeutic vaccines within the purview of traditional biopharmaceutical product channels and dramatically expand our pool of corporate partners.

·

We believe our technology can readily be adapted to incorporate new cancer types. Because of this, and the fact that our vaccine approach is allogeneic (“off-the-shelf”), we are able to rapidly develop new vaccines for different types of cancers and other diseases.

·

Our therapy does not require an adjuvant. Some vaccines require the addition of another drug, called an adjuvant, to enhance their effectiveness. Adjuvants typically cause irritation at the injection site. As HS-110 is itself an adjuvant, we do not have to use additional adjuvants to generate and maintain an activated immune response.

·

We believe our business model is capital efficient as we continue to leverage academic and institutional resources to develop new products and to move these products into and through clinical trials.

Our Strategy

Our strategy is to utilize our novel ImPACT technology platform to produce a pipeline of novel immunotherapies for the treatment of various cancers and infectious diseases and rapidly and efficiently progress these products through clinical trials towards regulatory approval. Our near term strategy includes attempting to achieve the following:

·

Develop and obtain regulatory approval for our ImPACT-based products;

·

Maximize commercial opportunity for our ImPACT technology;

·

Further expand our broad patent portfolio;

·

Manage our business with efficiency and discipline; and

·

Obtain additional grant funding to more fully develop our ImPACT technology platform and its application to a variety of human diseases.

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Corporate Information

We were incorporated on June 10, 2008 under the laws of the State of Delaware under the name Heat Biologics, Inc.  Our executive offices are located at 100 Europa Drive, Chapel Hill, North Carolina 27517 and our telephone number is (919) 240-7133. Our website address is www.heatbio.com.  The information contained in, and that can be accessed through, our website is not incorporated into and is not part of this prospectus.

References to Heat Biologics also include references to our subsidiaries Heat Biologics I, Inc. (of which we own a 92.5% interest), Heat Biologics III, Inc., Heat Biologics IV, Inc. and Heat Biologics GmbH unless otherwise indicated. In June 2012, we divested our 92.5% interest in Heat Biologics II, Inc., which resulted in Heat Biologics II, Inc. being classified as discontinued operations in our consolidated financial statements for the years ended December 31, 2012 and 2011. On May 30, 2012, we formed two wholly-owned subsidiaries, Heat Biologics III, Inc. and Heat Biologics IV, Inc.  We assigned our proprietary rights related to the development and application of our ImPACT Therapy for the treatment of non-small lung cancer to Heat Biologics III, Inc. and our proprietary rights related to the development and application of our ImPACT Therapy to the treatment of bladder cancer to Heat Biologics IV, Inc.

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The Offering

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The number of shares of our common stock that will be outstanding immediately after this offering is based on 8,151,736 shares of common stock outstanding as of May 1, 2013, and assumes that all outstanding shares of our convertible Preferred Stock convert into shares of our common stock upon the closing of this initial public offering and excludes:

·

1,435,564 shares of our common stock issuable upon the exercise of stock options  as of May 1, 2013, with a weighted average exercise price of $0.35 per share;

·

122,262 additional shares of our common stock issuable upon the exercise of outstanding warrants as of May 1, 2013, at a weighted average exercise price of $0.94per share; and

·

282,155 additional shares of our common stock reserved for future issuance under our equity incentive plans as of May 1, 2013.

Except for historical financial information or as otherwise indicated herein, all information in this prospectus, including the number of shares that will be outstanding after this offering, assumes or gives effect to:

·

the conversion of all outstanding shares of our convertible Preferred Stock into an aggregate of 3,869,445 shares of our common stock which will occur automatically upon the closing of this offering; and

·

no exercise by the underwriters of their option to purchase up to       additional shares of our common stock from us in this offering.

We anticipate effecting a      - for-     reverse stock split just prior to the date of this prospectus.  Unless we indicate otherwise, all references to share numbers in this prospectus reflect the effects of this reverse stock split.

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SUMMARY CONSOLIDATED FINANCIAL DATA

The following table sets forth our summary statement of operations data for the years ended December 31, 2012 and 2011, and inception through December 31, 2012, derived from our audited consolidated financial statements and related notes included elsewhere in this prospectus. Our financial statements are prepared and presented in accordance with generally accepted accounting principles in the United States. Our historical results are not necessarily indicative of the results to be expected for any future periods and our interim results are not necessarily indicative of the results to be expected for the full fiscal year. Pro forma net loss per common share and the pro forma balance sheet data have been calculated assuming the conversion of all outstanding shares of our Preferred Stock into 3,869,455 shares of common stock upon completion of this offering. Pro forma net loss per share does not include the recognition of noncash debt discounts and beneficial conversion amounts that would occur upon conversion of the promissory notes. The pro forma as adjusted balance sheet data reflects the balance sheet data at December 31, 2012 as adjusted to reflect our receipt of the net proceeds from the sale by us in this offering of       shares of common stock at an assumed initial public offering price of $       per share, the midpoint of the estimated price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and conversion of all of our outstanding shares of Preferred Stock into 3,869,455 shares of common stock upon completion of this offering and the repayment of certain indebtedness. You should read this information together with the sections entitled “Capitalization,” “Selected Consolidated Financial Data,” “Management’s Discussion and Analysis of Financial Condition & Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus.

(dollars in thousands, except share and per share data)

Statement of Operations Data:

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Balance Sheet Data:

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(1)

A $1.00 increase (decrease) in the assumed initial public offering price of $       per share of our common stock, the midpoint of the estimated price range set forth on the cover of this prospectus, would increase (decrease) each of cash, total assets, and total stockholders’ equity (deficit) by $       million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

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RISK FACTORS

Investors should carefully consider the risks described below before deciding whether to invest in our securities. If any of the following risks actually occurs, our business, financial condition or results of operations could be adversely affected. In such case, the trading price of our common stock could decline and you could lose all or part of your investment. Our actual results could differ materially from those anticipated in the forward-looking statements made throughout this prospectus as a result of different factors, including the risks we face described below.

Risks Relating to our Company

We have had limited operations to date.

We are a start-up entity and have had limited operations to date.  As a start-up entity, we are subject to many of the risks common to such enterprises, including our ability to implement our business plan, market acceptance of our proposed business and products, under-capitalization, cash shortages, limitations with respect to personnel, financing and other resources, competition from better funded and experienced companies, and uncertainty of our ability to generate revenues. There is no assurance that our activities will be successful or will result in any revenues or profit, and the likelihood of our success must be considered in light of the stage of our development. Even if we generate revenue, there can be no assurance that we will be profitable.  In addition, no assurance can be given that we will be able to consummate our business strategy and plans, as described herein, or that financial, technological, market, or other limitations may force us to modify, alter, significantly delay, or significantly impede the implementation of such plans.  We have insufficient results for investors to use to identify historical trends or even to make quarter to quarter comparisons of our operating results.  You should consider our prospects in light of the risk, expenses and difficulties we will encounter as an early stage company.  Our revenue and income potential is unproven and our business model is continually evolving.  We are subject to the risks inherent to the operation of a new business enterprise, and cannot assure you that we will be able to successfully address these risks.

We have a limited operating history upon which to evaluate our ability to commercialize our products.

We are a development-stage company and our success is dependent upon our ability to commercialize our products and we have not demonstrated an ability to perform the functions necessary for the successful commercialization of any product candidates. The successful commercialization of any product candidates will require us to perform a variety of functions, including:

·

continuing to undertake pre-clinical development and clinical trials;

·

participating in regulatory approval processes;

·

formulating and manufacturing products; and

·

conducting sales and marketing activities.

Our operations have been limited to organizing and staffing the Company, acquiring, developing and securing our proprietary technology and undertaking pre-clinical and clinical trials of our product candidates. These operations provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing in our securities.

We currently have no product revenues and may not generate revenue at any time in the near future, if at all.

We currently have no products for sale and we cannot guarantee that we will ever have any drug products approved for sale. We and our product candidates are subject to extensive regulation by the U.S. Food and Drug Administration, or FDA (“FDA”) and comparable regulatory authorities in other countries governing, among other things, research, testing, clinical trials, manufacturing, labeling, promotion, selling, adverse event reporting and recordkeeping.  Until, and unless, we receive approval from the, and other regulatory authorities for our product candidates, we cannot sell our vaccines and will not have product revenues. For the foreseeable future, we will have to fund all of our operations and capital expenditures from cash on hand, and grants, and potentially, future offerings. At the conclusion of this offering, we believe we have cash on hand to fund our Phase II clinical trial for

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NSCLC, and our Phase I clinical trial for bladder cancer. However, changes may occur that would consume our available capital before that time, including changes in and progress of our development activities, acquisitions of additional candidates and changes in regulation.  Moreover, pre-clinical studies and clinical trials may not start or be completed as we forecast and may not achieve the desired results.

We may continue to generate operating losses and experience negative cash flows and it is uncertain whether we will achieve profitability.

For the years ended December 31, 2012 and December 31, 2011, we incurred a net loss of ($2,471,147) and ($2,113,142), respectively.  We have also incurred an accumulated deficit since inception of ($5,935,282). We may continue to incur operating losses until such time, if ever, as we are able to achieve sufficient levels of revenue from operations.  Our ability to achieve profitability will depend on the market acceptance of our product offerings and our capacity to develop, introduce and sell our products to our targeted markets.  There can be no assurance that we will ever generate significant sales or achieve profitability.  Accordingly, the extent of future losses and the time required to achieve profitability, if ever, cannot be predicted at this point.

Even if we succeed in developing and commercializing one or more product candidates, we expect to incur substantial losses for the foreseeable future and may never become profitable. We also expect to continue to incur significant operating and capital expenditures and anticipate that our expenses will increase substantially in the foreseeable future as we:

·

continue to undertake pre-clinical development and clinical trials for product candidates;

·

seek regulatory approvals for product candidates;

·

implement additional internal systems and infrastructure; and

·

hire additional personnel.

We also expect to experience negative cash flows for the foreseeable future as we fund our operating losses and capital expenditures. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability would likely negatively impact the value of our securities and could prevent us from continuing as a going concern.

If we default on our secured loans with Square 1 Bank, we would be forced to suspend all operations.

We have entered into loans with Square 1 Bank that are secured by substantially all of our assets, excluding our intellectual property.  Our loan agreement with Square 1 Bank sets forth various affirmative and negative covenants that we must comply with, including covenants regarding financial reporting, limits on our cash burn, incurrence of indebtedness and liens and merger and acquisitions.  If we fail to comply with these covenants or if we fail to make timely monthly payments under the secured loans when due, Square 1 Bank could declare our loans in default.  Additionally, if we do not commercialize a product by the maturity date of the loan, we may be unable to repay the loans to Square 1 Bank. If we default on the loans, Square 1 Bank has the right to seize the collateral secured by the loans, which would result in our licenses reverting back to our licensor and would force us to suspend all operations.  In order to comply with the covenants of the loans and to make timely payments to Square 1 Bank under the loans, we may need to raise additional capital, which might not be available to us on favorable terms or at all.

Risks Relating to our Business

If we do not obtain the necessary U.S. or worldwide regulatory approvals to commercialize any product candidate, we will not be able to sell our product candidates.

We cannot assure you that we will receive the approvals necessary to commercialize any of our product candidates or any product candidates we acquire or develop in the future. We will need FDA approval to commercialize our product candidates in the U.S. and approvals from the FDA-equivalent regulatory authorities in foreign jurisdictions to commercialize our product candidate in those jurisdictions. In order to obtain FDA approval of any product candidates, we must submit to the FDA a New Biologics License Application, or BLA, demonstrating that the product candidate is safe for humans and effective for its intended use. This demonstration requires significant

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research and animal tests, which are referred to as pre-clinical studies, as well as human tests, which are referred to as clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing. We cannot predict whether our clinical trials will demonstrate achievement of our endpoints or if the final results of our clinical trial will meet the FDA’s requirements to approve product commercialization and marketing.  We also cannot predict whether our research and clinical approaches will result in drugs or therapeutics that the FDA considers safe for humans and effective for indicated uses. The FDA has substantial discretion in the drug approval process. The approval process may be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may:

·

delay commercialization of, and our ability to derive product revenues from, our product candidate;

·

impose costly procedures on us; and

·

diminish any competitive advantages that we may otherwise believe that we hold.

Even if we comply with all FDA requests, the FDA may ultimately reject one or more of our NDAs or may not approve our manufacturing processes or facilities. We may never obtain regulatory clearance for any of our product candidates. Failure to obtain FDA approval of any of our product candidates will severely undermine our business by leaving us without a saleable product, and therefore without any source of revenues, until another product candidate can be developed. There is no guarantee that we will ever be able to develop or acquire another product candidate.

In addition, the FDA may require us to conduct additional pre-clinical and clinical testing or to perform post-marketing studies. As a condition to granting marketing approval of a product, the FDA may require a company to conduct additional clinical trials. Regulatory approval of oncology products often requires that patients in clinical trials be followed for long periods to determine the overall survival benefit of the drug.  The results generated in these Phase IV trials could result in loss of marketing approval, changes in product labeling, and/or new or increased concerns about the side effects or efficacy of a product. The Food and Drug Administration Amendments Act of 2007 (the FDAAA) gave the FDA enhanced post-market authority, including the explicit authority to require post-market studies and clinical trials, labeling changes based on new safety information, and compliance with FDA-approved risk evaluation and mitigation strategies. The FDA’s exercise of its authority under the FDAAA has in some cases resulted, and in the future could result, in delays or increased costs during product development, clinical trials and regulatory review, increased costs to comply with additional post-approval regulatory requirements and potential restrictions on sales of approved products.  

In foreign jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize any vaccines. Foreign regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above. We cannot assure you that we will receive the approvals necessary to commercialize our product candidate for sale outside the United States.

There is uncertainty as to market acceptance of our technology and products.

We have conducted our own research into the markets for our products; however because we will be a new entrant into the market we cannot guarantee market acceptance of our products and have somewhat limited information on which to estimate our anticipated level of sales.  Our products will require patients and doctors to adopt our technology.  Our industry is susceptible to rapid technological developments and there can be no assurance that we will be able to match any new technological advances.  If we are unable to match the technological changes in the needs of our customers the demand for our products will be reduced.

Our product candidates are in early stages of clinical trials.

Because our product candidates are in early stages of development they will require extensive pre-clinical and clinical testing.  Only one product candidate is currently ready for Phase II clinical trials.  We cannot predict with any certainty if or when we might submit a BLA for regulatory approval for any of our product candidates or whether any such BLA will be accepted.

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Clinical trials are very expensive, time-consuming and difficult to design and implement.

As part of the regulatory process, we must conduct clinical trials for each product candidate to demonstrate safety and efficacy to the satisfaction of the FDA and other regulatory authorities.  The number and design of the clinical trials that will be required varies depending upon product candidate, the condition being evaluated the trial results and regulations applicable to any particular product candidate. Therefore, it is difficult to accurately estimate the cost of the clinical trials. Human clinical trials are very expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming. We estimate that clinical trials of our product candidate will take at least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including:

·

unforeseen safety issues;

·

determination of dosing issues;

·

the cost of our clinical trials may be greater than we currently anticipate;

·

lack of effectiveness during clinical trials;

·

slower than expected rates of patient recruitment;

·

the drop-out or discontinuation rates of patients;

·

inability to monitor patients adequately during or after treatment;

·

third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;

·

insufficient or inadequate supply or quality of drug product candidates or other necessary materials to conduct our trials;

·

potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;

·

problems engaging IRBs to oversee trials or in obtaining and maintaining IRB approval of studies;

·

regulators may hold or suspend our clinical trials while collecting supplemental information on, or clarification of, our clinical trials or other clinical trials, including trials conducted in other countries or trials conducted by other companies; and

·

inability or unwillingness of medical investigators to follow our clinical protocols.

In addition, we or the FDA may suspend or terminate our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our Investigational New Drug, or IND, submissions or the conduct of these trials. Therefore, we cannot predict with any certainty the schedule for future clinical trials.

The results of our clinical trials may not support our product candidate claims.

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and pre-clinical testing. The clinical trial process may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a product candidate and may delay development of other product candidates. Any delay in, or termination of, our clinical trials will delay the

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filing of our BDAs with the FDA and, ultimately, our ability to commercialize our product candidates and generate product revenues. In addition, our clinical trials involve a small patient population. Because of the small sample size, the results of these clinical trials may not be indicative of future results.

Physicians and patients may not accept and use our product candidates.

Even if the FDA approves one or more of our product candidates, the products may not gain broad market acceptance among physicians, healthcare payors, patients, and the medical community.  Acceptance and use of our products will depend upon a number of factors including:

·

perceptions by members of the health care community, including physicians, about the safety and effectiveness of our therapeutics;

·

cost-effectiveness of our products relative to competing products;

·

convenience and ease of administration;

·

potential advantages of alternative treatment methods;

·

availability of reimbursement for our products from government or other healthcare payers; and

·

effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

Because we expect sales of our current product candidates, if approved, to generate substantially all of our product revenues for the foreseeable future, the failure of these therapeutics to find market acceptance would substantially harm our business and would adversely affect our revenue.

Our development program depends upon third-party researchers who are outside our control.

We are dependent upon independent investigators and collaborators, such as universities and medical institutions, to conduct our pre-clinical and clinical trials under agreements with us. These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These investigators may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If outside collaborators fail to devote sufficient time and resources to our development programs, or if their performance is substandard, the approval of our FDA applications, if any, and our introduction of new product candidates, if any, will be delayed if obtained at all. These collaborators may also have relationships with other commercial entities, some of whom may compete with us. If our collaborators assist our competitors at our expense, our competitive position would be harmed.

We have little control over the direction of the NIH grant funds that have been received by the primary inventor of the technology we license and since payment is made to the inventor as opposed to us we do not recognize any revenue from such grant funds nor do they fund any expenses that we incur.

To date, in excess of $14,000,000 of funding has been awarded by the NIH to the primary inventor of the technology we license.  Although earmarked for further development of the technology that we license, any funds awarded to the primary inventor are used in his discretion and we have little control over his use of the funds.

We will rely exclusively on third parties to formulate and manufacture our product candidate.

We have no experience in the formulation or manufacturing of therapeutics and do not intend to establish our own manufacturing facilities. We lack the resources and expertise to formulate or manufacture our own product candidates. The supplies for our Phase I and Phase II clinical trials are currently manufactured by our cGMP contractors under current good manufacturing practices and we have entered into an agreement with one manufacturer for the manufacture and supply of the material for our Phase III clinical trials and commercialization efforts. If any of our current product candidates or any product candidates we may develop or acquire in the future receive FDA approval, we will rely on one or more third-party contractors to manufacture our vaccines. Our anticipated future reliance on a limited number of third-party manufacturers exposes us to the following risks:

·

We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any contractor. This approval would require new

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testing and compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products after receipt of FDA approval, if any.

·

Our third-party manufacturers might be unable to formulate and manufacture our vaccines in the volume and of the quality required to meet our clinical needs and commercial needs, if any.

·

Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products.

·

Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, and corresponding state agencies to ensure strict compliance with good manufacturing practice and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards.

·

If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation.

Each of these risks could delay our clinical trials, the approval, if any, of our product candidates by the FDA or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenues.

We have no experience selling, marketing or distributing products and have no internal capability to do so.

We currently have no sales, marketing or distribution capabilities. We do not anticipate having the resources in the foreseeable future to allocate to the sales and marketing of our proposed products. Our future success depends, in part, on our ability to enter into and maintain collaborative relationships for such capabilities, the collaborator’s strategic interest in the products under development and such collaborator’s ability to successfully market and sell any such products. We intend to pursue collaborative arrangements regarding the sales and marketing of our products, however, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if able to do so, that our collaborators will have effective sales forces. To the extent that we decide not to, or are unable to, enter into collaborative arrangements with respect to the sales and marketing of our proposed products, significant capital expenditures, management resources and time will be required to establish and develop an in-house marketing and sales force with technical expertise. There can also be no assurance that we will be able to establish or maintain relationships with third party collaborators or develop in-house sales and distribution capabilities. To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful. In addition, there can also be no assurance that we will be able to market and sell our products in the United States or overseas.

We may not be successful in establishing and maintaining strategic partnerships, which could adversely affect our ability to develop and commercialize products.

We may seek to enter into strategic partnerships in the future, including alliances with other biotechnology or pharmaceutical companies, to enhance and accelerate the development and commercialization of our products. We face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for any future product candidates and programs because our research and development pipeline may be insufficient, our product candidates and programs may be deemed to be at too early of a stage of development for collaborative effort and/or third parties may not view our product candidates and programs as having the requisite potential to demonstrate safety and efficacy. Even if we are successful in our efforts to establish strategic partnerships, the terms that we agree upon may not be favorable to us and we may not be able to maintain such strategic partnerships if, for example, development or approval of a product candidate is delayed or sales of an approved product are disappointing.

If we ultimately determine that entering into strategic partnerships is in our best interest but either fail to enter into, are delayed in entering into or fail to maintain such strategic partnerships:

·

the development of certain of our current or future product candidates may be terminated or delayed;

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·

our cash expenditures related to development of certain of our current or future product candidates would increase significantly and we may need to seek additional financing;

·

we may be required to hire additional employees or otherwise develop expertise, such as sales and marketing expertise, for which we have not budgeted;

·

we will bear all of the risk related to the development of any such product candidates;

·

the competitiveness of any product candidate that is commercialized could be reduced;

To the extent we elect to enter into licensing or collaboration agreements to partner our product candidates, our dependence on such relationships may adversely affect our business.

Our commercialization strategy for certain of our product candidates may depend on our ability to enter into agreements with collaborators to obtain assistance and funding for the development and potential commercialization of these product candidates. Supporting diligence activities conducted by potential collaborators and negotiating the financial and other terms of a collaboration agreement are long and complex processes with uncertain results. Even if we are successful in entering into one or more collaboration agreements, collaborations may involve greater uncertainty for us, as we have less control over certain aspects of our collaborative programs than we do over our proprietary development and commercialization programs. We may determine that continuing a collaboration under the terms provided is not in our best interest, and we may terminate the collaboration. Our collaborators could delay or terminate their agreements, and our products subject to collaborative arrangements may never be successfully commercialized.

Further, our future collaborators may develop alternative products or pursue alternative technologies either on their own or in collaboration with others, including our competitors, and the priorities or focus of our collaborators may shift such that our programs receive less attention or resources than we would like, or they may be terminated altogether. Any such actions by our collaborators may adversely affect our business prospects and ability to earn revenues. In addition, we could have disputes with our future collaborators, such as the interpretation of terms in our agreements. Any such disagreements could lead to delays in the development or commercialization of any potential products or could result in time-consuming and expensive litigation or arbitration, which may not be resolved in our favor.

If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and our business will suffer.

The market for our product candidates is characterized by intense competition and rapid technological advances. If any of our product candidates receives FDA approval, it will compete with a number of existing and future drugs and therapies developed, manufactured and marketed by others. Existing or future competing products may provide greater therapeutic convenience or clinical or other benefits for a specific indication than our products, or may offer comparable performance at a lower cost. If our products fail to capture and maintain market share, we may not achieve sufficient product revenues and our business will suffer.

We will compete against fully integrated pharmaceutical companies and smaller companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. Many of these competitors have oncology compounds already approved or in development. In addition, many of these competitors, either alone or together with their collaborative partners, operate larger research and development programs or have substantially greater financial resources than we do, as well as significantly greater experience in:

·

developing drugs and therapies;

·

undertaking pre-clinical testing and human clinical trials;

·

obtaining FDA and other regulatory approvals of drugs and therapies;

·

formulating and manufacturing drugs and therapies; and

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·

launching, marketing and selling drugs and therapies.

We have limited protection of our intellectual property.  

We intend to rely on a combination of common law copyright, patent, trademark, and trade secret laws and measures to protect our proprietary information.  We have obtained exclusive rights to license the technology for which patent protection has been obtained; however such protection does not prevent unauthorized use of such technology.  Trademark and copyright protections may be limited, and enforcement could be too costly to be effective.  It may also be possible for unauthorized third parties to copy aspects of, or otherwise obtain and use, our proprietary information without authorization, including, but not limited to, product design, software, customer and prospective customer lists, trade secrets, copyrights, patents and other proprietary rights and materials.  Other parties can use and register confusingly similar business, product and service names, as well as domain names, which could divert customers, resulting in a material adverse effect on our business, operating results and financial condition.

If we fail to successfully enforce our intellectual property rights, our competitive position could suffer, which could harm our operating results. Competitors may challenge the validity or scope of our patents or future patents we may obtain.  In addition, our licensed patents may not provide us a meaningful competitive advantage. We may be required to spend significant resources to monitor and police our licensed intellectual property rights. We may not be able to detect infringement and our competitive position may be harmed. In addition, competitors may design around our technology or develop competing technologies. Intellectual property rights may also be unavailable or limited in some foreign countries, which could make it easier for competitors to capture market share.

The technology we license may be found to infringe third-party intellectual property rights.  

Third parties may in the future assert claims or initiate litigation related to their patent, copyright, trademark and other intellectual property rights in technology that is important to us.  The asserted claims and/or litigation could include claims against us, our licensors or our suppliers alleging infringement of intellectual property rights with respect to our products or components of those products.  Regardless of the merit of the claims, they could be time consuming, result in costly litigation and diversion of technical and management personnel, or require us to develop a non-infringing technology or enter into license agreements.  We cannot assure you that licenses will be available on acceptable terms, if at all. Furthermore, because of the potential for significant damage awards, which are not necessarily predictable, it is not unusual to find even arguably unmeritorious claims resulting in large settlements.  If any infringement or other intellectual property claim made against us by any third party is successful, or if we fail to develop non-infringing technology or license the proprietary rights on commercially reasonable terms and conditions, our business, operating results and financial condition could be materially adversely affected.

If our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial costs and we may have to:

·

obtain licenses, which may not be available on commercially reasonable terms, if at all;

·

abandon an infringing drug or therapy candidate;

·

redesign our products or processes to avoid infringement;

·

stop using the subject matter claimed in the patents held by others;

·

pay damages; or

·

defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

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We rely on licenses to use various technologies that are material to our business and if the agreements were to be terminated, it would halt our ability to market our products and technology, as well as have an immediate material adverse effect on our business, operating results and financial condition.

We have licensing agreements with certain universities granting us the right to use certain critical intellectual property.  The terms of the licensing agreements continues until the end of the life of the last patent to expire. If we breach the terms of these licensing agreements, including any failure to make minimum royalty payments required thereunder or failure to reach certain developmental milestones such as use best effort to introduce a licensed product in certain territories by 2020, the licensor has the right to terminate the license. If we were to lose or otherwise be unable to maintain these licenses on acceptable terms, it would halt our ability to market our products and technology, which would have an immediate material adverse effect on our business, operating results and financial condition.

We may be unable to generate sufficient revenues to meet the minimum royalties or developmental milestones required under our license agreements,  

For the years ended December 31, 2013, 2014, 2015, 2016, 2017 and thereafter our minimum royalty obligations under our  licensing agreements are $20,000, $20,000, $20,000, $20,000, $270,000 and $180,000, respectively.  No assurance can be given that we will generate sufficient revenue or raise additional financing to make these minimum royalty payments.  The license agreements also provide for certain developmental milestones.  No assurance can be given that we will meet all of the required developmental milestones. Any failure to make the payments or reach the milestones required by the license agreements would permit the licensor to terminate the license. If we were to lose or otherwise be unable to maintain these licenses, it would halt our ability to market our products and technology, which would have an immediate material adverse effect on our business, operating results and financial condition.

Our ability to generate product revenues will be diminished if our therapies sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.

Our ability to commercialize our vaccines, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

·

government and health administration authorities;

·

private health maintenance organizations and health insurers; and

·

other healthcare payers.

Significant uncertainty exists as to the reimbursement status of newly approved healthcare products. Healthcare payers, including Medicare, are challenging the prices charged for medical products and services. Cost control initiatives could decrease the price that we would receive for any products in the future, which would limit our revenue and profitability. Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for drugs and therapeutics. We might need to conduct post-marketing studies in order to demonstrate the cost-effectiveness of any future products to such payers’ satisfaction. Such studies might require us to commit a significant amount of management time and financial and other resources. Our future products might not ultimately be considered cost-effective.  Even if one of our product candidates is approved by the FDA, insurance coverage may not be available, and reimbursement levels may be inadequate, to cover such vaccines. If government and other healthcare payers do not provide adequate coverage and reimbursement levels for one of our products, once approved, market acceptance of such product could be reduced.

Legislative and regulatory changes affecting the health care industry could adversely affect our business

Political, economic and regulatory influences are subjecting the health care industry to potential fundamental changes that could substantially affect our results of operations.  U.S. and foreign governments, for example, continue to propose and pass legislation designed to reduce the cost of healthcare.  In some foreign markets, the government controls the pricing and profitability of prescription pharmaceuticals. In the U.S., we expect that there will continue to be federal and state proposals to implement similar governmental controls. In addition, recent changes in the Medicare program and increasing emphasis on managed care in the United States will continue to put pressure on pharmaceutical product pricing.  It is uncertain whether or when any legislative proposals will be

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adopted or what actions federal, state, or private payers for health care treatment and services may take in response to any health care reform  proposal or legislation.  We cannot predict the effect health care reforms may have on our business and we can offer no assurances that any of these reforms will not have a material adverse effect on our business.  These actual and potential changes are causing the marketplace to put increased emphasis on the delivery of more cost-effective treatments.  In addition, uncertainly remains regarding proposed significant reforms to the U.S. health care system.  

We may not successfully effect our intended expansion.

Our success will depend upon the expansion of our operations and the effective management of our growth, which will place a significant strain on our management and on our administrative, operational and financial resources. To manage this growth, we must expand our facilities, augment our operational, financial and management systems and hire and train additional qualified personnel. If we are unable to manage our growth effectively, our business would be harmed.

We may be exposed to liability claims associated with the use of biological and hazardous materials and chemicals.

Our research and development activities may involve the controlled use of biological and hazardous materials and chemicals. Although we believe that our safety procedures for using, storing, handling and disposing of these materials comply with federal, state and local laws and regulations, we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations. In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could materially adversely affect our business, financial condition and results of operations.

We rely on key executive officers and scientific and medical advisors, and their knowledge of our business and technical expertise would be difficult to replace.

We are highly dependent on our principal scientific, regulatory and medical advisors and our chief executive officer. We do not have “key person” life insurance policies for any of our officers or advisors. The loss of the technical knowledge and management and industry expertise of any of our key personnel could result in delays in product development, loss of customers and sales and diversion of management resources, which could adversely affect our operating results.

If we are unable to hire additional qualified personnel, our ability to grow our business may be harmed.

We will need to hire additional qualified personnel with expertise in pre-clinical testing, clinical research and testing, government regulation, formulation and manufacturing, sales and marketing and accounting and financing. In particular, over the next 12 months, we expect to hire up to 10 new employees. We compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions. Competition for such individuals is intense, and we cannot be certain that our search for such personnel will be successful. Attracting and retaining qualified personnel will be critical to our success.

Certain of our officers may have a conflict of interest.  

Some of our officers are currently working for the Company on a part-time basis.  Several of the part-time employees also work at other jobs and have discretion to decide what time they devote to our activities, which may result in a lack of availability when needed due to responsibilities at other jobs.  We expect that some of these officers may join the Company on a full-time basis at the completion of this offering, but there can be no assurance given that any or all of our officers will be so employed.

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We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

The testing and marketing of medical products entail an inherent risk of product liability. Product liability claims might be brought against us by consumers, health care providers or others selling or otherwise coming into contact with our products. Clinical trial liability claims may be filed against us for damages suffered by clinical trial subjects or their families. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products which could impact our ability to continue as a going concern. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with collaborators. In addition, regardless of merit or eventual outcome, product liability claims may result in:

·

decreased demand for any approved drug candidates;

·

impairment of our business reputation;

·

withdrawal of clinical trial participants;

·

costs of related litigation;

·

distraction of management’s attention;

·

substantial monetary awards to patients or other claimants;

·

loss of revenues; and

·

the inability to successfully commercialize any approved drug candidates.

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

Our business strategy incorporates international expansion, including establishing and maintaining clinician marketing and education capabilities outside of the United States and expanding our relationships with distributors and manufacturers. Doing business internationally involves a number of risks, including:

·

multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

·

failure by us or our distributors to obtain regulatory approvals for the sale or use of our tests in various countries, including failure to achieve “CE Marking,” a conformity mark which is required to market in vitro diagnostic medical devices in the European Economic Area and which is broadly accepted in other international markets;

·

difficulties in managing foreign operations;

·

complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;

·

logistics and regulations associated with shipping tissue samples, including infrastructure conditions and transportation delays;

·

limits on our ability to penetrate international markets if our diagnostic tests cannot be processed by an appropriately qualified local laboratory;

·

financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

·

reduced protection for intellectual property rights;

·

natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and

·

failure to comply with the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, by maintaining accurate information and control over sales and distributors’ activities.

Any of these risks, if encountered, could significantly harm our future international expansion and operations and, consequently, have a material adverse effect on our financial condition, results of operations and cash flows.

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We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

As part of our business strategy, we may pursue acquisitions of businesses and assets. We also may pursue strategic alliances and joint ventures that leverage our core technology and industry experience to expand our offerings or distribution. We have no experience with acquiring other companies and limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing business. We may experience losses related to investments in other companies, which could have a material negative effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.

To finance any acquisitions or joint ventures, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.

Declining general economic or business conditions may have a negative impact on our business.

Continuing concerns over United States health care reform legislation and energy costs, geopolitical issues, the availability and cost of credit and government stimulus programs in the United States and other countries have contributed to increased volatility and diminished expectations for the global economy. These factors, combined with low business and consumer confidence and high unemployment, precipitated an economic slowdown and recession. If the economic climate does not improve or continues to deteriorate, our business, including our access to patient samples and the addressable market for diagnostic tests that we may successfully develop, as well as the financial condition of our suppliers and our third-party payors, could be adversely affected, resulting in a negative impact on our business, financial condition and results of operations.

The U.S. government may have “march-in rights” to certain of our probe related intellectual property.

Because federal grant monies were used in support of the research and development activities that resulted in certain of our issued U.S. patents, the federal government retains what are referred to as “march-in rights” to these patents.

In particular, the National Institutes of Health, which administered grant monies to the primary inventor of the technology we license, technically retain the right to require us, under certain specific circumstances, to grant the U.S. government either a nonexclusive, partially exclusive or exclusive license to the patented invention in any field of use, upon terms that are reasonable for a particular situation. Circumstances that trigger march-in rights include, for example, failure to take, within a reasonable time, effective steps to achieve practical application of the invention in a field of use, failure to satisfy the health and safety needs of the public and failure to meet requirements of public use specified by federal regulations. The National Institutes of Health can elect to exercise these march-in rights on their own initiative or at the request of a third-party.

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Risks Related to this Offering

Upon the sale of the shares offered in this prospectus, our Preferred Stock will convert into shares of common stock.

Holders of our Preferred Stock have several rights that our common shareholders do not have such as preference on payment of dividends and liquidation distributions, the right to elect a certain number of directors, the right to adjustment in the event that securities are issued at a price per share less than that paid by the holders of the Preferred Stock. Our Third Amended and Restated Certificate of Incorporation provides that our Preferred Stock automatically converts to common stock upon the earlier of (i) a closing of a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, or the Securities Act,  resulting in at least $15,000,000 of net proceeds to us; (ii) with respect to the Series 1 Preferred Stock, written consent or agreement two thirds of the then outstanding shares of Series 1 Preferred Stock; (iii) with respect to the Series A Preferred Stock, (which must include the lead investor) written consent or agreement two thirds of the then outstanding shares of Series A Preferred Stock; (iv) with respect to the Series B-1 Preferred Stock, written consent or agreement two thirds of the then outstanding shares of Series B-1 Preferred Stock; and (v) with respect to the Series B-2 Preferred Stock, written consent or agreement of two thirds of the then outstanding shares of Series B-2 Preferred Stock.  Upon the conversion of the Preferred Stock the holders of common stock will experience additional dilution.

Certain of our officers and directors have sufficient voting power to make corporate governance decisions that could have a significant effect on us and the other stockholders.

Our officers and directors together will control approximately       % of our outstanding common stock on a fully diluted basis after consummation of this offering assuming the issuance of all       shares of common stock offered in this offering. Mr. Wolf alone through his direct and indirect holdings will control approximately       % of our outstanding common stock on a fully diluted basis after consummation of this offering assuming the issuance of all       shares of common stock offered in this offering. As a result, Mr. Wolf, alone will be able to exert a significant degree of influence over our management and affairs and over matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. In addition, this concentration of ownership may delay or prevent a change in our control and might affect the market price of our common stock, even when a change in control may be in the best interest of all stockholders. Furthermore, the interests of this concentration of ownership may not always coincide with our interests or the interests of other stockholders. Accordingly, these stockholders could cause us to enter into transactions or agreements that we would not otherwise consider.

The possible issuance of common stock subject to options and warrants may dilute the interest of stockholders.

In 2009, we adopted a 2009 Stock Option and Restricted Stock Plan under which we may grant awards to purchase 2,000,000 shares of our common stock, of which, 1,435,564 options were outstanding as of May 1, 2013. In addition, as of May 1, 2013, we have 122,262 shares issuable upon exercise of warrants granted to third parties in connection with prior private placements of our equity securities and debt. To the extent that outstanding stock options and warrants are exercised, or additional securities are issued, dilution to the interests of our stockholders may occur. Moreover, the terms upon which we will be able to obtain additional equity capital may be adversely affected since the holders of the outstanding options can be expected to exercise them at a time when we would, in all likelihood, be able to obtain any needed capital on terms more favorable to us than those provided in such outstanding options.

We have additional securities available for issuance, which, if issued, could adversely affect the rights of the holders of our common stock.

Our Third Amended and Restated Certificate of Incorporation authorizes the issuance of 50,000,000 shares of our common stock and 8,212,500 shares of Preferred Stock. The common stock and preferred stock, as well as the awards available for issuance under the 2009 Stock Option and Restricted Stock Plan, can be issued by our board of directors, without stockholder approval. Any future issuances of such stock would further dilute the percentage ownership of us held by holders of Preferred Stock and common stock. The classes of Preferred Stock that are

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currently outstanding, which will convert to common stock upon consummation of this offering, rank ahead of our common stock in terms of dividends, liquidation rights and voting rights and could adversely affect the voting power and the rights of our holders of common stock. In addition, the issuance of Preferred Stock may be used as an “anti-takeover” device without further action on the part of our stockholders, and may adversely affect the holders of the common stock.

We have never paid dividends and have no plans to pay dividends in the future.

Holders of shares of our common stock are entitled to receive such dividends as may be declared by our board of directors. To date, we have paid no cash dividends on our shares of our preferred or common stock and we do not expect to pay cash dividends in the foreseeable future. We intend to retain future earnings, if any, to provide funds for operations of our business. Therefore, any return investors in our preferred or common stock may have will be in the form of appreciation, if any, in the market value of their shares of common stock. See “Dividend Policy.”

Shareholders purchasing shares in this offering will experience immediate and substantial dilution, causing their investment to immediately be worth less than their purchase price.

If you purchase common stock in this offering, you will experience an immediate and substantial dilution in the projected book value of the common stock from the price you pay in this offering.

After consummation of this offering and assuming the consummation of this offering and conversion of all of the outstanding Preferred Stock exclusive of the over-allotment option, you will have an immediate dilution of $       per common share and an immediate increase in net tangible book value to our present shareholders from $       to $       per share will occur.

We are an “emerging growth company,” and any decision on our part to comply with certain reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act enacted in April 2012, and, for as long as we continue to be an emerging growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, not being required to comply with any new requirements adopted by the Public Company Accounting Oversight Board, or the PCAOB, requiring mandatory audit firm rotation or a supplement to the auditor's report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer, not being required to comply with any new audit rules adopted by the PCAOB after April 5, 2012 unless the SEC determines otherwise, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could remain an emerging growth company until the earliest of : (i) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of our first sale of common equity securities pursuant to an effective registration statement; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer. We cannot predict if investors will find our common stock less attractive if we choose to rely on these exemptions. If some investors find our common stock less attractive as a result of any choices to reduce future disclosure, there may be a less active trading market for our common stock and our stock price may be more volatile. Further, as a result of these scaled regulatory requirements, our disclosure may be more limited than that of other public companies and you may not have the same protections afforded to shareholders of such companies.

Under Section 107(b) of the Jumpstart Our Business Startups Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

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As a result of our becoming a public company, we will become subject to additional reporting and corporate governance requirements that will require additional management time, resources and expense.

In connection with this filing, we will become obligated to file with the U.S. Securities and Exchange Commission annual and quarterly information and other reports that are specified in the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act. We will also become subject to other reporting and corporate governance requirements under the Sarbanes-Oxley Act of 2002, as amended, and the rules and regulations promulgated thereunder, all of which will impose significant compliance and reporting obligations upon us and require us to incur additional expense in order to fulfill such obligations.

We have identified material weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future. If our internal control over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud, or file our periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information and may lead to a decline in our stock price.

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a-15(f) under the Exchange Act. We have historically operated as a private company and the number and qualifications of our finance and accounting staff have not been consistent with those of a public company. We have identified material weaknesses in our internal controls with respect to our financial statement closing process of our consolidated financial statements for the years ended December 31, 2012 and 2011. Our management discovered certain conditions that we deemed to be material weaknesses and significant deficiencies in our internal controls, as follows:

·

A lack of accounting and finance resources as well as effective oversight by those in charge of governance resulted in insufficient controls over timely financial statement preparation and review as well as the preparation and review around accounting for certain complex transactions.

·

The design of monitoring controls used to assess the design and operating effectiveness of our internal controls is inadequate. We also do not have an adequate internal process to report deficiencies in internal control to management on a timely basis.

We have begun to take actions that we believe will substantially remediate the material weaknesses identified. In response to the identification of our material weaknesses, we (i) intend to hire additional finance and accounting personnel; (ii) are in the process of establishing a review process for key aspects of our financial reporting process, including the accounting for complex transactions; and (iii) will seek to establish better operating controls and involve our board of directors in our internal controls process, which will involve establishing formal procedures to communicate deficiencies in internal controls on a timely basis, and encourage our board of directors to more actively participate in guiding management as it relates to internal controls matters. However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future. Regardless, following the completion of this offering we will be required to expend time and resources to further improve our internal controls over financial reporting, including by expanding our finance and accounting staff.

Future sales of our common stock by our existing shareholders could cause our stock price to decline.

The Company will have a significant number of restricted shares that will become eligible for sale shortly after this registration statement is declared effective. We currently have 4,282,281 shares of our common stock outstanding, all of which are restricted securities. The shares being registered herein       shares will be eligible for sale immediately upon the effectiveness of this registration statement. All of the remaining shares will be eligible for resale under Rule 144 within ninety days of us being a reporting company under Section 13 or 15 of the Exchange Act; however       shares will be held by affiliates and will be subject to the limitations described under “Shares Eligible For Future Sale.” It is conceivable that following the holding period, many shareholders may wish to sell some or all of their shares. If our shareholders sell substantial amounts of our common stock in the public market at the same time, the market price of our common stock could decrease significantly due to an imbalance in the supply

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and demand of our common stock. Even if they do not actually sell the stock, the perception in the public market that our shareholders might sell significant shares of our common stock could also depress the market price of our common stock.

A decline in the price of shares of our common stock might impede our ability to raise capital through the issuance of additional shares of our common stock or other equity securities, and may cause you to lose part or all of your investment in our shares of common stock.

Our common stock may be thinly traded, so you may be unable to sell at or near ask prices or at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.

Prior to this offering, you could not buy or sell our common stock publicly. We cannot predict the extent to which investors’ interests will lead to an active trading market for our common stock or whether the market price of our common stock will be volatile following this offering. If an active trading market does not develop, investors may have difficulty selling any of our common stock that they buy. There may be limited market activity in our stock and we are likely to be too small to attract the interest of many brokerage firms and analysts. We cannot give you any assurance that a public trading market for our common stock will develop or be sustained. The market price of our common stock could be subject to wide fluctuations in response to quarterly variations in our revenues and operating expenses, announcements of new products or services by us, significant sales of our common stock, including “short” sales, the operating and stock price performance of other companies that investors may deem comparable to us, and news reports relating to trends in our markets or general economic conditions.

The offering price of the shares may not be indicative of the value of our assets or the price at which shares can be resold.

The offering price of the common stock may not be an indication of our actual value. Prior to this offering, there has been no public market for our securities.  The offering price of $     per share was determined based upon negotiations between the underwriters and us.  Factors considered in determining such price in addition to prevailing market conditions include an assessment of our future prospects, an increase in value of our stock due to becoming a public company and prior valuations of certain minority interests prepared for us. Such price does not have any relationship to any established criteria of value, such as book value or earnings per share.  Such price is not indicative of the current market value of our assets.  No assurance can be given that the shares can be resold at the public offering price.

Our need for future financing may result in the issuance of additional securities which will cause investors to experience dilution.  

Our cash requirements may vary from those now planned depending upon numerous factors, including the result of future research and development activities. We believe that the proceeds derived from the sale of the shares in this offering will provide us with sufficient working capital to fund our Phase II clinical trial for Non-Small Cell Lung Cancer and our Phase I clinical trial for bladder cancer.  Thereafter, we expect to require additional funds in the future to conduct additional clinical trials even if the maximum amount is raised in this offering.  There are no other commitments by any person for future financing other than: (i) a loan from Square 1 Bank for an amount up to $3,000,000; however in order to continue to borrow under the loan there are several conditions which must be met and there can be no assurance that we will meet such conditions or be able to borrow the entire $3,000,000 and (ii) a commitment from investors to purchase 433,122 shares of Series B-2 Preferred Stock for additional gross proceeds to us of $2,165,610; however in order to receive such proceeds there are various closing conditions which must first be met. There can be no assurance given that we will meet these closing conditions.  Through May 1, 2013, we have outstanding $725,000 under our loan from Square 1 Bank.  Our securities may be offered to other investors at a price lower than the price per share offered to the investors in the offering, or upon terms which may be deemed more favorable than offered hereunder.  In addition, the issuance of securities in this offering as well as any future financing using our securities may dilute an investor's equity ownership.  Moreover, we may issue derivative securities, including options and/or warrants, from time to time, to procure qualified personnel or for other business reasons.  The issuance of any such derivative securities, which is at the discretion of our board of directors, may further dilute the equity ownership of our stockholders, including the investors in this offering.  No assurance can be given as to our ability to procure additional financing, if required, and on terms deemed favorable to us.  To the

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extent additional capital is required and cannot be raised successfully, we may then have to limit our then current operations and/or may have to curtail certain, if not all, of our business objectives and plans.

We have adopted certain measures that may have anti-takeover effects which may make an acquisition of our Company by another company more difficult.

We have adopted, and may in the future adopt, certain measures that may have the effect of delaying, deferring or preventing a takeover or other change in control of our Company that a holder of our common stock might not consider in its best interest. Our certificate of incorporation and bylaws contain provisions which may have anti-takeover effects. These include: (a)  requiring that certain shareholder groups elect a certain number of directors until we consummate a firm commitment underwritten public offering with net proceeds of at least $15,000,000; (b) requiring that for so long as any shares of Preferred Stock remain outstanding and until we consummate a firm commitment underwritten public offering with net proceeds to us of at least $15,000,000 a majority of each of the Series B Preferred shareholders, Series A Preferred shareholders, the Series 1 Preferred shareholders and the common shareholders approve certain actions including (i) amendments to our bylaws or certificate of incorporation; (ii) creation of additional classes of stock or increases in the authorized shares of an existing class of stock unless they rank junior to the Series A Preferred Stock with respect to the distribution of assets on liquidation and the payment of dividends, reclassification stock or redemption of stock; (iii) action to reclassify, alter or amend existing securities that are junior to or pari passu with the Series A Preferred if such action would render such security senior to or pari passu with the Series A Preferred Stock in respect of the distribution of assets upon liquidation or payment of a dividend other than with respect to a firm commitment underwritten public offering with net  proceeds to us of at least $15,000,000; (iv) purchase or redeem or otherwise declare or pay a dividend, action to liquidate or sell all or substantially all of our assets; (c) requiring that for so long as a majority of the originally issued shares of Series B Preferred Stock remain outstanding and until we receive $20,000,000 through financing, grant or a licensing or joint venture agreement or until we consummate of  a firm commitment underwritten public offering with net proceeds to us of at least $15,000,000 a majority of Series B Preferred shareholders approve certain actions including (i) operation of any business other than our business as currently carried out; (ii) making of a loan to any entity or subsidiary other than an 80% owned subsidiary, (iii) disposition or acquisition of an interest in a business; (iv) entering into a joint venture or making an investment in excess of $5,000,000; (v) making or committing to make an expenditure of $5,000,000 or more; (vi) making a loan of in excess of $5,000; (vii) issuing debt in excess of $5,000,000 other than under existing agreements; and (viii) an annual budget, and (d) providing that directors may be removed only for "cause." These measures and those described above may have the effect of delaying, deferring or preventing a takeover or other change in control of the Company that a holder of our common stock might consider in its best interest.

In addition, we are subject to the provisions of Section 203 of the General Corporation Law of the State of Delaware, which prohibits a Delaware corporation from engaging in any business combination, including mergers and asset sales, with an interested stockholder (generally, a 15% or greater stockholder) for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. The operation of Section 203 may have anti-takeover effects, which could delay, defer or prevent a takeover attempt that a holder of our common stock might consider in its best interest.

Our management will have broad discretion over the use of the proceeds we receive in this offering, and may not apply the proceeds in ways that increase the value of your investment.

If the underwriters exercise their option to purchase additional shares in this offering in full, we estimate that net proceeds of the sale of the common stock that we are offering will be approximately $       million. Our management will have broad discretion to use the net proceeds from this offering, and you will be relying on the judgment of our management regarding the application of these proceeds. Although we intend to use a portion of the net proceeds from this offering for research, development and commercialization of our products  and payment of outstanding indebtedness, because of the number and variability of factors that will determine our use of the net proceeds from this offering, we cannot specify with certainty the particular use of the net proceeds that we will receive from this offering, and we cannot assure you that we will use the proceeds in a manner that will increase the value of your investment or of which you would approve. Moreover, you will not have the opportunity to influence our decision on how to use the proceeds from this offering. We may use the proceeds for corporate purposes that do not immediately enhance our prospects for the future or increase the value of your investment. See the Section entitled “Use of Proceeds.”

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements, including statements regarding the progress and timing of our product development, the goals of our development activities, estimates of the potential markets for our product candidates, estimates of the capacity of manufacturing and other facilities to support our products, our expected future revenues, operations and expenditures and projected cash needs. The forward-looking statements are contained principally in the sections entitled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” These statements relate to future events of our financial performance and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. Those risks and uncertainties include, among others:

·

our ability to implement our business plan;

·

our ability to raise additional capital to meet our liquidity needs;

·

our ability to generate product revenues;

·

our ability to achieve profitability;

·

our ability to comply with our loan covenants;

·

our ability to satisfy U.S. (including FDA) and international regulatory requirements;

·

our ability to obtain market acceptance of our technology and products;

·

our ability to compete in the market;

·

our ability to advance our clinical trials;

·

our ability to fund, design and implement clinical trials;

·

our ability to maintain our present customer base and retain new customers;

·

our ability to demonstrate that our product candidates are safe for human use and effective for indicated uses;

·

our ability to gain acceptance of physicians and patients for use of our products;

·

our dependency on third-party researchers and manufacturers and licensors;

·

our ability to establish and maintain strategic partnerships, including for the distribution of products;

·

our ability to attract and retain a sufficient qualified personnel;

·

our ability our ability to obtain or maintain patents or other appropriate protection for the intellectual property;

·

our dependency on the intellectual property licensed to us or possessed by third parties;

·

our ability to adequately support future growth; and

·

potential product liability or intellectual property infringement claims.

Forward-looking statements include all statements that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” or the negative of those terms, and similar expressions and comparable terminology intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this prospectus and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this prospectus. You should read this prospectus and the documents referenced in this prospectus and filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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USE OF PROCEEDS

We estimate that we will receive net proceeds of approximately $       million from the sale of shares of common stock offered in this offering, or approximately $       million if the underwriters exercise their over-allotment option in full, based on an assumed initial public offering price of $       per share (the midpoint of the price range set forth on the cover page of this prospectus) and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $       per share (the midpoint of the price range set forth on the cover page of this prospectus) would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $       , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same. We may also increase or decrease the number of shares we are offering. An increase (decrease) of       in the number of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $        million, assuming the initial public offering price per share stays the same. An increase of       in the number of shares we are offering, together with a $1.00 increase in the assumed initial public offering price per share, would increase the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $       million. A decrease of       in the number of shares we are offering, together with a $1.00 decrease in the assumed initial public offering price per share, would decrease the net proceeds to us from this offering, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, by approximately $       million. We do not expect that a change in the offering price per share or the number of shares by these amounts would have a material effect on our intended uses of the net proceeds from this offering, although it may impact the amount of time prior to which we may need to seek additional capital.

We intend to use the net proceeds from this offering as follows:

·

approximately $8,350,000 to complete our Phase II clinical trials for HS-110 against non-small lung cancer and the submission of related materials to the FDA or an equivalent amount as grant matching funds to fund an expanded clinical trial;

·

approximately $1,000,000 for initiation and completion of Phase I clinical trials of HS-410 against bladder cancer;

·

approximately $100,000 to enhance the scope  of and pay regulatory fees for our HS-110 lung cancer investigator-sponsored trial to test the use of HS-110 as a combination therapy against lung cancer; 

·

approximately $1,500,000  to fund one to two additional Phase 1 clinical trials on additional cancer indications;

·

$300,000 to repay the portion of the loan from Square 1 Bank that is due and payable in the next eighteen months; and

·

the remaining net proceeds will be used for general corporate purposes, including ongoing operations, vendor payables and expansion of the business, further research and development, potential regulatory submissions and hiring additional sales and marketing personnel to support increased sales and marketing activities.

·

HS-110 non-small cell lung cancer trial.  We plan to initiate a 125 patient Phase II trial on patients with advanced non-small cell lung cancer.  Our Phase II study has been designed as a maintenance therapy study in patients with Stage III/IV NSCLC who have completed a 1^st line regimen consisting of a platinum doublet, crizotinib or erlotinib and achieved at least stable disease.  We plan to use up to approximately $8.35 million from the net proceeds of this offering to finance this trial.  We have applied for grant funding to enable us to expand the size and scope of this clinical trial and if the grant funding is received, will use up the $8.35 million of the net proceeds from this offering as

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“matching funds” as required by the granting organization to expand the size and scope of our trial. There can be no assurance that the grant funding will be received.  If sufficient grant funding is not received by the commencement of the trial to fund the trial, we will use the net proceeds of this offering to provide the needed funding.

·

HS-410 bladder cancer trial.  We plan to file an IND for use of HS-410 to prevent the recurrence of bladder cancer.  This initial IND will include a 93 patient, Phase I/II trial to examine safety, tolerability, immune response and preliminary clinical activity of HS-410 in patients with high risk, superficial bladder cancer who have completed surgical resection and 6 weekly intravesical bacillus Calmet-Guerin (BCG) immunotherapy installations.  We plan to use approximately $1 million from the net proceeds of this offering to enhance the scope of this trial as currently designed and funded.

·

HS-110 non-small cell lung cancer combination trial.   Our HS-110 lung cancer trial is an investigator-sponsored trial to test the use of HS-110 as a combination therapy against lung cancer.  While the trial is fully-funded by the Marcus Foundation, we plan to use approximately $100,000 to enhance to scope of this trial and prepare appropriate regulatory filings.

·

Additional clinical trials.  We are creating and have created ImPACT-based drugs against additional cancers and plan to use approximately $1.5 million from the net proceeds of this offering to fund one to two additional Phase 1 clinical trials on additional cancer indications.

·

Repayment of debt.  We plan to use approximately $300,000 of the net proceeds of this offering to repay the portion of the loans from Square 1 Bank that is due and payable in the next eighteen months.  One loan from Square 1 Bank is payable on September 7, 2013 in 36 monthly installments of principal and interest.  The other loan is payable on August 7, 2013 and August 7, 2014 for 5% of the outstanding principal and accrued interest each and then the remaining principal and accrued interest is due December 14, 2014. Both loans accrue interest monthly at an interest rate of 3% plus prime or 6% per annum whichever is greater. Finally, the last loan is payable as interest only until January 9, 2014 when the entire principal balance is due and it accrues interest monthly at an interest rate of 4.25% per annum.  As of May 1, 2013, we had outstanding $725,000 under the Square 1 Bank loans.

·

The remaining net proceeds will be used for general corporate purposes, including ongoing operations, vendor payables and expansion of the business, further research and development, potential regulatory submissions and hiring additional sales and marketing personnel to support increased sales and marketing activities.

The expected use of the net proceeds from this offering represents our current intentions based on our present plans and business conditions. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to be received from this offering. The amounts and timing of our actual expenditures will depend on numerous factors including the progress in, and costs of, our clinical trials and other preclinical development programs and the amount of funding, if any, received from grants. Accordingly, our management will have broad discretion in the application of the net proceeds, and investors will be relying on the judgment of management regarding the application of the net proceeds from the offering. We may find it necessary or advisable to reallocate the net proceeds of this offering; however any such reallocation would be substantially limited to the categories set forth above to use the net proceeds for other purposes. Pending such uses set forth above, we plan to invest the net proceeds in government securities and other short-term investment grade, marketable securities.  

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DIVIDEND POLICY

We have never declared or paid any cash dividends on our capital stock and we do not currently intend to pay any cash dividends on our common stock in the foreseeable future.  We expect to retain all available funds and future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends, if any, on our common stock will be at the discretion of our board of directors and will depend on, among other factors, our results of operations, financial condition, capital requirements and contractual restrictions.

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CAPITALIZATION

The following table sets forth our capitalization as of December 31, 2012:

·

on an actual basis;

·

on a pro forma basis as of December 31, 2012, to reflect the automatic conversion upon the closing of this offering of all outstanding shares of Preferred Stock into 1,978,036 shares of common stock; and

·

on a pro forma as-adjusted basis to give effect to the sale of       shares of the common stock we are offering at an assumed initial public offering price of $       per share, which is the midpoint of the estimated price range shown on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as-adjusted column assumes no exercise by the underwriters of their over-allotment option.

The information below is illustrative only and our capitalization following the completion of this offering will be adjusted based on the actual initial public price. You should read this table together with the sections entitled “Use of Proceeds” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as well as our financial statements and the related notes, which appear elsewhere in this prospectus.

———————

(1)

A $1.00 increase (decrease) in the assumed initial public offering price of $  per share of our common stock, the midpoint of the estimated price range set forth on the cover page of this prospectus, in this offering would

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increase (decrease) each of cash, total stockholders’ deficit and total capitalization by $       million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The number of shares of common stock to be outstanding after the offering is based on the number of shares outstanding as of December 31, 2012, and excludes:

·

1,357,064 shares of our common stock issuable upon the exercise of stock options as of May  1, 2013, with a weighted average exercise price of $0.32 per share;

·

122,262 additional shares of our common stock issuable upon the exercise of outstanding warrants as of May 1, 2013, at a weighted average exercise price of $0.94 per share;

·

60,655 additional shares of our common stock reserved for future issuance under our equity incentive plans as of May 1, 2013, of which; and

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per share of our common stock in this offering and our pro forma as adjusted net tangible book value per share immediately after this offering. We calculate net tangible book value per share by dividing our net tangible book value, which is tangible assets less total liabilities less debt discounts related to debt to be paid or converted as a result of this offering, by the number of outstanding shares of our common stock. Prior to considering the effects of the proceeds of this offering, but giving effect to the automatic conversion of our outstanding shares of Series A, Series 1 and Series B Preferred Stock into 3,869,455 shares of our common stock upon completion of this offering and the conversion of promissory notes and accrued interest in the amount of $       million, at a conversion price of $       per share, which is the midpoint of the range set forth on the cover page of this prospectus, into an aggregate of       shares of our common stock, our pro forma net tangible book value (deficit) as of December 31, 2012 was approximately $(    ) million, or approximately $(    ) per share. Upon completion of this offering, our pro forma net tangible book value as of December 31, 2012 will be approximately $(    ) million or approximately $(    ) per share. This represents an immediate increase in pro forma net tangible book value of $       per share to our existing stockholders and an immediate dilution of $       per share to new investors purchasing our common stock in this offering. The following table illustrates the per share dilution:

Each $1.00 increase in the assumed initial public offering price of $       per share, the midpoint of the range set forth on the cover page of this prospectus, would increase our pro forma net tangible book value by approximately $        million, the pro forma net tangible book value per share by approximately $       per share and the dilution to investors purchasing shares of our common stock in this offering by approximately $       per share, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 decrease in the assumed initial public offering price of $       per share, the midpoint of the range set forth on the cover page of this prospectus, would decrease our pro forma net tangible book value by approximately $       million, the pro forma net tangible book value per share by approximately $       per share and the dilution to investors purchasing shares of our common stock in this offering by approximately $       per share, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

The information above assumes that the underwriters do not exercise their over-allotment option. If the underwriters exercise their over-allotment option in full, the pro forma as adjusted net tangible book value will increase to $(    ) per share, representing an immediate increase to existing stockholders of $       per share and an immediate dilution of $       per share to new investors. If any shares are issued upon exercise of outstanding options or warrants, new investors will experience further dilution.

The following table summarizes, on a pro forma as adjusted basis as of December 31, 2012, the differences between the number of shares of common stock purchased from us, the total consideration and the average price per share paid by existing stockholders and by investors participating in this offering, after deducting estimated underwriting discounts and commissions and estimated offering expenses, at an assumed initial public offering price of $       per share, the midpoint of the estimated price range shown on the cover page of this prospectus.

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The number of shares purchased from us by existing stockholders is based on       shares of our common stock outstanding as of December 31, 2012 after giving effect to the conversion of promissory notes and accrued interest in the amount of $       million, at a conversion price of $       per share, which is the midpoint of the range set forth on the cover page of this prospectus, and to the automatic conversion of all of our outstanding shares of Series A Preferred Stock, Series 1 Preferred Stock  and Series B Preferred Stock into common stock upon the completion of this offering. This number excludes:

·

1,435,564 shares of our common stock issuable upon the exercise of stock options as of May 1, 2013, with a weighted average exercise price of $0.35 per share

·

122,262 additional shares of our common stock issuable upon the exercise of outstanding warrants as of May 1, 2013, at a weighted average exercise price of $0.94 per share;

·

 282,155 additional shares of our common stock reserved for future issuance under our equity incentive plans as of May 1, 2013, of which; and

If the underwriters exercise their option to purchase additional shares from us in full, the number of shares held by new investors will increase to       , or       % of the total number of shares of common stock outstanding after this offering and the shares held by existing stockholders will be       , but the percentage of shares held by existing stockholders will decrease to       % of the total shares outstanding.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis should be read in conjunction with our audited annual consolidated financial statements and the related notes that appear elsewhere in this prospectus. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. Actual results may differ materially from those discussed in these forward-looking statements due to a number of factors, including those set forth in the section entitled “Risk Factors”, “Special Note Regarding Forward-Looking Statements” and elsewhere in this prospectus.

Overview 

We are a clinical-stage biopharmaceutical company engaged in the development of novel allogeneic, “off-the-shelf” cellular therapeutic vaccines to combat a wide range of cancers and infectious diseases. Our proprietary ImPACT™ cancer therapy delivers live, genetically-modified, irradiated human cells which are “reprogrammed” to “pump out” a broad spectrum of cancer associated antigens together with a potent immune adjuvant called “gp96” to educate and activate a cancer patient’s immune system to recognize and kill cancerous cells. The secreted antigen-adjuvant complexes are designed to generate an anti-cancer immune response in patients by mobilizing and activating killer T cells that target multiple cancer antigens, thus harnessing a patient’s own immune system to fight cancer.  In a phase I clinical trial in non-small cell lung cancer patients (NSCLC), in which 18 patients were vaccinated and 15 patients remained at the end of the trial and were evaluated, we believe our “off-the-shelf” therapeutic vaccine candidate HS-110 generated anti-cancer immune responses in 11 patients (including the mobilization and activation of killer T cells against multiple cancer antigens), was generally well tolerated and demonstrated preliminary indications of clinical efficacy.

As an “off-the-shelf” therapeutic vaccine, ImPACT uses a common master cell line to mass-produce a single vaccine product applicable to all patients for each particular cancer type, and thus, we believe, providing a traditional biopharmaceutical approach to deliver pan-antigen immunotherapy with logistical, manufacturing and cost of goods benefits compared to autologous patient-specific approaches.

We are in the process of initiating a Phase II clinical trial in non-small cell lung cancer (NSCLC) with our therapeutic vaccine candidate HS-110, which is derived from a genetically-modified human lung cancer cell line. The results of our recently completed Phase I clinical trial in lung cancer patients demonstrated that HS-110 was generally well tolerated with minimal indications of treatment-related toxicity with positive correlations between levels of observed immune responses and therapeutic efficacy. Specifically, the trial demonstrated a response rate in 11 of 15 patients and a median survival of 16.5 months for immune responders, versus a median survival of 4.5 months for immune non-responders. These findings were consistent with those of our multiple pre-clinical published studies.

We have also developed ImPACT therapeutic vaccines for bladder cancer, breast cancer and ovarian cancer. We plan to initiate a Phase I/II clinical trial for bladder cancer in mid 2013 with HS-410, a genetically-modified bladder cancer cell line. To date, in excess of $14,000,000 of funding has been awarded to the primary inventor of the technology that we license by the National Institutes of Health (NIH) and through other research and clinical grant in order to fund development of the technology that we license. We have little control over the direction of the NIH grant funds that have been received by the primary inventor of the technology we license and since payment is made to the inventor as opposed to us we do not recognize any revenue from such grant funds nor do they fund any expenses that we incur. Although earmarked for further development of the technology that we license, any funds awarded to the primary inventor are used in his discretion and we have little control over his use of the funds.

The actual amount of funds we will need to complete our 93-patient, Phase I/II trial of HS-410 is estimated to be $3.5 million of which $1,000,000 will be derived from the net proceeds of this offering and is subject to many factors, some of which are beyond our control. These factors include, but are not limited to, the following:

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the progress and cost of our research and development activities;

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the number and scope of our research and development programs;

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the progress and cost of our preclinical and clinical development activities;

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·

our ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements;

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our ability to achieve our milestones under licensing arrangements;

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the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

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the costs and timing of regulatory approvals.

Recent Developments

In March 2013, we closed the first tranche of our Series B Preferred Stock private placement offering in which we sold an aggregate of 1,891,419 shares of our Series B-1 Preferred Stock for gross proceeds of $5,050,090.  The investors in the offering committed to purchase and we agreed to sell an additional 433,122 shares of our Series B-2 Preferred Stock at a second tranche closing to be held after fulfillment of certain conditions including receipt of $16,750,000 in grant funding.  In addition, at the second tranche closing, each investor will receive a warrant exercisable for two shares of Series B-1 Preferred Stock for each share of Series B-2 Preferred Stock purchased by such investor at the second tranche closing.  All shares of Series B Preferred Stock automatically convert into shares of our common stock upon the consummation of a firm commitment underwritten public offering resulting in aggregate net cash proceeds to us of at least $15,000,000.

Critical Accounting Policies

Revenue Recognition

We recognize government grants when there is reasonable assurance that they will comply with the conditions attached to the grants and that the grants will be received.  The grants are recognized using an income approach and grant revenue is recognized as the related expenses are incurred.

Stock Based Compensation

We account for stock-based compensation arrangements with employees and non-employee directors using a fair value method which requires the recognition of compensation expense for costs related to all stock-based payments, including stock options. The fair value method requires us to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. Stock-based compensation costs are based on the fair value of the underlying option calculated using the Black Scholes option-pricing model on the date of grant for stock options and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. Determining the appropriate fair value model and related assumptions requires judgment, including estimating stock price volatility, forfeiture rates and expected term. The expected volatility rates are estimated based on the actual volatility of comparable public companies over the expected term. The expected term for the years ended December 31, 2012 and 2011 represents the average time that options are expected to be outstanding based on the mid-point between the vesting date and the end of the contractual term of the award. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. We have not paid dividends and do not anticipate paying a cash dividend in the foreseeable future and, accordingly, uses an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards. The measurement of nonemployee share-based compensation is subject to periodic adjustments as the underlying equity instruments vest and is recognized as an expense over the period over which services are received.

The fair value of the common stock underlying our stock options was determined at each grant date by our board of directors and supported by periodic independent third-party valuations. Our board of directors intended all options to be exercisable at a price per share not less than the per share price fair value of our common stock underlying those options on the date of grant. The valuations of our common stock were determined in accordance with the guidelines outlined in the American Institute of Certified Public Accountants Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation. For grants of stock awards made on dates for which there was no valuation performed by a valuation specialist, our board of directors determined the fair value of our common stock on the date of grant based upon the immediately preceding valuation and other pertinent information (such as significant changes in our activities) available at the time of grant.

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We have granted stock options during the period from January 1, 2011 through May 1, 2013 as summarized below:

Three valuations were performed by independent valuation specialists on March 31, 2011, March 31, 2012, and December 31, 2012.

To determine the fair value of the common stock, we considered three enterprise value allocation methods consistent with the American Institute of Certified Public Accountants Practice Aid, “Valuation of Privately-Held Company Equity Securities Issued as Compensation.” These methods are: (i) current-value method; (ii) the option pricing method; and (iii) the probability-weighted expected return method. Under the option pricing method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preference at the time of a liquidity event. The option-pricing method uses the Black-Scholes option model to price the call options. After considering several factors and circumstances, we utilized the option pricing backsolve method. The option pricing backsolve method treats common stock and Preferred Stock as call options on the enterprise/equity value, with exercise prices based on the liquidation preference of the Preferred Stock.

In order to estimate the fair value of the equity as of March 31, 2011, we did an option pricing backsolve method based on the recently issued convertible note. In May 2010 and September 2010, we completed the issuance of convertible promissory notes with an unrelated party which was considered to be at “arms-length.” We estimated the implied equity value to be approximately $3.4 million as of March 31, 2011. After consideration of specific facts and circumstances, the board of directors and management assumed a 3.5 years to a liquidity event. The anticipated timing and probability of a liquidity event was based on then-current plans and estimates of our board of directors and management regarding a liquidity event. Furthermore, volatility was estimated based on 3.5-year historical volatility of peer companies.  To derive the value of the common stock, the proceeds to the common stockholders were calculated based on the preferences and priorities of the preferred and common stock, including the participation features of certain series of the preferred shares. A discount in the amount of 40% for lack of marketability was applied to reflect the risk arising from the inability to readily sell the shares. The discount for lack of marketability was based on our size, pre-profit stage, attraction to outside investors, and expectation of liquidity. After applying the 40% discount for lack marketability, we concluded the fair value of our common stock on a minority, non-marketable basis to be $0.28 per share.

To determine the fair value of our common stock as of March 31, 2012, we considered two scenarios based on the specific facts and our circumstances as of March 31, 2012. As of March 31, 2012, we had specific needs of cash in order to continue operations. As such, we were planning a series B round of financing. Based on the specific facts and circumstances, the first scenario assumes we will raise the Series B round of financing (“Going Concern”) and the second scenario assumes the Company will liquidate in the next three months (“Liquidation Scenario”).

Under the first scenario, the fair value of the common stock was determined by applying the option pricing backsolve method. A 5-year to liquidity was assumed by management and the board of directors based on the anticipated timing and probability of a liquidity event. Volatility was assumed based on historical volatility of peer companies. In order to estimate the implied equity value, we assumed terms and conditions based on the Series B

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round of financing. An option pricing backsolve method was applied to determine the value of the equity based on the anticipated Series B round of financing, which was expected to occur during the latter half of 2012 with an unrelated investor. Under the second scenario, the fair value of the common stock was determined by applying the current method given the immediate liquidity event. Our management and our board of directors (the “Board”) assumed that we will liquidate in the next three months. Given the facts and circumstances, we assumed that there would be no proceeds available for distribution to the common stockholders, indicating the fair value of the common stock to be zero. After considering both scenarios, a weighted average of the current value approach and the OPM was calculated to estimate the fair value of the common stock as of March 31, 2012.  A discount in the amount of 40% for lack of marketability was applied to reflect the risk arising from the inability to readily sell the shares. The discount for lack of marketability was based on our size, pre-profit stage, attraction to outside investors, and expectation of liquidity. After applying the 40% discount for lack marketability present in the common stock, we concluded the fair value of our common stock on a minority, non-marketable basis to be $0.33 per share.

To determine the fair value of the common stock as of December 31, 2012, the Company utilized the probability-weighted return method (“PWERM”) to allocate the total equity value to the various securities, including Preferred Stock warrants.  The PWERM model reflected our continued development, including the anticipation of the closing of Series B-1 convertible Preferred Stock financing.  The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of four future scenarios:  an immediate IPO, a delayed IPO, a sale or merger, or liquidation. The equity is allocated pro rata among the total common shares on as-converted basis.  The value per share under each scenario was then probability weighted and the resulting weighted values were summed to determine the fair value per share for each class. Our calculated discounts for the lack of marketability through the use of the Black-Scholes-Option Pricing Model, and applied an implied discount for marketability of 20.5% for the immediate IPO scenario, 29% for the delayed IPO scenario, and 61.7% for the sale or merger scenario.  The expected outcomes were weighted based on a probability of forty percent (40%) for the liquidation scenario, with a lower probability for an IPO scenario of twenty-five percent (25%) and a probability of thirty-five percent (35%) for the sale or merger scenario.  The fair values of the equity determined using the IPO and non-IPO scenarios were weighted according to our estimate of the probability of each scenario.  Based on the PWERM model, the Board of Directors determined the fair value of our common stock at November 8, 2012 to be $0.97.

On April 7, 2011, we granted stock options to purchase a total of 29,000 and 250,000 shares at an exercise price of $0.28 and $0.31, respectively. We determined that the fair value of the common stock on the date of grant was $0.28 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of March 31, 2011 that indicated a valuation price of $0.28 per share; and

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that there were no material changes in factors impacting the common stock per share value from March 31, 2011 to April 7, 2011.

On April 12, 2011, we granted stock options to purchase a total of 326,250 shares at an exercise price of $0.28. We determined that the fair value of the common stock on the date of grant was $0.28 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of March 31, 2011 that indicated a valuation price of $0.28 per share; and

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that there were no material changes in factors impacting the common stock per share value from March 31, 2011 to April 12, 2011.

On October 25, 2011, we granted stock options to purchase a total of 113,000 shares at an exercise price of $0.28. We determined that the fair value of the common stock on the date of grant was $0.28 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of March 31, 2011 that indicated a valuation price of $0.28 per share; and

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·

that there were no material changes in factors impacting the common stock per share value from March 31, 2011 to October 25, 2011.

On November 22, 2011, we granted stock options to purchase a total of 50,000 shares at an exercise price of $0.28. We determined that the fair value of the common stock on the date of grant was $0.28 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of March 31, 2011 that indicated a valuation price of $0.28 per share; and

·

that there were no material changes in factors impacting the common stock per share value from March 31, 2011 to November 22, 2011.

On April 25, 2012, we granted stock options to purchase a total of 230,595 shares at an exercise price of $0.33. We determined that the fair value of the common stock on the date of grant was $0.33 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of March 31, 2012 that indicated a valuation price of $0.33 per share; and

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that there were no material changes in factors impacting the common stock per share value from March 31, 2012 to April 25, 2012.

On May 30, 2012, we granted stock options to purchase a total of 3,000 shares at an exercise price of $0.33. We determined that the fair value of the common stock on the date of grant was $0.33 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of March 31, 2012 that indicated a valuation price of $0.33 per share; and

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that there were no material changes in factors impacting the common stock per share value from March 31, 2012 to May 30, 2012.

On November 8, 2012, we granted stock options to purchase a total of 177,500 shares at an exercise price of $0.33. We determined that the fair value of the common stock on the date of grant was $0.97 per share. To assess the reasonableness of our fair value on this date, we considered:

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the independent valuation report of December 31, 2012 that indicated a valuation price of $0.97 per share.

·

that there were no material changes in factors impacting the common stock per share value from November 8, 2012 to December 31, 2012.

On April 29, 2013, we granted stock options to purchase a total of 78,500 shares at an exercise price of $0.97. We determined that the fair value of the common stock on the date of grant was $0.97 per share. To assess the reasonableness of our fair value on this date, we considered:

·

the independent valuation report of December 31, 2012 that indicated a valuation price of $0.97 per share; and

·

that there were no material changes in factors impacting the common stock per share value from December 31, 2012 to April 29, 2013.

Preferred Stock Warrant Liability

We account for our freestanding warrants to purchase our Series A Preferred Stock as liabilities at fair value on the accompanying consolidated balance sheets. The warrants may only be settled in shares of Series A Preferred Stock. The warrants are subject to re-measurement at each balance sheet date, and the change in fair value, if any, is recognized as other income (expense). We will continue to adjust the liability for changes in fair value until the earlier of (i) exercise of the warrants; (ii) conversion of the warrants into warrants to purchase common stock upon

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an event such as the completion of an initial public offering; or (iii) expiration of the warrants. Upon conversion, the Preferred Stock warranty liability will be reclassified into additional paid-in capital. We used a Monte Carlo simulation in evaluating the fair value of the warrants, taking into consideration the down-round protection feature included within the warrant agreement.

Significant assumptions used in the valuation of the warrants were as follows:

Material Weaknesses in our Internal Control.

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a-15(f) under the Exchange Act.

We have historically operated as a private company and the number and qualifications of our finance and accounting staff have not been consistent with those of a public company. We have identified material weaknesses in our internal controls with respect to our financial statement closing process of our consolidated financial statements for the years ended December 31, 2012 and 2011. Our management discovered certain conditions that we deemed to be material weaknesses in our internal controls, as follows:

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A lack of accounting and finance resources as well as effective oversight by those in charge of governance resulted in insufficient controls over timely financial statement preparation and review as well as the preparation and review around accounting for certain complex transactions.

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The design of monitoring controls used to assess the design and operating effectiveness of our internal controls is inadequate. We also do not have an adequate internal process to report deficiencies in internal control to management on a timely basis.

We have begun to take actions that we believe will substantially remediate the material weaknesses identified. In response to the identification of our material weaknesses, we (i) intend to hire additional finance and accounting personnel; (ii) are in the process of establishing a review process for key aspects of our financial reporting process, including the accounting for complex transactions; and (iii) will seek to establish better operating controls and involve our board of directors in our internal controls process, which will involve establishing formal procedures to communicate deficiencies in internal controls on a timely basis, and encourage our board of directors to more actively participate in guiding management as it relates to internal controls matters. However, we cannot assure you that our internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future. Regardless, following the completion of this offering we will be required to expend time and resources to further improve our internal controls over financial reporting, including by expanding our finance and accounting staff.

Results of Operations

For Years Ended December 31, 2012 and 2011

Revenues 

Total revenue for the twelve months ended December 31, 2012, decreased approximately 98% to $3,110 as compared to $187,787 for the twelve months ended December 31, 2011. For both periods our revenue was entirely comprised of grant awards. In October 2010, we were awarded a grant from the Internal Revenue Service of $244,479 for the reimbursement of qualified investments in a therapeutic discovery project under section 48 of the

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Internal Revenue Service Code.  The grant proceeds were paid in two installments of which $162,435 was paid in 2011 and was included in revenue for the twelve months ended December 31, 2011.  We plan to continue our efforts to secure future grant funding to subsidize our ongoing research and developments costs.

Operating Expenses

Operating expenses are primarily comprised of research and development expenses and general and administrative expenses.  For the twelve months ended December 31, 2012, research and development expenses represented approximately 38% of operating expenses, clinical trials and regulatory represented approximately 11% of operating expenses, and general and administrative expenses represented approximately 51% of operating expenses. For the twelve months ended December 31, 2011, research and development expenses represented approximately 56% of operating expenses, clinical trials and research represented approximately 11% of operating expenses, and general and administrative expenses represented approximately 33% of operating expenses. For the twelve months ended December 31, 2012, total operating expenses increased 5.5% to $2,345,787 from $2,222,587 for the twelve months ended December 31, 2011. Research and development expenses decreased approximately 28% to $902,938 for the twelve months ended December 31, 2012 from $1,246,587 for the twelve months ended December 31, 2011. This decline was due to expenses of approximately $162,000 for a large research project and approximately $146,000 for past patent expenses to the University of Miami which were incurred during 2011.  For the twelve months ended December 31, 2012, approximately $330,699 and $94,397 of the research and development expenses were attributable solely to research related to our lung cancer and ovarian cancer projects, respectively, and the balance of such expenses were not attributable solely to any one project but were attributable to research relevant to all of our projects. Also, research and development manufacturing costs decreased by approximately $101,000 as manufacturing was being phased into the clinical and regulatory phase.  Clinical trials and regulatory expenses decreased approximately .08% to $253,189 for the twelve months ended December 31, 2012, from $255,210 for the twelve months ended December 31, 2011, which is consistent between the two periods.  General and administrative expenses increased approximately 65% to $1,189,660 for the twelve months ended December 31, 2012, from $720,790 for the twelve months ended December 31, 2011, primarily as a result of our decision to retain a full-time CEO in the second quarter of 2011 which resulted in additional expense of $200,450. Additionally, we incurred additional expenses of $72,723 for a contracted and full-time accounting staff. Finally, during the twelve months ended December 31, 2012 we incurred additional insurance expenses of $13,348 associated with enhanced risk management such as Directors and Officers Insurance and additional liability coverage, additional rent expense and administrative expenses of $31,641 due primarily to the execution of a new lease, additional stock compensation expense of approximately $138,350, additional financing costs of approximately $38,000,  and additional audit fees of approximately $24,000.  The additional unspecified increase in the general and administrative expense was attributable to our expansion.

Non-Operating Expenses 

Non-Operating Expenses was primarily comprised of interest expense from our convertible notes and the 2012 write off of the debt discount associated with debt paid off during the period which increased to $101,086 for the year ended December 31, 2012 from $63,173 for the year ended December 31, 2011.

Net Loss

Our net loss after deducting the non-controlling interest increased 15% to $2,420,200 for the year ended December 31, 2012 from $2,104,884 for the year ended December 31, 2011.  Although research and development costs declined by 28% due to decreased patent expenditures, the maturation of the company required additional staffing.  A Vice President of Clinical and Regulatory was hired to manage our clinical trials as well as a full time Director of Finance.  Additionally, the salary of the CEO was increased as stipulated in his employment agreement.

Liquidity and Capital Resources

We have financed our operations since inception primarily through proceeds from equity financings and debt financings, primarily involving private sales of our common stock and other debt and equity securities, and to a lesser extent from the proceeds from grant awards and commitments from banks and vendors.

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In March 2013, we closed the first tranche of our Series B Preferred Stock private placement offering in which we sold an aggregate of 1,891,419 shares of our Series B-1 Preferred Stock for gross proceeds of $5,050,090.  The investors in the offering committed to purchase and we agreed to sell an additional 433,122 shares of our Series B-2 Preferred Stock at a second tranche closing to be held after fulfillment of certain conditions including receipt of $16,750,000 in grant funding.  In addition, at the second tranche closing, each investor will receive a warrant exercisable for two shares of Series B-1 Preferred Stock for each share of Series B-2 Preferred Stock purchased by them at the second tranche closing.  

Our cash and cash equivalents totaled $5,030 as of December 31, 2012, a decrease of $93,616 from December 31, 2011.  During the year ended December 31, 2012, the primary sources of cash were issuances of stock and the draw downs on Square 1’s promissory notes. In 2012, $725,000 was drawn on the Square 1 promissory notes and the outstanding principal balance at December 31, 2012 was $725,000. As of May 1, 2013, the Company has outstanding $725,000 on the promissory notes, with $2,275,000 available for future use. The Tranche A Loan principal balance is $500,000, the interest rate is currently at 6%, and the maturity date is August 7, 2016.  The Term Loan B principal balance is $225,000, the interest rate is 4.25%, and the maturity date is December 14, 2014.  The primary use of cash during the year ended December 31, 2011 was for working capital requirements.

Since inception we have raised $2,623,709 from the issuance of convertible notes to investors, of which notes in the principal amount of $2,273,709 were issued to one investor, Brightline Ventures III, LLC, the managing member of which is Mr. Smith, a member of our Board.  As of December 31, 2010, we had notes outstanding to three investors in the aggregate principal amount of $1,176,000.  The notes accrued interest at a rate of 3% per annum and were scheduled to mature 18 months after issuance.  In 2011, we raised an additional $1,447,709 from the issuance of notes to three investors, one of which was Brightline Ventures III, LLC. The notes accrued interest at a rate of 3% per annum and were scheduled to mature 18 months after issuance. All of the notes were converted into shares of Series A Preferred Stock in September 2011.

Our continued operations will primarily depend on our ability to raise additional capital from various sources, including equity and debt financings, as well as grants and bank financings.  On October 20, 2011, we entered into an agreement with a vendor that allowed us to make up to $950,000 of payments for invoiced services rendered by such vendor through the issuance of a convertible note.  In May 2013, the note with the vendor was extinguished and the vendor extended the due date of all payables owed , including amounts previously due under the Note, until the closing of this offering.  On December 14, 2011, we entered into a promissory note with the North Carolina Biotechnology Center pursuant to which we could borrow up to $250,000. The note accrued interest at a rate of 4.25% per annum.  The principal was payable in annual installments in the amount of five percent (5%) of the outstanding principal as of the date of such payment, commencing on the anniversary date of the related loan agreement  and continuing annually on the same day of each calendar period thereafter until December 13, 2014.  In August 2012, we repaid all amounts outstanding under the note from the proceeds of the Square 1 Bank loan described below. In connection with the loan from North Carolina Biotechnology Center, we issued the North Carolina Biotechnology Center a warrant exercisable for 29,762 shares of our common stock at an exercise price of $2.10 per share, which warrant expires on December 13, 2021.  In August 2012, we entered into a secured loan with Square 1 Bank, the proceeds of which were used in part to pay off the loan from North Carolina Biotechnology Center.  The loan and security agreement that we entered with Square 1 Bank in connection with the secured loan (the “Square 1 Agreement”) provides that  Square 1 Bank will provide us with a term loan in the aggregate principal amount not to exceed $1,000,000 to be used for working capital and capital expenditures (the “Tranche A Loan”).  The Tranche A Loan will be available to us until August 7, 2013.  The Tranche A Loan is payable on August 7, 2013 in 36 monthly installments of principal and accrued interest. The Tranche A Loan matures on August 7, 2016.  If we receive a grant that provides aggregate funds with a value of $16,000,000, the maximum aggregate of the Tranche A Loan and the Tranche B Loan amount increases to $2,775,000.  Both the Tranche A Loan and the Tranche B Loan accrue interest monthly at an interest rate of 3% plus prime or 6% per annum whichever is greater.  The Square 1 Agreement, as amended, also provides that if we receive at least $4,500,000 from the sale of our equity to investors after February 15, 2013 but on or before March 31, 2013 (such date we receive such funds being referred to as the “Trigger Date”), we can borrow an additional term loan in the aggregate principal amount not to exceed $1,000,000 to be used for working capital and capital expenditures (the “Tranche B Loan”).  Due to the closing of the Series B-1 Preferred Stock private placement in March 2013, we will be able to borrow an additional $1,000,000 under such loan.  The Tranche B Loan is payable as interest-only prior to the twelve month anniversary of the Trigger Date month after until August 7, 2013 and thereafter is payable in equal monthly installments of principal plus accrued interest until August 7, 2016.  The Tranche B Loan matures on August 7, 2016.  Square 1

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Bank also made one term loan in the amount of $225,000, which was used to repay our debt to North Carolina Biotechnology Center (the “Term B Loan”).  The Term B Loan matures December 14, 2014 and requires payments on the one and two year anniversary of the date of issuance equal to five percent of the principal amount of the loan plus accrued interest, with the balance of the loan being paid on maturity.  The Term B Loan accrues interest monthly at an interest rate of 4.25% per annum.  Once repaid the loans may not be re-borrowed. The loans are secured by a lien on substantially all of our assets, including our stock in our subsidiaries but excluding our intellectual property. Finally, Square 1 Bank also made one Non-Formula Advance (the “Non-Formula Advance”) in the aggregate principal amount of $200,000 which is payable as interest-only on the 5^th calendar day of each month through January 9, 2014 when the entire principal amount is due.  As of May 1, 2013, we had outstanding $725,000 under the Square 1 Bank loans.  In connection with the loan, we issued Square 1 Bank a warrant exercisable for 17,500 shares of our Series A Preferred Stock.  The warrant is exercisable for ten years at a price of $2.10, which price is subject to adjustment for certain transactions including certain dilutive transactions.  The warrant holder is entitled to piggyback registration rights with respect to the underlying shares.

The loan and security agreement with Square 1 Bank sets forth various affirmative and negative covenants that the Company must comply with, including covenants regarding financial reporting, and “cash maintenance” burn” requirements, incurrence of indebtedness and mergers and acquisitions.  We plan to use approximately $300,000 of the proceeds of this offering to repay the portion of the loans from Square 1 Bank due over the 12 months beginning September 2013.  We currently have: (i) $500,000 outstanding under the Tranche A Loan and under the terms of the loan we are required to pay the principal balance plus accrued interest in 36 monthly installments beginning September 7, 2013 and ending August 7, 2016 and (ii) $225,000 outstanding under the Term Loan B, and under the terms of the loan we are required to make payments of 5% of the outstanding principal balance plus accrued interest each on August 2013 and 2014, with the remaining principal balance, plus all accrued interest, due December 14, 2014. In 2012 we borrowed $200,000 under the Non-Formula Advance from Square 1 Bank which was repaid in full in 2013 and $200,000 cannot be reborrowed.

In April 2010, we were awarded a grant award from the National Institute of Health in the amount of $300,000, of which $248,648 was paid to us in 2011. In October 2010, we were awarded a grant from the Internal Revenue Service of $244,479, of which $162,435 was paid in 2011.

Current and Future Financing Needs

We have incurred an accumulated deficit of approximately $5,935,282 as of December 31, 2012. We have incurred negative cash flows from operations since we started our business. We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials, and our research and discovery efforts.

The actual amount of funds we will need to complete our 125 patient Phase II trial on patients with advanced non-small cell lung cancer and a 93 patient, Phase I/II trial of HS-410, in bladder cancer which is estimated to be $9,350,000, is subject to many factors, some of which are beyond our control. These factors include, but are not limited to, the following:

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the progress and cost of our research and development activities;

·

the number and scope of our research and development programs;

·

the progress and cost of our preclinical and clinical development activities;

·

our ability to maintain current research and development licensing arrangements and to establish new research and development and licensing arrangements;

·

our ability to achieve our milestones under licensing arrangements;

·

the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and

·

the costs and timing of regulatory approvals.

We have based our estimate on assumptions that may prove to be wrong. We continue to require additional funds to fully implement our planned research and development and may need to obtain these funds sooner or in greater amounts than we currently anticipate. Potential sources of financing include corporate partnerships or public or private sales of our shares or debt and other sources. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. We do not have any committed sources of financing at this time other than as described previously and there can be no assurance given that any additional

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funding will be available when we need it on terms that will be acceptable to us, or at all. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interest of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations and, as a result, our business, financial condition and results of operations would be materially harmed.

License and Contractual Obligations

Below is a table of our contractual obligations for the years 2013 through 2017 and thereafter (in thousands):

————————

(1)

Represents minimum royalty payment commitments under our license agreements.

(2)

In November 2011, we entered into a thirteen month lease agreement for office space commencing February 1, 2012 for a monthly rent of $3,870.  The lease term may be extended for an additional 24 months on substantially the same terms. On December 19, 2012, we entered into a lease modification agreement which extended the lease term until July 31, 2013 and the monthly rent increased to $4,046. Future minimum lease payments are as set forth above.

Below is a table of our contractual payments under the Company’s notes payable agreements for the years 2013 through 2016 (in thousands):

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BUSINESS

Overview  

We are a clinical-stage biopharmaceutical company engaged in the development of novel allogeneic, “off-the-shelf” cellular therapeutic vaccines to combat a wide range of cancers and infectious diseases. Our proprietary ImPACT “gp96-Ig” cancer therapy is being designed to deliver live, genetically-modified, irradiated human cells that are “reprogrammed” to “pump out” a broad spectrum of cancer associated antigens together with a potent immune adjuvant called “gp96” to educate and activate a cancer patient’s immune system to recognize and kill cancerous cells. We intend for our ImPACT cells to secrete an antigen-adjuvant complex that generates anti-cancer immune responses in patients by mobilizing and activating killer T cells that target multiple cancer antigens, thus harnessing a patient’s own immune system to fight cancer.  In a phase I clinical trial in NSCLC, we believe our “off-the-shelf” therapeutic vaccine candidate HS-110 generated anti-cancer immune responses in patients (including the mobilization and activation of killer T cells against multiple cancer antigens), was generally well tolerated and demonstrated preliminary indications of clinical efficacy.

Unlike “autologous” or personalized therapeutic vaccine approaches which require extraction and processing of cancer or blood from each individual, our ImPACT therapeutic vaccine uses a common master cell line to mass-produce a single vaccine product applicable to all patients for each particular cancer type. We believe our off-the-shelf, allogenic immunotherapy offers logistical, manufacturing and cost of goods benefits compared to autologous patient-specific approaches.

We have filed an IND to initiate a Phase II clinical trial in NSCLC patients with our therapeutic vaccine candidate HS-110, which is derived from a genetically-modified human lung cancer cell line.  We believe that the results of our recently completed Phase I clinical trial in NSCLC demonstrated that our HS-110 is designed to generate anti-cancer immune responses.  Eighteen patients were vaccinated, and 15 of the 18 vaccinated patients completed the first course of three planned courses of therapy.

Based on our evaluation, 11 of 15 patients responded to our therapy with a median survival of 16.5 months for immune responders, versus a median survival of 4.5 months for immune non-responders and the historical control group.  The one-year overall survival rate of patients in our study was 44%, comparing quite favorably with the 5% rate for the historical control group. One of our late-stage lung cancer patients is surviving over four years since starting our therapy and another patient is surviving over three years since starting our therapy. These findings were consistent with multiple pre-clinical published studies on ImPACT therapy.  

We have also developed ImPACT therapeutic vaccines for bladder cancer, breast cancer and ovarian cancer. We plan to initiate a Phase I/II clinical trial for bladder cancer in mid-2013 with HS-410, a genetically-modified bladder cancer cell line. We also plan to initiate a second grant-funded, investigator-sponsored Phase I clinical trial of our ImPACT therapy against SCLC in the second quarter of 2013.  To date, in excess of $14,000,000 of funding has been awarded to the primary inventor of the technology we license by the National Institutes of Health (NIH) and through other research and clinical grants, which has been used to further develop our ImPACT technology platform that we license. We have little control over the direction of the NIH grant funds that have been received by the primary inventor of the technology we license and since payment is made to the inventors as opposed to us we do not recognize any revenue from such grant funds nor do they fund any expenses that we incur. Although earmarked for further development of the technology that we license, any funds awarded to the primary inventor are used in his discretion and we have little control over his use of the funds.

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The table below summarizes our current product candidates and their stages of development:

We plan to begin clinical trials against breast and ovarian cancer in 2014, pending receipt of additional grants or financing. The NIH is also currently fully funding an advanced study of our HS-HIV product candidate in non-human primates with a therapeutic and prophylactic vaccine for the treatment and prevention of HIV utilizing our ImPACT approach.

ImPACT Therapy—Novel Pan-Antigen Immune Activation

Our ImPACT therapy is a novel technology platform designed to educate and stimulate the immune system to combat specific disease targets, such as cancer cells. ImPACT utilizes live attenuated, human-derived, genetically-modified cells to generate an array of cellular antigens and secrete an essential immunostimulatory protein called “gp96-Ig”. The secreted proteins are designed to generate an immune response to cancer cells by mobilizing and activating a patient’s own killer T cells to recognize and attack a broad array of different tumor antigens with the goal of eliminating cancer cells. In contrast with other vaccine technologies that target only one antigen, ImPACT’s pan-antigen approach which may enable the body to induce and maintain an immune response against a broad array of tumor-specific proteins, by potentially providing a more robust immune response and limiting cancer cells’ ability to evade the immune system. We believe our clinical and pre-clinical results suggest that ImPACT generates anti-tumor immune responses capable of targeting and destroying tumors. We believe our novel, off-the-shelf, live cell therapy has the potential to be used to not only combat a wide range of cancers, but also against various infectious diseases, such as hepatitis C, malaria and HIV, for which non-human primate studies, which we believe are encouraging, have been completed. We have leveraged our existing infrastructure by developing additional clinical candidates in areas where we can use our proprietary technology. Our success will depend on the clinical and regulatory success of our product candidates and our ability to retain, on commercially reasonable terms, financial and managerial resources, which are currently limited. To date, we have not received regulatory approval for any of our product candidates or derived any revenues from their sales. Moreover, there can be no assurance that we will ever receive regulatory approval for any of our product candidates or derive any revenues from their sales. We should have sufficient capital from the offering to operate the company for 24-30 months.

Our ImPACT Therapy Product Candidates

We plan to initiate our Phase II clinical trial with HS-110, our lead drug candidate, against non-small cell lung cancer (NSCLC).  Our Phase II trial will expand upon the Phase I results as described below.  

We also plan to initiate a Phase I/II clinical trial against bladder cancer in mid-2013 using our HS-410 drug candidate, which is currently being manufactured in accord with cGMP production guidelines. We plan to utilize this drug as an immunotherapy to prevent the recurrence of bladder cancer in post-resected bladder cancer patients.

We are also anticipating initiating clinical trials using our ImPACT-based product candidates against a number of other diseases, including ovarian cancer and breast cancer.

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Our Product Candidates and Clinical Development Programs

Our development program involves testing our ImPACT-based product candidates against a number of disease targets, including non-small cell lung cancer, breast cancer, ovarian cancer, bladder cancer and HIV. We are planning to enter a Phase II clinical trial with our first therapeutic vaccine, HS-110, for non-small cell lung cancer (NSCLC). We are also planning to initiate a Phase I clinical trial of HS-410 for bladder cancer in mid-2013. In addition, we may also initiate Phase I clinical trials for breast and/or ovarian cancer in 2014, dependent upon the receipt of additional non-dilutive grants and/or product financings. We have an ongoing advanced study in non-human primates with a therapeutic and prophylactic vaccine for the treatment and prevention of HIV. This ongoing study is fully funded by the NIH.

Strengths and Competitive Advantages

·

We believe our ImPACT technology combines broad antigen targeting complexed with a potent immune adjuvant. We believe ImPACT has already been shown to activate the immune system against a wide variety of antigens by eliciting a significant cytotoxic T cell immune response as measured by extensive pre-clinical and clinical immunological testing.  The activated immune response generated by our ImPACT Therapy may be useful in treating wide range of cancers and infectious diseases.

·

We have filed an IND to initiate a Phase II clinical trial in NSCLC patients with our therapeutic vaccine candidate HS-110, which is derived from a genetically-modified human lung cancer cell line. We expect to initiate Phase I/II clinical trials for bladder cancer with our second product candidate, HS-410, in mid-2013.

·

The National Institute of Health (NIH) and other organizations have provided funding to the primary inventor of the technology that we license for both our pre-clinical and clinical studies.

·

Our proprietary technology platform, ImPACT, is being applied to develop multiple therapeutic vaccines against a wide range of cancers and infectious diseases. We believe we have many opportunities to generate positive results and to gain FDA approval, which lowers our dependence on any one drug in order to generate returns.  

·

We believe our therapeutic vaccines are easier and less expensive to manufacture than autologous vaccines because our therapeutic vaccines do not require the harvesting of blood and/or cancer cells from each patient in order to manufacture a course of treatment. We believe this is highly advantageous because it can bring the logistics, manufacturing, cost and distribution of our therapeutic vaccines within the purview of traditional biopharmaceutical product channels and dramatically expand our pool of corporate partners.

·

We believe our technology can readily be adapted to incorporate new cancer types. Because of this, and the fact that our vaccine approach is allogeneic (“off-the-shelf”), we are able to rapidly develop new vaccines for different types of cancers and other diseases.

·

Our therapy does not require an adjuvant. Some vaccines require the addition of another drug, called an adjuvant, to enhance their effectiveness. Adjuvants typically cause irritation at the injection site. As HS-110 is itself an adjuvant, we do not have to use additional adjuvants to generate and maintain an activated immune response.

·

We believe our business model is capital efficient as we continue to leverage academic and institutional resources to develop new products and to move these products into and through clinical trials.

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Strategy

Our objective is to become a leading biopharmaceutical company specializing in the development and commercialization of allogeneic, off-the-shelf therapeutic vaccines. We are focused on discovering, developing and applying our core platform ImPACT technology towards a number of disease indications.  The key elements of our strategy are:

·

Develop and obtain regulatory approval for our ImPACT-based products. We plan to initiate a Phase II clinical trial against NSCLC and intend to conduct a Phase I/II clinical trial against bladder cancer in mid-2013. Additionally, we plan to initiate clinical trials against breast and ovarian cancer in 2014, pursuant to receiving additional non-dilutive grants and/or product financings. After NSCLC, bladder, breast and ovarian cancers, we plan to initiate additional clinical trials against other disease targets utilizing our ImPACT technology platform.

·

Maximize commercial opportunity for our ImPACT technology. Our product candidates target large markets with significant unmet medical need. For each of our product candidates, we seek to retain all manufacturing, marketing and distribution rights which should give us the ability to maximize the economic potential of any future U.S. or international corporate partnerships. We believe that we should be well positioned to successfully commercialize our product candidates independently or through U.S. and international corporate partnerships.

·

Further expand our broad patent portfolio. We have made a significant investment in the development of our patent portfolio to protect our technologies and programs, and we intend to continue to do so. We have obtained exclusive rights to five different patent families directed to therapeutic compositions and methods related to our vaccine platform and preclinical development programs for cancer. These families comprise five PCT applications, six issued patents, one allowed or accepted patent application, and thirty-eight pending patent applications. These patents and applications cover the United States, Europe, and Japan as well as several other countries having commercially significant markets.

·

Manage our business with efficiency and discipline. We believe we have efficiently utilized our capital and human resources to develop and acquire our product candidates and programs, and create a broad intellectual property portfolio. We operate cross-functionally and are led by an experienced management team with backgrounds in developing and commercializing product candidates. We use project management techniques to assist us in making disciplined strategic program decisions and to attempt to limit the risk profile of our product pipeline.

·

Obtain additional grant funding. To more fully develop our ImPACT technology platform and its application to a variety of human diseases, we plan to continue to seek and access external sources of grant funding on our own behalf and in conjunction with our academic partners to support the development of our pipeline programs.  While we intend to work with our academic partners to secure additional grant funding, these partners have no obligation to work with us to secure such funding.  We also intend to continue to evaluate opportunities and, as appropriate, acquire or license technologies that meet our business objectives.

Disease Targets and Markets

The Oncology Market

The American Cancer Society estimates that 1.66 million people in the U.S. will be diagnosed with cancer in 2013. The lifetime probability of being diagnosed with an invasive cancer is 45% for men and 38% for women.  It is projected that 580,350 Americans will die from cancer in 2013.

Despite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need as the overall five-year survival rate for cancer patients diagnosed between 2001 and 2007 is an average of 67%.  According to the Center of Disease Control, in 2011, cancer was the second leading cause of mortality in the U.S. (23.2%) behind heart disease (24.1%).  The American Cancer Society estimates that one in four deaths in the U.S. is due to cancer.  

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The main treatments for cancer are surgery, radiotherapy and chemotherapy.  There are often, however, significant debilitating effects resulting from these treatments or lingering morbidity associated with these approaches to treatment of cancer.  Our goal is to develop compounds that can lengthen survival times and improve the quality of life of cancer patients and survivors.

Although there are a large number of patients, treatment and management of cancer is performed by a relatively concentrated pool of medical professionals.  We plan to reach this prescriber base using a relatively small commercial infrastructure that we intend to develop in the future by either hiring internally, partnering or contracting with one or more third-party entities with an established sales force.  These development plans are dependent on our raising additional capital, the success of HS-110, HS-310, HS-410 and HS-510 and any technologies we might develop in the future and successful negotiation of commercial relationships, none of which we have completed to date. We believe, however, assuming the efficacy and safety of HS-110 and any other technology we might acquire, that our experienced management team will raise the capital and establish the commercial relationships necessary for success.

Limitations of Current Cancer Therapies

We believe current cancer treatment alternatives suffer from a number of limitations that impair their effectiveness in improving patient survival and overall quality of life including:

·

Toxicity.  Chemotherapeutic agents are highly toxic to the human body and very often cause a variety of significant and debilitating side effects, including, but not limited to, nausea and vomiting, bleeding, anemia and mucositis. Some targeted therapeutics have fewer systemic toxicities, but still typically have off-target effects such as gastrointestinal inflammation, severe skin reactions and breathing difficulties. These side effects limit a patient's ability to tolerate treatment and as such can deprive the patient of the potential benefit of additional treatments or treatment combinations that might otherwise destroy or prevent the growth of cancer cells. Once they become aware of the limited efficacy, limited increased survival and potentially significant toxicity of existing treatment alternatives, many patients diagnosed with terminal cancer often choose to limit or forego therapy in order to avoid further compromising their quality of life. Patients with advanced stage cancer also often cannot tolerate cancer therapy, and certain therapies can hasten death as the patient's health further deteriorates from the therapy applied.

·

Mechanism of action.  While many current therapeutic approaches can be effective against specific targeted cells, the efficacy of these therapies on treating cancer over the long term generally is limited by the abundance and diversity of the cancer and tumor cells, which is believed to enable the targeted cells to adapt and become resistant to the current therapeutic approach over time.

·

Short-term approach.  Other than tumor removal in a surgical procedure, curing the cancer is often not the intent or a potential outcome of many current cancer therapies. Rather, survival benefit is the primary focus of many currently marketed and development-stage cancer therapeutics. In this regard, many cancer therapies show only a modest impact on the overall survival of the patients and only affect the length of time that passes after treatment begins and before the patient’s disease worsens or the patient dies.

·

Immune system suppression.  A weakened immune system not only further inhibits the body's natural ability to fight cancer, but also causes patients to become more susceptible to infections and other diseases. Current approaches to cancer treatment generally involve introduction of an agent, such as a chemical, an antibody or radiation, which causes cell apoptosis (programmed cell death) or inhibit the proliferation of all cells, including immune cells, which has the unintended consequence of indirectly suppressing the immune system.

Immunotherapy Overview

Our ImPACT technology is a form of immunotherapy.  Immunotherapy involves administration of a therapeutic approach that enlists or boosts a subject’s immune system in order to fight disease.  

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Commonly recognized successful examples of immunotherapy include prophylactic vaccines, such as, childhood immunizations against infectious diseases such as measles, mumps, and rubella.  In these cases, usually weakened (attenuated) or inactivated viruses are injected into the body to educate certain immune system cells to recognize and remember small pieces of viral or bacterial proteins (antigens).  If and when an individual is subsequently exposed to this same pathogen, the immune system will recognize these antigens immediately and mount a potent immune response to neutralize and eliminate the pathogenic threat.

Therapeutic vaccines, such as ImPACT-based product candidates, operate in a fashion similar to prophylactic vaccines except that therapeutic vaccines are administered the onset of a particular disease.  In each case, the human immune system is educated and harnessed to recognize and fight the disease of interest.  Cancer can be considered a failure of the immune system to effectively recognize and eliminate inappropriately dividing and multiplying (malignant) cells.  Under ordinary circumstances the human immune system continuously monitors and eliminates inappropriately dividing cells.  However, for reasons that are not entirely understood, under cancerous conditions the human system fails to recognize malignant cells and such cells evade the immune system and are permitted to inappropriately multiply, grow and metastasize to form tumors which eventually become life threatening.  Our therapeutic vaccines are designed to assist the immune system in identifying and eliminating malignant cells.  Our approach involves the introduction of cellular antigens that are characteristic of malignant cells with the goal of generating an immune response against the particular form of cancer. In our approach, in addition to introducing a number of cancer-specific antigens, we also introduce a protein known as gp96 which stimulates and primes the immune system in further recognizing cancer antigens and generates a potent and broad pan-antigen immune response against cancerous cells.

Immunotherapy Approaches

Immunotherapy is designed to stimulate and enhance the body’s natural mechanism for killing cancer cells and virus-infected cells. Generally, immunotherapeutic approaches to treat disease can be separated into two distinct classes, passive and active, based on their mechanism of action.

Passive Immunotherapy:  Passive immunotherapies generally consist of monoclonal antibodies directed at a single disease-specific enzyme or protein on the surface of the targeted cells with the goal of either killing the targeted cells or preventing them from dividing. Rather than stimulate or otherwise use the body’s immune system to initiate the attack on the disease, the attack is made by the therapy which is produced ex vivo, or outside of the body. These therapies also are not usually personalized for the patient.

Active Immunotherapy: Active immunotherapies generally consist of therapies intended to trigger or stimulate the body’s own immune system to fight disease.  It is a more specific approach to immunotherapy than passive immunotherapy because active immunotherapies have no direct therapeutic action but rather contain antigens specifically designed to activate the patient’s own immune system to find and kill the targeted cells that carry the same antigen. Active immunotherapies depend on the patient’s immune system to seek out and destroy targeted cells or tumors.  Most active immunotherapies utilize off-the-shelf antigens, known as “defined” antigens, rather than individualized, patient specific antigens, and are often paired with adjuvants, which are agents that generally activate the immune system cells to increase immune response.

Shortcomings of Immunotherapies:  Both passive and active immunotherapy approaches have shortcomings, which include:

·

Most active immunotherapies use normal, non-mutated, self-antigens which are typically poor at stimulating immune responses, even from healthy immune systems. In fact, the human immune system generally does not generate immune responses against self-antigens. Most passive and active immunotherapies also target one or only a few antigens, which increases the probability that infected cells will escape detection by the immune system and immunotherapy.

·

Most active immunotherapies employ defined antigens that are not effective against multiple types of cancer. As such, further preclinical development is necessary to help identify the relevant antigens that address the targeted cancer(s).

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·

Most immunotherapies can suffer from toxicity side effects resulting in damage to healthy tissues if the target antigen is absorbed by normal cells in addition to the targeted cancer or virus-infected cells.

·

Many patients may not be able to mount effective immune responses with immunotherapy due to tumor or virus induced immunosuppression of accessory cells such as CD4+ helper T cells, which are necessary for the immunotherapies to be effective but may be functionally impaired by the patient’s disease.

·

It can be difficult to commercialize immunotherapies based on cells derived from individual patients in a cost-effective manner as a result of the need to use manual processes to produce from a limited amount of patient material multiple doses and to store and ship the individual doses.

·

Immunotherapies that rely on defined, off-the-shelf antigens or a single targeted antigen may have limited effectiveness because even within the same type of cancer, the genetic makeup and distinct antigens of a tumor can vary significantly from patient to patient.

These shortcomings were highlighted by the findings of a study recently published in Nature Medicine (Finak and Park (2008), Stromal gene expression predicts clinical outcome in breast cancer, Nature Medicine, 14, 518 – 527) where the whole genomes of 50 patients’ breast cancer tumors were sequenced alongside matching DNA from the same patients’ healthy cells to identify the genetic alterations present in the cancerous cells. The study found that the genomic pattern of each of the tumors varied significantly. Of the approximately 1,700 gene mutations found in total, most were specific and unique to the individual patients’ cancerous tumors, and that only three of the genetic mutations occurred in 10% or more of the patients.

Although many of the immunotherapies currently in clinical development have shown promising results, we do not believe that any of them utilizes a technology that employs the patient’s own cancer or virus-infected cells to create a fully personalized immunotherapy that is directly targeted to the patient’s unique genetic disease.

Our Solution: ImPACT Therapy

We believe our ImPACT Therapy has a number of advantages over existing therapies. These advantages, elaborated below, may enable us to develop commercial products that extend the survival of, and improve the quality of life for, cancer patients:

·

It is designed to fight cancer by activating the immune system against a wide variety of cancer antigens.

·

It is intended to continually secrete a wide variety of cancer-associated antigens, thus issuing a broad and sustained pan-antigen cytotoxic T cell attack against the targeted cancer. We believe this broad-based attack increases the probability of destroying the targeted cancer.

·

It is designed to stimulate a natural immune response against specific cancer cells. We have not observed in our clinical trials or in our numerous published animal studies any serious adverse events that were considered by the trial investigators to be treatment-related.

·

We believe that the novel mechanism of action, good tolerability and favorable safety profile will enable our ImPACT product candidates to have potential benefits across multiple disease stages and tumor types and in combination with other therapies. We believe our ImPACT technology can be targeted to additional specific tumor types by modifying cells from the cancer type of interest.

·

Our ImPACT Therapy represents a first-in-class adjuvant that functions as both an immune activator and an antigen-delivery vehicle. ImPACT is the only adjuvant technology platform currently known to us in clinical development that is specific to CD8+ cytotoxic T cell immune response, which is especially important for developing therapeutics in oncology as well as a number of other infectious disease indications.

·

We believe many patients who are too ill to tolerate chemotherapy due to the associated toxicities may be able to benefit from our ImPACT product candidates.

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ImPACT TECHNOLOGY PLATFORM

ImPACT Background

Our ImPACT technology represents an allogenic or “off-the-shelf” method to deliver cancer antigens accompanied by heat shock proteins (“HSPs”) to illicit an immune response.  Heat shock proteins are used as a signaling mechanism by the immune system to identify mutated proteins (“antigens”), including those from tumor cells. Although always present within certain cells, HSPs are normally only released whenever cells die by necrosis or unnatural cell death (rather than apoptosis or natural programmed cell death) and upon release are recognized by the host’s immune system.  Upon detection of HSPs, the immune system can then direct an immune response against any foreign (pathogenic) proteins bound to the heat shock protein at the time the cell that released it died by necrosis.

When a cell dies an unnatural death through a process called “necrosis”, such as when it is infected and killed by a flu virus or other pathogen, it breaks open and emits its contents including HSPs into the surrounding tissue.  Because heat shock proteins very rarely leave cells, the immune system has evolved to recognize heat shock proteins that have been released from dying cells as the sentries of a molecular alarm system.

HSP’s have several functions including:

·

Protecting tissues from pathogens by activating the immune system.

·

Acting as a chaperone to:

o

Facilitate proper protein folding within the endoplasmic reticulum.

o

Enable proper function of toll-like receptors and the innate immune system.

o

Carry irreparable proteins to intracellular garbage disposals to be degraded into peptides (short chains of amino acids – protein fragments).

·

Loading peptides onto another class of proteins known as MHC I molecules.  MHC I molecules move to the cellular surface where they are monitored by the immune system.  

Heat shock protein gp96 is one of the most abundantly expressed proteins in the human body and is expressed by all cells. It is normally retained within cells in a compartment called the endoplasmic reticulum (ER), where it facilitates the folding of newly synthesized proteins so that they may perform their various tasks properly. Gp96 is particularly important in the process of detecting antigens as it is present in all cell types, it is able to recognize all antigens. It also induces the immune system to activate CD8+ (“killer”) T cells which then seek out and destroy the cells that are marked by antigens. Gp96 is normally only contained inside the endoplasmic reticulum of cells, however when a cell dies an abnormal death through necrosis it breaks open and releases gp96 into the surrounding tissue microenvironment.  ImPACT works by modifying the chemical structure of gp96 so that a cell can continuously release it into the extracellular space accompanied by the unique peptide that it is folding at the time without causing necrosis. This allows the immune system to seek out and destroy cells characterized with antigens before the body would otherwise have detected them.

ImPACT Technology Overview

The problem with utilizing gp96 as a cancer immunotherapy is that it is normally retained within cells by a small region called a “KDEL sequence” that acts like a “leash”, preventing gp96 from leaving the endoplasmic reticulum. Therefore, in order to utilize gp96 as a therapeutic gp96 would either have to be purified from individual cells or engineered to be secreted from cells.

To overcome this problem, a team of scientists led by Eckhard, Podack, MD, Ph.D., the Chairman of our Scientific Advisory Board and the inventor of our technology, deleted this KDEL sequence and replaced it with another sequence that causes the new fusion protein, called gp96-Ig, to be released from cells continuously.  Multiple tumor cell lines were then made to express gp96-Ig, and as expected, secreted it continuously into the extracellular space in a complex with tumor proteins. Dr. Podack demonstrated that gp96-Ig vaccination effectively cross-presented tumor specific antigens to immune cells, led to expansion of Cytotoxic T Lymphocytes (CTL) and the subsequent rejection

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of injected tumor cells.  Importantly, these studies demonstrated that the secreted protein gp96-Ig maintained the critical characteristics of the native gp96 protein required to generate anti-tumor immune responses.  Thus, proof-of-principle was established that the innovation, gp96-Ig, not only retained the desired properties of the native gp96 protein, but enhanced those functions and led to tumor-killing immune responses.

Our ImPACT technology platform:

·

Effectively cross-presents tumor antigens and leads to cytotoxic killer T cell activation

Published studies in mice showed that killer T cell activation was approximately 10 million times greater with ImPACT secreted gp96-Ig than with a corresponding gp96 protein injection. The modified cell secretes gp96 in a sustained release for several days after injection. This creates a sustained immune response. Additionally, the immune response kills tumor cells, releasing additional gp96 and creating a continuous response loop that supports persistent activation of killer T cells. This data suggests that gp96-chaperoned peptides may represent the most efficient, robust pathway for presenting a cell’s antigens to the immune system and activating killer T cell.  

·

Binds and presents all potential tumor antigens to the immune system simultaneously

A single type of tumor (or virus) might have multiple strains derived from numerous tumor cells. These different strains have different antigens, all of which are capable of initiating an immune response. By creating a vaccine from a native tumor-cell line, we believe that ImPACT’s technology can develop a therapy that shares many common features with patients’ tumors of the same origin. We believe this “blanket” approach will provide each patient with a higher likelihood of a positive response to the therapy.

·

Features killer T cell Activation that is independent of CD4+ T cell help

Animal studies have confirmed that our technology initiates a mechanism called cross-presentation that is critical to inducing tumor rejection. Importantly, it does this independently and successfully without additional CD4+ T cell recruitment, which is typically required in a normal immune system response. This is particularly important in cancer and HIV because helper T cell activity is frequently impaired in these disease states.  

·

Causes few side effects

We believe our technology allows the body to recognize cancer as a foreign entity and uses the body’s natural immune mechanism to fight it. In doing so, we believe Heat’s therapy will generate fewer side effects and that patients will be able to maintain a higher quality of life.

The distinguishing characteristics of ImPACT are:

(i)

While most other immunotherapy approaches target only a single antigen, Heat’s patented approach uses modified heat shock proteins to stimulate an immune response against multiple antigens contained within cancer cells. Cancer cells express different antigens that can be used to initiate an immune response. Each ImPACT vaccine is created from a native tumor-cell line that we believe expresses the widest array of antigens common to a particular type of cancer. We believe this “pan-antigen” approach provides each patient with a higher likelihood of a response to the therapy.

(ii)

Heat’s vaccines are “off-the-shelf” (allogeneic) and may therefore be less expensive to manufacture than patient-specific (autologous) vaccines. Heat’s vaccines are mass-produced from a single source while other immunotherapy approaches require physicians to extract a patient’s blood and/or cells, send them to a lab where a personalized vaccine is created, and then have them shipped back to the physician for injection into the patient.

(iii)

While there are competing companies that are developing therapies that are both “off-the-shelf” and which target multiple antigens, Heat’s ImPACT technology is the only known “off-the-shelf” (allogeneic) vaccine to us that directly induces “cross-presentation” to the CD8+ (“killer”) T cells, which are the cytotoxic arm of the immune system. Stimulating these CD8 (killer) T cells through “cross-presentation” has recently been shown to be critical to the induction of effective anti-tumor immunity. We believe Heat is able to leverage gp96 to serve as its own powerful immune stimulant (adjuvant) while other companies’ technologies rely on the use of a secondary adjuvant like GMCSF or Alum.

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Our Product Candidates and Clinical Development Programs

We have initiated a clinical development program to target our ImPACT technology platform against a range of diseases, including non-small cell lung cancer, bladder cancer, breast cancer and ovarian cancer. We have filed to initiate a Phase II clinical trial with our first therapeutic vaccine, HS-110, against NSCLC in 2013, and we are planning to initiate a Phase I/ II clinical trial for bladder cancer in mid-2013. We plan to initiate Phase I trials for breast and ovarian cancer in 2014, pursuant to receiving additional non-dilutive grants and/or other financings. Our lead scientist has also completed advanced study in primates for the development of a therapeutic and prophylactic vaccine for the treatment and prevention of HIV. This study continues to be fully funded by the NIH.  The HIV trials were initiated by the primary inventor and to date have been funded by grants awarded to the primary inventor, which can be used in the discretion of the inventor.  We have no funding obligation for such trials and the primary inventor is responsible for future development and research.

Summary of HS-110 Clinical Trials

Phase I HS-110 Clinical Trials

Background

A Phase I clinical trial with HS-110 in patients with very late stage IIIB/IV NSCLC was completed at the Sylvester Comprehensive Cancer Center with a total of 18 patients dosed, 15 of which completed the first course of three planned courses of therapy and were evaluated. The primary purpose of this trial was to demonstrate safety of HS-110, while the secondary endpoints were the induction of gp96-Ig specific immune responses and the overall survival rate. The patients were divided into 3 arms. Due to statistical and safety considerations, the patients in the trial were not evenly divided among the three arms.  Arm 1, which consisted of 11 patients, received 40 million cells every two weeks for 18 weeks, arm 2, which consisted of 4 patients, received 20 million cells every week for 18 weeks and arm 3, which consisted of 3 patients, received 10 million cells twice a week for 18 weeks. Three of the patients, who were late stage lung cancer patients, died before we could evaluate their immune response and were not included in the valuation set at the end of the trial.

Our Phase I trial was conducted as an investigator-sponsored IND and was fully funded by the NIH. The criteria for inclusion was: (i) patients with histologically confirmed NSCLC stage IIIB, stage IV, or recurrent disease; (ii) at least one site of bi-dimensionally measurable disease; (iii) treated brain metastasis must be stable by CT scan or MRI for at least 8 weeks; (iv) patient must have received and failed at least two lines of therapy (one of them erlotinib); (v) age ≥ 18 years; ECOG performance status 0-2; life expectancy ≥ 3 months; and (vi) signed informed consent.

The median age was 67 years (range 38-86). None of the reported serious adverse events were considered by the trial investigator to be treatment-related.   Most adverse events were grade 1 or 2 involving transitory erythema and skin induration. Seven of 18 (39%) patients achieved disease stabilization for a clinical benefit of 39%. Median survival was 8.1 months. In 11 of 15 patients (73%) there was a twofold or greater increase CD8 cells secreting interferon gamma (CD8-CTL IFN-γ) following vaccination, and these patients showed a median survival of 16.5 months. There were no serious adverse events (SAE) or immune related events (IRE) with the vaccine or the vaccinations. Most of the adverse events (AEs) were grade 1 or 2 and involved erythema and skin induration that were transitory and usually resolved in 1-2 weeks.

We believe our preliminary Phase I results indicate that HS-110 may increase median survival for responding patients as compared to historical controls. For this analysis, the overall survival of the patients on the trial is compared to published historical controls. The historical control used for this analysis was determined using a meta-analysis of patients with stage IIIB/IV NSCLC with an equivalent performance status (0-1) of the patients on the current trial who had failed 4 prior lines of therapy. The patients enrolled in our trial had failed an average of 7 prior lines of therapy. Although preliminary in nature, the data indicates that the patients treated with the HS-110 vaccine may have an increase in survival over historical controls both in terms of median survival and overall survival. It is also important to note that, based upon IND requirements and the randomization protocol then in place, 11 of the 18 patients enrolled in the trial at the time of the interim analysis were on arm 1, the least frequent dosing arm which was administered once every two weeks, which is expected to be the least effective based on preclinical studies.

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Other patients were enrolled in arms 2 and 3, where we would anticipate improved responses in patients due to the more frequent dosing schedule. To date, several patients’ disease have stabilized, including some patients with very large primary lesions in the lung as well as multiple distant metastatic sites, including the liver and lymph nodes.

HS-110 Generally Well Tolerated

We believe HS-110 was generally well tolerated. There were no serious adverse events (SAEs) that were considered by the trial investigator to be treatment-related. Most of the adverse events (AEs) were reported as mild or moderate (grade 1 or 2) with the most frequent being skin induration and rash that were transitory and usually resolved in 1 to 2 weeks. There were no immune-related events with the vaccine or the vaccinations.

Based upon these Phase I results, we believe HS-110 appears to be generally well tolerated and capable of generating CD8-CTL IFN-γ immune responses in patients with advanced NSCLC.   Skin reactions at the vaccination site were minimal and of short duration and there was no evidence of the generation of any autoimmune phenomena. In lieu of a dose escalation design, the design of the Phase I trial involved increasing the frequency of vaccination, while still retaining the total dose of vaccine cells administered. A more frequent vaccination schedule caused increased tumor rejection in preclinical models and also anecdotally appeared to be of benefit in this study.

Positive Immunological Response

In 11 of the 15 patients completing the first course of therapy (73%) with HS 110, there was a twofold or greater increase CD8 cells secreting interferon gamma (CD8-CTL IFN-γ) following vaccination, and these patients showed a median survival of 16.5 months.

Since NSCLC is known to be highly immunosuppressive, we believe that by overcoming tumor-induced-suppression with frequent vaccinations as observed anecdotally in the Phase I study and the generation of an observed potent polyepitope specific CD8 CTL is encouraging and warrants further study.

Clinical Benefit

We believe HS-110 appears to provide clinical benefit to the 11 patients that responded to the therapy.  Clinical benefit is defined as evidence of improved symptomology, disease control, progression-free survival or overall survival as compared to matched historical controls (i.e. patients with advanced NSCLC who have progressed on 2 or more prior therapies).  Seven of 15 patients completing the first course of therapy (39%; 95% CI: 17.3- 64.3%) achieved disease stabilization after the first course of vaccinations (6 weeks) and 8 patients had disease progression. The Kaplan Meier estimate of median time to progression was 1.4 months (95% CI: 1.3-2.7), and the PFS rates at 1, 2 and 3 months were 88.9% (95% CI: 62.4- 97.1%), 38.9% (95% CI: 17.5-60.0%), and 11.1% (95% CI: 1.9-29.8%), respectively. Of note, two patients remained progression free for just over 7 months.

The typical median survival period for late-stage lung cancer is 4.5 months for patients who are not receiving any treatment.  As of March 2013, 2 of the 15 patients who completed the first course of therapy remain alive and have been followed for over 3 years and 4 years, respectively. The Kaplan-Meier estimate of median survival was 8.1 months (95% CI: 6.7- 18.2), and the 1, 2, and 3-year OS rates were 44.4% (95% CI: 21.6-65.1%), 19.0% (95% CI: 4.8- 40.3%), and 9.5% (95% CI: 0.8-32.1%), respectively.

In summary, based on the results of this Phase 1 trial in 18 patients, in which 15 patients remained at the end of the trial and were evaluated, we believe HS-110 appears to be generally well tolerated and capable of generating CD8-CTL IFN-γ immune responses in patients with advanced NSCLC.  We believe that clinical benefit, based on stabilization of disease and overall survival, was observed with the overall rate of survival above the historically expected rate for these heavily pretreated patients with very poor prognoses.

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Adverse Events by Body System

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a

All grade 2 AEs except 4 were classified as non-related to treatment.  The grade 2 treatment-related AEs were 1 musculoskeletal event (joint pain) rated as definitely related. 1 musculoskeletal event (knee weakness) rated as possibly related. 1 endocrine event (hot flashes) rated as unlikely related and 1 skin event (pruritus) rated as unlikely related.

b

The single grade 3 AE was in the body as a whole category (fatigue) and was rated as possibly related.

Injection Site Reactions

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ONCOLOGY INDICATIONS of ImPACT

Lung Cancer

Disease

Lung cancer is the leading cause of cancer-related death in the United States.  According to the National Cancer Institute, in 2013, lung cancer is expected to account for 26% of all female cancer deaths and 29% of all male cancer deaths.  An expected 228,190 people will be diagnosed with lung cancer in the United States in 2012.  Of these lung cancers, roughly 85-90% will present as non-small cell lung cancer. Patients with advanced clinical stage IIIB/IV disease visible on chest radiography have a 5-year survival rate as low as 1-5%.  

Clinical Development

Our technology was the subject of an investigator initiated Phase I clinical trial conducted at the Sylvester Cancer Center for the treatment of non-small cell lung cancer (“NSCLC” or “lung cancer”) to establish safety and  proof of concept clinical efficacy.

After completion of the 18 patient Phase I trial, in which 15 patients completed the first course of three planned course of therapy and were evaluated, we successfully opened a new IND to conduct additional trials with HS-110 in patients with NSCLC.  Our Phase II study has been designed as a maintenance therapy study in patients with Stage III/IV NSCLC who have completed a 1^st line regimen consisting of a platinum doublet, crizotinib or erlotinib and achieved at least stable disease. The trial is structured as a multicenter randomized, active controlled add-on dosing study to evaluate the immune response, safety and efficacy endpoints of HS-110 when administered weekly for 18 weeks in patients with non-small cell lung cancer (NSCLC).  We anticipate opening approximately 15-20 clinical sites and enrolling approximately 125 patients with an expected enrollment period of 2.5 years. The trial is a 3-stage, randomized, double-blind, placebo-controlled design.  In stage 1 (dose-finding), patients will be randomized to either placebo treatment, low dose HS-110 (2 x 10⁶ cells) or high dose HS-110 (1 x 10⁷ cells), administered weekly for 18 doses (18 weeks).  In stage 2 (proof of concept), patients will be randomized to either placebo treatment or HS-110 at the dose determined to produce the optimal immune response in Stage 1.  In Stage 3 (biocomparability), patients will be randomized to one of two dose preparations of HS-110 administered weekly for 18 weeks at the dose determined to produce the optimal immune response in Stage 1. The primary endpoint in Stages 1 and 3 will be immune response; the primary endpoint in Stage 2 will be progression-free survival.  All stages will examine additional secondary endpoints including overall survival.

In addition to our Phase II study, our chief scientist has received a grant award from the Marcus Foundation that fully funds a 36 patient Phase I investigator-sponsored Phase I study for use of HS-110 as a combination therapy with theophylline and oxygen.  We expect to begin this study in Q2-2013.

Bladder Cancer

Disease

In the United States, bladder cancer is the fourth most common type of cancer in men and the ninth most common cancer in women. According to the National Institutes of Cancer, 1 in 42 men and women will be diagnosed with bladder cancer during their lifetime, a total of more than half a million patients in the US.  There are more than 60,000 cases of bladder cancer diagnosed each year in the United States, resulting in over 14,000 deaths per year. Available treatments are currently not effective, thus this remains an area of high unmet need.

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Clinical Development

The Bladder Cancer Phase I/II Trial

cGMP-grade cell lines are currently being developed that will be used to treat patients with advanced bladder cancer. It is anticipated that these cellular vaccines will be completed by the 2nd quarter of 2013, with a Phase I/II clinical trial beginning shortly thereafter. In parallel with our clinical development plans, we have engaged a vendor as our clinical grade contract manufacturer for our future potential Phase III trial.

Preparation of IND documents in support of HS-410 for bladder cancer are in progress. We anticipate IND activation in 2013.  This IND will include a 93 patient, Phase I/II trial to examine safety, tolerability, immune response and preliminary clinical activity of HS-410 in patients with high risk, superficial bladder cancer who have completed surgical resection and 6 weekly intravesical bacillus Calmet-Guerin (BCG) immunotherapy installations. We anticipate including approximately 8-10 clinical sites with an enrollment period of 12-18 months.

The Phase I portion will randomize 18 patients in 1:1 fashion to either a high or low dose group. Patients will receive weekly intradermal injections of HS-410 for 18 weeks and immune response will be evaluated at baseline, week 6, week 12 and week 18.  The first 4 patients in each dose group will be enrolled at 2 week intervals to allow opportunity to assess safety and tolerability of HS-410.  At the completion of the Phase I program, the dose resulting in the optimal immune response will be advanced to Phase II.  In the phase II portion, 75 patients will be enrolled in 2:1 fashion to HS-410 or placebo. Primary endpoint will examine time to 1^st recurrence of bladder cancer.  Other endpoints will include recurrence rate, progression rate and immune response.

Triple Negative Breast Cancer

According to the American Cancer Society, there will be 232,340 new cases of breast cancer diagnosed in 2013. Approximately 10-20% of those cases will be triple negative breast cancer (TNBC), an aggressive form of the disease marked by earlier age of onset, worse clinical outcome, and a higher rate of local relapse. This disease cannot be treated by hormone therapy or receptor-directed monoclonal antibodies. New approaches for treatment to prevent relapse in this disease after early treatment need to be investigated.

Clinical Development

The TNBC Phase I Trial

cGMP grade cell lines are currently being developed that will be used to treat patients with TNBC. It is anticipated that these cell lines will be completed by the 2nd quarter of 2013, with a Phase I clinical trial in early 2014.

Ovarian Cancer

Disease

Ovarian cancer accounts for about 3% of all cancers among women and ranks the second among gynecologic cancers. According to the American Cancer Institute, an estimated 22,240 new cases are expected in the US in 2013. Ovarian cancer causes more deaths than any other cancer of the female reproductive system, and will lead to an estimated 14,230 deaths in the United States in 2013.¹⁶ Due to the prevalence of ovarian cancer and its poor prognosis, particularly when discovered late, the development of novel therapeutics for the treatment of ovarian cancer is a high priority.

Clinical Development

To address this problem, cGMP-grade cellular vaccines are being developed that will be used to treat patients with advanced serous ovarian carcinoma. It is anticipated that these cell lines will be completed by early 2013, with a Phase I clinical trial pending the availability of adequate funding.

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Other Cancers

Our ImPACT-technology is a broad based approach and can be used to combat a variety of cancers. We are in the process of identifying available cell lines, such as pancreatic cancer, melanoma, glioblastoma, and vesicular lymphoma. We expect to have several additional ImPACT-based products in the clinic in 2013.

Infectious Diseases

To date, over $4,000,000 in governmental and institutional funding has been provided to the inventor of the technology we license for HIV and hepatitis C virus (HCV) research using our ImPACT-technology.  We do not intend to use any of the proceeds of this offering to further any HIV or HCV research and instead plan to conduct additional research with respect to the use of our ImPACT-technology for the treatment of such diseases solely through additional governmental and institutional grants, if any, that may be received.

Manufacturing

We rely on third-party manufacturers to produce and store our product candidates for clinical use and currently do not own or operate manufacturing facilities. The HS-110 used in our Phase I and Phase II clinical trials was and is currently manufactured by our cGMP contractors under current good manufacturing practices (cGMP).

We have retained a vendor, who has begun production of HS-110 to be used in our potential Phase III clinical trials.  We entered into an eight year Manufacturing Services Agreement, dated October 19, 2011, with the vendor (the “Manufacturing Agreement”). The Manufacturing Agreement provides that the vendor will manufacture products based on our ImPACT technology intended for use in pharmaceutical or medicinal end products, including, without limitation, products in a final packaged form and labeled for use in clinical trials or for commercial sales to end users in accordance with the terms and conditions of individual statements of work. The Manufacturing Agreement requires that we purchase certain minimum amounts each year from the vendor. The Manufacturing Agreement may be terminated by the parties upon mutual agreement, and by each party for a material breach by the other party that is not cured within the cure period, upon notice that a clinical trial for which product is being produced under the agreement is suspended or terminated or upon the other party’s insolvency, dissolution or liquidation.

The HS-110 used in our clinical trials was and is currently manufactured under current good manufacturing practices (cGMP). The vaccine is grown in large quantities and quality tested according to FDA guidelines. Following testing,  the vaccine is irradiated, which is a commonly used attenuation process that eliminates the ability of the gp96-Ig-containing vaccine cell lines from replicating, but allows it to continue secreting gp96-Ig for a period of several days. Quality tested, irradiated batches of the vaccine are then dispensed into individual doses and frozen in liquid nitrogen. These batches of frozen vaccines are stable for long periods of time, and are thawed immediately prior to administration to patients. Sufficient material to complete the phase I/II study has already been produced, and preparations are underway to produce quantities required for subsequent clinical trials.  

Competition

The pharmaceutical industry and biologics industry are each highly competitive and characterized by a number of established, large pharmaceutical companies and other companies, as well as smaller companies like ours.  If our competitors market products that are less expensive, safer or more effective than any future products developed from our product candidates, or that reach the market before our approved product candidates, we may not achieve commercial success. Technological developments in our field of research and development occur at a rapid rate and we expect competition to intensify as advances in this field are made. We will be required to continue to devote substantial resources and efforts to our research and development activities.

As a biotech company with a cancer immunotherapy as its lead therapeutic, we compete with a broad range of companies. At the highest level, cancer immunotherapy can be seen as both a complement and a potential competitor to any oncology therapy, most notably chemotherapy, biologics and small molecule drugs. Not only do we compete with companies engaged in various cancer treatments including radiology and chemotherapy but we also compete with various companies that have developed or are trying to develop an immunology vaccine for the treatment of cancer.  Certain of our competitors have substantially greater capital resources, large customer bases, broader product lines, larger sales forces, greater marketing and management resources, larger research and development staffs and larger facilities than ours and have more established reputations as well as global distribution

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channels that may be more effective than ours. Our most significant competitors, among others, are fully integrated pharmaceutical companies such as Eli Lilly (Alimta), Bristol-Myers Squibb (Erbitux) and Sanofi-Aventis (Eloxatin), and more established biotechnology companies such as Roche/Genentech (Avastin and Tarceva), and competing cancer autologous immunotherapy companies such as Dendreon and others which have substantially greater financial, technical, sales, marketing, and human resources than we do. These companies might succeed in obtaining regulatory approval for competitive products more rapidly than we can for our products. In addition, competitors might develop technologies and products that are cheaper, safer or more effective than those being developed by us or that would render our technology obsolete. In addition, the pharmaceutical and biotechnology industry is characterized by rapid technological change. Because our research approach integrates many technologies, it may be difficult for us to remain current with the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Our competitors may render our technologies obsolete by advancing their existing technological approaches or developing new or different approaches.

We expect to compete with other pharmaceutical and biotechnology companies, and our competitors may:

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develop and market products that are less expensive, more effective or safer than our future products;

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commercialize competing products before we can launch any products developed from our product candidates;

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operate larger research and development programs, possess greater manufacturing capabilities or have substantially greater financial resources than we do;

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initiate or withstand substantial price competition more successfully than we can;

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have greater success in recruiting skilled technical and scientific workers from the limited pool of available talent;

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amore effectively negotiate third-party licenses and strategic relationships; and

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take advantage of acquisition or other opportunities more readily than we can.

We expect to compete for market share against large pharmaceutical and biotechnology companies, smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations.

Many major pharmaceutical companies have at least one immunotherapy drug or therapeutic in development, either directly or in partnership with a smaller biotech firm.  Some of our competitors that are developing competitive  immunology drugs and therapeutics include Merck kGaA/Oncothyreon’s Stimuvax for the treatment of breast cancer  and NSCLC; Transgene and its product TG4010 for the treatment of NSCLC lung cancer; GlaxoSmithKline and its product MAGE-A3 for the treatment of melanoma, NSCLC, multiple myeloma and squamous cell carcinoma; Oxford BioMedica and its product TroVax for the treatment of prostate, kidney and colorectal cancer); NewLink Genetics and its treatment for pancreatic cancer and lung cancer; Celldex/Pfizer and their product  CDX-110 for the treatment of malignant brain cancer; and Dendreon and its product Provenge for the treatment of prostate cancer.

The primary treatments for non-small cell lung cancer are surgery, radiation, chemotherapy and various combinations of each of these treatments. A large number of patients, particularly with advanced disease, are refractory to these treatments and are subsequently treated with a number of emerging biologic agents, including immunotherapy. Some examples of therapies commonly attempted with stage IIIB/IV NSCLC patients include: Alimta (pemetrexed), Avastin (bevacizumab), Tarceva (EGF inhibitor), Gemzar (gemcitabine), Erbitux (cetuximab), Carboplatin, Taxol, VP16 and Arlibercept. It is unlikely that biologic agents will compete with more traditional therapies in the short-term, but many oncologists believe that such therapies will eventually become the mainstay of lung cancer therapy. None of these agents have proven particularly effective for stage IIIB/IV NSCLC patients, with the most effective therapies only increasing survival by a few months. As a result, we do not consider these agents to be direct competitors to HS-110 because they are likely to be given either in sequence or in conjunction with some of the agents listed. Furthermore, many patients cannot tolerate many of the chemotherapeutics listed. Thus, we believe if HS-110 has a positive safety profile (without observation of local or systemic toxicities, none of which have been seen to date), it is likely that HS-110 would be preferred both by physicians and patients in this stage of disease.

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As previously stated we compete with other forms of cancer treatment such as biologic therapies in addition to immunology therapies.  There are several biologic therapies in clinical development against NSCLC that have been identified as potential competitors to HS-110. In particular, a cell-based vaccine therapy, Lucanix, is in development by NovaRx. Lucanix has entered phase III clinical trials.

Our strategy is to emphasize what we believe to be our competitive advantages which are that our therapy will have less side effects than most other chemotherapies,  will be available at lower prices than other therapies and will work on almost all types of cancer and not just one specific type.

Although all chemotherapy drugs have severe side-effects such as overall damage to the immune system, not only to cancerous cells, leading to hair loss, nausea and vomiting, and considerable pain, etc., the side effects from immunotherapy are typically reduced because immunotherapy works with the body’s own immune response.

According to Schreiber et al, patient-specific vaccines are not more effective than off-the shelf vaccines in reducing tumors. Furthermore, patient-specific vaccines cost far more to produce than off the shelf (allogeneic) vaccines, where any donor tissue can be used. Over 95% of newly developed cancer immunotherapies cost over $20,000 per course of treatment.

Grant Funding

To date, in excess of $14,000,000 in grants, have been awarded to the primary inventor of the technology we license to fund development of ImPACT technology and clinical trials upon which our clinical programs are based. We have little control over the direction of the NIH grant funds that have been received by the primary inventor of the technology we license and since payment is made to the inventors as opposed to us we do not recognize any revenue from such grant funds nor do they fund any expenses that we incur.  Although earmarked for further development of the technology that we license, any funds awarded to the primary inventor are used in his discretion and we have little control over his use of the funds.  

Previous Grant awards for development of ImPACT

Intellectual Property

License Agreements and Intellectual Property

Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies, preserve our trade secrets and rights in our unique biological materials, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. Our

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policy is to actively seek to obtain, where appropriate, the strongest intellectual property protection possible for our current product candidates (ImPACT therapy) and any future product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and abroad.  However, even patent protection may not always afford us with complete protection against competitors who seek to circumvent our patents. See “Risk Factors - Risks Relating to Our Business” – “We have limited protection of our intellectual property.”  

We will continue to depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors, none of which is patentable. To help protect our proprietary know-how, which is not patentable, and for inventions for which patents may be difficult to enforce, we currently rely and will in the future rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

License Agreements

In July 2008, we entered into an exclusive license agreement with the University of Miami (the “University”) for intellectual and tangible property rights relating to ImPACT, technology.  This license agreement was subsequently assigned to our subsidiary Heat Biologics I, Inc. which issued to the University shares of its common stock representing seven and one half percent (7.5%) of its common stock, of which 5% was non-dilutable until our receipt of the proceeds of our recent Series B-1 Preferred Stock private placement in March 2013. The term of the license is the length of the last to expire patent, unless terminated earlier.  The license agreement grants Heat Biologics I, Inc. exclusive, worldwide rights to make, use or sell licensed materials based upon the following patent-related rights:

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U.S. patent applications: Serial number 60/075.358 (the “ ‘358 application”) entitled “Modified Heat Shock Protein-Antigenic Peptide Complex” and filed on February 20, 1998; Serial number 09/253,439 (the “ ‘439 application”) entitled “Modified Heat Shock Protein-Antigenic Peptide Complex ” and filed on February 19, 1999; serial number 11/878,460 (the “ ‘460 application”) entitled “Recombinant Cancer Cell Secreting Modified Heat Shock Protein-Antigenic Peptide Complex” and filed on July 24, 2007; and all U.S. patents and foreign patents and patent applications based on these U.S. applications; as well as all divisionals, continuations,  and those claims in continuations-in-parts (to the extent they are sufficiently described in the ‘358, ‘439, or ‘460 applications) of the foregoing, and any re-examinations or reissues of the foregoing (the “GP96 Vaccine Technology Portfolio”)

As consideration for the rights granted in the license agreement, the licensee is obligated to pay the University upfront license fees, additional yearly and milestone payments and a royalty based on net sales of products covered by the patent-related rights set forth above. More specifically, the licensee is obligated to pay the University (i) all past and future patent costs associated with the licensed patent-related rights; (ii) a license issue fee of $150,000; (iii) annual payments  of $10,000 in 2010, 2011 and 2012, and $20,000 each year thereafter; (iv) a milestone payment of $250,000 by the earlier of May 31, 2017 or approval of a BLA for the lung cancer vaccine or for a cancer vaccine other than lung cancer; and (v) royalties equal to a percent (ranging from low to mid single digits ) of net sales of licensed products.  The royalty rate is subject to reduction if additional license rights from third parties are required to commercialize licensed products.  In the event of a sublicense to a third party, Heat Biologics I, Inc. is obligated to pay royalties to the University equal to a percentage  of what it would have been required to pay to the University had it sold the products under sublicense itself.  In exchange for additional consideration, the University has agreed to postpone the payment due dates of this license agreement.  To date, a total of $360,113 has been paid to the University with respect to such license agreement. The license agreements provide that the licensor has the right to terminate the license if we have not introduced, or at least used our best efforts to introduce, a licensed product in the commercial marketplace in the US, EU, or Japan by December 31, 2020; and otherwise exercise diligence to bring licensed products to market or in the event of our insolvency or bankruptcy.  In addition, either party has a right to terminate the license agreement upon a material breach of an obligation under the license agreement by the other party if such breach is not cured and we have the right to terminate upon 90 days notice.  In the event of a termination, we are obligated to pay all amounts that accrued prior to such termination.  In the event

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that we breach a material term of one or both of the license agreements, the University has the option to terminate the agreement following the giving of notice and an opportunity to cure any such breach.  The license agreement also contains other customary clauses and terms as are common in similar agreements between industry and academia.  

In February 2011, our subsidiary, Heat Biologics I, Inc., entered into four additional exclusive license agreements with the University. The terms of each of these additional licenses runs until all the patent-related rights licensed therein have expired, unless terminated earlier.  In each of these additional exclusive license agreements, Heat Biologics I, Inc. obtained exclusive, worldwide rights to make, use or sell products covered under the following patent-related rights:

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U.S. patent application serial number 61/347,336 entitled “Cancer Treatment” and filed on May 21, 2010, all U.S. patents and foreign patents and patent applications based on these U.S. applications; as well as all divisionals, continuations, and those claims in continuations-in-parts (to the extent they are sufficiently described in the applications) of the foregoing, and any re-examinations or reissues of the foregoing (the “Cancer Treatment Portfolio”).

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U.S. patent application serial number 61/033,425 entitled “Allogeneic Cancer –Based Immunotherapy” and filed on March 3, 2008 and PCT  application number PCT/2009/001330 “Allogeneic Cancer –Based Immunotherapy” filed on March 3, 2009, all U.S. patents and foreign patents and patent applications based on these U.S. applications as well as all divisionals, continuations, and those claims in continuations-in-parts (to the extent they are sufficiently described in the applications) of the foregoing, and any re-examinations or reissues of the foregoing (the “Allogeneic Cancer –Based Immunotherapy Portfolio”).

·

U.S. patent application serial number 61/033,425 entitled “Heat Shock Protein GP96 Vaccination and Methods of Using Same” filed on March 20, 2008 and PCT application number PCT/ 2009/001727 “Heat Shock Protein GP96 Vaccination and Methods of Using Same “filed on March 19, 2009, all U.S. patents and foreign patents and patent applications based on these U.S. applications as well as all divisionals, continuations,  and those claims in continuations-in-parts (to the extent they are sufficiently described in the applications) of the foregoing, and any re-examinations or reissues of the foregoing (the “Heat Shock Protein GP96 Vaccination Portfolio”).

·

U.S. patent application serial number 61/116.971 entitled “HIV/SIV Vaccine for the Generation of Mucosal and Systemic Immunity” filed November 28, 2008 and PCT application number PCT/ 2009/065500” “HIV/SIV Vaccine for the Generation of Mucosal and Systemic Immunity” filed on November 23, 2009 all U.S. patents and foreign patents and patent applications based on these U.S. applications as well as all divisionals, continuations, and those claims in continuations-in-parts (to the extent they are sufficiently described in the applications) of the foregoing, and any re-examinations or reissues of the foregoing (the “HIV/SIV Vaccine Portfolio”).

As consideration for the rights granted in these additional four license agreements, the licensee is obligated to pay the University certain upfront license fees, past and future patent costs and royalties based on net sales on commercialized products covered by the patent-related rights set forth above. No annual or milestone payments are required under any of these four additional license agreements. The upfront license fees for the Cancer Treatment Portfolio and the HIV/SIV Vaccine Portfolio license agreements are $10,000 and $50,000, respectively.  No upfront license fees were required under the license agreements for the Allogeneic Cancer–Based Immunotherapy and the Heat Shock Protein GP96 portfolios.  Under each of these four additional license agreements, the royalties are equal to a percent (ranging from low to mid single digits) of net sales of products covered by the patent-related rights in the respective license agreements. These royalty rates are subject to reduction if additional license rights from third parties are required to commercialize licensed products.  In the event of a sublicense to a third party, Heat Biologics I, Inc. is obligated to pay royalties to the University equal to a percentage of what it would have been required to pay to the University had it sold the products under sublicense itself.  Each of these additional license agreements also provide that the licensee will not have to pay more than above royalty rates and sublicense fees if more than one license from the University is required to sell products covered by the licensed patent-related rights.  In exchange for additional consideration (including the requirement that Heat Biologics I, Inc. pay additional milestone payments of

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$25,000 before initiation of any phase III clinical trials for products covered by any of the license agreements, and an additional payment equal to 18% annual interest on the amounts due or a note convertible into an equivalent value of shares in Heat’s Preferred Stock), the University agreed to postpone the payment due dates for each of these four additional licenses.  On April 26, 2013, the outstanding balances to the University under the license agreements were paid in full.

All five of the above-described license agreements provide that the licensor has the right to terminate a subject license if the licensee has (i) not introduced, or at least use it best efforts to introduce, a licensed product in the commercial marketplace in the US, EU, or Japan by December 31, 2020; (ii) not  otherwise exercise diligence to bring licensed products to market; or (iii) files, or has filed against it, a proceeding under the Bankruptcy Act, is adjudged insolvent, makes an assignment for the benefit of its creditors, or has an unreleased or unsatisfied writ of attachment or execution levied upon it.  In addition, upon an uncured material breach of an obligation under any one of these license agreements by a party, the other party has the right to terminate that agreement upon 90 days notice or 30 days notice if the breach relates to payments due to the University.  In the event of a termination, Heat Biologics I, Inc. will be obligated to pay all amounts that accrued prior to such termination.   Each of the license agreements also contains other customary clauses and terms as are common in similar agreements between industry and academia, including the licensee’s agreement to indemnify the University for liabilities arising out of the negligence of licensee, making the license grant subject to the Bayh-Dole act (35 U.S.C. 200 et seq.), the reservation of licensor of the right to use the licensed intellectual property rights for its internal, non-commercial purposes, limitations/disclaimers of various warranties and representations, reporting and record-keeping requirements, and licensee liability insurance requirements.

In April 2013, we entered into an agreement with the University under which the University granted us an option to obtain an exclusive license to the following patent-related rights:

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U.S. patent application serial number 12/303,036 entitled “Perforin-2 Proteins” filed December 2, 2008  and  U.S. patent application serial number 61/637.455  entitled “Perforin-2 Defense Against Invasive and Multi-drug Resistant Bacteria” filed Modified Heat Shock Protein-Antigenic Peptide Complex ” and filed on April 21, 2012; all U.S. patents and foreign patents and patent applications based on these U.S. applications; as well as all divisionals, continuations, and those claims in continuations-in-parts (to the extent they are sufficiently described in the aforementioned applications) of the foregoing, and any re-examinations or reissues of the foregoing.

In consideration for the option, we are obligated to pay the University an option fee of $2,000 and to reimburse the University $3,000 for past patent costs. The term of the option is twelve months and is extendible so long as we continue to pay ongoing patent expenses.

In addition to the licenses obtained from the University, we have entered into agreements with (i) the Regents of the University of Michigan (“U.Mich”); and (ii) the American Type Culture Collection (“ATCC”) for the evaluation of, acquisition of commercial rights to, certain biological materials.

In July 2011, we exercised an option agreement with U.Mich and entered into an exclusive license agreement with U.Mich to use, market, offer for sale, sell and/or sublicense materials and processes related to certain bladder cancer cell lines. The term of the license is perpetual, unless terminated earlier by us or by U.Mich.  As consideration for the rights granted in the license agreement, we agreed to pay U.Mich up-front license fees and additional yearly and milestone payments. We also assumed under the license agreement responsibility for any infringement of third party rights caused by our use of the licensed materials. We paid an option fee of $2,000, a license issue fee of $10,000 and are obligated to pay an annual maintenance fee of $10,000 each year until the first commercial sale of a licensed product at which time the annual maintenance fee increases to $50,000. In addition, we are obligated to make milestone payments of $25,000, $50,000 and $75,000 upon completion of a Phase I, Phase II and Phase III trial and $250,000 upon the first commercial sale of a licensed product and $350,000 upon annual net sales of $250,000,000 or more.  To date, we have paid $22,000 to U.Mich. with respect to such license. The license agreements provide that the licensor has the right to terminate the license should we cease to carry on our business, fail to make a required payment or otherwise materially breach or default in our obligations under the license agreement following the giving of notice and an opportunity to cure any such breach.  The license agreement provides that if we do not achieve the following milestones within the required period, U.Mich has the right to terminate the license

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agreement: completion of a Phase I clinical trial on or before January 1, 2015, a Phase II clinical trial on or before January 1, 2017, a Phase III clinical trial on or before January 1, 2019 and the first commercial sale of a product that includes the materials supplied by U.Mich on or before January 1, 2020.  The license agreement also contains other customary clauses and terms as are common in similar agreements between industry and academia.  

In April 2011 we entered into an evaluation and biological material license agreement with the ATCC to evaluate, use, market, offer for sale, sell and/or sublicense materials and processes related to various different cell lines.  The agreement with ATCC provides for an evaluation term of twelve months subject to two additional twelve-month renewals and a non-exclusive commercial use license upon termination of the evaluation period to utilize the products we obtain in the evaluation to develop, make, use and sell licensed products. The agreement with ATCC has a term of forty years.  We paid an evaluation fee of $5,000, two $5,000 evaluation fees, and are obligated to pay a license issue fee of $50,000 and a percent of net sales (low single digits) based on sales of licensed products.  In addition, we are obligated to make milestone payments of $15,000, $30,000 and $60,000 upon initiation of a Phase I, Phase II, and Phase III trial, respectively; and $200,000 upon receipt of marketing authorization.  To date, we have paid $15,000 to the ATCC with respect to such license.

Under the license agreements with the University, we have obtained exclusive rights to five different patent families directed to therapeutic compositions and methods related to our vaccine platform and preclinical development program for cancer.  These families comprise five PCT applications, seven granted patents, sixteen patent validations in European countries, one allowed patent application and thirty seven other pending patent applications. These patents and applications cover the United States, Europe and Japan as well as several other countries having commercially significant markets. For each platform or program, our decision to seek patent protection in specific foreign markets, in addition to the U.S., is based on many factors, including one or more of the following: our available resources, the size of the commercial market, the presence of a potential competitor or a contract manufacturer in the market and whether the legal authorities in the market effectively enforce patent rights. The patent families associated with our ImPACT platform are:

“Recombinant cancer cell secreting modified heat shock protein-antigenic peptide complex.”

This family of patent filings relates to methods and compositions for enhancing an immune response.  More particularly, the application describes the creation of a tumor cell therapy including a cancer cell that has been engineered to secrete a heat shock protein (gp96), and the use of such therapy to enhance an anti-tumor immune response.  Within this family are one pending US application, one granted Australian patent, one pending Canadian application, one pending European application, two granted European patents (collectively validated in 16 countries), one pending Japanese application, and one granted Japanese patent. Not including any patent term adjustments or extensions (e.g., for patent office delays or extensions/exclusivity periods provided for new drug approvals in the US and some foreign countries), the term for patents in this family extends until 2019.

“Heat Shock Protein gp96 Vaccination and Methods of Using Same”

This family of patent filings also relates to methods and compositions for enhancing an immune response.  It further describes: (a) how intraperitoneal gp96-Ig administration increases recruitment of innate immune cells into the administration site, mediates proliferation of dendritic cells (DCs) and CD8 cells, and activates natural killer (NK) cells; (b) that gp96-Ig-secreting cell vaccines are more effective when gp96-Ig is continuously released; (c) that frequent gp96 immunizations can overcome tumor-induced immune suppression and retards tumor growth; and (d) that B cell depletion can enhance gp96-Ig -mediated recruitment of NK cells and retention of DCs in the administration site. Within this family are one granted Australian patent, and one pending application each in the U.S., Canada, China, Europe, Israel, India, Japan, South Korea, and Hong Kong.  Not including any patent term adjustments or extensions, the term for patents in this family extends until 2029.

“Allogenic Cancer Cell Based Immunotherapy”

This family of patent filings also relates to methods and compositions for enhancing an immune response. It further describes: (a) making vaccines cells allogeneic by expressing exogenous major histocompatibility complex (MHC) antigens; (b) B cell depletion to augment the effectiveness of the vaccines; and (c) the enhancement of anti-tumor immune responses using multiple immunizations less than two weeks apart. Within this family are one granted

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Australian patent, one allowed U.S. application, and one pending application each in Canada, China, Europe, Israel, India, Japan, and South Korea.  Not including any patent term adjustments or extensions, the term for patents in this family extends until 2029.

“Cancer Treatment”

This family of patent filings contains results from a phase I clinical trial of human subjects with cancer. Within this family are one pending application each in the U.S., Australia, China, Europe, India, Israel, Japan, and South Korea.  Filings in Canada and Hong Kong are intended to be made before the respective deadlines.  Not including any patent term adjustments or extensions, the term for patents in this family extends until 2031.

“HIV/SIV Vaccines to Generate Mucosal and Systemic Immunity” Within this family are one allowed South African application, and one pending application each in the U.S., Australia, Canada, China, Europe, India, the Philippines, Singapore, and Hong Kong.  Not including any patent term adjustments or extensions, the term for patents in this family extends until 2029.

This patent family relates to the use of host cells that have been engineered to secrete a heat shock protein (gp96) to treat various chronic viral infections including those caused by HIV.

Government Regulation

In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, (“FDCA”), and its implementing regulations.  Neither HS-110, HS-310, HS-410 or HS-510 nor our future therapeutics, if any, may be marketed in the United States until they received FDA approval.  The steps required before a therapeutic, including may be marketed in the United States include:

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preclinical laboratory tests, animal pharmacology and toxicology studies, and formulation studies;

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submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials might begin;

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adequate and well-controlled human clinical trials to establish the safety and efficacy of the therapeutic for each indication;

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submission to the FDA of a BLA;

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FDA review and approval of the BLA; and

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the therapeutic is produced to assess compliance with current good manufacturing practices(GMPs).

Preclinical tests include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies.  The conduct of the preclinical tests and formulation of the compounds for testing must comply with federal regulations and requirements.  The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND, which must become effective before human clinical trials might begin.  An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct of the trials as outlined in the IND.  In such a case, the IND sponsor and the FDA must resolve any outstanding FDA concerns or questions before clinical trials can proceed.  Our Phase I clinical trials for HS-110 began on July 2007 and we have an open IND to begin a Phase II clinical trial. We were formed in 2008.  We cannot be sure that submission of any future IND for another therapeutic study will result in the FDA allowing clinical trials to begin.  

Clinical trials involve the administration of the investigational drug or therapeutic to human subjects under the supervision of qualified investigators.  Clinical trials are conducted under protocols detailing the objectives of the study, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated.  Each protocol must be submitted to the FDA as part of the IND.

Clinical trials typically are conducted in three sequential phases, although the phases might overlap.  The study protocol and informed consent information for study subjects in clinical trials must also be approved by an

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institutional review board for each institution where the trials will be conducted.  Study subjects must sign an informed consent form before participating in a clinical trial.  

Phase I usually involves the initial introduction of the investigational drug or therapeutic into humans to evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics and pharmacologic actions, and, if possible, to gain an early indication of its effectiveness.  Our Phase I study for HS-110 was designed to determine the safety of HS-110 for use in human patients and secondary endpoints included immune response and increased survival.  We met our primary endpoint and are in the process of initiating a Phase II clinical trial. Phase II usually involves trials in a limited patient population to:

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evaluate dosage tolerance and appropriate dosage;

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identify possible adverse effects and safety risks; and

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evaluate preliminarily the efficacy of the drug or therapeutic for specific indications.

Phase III trials usually further evaluate clinical efficacy and test further for safety by using the drug or therapeutic in its final form in an expanded patient population.  There can be no assurance that Phase I, Phase II, or Phase III testing will be completed successfully within any specified period of time, if at all.  Further, clinical trials might be suspended by us or the FDA at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

The FDCA permits the FDA and the IND sponsor to agree in writing on the design and size of clinical studies intended to form the primary basis of an effectiveness claim in a BLA application.  This process is known as Special Protocol Assessment, or SPA.  These agreements may not be changed after the clinical studies begin, except in limited circumstances.

Assuming successful completion of the required clinical testing, the results of the preclinical studies and of the clinical studies, together with other detailed information, including information on the manufacture and composition of the drug, are submitted to the FDA in the form of a BLA requesting approval to market the product for one or more indications.  The testing and approval process requires substantial time, effort, and financial resources.  The FDA reviews the application for adequacy.  We cannot be sure that any approval will be granted on a timely basis, if at all.  The FDA might also refer the application to the appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation as to whether the application should be approved.  The FDA is not bound by the recommendations of the advisory committee.

The FDA has various programs, including fast track, priority review, and accelerated approval, that are intended to expedite or simplify the process for reviewing drugs, or provide for approval on the basis of surrogate endpoints.  Generally, drugs that might be eligible for one or more of these programs are those for serious or life-threatening conditions, those with the potential to address unmet medical needs, and those that provide meaningful benefit over existing treatments.  We cannot be sure that, if desired, any of our therapeutics will qualify for any of these programs, or that, if a therapeutic does qualify, that the review time will be reduced.

Section 505(b)(2) of the FDCA allows the FDA to approve a follow-on drug or therapeutic on the basis of data in the scientific literature or data used by FDA in the approval of other drugs.  This procedure potentially makes it easier for generic drug manufacturers to obtain rapid approval of new forms of therapeutics based on proprietary data of the original drug manufacturer.

Before approving a BLA, the FDA usually will inspect any facility at which the drug or therapeutic is manufactured, and will not approve the product unless cGMP compliance is satisfactory.  If the FDA evaluates the BLA and the manufacturing facilities as acceptable, the FDA might issue an approval letter, or in some cases, an approvable letter followed by an approval letter.  An approval letter usually contains a number of conditions that must be met in order to secure final approval of the BLA.  When and if those conditions have been met to the FDA’s satisfaction, the FDA will issue an approval letter.  The approval letter authorizes commercial marketing of the drug or therapeutic for specific indications.  As a condition of BLA approval, the FDA might require postmarketing testing and surveillance to monitor the drug’s or therapeutics’ safety or efficacy, or impose other conditions.

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After approval, certain changes to the approved product, such as adding new indications, making certain manufacturing changes, or making certain additional labeling claims, are subject to further FDA review and approval.  Before we could market any product for additional indications, we would have to obtain additional approvals from the FDA.  Obtaining approval for a new indication generally requires that additional clinical studies be conducted.  We cannot be sure that additional approval for new indications, if any, will be approved on a timely basis, or at all.

Post-Approval Requirements

Even after a drug or therapeutic has been approved by the FDA for sale, the FDA might require that certain post-approval requirements be satisfied, including the conduct of additional clinical studies.  If such post-approval conditions are not satisfied, the FDA might withdraw its approval of the drug or therapeutic.  In addition, holders of an approved BLA are required to:

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report certain adverse reactions to the FDA;

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comply with certain requirements concerning advertising and promotional labeling for their products; and

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continue to have quality control and manufacturing procedures conform to cGMP after approval.

The FDA periodically inspects the sponsor’s records related to safety reporting or manufacturing facilities, including an assessment of compliance with cGMP.  Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance.  We intend to use third party manufacturers to produce our products in clinical and commercial quantities, and future FDA inspections might identify compliance issues at the facilities of our contract manufacturers that could disrupt production or distribution, or require substantial resources to correct.  

In addition, discovery of problems with a product or noncompliance with regulatory requriements and standards after approval might result in restrictions on a product, manufacturer, or holder of an approved BLA, including withdrawal of the product from the market.  

Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, imposition of post-market studies or clinical trials to assess new safety risks or imposition of distribution or other restrictions under a Risk Evaluation and Mitigation Strategy program. Other potential consequences include, among other things:

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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

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fines, warning letters or holds on post-approval clinical trials;

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refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

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product seizure or detention, or refusal to permit the import or export of products; or

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consent decrees, injunctions or the imposition of civil or criminal penalties.

Anti-kickback and false claims laws

In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices in the pharmaceutical industry in recent years. These laws include anti-kickback statutes and false claims statutes. The federal healthcare program anti-kickback statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other. Violations of the anti-kickback statute

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are punishable by imprisonment, criminal fines, civil monetary penalties and exclusion from participation in federal healthcare programs. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to have a false claim paid. Recently, several pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. In addition, certain marketing practices, including off-label promotion, may also be found to violate false claims laws. The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payer.

Orphan Drug Designations

The FDA may grant orphan drug designation to drugs or therapeutics intended to treat a “rare disease or condition,” which generally is a disease or condition that affects fewer than 200,000 individuals in the U.S. Orphan drug designation must be requested before submitting a BLA.  If the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are publicly disclosed by the FDA.  Orphan drug designation does not convey an advantage in, or shorten the duration of, the review and approval process.  If a product that has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan exclusivity, meaning that the FDA might not approve any other applications to market the same drug or therapeutic for the same indication, except in certain very limited circumstances, for a period of seven years.  Orphan drug designation does not prevent competitors from developing or marketing different drugs or therapeutics for that indication.

We have not applied for orphan drug designation for HS-110.  We may apply for orphan drug designation for HS-310, HS-410 and HS-510 if the results of their respective Phase I clinical trials are positive.  We have not established a timeline for such applications.

Subpart H Approval

The FDA may grant marketing approval of a drug or therapeutic under its subpart H regulations.  This program makes it possible for a drug or therapeutic candidate for a life-threatening disease to be approved more quickly than the normal application process.  Approval is based on a surrogate endpoint or on restrictions to ensure safe usage.

The FDA may grant marketing approval for a new drug or therapeutic on the basis of one or more adequate and well-controlled clinical trials that establish that the drug or therapeutic has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.  Approval is subject to the requirement that the applicant study the drug or therapeutic further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome.  Post-marketing studies generally would be studies already underway.  When required to be conducted, such studies must also be adequate and well-controlled.

If the FDA concludes that a drug or therapeutic shown to be effective can be safely used only if distribution or use is restricted, it will require such post-marketing restrictions as it deems necessary to assure safe use of the drug or therapeutic product, such as:

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distribution restricted to certain facilities or physicians with special training or experience; or

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distribution conditioned on the performance of specified medical procedures.

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The limitations imposed would be commensurate with the specific safety concerns presented by the drug or therapeutic.

Non-U.S. Regulation

Before our products can be marketed outside of the U.S., they are subject to regulatory approval of the respective authorities in the country in which the product should be marketed.  The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widely from country to country.  No action can be taken to market any product in a country until an appropriate application has been approved by the regulatory authorities in that country.  The current approval process varies from country to country, and the time spent in gaining approval varies from that required for FDA approval.  In certain countries, the sales price of a product must also be approved.  The pricing review period often begins after market approval is granted.  Even if a product is approved by a regulatory authority, satisfactory prices might not be approved for such product.

In Europe, marketing authorizations may be submitted at a centralized, a decentralized or national level.  The centralized procedure is mandatory for the approval of biotechnology products and provides for the grant of a single marketing authorization that is valid in all European Union member states.  As of January 1995, a mutual recognition procedure is available at the request of the applicant for all medicinal products that are not subject to the centralized procedure.  There can be no assurance that the chosen regulatory strategy will secure regulatory approvals on a timely basis or at all.

While we intend to market our products outside the United States in compliance with our respective license agreements, we have not made any applications with non-U.S. authorities and have no timeline for such applications or marketing.  

Research and Development

We have built an internal and external research and development organization that includes expertise in discovery research, preclinical development, product formulation, analytical and medicinal chemistry, manufacturing, clinical development and regulatory and quality assurance. We engage third parties on a limited basis to conduct portions of our preclinical research; however, we are not substantially dependent upon any third parties for our preclinical research nor do any of these third parties conduct a major portion of our preclinical research. Research and development expenses were $902,938 and $1,246,587 during the years ended December 31, 2012 and 2011, respectively. 

Employees

As of May 1, 2013, we had a total of 12 employees and consultants, of which 6 are full-time employees and 6 are part-time employees or consultants.  We believe our relationships with our employees are satisfactory.  None of our employees is represented by a labor union. We anticipate that we will need to identify, attract, train and retain other highly skilled personnel to pursue our development program.  Hiring for such personnel is competitive, and there can be no assurance that we will be able to retain our key employees or attract, assimilate or retain the qualified personnel necessary for the development of our business.

Facilities

We lease approximately 2,111 square feet of office space in Chapel Hill, North Carolina under a lease that expired December 31, 2012, which could be extended for an additional 24 months on substantially the same terms. The monthly lease payments for these facilities, including common area maintenance and related operating expenses, were approximately $3,870. On December 19, 2012, we entered into a lease modification agreement that extended the lease term until July 31, 2013 and the monthly rent was increased to $4,046. Based on our current operational plans, we believe that such facilities are adequate for our operations for the near future.

Legal Proceedings

There are currently no pending legal proceedings against the company or its subsidiaries.

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MANAGEMENT AND BOARD OF DIRECTORS

Board of Directors

Our business and affairs are organized under the direction of our board of directors, or our Board, which currently consists of five members. The primary responsibilities of our board are to provide oversight, strategic guidance, counseling and direction to our management. Our Board meets on a regular basis and additionally as necessary.

Executive Officers and Board of Directors

All of the officers listed above are full-time employees of the Company other than Dr. Silberman and Dr. Harris who work on a part-time basis.

Jeffrey Wolf, Chairman, Chief Executive Officer, Chief Financial Officer and Director

Mr. Wolf founded Heat Biologics in August, 2008.  Prior to founding Heat, from June 1997 to March 2011, Mr. Wolf has served as managing director at Seed-One Ventures, LLC a medically-focused venture capital firm.  Since founding Seed-One, Mr. Wolf has founded and run several medical companies. Mr. Wolf’s start-ups include Avigen, a San Francisco-based gene therapy company where he was a co-founder and director; TyRx Pharma, a Princeton-based company focused on the development of bio-compatible polymers where he was a co-founder and Chairman; EluSys Therapeutics, a New Jersey company focused on the development of a novel technology to remove blood-borne pathogens where he was a co-founder, Chairman and Chief Executive Officer; and GenerationOne, a Miami-based company focused on mobile-based collaborative care, where he was the founder, Chairman and Chief Executive Officer.  Mr. Wolf received his M.B.A. from Stanford Business School, his J.D. from New York University School of Law and his B.A. from the University of Chicago, where he graduated with honors in Economics.  Mr. Wolf serves as a director of several Seed-One portfolio companies and serves as a director of Synthetic Biologics, Inc., a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses.

We selected Mr. Wolf to serve on our Board as our chairman because he brings to the board extensive knowledge of the pharmaceutical and biotechnology industries. Having served in senior corporate positions in several biomedical companies, he has a vast knowledge of the industry and brings to the board significant executive leadership and operational experience. His business experience provides him with a broad understanding of the operational, financial and strategic issues facing public companies and his service on other public company boards provides him with extensive corporate governance knowledge.

Sandra Silberman, MD, Ph.D., Chief Medical Officer

Dr. Silberman began her career in clinical development at Pfizer, Inc., where from 1992-1999 she initiated the company's first program in clinical oncology and oversaw the introduction of Tarceva™ into clinical trials. From 2000-2004, she served as Senior Director for Novartis Clinical Research, where she led the global development of Gleevec(TM), a highly innovative drug and the first targeted therapy for chronic myelogenous leukemia. Dr. Silberman then joined Eisai Medical Research as Global Therapeutic Area Head (Oncology) in 2004 until 2006,

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a role in which she advanced six novel compounds into Phases I through III of clinical development. From 2009 until 2013, Dr. Silberman has served as Vice-President of Quintiles.

Dr. Silberman received her Ph.D. in Tumor Immunology from Johns Hopkins University and her M.D. from Cornell University Medical College. She completed a fellowship in hematology/oncology at the Brigham & Women's and the Dana Farber Cancer Institute in Boston. She has numerous publications and is named on several patents in the cancer drug development field, including novel anti-tubulin agents for advanced solid tumors. She is board certified in Internal Medicine and Hematology.

Jennifer Harris, Pharm.D, Vice President of Clinical and Regulatory Affairs

Dr. Harris is responsible for coordinating the clinical development and operational efforts at Heat Biologics. Dr. Harris has over 20 years of oncology-focused clinical trial experience within the pharmaceutical and biotechnology industries and academic clinical research settings. In 2010 until joining Heat Biologics in 2011, she served as a Medical Science Liaison for Dendreon Corporation, where she was instrumental in coordinating Phase IV clinical trials of sipuleucel-T (Provenge), the first approved autologous cellular immune therapy to treat prostate cancer. From 2009-2010 while at Novaquest, Dr. Harris lead international, multi-disciplinary teams providing operational trial oversight for early-stage compounds, including protocol development, study report preparation, investigator brochure preparation, regulatory submissions, recruitment of investigator sites, and establishment of clinical trial budgets. From 2006-2008, Dr. Harris was Medical Science Liaison at Celgene Corporation, where she helped conduct multiple clinical trials. She has worked on over 20 IND programs from Phase I-III, as well as several NDAs.

Dr. Harris received her B.S. and Pharm.D. from the University of North Carolina at Chapel Hill. She has also written multiple clinical publications and meeting abstracts.

Vadim V. Deyev, M.D., Ph.D., Director of Applied Research

Dr. Deyev joined Heat Biologics in January 2009 as Director of Applied Research. Prior to joining Heat Biologics, Dr. Deyev worked from 2006-2008 as Associate Scientist of Microbiology and Immunology and Hybridoma and Fusion Protein Core Director at the University of Miami School of Medicine. Working with Dr. Eckhard Podack, Heat Biologics’ Scientific Advisor and Chairman of its Scientific Advisory Board, Dr. Deyev has made major contributions to the development of technologies later licensed by the Company.  Since 2001, Dr. Deyev has authored numerous publications on immunology and oncology based upon his work with Dr. Podack at the University of Miami. Dr. Deyev joined the team at University of Miami in 1996 until present, after leading the Immunopharmacology Group at the Cancer Research Center in Moscow, Russia Dr. Deyev received his Ph.D. in Immunology/Oncology from Cancer Research Center in Moscow, Russia and his M.D. from Russian State Medical University.

John Monahan, Ph.D., Director

Dr. Monahan is currently the Chief Technology Officer of Synthetic Biologics, Inc., a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses. Dr. Monahan Co-Founded Avigen Inc. (NASDAQ:AVGN) in 1992, a company which has become a leader in its sector for the development of novel pharmaceutical products for the treatment of serious human diseases. Over a 12 year period as CEO of Avigen he raised over $235M in several private and public financings including its IPO. From 1989-1992, he was VP of R&D at Somatix Therapy Corp., Alameda, CA and from 1985-1989 he was Director of Molecular & Cell Biology at Triton Biosciences Inc., Alameda, CA. Prior to that from 1982-1985, he was Research Group Chief, Department of Molecular Genetics, Hoffmann-LaRoche, Inc. Nutley, NJ, and from 1975 to 1977 he was an Instructor at Baylor College of Medicine, Houston TX. He received his Ph.D. in Biochemistry in 1974 from McMaster University, Canada and his B.Sc. from University College Dublin, Ireland in 1969. Dr Monahan is a board member of Tacere Therapeutics, CA. He is also a board member of a number of Irish biotech companies including Genable, Cellix, Luxcel, Identigen, Pharmatrin and GK Technologies.

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We selected Dr. Monahan to serve on our Board because he brings to the board extensive knowledge of the pharmaceutical and biologics industry. Having served in senior corporate positions in many medical companies he has a vast knowledge of the industry.

Paul Belsky, M.D., Director

Dr. Belsky has served on our Board since November 2009.  Dr. Belsky is currently a medical and scientific advisor at Seed-One Ventures and has been a partner at Concorde Medical Group, LLC since June of 1998.  Dr. Belsky served as a scientific advisor to Elusys Therapeutics, Sensatex, GenerationOne and TyRx Pharma.  Dr. Belsky has extensive expertise in the clinical practice of internal medicine and cardiovascular diseases, and was formerly on the clinical academic faculty at Weill College of Medicine, Cornell University. He is a fellow of the American College of Cardiology and the American College of Chest Physicians, is a member of the American College of Physicians, and a Clinical Assistant Professor of Medicine at New York University School of Medicine.  Dr. Belsky received his MD from the University of California at San Francisco, and his AB in Biology from Brown University, where he was elected Phi Beta Kappa.

We selected Dr. Belsky to serve on our Board because he brings to the board extensive knowledge of the medical industry. His medical background aids in the understanding of the detailed science behind our intellectual property.

Michael Kharitonov, Ph.D., Director

Dr. Kharitonov has been the Chief Executive Officer of Voleon Capital Management, an investment management firm, since July 2007 until present. He is a high technology entrepreneur and computer scientist whose areas of expertise include advanced computer and communication technologies and quantitative finance. Dr. Kharitonov is a founder and CEO of Voleon Capital Management LLC. Dr. Kharitonov was a co-founder and former Chairman and CEO of Netli, Inc., a successful Silicon Valley startup that pioneered the development of Application Delivery Networks. Under Dr. Kharitonov’s leadership Netli raised over $20 million in venture financing from a number of Silicon Valley’s best known venture capital firms. In 2007 Netli was acquired by Akamai Technologies (NASDAQ: AKAM). Dr. Kharitonov also served as a Vice President of D. E. Shaw and Co., an international investment firm known as one of the most quantitatively advanced and computerized securities trading firms in the world.  Dr. Kharitonov holds a Ph.D. degree from the Department of Computer Science at Stanford University. At Stanford he was awarded a Hertz Fellowship and was a winner of several scholarly awards. He also holds a B.A. in Computer Science and Mathematics with highest honors from University of California at Berkeley.

We selected Dr. Kharitonov to serve on our Board because he brings a strong start-up and finance background to the Company, and adds significant strategic, business and financial experience.  His prior successful management experience and fundraisings provides him with a broad understanding issues faced by growing companies and of the financial markets and the financing opportunities available to us.

Edward B. Smith, Director

Since April 2005, Mr. Smith has been the Managing Partner of Brightline Capital Management, LLC (“BCM”), a New York-based investment firm founded in 2005. BCM is the investment manager of Brightline Ventures I, LLC, Brightline Ventures II, LLC, Brightline Ventures III, LLC and Brightline Capital Partners, LP. Prior to founding BCM, Mr. Smith worked at Gracie Capital from 2004-2005, GTCR Golder Rauner from 1999-2001 and Credit Suisse First Boston from 1997-1999.  Mr. Smith holds a Bachelor of Arts in Social Studies from Harvard College and a Masters in Business Administration from Harvard Business School.  He is currently a Director of Z Trim Holdings Inc (OTC:ZTHO), a manufacturer of environmentally friendly agricultural functional ingredients.

We selected Mr. Smith to serve on our Board because he brings a strong business background to the Company, and adds significant strategic, business and financial experience.  Mr. Smith’s business background provides him with a broad understanding of the issues facing us, the financial markets and the financing opportunities available to us. His service on other public company boards provides him with extensive corporate governance knowledge and insight into issues faced by companies similar to ours.

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Scientific Advisory Board

In addition to our Board, we also have a scientific advisory board comprised of six individuals. The Scientific Advisory Board is responsible for providing scientific advice and for assessing the scientific progress of our research and development efforts.  We have entered into written agreements and confidentiality agreements with all of our members of our Scientific Advisory Board.  The members of our Scientific Advisory Board are compensated for their services. Drs. Allison, Stebbing and Nemunaitis are each entitled to receive $1,500 per board meeting in addition to a reimbursement for travel and related.  In addition, Drs. Allison, Stebbing and Von Hoff each received options to purchase 15,000 shares of our common stock, which options vest over a four year period.  Dr. Von Hoff is entitled to receive $4,000 per onsite advisory board meeting, $2,000 per telephonic meeting and an hourly rate of $500 per hour for consultative discussions with management.  Dr. Podack receives consulting fees equal to $3,125 per month subject to increase to $4,167 per month.

Eckhard Podack, M.D., Ph.D., Scientific Advisor and Chairman, Scientific Advisory Board

Dr. Podack, the inventor of the Company’s technology, serves as Chairman of its Scientific Advisory Board.  Dr. Podack received his medical degree from the Johan Wolfgang Goethe University in Frankfurt in 1968 and his Medical License in 1970. Following service in the German Army as Captain and Battalion Physician, he completed his Ph.D. in the field of Biochemistry at the Georg August University in Gottingen. From 1974-1984 he studied Immunology at the Scripps Clinic and Research Foundation in La Jolla CA where he received an Established Investigatorship from the American Heart Association. Dr. Podack is the discoverer of Perforin and well recognized as the “Father” of the field of core forming proteins.  Dr. Podack is the Sylvester Distinguished Professor of Microbiology & Immunology and Medicine and Chairman of the Department of Microbiology at the University of Miami, Miller School of Medicine.

James Allison, Ph.D., Scientific Advisor

Dr. Allison is a leader in the field of immunology, particularly in developing ways to help the immune system recognize and destroy cancer cells. His research is focused on the mechanisms that regulate the immunological response of T lymphocytes, especially strategies to manipulate those responses in clinically relevant areas, including autoimmunity, allergies, vaccinations, and tumor therapy. Dr. Allison is Chairman of the Immunology Program, Director of the Ludwig Center for Cancer Immunotherapy, Attending Immunologist, and David H. Koch Chair in Immunologic Studies at Memorial Sloan-Kettering Cancer Center in New York City.

Sol Barer, Ph.D., Scientific Advisor

Dr. Barer is the former Chairman and Chief Executive Officer of Celgene Corp., a global biopharmaceutical company engaged in the discovery, development, and commercialization of novel therapies for the treatment of cancer and inflammatory diseases. Dr. Barer has spent the last 20 years with Celgene and its predecessor, Celanese Research Company, serving as President, COO, CEO, Senior Vice President of Science and Technology, and Vice President/General Manager of the Chiral Products Division. Dr. Barer received his B.S. from Brooklyn College and his Ph.D. in organic chemistry from Rutgers University.  

John Nemunaitis, M.D., Scientific Advisor

Dr. Nemunaitis is an oncologist and Executive Medical Director of the Mary Crowley Cancer Research Centers (MCCRC) and has been exploring novel targeted therapies for treating cancer patients for over 20 years. Dr. Nemunaitis received his B.A. and M.D. degrees from Case Western Reserve University. He completed his residency at Boston City Hospital and then performed his Hematology and Oncology fellowship at the University of Washington and the Fred Hutchinson Cancer Research Center in Seattle from 1988 to 1993. Dr. Nemunaitis came to Dallas in 1993 to establish the clinical research program for Texas Oncology Physicians Association (TOPA). He later established a not-for-profit translational research program (the MCCRC). He is a committee member of the Western Institutional Review Board (WIRB) and recently co-founded a molecular therapeutic/vaccine biotechnology company with GMP manufacturing capacity called Gradalis, Inc. Dr. Nemunaitis has authored over 250 peer-reviewed publications and 36 book chapters. He has instituted study establishment of over 350 trials, overseen FDA sponsored experimental treatment of nearly 4,000 cancer patients at MCCRC, and has carried out 14

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government regulatory (FDA, RAC) presentations for biotechnology product development. He is also developer and holder of 8 new molecular and vaccine Investigational New Drug Applications (IND’s). His research focus is clinical in orientation and involves determination of molecular signals in order to optimize targeted therapy, development of RNAi based therapeutics, and cancer vaccine approaches.

Justin Stebbing, M.D., MA, FRCP, FRCPath, Ph.D., Scientific Advisor

Dr. Stebbing is a member of the Royal College of Physicians, American Board of Internal Medicine and a Fellow of the Royal College of Pathologists. Originally, Justin trained in medicine at Trinity College Oxford, obtaining a triple first class degree. After completion of junior doctor posts in Oxford, he undertook a residency (junior doctor) training at The Johns Hopkins Hospital in the US, before returning to London to continue his training in oncology at The Royal Marsden. Justin then undertook a PhD, funded by the Medical Research Council, investigating the interplay between the immune system and cancer. Specifically, the role of heat shock proteins in viral infections and tumorigenesis were examined helping in the development of vaccines that are currently in clinical trials.  Dr. Stebbing has published over 300 peer-reviewed papers in journals such as the Lancet, New England Journal, Blood, PNAS, The Journal of Clinical Oncology and Annals of Internal Medicine, the majority as first or last author, as well as over 100 book chapters. His publications mainly focus on early and late stage trials of new drugs, mechanisms of disease, and prognostic indicators. He is on the scientific advisory board of a number of biotechnology companies and the editorial board of a number of world-leading journals such as the Journal of Clinical Oncology. He is now a senior lecturer at Imperial College, London.

Daniel D. Von Hoff, M.D., Scientific Advisor

Daniel D. Von Hoff, M.D., is currently Physician in Chief and Director of Translational Research at TGen (Translational Genomics Research Institute) in Phoenix, Arizona. He is also Chief Scientific Officer for Scottsdale Healthcare’s Clinical Research Institute and Scientific Medical Officer for US Oncology. He holds an appointment as Clinical Professor of Medicine, University of Arizona, College of Medicine. Dr. Von Hoff’s major interest is in the development of new anti-cancer agents, both in the clinic and in the laboratory. He and his colleagues were involved in the beginning of the development of many of the agents that are now used routinely, including: mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine, lapatinib and others. At present, he and his colleagues are concentrating on the development of molecularly targeted therapies particularly for patients with advanced pancreatic cancer. Dr. Von Hoff has published more than 559 papers, 134 book chapters and over 1,000 abstracts.

Dr. Von Hoff served as an appointee to President Bush’s National Cancer Advisory Board from June 2004 to March 2010. Dr. Von Hoff is the past President of the American Association for Cancer Research (the world’s largest cancer research organization), a Fellow of the American College of Physicians, and a member and past board member of the American Society of Clinical Oncology. He is a founder of ILEX™ Oncology, Inc. (acquired by Genzyme after Ilex had 2 agents, alemtuzumab and clofarabine approved for patients with leukemia). He is founder and the Editor Emeritus of Investigational New Drugs – The Journal of New Anticancer Agents; and, Editor-in-Chief of Molecular Cancer Therapeutics. He is also proud to have been a mentor and teacher for multiple medical students, medical oncology fellows, graduate students, and post-doctoral fellows. He is a co-founder of the AACR/ASCO Methods in Clinical Cancer Research Workshop. Dr. Von Hoff currently serves as Physician in Chief for the Translational Genomics Research Institute (TGen) in Phoenix, Arizona and Chief Scientific Officer of Scottsdale Healthcare and US Oncology. Dr. Von Hoff received his MD degree from Columbia University.

Size of Board

Our Third Amended and Restated Certificate of Incorporation provides that the number of directors that constitute our whole board of directors shall be not less than seven (subject to vacancies which may be filled stockholders having rights to nominate a director to fill such vacancy) and thereafter shall be fixed in accordance with our bylaws which provide that such number shall be determined from time to time by resolution of the Board.  Our Board is currently comprised of five board members, leaving two vacancies.  The Third Amended and Restated Certificate of Incorporation provides that until such time as we consummate a firm commitment underwritten public offering for net proceeds of at least $15,000,000 so long as any shares of Series 1 Preferred Stock remain outstanding, the holders of the Series 1 Preferred Stock voting as single class have the right to elect one director; so long as any

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shares of Series A remain outstanding, the holders of the Series A Preferred Stock voting as single class have the right to elect one director; so long as any shares of Series B Preferred Stock remain outstanding, the holders of the Series B Preferred Stock voting as single class have the right to elect one director; so long as any shares of Series 1 Preferred Stock remain outstanding, the holders of the Series 1 Preferred Stock and the holders of the common stock voting as single class on an as converted basis have the right to elect two directors, the holders of the common stock and Preferred Stock voting together as a single class on an as converted basis are entitled to elect one director; and the holders of the common stock are entitled to elect one director exclusively as a separate class.

Committees of the Board of Directors

We have applied to have our common stock listed on the NASDAQ Capital Market upon completion of this offering. Under the rules of NASDAQ, independent directors must comprise a majority of a listed company’s board of directors within twelve months of the completion of an initial public offering. In addition, the rules of The NASDAQ Stock Market require that: (i) on the date of the completion of the offering, at least one member of each of a listed company’s audit, compensation and nominating and corporate governance committees be independent; (ii) within 90 days of the date of the completion of the offering, a majority of the members of such committees be independent; and (iii) within one year of the date of the completion of the offering, all the members of such committees be independent. Audit committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act. Under the rules of The NASDAQ Stock Market, a director will only qualify as an “independent director” if, in the opinion of that company’s board of directors, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.

In order to be considered to be independent for purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity as a member of the audit committee, the board of directors, or any other board committee: (1) accept, directly or indirectly, any consulting, advisory or other compensatory fee from the listed company or any of its subsidiaries or (2) be an affiliated person of the listed company or any of its subsidiaries.

Our Board undertook a review of its composition, the composition of its committees and the independence of each director. Based upon information requested from and provided by each director concerning his background, employment and affiliations, including family relationships, our Board has determined that Dr. Belsky, Dr. Kharitonov Dr. Monahan and Mr. Smith, representing four of our five directors, do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these directors is “independent” as that term is defined under the rules of The NASDAQ Stock Market.  In making this determination, our Board considered the relationships that each non-employee director has with us and all other facts and circumstances our Board deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director. We intend to comply with the other independence requirements for committees within the time periods specified above.

We currently have: (i) an audit committee comprised of Dr. Monahan,,Mr. Smith, and Mr. Wolf, two  of whom are deemed to be independent in accordance with the NASDAQ definition of independence as well as qualify as “audit committee financial experts” as that term is used in Section 407 of Regulation S-K; (ii) a compensation committee comprised of Dr. Belsky, Dr. Monahan and Dr. Kharitonov, each of whom is deemed to be independent in accordance with the NASDAQ definition of independence; and (iii) a nominating and corporate governance committee comprised of Dr. Belsky, Dr. Kharitonov and Mr. Smith.  Dr. Monahan and Mr. Smith are deemed to be independent in accordance with the NASDAQ definition of independence. Dr. Monahan and Mr. Wolf qualify as “audit committee financial experts” as that term is used in Section 407 of Regulation S-K.

Leadership Structure

Our Chief Executive Officer also serves as our Chairman of the Board. Our Board does not have a lead independent director. Our board of directors has determined its leadership structure was appropriate and effective for us given our stage of development.

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2012 Director Compensation

Compensation of Directors

The following table sets forth information for the fiscal year ended December 31, 2012 regarding the compensation of our directors who at December 31, 2012 were not also named executive officers.

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(1)

The amounts in the “Option Awards” column reflect the dollar amounts recognized as compensation expense for the financial statement reporting purposes for stock options for the fiscal year ended December 31, 2012 in accordance with SFAS 123(R). The fair value of the options was determined using the Black-Scholes model.

Commencing after this offering, directors who are not employees will receive an annual cash fee of $15,000 as well as a cash fee of $5,000 for each committee on which they serve.  Upon election to the Board, each non-employee director receives a grant of stock options exercisable for 50,000 shares of common stock vesting over four years having an exercise price equal to the fair market value of the common stock on the date of the grant.

EXECUTIVE COMPENSATION

Set forth below is the compensation that was paid to all executive officers during the years ended December 31, 2012 and December 31, 2011 that exceeded $100,000.

Summary Compensation Table

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(1)

Represents payment for health insurance

Outstanding Equity Awards At Fiscal Year-End (December 31, 2012)