HTBX Heat Biologics Inc.

6.95
+0.04  (+1%)
Previous Close 6.91
Open 6.95
52 Week Low 4.9
52 Week High 30.1
Market Cap $176,511,124
Shares 25,397,284
Float 24,289,014
Enterprise Value $52,559,212
Volume 295,233
Av. Daily Volume 1,187,189
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Upcoming Catalysts

Drug Stage Catalyst Date
PTX-35
Solid tumors
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
HS-110 and OPDIVO (nivolumab)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 data announced February 9, 2021 - median progression free survival (PFS) of 1.8 months and median overall survival (OS) of 24.6 months.
HS-130
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced December 16, 2019.
COVID vaccine
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 trial planned.
HS-410
Bladder cancer
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - November 30, 2016.

Latest News

  1. DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world's largest oncology conference showcasing the latest advancements in cancer research…

    DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world's largest oncology conference showcasing the latest advancements in cancer research.

    HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year's ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO® (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:

    • Median overall survival (mOS) of 24.6 months was observed in previously treated, CPI naïve patients with advanced NSCLC (Cohort A, n=47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting.
    • mOS of 11.9 months was reported in NSCLC patients who were previously treated with CPI and whose disease had subsequently progressed (Cohort B, n=68). Published data from other studies stated median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after CPI progression.
    • Multiple subset analyses including injection-site reaction (ISR) and tumor PD-L1 expression were performed.
      • Significantly longer mOS was observed in patients with ISR compared with those without such a reaction for both Cohorts A and B.  
      • Extended survival benefit was observed in PD-L1 positive patients in Cohort A.
      • A trend of improved overall survival was observed in patients with low blood tumor mutation burden in Cohort B.

    Dr. Roger B. Cohen, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, commented, "HS-110 is a promising agent for treatment of incurable NSCLC. The latest data presented support further clinical evaluation in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors."

    Jeff Wolf, Chief Executive Officer of Heat, commented, "This data further reinforces the potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC. The growing body of clinical data demonstrates that HS-110 in combination with a CPI is well tolerated and has the potential to enhance survival benefit when given with a CPI. Our latest results, consistent with previously reported data, provide a strong foundation for the Company to discuss possible Phase 3 registration trial designs with the FDA and potential partners."

    About HS-110

    HS-110 is a first-in-class, off-the-shelf, allogeneic cell therapy designed to utilize gp96 for immune activation against multiple tumor testis antigens. Phase 2 trial of HS-110 in combination with Bristol Myers Squibb's OPDIVO® (nivolumab) has completed enrollment in patients with incurable or metastatic NSCLC. OPDIVO® is a programmed death-1 immune checkpoint inhibitor. HS-110 has broad potential for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. Positive interim survival data has been demonstrated in two distinct treatment settings in previously treated NSCLC patients who have not been treated with CPI as well as patients who have progressed during or after previous treatment with a CPI. Combination of HS-110 and PD-(L)1 therapies may confer additional survival benefit.

    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.

    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 the HS-110, in combination with a checkpoint inhibitor (CPI), being a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC), HS-110 being a promising agent for treatment of incurable NSCLC, potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC, HS-110 in combination with a CPI having the potential to enhance survival benefit when given with a CPI and HS-110 being administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including 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 of HS-110, in combination with a CPI to be utilized in multiple treatment settings of NSCLC and to improve survival benefit for patients with non-small cell lung cancer (NSCLC), the ability HS-110 to be administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors, Heat's vaccine platform to provide protection against COVID-19, 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



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  2. DURHAM, N.C., May 20, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that the latest data from HS-110, the Company's lead product, has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. The ASCO Annual Meeting is the largest international conference to showcase the latest advancements in oncology.

    Abstract Title: Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings

    Session

    DURHAM, N.C., May 20, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that the latest data from HS-110, the Company's lead product, has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. The ASCO Annual Meeting is the largest international conference to showcase the latest advancements in oncology.

    Abstract Title: Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings

    Session Title: Poster Session: Lung Cancer—Non-Small Cell Metastatic

    Abstract Number: 9100

    Lead Author and Presenter: Roger B. Cohen, MD, Perelman School of Medicine at the University of Pennsylvania

    According to ASCO, more than 5,400 abstracts were reviewed for the 2021 ASCO Annual Meeting. Additional information about the conference may be accessed at https://conferences.asco.org/am/attend.

    About HS-110

    HS-110 is a first-in-class, off-the-shelf, allogeneic cell therapy designed to utilize gp96 for immune activation against multiple tumor testis antigens. Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb's (BMS) OPDIVO® (nivolumab) has completed enrollment in patients with incurable or metastatic NSCLC. OPDIVO® is a programmed death-1 immune checkpoint inhibitor (PD-1 inhibitor). HS-110 has broad potential for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. Positive interim survival data has been demonstrated in two distinct treatment settings in previously treated NSCLC patients who have not been treated with PD-1 inhibitor or programmed death-ligand 1 inhibitor (PD-L1 inhibitor) as well as patients who have progressed during or after previous treatment with a PD-1 or PD-L1 [PD-(L)1] inhibitor. Combination of HS-110 and PD-(L)1 therapies may confer additional survival benefit.

    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.

    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 the broad potential of HS-110 for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, 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, Heat's vaccine platform to provide protection against COVID-19, 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



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  3. DURHAM, N.C., May 19, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that PTX-35 will be featured in several presentations and panel discussions at the 3rd Annual Treg Directed Therapies Summit on May 19-20. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells.

    • On Wednesday, May 19th at 4PM EDT, Heat Biologics will present: "A Novel TNFRSF25-Agonist for Regulatory T-Cell Expansion." The presenter, Matthew Seavey, Ph.D., Heat Biologics' Executive Director of Special Projects…

    DURHAM, N.C., May 19, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that PTX-35 will be featured in several presentations and panel discussions at the 3rd Annual Treg Directed Therapies Summit on May 19-20. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells.

    • On Wednesday, May 19th at 4PM EDT, Heat Biologics will present: "A Novel TNFRSF25-Agonist for Regulatory T-Cell Expansion." The presenter, Matthew Seavey, Ph.D., Heat Biologics' Executive Director of Special Projects, plans to discuss how TNFRSF25-engagement by PTX-35 can expand regulatory T-cells in vivo and reduce disease severity in several animal models of GVHD & inflammatory disease.



    • On Thursday, May 20th at 3:30PM EDT, Robert B. Levy, Ph.D., Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine, will present: "Improving Outcomes of Allo-HCT: Manipulating the Regulatory Cell Compartment in vivo to Ameliorate GVHD."



    • Dr. Seavey will also chair two panels, including: "Exploring Key Questions to Advance Understanding of Treg Behavior," and "Maximizing Immune Tolerance through Generation of Antigen Specific Tregs."

    The 3rd Annual Treg Directed Therapies Summit is focused on targeting and translating Treg modifying therapies and brings together executives and leading researchers from large pharma, biotech and academia to discuss developments in Treg therapies.

    About PTX-35

    PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells. PTX-35 is currently enrolling in a Phase 1 clinical trial for the treatment of patients with solid tumors.

    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.

    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 the planned presentations. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the contributions of, 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, Heat's vaccine platform to provide protection against COVID-19, 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



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  4. DURHAM, N.C., May 10, 2021 (GLOBE NEWSWIRE) --  Heat Biologics, Inc. (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 announced the appointment of Anthony Manning, Ph.D. as Chief Scientific Advisor. Dr. Manning will be responsible for strategic initiatives to accelerate the development of Heat Biologics' product portfolio.

    Dr. Manning brings over three decades of experience in immunology and autoimmune disease research and development. Most recently, Dr. Manning served as Chief Scientific Officer and Head of Research at Momenta Pharmaceuticals, a biotechnology company focused…

    DURHAM, N.C., May 10, 2021 (GLOBE NEWSWIRE) --  Heat Biologics, Inc. (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 announced the appointment of Anthony Manning, Ph.D. as Chief Scientific Advisor. Dr. Manning will be responsible for strategic initiatives to accelerate the development of Heat Biologics' product portfolio.

    Dr. Manning brings over three decades of experience in immunology and autoimmune disease research and development. Most recently, Dr. Manning served as Chief Scientific Officer and Head of Research at Momenta Pharmaceuticals, a biotechnology company focused on biologic therapeutics to treat rare immune-mediated diseases. At Momenta, Dr. Manning provided strategic leadership to all research activities, including the discovery and development of three novel autoimmune drug candidates. Momenta was recently acquired by Johnson & Johnson for approximately $6.5 billion. Prior to Momenta, Dr. Manning served as Senior Vice President of Research and Preclinical Development at Aileron Therapeutics, where he oversaw target selection, lead identification and optimization, clinical candidate selection, and IND-enabling studies. Before Aileron, Dr. Manning served as Vice President and Head of Inflammation and Autoimmune Disease Research at Biogen, and previously served as Vice President and Global Therapy Area Head of Inflammation, Autoimmunity & Transplantation Research at Roche. Dr. Manning is a member of the Board Directors of Palatin Technologies, Inc, Chairman of the Institute for Biomedical Entrepreneurship, and an Advisor to the Harvard Medical School Therapeutics Initiative. He is an author and inventor on over 120 publications and patents relating to autoimmune disease and novel drug discovery.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We are thrilled to welcome Dr. Manning to our team. With his proven track record in the drug discovery, research and development, Dr. Manning will provide strategic leadership and invaluable insight to accelerate the development of our portfolio programs. "

    "I am excited to be joining Jeff and the team at Heat Biologics," stated Dr. Manning. "My entire professional career has been aimed at targeting the immune system and Heat's first-in-class pipeline holds immense promise for improving current standard of care. I look forward to working with the team to expand and advance the innovative pipeline programs."

    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.

    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 Dr. Manning offering invaluable insight as Heat advances its product pipeline.. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the contributions of Dr. Manning to Heat, 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, Heat's vaccine platform to provide protection against COVID-19, 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



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  5. DURHAM, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- 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 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…

    DURHAM, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- 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 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)

    HEAT BIOLOGICS, INC.

    Consolidated Balance Sheets

     March 31,  December 31, 
     2021     2020 
      (unaudited)   
    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 
            
            

    HEAT BIOLOGICS INC.

    Consolidated Statements of Operations and Comprehensive Loss

    (unaudited)

     Three Months Ended
     March 31, 
     2021     2020 
    Revenue:     
    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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