Heat Biologics Provides First Quarter 2021 Business Update; Reports Continued Progress on Oncology and COVID-19 Vaccine Programs

DURHAM, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- Heat Biologics (“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 provided financial, clinical and operational updates for the first quarter ended March 31, 2021.

Jeff Wolf, Chief Executive Officer of Heat, commented, “We continue to make tremendous progress on our clinical programs, including both our oncology program and COVID-19 vaccine program, which we recently advanced into scale-up manufacturing. We are currently reviewing a variety of possible Phase 3 registration settings for HS-110 in combination with checkpoint inhibitors, following positive interim data from our Phase 2 trial in patients with advanced non-small cell lung cancer (NSCLC).”

“We recently announced promising new preclinical data around PTX-35, our potential first-in-class T-cell co-stimulatory antibody at the AACR Annual Meeting 2021. We are completing enrollment in our Phase 1 PTX-35 trial in patients with solid tumors and expect to share interim data later this year.”

“Finally, we have maintained a solid balance sheet with over $128 million of cash and short-term investments, which should provide us substantial runway to fund our current clinical programs and further expand our therapeutic portfolio. Moreover, we believe that upcoming catalysts and milestones have the potential to drive significant shareholder value in 2021,” concluded Mr. Wolf.

First Quarter 2021 Financial Results

  • Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT and NIH grant compared to $0.9 million of grant revenue for the same period last year. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of March 31, 2021, we had deferred revenue of $0.09 million for CPRIT proceeds received but for which the costs had not been incurred or the conditions of the award had not been met.
  • Research and development expenses was $3.4 million and $2.8 million for the three months ended March 31, 2021 and 2020, respectively.
  • General and administrative expense was $4.8 million and $3.3 million for the three months ended March 31, 2021 and 2020. The increase was primarily due to stock compensation expense.
  • Net loss attributable to Heat Biologics was approximately $7.5 million, or ($0.31) per basic and diluted share for the quarter ended March 31, 2021 compared to a net loss of approximately of $6.3 million, or ($0.77) per basic and diluted share for the quarter ended March 31, 2020.
  • As of March 31, 2021, the Company had approximately $132 million in cash, cash equivalents and short investments.

About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’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.

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 sharing interim data later this year from the Phase 1 PTX-35 trial in patients with solid tumors, cash and short-term investments providing Heat a substantial runway to fund Heat’s current clinical programs and further expand Heat’s therapeutic portfolio, and upcoming catalysts and milestones having the potential to drive significant shareholder value in 2021. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the timing of providing interim data from the Phase 1 PTX-35 trial in patients with solid tumors, ability of Heat's vaccine platform to provide prevention and treatment of cancer and infectious diseases, such as 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 and its cash and short-term investments providing significant runway to fund Heat’s current clinical programs and further expand Heat’s therapeutic portfolio, 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 annual report on Form 10-K for the year ended December 31, 2020 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

(tables follow)

Consolidated Balance Sheets

  March 31,    December 31, 
  2021        2020  
Current Assets          
Cash and cash equivalents $ 31,156,747     $ 10,931,890  
Short-term investments   100,899,984       100,842,438  
Accounts receivable   103,232       177,239  
Prepaid expenses and other current assets   1,718,364       1,842,620  
Total Current Assets   133,878,327       113,794,187  
Property and Equipment, net   967,582       676,262  
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   1,947,192       2,035,882  
Finance lease right-of-use asset   217,469       247,194  
Deposits   141,201       122,779  
Total Other Assets   9,624,200       9,724,193  
Total Assets $ 144,470,109     $ 124,194,642  
Liabilities and Stockholders' Equity            
Current Liabilities            
Accounts payable $ 792,545     $ 1,051,764  
Deferred revenue, current portion   93,529       603,717  
Operating lease liability, current portion   285,927       278,753  
Finance lease liability, current portion   109,757       108,127  
Accrued expenses and other liabilities   1,764,385       1,614,534  
Total Current Liabilities   3,046,143       3,656,895  
Long Term Liabilities            
Other long-term liabilities   43,754       36,243  
Derivative warrant liability   42,481       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   1,227,634       1,301,636  
Financing lease liability, net of current portion   132,181       160,240  
Contingent consideration, net of current portion   2,255,480       2,250,844  
Contingent consideration, related party - net of current portion   663,035       661,671  
Total Liabilities   8,010,119       8,700,719  
Stockholders' Equity            
Common stock, $.0002 par value; 250,000,000 and 250,000,000 shares authorized, 25,137,410 and 22,592,500 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively   5,027       4,519  
Additional paid-in capital   275,618,780       247,048,349  
Accumulated deficit   (138,179,663 )     (130,647,485 )
Accumulated other comprehensive loss   (147,788 )     (166,056 )
Total Stockholders' Equity - Heat Biologics, Inc.   137,296,356       116,239,327  
Non-Controlling Interest   (836,366 )     (745,404 )
Total Stockholders' Equity   136,459,990       115,493,923  
Total Liabilities and Stockholders' Equity $ 144,470,109     $ 124,194,642  

Consolidated Statements of Operations and Comprehensive Loss

  Three Months Ended
  March 31, 
  2021        2020  
Grant and contract revenue $ 538,645     $ 901,880  
Operating expenses:            
Research and development   3,406,248       2,782,506  
General and administrative   4,767,645       3,270,548  
Change in fair value of contingent consideration   6,000       (27,000 )
Total operating expenses   8,179,893       6,026,054  
Loss from operations   (7,641,248 )     (5,124,174 )
Change in fair value of warrant liability   (8,702 )     (977,710 )
Investor relations expense         (66,767 )
Interest income   195,165       52,710  
Other expense, net   (168,355 )     (257,479 )
Total non-operating income (loss)   18,108       (1,249,246 )
Net loss before income taxes   (7,623,140 )     (6,373,420 )
Income tax expense          
Net loss   (7,623,140 )     (6,373,420 )
Net loss - non-controlling interest   (90,962 )     (81,314 )
Net loss attributable to Heat Biologics, Inc. $ (7,532,178 )   $ (6,292,106 )
Net loss per share, basic and diluted $ (0.31 )   $ (0.77 )
Weighted-average common shares outstanding, basic and diluted   24,199,916       8,183,154  
Comprehensive loss:            
Net loss $ (7,623,140 )   $ (6,373,420 )
Unrealized gain on foreign currency translation   18,268       218,804  
Total comprehensive loss   (7,604,872 )     (6,154,616 )
Comprehensive loss attributable to non-controlling interest   (90,962 )     (81,314 )
Comprehensive loss - Heat Biologics, Inc. $ (7,513,910 )   $ (6,073,302 )

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