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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.

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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 with other 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
+1 919 289 4017


Consolidated Balance Sheets

  September 30,   December 31,  
  2020  2019 
Current Assets      
Cash and cash equivalents $24,808,083  $9,039,887 
Short-term investments  92,501,019   5,713,922 
Accounts receivable  212,141   34,986 
Prepaid expenses and other current assets  1,620,504   420,328 
Total Current Assets  119,141,747   15,209,123 
Property and Equipment, net  720,396   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  2,123,414   2,287,500 
Finance lease right-of-use asset  276,918   187,573 
Deposits  129,505   394,637 
Total Other Assets  9,848,175   10,188,048 
Total Assets $129,710,318  $25,956,581 
Liabilities and Stockholders' Equity        
Current Liabilities        
Accounts payable $753,872  $1,503,342 
Deferred revenue, current portion  1,166,481   3,410,319 
Contingent consideration, current portion  -   1,124,970 
Contingent consideration, related party - current portion  -   454,364 
Operating lease liability, current portion  271,703   216,832 
Finance lease liability, current portion  106,409   49,104 
Accrued expenses and other liabilities  1,503,899   1,676,467 
Total Current Liabilities  3,802,364   8,435,398 
Long Term Liabilities        
Other long-term liabilities  26,331   - 
Derivative warrant liability  60,915   - 
Deferred tax liability  361,911   361,911 
Deferred revenue, net of current portion  240,000   200,000 
Operating lease liability, net of current portion  1,374,141   1,519,574 
Financing lease liability, net of current portion  187,881   142,667 
Contingent consideration, net of current portion  2,131,830   1,653,197 
Contingent consideration, related party - net of current portion  626,685   485,984 
Total Liabilities  8,812,058   12,798,731 
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  31,402   6,757 
Additional paid-in capital  245,740,939   118,173,843 
Accumulated deficit  (124,195,893)  (104,597,748)
Accumulated other comprehensive loss  (35,910)  (11,250)
Total Stockholders' Equity - Heat Biologics, Inc.  121,540,538   13,571,602 
Non-Controlling Interest  (642,278)  (413,752)
Total Stockholders' Equity  120,898,260   13,157,850 
Total Liabilities and Stockholders' Equity $129,710,318  $25,956,581 

Consolidated Statements of Operations and Comprehensive Loss (unaudited)

   Three Months Ended     Nine Months Ended  
   September 30,     September 30,  
   2020    2019    2020    2019 
Grant and contract revenue  849,732    6,439    2,344,777    1,049,988 
Operating expenses:                               
Research and development    3,172,663      3,129,356      8,745,966      9,725,744 
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 warrant liability    (37,230)    -      (1,039,303)    - 
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 diluted    143,728,870      33,650,829      96,481,271      33,255,535 
Comprehensive loss:                               
Net loss  (8,916,433)  (6,330,913)  (19,826,671)  (17,094,899)
Unrealized (loss) gain on foreign currency translation    (63,954)    63,711      (24,660)    72,134 
Total comprehensive loss    (8,980,387)    (6,267,202)    (19,851,331)    (17,022,765)
Comprehensive loss attributable to non-controlling interest    (64,824)    (136,315)    (228,526)    (413,955)
Comprehensive loss - Heat Biologics, Inc.  (8,915,563)  (6,130,887)  (19,622,805)  (16,608,810)

SOURCE: Heat Biologics, Inc.

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