8-K

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): March 25, 2021

Heat Biologics, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)

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001-35994	26-2844103
(Commission File Number)	(IRS Employer Identification No.)

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627 Davis Drive, Suite 400

Morrisville, North Carolina 27560

(Address of principal executive offices and zip code)

(919) 240-7133

(Registrant’s telephone number including area code)

N/A

(Former Name and Former Address)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

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◻Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

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Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0002 par value per share	HTBX	The Nasdaq Stock Market, LLC<br><br>(The Nasdaq Capital Market)

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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Emerging growth company  ◻

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If an emerging growth company, indicate by checkmark 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. ◻

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Item 2.02  Results of Operations and Financial Condition.

On March 25, 2021, Heat Biologics, Inc., a Delaware corporation (the “Registrant”), issued the attached press release that included financial information for its year ended December 31, 2020. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in the press release is being furnished to the Securities and Exchange Commission (the “Commission”) and shall not be deemed incorporated by reference into any of the Registrant’s registration statements or other filings with the Commission.

Item 9.01  Financial Statements and Exhibits.

(d)	Exhibits.

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Exhibit<br>Number		Description
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99.1	​	Press Release issued by Heat Biologics, Inc. March 25, 2021.

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SIGNATURES

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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Dated:  March 25, 2021	HEAT BIOLOGICS, INC.
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​	By:	/s/ Jeffrey Wolf
​	Name:	Jeffrey Wolf
​	Title:	Chairman, President and
​	​	Chief Executive Officer

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EXHIBIT 99.1

Heat Biologics Provides Year-End Business Update

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Durham, NC – March 25, 2021 **** – Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today provided financial, clinical and operational updates for the year ended December 31, 2020.

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Jeff Wolf, Chief Executive Officer of Heat, commented, “We made tremendous progress on our clinical programs in 2020. Earlier this year, we reported positive interim data from our Phase 2 non-small cell lung cancer trial of HS-110, which demonstrated evidence of substantial survival benefit. We are currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intend to review these plans with the FDA as well as potential partners. In 2020, we initiated a Phase 1 clinical trial of our PTX-35 first-in-class antibody therapeutic in patients with solid tumors. Leveraging our proprietary gp96 platform and in response to the COVID-19 pandemic, we initiated a COVID-19 vaccine program in collaboration with the University of Miami and have advanced this program into scale-up manufacturing. We have a strong balance sheet with approximately $132 million of cash, which should allow us to accelerate our current clinical programs and enhance our development and manufacturing capability to expand our therapeutic portfolio. We look forward executing key milestones in our growing pipeline in 2021.”

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Pipeline Highlights and Updates

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HS-110

●	In previously treated, checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC) (Cohort A, N = 47), the median overall survival (OS) observed was 24.6 months was with a median follow-up time of 19.4 months and the one-year survival rate was 61.7%.
o	The median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the BMS CheckMate 057 study^1^.
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o	The addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for checkpoint inhibitor naïve NSCLC patients.
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●	For NSCLC patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed (Cohort B, N = 68), a median OS of 11.9 months was observed.
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o	Published data from other studies reported median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after PD-(L)1 progression^2,3^.
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o	NSCLC patients whose disease progresses following checkpoint inhibitor therapy have limited treatment options^4^.
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o	The addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy.
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●	As of this data cut, there were no treatment-emergent serious adverse reactions related to HS-110.
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PTX-35

●	In June 2020, the Company initiated a first-in-human Phase 1 clinical trial evaluating PTX-35.
●	PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction.
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COVID-19

●	In March 2020, the Company initiated a COVID-19 vaccine program leveraging its proprietary gp96 technology platform in collaboration with University of Miami.
●	Positive preclinical data demonstrated a robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2, including induction of systemic and tissue-specific memory CD8+ T-cells and tissue-resident memory CD8+ T-cells in the lung.
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●	The Company has initiated manufacturing of ZVX-60 and is conducting IND-enabling activities.
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2020 Financial Results

●	As of December 31, 2020, the Company had approximately $111.8 million in cash and cash equivalents and short-term investments.
●	Research and development expenses stayed consistent at $12.9 million and $13.0 million for the years ended December 31, 2020 and December 31, 2019.
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●	General and administrative expense increased approximately 59% to $14.9 million for the year ended December 31, 2020 compared to $9.4 million for the year ended December 31, 2019. The increase of $5.5 million is primarily due to the increase in personnel and stock compensation expense.
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●	Net loss attributable to Heat Biologics, Inc. was $26.0 million, or ($1.63) per basic and diluted share for the year ended December 31, 2020 compared to a net loss attributable to Heat Biologics, Inc. of $20.0 million, or ($4.21) per basic and diluted share for the year ended December 31, 2019.
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About Heat Biologics, Inc.

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Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. The Company's gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.

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Forward Looking Statement

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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 the Heat’s strong balance sheet allowing it to accelerate its current clinical programs and enhance our development and manufacturing capability to expand its therapeutic portfolio, he addition of HS-110 to a checkpoint inhibitor to improve survival benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy,  and possible Phase 3 registration pathways of HS-110 in combination with a checkpoint inhibitor and intended discussion of these plans with the FDA as well as potential partners. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of HS-110 when added to a checkpoint inhibitor to improve survival benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy, the ability of Heat to successfully design a registrational pathway for HS-110, the ability of Heat's platform to have utility for NSCLC and potentially other types of cancer , the ability of Heat to accelerate its current clinical programs and enhance its development and manufacturing capability to expand its therapeutic portfolio, 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.

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Reference

^1^ Borghaei et al. Five-Year Outcomes from the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Jan 15.

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^2^ Costantini et al. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2):00120-2017.

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^3^ Schvartsman et al. Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2017 Oct;112:90-95.

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^4^ NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer Version 2.2021-Dec 15, 2020.

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Media and Investor Relations Contact	​
David Waldman	​
+1 919 289 4017	​
[email protected]	​

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(tables follow)

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HEAT BIOLOGICS, INC.

Consolidated Balance Sheets

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​	​	​	​	​	​	​
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​	****	December 31,		​	December 31,
​	​	2020		****	2019
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Current Assets	​	​	​	​	​	​
Cash and cash equivalents	​	$	10,931,890	​	$	9,039,887
Short-term investments	​		100,842,438	​		5,713,922
Accounts receivable	​		177,239	​		34,986
Prepaid expenses and other current assets	​		1,842,620	​		420,328
Total Current Assets	​		113,794,187	​		15,209,123
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Property and Equipment, net	​		676,262	​		559,410
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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	​	​	2,035,882	​	​	2,287,500
Finance lease right-of-use asset	​	​	247,194	​	​	187,573
Deposits	​		122,779	​		394,637
Total Other Assets	​		9,724,193	​		10,188,048
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Total Assets	​	$	124,194,642	​	$	25,956,581
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Liabilities and Stockholders' Equity	​			​
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Current Liabilities	​			​
Accounts payable	​	$	1,051,764	​	$	1,503,342
Deferred revenue, current portion	​		603,717	​		3,410,319
Contingent consideration, current portion	​		—	​		1,124,970
Contingent consideration, related party - current portion	​		—	​		454,364
Operating lease liability, current portion	​	​	278,753	​	​	216,832
Finance lease liability, current portion	​	​	108,127	​	​	49,104
Accrued expenses and other liabilities	​		1,614,534	​		1,676,467
Total Current Liabilities	​		3,656,895	​		8,435,398
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Long Term Liabilities	​			​
Other long-term liabilities	​		36,243	​		—
Derivative warrant liability	​	​	33,779	​	​	—
Deferred tax liability	​		361,911	​		361,911
Deferred revenue, net of current portion	​		237,500	​		200,000
Operating lease liability, net of current portion	​		1,301,636	​		1,519,574
Financing lease liability, net of current portion	​		160,240	​		142,667
Contingent consideration, net of current portion	​	​	2,250,844	​	​	1,653,197
Contingent consideration, related party - net of current portion	​	​	661,671	​	​	485,984
Total Liabilities	​		8,700,719	​		12,798,731
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Commitments and Contingencies	​			​
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Stockholders' Equity	​			​
Common stock, $.0002 par value; 250,000,000 and 100,000,000 shares authorized, 22,592,500 and 4,826,565 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively	​		4,519	​		965
Additional paid-in capital	​		247,048,349	​		118,179,635
Accumulated deficit	​		(130,647,485)	​		(104,597,748)
Accumulated other comprehensive loss	​		(166,056)	​		(11,250)
Total Stockholders' Equity - Heat Biologics, Inc.	​		116,239,327	​		13,571,602
Non-Controlling Interest	​		(745,404)	​		(413,752)
Total Stockholders' Equity	​		115,493,923	​		13,157,850
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Total Liabilities and Stockholders' Equity	​	$	124,194,642	​	$	25,956,581

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HEAT BIOLOGICS INC.

Consolidated Statements of Operations and Comprehensive Loss

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​	​	​	​	​	​
​	Year ended
​	December 31,
​	2020		****	2019
Revenue:	​	​	​	​	​
Grant and contract revenue	$	2,947,969	​	$	3,049,104
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Operating expenses:			​
Research and development		12,938,895	​		13,013,604
General and administrative		14,934,436	​		9,431,015
Goodwill impairment loss	​	—	​	​	737,000
Change in fair value of contingent consideration		1,199,000	​		613,290
Total operating expenses		29,072,331	​		23,794,909
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Loss from operations		(26,124,362)	​		(20,745,805)
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Change in fair value of warrant liability	​	(1,012,167)	​	​	—
Investor relations expense	​	(66,767)	​	​	—
Interest income		566,718	​		431,824
Other income (expense), net		255,189	​		(25,557)
Total non-operating (loss) income		(257,027)	​		406,267
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Net loss before income taxes		(26,381,389)	​		(20,339,538)
Income tax expense		—	​		(45,178)
Net loss		(26,381,389)	​		(20,384,716)
Net loss - non-controlling interest		(331,652)	​		(367,148)
Net loss attributable to Heat Biologics, Inc.	$	(26,049,737)	​	$	(20,017,568)
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Net loss per share attributable to Heat Biologics, Inc.-			​
Net loss per share attributable to Heat Biologics, Inc.-basic and diluted	$	(1.63)	​	$	(4.21)
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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		15,982,568	​		4,754,542
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Comprehensive loss:			​
Net loss		(26,381,389)	​		(20,384,716)
Unrealized (loss) gain on foreign currency translation		(154,806)	​		8,654
Total comprehensive loss		(26,536,195)	​		(20,376,062)
Comprehensive loss attributable to non-controlling interest		(331,652)	​		(367,148)
Comprehensive loss - Heat Biologics, Inc.	$	(26,204,543)	​	$	(20,008,914)

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