Heat Biologics Commences Manufacturing Process for ZVX-60
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Heat Biologics Commences Manufacturing Process for ZVX-60

Tuesday, January 19, 2021 7:30 AM
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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 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
[email protected]

 

HEAT BIOLOGICS, INC.
Consolidated Balance Sheets

 
  September 30,     December 31,  
 
  2020     2019  
 
  (unaudited)        
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  
                 
 

HEAT BIOLOGICS INC.
Consolidated Statements of Operations and Comprehensive Loss (unaudited)

 
  Three Months Ended     Nine Months Ended  
 
  September 30,     September 30,  
 
  2020     2019     2020     2019  
Revenue:
                       
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.

Heat Biologics, Inc.
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