On March 14, 2022 Heat Biologics, Inc. ("Heat") (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that provided strategic, financial, and operational updates for the year ended December 31, 2021 (Press release, Heat Biologics, MAR 14, 2022, View Source [SID1234610043]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Jeff Wolf, Chief Executive Officer of Heat, commented, "2021 was a transformative year for Heat as we progress our strategic evolution to become a fully-integrated biopharmaceutical company. On the clinical front, we presented favorable survival data at The American Association of Cancer Research (AACR) (Free AACR Whitepaper) of HS-110 in combination with checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). We recently submitted meeting requests to the FDA for separate Type B ("End of Phase 2 Meeting") and Type C (Phase 3 "CMC Readiness Meeting") meetings to receive feedback on our proposed trial design and regulatory path forward. We anticipate these meetings will be scheduled for the second quarter of 2022. Following these meetings, we should be in a better position to advance potential strategic discussions regarding this program."
"In September, based on our positive review of the Phase 1 data generated to date, we announced additional dose levels for our Phase 1 clinical trial evaluating the safety of PTX-35 monotherapy in patients with solid tumors and look forward to reporting the results of this trial later this year. We also recently announced new data demonstrating a single dose of the preclinical version of PTX-35 (mPTX-35), was able to expand regulatory T cells (Tregs) and significantly improve disease and graft survival outcome in a model of pancreatic islet allotransplantation for the treatment of diabetes."
"We continued to make great strides towards becoming a fully integrated biotech capable of driving innovations from discovery through delivery. With the formation of Skunkworx Bio, we have ramped up our in-house discovery of biologics for our preclinical and clinical development efforts."
"Our biomanufacturing and analytical team at Scorpion Biological Services broke ground on a new facility in San Antonio, Texas, designed to decrease our dependence on third-party CDMOs, reducing costs and accelerating timelines. In addition to supporting our own internal operations, we intend to offer manufacturing services to other biopharma companies on a fee-for-service basis. These efforts reinforce our goal of maximizing efficiency of drug development to expedite the delivery of novel immune activating therapies."
"At the World Vaccine Conference, we announced our new biosecurity/biodefense initiative led by RapidVax, a novel vaccine platform designed to enable an accelerated response and long-lasting immunological memory against a wide variety of infectious agents. RapidVax is designed to utilize a common unprogrammed vaccine base that can be manufactured in bulk, stockpiled, and rapidly customized upon identification of a biological threat to enable an accelerated time to clinic that can harness shared development, clinical safety, and manufacturing synergies. Our gp96-based cellular vaccines have previously demonstrated prophylactic protection in animal models against a range of diseases, including malaria, HIV/SIV, Zika and SARS-CoV-2 in multiple DOD and NIH-funded studies. Since launching this program, we have filed patents to protect our proprietary technology and have established our new Biothreat Advisory Board, which includes highly renowned individuals in the fields of biosecurity and biodefense, to guide the development of our programs."
"In addition to our internal biodefense initiatives, we announced a definitive merger agreement to acquire Elusys Therapeutics, a commercial-stage biodefense company and the manufacturer of ANTHIM (obiltoxaximab), which is approved for the treatment of inhalation anthrax in the U.S., Canada, Europe. Since announcing this acquisition, Elusys completed the first phase of a contract for $50 million with an option to procure up to an additional $31 million of ANTHIM by the first half of 2023. Given the growing global uncertainty, we believe the risks of anthrax and other biological threats are more present than ever. This acquisition is aligned with our strategy to take a leading role in the biodefense market."
2021 Financial Results
Recognized $2.1 million of grant and contract revenue, primarily for qualified expenditures under the CPRIT grant for the year ended December 31, 2021 compared to $2.9 million for the year ended December 31, 2020. 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 December 31, 2021, we had a grant receivable balance of $1.3 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
Research and development expense was $18.8 million and $12.9 million for the years ended December 31, 2021 and 2020, respectively. The increase was primarily due to manufacturing and patient costs for PTX-35, consulting expenses in our clinical and CMC groups, and a $2.4 million impairment of IPR&D.
General and administrative expense was $16.8 million and $14.9 million for the years ended December 31, 2021 and 2020. The increase was primarily due to the increase in salaries, D&O insurance expense, and legal fees.
Net loss attributable to Heat Biologics was approximately $35.1 million, or ($1.41) per basic and diluted share for the year ended December 31, 2021 compared to a net loss of approximately of $26.0 million, or ($1.63) per basic and diluted share for the year ended December 31, 2021.
As of December 31, 2021, the Company had approximately $96.4 million in cash, cash equivalents and short term investments.