Organization	12 Months Ended
Dec. 31, 2021
Organization
Organization	1. Organization Heat Biologics is a biopharmaceutical company primarily engaged in the development of immune therapies and vaccines. Our gp96 platform is designed to activate the immune system. This platform has broad applications in cancer and infectious disease. The Company platform leverages gp96’s role as a natural molecular warning system that presents antigens to the immune system. HS-110 (viagenpumatucel-L) is the Company’s first allogeneic (“off-the-shelf”) cell line biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient’s T-cells to destroy cancer. HS-130 is an allogeneic cell line engineered to express the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T-cells, with the potential to augment antigen-specific CD4+ T-cell and CD8+ T-cell responses. We have initiated development of a new COVID-19 vaccine program under our Zolovax, Inc. subsidiary that utilizes our gp96 platform to secrete SARS-CoV-2 antigens. The Company’s subsidiary Pelican Therapeutics, Inc. (“Pelican”), is developing PTX-35, a novel T-cell co-stimulator agonist antibody targeting DR3/TNFRSF25 for systemic administration. The Company is also designing and building a cGMP facility in San Antonio, Texas for bioanalytics, process development, and manufacturing activities via its subsidiary Scorpion Biological Services, Inc. These programs are designed to harness the body's natural antigen specific immune activation and tolerance mechanisms to reprogram immunity and provide a long-term, durable clinical effect. The Company has completed recruiting patients in its Phase 2 HS-110 non-small cell lung cancer (NSCLC) trial, dosed twelve patients in our Phase 1 clinical trial of HS-130 and dosed five patients in our Phase 1 clinical trial of PTX-35. The Company is also providing pre-clinical, CMC development, and administrative support for these operations; while constantly focusing on protecting and expanding our intellectual property in areas of strategic interest. As the Company advances its clinical programs, it is in close contact with the CROs and clinical sites and are assessing the impact of COVID-19 on the studies and current timelines and costs. On December 20, 2021, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with our wholly owned subsidiary (“Merger Sub”), Elusys Therapeutics, Inc., a Delaware corporation (“Elusys”) and Fortis Advisors LLC, pursuant to which, subject to certain conditions, we will acquire Elusys through the merger (the “Merger”) of Merger Sub with Elusys. Following the closing of the Merger, Elusys will become a wholly owned subsidiary. Elusys is a company focused on the commercialization of ANTHIM® (obiltoxaximab), which is a monoclonal antibody antitoxin for the “Category A” biological warfare and bioterrorism threat anthrax designed to combat a potential anthrax attack. As of December 31, 2021, the merger has not been consummated. Unless otherwise noted, all share and per share data referenced in the consolidated financial statements and the notes thereto have been retroactively adjusted to reflect the one-for-seven reverse stock split effective December 11, 2020. As a result of the reverse stock split, amounts within the consolidated balance sheets were reclassified between common stock and additional paid-in capital.

Organization

12 Months Ended

Dec. 31, 2021

1. Organization

Heat Biologics is a biopharmaceutical company primarily engaged in the development of immune therapies and vaccines. Our gp96 platform is designed to activate the immune system. This platform has broad applications in cancer and infectious disease. The Company platform leverages gp96’s role as a natural molecular warning system that presents antigens to the immune system. HS-110 (viagenpumatucel-L) is the Company’s first allogeneic (“off-the-shelf”) cell line biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient’s T-cells to destroy cancer. HS-130 is an allogeneic cell line engineered to express the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T-cells, with the potential to augment antigen-specific CD4+ T-cell and CD8+ T-cell responses. We have initiated development of a new COVID-19 vaccine program under our Zolovax, Inc. subsidiary that utilizes our gp96 platform to secrete SARS-CoV-2 antigens. The Company’s subsidiary Pelican Therapeutics, Inc. (“Pelican”), is developing PTX-35, a novel T-cell co-stimulator agonist antibody targeting DR3/TNFRSF25 for systemic administration. The Company is also designing and building a cGMP facility in San Antonio, Texas for bioanalytics, process development, and manufacturing activities via its subsidiary Scorpion Biological Services, Inc.

These programs are designed to harness the body's natural antigen specific immune activation and tolerance mechanisms to reprogram immunity and provide a long-term, durable clinical effect. The Company has completed recruiting patients in its Phase 2 HS-110 non-small cell lung cancer (NSCLC) trial, dosed twelve patients in our Phase 1 clinical trial of HS-130 and dosed five patients in our Phase 1 clinical trial of PTX-35. The Company is also providing pre-clinical, CMC development, and administrative support for these operations; while constantly focusing on protecting and expanding our intellectual property in areas of strategic interest. As the Company advances its clinical programs, it is in close contact with the CROs and clinical sites and are assessing the impact of COVID-19 on the studies and current timelines and costs.

On December 20, 2021, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with our wholly owned subsidiary (“Merger Sub”), Elusys Therapeutics, Inc., a Delaware corporation (“Elusys”) and Fortis Advisors LLC, pursuant to which, subject to certain conditions, we will acquire Elusys through the merger (the “Merger”) of Merger Sub with Elusys. Following the closing of the Merger, Elusys will become a wholly owned subsidiary. Elusys is a company focused on the commercialization of ANTHIM® (obiltoxaximab), which is a monoclonal antibody antitoxin for the “Category A” biological warfare and bioterrorism threat anthrax designed to combat a potential anthrax attack. As of December 31, 2021, the merger has not been consummated.

Unless otherwise noted, all share and per share data referenced in the consolidated financial statements and the notes thereto have been retroactively adjusted to reflect the one-for-seven reverse stock split effective December 11, 2020. As a result of the reverse stock split, amounts within the consolidated balance sheets were reclassified between common stock and additional paid-in capital.