Heat Biologics : Commences Manufacturing Process for ZVX-60

January 19, 2021

Heat Biologics Commences Manufacturing Process for ZVX-60

DURHAM, NC / ACCESSWIRE / January 19, 2021 /Heat Biologics, Inc. ("Heat") (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 announces it has transferred its gp96- based COVID-19 vaccine cell line ("ZVX-60") to Waisman Biomanufacturing to initiate the manufacturing process for ZVX-60, which is being developed for use as either a standalone vaccine, or in combination with other vaccines, to enhance prophylactic protection against COVID-19.

Jeff Wolf, Heat's CEO, commented, "Initiation of our manufacturing process is an important milestone as we progress ZVX-60 into human clinical trials. As previously announced, recent data generated with our collaborators at the University of Miami Miller School of Medicine confirmed ZVX-60 expression of gp96, OX40L and the COVID-19 Spike protein. We believe ZVX-60 holds promise to enhance protection as a stand-alone vaccine or in combination with other vaccine approaches, and look forward to working with Waisman to manufacture ZVX-60 for our first-in-human clinical trial."

About Heat Biologics, Inc.

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 pathogenic antigens. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, HS-130 in Phase 1, and a COVID-19 vaccine program in preclinical development. In addition, Heat is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 which is enrolling in a Phase 1 trial.

For more information, please visit: www.heatbio.com, and also follow us on Twitter.

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 ZVX-60 holding promise to enhance protection as a stand-alone vaccine or in combination withother vaccine approaches and the gp96 platform activating immune responses against cancer or

pathogenic antigens. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of ZVX-60 to enhance protection as a stand-alone vaccine or in combination with other vaccine approaches, 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

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HEAT BIOLOGICS, INC.

Consolidated Balance Sheets

Current Assets

Cash and cash equivalents Short-term investments Accounts receivable

Prepaid expenses and other current assets

Total Current Assets

Property and Equipment, net

Other Assets In-process R&D Goodwill

Operating lease right-of-use asset Finance lease right-of-use asset Deposits

September

30, December 31,

2020 2019

(unaudited)

• 24,808,083 $ 9,039,887
  92,501,019 5,713,922
  212,141 34,986
  1,620,504 420,328

119,141,747 15,209,123

720,396 559,410

5,866,000 5,866,000

1,452,338 1,452,338

2,123,414 2,287,500

276,918 187,573

129,505 394,637

Total Other Assets

Total Assets

Liabilities and Stockholders' Equity

Current Liabilities

Accounts payable

Deferred revenue, current portion Contingent consideration, current portion Contingent consideration, related party - current portion Operating lease liability, current portion

Finance lease liability, current portion Accrued expenses and other liabilities

Total Current Liabilities

Long Term Liabilities

Other long-term liabilities Derivative warrant liability Deferred tax liability

Deferred revenue, net of current portion Operating lease liability, net of current portion Financing lease liability, net of current portion Contingent consideration, net of current portion Contingent consideration, related party - net of current portion

Total Liabilities

Commitments and Contingencies (Note 13)

Stockholders' Equity

Common stock, $.0002 par value; 250,000,000 shares authorized, 157,021,194 and 33,785,999 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

Additional paid-in capital Accumulated deficit

Accumulated other comprehensive loss

Total Stockholders' Equity - Heat Biologics, Inc.

Non-Controlling Interest

Total Stockholders' Equity

Total Liabilities and Stockholders' Equity

9,848,175 10,188,048

$ 129,710,318 $ 25,956,581

• 753,872 $ 1,503,342

1,166,481 3,410,319

• 1,124,970
• 454,364
  271,703 216,832
  106,409 49,104

1,503,899	1,676,467
3,802,364		8,435,398
26,331	-
60,915	-
361,911	361,911
240,000	200,000
1,374,141	1,519,574
187,881	142,667
2,131,830	1,653,197
626,685	485,984
8,812,058		12,798,731

31,402 6,757

245,740,939 118,173,843

(124,195,893) (104,597,748)

(35,910) (11,250)

121,540,538 13,571,602

(642,278) (413,752)

120,898,260 13,157,850

$ 129,710,318 $ 25,956,581

HEAT BIOLOGICS INC.

Consolidated Statements of Operations and Comprehensive Loss (unaudited)

Three Months Ended

Nine Months Ended

		September 30,		September 30,
Revenue:		2020			2019			2020			2019
$	849,732		$	6,439		$	2,344,777		$	1,049,988
Grant and contract revenue
Operating expenses:		3,172,663			3,129,356			8,745,966			9,725,744
Research and development
General and administrative		6,579,193			1,993,136			11,651,415			7,201,196
Goodwill impairment loss		-			737,000			-			737,000
Change in fair value of
contingent consideration		229,000			502,000			1,045,000			728,290
Total operating expenses		9,980,856			6,361,492			21,442,381			18,392,230
Loss from operations		(9,131,124)		(6,355,053)		(19,097,604)		(17,342,242)
Change in fair value of
	(37,230)		-			(1,039,303)		-
warrant liability
Investor relations expense		-			-			(66,767)		-
Interest income		140,614			97,415			249,404			373,060
Other income (expense), net		111,307			(73,275)		127,599			(80,539)
Total non-operating income
(loss)		214,691			24,140			(729,067)		292,521
Net loss before income taxes		(8,916,433)		(6,330,913)		(19,826,671)		(17,049,721)
Income tax expense		-			-			-			(45,178)
Net loss		(8,916,433)			(6,330,913)			(19,826,671)			(17,094,899)
Net loss - non-controlling
interest		(64,824)		(136,315)		(228,526)		(413,955)
Net loss attributable to Heat
Biologics, Inc.	$	(8,851,609) $	(6,194,598) $	(19,598,145) $	(16,680,944)
Net loss per share attributable
to Heat Biologics, Inc.-
Net loss per share
attributable to Heat Biologics,
Inc.-basic and diluted	$	(0.06) $	(0.18) $	(0.20) $	(0.50)
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		143,728,870			33,650,829			96,481,271			33,255,535
diluted
Comprehensive loss:	$	(8,916,433)	$	(6,330,913)	$	(19,826,671)	$	(17,094,899)
Net loss
Unrealized (loss) gain on
foreign currency translation		(63,954)		63,711			(24,660)		72,134