Form: 8-K

Current report filing

May 15, 2020

Exhibit 99.1

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Heat Biologics Provides First Quarter 2020 Business Update

Durham, NC – May 15, 2020 Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today provided financial, clinical and operational updates for the first quarter ended March 31, 2020.

Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, “We continue to make progress advancing our unique COVID-19 vaccine utilizing our robust gp-96 vaccine platform in collaboration with researchers at University of Miami.  We plan to commence preclinical testing for the COVID-19 vaccine this quarter and are finalizing our manufacturing plans, which we believe will help shorten the clinical timeline.  Additionally, we are applying for grants to support clinical development of this program and are advancing collaboration discussions.  Earlier this year we also announced a collaboration with the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test.  We suspended this program due to the progress made by other diagnostic manufacturers utilizing a similar approach, and our desire to focus resources on our highly-differentiated COVID-19 vaccine.  Nevertheless, in the process, we developed our own unique diagnostic intellectual property, and plan to opportunistically explore partnership opportunities around this technology.”

“We also continue to achieve key milestones related to HS-110 in combination with Opdivo® (nivolumab) in advanced non-small cell lung cancer (NSCLC). We recently announced that an abstract has been posted on The American Society of Clinical Oncology’s (ASCO) website. We look forward to presenting additional data at the upcoming ASCO Conference on May 29.  Importantly, given the strength of the data, we plan to initiate an end of Phase 2 Type B meeting with the FDA to discuss our registrational strategy.

“We ended the quarter with over $26 million of cash and short-term investments as of March 31, 2020, which we believe provides us significant resources to advance each of our programs,” concluded Mr. Wolf.

Q1 2020 Financial Results

      Research and development expenses decreased approximately 12.5% to $2.8 million for the quarter ended March 31, 2020 compared to $3.2 million for the quarter ended March 31, 2019.

      General and administrative expense was $3.3 million for the quarters ending March 31, 2020 and 2019.

      Net loss attributable to Heat Biologics was approximately $6.3 million, or ($0.11) per basic and diluted share for the quarter ended March 31, 2020 compared to a net loss of $5.7 million, or ($0.17) per basic and diluted share for the quarter ended March 31, 2019.

      As of March 31, 2020, the Company had approximately $26.4 million in cash, cash equivalents and short-term investments.


About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine.  HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

Forward Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as continuing to make progress advancing our unique COVID-19 vaccine utilizing our robust gp-96 vaccine platform in collaboration with researchers at University of Miami, plans to commence preclinical testing for the COVID-19 vaccine this quarter, finalizing our manufacturing plans, which we believe will help shorten the clinical timeline, plans to opportunistically explore partnership opportunities around the diagnostic intellectual property, presenting additional data at the upcoming ASCO Conference on May 29, plans to initiate an end of Phase 2 Type B meeting with the FDA to discuss our registrational strategy and. cash and short-term investments as of March 31, 2020, providing us significant resources to advance each of our programs. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against COVID-19, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.

Media and Investor Relations Contact

David Waldman

+1 919 289 4017

investorrelations@heatbio.com


HEAT BIOLOGICS, INC.

Consolidated Balance Sheets

March 31,

December 31,

    

2020

    

2019

(unaudited)

Current Assets

Cash and cash equivalents

$

20,738,776 

$

9,039,887 

Short-term investments

5,706,082 

5,713,922 

Accounts receivable

144,119 

34,986 

Prepaid expenses and other current assets

537,653 

420,328 

Total Current Assets

27,126,630 

15,209,123 

Property and Equipment, net

705,553 

559,410 

Other Assets

  

  

In-process R&D

5,866,000 

5,866,000 

Goodwill

1,452,338 

1,452,338 

Operating lease right-of-use asset

2,211,506 

2,287,500 

Finance lease right-of-use asset

336,368 

187,573 

Deposits

122,905 

394,637 

Total Other Assets

9,989,117 

10,188,048 

Total Assets

$

37,821,300 

$

25,956,581 

Liabilities and Stockholders' Equity

  

  

Current Liabilities

  

  

Accounts payable

$

1,350,476 

$

1,503,342 

Deferred revenue, current portion

2,508,809 

3,410,319 

Contingent consideration, current portion

1,659,000 

1,579,334 

Operating lease liability, current portion

222,752 

216,832 

Finance lease liability, current portion

103,269 

49,104 

Accrued expenses and other liabilities

1,092,235 

1,676,467 

Total Current Liabilities

6,936,541

8,435,398 

Long Term Liabilities

  

  

Other long-term liabilities

14,216 

Derivative warrant liability

41,360 

Deferred tax liability

361,911 

361,911 

Deferred revenue, net of current portion

200,000 

200,000 

Operating lease liability, net of current portion

1,462,005 

1,519,574 

Financing lease liability, net of current portion

241,938 

142,667 

Contingent consideration, net of current portion

2,032,515 

2,139,181 

Total Liabilities

11,290,486 

12,798,731 

Commitments and Contingencies (Note 9 and 13)

  

  

Stockholders' Equity

  

  

Common stock, $.0002 par value; 100,000,000 shares authorized, 77,924,516 and 33,785,999 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively

15,627

6,757

Additional paid-in capital

137,692,553

118,173,843

Accumulated deficit

(110,889,854)

(104,597,748)

Accumulated other comprehensive income (loss)

207,554

(11,250)

Total Stockholders' Equity - Heat Biologics, Inc.

27,025,880

13,571,602

Non-Controlling Interest

(495,066)

(413,752)

Total Stockholders' Equity

26,530,814

13,157,850

Total Liabilities and Stockholders' Equity

$

37,821,300 

$

25,956,581


HEAT BIOLOGICS INC.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended

March 31,

    

2020

    

2019

Revenue:

Grant and licensing revenue

$

901,880 

$

701,062 

Operating expenses:

  

  

Research and development

2,782,506 

3,172,247 

General and administrative

3,270,548 

3,347,601 

Change in fair value of contingent consideration

(27,000)

114,290 

Total operating expenses

6,026,054 

6,634,138 

Loss from operations

(5,124,174)

(5,933,076)

Change in fair value of warrant liability

(977,710)

Investor relations expense

(66,767)

Interest income

52,710 

150,852 

Other (expense) income, net

(257,479)

8,321 

Total non-operating income (loss)

(1,249,246)

159,173 

Net loss before income taxes

(6,373,420)

(5,773,903)

Income tax (expense) benefit

(45,178)

Net loss

(6,373,420)

(5,819,081)

Net loss - non-controlling interest

(81,314)

(103,605)

Net loss attributable to Heat Biologics, Inc.

$

(6,292,106)

$

(5,715,476)

Net loss per share attributable to Heat Biologics, Inc.-

  

  

Net loss per share attributable to Heat Biologics, Inc.-basic and diluted

$

(0.11)

$

(0.17)

Weighted-average number of common shares used in net loss per share attributable to common stockholders -

  

  

Weighted-average number of common shares used in net loss per share attributable to Heat Biologics, Inc.—basic and diluted

57,282,075 

33,225,164 

Comprehensive loss:

  

  

Net loss

$

(6,373,420)

$

(5,819,081)

Unrealized gain (loss) on foreign currency translation

218,804 

(8,189)

Total comprehensive loss

(6,154,616)

(5,827,270)

Comprehensive loss attributable to non-controlling interest

(81,314)

(103,605)

Comprehensive loss – Heat Biologics, Inc.

$

(6,073,302)

$

(5,723,665)