Form: 10-Q

Quarterly report pursuant to Section 13 or 15(d)

November 10, 2021

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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2021

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______________ to _______________

Commission file number: 001-35994

Heat Biologics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of

Incorporation or Organization)

26-2844103

(I.R.S. Employer

Identification No.)

627 Davis Drive, Suite 400

Morrisville, NC

(Address of Principal Executive Offices)

27560

(Zip Code)

(919240-7133

(Registrant’s Telephone Number, including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

HTBX

The Nasdaq Stock Market, LLC

(The Nasdaq Capital Market)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes   No 

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

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  No 

As of November 9, 2021, there were 25,403,519 shares of Common Stock, $0.0002 par value per share, outstanding.

Table of Contents

HEAT BIOLOGICS, INC.

TABLE OF CONTENTS

Page No.

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements

2

Consolidated Balance Sheets as of September 30, 2021 (unaudited) and December 31, 2020

2

Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2021 and September 30, 2020

3

Consolidated Statements of Stockholders’ Equity (unaudited) for the three and nine months ended September 30, 2021 and September 30, 2020

4

Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2021 and September 30, 2020

6

Notes to the Consolidated Financial Statements (unaudited)

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

32

Item 4.

Controls and Procedures

32

PART II—OTHER INFORMATION

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

33

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 3.

Defaults Upon Senior Securities

35

Item 4.

Mine Safety Disclosures

35

Item 5.

Other Information

35

Item 6.

Exhibits

36

SIGNATURES

38

Table of Contents

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are not guarantees of future performance and our actual results could differ materially from the results discussed in the forward-looking statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, our ability to raise additional capital to support our clinical development program and other operations, our ability to develop products of commercial value and to identify, discover and obtain rights to additional potential product candidates, our ability to protect and maintain our intellectual property and the ability of our licensors to obtain and maintain patent protection for the technology or products that we license from them, the outcome of research and development activities, our reliance on third-parties, our ability to successfully operate a manufacturing facility, competitive developments, the effect of current and future legislation and regulation and regulatory actions, as well as other risks described more fully in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission (the “SEC”). Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A. “Risk Factors” and elsewhere herein and those identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 25, 2021 (the “2020 Annual Report”). Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.

As a result of these and other factors, we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NOTE REGARDING COMPANY REFERENCES

Throughout this Quarterly Report on Form 10-Q, “Heat Biologics,” “the Company,” “we” and “our” refer to Heat Biologics, Inc.

1

Table of Contents

PART I—FINANCIAL INFORMATION

ITEM 1.       FINANCIAL STATEMENTS

HEAT BIOLOGICS, INC.

Consolidated Balance Sheets

    

September 30, 

December 31, 

2021

    

2020

(unaudited)

Current Assets

Cash and cash equivalents

$

7,882,412

$

10,931,890

Short-term investments

 

101,032,250

 

100,842,438

Accounts receivable

 

71,420

 

177,239

Prepaid expenses and other current assets

 

2,845,226

 

1,842,620

Total Current Assets

 

111,831,308

 

113,794,187

Property and Equipment, net

 

1,766,898

 

676,262

Other Assets

 

  

 

  

In-process R&D

 

5,866,000

 

5,866,000

Goodwill

 

1,452,338

 

1,452,338

Grant receivable

 

870,032

 

Operating lease right-of-use asset

1,885,681

2,035,882

Finance lease right-of-use asset

533,561

247,194

Other assets

 

8,199,850

 

Deposits

 

249,557

 

122,779

Total Other Assets

 

19,057,019

 

9,724,193

Total Assets

$

132,655,225

$

124,194,642

Liabilities and Stockholders' Equity

 

  

 

  

Current Liabilities

 

  

 

  

Accounts payable

$

1,065,663

$

1,051,764

Deferred revenue, current portion

 

 

603,717

Operating lease liability, current portion

341,977

278,753

Finance lease liability, current portion

222,313

108,127

Accrued expenses and other liabilities

 

1,660,288

 

1,614,534

Total Current Liabilities

 

3,290,241

 

3,656,895

Long Term Liabilities

 

  

 

  

Other long-term liabilities

 

50,511

 

36,243

Derivative warrant liability

30,971

33,779

Deferred tax liability

 

361,911

 

361,911

Deferred revenue, net of current portion

 

237,500

 

237,500

Operating lease liability, net of current portion

 

1,152,008

 

1,301,636

Financing lease liability, net of current portion

 

348,128

 

160,240

Contingent consideration

2,564,608

2,250,844

Contingent consideration, related party

753,907

661,671

Total Liabilities

 

8,789,785

 

8,700,719

Commitments and Contingencies

 

  

 

  

Stockholders' Equity

 

  

 

  

Common stock, $.0002 par value; 250,000,000 and 250,000,000 shares authorized, 25,143,315 and 22,592,500 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

5,028

 

4,519

Additional paid-in capital

 

277,097,787

 

247,048,349

Accumulated deficit

 

(152,155,580)

 

(130,647,485)

Accumulated other comprehensive loss

 

(52,545)

 

(166,056)

Total Stockholders' Equity - Heat Biologics, Inc.

 

124,894,690

 

116,239,327

Non-Controlling Interest

 

(1,029,250)

 

(745,404)

Total Stockholders' Equity

 

123,865,440

 

115,493,923

Total Liabilities and Stockholders' Equity

$

132,655,225

$

124,194,642

See Notes to Consolidated Financial Statements

2

Table of Contents

HEAT BIOLOGICS, INC.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2021

    

2020

    

2021

    

2020

    

Revenue:

Grant and contract revenue

$

501,567

$

849,732

$

1,499,706

$

2,344,777

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

4,381,542

 

3,172,663

 

12,004,084

 

8,745,966

General and administrative

 

3,390,093

 

6,579,193

 

11,011,003

 

11,651,415

Change in fair value of contingent consideration

 

295,000

 

229,000

 

406,000

 

1,045,000

Total operating expenses

 

8,066,635

 

9,980,856

 

23,421,087

 

21,442,381

Loss from operations

 

(7,565,068)

 

(9,131,124)

 

(21,921,381)

 

(19,097,604)

Change in fair value of warrant liability

6,831

(37,230)

2,808

(1,039,303)

Investor relations expense

(66,767)

Interest income

 

195,344

 

140,614

 

567,307

 

249,404

Other (expense) income, net

 

(185,332)

 

111,307

 

(440,675)

 

127,599

Total non-operating income (loss)

 

16,843

 

214,691

 

129,440

 

(729,067)

Net loss before income taxes

 

(7,548,225)

 

(8,916,433)

 

(21,791,941)

 

(19,826,671)

Income tax expense

 

 

 

 

Net loss

 

(7,548,225)

 

(8,916,433)

 

(21,791,941)

 

(19,826,671)

Net loss - non-controlling interest

 

(115,505)

 

(64,824)

 

(283,846)

 

(228,526)

Net loss attributable to Heat Biologics, Inc.

$

(7,432,720)

$

(8,851,609)

$

(21,508,095)

$

(19,598,145)

Net loss per share, basic and diluted

$

(0.30)

$

(0.43)

$

(0.87)

$

(1.42)

Weighted-average common shares outstanding, basic and diluted

 

25,137,628

 

20,532,696

 

24,828,438

 

13,783,039

Comprehensive loss:

 

  

 

  

 

  

 

  

Net loss

$

(7,548,225)

$

(8,916,433)

$

(21,791,941)

$

(19,826,671)

Unrealized gain (loss) on foreign currency translation

 

68,582

 

(63,954)

 

113,511

 

(24,660)

Total comprehensive loss

 

(7,479,643)

 

(8,980,387)

 

(21,678,430)

 

(19,851,331)

Comprehensive loss attributable to non-controlling interest

 

(115,505)

 

(64,824)

 

(283,846)

 

(228,526)

Comprehensive loss - Heat Biologics, Inc.

$

(7,364,138)

$

(8,915,563)

$

(21,394,584)

$

(19,622,805)

See Notes to Consolidated Financial Statements

3

Table of Contents

HEAT BIOLOGICS INC.

Consolidated Statements of Stockholders’ Equity

(Unaudited)

Three Months Ended September 30, 2021

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

(Loss) Income

    

Interest

    

Equity

Balance at June 30, 2021

$

5,027

$

276,225,048

$

(144,722,860)

$

(121,127)

$

(913,745)

$

130,472,343

Issuance of common stock from vesting of restricted stock awards

1

(1)

Stock-based compensation

872,740

872,740

Other comprehensive income

 

 

 

68,582

 

 

68,582

Net loss

 

 

 

(7,432,720)

 

 

(115,505)

 

(7,548,225)

Balance at September 30, 2021

 

$

5,028

 

$

277,097,787

 

$

(152,155,580)

 

$

(52,545)

 

$

(1,029,250)

 

$

123,865,440

Nine Months Ended September 30, 2021

    

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

(Loss) Income

    

Interest

    

Equity

Balance at December 31, 2020

$

4,519

$

247,048,349

$

(130,647,485)

$

(166,056)

$

(745,404)

$

115,493,923

Issuance of common stock under ATM, net of issuance costs

420

26,303,862

26,304,282

Issuance of common stock from vesting of restricted stock awards

83

(83)

Stock issuance costs

(658,184)

(658,184)

Stock-based compensation

4,376,588

4,376,588

Issuance of restricted stock

 

3

 

(3)

 

 

 

 

Exercise of options

 

6

27,255

27,261

Cancellation and payout of fractional shares

(3)

3

Other comprehensive income

 

 

 

 

113,511

 

 

113,511

Net loss

 

 

 

(21,508,095)

 

 

(283,846)

 

(21,791,941)

Balance at September 30, 2021

 

$

5,028

 

$

277,097,787

 

$

(152,155,580)

 

$

(52,545)

 

$

(1,029,250)

 

$

123,865,440

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HEAT BIOLOGICS INC.

Consolidated Statements of Stockholders’ Equity

(Unaudited)

Three Months Ended September 30, 2020

    

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

Income (Loss)

    

Interest

    

Equity

Balance at June 30, 2020

$

3,144

$

163,026,420

$

(115,344,284)

$

28,044

$

(577,454)

$

47,135,870

Issuance of common stock under ATM, net of issuance costs

 

1,330

 

79,296,779

 

 

 

 

79,298,109

Stock issuance costs

 

 

(1,984,155)

 

 

 

 

(1,984,155)

Stock-based compensation

 

 

4,728,894

 

 

 

 

4,728,894

Exercise of warrants

 

12

 

699,917

 

 

 

 

699,929

Other Comprehensive loss

(63,954)

(63,954)

Net loss

 

 

 

(8,851,609)

 

 

(64,824)

 

(8,916,433)

Balance at September 30, 2020

 

$

4,486

 

$

245,767,855

 

$

(124,195,893)

 

$

(35,910)

 

$

(642,278)

 

$

120,898,260

Nine Months Ended September 30, 2020

    

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

Loss

    

Interest

    

Equity

Balance at December 31, 2019

$

965

$

118,179,635

$

(104,597,748)

$

(11,250)

$

(413,752)

$

13,157,850

January 2020 investment offering, net of underwriters discounts

 

571

 

4,105,577

 

 

 

 

4,106,148

Issuance of common stock under ATM, net of issuance costs

 

2,612

 

116,294,150

 

 

 

 

116,296,762

Issuance of common stock from vesting of restricted stock awards

 

47

 

(47)

 

 

 

 

Stock issuance costs

 

 

(3,076,915)

 

 

 

 

(3,076,915)

Stock-based compensation

 

 

6,050,094

 

 

 

 

6,050,094

Exercise of warrants

 

227

 

3,442,095

 

 

 

 

3,442,322

Exchange of warrants

 

64

 

773,266

 

 

 

 

773,330

Other comprehensive income

 

 

 

 

(24,660)

 

 

(24,660)

Net loss

 

 

 

(19,598,145)

 

 

(228,526)

 

(19,826,671)

Balance at September 30, 2020

 

$

4,486

 

$

245,767,855

 

$

(124,195,893)

 

$

(35,910)

 

$

(642,278)

 

$

120,898,260

See Notes to Consolidated Financial Statements

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HEAT BIOLOGICS, INC.

Consolidated Statements of Cash Flows

(Unaudited)

For the Nine Months Ended

September 30, 

    

2021

    

2020

Cash Flows from Operating Activities

Net loss

$

(21,791,941)

$

(19,826,671)

Adjustments to reconcile net loss to net cash used in operating activities:

 

  

 

  

Depreciation and amortization

 

415,270

 

242,623

Noncash lease expense

63,797

73,524

Noncash interest expense

14,900

13,838

Noncash investor relations expense

66,767

Stock-based compensation

 

4,376,588

 

6,050,094

Change in fair value of common stock warrants

(2,808)

1,039,303

Change in fair value of contingent consideration

 

406,000

 

1,045,000

Unrealized loss (gain) on investments

 

278,172

 

(47,923)

Increase (decrease) in cash arising from changes in assets and liabilities:

 

 

Accounts receivable

 

104,598

 

(173,447)

Prepaid expenses and other current assets

 

(1,029,581)

 

(1,199,730)

Grant receivable

 

(870,032)

 

Other assets

(8,199,850)

Accounts payable

 

14,766

 

(748,410)

Accrued expenses and other liabilities

 

197,428

 

(201,199)

Deferred revenue

 

(603,717)

 

(2,203,838)

Other long-term liabilities

 

14,268

 

26,331

Deposits

 

(126,778)

 

265,132

Net Cash Used in Operating Activities

 

(26,738,920)

 

(15,578,606)

Cash Flows from Investing Activities

 

  

 

  

Purchase of short-term investments

 

(66,665,908)

 

(95,034,396)

Sale of short-term investments

66,197,924

8,295,222

Purchase of property and equipment

(1,383,596)

(321,301)

Proceeds from disposal of property and equipment

 

 

2,168

Net Cash Used in Investing Activities

 

(1,851,580)

 

(87,058,307)

Cash Flows from Financing Activities

 

  

 

  

Proceeds from public offering of common stock and warrants, net of issuance costs

 

 

6,600,970

Proceeds from the issuance of common stock, net of underwriting discounts and commissions

 

26,304,282

 

116,296,762

Proceeds from exercise of stock options

27,261

Proceeds from the exercise of warrants

 

 

675,675

Stock issuance costs

 

(658,184)

 

(3,076,915)

Payment of contingent consideration

(2,005,000)

Proceeds from PPP loan

702,000

Repayment of PPP loan

(702,000)

Repayments on principal of finance lease

(121,503)

(85,140)

Net Cash Provided by Financing Activities

 

25,551,856

 

118,406,352

Effect of exchange rate changes on cash and cash equivalents

 

(10,834)

 

(1,243)

Net Change in Cash and Cash Equivalents

 

(3,049,478)

 

15,768,196

Cash and Cash Equivalents – Beginning of Period

 

10,931,890

 

9,039,887

Cash and Cash Equivalents – End of Period

$

7,882,412

$

24,808,083

Supplemental Disclosure for Cash Flow Information:

 

  

 

  

Right-of-use assets obtained on operating lease commencements

$

88,596

$

75,244

Right-of-use assets obtained on operating lease modifications

$

37,767

$

Right-of-use assets obtained on financing lease commencements

$

408,677

$

173,822

Supplemental disclosure of non-cash investing and financing activities:

Allocation of proceeds from public offering to warrant liabilities

$

$

2,494,823

Cashless exercise of warrants classified as liabilities

$

$

2,766,647

Cashless exchange of warrants classified as liabilities

$

$

773,330

See Notes to Consolidated Financial Statements

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1. Basis of Presentation and Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial reporting. Certain information or footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed, or omitted, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). In the opinion of the Company’s management, these financial statements include all normal and recurring adjustments necessary for the fair statement of the results for the interim periods presented. The results for the nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2021.

The consolidated financial statements as of and for the three and nine months ended September 30, 2021 and 2020 are unaudited. The balance sheet as of December 31, 2020 is derived from the audited consolidated financial statements as of that date. These financial statements should be read in conjunction with the audited consolidated financial statements and related notes, together with Management’s Discussion and Analysis of Financial Condition and Results of Operations, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 25, 2021 (the “2020 Annual Report”).

The accompanying unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2021 and 2020 include the accounts of Heat Biologics, Inc. (“the Company”), and its subsidiaries, Pelican Therapeutics, Inc. (“Pelican”), Heat Biologics I, Inc. (“Heat I”), Heat Biologics III, Inc. (“Heat III”), Heat Biologics IV, Inc. (“Heat IV”), Heat Biologics GmbH, Heat Biologics Australia Pty Ltd., Zolovax, Inc., Skunkworx Bio, Inc. (formerly known as Delphi Therapeutics, Inc.), Scorpion Biological Services, Inc. (formerly Scorpion Biosciences, Inc), Blackhawk Bio, Inc, and Abacus Biotech, Inc. The functional currency of the entities located outside the United States of America (the foreign entities) is the applicable local currency of the foreign entities. Assets and liabilities of the foreign entities are translated at period-end exchange rates. Statement of operations accounts are translated at the average exchange rate during the period. The effects of foreign currency translation adjustments are included in other comprehensive loss, which is a component of accumulated other comprehensive loss in stockholders’ equity. All significant intercompany accounts and transactions have been eliminated in consolidation. At September 30, 2021 and December 31, 2020, Heat held 85% controlling interest in Pelican. Heat accounts for its less than 100% interest in accordance with U.S. GAAP. Accordingly, the Company presents non-controlling interest as a component of stockholders’ equity on its consolidated balance sheets and reports non-controlling interest net loss under the heading “net loss – non-controlling interest” on its consolidated statements of operations and comprehensive loss.

On December 11, 2020, we effected a one-for-seven- reverse stock split. All per share numbers reflect the one-for seven reverse stock split.

Liquidity and Capital Resources

The Company has an accumulated deficit of approximately $152.2 million as of September 30, 2021 and a net loss of approximately $7.5 million and $21.8 million for the three and nine months ended September 30, 2021 and has not generated significant revenue or positive cash flows from operations. The Company expects to incur significant expenses and continued losses from operations for the foreseeable future. The Company expects its expenses to increase in connection with its ongoing activities, particularly as the Company continues its research and development and advances its clinical trials of, and seeks marketing approval for, its product candidates, builds its in-house bioanalytic, process development and manufacturing facility and expands its infectious disease/biological threat program. In addition, if the Company obtains marketing approval for any of its product candidates, the Company expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Furthermore, any new business ventures that the Company may engage in are likely to require commitments of capital. Accordingly, the Company will in the future need to obtain substantial additional funding in connection with its planned operations. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its research and

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development programs or any future commercialization efforts. To meet its capital needs, the Company intends to continue to consider multiple alternatives, including, but not limited to, additional equity financings such as sales of its common stock under at-the-market offerings, if available, debt financings, partnerships, collaborations and other funding transactions. As of September 30, 2021, the Company had approximately $108.9 million in cash and cash equivalents and short-term investments, which it believes is sufficient to fund its operations for at least one year from the date these consolidated financial statements were issued. This is based on the Company’s current estimates, and the Company could use its available capital resources sooner than it currently expects. The Company is continually evaluating various cost-saving measures considering its cash requirements in order to focus resources on its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so.

With the global spread of the ongoing novel coronavirus (“COVID-19”) pandemic, the Company has implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on its employees and business. While the Company is experiencing limited financial impacts at this time, given the global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties which the Company faces.

Risk and Uncertainties

The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates or its manufacturing facility, uncertainty of market acceptance of the Company’s products or manufacturing capability or success of new business ventures, competition from substitute products and larger companies, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers.

In March 2020, the World Health Organization declared COVID-19 a global pandemic. This contagious disease outbreak, which has continued to spread, and any related adverse public health developments, has adversely affected workforces, economies, and financial markets globally, potentially leading to an economic downturn. It has also disrupted the normal operations of many businesses. The extent to which the COVID-19 pandemic impacts the Company’s business, the clinical development of the Company’s products, the business of the Company’s suppliers and other commercial partners, the Company’s corporate development objectives and the value of and market for the Company’s common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The Company’s in human phase 1 trial of HS-130 was subject to an approximate 8 week enrollment pause in April and May 2020 due to lack of personal protection equipment (“PPE”) at a clinical site. The site ceased all non-critical/non-essential patient procedures until PPE supplies were available. Enrollment resumed at the end of the second quarter of 2020 and no delays in overall development milestones are expected for the development of HS-130.

The Company relies on third-party manufacturers to purchase from their third-party vendors the materials necessary to produce product candidates and manufacture product candidates for clinical studies. The Company also depends on third-party suppliers for key materials and services used in research and development, as well as manufacturing processes, and are subject to certain risks related to the loss of these third-party suppliers or their inability to supply adequate materials and services. The Company does not control the manufacturing processes of the contract development and manufacturing organizations, or CDMOs, with whom it contracts and is dependent on these third parties for the production of its therapeutic candidates in accordance with relevant regulations (such as current Good Manufacturing Practices, or cGMP, which includes, among other things, quality control, quality assurance and the maintenance of records and documentation.

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Cash and Cash Equivalents

The Company considers all cash and other highly liquid investments with initial maturities from the date of purchase of three months or less to be cash and cash equivalents.

Derivative Financial Instruments

The Company has issued common stock warrants in connection with the execution of certain equity financings. The fair value of the warrants, which were deemed to be derivative instruments, was recorded as a derivative liability under the provisions of ASC Topic 815 Derivatives and Hedging (“ASC 815”) because they are not considered indexed to the Company’s own stock. Subsequently, the liability is adjusted to fair value as of the end of each reporting period and the changes in fair value of derivative liabilities are recorded in the consolidated statements of operations and comprehensive loss under the caption “Change in fair value of warrant liability.” See Note 3 for additional information.

The fair value of the warrants, including the warrants issued in connection with the January 2020 common stock offering and recorded as liability, were determined using the Monte Carlo simulation model, deemed to be an appropriate model due to the terms of the warrants issued.

The fair value of warrants was affected by changes in inputs to the Monte Carlo simulation model including the Company’s stock price, expected stock price volatility, the remaining term, and the risk-free interest rate. This model uses Level 3 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820 Fair Value Measurement. At September 30, 2021, the fair value of such warrants was $30,971, which is classified as a long-term derivative warrant liability on the Company’s consolidated balance sheets.

Short-term Investments

The Company’s short-term investments are equity securities and are carried at their fair value based on quoted market prices. Realized and unrealized gains and losses on equity securities are included in net earnings in the period earned or incurred.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Estimates are used for, but not limited to, useful lives of fixed assets, contingent consideration, valuation of goodwill and in process research and development (“IPR&D”), income taxes, valuation of warrant liabilities, and stock-based compensation. Actual results may differ from those estimates.

Segments

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed the operations and managed the business as one segment.

Business Combinations

The Company accounts for acquisitions using the acquisition method of accounting, which requires that all identifiable assets acquired, and liabilities assumed be recorded at their estimated fair values. The excess of the fair value of purchase consideration over the fair values of identifiable assets and liabilities is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions. Critical estimates in valuing certain intangible assets include but are not limited to future expected cash flows from acquired patented technology. Management’s estimates of fair value are based upon assumptions believed to be reasonable, but are inherently uncertain and unpredictable and, as a result, actual results may differ from estimates.

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Goodwill and In-Process Research and Development

The Company classifies intangible assets into three categories: (1) intangible assets with definite lives subject to amortization, (2) intangible assets with indefinite lives not subject to amortization and (3) goodwill. The Company determines the useful lives of definite-lived intangible assets after considering specific facts and circumstances related to each intangible asset. Factors the Company considers when determining useful lives include the contractual term of any agreement related to the asset, the historical performance of the asset, and other economic facts; including competition and specific market conditions. Intangible assets that are deemed to have definite lives are amortized, primarily on a straight-line basis, over their estimated useful lives. Intangible assets that are deemed to have indefinite lives, including goodwill, are reviewed for impairment annually, or more frequently if events or changes in circumstances indicate that the asset might be impaired. The impairment test for indefinite-lived intangibles, other than goodwill, consists of a comparison of the fair value of the intangible asset with its carrying amount. If the carrying amount exceeds the fair value, an impairment charge is recognized in an amount equal to that excess. Indefinite-lived intangible assets, such as goodwill, are not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or when events or changes in circumstances indicate evidence a potential impairment exists, using a fair value-based test. Pursuant to ASU 2017-04, the Company must record a goodwill impairment charge if a reporting unit’s carrying value exceeds its fair value. No impairment existed at September 30, 2021.

In-process research and development, or IPR&D, assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. IPR&D assets represent the fair value assigned to technologies that the Company acquires, which at the time of acquisition have not reached technological feasibility and have no alternative future use. During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of carrying value of the IPR&D assets over fair value.

Contingent Consideration

Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. The Company estimates the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. The milestone payments will be made upon the achievement of clinical and commercialization milestones as well as single low digit royalty payments and payments upon receipt of sublicensing income. Subsequent to the date of acquisition, the Company reassesses the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long term liabilities in the consolidated balance sheets.

Deferred Revenue

Deferred revenue is comprised of grant funds received from an economic development grant agreement with the City of San Antonio (“Economic Development Grant”) that we entered into on November 1, 2017. Under the Economic Development Grant, we received $0.2 million in state enterprise fund grants for the purpose of defraying costs toward the purchase of laboratory equipment. As part of the agreement, we will provide the city of San Antonio with a purchase money security interest in the equipment to secure the repayment of grant funds should we fail to perform under the terms and conditions of the agreement. Our obligations under the agreement include meeting certain employment levels for a period of not less than seven years commencing on or before December 31, 2017 and establishing Pelican’s corporate

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headquarters in San Antonio. The Economic Development Grant funds will be recognized as income upon the achievement of the performance criteria and determination that the cash is no longer refundable to the State of Texas.

Research and Development

Research and development includes costs associated with developmental products not yet approved by the FDA as well as costs associated with bringing developmental products into advanced phase clinical trials as incurred. These costs consist primarily of pre-manufacturing and manufacturing drug costs, clinical trial execution, investigator payments, license fees, salaries, stock-based compensation and related personnel costs. Other costs include fees paid to consultants and outside service providers related to the development of the Company’s product candidates and other expenses relating to the design, development, and testing and enhancement of its product candidates.

Grants Receivable and Revenue Recognition

Effective January 1, 2019, the Company has adopted ASU No. 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made. The Company’s primary source of revenue is grant revenue related to the CPRIT contract, which is being accounted for under ASC 958 as a conditional non-exchange contribution.

The CPRIT grant covers the periods from June 1, 2017 through May 31, 2022, for a total grant award of up to $15.2 million. CPRIT advances grant funds upon request by the Company consistent with the agreed upon amounts and schedules as provided in the contract. The first tranche of funding of $1.8 million was received in May 2017, and a second tranche of funding of $6.5 million was received in October 2017, and the third tranche of funding of $5.4 million was received in December 2019. The remaining $1.5 million will be awarded, on a reimbursement basis, after the Company has fulfilled every requirement of the grant and the grant has been approved to be finalized. Funds received are reflected in deferred revenue as a liability until revenue is earned. Grant revenue is recognized when qualifying costs are incurred. When grant funds are received after costs have been incurred, the Company records revenue and a corresponding grants receivable until grant funds are received.

On January 7, 2020, the Company was awarded a grant of up to $224,713 from the NIH. The NIH grant provides funding for continued development of the Company’s technologies for PTX-35. The grant funds will be made available by the NIH to the Company as allowable expenses are incurred. For the three and nine months ended September 30, 2021, the Company incurred approximately $0.0 million and $0.03 million of allowable expenses under the NIH grant and recognized a corresponding amount of grant revenues. For the three and nine months ended September 30, 2020, no revenue was recognized.

Prepaid Expenses and Other Current Assets

The Company’s prepaid expenses and other current assets consist primarily of the amount paid in advance for manufacturing activities, clinical trial support, and insurance.

Income Taxes

Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance to the extent that utilization is not presently more likely than not.

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Significant Accounting Policies

The significant accounting policies used in preparation of these interim financial statements are disclosed in the 2020 Annual Report and have not changed significantly since such filing.

Recently Issued Accounting Pronouncements

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses which requires financial assets measured at amortized cost basis to be presented at the net amount expected to be collected. This standard is effective for fiscal years beginning after December 15, 2022 and the Company is currently evaluating the expected impact of this standard but does not expect it to have a material impact on its consolidated financial statements upon adoption.

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This ASU simplifies the accounting for convertible instruments. This ASU also requires entities to use the if-converted method for all convertible instruments in calculating diluted earnings-per-share. The ASU is effective for annual periods beginning after December 15, 2023 with early adoption permitted. We are currently evaluating the impact this standard will have on our consolidated financial statements.

2. Acquisition of Pelican Therapeutics

In 2017, the Company consummated the acquisition of 80% of the outstanding equity of Pelican, a related party, and Pelican became a majority owned subsidiary of the Company. During the quarter ended March 31, 2018, cash consideration of approximately $300,000 was distributed to the participating Pelican stockholders and the remainder of approximately $200,000 for certain Pelican liabilities not satisfied was recognized as other income in the statements of operations and comprehensive loss for the period. In October 2018, the Company entered into an agreement with the University of Miami (“UM”) whereby UM exchanged its shares of stock in the Company’s subsidiaries, Heat I, Inc. and Pelican. The stock exchange resulted in the Company increasing its controlling ownership in Pelican from 80% to 85%.

Under the Pelican stock acquisition agreement, the Company is also obligated to make future payments based on the achievement of certain clinical and commercialization milestones, as well as low single digit royalty payments and payments upon receipt of sublicensing income. The fair value of these future milestone payments is reflected in the contingent consideration account under current liabilities with the non-current portion under long term liabilities on the balance sheet. The estimated fair value of the contingent consideration was determined using a probability-weighted income approach. The Company estimates the fair value of the contingent consideration on a quarterly basis. At the time of the Pelican acquisition, the Company’s CEO and certain affiliated entities as well as two of the Company’s directors and certain affiliated entities directly or indirectly owned shares of Pelican common stock purchased by the Company. As a result, approximately 22.7% of any such milestone payments will be paid to certain directors of the Company which is presented separately on the balance sheet as contingent consideration, related party - net of current portion. On June 22, 2020, the Company achieved the first milestone when it dosed the first patient in the first Phase 1 clinical trial of PTX-35.

Goodwill was calculated as the difference between the acquisition-date fair value of the consideration transferred and the fair values of the assets acquired and liabilities assumed. The goodwill resulting from this acquisition related largely to synergies expected from combining the operations. The goodwill is not deductible for income tax purposes. In-process research and development assets are treated as indefinite-lived until the completion or abandonment of the associated research and development (“R&D”) program, at which time the appropriate useful lives will be determined. The Company calculated the fair value of the non-controlling interest acquired in the acquisition as 20% of the equity interest of Pelican, adjusted for a minority interest discount.

As discussed in Note 10, in May 2016, Pelican was awarded a $15.2 million CPRIT Grant from CPRIT for development of Pelican’s lead product candidate, PTX-35. The CPRIT Grant supports Pelican in developing PTX-35 through its current Phase 1 clinical trial designed to evaluate PTX-35 in combination with other immunotherapies.

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3. Fair Value of Financial Instruments

The carrying amount of certain of the Company’s financial instruments, including cash and cash equivalents, accounts payable and accrued expenses and other payables approximate fair value due to their short maturities.

As a basis for determining the fair value of certain of the Company’s financial instruments, the Company utilizes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

Level I – Observable inputs such as quoted prices in active markets for identical assets or liabilities.

Level II – Observable inputs, other than Level I prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level III – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the entire fair value measurement requires management to make judgments and consider factors specific to the asset or liability. The Company’s cash equivalents are classified within Level I of the fair value hierarchy.

The Company’s short-term investments consist of Level I securities which are comprised of highly liquid money market funds. The estimated fair value of the short-term investments was based on quoted market prices. There were no transfers between fair value hierarchy levels during the quarters ended September 30, 2021 or 2020.

In January 2020, the Company issued warrants in connection with the public offering of common stock (the “January 2020 Warrants”). Pursuant to the terms of these warrants, the warrants were not considered indexed to the Company’s own stock and therefore are required to be measured at fair value and reported as a liability in the consolidated balance sheets. Additionally, upon the closing of the January 2020 offering, 479,595 outstanding warrants were evaluated for whether they were modified for accounting purposes and it was determined that they were required to be classified as a liability. The fair value of the warrant liability is based on the Monte Carlo methodology. The Company is required to revalue the warrants at each reporting date with any changes in fair value recorded on our consolidated statement of operations and comprehensive loss. The valuation of the warrants is classified under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that are both significant to the fair value measurement and unobservable. In order to calculate the fair value of the warrants, certain assumptions were made, including the selling price or fair market value of the underlying common stock, risk-free interest rate, volatility, and remaining life. Changes to the assumptions could cause significant adjustments to valuation. The Company estimated a volatility factor utilizing its own data. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity.

The following table presents quantitative information about the inputs used in the valuation for the Company’s fair value measurement of the warrant liability classified as Level 3:

September 30, 2021

December 31, 2020

Current stock price

$

5.95

$

5.36

Estimated volatility of future stock price

132.73

%

141.28

%

Risk free interest rate

0.41

%

0.17

%

Contractual term

2.16

years

2.90

years

During the year ended December 31, 2020, 470,238 warrants were exchanged for 319,756 shares of common stock. As of September 30, 2021, there were a total of 9,357 warrants outstanding that were reported as a liability on the consolidated balance sheet.

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Table of Contents

The fair value of financial instruments measured on a recurring basis is as follows:

As of September 30, 2021

Description

    

Total

    

Level 1

    

Level 2

    

Level 3

Assets:

Short-term investments

$

101,032,250

$

101,032,250

 

 

Liabilities:

 

  

 

  

 

  

 

  

Contingent consideration

$

3,318,515

 

$

3,318,515

Warrant liability

$

30,971

 

 

$

30,971

As of December 31, 2020

Description

    

Total

    

Level 1

    

Level 2

    

Level 3

Assets:

Short-term investments

$

100,842,438

$

100,842,438

 

 

Liabilities:

 

  

 

  

 

  

 

  

Contingent consideration

$

2,912,515

 

$

2,912,515

Warrant liability

$

33,779

 

$

33,779

The following table summarizes the change in fair value, as determined by Level 3 inputs, for all assets and liabilities using unobservable Level 3 inputs for the nine months ended September 30, 2021:

Contingent 

 

Warrant

    

Consideration

 

Liability

Balance at December 31, 2020

$

2,912,515

$

33,779

Change in fair value

 

406,000

(2,808)

Balance at September 30, 2021

$

3,318,515

$

30,971

The change in the fair value of the contingent consideration for the nine months ended September 30, 2021 was primarily due to the increase in the estimated probability of achieving the secondary milestone, a change in discount rate and the passage of time on the fair value measurement. The change in fair value of the warrant liability for the nine months ended September 30, 2021 was primarily due to increase in the fair value of the underlying stock. Adjustments associated with the change in fair value of contingent consideration and warrant liability are included in the Company’s consolidated statement of operations and comprehensive loss.

The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements of contingent consideration classified as Level 3 as of September 30, 2021: