1. DURHAM, NC / ACCESSWIRE / February 12, 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 announced that it will be presenting at the 2021 BIO CEO & Investor Digital Conference being held virtually between February 16-18, 2021.

    A webcast of Heat's presentation will be available on-demand to registered attendees beginning Tuesday, February 16th, and will be accessible for 30 days via the conference platform. Subsequent to the conference, the presentation will be made available on the investor relations section of Heat Biologics' website at https://ir.heatbio.com/ir-calendar

    DURHAM, NC / ACCESSWIRE / February 12, 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 announced that it will be presenting at the 2021 BIO CEO & Investor Digital Conference being held virtually between February 16-18, 2021.

    A webcast of Heat's presentation will be available on-demand to registered attendees beginning Tuesday, February 16th, and will be accessible for 30 days via the conference platform. Subsequent to the conference, the presentation will be made available on the investor relations section of Heat Biologics' website at https://ir.heatbio.com/ir-calendar.

    At the BIO CEO & Investor Digital Conference attendees will hear key biotech and pharma leaders discuss the most pertinent industry trends, the market outlook, and best practices for executive leadership. For more information about the BIO CEO & Investor Conference, please visit the conference website at https://www.bio.org/events/bio-ceo-investor-digital-conference.

    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 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 is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.



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  2. Median overall survival of 24.6 months in previously treated checkpoint inhibitor naïve non-small cell lung cancer patients who received HS-110 in combination with nivolumab

    DURHAM, NC / ACCESSWIRE / February 9, 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 reported positive interim data of the Company's fully-enrolled Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb's (BMS) OPDIVO® (nivolumab) in advanced non-small cell lung cancer (NSCLC). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate…

    Median overall survival of 24.6 months in previously treated checkpoint inhibitor naïve non-small cell lung cancer patients who received HS-110 in combination with nivolumab

    DURHAM, NC / ACCESSWIRE / February 9, 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 reported positive interim data of the Company's fully-enrolled Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb's (BMS) OPDIVO® (nivolumab) in advanced non-small cell lung cancer (NSCLC). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple cancer testis antigens to elicit a diverse and robust immune response against tumor cells.

    Substantial survival benefit was observed in a cohort of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC (Cohort A, N = 47). A median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed with a median follow-up time of 19.4 months. The one-year survival rate of Cohort A is 61.7%. The median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the BMS CheckMate 057 study1. Our data suggests that addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for checkpoint inhibitor naïve NSCLC patients.

    For NSCLC patients who had previously been treated with a checkpoint inhibitor and whose disease had subsequently progressed (Cohort B, N = 68), a median PFS of 2.8 months and median OS of 11.9 months was observed with a median follow-up time of 11.9 months. NSCLC patients whose disease progresses following checkpoint inhibitor therapy have limited treatment options2. Published data from other studies reported median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after PD-(L)1 progression3,4. Our data of HS-110 in combination with nivolumab in Cohort B suggests potential treatment benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy.

    As of this data cut, 30% of the patients in Cohort A and 26% of the patients in Cohort B are still alive. HS-110 has a favorable safety profile and has been administered in approximately 200 patients to date. As of this data cut, there have been no treatment-related serious adverse reactions. A review of immune-related adverse events reported in the study raised no safety concerns. The data to date demonstrate that combination of HS-110 and nivolumab is well-tolerated.

    "We are thrilled to report this latest positive survival data from our Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb's OPDIVO® (nivolumab) in advanced non-small cell lung cancer demonstrating HS-110's broad potential for providing multiple treatment options to NSCLC patients," stated Jeff Wolf, Chief Executive Officer of Heat Biologics. "HS-110 is the lead candidate in our portfolio of therapeutic products and vaccines utilizing Heat's gp96 technology platform and showcases the broad utility of this platform for NSCLC and potentially other types of cancer. We are currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor and intend to review these plans with the FDA as well as potential partners."

    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 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 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 the potential of the addition of HS-110 to a checkpoint inhibitor to improve survival benefit for checkpoint inhibitor naïve NSCLC patients, the potential treatment benefit of HS-110 in combination with nivolumab for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy, HS-110's broad potential for providing multiple treatment options to NSCLC patients, possible Phase 3 registration pathways of HS-110 in combination with a checkpoint inhibitor and intended discussion of these plans with the FDA as well as potential partners and the broad utility of this platform for NSCLC and potentially other types of cancer. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of HS-110 when added to a checkpoint inhibitor to improve survival benefit for checkpoint inhibitor naïve NSCLC patients, the ability of HS-110 in combination with nivolumab to have a potential treatment benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy, the ability of HS-110's to provide multiple treatment options to NSCLC patients, the ability of Heat to successfully design a registrational pathway for HS-110, the ability of Heat's platform to have utility for NSCLC and potentially other types of cancer , Heat's vaccine platform to provide protection against 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, 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.

    Reference

    1 Borghaei et al. Five-Year Outcomes from the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Jan 15.

    2 NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer Version 2.2021-Dec 15, 2020.

    3 Costantini et al. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2):00120-2017.

    4 Schvartsman et al. Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2017 Oct;112:90-95.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.



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  3. Spike specific CD8+ and CD4+ T-cell memory responses observed 30- and 60- days post vaccination

    DURHAM, NC / ACCESSWIRE / January 27, 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, announces the publication of additional preclinical COVID-19 results in Frontiers in Immunology, a leading peer reviewed journal, which is available online.

    The publication highlights additional data sets around memory T-cells that builds upon data previously reported and published in bioRxiv. Specifically, the new data demonstrates polyfunctional, anti-viral cytokine…

    Spike specific CD8+ and CD4+ T-cell memory responses observed 30- and 60- days post vaccination

    DURHAM, NC / ACCESSWIRE / January 27, 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, announces the publication of additional preclinical COVID-19 results in Frontiers in Immunology, a leading peer reviewed journal, which is available online.

    The publication highlights additional data sets around memory T-cells that builds upon data previously reported and published in bioRxiv. Specifically, the new data demonstrates polyfunctional, anti-viral cytokine releasing, Spike protein specific CD8+ and CD4+ T-cell memory responses in the lungs and spleen of immunized animals, observed 30 days post single vaccination. Additionally, memory CD8+ T-cell responses were observed 60 days post vaccination in the lungs of mice.

    The new data points to the significance of lung tissue-resident memory T-cells which are required for clearance of respiratory virus infections. Vaccination strategies that target generation of tissue-resident memory T-cells and their persistence may provide enhanced immunity compared with vaccines that rely on circulating responses.

    Jeff Wolf, Heat's CEO, commented, "We are excited to announce the publication of this latest data, further reinforcing the potential of our COVID-19 vaccine to induce a durable cellular immune response and protect against reinfection."

    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 vaccination strategies that target generation of tissue-resident memory T-cells and their persistence providing enhanced immunity compared with vaccines that rely on circulating responses and the potential of our COVID-19 vaccine to induce a durable cellular immune response and protect against reinfection These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against COVID-19 and induce a durable cellular immune response and protect against reinfection, 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
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  4. DURHAM, NC / ACCESSWIRE / January 20, 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 announced that Jeff Wolf, Chief Executive Officer of Heat Biologics, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference.

    The Heat's presentation will be webcast live at 11:30 a.m. EST on Thursday, January 21, 2021. The presentation will be open to registered conference attendees, institutional investors and investor relations professionals, who may register to view the live webcast at https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup

    DURHAM, NC / ACCESSWIRE / January 20, 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 announced that Jeff Wolf, Chief Executive Officer of Heat Biologics, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference.

    The Heat's presentation will be webcast live at 11:30 a.m. EST on Thursday, January 21, 2021. The presentation will be open to registered conference attendees, institutional investors and investor relations professionals, who may register to view the live webcast at https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup. After completion of the event, a replay of the presentation will be publicly available under the "Investors - News/Events" tab on the Heat Biologics website at www.heatbio.com.

    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.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/624982/Heat-Biologics-CEO-to-Participate-in-a-Fireside-Chat-at-the-B-Riley-Securities-Oncology-Investor-Conference-on-Jan-21-2021

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  5. 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…

    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

    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.



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  6. DURHAM, NC / ACCESSWIRE / January 11, 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 appointed William Ostrander as its Chief Financial Officer, effective January 4, 2021. Mr. Ostrander has over two decades of experience in financial management at public and private companies and previously served as the Company's Vice President of Finance since joining in September 2019.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "The Board and I have enthusiastically promoted Mr. Ostrander to the role of Chief Financial…

    DURHAM, NC / ACCESSWIRE / January 11, 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 appointed William Ostrander as its Chief Financial Officer, effective January 4, 2021. Mr. Ostrander has over two decades of experience in financial management at public and private companies and previously served as the Company's Vice President of Finance since joining in September 2019.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "The Board and I have enthusiastically promoted Mr. Ostrander to the role of Chief Financial Officer to reflect the tremendous work that Bill has done to navigate our finances and carefully manage our expenses. Bill's work has helped bring us to a stronger financial position than at any point in the Company's history-with over $117 million in cash and short-term investments at the end of the third quarter of 2020."

    Bill Ostrander, further noted, "It is an honor to serve as Chief Financial Officer of Heat Biologics at this exciting stage in the Company's development. We are well positioned, both operationally and financially, to execute on a number of key milestones in 2021 that we believe will drive significant value for shareholders."

    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 regarding being well positioned, both operationally and financially, to execute on a number of key milestones in 2021 that will drive significant value for shareholders. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of execute on a number of key milestones, 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

    SOURCE: Heat Biologics, Inc.



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  7. DURHAM, NC / ACCESSWIRE / January 8, 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, has announced that it will be presenting at the H.C. Wainwright BioConnect 2021 Conference, being held virtually between January 11-14, 2021.

    A webcast of Heat's presentation will be available on-demand as of 6:00 am ET, Monday, January 11, 2021, and will be accessible for 90 days. The webcast can be accessed here and the investor relations section of Heat Biologics' website at https://ir.heatbio.com/ir-calendar.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical…

    DURHAM, NC / ACCESSWIRE / January 8, 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, has announced that it will be presenting at the H.C. Wainwright BioConnect 2021 Conference, being held virtually between January 11-14, 2021.

    A webcast of Heat's presentation will be available on-demand as of 6:00 am ET, Monday, January 11, 2021, and will be accessible for 90 days. The webcast can be accessed here and the investor relations section of Heat Biologics' website at https://ir.heatbio.com/ir-calendar.

    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.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.



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  8. Preparations for manufacturing underway

    DURHAM, NC / ACCESSWIRE / December 16, 2020 / 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 completed its gp96-based COVID-19 vaccine cell line ("ZVX-60"), which is being developed for use as either a standalone vaccine, or in combination with other vaccines to enhance prophylactic protection. Data, generated at the University of Miami Miller School of Medicine, has confirmed expression of gp96, OX40L and Spike protein. The Company also reports it has begun preparations for manufacturing…

    Preparations for manufacturing underway

    DURHAM, NC / ACCESSWIRE / December 16, 2020 / 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 completed its gp96-based COVID-19 vaccine cell line ("ZVX-60"), which is being developed for use as either a standalone vaccine, or in combination with other vaccines to enhance prophylactic protection. Data, generated at the University of Miami Miller School of Medicine, has confirmed expression of gp96, OX40L and Spike protein. The Company also reports it has begun preparations for manufacturing, as the next-step towards first-in-human Phase 1 clinical trials.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We are encouraged by the recent Phase 3 data reported by other vaccine developers, and commend the FDA for their fast action to accelerate approval. Importantly, we believe ZVX-60 holds promise as an adjunct therapy to enhance protection provided by other vaccine approaches. Our preclinical data thus far suggests that our cell line generates a robust T-cell mediated immune response directed against the Spike protein of SARS-CoV-2. Notably, the cell line induced expansion of both "killer" CD8+ T-cells that destroy virus infected cells, as well as "helper" CD4 T-cells that assist in producing anti-viral antibodies."

    "We are also excited to report that preparations for manufacturing the vaccine are well underway. Given the utility and versatility of our vaccine platform, we look forward to advancing ZVX-60 into clinical development."

    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 regarding ZVX-60 holding promise as an adjunct therapy to enhance protection provided by other vaccine approaches, the cell line generating a robust T-cell mediated immune response directed against the Spike protein of SARS-CoV-2 and advancing ZVX-60 into clinical development. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to enhance protection provided by other vaccine approaches and to provide protection against 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, 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

    SOURCE: Heat Biologics, Inc.


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  9. DURHAM, NC / ACCESSWIRE / December 10, 2020 / 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 announced a planned reverse stock split of its shares of common stock at a ratio of 1-for-7. The reverse stock split will take effect as of 12:01 a.m. ET, December 11, 2020. Shares of Heat common stock will trade on a post-split basis on the Nasdaq Capital Market under the existing trading symbol, "HTBX," at the market open on December 11, 2020.

    Jeff Wolf, CEO of Heat, commented, "Our sole purpose in conducting this reverse-split was to address market concerns…

    DURHAM, NC / ACCESSWIRE / December 10, 2020 / 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 announced a planned reverse stock split of its shares of common stock at a ratio of 1-for-7. The reverse stock split will take effect as of 12:01 a.m. ET, December 11, 2020. Shares of Heat common stock will trade on a post-split basis on the Nasdaq Capital Market under the existing trading symbol, "HTBX," at the market open on December 11, 2020.

    Jeff Wolf, CEO of Heat, commented, "Our sole purpose in conducting this reverse-split was to address market concerns related to the Nasdaq minimum bid price requirement. Importantly, we remain in compliance with Nasdaq requirements and have important upcoming milestones related to our programs that we expect to announce soon, which we believe will further validate our strategy. It's also important to note that we have a solid balance sheet with over $113 million of cash as of December 9, 2020."

    During the Company's special shareholder meeting held February 27, 2020, shareholders approved the Company's reverse stock split, and granted the board of directors the authority to implement and determine the exact split ratio, which was set by the board at 1-for-7. Following the reverse stock split, the new CUSIP number will be 42237K 409, with the par value per share of common stock remaining at $0.0002. A proportionate adjustment will be made to the per-share exercise prices and number of shares issuable under all outstanding stock options and warrants.

    The reverse stock split is intended to increase the market price per share of the Company's common stock to help ensure a share price high enough to satisfy the $1.00 minimum bid price requirement by Nasdaq and to potentially increase the visibility of our company among a larger pool of institutional investors.

    When the reverse stock split becomes effective, every seven shares of the Company's issued and outstanding common stock will be combined into one share of common stock. Effecting the reverse stock split will reduce the number of issued and outstanding common stock from approximately 159.8 million shares to approximately 22.8 million. The reverse stock split will also subsequently adjust outstanding options issued under Heat's equity incentive plan and outstanding warrants to purchase common stock.

    No fractional shares will be issued in connection with the reverse stock split. Shareholders of record will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. Shareholders with shares held in certificate form will receive a Letter of Transmittal with instructions from Heat's transfer and exchange agent, Continental Stock Transfer & Trust Company. Shareholders that hold shares in book-entry form or in brokerage accounts are not required to take any action, and will see the impact of the reverse stock split reflected in their accounts. Additionally, beneficial holders may contact their bank, broker, custodian or other nominee with questions regarding processing procedures for the reverse stock split. Additional information is available in the Form 8-K filed today with the U.S. Securities and Exchange Commission, and in the definitive proxy statement filed on January 24, 2020.

    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.

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on Heat's 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, expectations and assumptions and include statements regarding important upcoming milestones related to Heat's programs that will further validate its strategy and Heat's ability to realize any anticipated benefits from the reverse stock split, including maintaining its listing on the Nasdaq Capital Market and attracting new investors. 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 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

    SOURCE: Heat Biologics, Inc.



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    https://www.accesswire.com/620359/Heat-Biologics-Provides-Business-Update

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  10. Continued progress on oncology and COVID-19 vaccine programs

    Over $117 million of cash and short-term investments

    DURHAM, NC / ACCESSWIRE / November 9, 2020 / 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 third quarter ended September 30, 2020.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make progress on both our oncology and COVID-19 vaccine programs. We presented data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American…

    Continued progress on oncology and COVID-19 vaccine programs

    Over $117 million of cash and short-term investments

    DURHAM, NC / ACCESSWIRE / November 9, 2020 / 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 third quarter ended September 30, 2020.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make progress on both our oncology and COVID-19 vaccine programs. We presented data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology Annual Meeting demonstrating a strong survival benefit in a cohort of previously treated checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC). We are actively pursuing a variety of strategies to maximize value for the program."

    "At the same time, we continue to advance PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development. Earlier this year, we initiated the first clinical trial site for PTX-35 in multiple solid tumors and began dosing patients in the Phase 1 clinical trial. PTX-35 is 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. This study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care."

    "Importantly, we announced preclinical data for our gp96-based COVID-19 vaccine. The data, generated at the University of Miami Miller School of Medicine and published in bioRxiv, shows robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2. Our gp96-based COVID-19 vaccine induced the expansion of both "killer" CD8+ T-cells that destroy virus infected cells, as well as "helper" CD4+ T-cells that assist in producing highly specific antibodies. As a result, we believe our vaccine has the potential to be used as either a standalone vaccine, or in combination with other antibody-focused vaccine approaches to enhance prophylactic protection. These results highlight the potential utility and versatility of our vaccine platform to address SARS-CoV-2, relevant mutations and other pathogens of interest."

    "We continue to strengthen our IP portfolio and were recently awarded an additional U.S. patent covering Heat's gp96 platform in combination with a T cell costimulatory agonist in a single therapy. We believe the combination of our gp96 platform in a single therapy holds enormous promise in the prevention and treatment of cancer and infectious diseases, such as COVID-19."

    "Finally, we have maintained a solid balance sheet with over $117 million of cash and short-term investments as of September 30, 2020. We believe this capital will provide us significant runway to achieve a number of important clinical milestones that we believe will drive value for shareholders in the months and years ahead," concluded Mr. Wolf.

    Third Quarter 2020 Financial Results

    • Recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT and NIH grant. No grant revenue was recognized under the respective grants for the three months ended September 30, 2019. The increase 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 September 30, 2020, we had deferred revenue of $1.2 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 $3.2 million and $3.1 million for the three months ended September 30, 2020 and 2019, respectively.
    • General and administrative expense was $6.6 million and $2.0 million for the three months ended September 30, 2020 and 2019. General and administrative expenses primarily consist of personnel costs, including stock-based compensation expense, and consulting expenses to manage the business.
    • Net loss attributable to Heat Biologics was approximately $8.9 million, or ($0.06) per basic and diluted share for the quarter ended September 30, 2020 compared to a net loss of approximately of $6.2 million, or ($0.18) per basic and diluted share for the quarter ended September 30, 2019.
    • As of September 30, 2020, the Company had approximately $117.3 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. 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 PTX-35 being the potential first-in-class T- cell costimulatory antibody, the expected enrollment of the Phase 1 PTX-35 study, the potential of Heat's COVID-19 vaccine to be used as either a standalone vaccine or in combination with other antibody-focused vaccine approaches to enhance prophylactic protection, the combination of Heat's gp96 platform in a single therapy holding enormous promise in the prevention and treatment of cancer and infectious diseases, such as COVID-19 and Heat's capital providing a significant runway to achieve a number of important clinical milestones that will drive value for shareholders in the months and years ahead. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against 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, 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

    SOURCE: Heat Biologics, Inc.



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  11. New patent covers ICOS T cell co-stimulation in combination with Heat's proprietary gp96 platform

    DURHAM, NC / ACCESSWIRE / October 7, 2020 / 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 announced it has been issued a new US patent (US Patent No. 10,780,161) covering compositions of matter that are part of Heat's gp96 platform (antigen presentation, T cell activation, TLR activation) in combination with Inducible T cell Co-stimulator (ICOS) ligand or ICOSL, a T cell immune booster, in a single therapy. The goal of the combination therapy is to…

    New patent covers ICOS T cell co-stimulation in combination with Heat's proprietary gp96 platform

    DURHAM, NC / ACCESSWIRE / October 7, 2020 / 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 announced it has been issued a new US patent (US Patent No. 10,780,161) covering compositions of matter that are part of Heat's gp96 platform (antigen presentation, T cell activation, TLR activation) in combination with Inducible T cell Co-stimulator (ICOS) ligand or ICOSL, a T cell immune booster, in a single therapy. The goal of the combination therapy is to boost immunity to potentially overcome the immunosuppressive tumor microenvironment and address the needs of patients refractory to current therapies.

    This newly issued US patent complements Heat's growing patent estate around its platform technology, which also includes a U.S. patent covering Heat's gp96 platform in combination with OX40L, a T cell costimulatory agonist. Pre-clinical studies combining Heat's secreted gp96 plus OX40L T cell co-stimulator in a single therapy, administered locally, have demonstrated superior activity compared to gp96 in combination with conventional OX40 antibody administered systemically by IV infusion.

    Heat's gp96 combination with a T cell co-stimulator is expected to have utility in combating viral infections, beyond its potential in oncology. The presentation of immunogenic viral antigens via gp96 (for example the S-protein in COVID-19 infection) and induction of innate immunity along with potent activation/boost of cellular immunity via killer CD8+ T cells is expected to be instrumental in eradicating both SARS-CoV-2 infected cells or tumor cells. In pre-clinical studies, Heat's gp96 based COVID-19 vaccine has demonstrated the ability to generate lung tissue-resident memory CD8+ T cells which are vital in destroying SARS-CoV-2 infected cells. This novel COVID-19 vaccine approach may be particularly important in treating immunocompromised patient populations.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "This new patent strengthens our gp96 intellectual property portfolio by adding another T cell costimulatory agonist to our arsenal. We believe our novel single therapy combination approach that initiates local and specific T cell activation provides competitive advantages over conventional antibody therapies by limiting systemic toxicity and lowering the significant cost required when combining multiple biological therapies. We are progressing with our Phase 1 trials with gp96 (HS-110) in combination with local OX40L (HS-130) and checkpoint inhibition as well as our gp96-based COVID-19 vaccine, and look forward to providing further clinical updates."

    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 Heat's gp96 combination with T cell co-stimulator platform having utility in combating viral infections beyond its promise in oncology, the presentation of immunogenic viral antigens via gp96 and induction of innate immunity along with potent activation/boost of cellular immunity via killer CD8+ T cells being instrumental in eradicating both SARS-CoV-2 infected cells or tumor cells, Heat's COVID-19 vaccine approach being particularly important in treating compromised patient populations, Heat's combination single therapy approach that initiates local and specific T cell activation providing competitive advantages over conventional antibody therapies in limiting systemic toxicity and lowering the significant cost attributed to combining multiple biological therapies, Heat's innovative gp96 platform with T cell immune boosters holding significant potential, especially in treating the vast majority of checkpoint inhibitor refractory patients, progressing with Heat's Phase 1 trials with gp96 (HS-110) in combination with OX40L (HS-130) and checkpoint inhibition and providing further clinical updates. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability to use Heat's gp96 combination with T cell co-stimulator platform to combat viral infections, including COVID-19, the ability of immunogenic viral antigens via gp96 and induction of innate immunity along with potent activation/boost of cellular immunity via killer CD8+ T cells to eradicate both SARS-CoV-2 infected cells or tumor cells, the ability to use Heat's COVID-19 vaccine approach to treat compromised patient populations, the ability of Heat's combination single therapy approach to provide competitive advantages over conventional antibody therapies in limiting systemic toxicity and lowering the significant cost attributed to combining multiple biological therapies, the ability of Heat's gp96 platform with T cell immune boosters to treat checkpoint inhibitor refractory patients, 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
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  12. DURHAM, NC / ACCESSWIRE / September 9, 2020 / 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 announced that Jeff Wolf, CEO of Heat Biologics, will participate on a virtual panel, entitled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Tom Equels, CEO of AIM ImmunoTech Inc. (AIM); Dr. David Jin, President and CEO of Avalon GlobloCare Corp. (AVCO); Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd. (IPA) (IPATF) (TQB2) and Vered…

    DURHAM, NC / ACCESSWIRE / September 9, 2020 / 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 announced that Jeff Wolf, CEO of Heat Biologics, will participate on a virtual panel, entitled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Tom Equels, CEO of AIM ImmunoTech Inc. (AIM); Dr. David Jin, President and CEO of Avalon GlobloCare Corp. (AVCO); Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd. (IPA) (IPATF) (TQB2) and Vered Caplan, CEO of Orgenesis Inc. (ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the COVID-19 pandemic. The panel will be moderated by broadcast journalist Christine Corrado of Proactive Investors. Investors interested in attending the event can register at: https://zoom.us/webinar/register/8215990551540/WN_YFe8n6dQSm6mpgG3iWfF-w.

    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.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/605211/Heat-Biologics-CEO-to-Participate-in-Virtual-Panel-New-Approaches-to-COVID-19-Hidden-Breakthroughs-on-Thursday-September-10th

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  13. VICTORIA, BC, Sept. 8, 2020 /CNW/ - IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSXV:IPA) (OTCQB:IPATF) (FSE:TQB2), a leader in full-service, therapeutic antibody discovery and development, today announced that Dr. Jennifer Bath, CEO of IPA, will participate on a virtual panel, entitled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Tom Equels, CEO of AIM ImmunoTech Inc. (NYSE:AIM); Dr. David Jin, CEO of Avalon GlobloCare Corp. (NASDAQ:AVCO); Jeff Wolf, CEO of Heat Biologics, Inc. (NASDAQ:HTBX) and Vered Caplan, CEO of Orgenesis Inc. (NASDAQ:ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the COVID-19 pandemic. The panel will be moderated by broadcast journalist Christine Corrado of Proactive Investors. Investors interested in attending the event can register at: 

    https://zoom.us/webinar/register/8215990551540/WN_YFe8n6dQSm6mpgG3iWfF-w

    About ImmunoPrecise Antibodies Ltd.

    ImmunoPrecise is a global technology platform company with end-to-end solutions empowering companies to discover and develop therapies against any disease. The Company's experience and cutting-edge technologies enable unparalleled support of its partners in their quest to bring innovative treatments to the clinic. ImmunoPrecise's full-service capabilities dramatically reduce the time required for, and the inherent risk associated with, conventional multi-vendor product development. For further information, visit www.immunoprecise.com or contact .

    Forward Looking Information

    This news release contains statements that, to the extent they are not recitations of historical fact, may constitute "forward-looking statements" within the meaning of applicable Canadian securities laws. The Company uses words such as "may", "would", "could", "will", "likely", "expect", "believe", "intend", "should" and similar expressions to identify forward-looking statements and include the Company's beliefs with respect to the potential for its antibodies to be further developed or approved to treat COVID-19 (or SARS-CoV-2) or to complete any transactions with respect to those antibodies. Any such forward-looking statements are based on assumptions and analyses made by ImmunoPrecise in light of its experience and its perception of historical trends, current conditions and expected future developments. However, whether actual results and developments will conform to ImmunoPrecise's expectations and predictions is subject to any number of risks, assumptions and uncertainties. Many factors could cause ImmunoPrecise's actual results to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors include, among other things, actual revenues and earnings for IPA being lower than anticipated, and those risks and uncertainties described in ImmunoPrecise's annual management discussion and analysis for the previous quarter ended January 31, 2020 which can be accessed at www.sedar.com. The "forward-looking statements" contained herein speak only as of the date of this press release and, unless required by applicable law, ImmunoPrecise undertakes no obligation to publicly update or revise such information, whether as a result of new information, future events or otherwise.

    Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    SOURCE ImmunoPrecise Antibodies Ltd.

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2020/08/c1782.html

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  14. OCALA, FL / ACCESSWIRE / September 8, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), today announced that Thomas K. Equels, CEO of AIM ImmunoTech, will participate in a virtual panel titled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Dr. David Jin, President and CEO of Avalon Globlocare Corp. (NASDAQ:AVCO); Jeff Wolf, CEO of Heat Biologics, Inc. (NASDAQ:HTBX); Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd. (TSXV:IPA) (OTCQB:IPATF) (FSE:TQB2); and Vered Caplan, CEO of Orgenesis Inc. (NASDAQ:ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the…

    OCALA, FL / ACCESSWIRE / September 8, 2020 / AIM ImmunoTech Inc. (NYSE:AIM), today announced that Thomas K. Equels, CEO of AIM ImmunoTech, will participate in a virtual panel titled, "New Approaches to COVID-19: Hidden Breakthroughs," being held on Thursday, September 10, 2020 at 1:00 p.m. ET.

    The virtual panel discussion will also include: Dr. David Jin, President and CEO of Avalon Globlocare Corp. (NASDAQ:AVCO); Jeff Wolf, CEO of Heat Biologics, Inc. (NASDAQ:HTBX); Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd. (TSXV:IPA) (OTCQB:IPATF) (FSE:TQB2); and Vered Caplan, CEO of Orgenesis Inc. (NASDAQ:ORGS).

    The event brings together executives from leading biopharmaceutical companies to discuss how their companies are helping address the COVID-19 pandemic. The panel will be moderated by broadcast journalist Christine Corrado of Proactive Investors. Investors interested in attending the event can register at: https://zoom.us/webinar/register/8215990551540/WN_YFe8n6dQSm6mpgG3iWfF-w.

    About AIM ImmunoTech Inc.

    AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers. AIM's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

    Contacts:

    Crescendo Communications, LLC
    Phone: 212-671-1021
    Email:

    AIM ImmunoTech Inc
    Phone: 800-778-4042
    Email:

    SOURCE: AIM ImmunoTech Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/604807/AIM-ImmunoTech-CEO-to-Participate-in-Virtual-Panel-New-Approaches-to-COVID-19-Hidden-Breakthroughs-on-Thursday-September-10th

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  15. Superior pre-clinical activity compared to conventional costimulatory antibody combination administered systemically

    DURHAM, NC / ACCESSWIRE / September 2, 2020 / 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 announced it has been issued a patent (US Patent No. 10,758,611) by the U.S. Patent and Trademark Office (USPTO) covering compositions of matter that are part of Heat's gp96 platform in combination with a T cell costimulatory agonist in a single therapy. This newly issued US patent compliments Heat's growing patent estate on this platform…

    Superior pre-clinical activity compared to conventional costimulatory antibody combination administered systemically

    DURHAM, NC / ACCESSWIRE / September 2, 2020 / 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 announced it has been issued a patent (US Patent No. 10,758,611) by the U.S. Patent and Trademark Office (USPTO) covering compositions of matter that are part of Heat's gp96 platform in combination with a T cell costimulatory agonist in a single therapy. This newly issued US patent compliments Heat's growing patent estate on this platform technology, which also includes US Patent No. 10,046,047, with claims to compositions of matter covering Heat's gp96 platform in combination with OX40L, a T cell costimulatory agonist.

    Pre-clinical studies combining Heat's secreted gp96 plus OX40L T cell co-stimulator in a single therapy, administered locally, have demonstrated superior activity in preclinical studies compared to gp96 in combination with conventional OX40 antibody administered systemically by IV infusion. Additional potential advantages of this novel combination approach include enhanced memory T cell response, limited systemic toxicity and cost advantages compared to multiple systemic therapies.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "This newly issued patent represents a potential breakthrough in combination drug development. Current combination approaches under development hold significant promise but also face meaningful challenges such as systemic toxicity and a lack of measurable synergistic effect. In contrast, we have developed a unique approach, combining the strengths of our gp96 platform (including antigen presentation, T cell activation, and TLR activation) with an immune booster (providing, for instance, localized T cell co-stimulation) in a single therapy. We believe this combination therapy holds enormous promise in the treatment of cancer and infectious diseases, potentially including COVID-19."

    "Specifically, our preclinical studies have demonstrated more pronounced CD8+ T cell prime and memory response; increased antigen specificity; no off-target systemic inflammatory cytokines; greater anti-tumor immunity; and increased overall survival. Our Phase 1 trials with gp96 (HS-110) in combination with OX40L (HS-130) and checkpoint inhibition are now underway, and we look forward to providing further clinical updates."

    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 the potential advantages of this novel combination approach including enhanced memory T cell response, limited systemic toxicity and cost advantages compared to multiple systemic therapies, the new patent representing a potential breakthrough in combination drug development, and the combination therapy holding enormous promise in the treatment of cancer and infectious diseases, potentially including COVID-19. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of the novel combination to enhance memory T cell response, limit systemic toxicity and have cost advantages compared to multiple systemic therapies, the ability to use the combination therapy to treat cancer and infectious diseases, potentially including 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, 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/604472/Heat-Biologics-Issued-Key-Patent-on-Combination-Platform-Therapy

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    • Data supports a differentiated gp96-based COVID-19 vaccine that induces systemic and tissue-specific (lung) memory CD8+ T cells
    • Gp96-based vaccine generates tissue-resident memory CD8+ T cells that may be instrumental in eradicating SARS-CoV-2 infected cells
    • Tissue specific memory CD8+ T cells potentially important for compromised patient populations

    DURHAM, NC / ACCESSWIRE / August 26, 2020 / 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 announced publication of positive preclinical COVID-19 results in bioRxiv, which is available at: https://www.biorxiv.org/content/10.1101/2020.08.24.265090v1

    • Data supports a differentiated gp96-based COVID-19 vaccine that induces systemic and tissue-specific (lung) memory CD8+ T cells
    • Gp96-based vaccine generates tissue-resident memory CD8+ T cells that may be instrumental in eradicating SARS-CoV-2 infected cells
    • Tissue specific memory CD8+ T cells potentially important for compromised patient populations

    DURHAM, NC / ACCESSWIRE / August 26, 2020 / 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 announced publication of positive preclinical COVID-19 results in bioRxiv, which is available at: https://www.biorxiv.org/content/10.1101/2020.08.24.265090v1.

    Publication highlights for Heat's gp96 based COVID-19 vaccine (gp96-Ig-S):

    • Significantly increases the frequency of systemic and tissue-specific CD8+ T-cells by conferring cellular immunity that is essential against any viral infection, including SARS-CoV-2
    • Primes potent effector memory CD8+ T cell responses and tissue resident memory CD8+ T cells localized in lung which are essential in protection against respiratory virus infection
    • Elicits a robust immune response directed against the Spike protein of SARS-CoV-2, generating both helper CD4+ T-cells that aide in antibody production, as well as virus killing cytotoxic CD8+ T cells
    • Induces the secretion of cytokines (IFN-gamma, IL-2, TNF-alpha) from CD8+ and CD4+ T cells in both the spleen and lungs
    • Induces high frequencies of S-protein specific (against S1 and S2 epitopes) CD8+ T cells in the respiratory airways, the predominant site of viral infection

    Studies in COVID-19 patients with moderate or asymptomatic infection indicate that the expansion of memory CD8+ T cells directed at immunodominant epitopes on S protein may be important, including tissue resident CD8+ T cells that localize in high numbers in the lung tissue to protect against infection (1,2,3). The preclinical data demonstrates that Heat's vaccine achieves this objective with tissue resident memory CD8+ T cells that localize in lung tissue. The generation of a durable cellular immune response driven by memory CD8+ T cells may protect against re-infection. Heat's vaccine is designed to prophylactically "train" the immune system to induce this response in patients and should be especially effective in those individuals most prone to severe infection, such as the elderly, individuals with relevant comorbidities or other patients who are immuno-suppressed.

    Natasa Strbo, MD, DSc, Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine and co-developer of Heat's gp96 platform, commented, "Vaccines that can induce SARS-CoV-2 specific CD8+ T cells that home in to the airway epithelium are needed to effectively mount an immune response against SARS-CoV-2. Our latest publication demonstrates the importance of tissue resident memory CD8+ T cells triggered by our vaccine in protecting against infection."

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We believe that these results are a powerful reinforcement that this platform represents a unique and relevant paradigm for novel vaccine development, capable of inducing cellular immune responses in epithelial tissues such as the lungs. This publication demonstrates the potential utility and versatility of our vaccine platform to address SARS-CoV-2, relevant mutations and other pathogens of interest."

    1. Peng Y, Mentzer AJ, Liu G, Yao X, Yin Z, Dong D, et al. Broad and strong memory CD4 (+) and CD8 (+) T cells induced by SARS-CoV-2 in UK convalescent COVID-19 patients. bioRxiv. 2020. Epub 2020/06/25. doi: 10.1101/2020.06.05.134551. PubMed PMID: 32577665; PubMed Central PMCID: PMCPMC7302222.

    2. Sekine T, Perez-Potti A, Rivera-Ballesteros O, Strålin K, Gorin J-B, Olsson A, et al. Robust T cell immunity in convalescent individuals with asymptomatic or mild COVID-19. bioRxiv. 2020.

    3. Liao M, Liu Y, Yuan J, Wen Y, Xu G, Zhao J, et al. Single-cell landscape of bronchoalveolar immune cells in patients with COVID-19. Nat Med. 2020;26(6):842-4. doi: 10.1038/s41591-020-0901-9. PubMed PMID: 32398875.

    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 Heat's vaccine prophylactically "training" the immune system to induce this response in patients and being especially effective in those individuals most prone to severe infection, such as the elderly, individuals with relevant comorbidities or other patients who are immuno-suppressed, the results being a powerful reinforcement that this platform represents a unique and relevant paradigm for novel vaccine development, capable of inducing cellular immune responses in epithelial tissues such as the lungs and the potential utility and versatility of Heat's vaccine platform to address SARS-CoV-2, relevant mutations and other pathogens of interest. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against 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, 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
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  16. T cell driven immune response achieved with just a single dose

    Potential to be used in combination with other COVID-19 vaccine approaches

    DURHAM, NC / ACCESSWIRE / August 13, 2020 / 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 reported preclinical data for Heat's gp96-based COVID-19. The data, generated at the University of Miami Miller School of Medicine, shows robust T cell mediated immune response directed against the spike protein of SARS-CoV-2.

    Heat Biologics' COVID-19 vaccine induced the expansion of both "killer" CD8+ T cells that destroy…

    T cell driven immune response achieved with just a single dose

    Potential to be used in combination with other COVID-19 vaccine approaches

    DURHAM, NC / ACCESSWIRE / August 13, 2020 / 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 reported preclinical data for Heat's gp96-based COVID-19. The data, generated at the University of Miami Miller School of Medicine, shows robust T cell mediated immune response directed against the spike protein of SARS-CoV-2.

    Heat Biologics' COVID-19 vaccine induced the expansion of both "killer" CD8+ T cells that destroy virus infected cells, as well as "helper" CD4+ T cells that assist in producing highly specific antibodies. Both T cell subsets were shown to release cytokines that amplify the anti-viral immune response and, upon vaccination, memory CD8+ T cells migrated to the lungs and airways-the tissue-specific site of interest for SARS-CoV-2 infection. These lung and airway tissue resident memory CD8+ T cells are crucial in mounting an effective response to respiratory viruses.

    Natasa Strbo, MD, DSc, Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine and co-developer of Heat's gp96 platform, commented, "We are highly encouraged by the animal data generated around the COVID-19 vaccine and we look forward to publishing the full details of this study in the coming weeks. Specifically, we noted several important immune responses generated by the vaccine against SARS-CoV-2 after a single injection, including SARS-CoV-2 specific CD8+ and CD4+ T cells in the lungs and airways."

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We are encouraged by the progress being made by other companies developing vaccines against COVID-19. However, unlike most of these approaches that drive primarily an antibody response, our COVID-19 vaccine is designed to drive predominantly T cell immunity along with antibody responses and innate immunity. As a result, we believe our vaccine has the potential to be used as either a standalone vaccine, or in combination with these other approaches to enhance efficacy. I appreciate the tremendous support of Dr. Strbo and her team at the University of Miami, as well as the team at Heat who have worked around the clock given the urgency of the pandemic. We look forward to providing further updates as soon as possible."

    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 publishing the full details of this study in the coming weeks, the COVID-19 vaccine platform driving predominantly T cell immunity along with antibody responses and innate immunity, the vaccine being used as either a standalone vaccine, or in combination with these other approaches to enhance efficacy, and providing further updates as soon as possible . These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against 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, 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/601525/Heat-Biologics-COVID-19-Vaccine-Demonstrates-Robust-T-Cell-Driven-Immune-Response-to-SARS-CoV-2-in-Preclinical-Studies

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    • Progress on COVID-19 Vaccine Program
    • Reports over $100 million in cash and short-term investments as of August 6, 2020

    DURHAM, NC / ACCESSWIRE / August 7, 2020 / 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 second quarter ended June 30, 2020.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "This quarter we achieved significant milestones in advancing our unique COVID-19 vaccine program, which we are developing in collaboration with researchers at University of Miami…

    • Progress on COVID-19 Vaccine Program
    • Reports over $100 million in cash and short-term investments as of August 6, 2020

    DURHAM, NC / ACCESSWIRE / August 7, 2020 / 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 second quarter ended June 30, 2020.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "This quarter we achieved significant milestones in advancing our unique COVID-19 vaccine program, which we are developing in collaboration with researchers at University of Miami. Specifically, our latest pre-clinical studies demonstrated immunogenicity proof-of-concept, validating that the selected vaccine antigen may be appropriate for human testing. Preclinical testing demonstrated expansion of antibody-supporting CD4+, and virus killing CD8+ T-cells in the lungs of the animals, a major site for COVID-19 infection. We believe this platform may play an important role as a standalone vaccine or in combination with other antibody-generating vaccines to provide broad cellular T-cell and humoral protection against COVID-19, particularly for elderly patients and those with underlying health conditions who have an increased risk of complications and death from COVID-19."

    "Additionally, we established a partnership with Waisman Biomanufacturing to manufacture our COVID-19 vaccine for anticipated Phase 1 trials in humans. We believe that the unique capabilities and previous expertise gained working with Waisman on our cancer programs, HS-110 and HS-130 that are based upon the same gp96 platform, will help shorten the development timeline for our COVID-19 vaccine."

    "We recently presented our latest data for HS-110 in combination with Nivolumab in our Phase 2 lung cancer trial at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. Importantly, this data demonstrated a strong survival benefit in a cohort of previously treated checkpoint inhibitor (CPI) naïve patients with advanced non-small cell lung cancer (NSCLC) and further reinforced the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC."

    "We also continue to accelerate PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development. Specifically, we announced patient enrollment in our first-in-human clinical trial in multiple solid tumors following FDA clearance of our Investigational New Drug (IND) application. This study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care."

    "We have continued to strengthen our balance sheet, and now have over $100 million in cash and short-term investments as of August 6, 2020, which should provide us with the resources to significantly advance our clinical programs," concluded Mr. Wolf.

    Second Quarter 2020 Financial Results

    • Recognized $0.6 million of grant revenue for qualified expenditures under the CPRIT grant compared to $0.3 million for the quarter ended June 30, 2019. The increase in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contract. As of June 30, 2020, we had deferred revenue of $1.9 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 decreased approximately 17.6% to $2.8 million for the three months ended June 30, 2020 compared to $3.4 million for the quarter ended June 30, 2019.
    • General and administrative expense was $1.8 million and $1.9 million for the quarters ending June 30, 2020 and 2019. General and administrative expenses primarily consist of personnel costs, including stock-based compensation expense, and consulting expenses to manage the business.
    • Net loss attributable to Heat Biologics was approximately $4.5 million, or ($0.05) per basic and diluted share for the quarter ended June 30, 2020 compared to a net loss of approximately of $4.8 million, or ($0.14) per basic and diluted share for the quarter ended June 30, 2019.
    • As of June 30, 2020, the Company had approximately $47 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. 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 the platform playing an important role as a standalone vaccine or in combination with other antibody-generating vaccines to provide broad cellular T-cell and humoral protection against COVID-19, particularly for elderly patients and those with underlying health conditions that have an increased risk of complications and death from COVID-19, the unique capabilities and previous expertise gained working with Waisman on HS-130 helping shorten the clinical timeline for our potentially life-saving COVID-19 vaccine, the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC ,the continued acceleration of PTX-35, our potential first-in-class T-cell co-stimulatory antibody, through clinical development, the enrollment in the PTX-35 clinical trial of up to 30 patients with advanced solid tumors refractory to standard of care and having sufficient capital to significantly advance our clinical programs. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against 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, 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

    HEAT BIOLOGICS, INC.
    Consolidated Balance Sheets

    June 30, December 31,
    2020 2019
    (unaudited)
    Current Assets
    Cash and cash equivalents
    $20,668,241 $9,039,887
    Short-term investments
    26,312,039 5,713,922
    Accounts receivable
    26,967 34,986
    Prepaid expenses and other current assets
    593,924 420,328
    Total Current Assets
    47,601,171 15,209,123
    Property and Equipment, net
    669,401 559,410
    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
    2,134,573 2,287,500
    Finance lease right-of-use asset
    306,643 187,573
    Deposits
    122,905 394,637
    Total Other Assets
    9,882,459 10,188,048
    Total Assets
    $58,153,031 $25,956,581
    Liabilities and Stockholders' Equity
    Current Liabilities
    Accounts payable
    $779,642 $1,503,342
    Deferred revenue, current portion
    1,915,924 3,410,319
    Contingent consideration, current portion
    1,531,636 1,124,970
    Contingent consideration, related party - current portion
    454,364 454,364
    Operating lease liability, current portion
    228,776 216,832
    Finance lease liability, current portion
    104,828 49,104
    Accrued expenses and other liabilities
    1,202,705 1,676,467
    Total Current Liabilities
    6,217,875 8,435,398
    Long Term Liabilities
    Other long-term liabilities
    22,847 -
    Derivative warrant liability
    47,939 -
    Deferred tax liability
    361,911 361,911
    Deferred revenue, net of current portion
    200,000 200,000
    Operating lease liability, net of current portion
    1,402,962 1,519,574
    Financing lease liability, net of current portion
    215,112 142,667
    Contingent consideration, net of current portion
    1,969,538 1,653,197
    Contingent consideration, related party - net of current portion
    578,977 485,984
    Total Liabilities
    11,017,161 12,798,731
    Stockholders' Equity
    Common stock, $.0002 par value; 250,000,000 shares authorized, 110,023,783 and 33,785,999 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively
    22,006 6,757
    Additional paid-in capital
    163,007,558 118,173,843
    Accumulated deficit
    (115,344,284) (104,597,748)
    Accumulated other comprehensive income (loss)
    28,044 (11,250)
    Total Stockholders' Equity - Heat Biologics, Inc.
    47,713,324 13,571,602
    Non-Controlling Interest
    (577,454) (413,752)
    Total Stockholders' Equity
    47,135,870 13,157,850
    Total Liabilities and Stockholders' Equity
    $58,153,031 $25,956,581

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

    Three Months Ended Six Months Ended
    June 30, June 30,
    2020 2019 2020 2019
    Revenue:
    Grant and licensing revenue
    $ 593,165 $ 342,487 $ 1,495,045 $ 1,043,549
    Operating expenses:
    Research and development
    2,790,797 3,424,141 5,573,303 6,596,388
    General and administrative
    1,801,674 1,860,459 5,072,222 5,208,060
    Change in fair value of contingent consideration
    843,000 112,000 816,000 226,290
    Total operating expenses
    5,435,471 5,396,600 11,461,525 12,030,738
    Loss from operations
    (4,842,306) (5,054,113) (9,966,480) (10,987,189)
    Change in fair value of warrant liability
    (24,363) - (1,002,073) -
    Investor relations expense
    - - (66,767) -
    Interest income
    56,080 124,793 108,790 275,645
    Other income (expense), net
    273,771 (15,585) 16,292 (7,264)
    Total non-operating income (loss)
    305,488 109,208 (943,758) 268,381
    Net loss before income taxes
    (4,536,818) (4,944,905) (10,910,238) (10,718,808)
    Income tax expense
    - - - (45,178)
    Net loss
    (4,536,818) (4,944,905) (10,910,238) (10,763,986)
    Net loss - non-controlling interest
    (82,388) (174,035) (163,702) (277,640)
    Net loss attributable to Heat Biologics, Inc.
    $ (4,454,430) $ (4,770,870) $ (10,746,536) $ (10,486,346)
    Net loss per share attributable to Heat Biologics, Inc.-
    Net loss per share attributable to Heat Biologics, Inc.-basic and diluted
    $ (0.05) $ (0.14) $ (0.15) $ (0.32)
    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
    87,930,846 33,255,724 72,606,461 33,240,529
    Comprehensive loss:
    Net loss
    $ (4,536,818) $ (4,944,905) $ (10,910,238) $ (10,763,986)
    Unrealized (loss) gain on foreign currency translation
    (179,510) 16,612 39,294 8,423
    Total comprehensive loss
    (4,716,328) (4,928,293) (10,870,944) (10,755,563)
    Comprehensive loss attributable to non-controlling interest
    (82,388) (174,035) (163,702) (277,640)
    Comprehensive loss - Heat Biologics, Inc.
    $ (4,633,940) $ (4,754,258) $ (10,707,242) $ (10,477,923)

    SOURCE: Heat Biologics, Inc.



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  17. White paper highlights potential of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines

    DURHAM, NC / ACCESSWIRE / August 5, 2020 / 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 product candidate, today highlighted the importance of T cell immunity in preventing COVID-19 in a white paper released today. Heat's COVID-19 vaccine is being designed to generate robust T cell immunity against SARS-CoV-2, the virus responsible for COVID-19. To read the full white paper, please visit: www.heatbio.com/product-pipeline/scientific-publications

    White paper highlights potential of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines

    DURHAM, NC / ACCESSWIRE / August 5, 2020 / 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 product candidate, today highlighted the importance of T cell immunity in preventing COVID-19 in a white paper released today. Heat's COVID-19 vaccine is being designed to generate robust T cell immunity against SARS-CoV-2, the virus responsible for COVID-19. To read the full white paper, please visit: www.heatbio.com/product-pipeline/scientific-publications.

    Key highlights of the white paper include:

    • Published studies evaluating patients that have recovered from SARS-CoV-2 infection demonstrate that antibody responses to the virus are fleeting, suggesting that current vaccine approaches that generate a predominantly antibody response may fall short in generating a durable and protective immune response
    • Studies from the current COVID-19 pandemic and past studies from patients recovered from the related SARS and MERS outbreak demonstrate the reliance on T cell responses, where CD4 T cells are often required to generate effective antibody responses, and "killer" CD8 T cells may be required to destroy virus infected cells before the virus can replicate
    • An ideal vaccine against SARS-Cov-2 should activate multiple arms of the immune system, including innate, humoral (antibodies), and cellular immunity (T cells)
    • Heat's COVID-19 vaccine is designed to drive T cell immunity, while also activating antibody responses and innate immunity, which may complement conventional COVID-19 vaccines in combination approaches by enhancing T cell immunity, while contributing to innate immunity and antibody generation, especially in the more vulnerable aged population and/or those with comorbidities

    Jeff Wolf, CEO of Heat Biologics, commented, "Our COVID-19 vaccine platform is designed to drive predominantly T cell immunity-in contrast to most of the conventional approaches in clinical development, which focus on antibody immunity. We are designing our vaccine to be used as either a standalone vaccine, or as a prime and boost combination with other vaccines under development, to drive robust T cell immunity and bolster antibody responses, especially in high-risk populations with a compromised immune response. Our confidence is further bolstered by the latest pre-clinical studies demonstrating immunogenicity proof-of-concept. We look forward to advancing our unique vaccine towards human clinical trials."

    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. 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 the potential of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines, the vaccine platform being used either standalone, or as a prime and boost combination with other vaccines under development, to drive robust T cell immunity and bolster antibody responses, especially in high-risk populations with a compromised immune response, advancing Heat's unique vaccine towards human clinical trials and Heat's COVID-19 vaccine enhancing T cell immunity, while contributing significantly to innate immunity and antibody generation, especially in the more vulnerable aged population and/or those with comorbidities. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability of Heat's vaccine to boost T cell immunity, alone or in combination with other vaccines, the ability to use the vaccine platform either standalone, or as a prime and boost combination with other vaccines under development, in order to drive robust T cell immunity and bolster antibody responses, especially in high-risk populations with a compromised immune response, the ability to advance the vaccine toward clinical trials, 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop an effective proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/600337/Heat-Biologics-Highlights-Importance-of-T-cell-Immunity-to-Prevent-COVID-19

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  18. Confirms stimulation of human-HLA-restricted transgenic mouse T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein

    DURHAM, NC / ACCESSWIRE / July 29, 2020 / 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 announced successful pre-clinical testing of the Company's COVID-19 vaccine, which demonstrated in-vivo confirmation of vaccine immunogenicity in animal models, including expansion of human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein. Testing demonstrated expansion of antibody-supporting CD4+…

    Confirms stimulation of human-HLA-restricted transgenic mouse T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein

    DURHAM, NC / ACCESSWIRE / July 29, 2020 / 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 announced successful pre-clinical testing of the Company's COVID-19 vaccine, which demonstrated in-vivo confirmation of vaccine immunogenicity in animal models, including expansion of human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein. Testing demonstrated expansion of antibody-supporting CD4+, and virus killing CD8+ T-cells in the lungs of the animals, a major site for COVID-19 infection.

    "We are pleased to report this significant milestone in the development of our COVID-19 vaccine," said Jeff Wolf, CEO of Heat. "Specifically, our latest pre-clinical studies demonstrated immunogenicity proof-of-concept, illustrating that our vaccine can expand human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein, and validating that the selected vaccine antigen may be appropriate for human testing."

    Natasa Strbo MD, DSc, Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine and co-developer of Heat's gp96 platform, commented, "We are encouraged by the observed T-cell expansion and cytokine secretion in response to Spike protein stimulation in pre-clinical models. Measured cytokines, produced by anti-viral CD4+ T-cells, important for B cell antibody class switching, and CD8+ T-cells, important to clear virus-infected cells, suggests that an optimal immune response is being generated in response to our vaccination. These pre-clinical data imply that our vaccine is prompting a robust and effective immune response to support anti-viral immunity. In addition, stimulation of anti-viral killer CD8+ T-cells in human HLA-A2-positive transgenic mice provides encouraging pre-clinical data to support human trials, as we can expand cells specific for viral antigens presented in the context of the human immune system."

    Mr. Wolf continued, "I would like to thank Natasa Strbo and her team at the University of Miami, as well as the team at Heat who are working tirelessly to advance our COVID-19 vaccine platform in breakthrough time. Given this data, we are further encouraged by the outlook for our COVID-19 vaccine, and believe this platform may play an important role as a standalone vaccine or in combination with other antibody-generating vaccines by engaging both the humoral and cellular arms of the immune system to stimulate more robust prophylactic protection."

    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. Multiple product candidates in development leverage 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.

    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 vaccine expanding human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein, the selected vaccine antigen being appropriate for human testing, measured cytokines, produced by anti-viral CD4 T-cells, suggesting that an optimal immune response is being generated in response to our vaccination and this platform playing an important role as a standalone vaccine or in combination with other antibody-generating vaccines by engaging both the humoral and cellular arms of the immune system to stimulate more robust prophylactic protection. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability of the vaccine to expand human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein, the ability to validate the selected vaccine antigen for appropriate for human testing and to generate an optimal immune response, the ability of this platform to play an important role as a standalone vaccine or in combination with other antibody-generating vaccines, 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop an effective proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics Inc.



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  19. DURHAM, NC / ACCESSWIRE / July 27, 2020 / 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 product candidate, today announced that on July 24, 2020, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, Inc. ("Nasdaq"), confirming that the Company has regained compliance with the $1.00 per share minimum closing bid price requirement for continued listing on the Nasdaq Stock Market, pursuant to the Nasdaq marketplace rules. Nasdaq indicated in its letter that since the Company has regained compliance with Listing…

    DURHAM, NC / ACCESSWIRE / July 27, 2020 / 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 product candidate, today announced that on July 24, 2020, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, Inc. ("Nasdaq"), confirming that the Company has regained compliance with the $1.00 per share minimum closing bid price requirement for continued listing on the Nasdaq Stock Market, pursuant to the Nasdaq marketplace rules. Nasdaq indicated in its letter that since the Company has regained compliance with Listing Rule 5550(a)(2), or the Minimum Bid Price Rule, this matter is now closed.

    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. 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.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.



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    https://www.accesswire.com/598977/Heat-Biologics-Regains-Compliance-with-Nasdaq-Minimum-Bid-Price-Rule

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  20. DURHAM, NC / ACCESSWIRE / June 22, 2020 / 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 announced that the first patient has been treated in the Company's first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics' Pelican Therapeutics subsidiary.

    This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care. Eligible patients will be enrolled to receive PTX-35 every two weeks until disease progression. Escalating dose levels…

    DURHAM, NC / ACCESSWIRE / June 22, 2020 / 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 announced that the first patient has been treated in the Company's first-in-human Phase 1 clinical trial evaluating PTX-35, the first antibody product candidate developed by Heat Biologics' Pelican Therapeutics subsidiary.

    This first-in-human study is expected to enroll up to 30 patients with advanced solid tumors refractory to standard of care. Eligible patients will be enrolled to receive PTX-35 every two weeks until disease progression. Escalating dose levels of PTX-35 will be explored until optimal immunological dose or maximum tolerated dose is established. The objectives of the study include safety evaluation, determination of the recommended Phase 2 dose as well as exploratory analyses of clinical benefit and immunological effect of PTX-35. This trial is supported by a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

    Jeff Wolf, CEO of Heat Biologics, commented, "This is an important milestone as we advance our first antibody product candidate into clinical development. I am very pleased with our team's effort in accelerating the development of PTX-35 as well as the speed of execution to initiate our first-in-human study following FDA clearance of our Investigational New Drug (IND) Application. I believe that PTX-35, our potential first-in-class T-cell co-stimulatory antibody, will offer a differentiated approach to benefit cancer patients."

    About PTX-35

    PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.

    A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.

    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. 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.

    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 expected enrollment in the trial, the potential of PTX-35 as a first-in-class antibody T-cell co-stimulator, and PTX-35 offering a differentiated approach to benefit patients. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability to successfully enroll and complete the first-in-human clinical trial of PTX-35 in solid tumors, 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/594675/Heat-Biologics-Announces-First-Patient-Treated-in-First-in-Human-Clinical-Trial-of-PTX-35

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  21. Anthony Tolcher, M.D., FRCPC appointed as the lead investigator

    DURHAM, NC / ACCESSWIRE / June 18, 2020 / 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 announced initiation of the first clinical trial site for PTX-35. Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.

    PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced…

    Anthony Tolcher, M.D., FRCPC appointed as the lead investigator

    DURHAM, NC / ACCESSWIRE / June 18, 2020 / 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 announced initiation of the first clinical trial site for PTX-35. Anthony Tolcher, M.D., FRCPC, a medical oncologist and co-founder of NEXT Oncology, has been appointed the lead investigator for the Phase 1 clinical trial.

    PTX-35 is a novel, potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated that PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function. A favorable safety profile was demonstrated in preclinical studies, with no deleterious cytokine release in mice, non-human primates or in vitro human immune cells.

    Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "We are pleased to welcome Dr. Anthony Tolcher as the lead investigator for our PTX-35 Phase 1 trial. He is a distinguished medical oncologist with over 25 years of early drug development and clinical trial expertise and a principal investigator for 20 Phase 1 clinical studies of new agents that subsequently were FDA approved for the treatment of cancer, including Merck's pembrolizumab (Keytruda®). Dr. Tolcher has over 100 peer-reviewed publications in top scientific journals, and a proven track record of advancing multiple innovative oncology products through Phase 1. We believe NEXT Oncology under the leadership of Dr. Tolcher is an ideal site for our study and look forward to enrolling our first patient shortly."

    Dr. Tolcher said, "PTX-35 is a promising product candidate that exquisitely targets TNFRSF25. This is a first-in-class antibody that targets an important pathway to activate antigen-experienced memory CD8+ T cells. I believe PTX-35 may provide additional treatment options for patients when current therapy does not work in controlling their cancers. Immunotherapy is the most exciting and a rapidly growing area of oncology and we are just beginning to see the potential for expanding new avenues and targets in harnessing the immune system for the treatment of cancer."

    A $15.2 million grant has been awarded by Cancer Prevention and Research Institute of Texas (CPRIT) to support the pre-clinical development, manufacturing and Phase 1 clinical development for PTX-35.

    About NEXT Oncology

    NEXT Oncology is dedicated to the advancement of Phase 1 cancer research through clinical trials of anticancer agents with the goal of providing innovative developments in cancer treatment. Dr. Anthony Tolcher is a medical oncologist and co-founder of NEXT Oncology. He is dedicated to the advancement of new anticancer agents for patients whose current cancer therapy is no longer working to benefit them. Many of the initial Phase 1 studies of new agents that Dr. Tolcher was involved in were subsequently approved by FDA, including pembrolizumab (Keytruda®), copanlisib (Aliqopa®), trastuzumab emtansine (Kadcyla®), regorafenib (Stivarga®), liposomal vincristine (Marqibo®), cabazitaxel (Jevtana®), carfilzomib (Kyprolis®), gefitinib (Iressa®), erlotinib (Tarceva®) and eribulin (Halaven®). He is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research and Annals of Oncology, and chaired the Developmental Therapeutics Review Committee for the American Society for Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals.

    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. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in Phase 2, HS-130 in Phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35 in Phase 1. For more information, please visit www.heatbio.com.

    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 NEXT Oncology under the leadership of Dr. Tolcher being an ideal site for the study, enrolling the first patient shortly, PTX-35 being a promising product candidate, PTX-35 providing additional treatment options for patients when current therapy does not work in controlling their cancer and PTX-35 being a potential first-in-class antibody T-cell co-stimulator targeting TNFRSF25. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability to successfully initiate and complete the first-in-human clinical trial of PTX-35 in solid tumors, 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/594353/Heat-Biologics-Announces-Initiation-of-the-Lead-Clinical-Trial-Site-for-PTX-35

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  22. PTX-35 represents a potential first-in-class agonistic antibody of TNFRSF25

    DURHAM, NC / ACCESSWIRE / June 8, 2020 / 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 announced that the U.S. Food & Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PTX-35, developed by Heat's Pelican Therapeutics subsidiary. Pelican has near-term plans to initiate its Phase 1 clinical trial in patients with solid tumors.

    PTX-35 is a novel, first-in-class agonist antibody targeting TNFRSF25, also known as death receptor 3 (DR3…

    PTX-35 represents a potential first-in-class agonistic antibody of TNFRSF25

    DURHAM, NC / ACCESSWIRE / June 8, 2020 / 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 announced that the U.S. Food & Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PTX-35, developed by Heat's Pelican Therapeutics subsidiary. Pelican has near-term plans to initiate its Phase 1 clinical trial in patients with solid tumors.

    PTX-35 is a novel, first-in-class agonist antibody targeting TNFRSF25, also known as death receptor 3 (DR3), a receptor that is preferentially expressed by antigen-experienced T cells. TNFRSF25 agonism leads to activation of antigen-experienced memory CD8+ T cells, which are instrumental for tumor destruction. Preclinical studies have demonstrated PTX-35, in combination with antigen-driven immunotherapies, resulted in enhanced anti-tumor properties, including potent proliferation of antigen-specific T cells, production of effector cytokines and augmented effector immune function.

    Rahul Jasuja, PhD, CEO of Pelican Therapeutics, commented, "The mechanism of action for PTX-35 is highly differentiated compared to other co-stimulators. Activation of TNFRSF25 by PTX-35 in preclinical models leads to a more pronounced expansion of tumor antigen-specific cytotoxic, or "killer" T cells, resulting in enhanced tumor growth inhibition and prolonged survival. The team has delivered a robust IND package, demonstrating pre-clinical efficacy along with a favorable safety profile in mice and non-human primates."

    Jeff Wolf, CEO of Heat, said, "PTX-35 is a potential first-in-class therapy that may provide additional treatment options for cancer patients. We are close to initiating our first-in-human clinical trial of PTX-35 in multiple solid tumors and look forward to providing further updates as we achieve anticipated milestones. We would like to thank Cancer Prevention Research Institute of Texas (CPRIT) for the $15.2 million grant to support the preclinical work, cGMP manufacturing and Phase 1 development of PTX-35."

    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. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in phase 2, HS-130 in phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35. For more information, please visit www.heatbio.com.

    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 potential of PTX-35 as a potential first-in-class therapy that may provide additional treatment options for cancer patients and near-term plans to initiate a Phase 1 clinical trial in patients with solid tumors. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including, the ability to successfully initiate and complete the first-in-human clinical trial of PTX-35 in solid tumors, 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/593048/Heat-Biologics-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-PTX-35

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  23. On track to complete vaccine development and initiate manufacturing in August

    DURHAM, NC / ACCESSWIRE / June 4, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including a novel COVID-19 vaccine and multiple oncology product candidates, today announced further progress on its COVID-19 vaccine program.

    Jeff Hutchins, Chief Scientific and Operating Officer of Heat, stated, "I am pleased to report important advancements related to our COVID-19 vaccine program. Specifically, we have achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in our clinically validated human cell…

    On track to complete vaccine development and initiate manufacturing in August

    DURHAM, NC / ACCESSWIRE / June 4, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including a novel COVID-19 vaccine and multiple oncology product candidates, today announced further progress on its COVID-19 vaccine program.

    Jeff Hutchins, Chief Scientific and Operating Officer of Heat, stated, "I am pleased to report important advancements related to our COVID-19 vaccine program. Specifically, we have achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in our clinically validated human cell line, enabling selection of our COVID-19 vaccine. These steps are important milestones and necessary precursors to completion of our vaccine in preparation for its manufacture and use in clinical trials."

    Jeff Wolf, CEO of Heat, commented, "We remain on track to complete design and development of our COVID-19 vaccine in July, and expect that our gp96/nCoV-2 expressing cell line will be available for clinical-grade manufacturing with our partner, Waisman Biomanufacturing, in early August. Given our progress to date, we remain encouraged by the potential of our unique vaccine to provide broad cellular T-cell and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses."

    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. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in phase 2, HS-130 in phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35. For more information, please visit www.heatbio.com.

    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 remaining on track to complete development of the vaccine in July, Heat's gp96/nCoV-2 expressing cell line being available for clinical-grade manufacturing with its partner, Weisman Biomanufacturing, in early August and the potential of Heat's unique vaccine to provide broad cellular T-cell and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses. 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 to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine and to complete development of the vaccine within the anticipated timeline, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/592698/Heat-Biologics-Provides-Update-on-COVID-19-Vaccine-Efforts

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    • Median overall survival of 28.7 months in previously treated checkpoint inhibitor naïve non-small cell lung cancer patients
    • Significantly greater median overall survival of 42.1 months observed in patients with injection site reaction
    • Planning to engage FDA for end-of-phase 2 meeting

    DURHAM, NC / ACCESSWIRE / May 29, 2020 / 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 presented its latest data at the ASCO Annual Meeting. The poster presentation can be viewed on the ASCO meeting website at: https://meetinglibrary.asco.org/record/184864/poster

    • Median overall survival of 28.7 months in previously treated checkpoint inhibitor naïve non-small cell lung cancer patients
    • Significantly greater median overall survival of 42.1 months observed in patients with injection site reaction
    • Planning to engage FDA for end-of-phase 2 meeting

    DURHAM, NC / ACCESSWIRE / May 29, 2020 / 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 presented its latest data at the ASCO Annual Meeting. The poster presentation can be viewed on the ASCO meeting website at: https://meetinglibrary.asco.org/record/184864/poster and on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications

    HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple cancer testis antigens (CTAs) to elicit a diverse and robust T-cell attack against tumor cells. A Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb's (BMS) Opdivo® (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC) is ongoing, with enrollment of this trial completed in July 2019.

    This data demonstrated that significant survival benefit was observed in a cohort of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC; with a median overall survival (mOS) of 28.7 months for the intent-to-treat (ITT) patients (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. Notably, a statistically significant survival benefit with mOS of 42.1 months was observed in patients with injection site reaction (p = 0.0001). Exploratory biomarker analyses showed that overlapping CTA expression in patients' tumors at baseline with HS-110, as well as the expression of a specific CTA were both associated with statistically significant improved overall survival (p = 0.028 and 0.008, respectively).

    "Our exploratory biomarker analysis solidly establishes additional clinical evidence for the HS-110 mechanism of action," said Jeff Hutchins, Chief Scientific and Operating Officer of Heat. "This extended mOS also suggests that HS-110 treatment in combination with a CPI should be considered for any solid tumor type with sufficient CTA overlap with HS-110."

    This study has completed enrollment, and 21 of the 47 patients enrolled (45%) are still alive as of this data cut. HS-110 now has a positive safety profile in over 200 patients, and combination of HS-110 and nivolumab appears to be safe and well-tolerated.

    "This updated data demonstrates the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC", said Jeff Wolf, Chief Executive Officer of Heat. "Heat is planning an end-of-phase 2 meeting with the FDA to discuss registration trial design."

    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. Multiple product candidates in development leveraging the gp96 platform, including HS-110 in phase 2, HS-130 in phase 1, and COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies, including PTX-35. For more information, please visit www.heatbio.com.

    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 extended mOS suggesting that HS-110 treatment in combination with a CPI should be considered for any solid tumor type with sufficient CTA overlap with HS-110, the potential utility of HS-110 in combination with a checkpoint inhibitor as a frontline treatment for NSCLC, the planned end-of-phase 2 meeting with the FDA to discuss registration trial design and Heat's 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 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, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/591882/Heat-Biologics-Presents-Positive-Survival-Benefit-for-HS-110-in-Combination-with-Nivolumab-in-Phase-2-Lung-Cancer-Trial-at-2020-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting

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  24. DURHAM, NC / ACCESSWIRE / May 15, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today provided financial, clinical and operational updates for the first quarter ended March 31, 2020.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We continue to make progress advancing our unique COVID-19 vaccine utilizing our robust gp-96 vaccine platform in collaboration with researchers at University of Miami. We plan to commence preclinical testing for the COVID-19 vaccine this quarter and are finalizing our manufacturing plans, which we believe will help shorten the clinical…

    DURHAM, NC / ACCESSWIRE / May 15, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today provided financial, clinical and operational updates for the first quarter ended March 31, 2020.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We continue to make progress advancing our unique COVID-19 vaccine utilizing our robust gp-96 vaccine platform in collaboration with researchers at University of Miami. We plan to commence preclinical testing for the COVID-19 vaccine this quarter and are finalizing our manufacturing plans, which we believe will help shorten the clinical timeline. Additionally, we are applying for grants to support clinical development of this program and are advancing collaboration discussions. Earlier this year we also announced a collaboration with the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test. We suspended this program due to the progress made by other diagnostic manufacturers utilizing a similar approach, and our desire to focus resources on our highly-differentiated COVID-19 vaccine. Nevertheless, in the process, we developed our own unique diagnostic intellectual property, and plan to opportunistically explore partnership opportunities around this technology."

    "We also continue to achieve key milestones related to HS-110 in combination with Opdivo® (nivolumab) in advanced non-small cell lung cancer (NSCLC). We recently announced that an abstract has been posted on The American Society of Clinical Oncology's (ASCO) website. We look forward to presenting additional data at the upcoming ASCO Conference on May 29. Importantly, given the strength of the data, we plan to initiate an end of Phase 2 Type B meeting with the FDA to discuss our registrational strategy.

    "We ended the quarter with over $26 million of cash and short-term investments as of March 31, 2020, which we believe provides us significant resources to advance each of our programs," concluded Mr. Wolf.

    Q1 2020 Financial Results

    • Research and development expenses decreased approximately 12.5% to $2.8 million for the quarter ended March 31, 2020 compared to $3.2 million for the quarter ended March 31, 2019.
    • General and administrative expense was $3.3 million for the quarters ending March 31, 2020 and 2019.
    • Net loss attributable to Heat Biologics was approximately $6.3 million, or ($0.11) per basic and diluted share for the quarter ended March 31, 2020 compared to a net loss of $5.7 million, or ($0.17) per basic and diluted share for the quarter ended March 31, 2019.
    • As of March 31, 2020, the Company had approximately $26.4 million in cash, cash equivalents and short-term investments.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 continuing to make progress advancing our unique COVID-19 vaccine utilizing our robust gp-96 vaccine platform in collaboration with researchers at University of Miami, plans to commence preclinical testing for the COVID-19 vaccine this quarter, finalizing our manufacturing plans, which we believe will help shorten the clinical timeline, plans to opportunistically explore partnership opportunities around the diagnostic intellectual property, presenting additional data at the upcoming ASCO Conference on May 29, plans to initiate an end of Phase 2 Type B meeting with the FDA to discuss our registrational strategy and. cash and short-term investments as of March 31, 2020, providing us significant resources to advance each of our programs. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's vaccine platform to provide protection against 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, 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

    HEAT BIOLOGICS, INC.
    Consolidated Balance Sheets

    March 31, December 31,
    2020 2019
    (unaudited)
    Current Assets
    Cash and cash equivalents
    $ 20,738,776 $ 9,039,887
    Short-term investments
    5,706,082 5,713,922
    Accounts receivable
    144,119 34,986
    Prepaid expenses and other current assets
    537,653 420,328
    Total Current Assets
    27,126,630 15,209,123
    Property and Equipment, net
    705,553 559,410
    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
    2,211,506 2,287,500
    Finance lease right-of-use asset
    336,368 187,573
    Deposits
    122,905 394,637
    Total Other Assets
    9,989,117 10,188,048
    Total Assets
    $ 37,821,300 $ 25,956,581
    Liabilities and Stockholders' Equity
    Current Liabilities
    Accounts payable
    $ 1,350,476 $ 1,503,342
    Deferred revenue, current portion
    2,508,809 3,410,319
    Contingent consideration, current portion
    1,659,000 1,579,334
    Operating lease liability, current portion
    222,752 216,832
    Finance lease liability, current portion
    103,269 49,104
    Accrued expenses and other liabilities
    1,092,235 1,676,467
    Total Current Liabilities
    6,936,541 8,435,398
    Long Term Liabilities
    Other long-term liabilities
    14,216 -
    Derivative warrant liability
    41,360 -
    Deferred tax liability
    361,911 361,911
    Deferred revenue, net of current portion
    200,000 200,000
    Operating lease liability, net of current portion
    1,462,005 1,519,574
    Financing lease liability, net of current portion
    241,938 142,667
    Contingent consideration, net of current portion
    2,032,515 2,139,181
    Total Liabilities
    11,290,486 12,798,731
    Commitments and Contingencies (Note 9 and 13)
    Stockholders' Equity
    Common stock, $.0002 par value; 100,000,000 shares authorized, 77,924,516 and 33,785,999 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
    15,627 6,757
    Additional paid-in capital
    137,692,553 118,173,843
    Accumulated deficit
    (110,889,854 ) (104,597,748 )
    Accumulated other comprehensive income (loss)
    207,554 (11,250 )
    Total Stockholders' Equity - Heat Biologics, Inc.
    27,025,880 13,571,602
    Non-Controlling Interest
    (495,066 ) (413,752 )
    Total Stockholders' Equity
    26,530,814 13,157,850
    Total Liabilities and Stockholders' Equity
    $ 37,821,300 $ 25,956,581

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

    Three Months Ended
    March 31,
    2020 2019
    Revenue:
    Grant and licensing revenue
    $ 901,880 $ 701,062
    Operating expenses:
    Research and development
    2,782,506 3,172,247
    General and administrative
    3,270,548 3,347,601
    Change in fair value of contingent consideration
    (27,000 ) 114,290
    Total operating expenses
    6,026,054 6,634,138
    Loss from operations
    (5,124,174 ) (5,933,076 )
    Change in fair value of warrant liability
    (977,710 ) -
    Investor relations expense
    (66,767 ) -
    Interest income
    52,710 150,852
    Other (expense) income, net
    (257,479 ) 8,321
    Total non-operating income (loss)
    (1,249,246 ) 159,173
    Net loss before income taxes
    (6,373,420 ) (5,773,903 )
    Income tax (expense) benefit
    - (45,178 )
    Net loss
    (6,373,420 ) (5,819,081 )
    Net loss - non-controlling interest
    (81,314 ) (103,605 )
    Net loss attributable to Heat Biologics, Inc.
    $ (6,292,106 ) $ (5,715,476 )
    Net loss per share attributable to Heat Biologics, Inc.-
    Net loss per share attributable to Heat Biologics, Inc.-basic and diluted
    $ (0.11 ) $ (0.17 )
    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
    57,282,075 33,225,164
    Comprehensive loss:
    Net loss
    $ (6,373,420 ) $ (5,819,081 )
    Unrealized gain (loss) on foreign currency translation
    218,804 (8,189 )
    Total comprehensive loss
    (6,154,616 ) (5,827,270 )
    Comprehensive loss attributable to non-controlling interest
    (81,314 ) (103,605 )
    Comprehensive loss - Heat Biologics, Inc.
    $ (6,073,302 ) $ (5,723,665 )

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/590002/Heat-Biologics-Provides-First-Quarter-2020-Business-Update

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  25. Median overall survival (OS) of 28.7 months for HS-110 in combination with nivolumab in previously treated checkpoint inhibitor naïve non-small cell lung cancer (NSCLC) patients

    DURHAM, NC / ACCESSWIRE / May 14, 2020 / 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 announced that it has been selected to deliver a poster presentation at the ASCO Annual Meeting, to be held virtually during May 29 - 31, 2020. The ASCO Annual Meeting is the largest international conference to showcase the latest advancement in oncology. The abstracts published in…

    Median overall survival (OS) of 28.7 months for HS-110 in combination with nivolumab in previously treated checkpoint inhibitor naïve non-small cell lung cancer (NSCLC) patients

    DURHAM, NC / ACCESSWIRE / May 14, 2020 / 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 announced that it has been selected to deliver a poster presentation at the ASCO Annual Meeting, to be held virtually during May 29 - 31, 2020. The ASCO Annual Meeting is the largest international conference to showcase the latest advancement in oncology. The abstracts published in advance of the ASCO Annual Meeting were made available at 5:00 p.m. Eastern Daylight Time on May 13, 2020 on the ASCO meeting website at: https://meetinglibrary.asco.org/record/184864/abstract

    HS-110 is currently in Phase 2 trial in combination with Bristol-Myers Squibb's (BMS) Opdivo® (nivolumab) for multiple treatment settings in advanced non-small cell lung cancer (NSCLC). HS-110 is an "off-the-shelf" allogeneic cell-based therapy designed to activate patients' immune system against multiple tumor antigens to elicit a robust pan-antigen T-cell attack against tumor cells. Heat completed enrollment in this trial in July 2019.

    The abstract provides an update on the efficacy data of previously treated, checkpoint inhibitor (CPI) naïve patients with advanced NSCLC. The median overall survival (OS) was 28.7 months with a median follow up of 15.7 months. This study is ongoing and 21 of the 47 patients enrolled (45%) were still alive as of this datacut. Additional subset analysis will also be presented. HS-110 has a good safety profile in over 200 patients and combination of HS-110 and nivolumab appears to be safe and well-tolerated.

    Exploratory biomarker analysis on cancer testis antigens (CTAs) was performed using patients' tumor tissue at baseline. In this evaluation, improved overall survival (OS) was observed in patients whose tumors have 8 or more overlapping CTAs with the 39 CTAs overexpressed by HS-110. In addition, overexpression of zinc finger protein 492 (ZNF492) was associated with greater OS. ZNF492 is a transcription factor that is expressed in multiple cancers.

    Details of Heat Biologics' ASCO poster presentation:

    Abstract Title: Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab

    Session: Lung Cancer - Non-Small Cell Metastatic
    Abstract #: 9546
    Poster#: 312
    Date: Friday, May 29, 2020, 8am Eastern Time

    Following the presentation, a copy of the poster will be available on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications

    Reference:

    The Human Protein Atlas - ZNF492: https://www.proteinatlas.org/ENSG00000229676-ZNF492/pathology

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 Heat's gp96 platform activating immune responses against cancer or pathogenic antigens and Heat's developing pipeline. 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 to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/589819/Positive-Survival-Data-from-Phase-2-Lung-Cancer-Trial-Accepted-for-Presentation-at-2020-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting

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  26. DURHAM, NC / ACCESSWIRE / May 11, 2020 / 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 coronavirus COVID-19 vaccine, today provided an update on its Phase 2 trial of its T-cell activating HS-110, in combination with Opdivo® (nivolumab) in advanced non-small cell lung cancer (NSCLC).

    Recent highlights:

    • American Society of Clinical Oncology (ASCO) poster presentation on "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab" on May 29th presenting latest…

    DURHAM, NC / ACCESSWIRE / May 11, 2020 / 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 coronavirus COVID-19 vaccine, today provided an update on its Phase 2 trial of its T-cell activating HS-110, in combination with Opdivo® (nivolumab) in advanced non-small cell lung cancer (NSCLC).

    Recent highlights:

    • American Society of Clinical Oncology (ASCO) poster presentation on "Tumor antigen expression and survival of patients with previously treated advanced non-small cell lung cancer (NSCLC) receiving viagenpumatucel-L (HS-110) plus nivolumab" on May 29th presenting latest survival data of HS-110 in combination with nivolumab in previously treated, immunotherapy naïve patients with advanced non-small cell lung cancer (NSCLC)
    • Established partnership for biomarker development with Earle A. Chiles Research Institute of the Providence Cancer Institute in Portland, Oregon
    • Plan to initiate Type B end of Phase 2 meeting with the FDA to discuss registration strategy

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We continue to make good progress on our clinical-stage portfolio, as well as our COVID-19 vaccine platform, and look forward to presenting additional HS-110 data on May 29 at ASCO. Additionally, we are excited to proceed with our partnership for biomarker development with the Providence Cancer Institute to find a tissue-based marker that will help predict patient treatment response with HS-110 and nivolumab. Finally, we are in the process of preparing a data package for an End of Phase 2 Meeting (EOP2) with the FDA. This meeting will represent an important milestone in finalizing our registrational strategy for HS-110. We are highly encouraged by the data thus far and look forward to providing the latest study results at ASCO."

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 Coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 plans to initiate a Type B end of Phase 2 meeting with the FDA to discuss registration strategy and Heat continuing good progress on our clinical-stage portfolio, as well as our COVID-19 vaccine platform, the ability to find a tissue-based marker that will help predict patient treatment response with HS-110 and nivolumab,. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat to initiate a Type B end of Phase 2 meeting with the FDA to discuss registration, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 vaccine, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/589231/Heat-Biologics-Provides-Clinical-Update-Reports-Continued-Progress-Advancing-HS-110

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  27. DURHAM, NC / ACCESSWIRE / April 29, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19 caused by SARS-CoV-2 infection, reported that it continues to advance its COVID-19 vaccine program and provided an outline of its strategy as well as anticipated Q2 2020 milestones for this program.

    Heat's gp96 COVID-19 vaccine program is focused on providing prophylactic protection to elderly patients and those with underlying health conditions, the very group of patients with an increased risk of complications and death from COVID-19 infection.

    New data suggest that both T-cell (cellular immunity…

    DURHAM, NC / ACCESSWIRE / April 29, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19 caused by SARS-CoV-2 infection, reported that it continues to advance its COVID-19 vaccine program and provided an outline of its strategy as well as anticipated Q2 2020 milestones for this program.

    Heat's gp96 COVID-19 vaccine program is focused on providing prophylactic protection to elderly patients and those with underlying health conditions, the very group of patients with an increased risk of complications and death from COVID-19 infection.

    New data suggest that both T-cell (cellular immunity) and antibody (humoral immunity) are required for effective prophylactic protection against COVID-19. Heat's vaccine is being designed to clear virus infected cells by promoting long-term cellular immunity, which is essential for preventing the spread of re-infection in susceptible individuals such as the elderly and other high-risk patients with relevant comorbidities.

    Unlike most conventional vaccines that predominantly drive a humoral response, Heat's COVID-19 vaccine platform drives a prominent cellular immune response via CD8+ T cells, in addition to a humoral immune response via a neutralizing IgG antibody. Notably, it was observed that 30% of confirmed COVID-19 patients in China failed to develop high titers of neutralizing antibodies after COVID-19 infection, suggesting a requirement for cellular immunity for recovery. Heat's COVID-19 vaccine targets the Spike or S protein, and expresses gp96 and OX40L, a T cell co-stimulator. OX40L co-stimulation expands CD4+ helper T cells that promote B-cell differentiation and IgG/IgA antibody class switching.

    Anticipated Q2 2020 milestones include:

    • Completion of development of a cell-based vaccine expressing gp96-Ig, OX40L-Ig and SARS-CoV-2 protein S
    • Generation of proof-of-concept data demonstrating vaccine immunogenicity in relevant preclinical models:
      • SARS-CoV-2 protein S specific CD8+ T cells in blood and lungs
      • SARS-CoV-2 protein S specific antibodies in serum
    • Submission of grant applications to fund and accelerate COVID-19 vaccine development

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We are making progress advancing our COVID-19 vaccine program and remain encouraged by the potential of our platform to provide broad cellular and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses. Specifically, along with our University of Miami collaborators, we are finalizing completion of the vaccine and plan to commence preclinical testing this quarter. These studies will measure the antiviral immune response elicited by SARS-CoV-2 specific antigens in the context of potent immune activators, gp96 and OX40L, in both the blood and lungs of preclinical models. We expect to report our preliminary data shortly thereafter."

    Mr. Wolf continued, "While we are currently funding vaccine development and preclinical studies, we do not expect to use significant corporate resources to advance our COVID-19 vaccine program. We are applying for several large grants to support clinical development of this program and are engaged in collaboration discussions, which we believe may provide attractive and non-dilutive pathways to help accelerate development of our COVID-19 vaccine."

    Heat's gp96 platform has previously undergone rigorous testing in numerous National Institutes of Health (NIH) and U.S. Department of Defense (DOD)-funded mice and primate trials as a vaccine against SIV/HIV, malaria, zika and other infectious diseases. These trials have demonstrated gp96 is a powerful platform with demonstrated antiviral activity in the lungs, as evidenced by a potent immune response and effectiveness in the induction of mucosal immunity in several infectious disease models.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 Coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 Heat continuing to advance its COVID-19 vaccine program, completion of development of a cell-based vaccine expressing gp96-Ig, OX40L-Ig and SARS-CoV-2 protein S during Q2 2020, generation of proof of concept data demonstrating vaccine immunogenicity in relevant preclinical models during Q2 2020, submission of grant applications to fund and accelerate COVID-19 vaccine development during Q2 2020, the potential of the platform to provide broad cellular and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses, plans to commence preclinical testing this quarter and the expected reporting of preliminary data shortly thereafter, and grant funding and collaborations providing attractive and non-dilutive pathways to help accelerate development of our COVID-19 vaccine. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat to complete the development of a cell-based vaccine expressing gp96-Ig, OX40L-Ig and SARS-CoV-2 protein S during Q2 2020, generate proof-of- concept demonstrating vaccine immunogenicity in relevant preclinical models during Q2 2020, submit grant applications to fund and accelerate COVID-19 vaccine development during Q2 2020, commence preclinical testing this quarter and report preliminary data shortly thereafter, the potential of the platform to provide broad cellular and humoral protection against COVID-19, as well as possible future mutations or other coronaviruses, 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, 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 for the year ended December 31, 2019 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/587527/Heat-Biologics-Reports-Progress-on-COVID-19-Efforts-and-Timeline-of-Anticipated-Q2-2020-Milestones

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  28. DURHAM, NC / ACCESSWIRE / April 1, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, announced today the formation of its COVID-19 Advisory Board (CAB) with four key appointments: Justin Stebbing MD, PhD, Raymond Pickles, PhD, Natasa Strbo MD, DSc, and Lanying Du, PhD.

    Heat's COVID-19 Advisory Board was established with leading thought leaders to propel Heat's COVID-19 vaccine and COVID-19 diagnostic programs. The combined Advisory Board has expertise in areas of coronavirus and related respiratory virus biology and infection, immunotherapy, and vaccines. Heat recently announced a…

    DURHAM, NC / ACCESSWIRE / April 1, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, announced today the formation of its COVID-19 Advisory Board (CAB) with four key appointments: Justin Stebbing MD, PhD, Raymond Pickles, PhD, Natasa Strbo MD, DSc, and Lanying Du, PhD.

    Heat's COVID-19 Advisory Board was established with leading thought leaders to propel Heat's COVID-19 vaccine and COVID-19 diagnostic programs. The combined Advisory Board has expertise in areas of coronavirus and related respiratory virus biology and infection, immunotherapy, and vaccines. Heat recently announced a research collaboration with the University of Miami Miller School of Medicine to develop a vaccine leveraging Heat's proprietary gp96 platform designed to target the SARS-CoV-2 coronavirus that causes COVID-19. Under a separate collaboration with the University of Miami Miller School of Medicine, Heat also intends to develop a proprietary COVID-19 point-of-care diagnostic test.

    The CAB members include:

    • Justin Stebbing MD, PhD, Professor of Cancer Medicine and Oncology, Consultant Oncologist, at the Imperial College and Imperial College Healthcare NHS Trust
    • Raymond Pickles, PhD, Associate Professor of Microbiology and Immunology at the University of North Carolina School of Medicine with over 20 years of experience and expertise in respiratory research and newly emerging coronavirus including SARS
    • Natasa Strbo MD, DSc, Assistant Professor of Microbiology and Immunology at the University of Miami, Miller School of Medicine and co-developer of Heat's gp96 platform, she has spent years advancing the platform as a vaccine against HIV and malaria
    • Lanying Du, PhD, Member at the New York Blood Center (NYBC) and Head of Viral Immunology Laboratory at the Lindsley F. Kimball Research Institute of NYBC, where she focuses on development of vaccines and therapeutic agents to prevent and treat infectious diseases including COVID-19, MERS, SARS and Zika

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We are thrilled to have attracted leading experts in immunotherapy and vaccines to support Heat as we continue to develop Heat's COVID-19 vaccine and COVID-19 diagnostic programs. We look forward to working closely with the CAB to advance our programs to help combat the current COVID-19 pandemic."

    Justin Stebbing MD, PhD, is a Professor of Cancer Medicine and Oncology, Consultant Oncologist, at the Imperial College and Imperial College Healthcare NHS Trust. Professor Justin Stebbing specializes in a range of malignancies, their treatment with immunotherapy (breast, GI and lung and clinical trials), having originally trained in medicine at Trinity College Oxford, where he gained a first-class degree. After completion of junior doctor posts in Oxford, he undertook training and a residency program at The Johns Hopkins Hospital in the US, returning to London to continue his career in oncology at The Royal Marsden and then St Bartholomew's Hospitals. Professor Stebbing's original PhD research investigated the interplay between the immune system and cancer; he was appointed a senior lecturer in 2007, and a Professor in 2009. Professor Stebbing has published over 600 peer-reviewed papers in journals such as the Lancet, New England Journal, Blood, the Journal of Clinical Oncology, Annals of Internal Medicine, as well as writing regularly for national newspapers and presenting new data on optimal cancer therapies at the major international conferences.

    Raymond Pickles, PhD, is an associate professor in the Department of Microbiology and Immunology within the UNC School of Medicine. His research is focused on how viruses infect the respiratory tract of humans and other animal species and why highly pathogenic viruses often result in more severe airway disease. He has 30 years of experience working with models of the respiratory tract and has used these models to understand infection outcomes with Respiratory Syncytial Virus (RSV), Adenoviruses, newly emerging avian influenza viruses, and newly emerging coronaviruses including SARS. He received his PhD from the University of Cambridge before completing Post-Doctoral Studies in the Division of Pulmonary Medicine at UNC-Chapel Hill

    Natasa Strbo MD, DSc, is an assistant professor of microbiology and immunology at the University of Miami, Miller School of Medicine. Dr. Strbo is also a co-developer of Heat's gp96 platform and has spent many years advancing the platform as a vaccine against HIV and malaria. Dr. Strbo's current research is focused on devising a novel strategy for achieving as complete a protection as possible, the ultimate goal being the future development of an efficacious heat shock protein (HSP) gp96-Ig vaccine against HIV, malaria, ZIKA, CMV, COVID-19 and other emerging infectious diseases. Dr. Strbo was the recipient of a Miami CTSI KL2 Award (2013-2016) to study vaccine-induced immune responses in the reproductive tract of HIV-infected humanized mice and she was also awarded the University of Miami Glaser Award for 2016 to further develop HIV vaccine technology.

    Lanying Du, PhD, is a Member at the New York Blood Center (NYBC) and is the Head of Viral Immunology Laboratory at the Lindsley F. Kimball Research Institute of NYBC. Dr. Du's research focuses on the development of effective and safe vaccines and therapeutic agents to prevent and treat emerging and reemerging infectious diseases caused by coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also known as 2019 novel coronavirus (2019-nCoV), Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV, and other coronaviruses with pandemic potential, influenza viruses, as well as flaviviruses, including Zika virus and dengue virus. Dr. Du's research also focuses on the study of pathogenic mechanisms of these viruses, based on which to design novel vaccines and therapeutic antibodies. Her research tools include rational design of novel vaccines and therapeutics, mRNA technology, drug screening, antibody production and evaluation.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 Coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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, expectations, and assumptions and include statements such as the support to be received by the SAB members with respect to Heat's continued development of its COVID-19 vaccine and COVID-19 diagnostic programs and advancing Heat's programs to help combat the current COVID-19 pandemic. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the contribution of the SAB, the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test, the ability of Heat's vaccine platform to provide protection against 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, 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 for the year ended December 31, 2018 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.

    CONTACT:

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/583405/Heat-Biologics-Announces-Formation-of-COVID-19-Advisory-Board

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  29. Provides update on development of gp96 vaccine for preventing infection from the SARS-CoV-2 coronavirus that causes COVID-19

    Reports progress on development of COVID-19 30-minute point of care diagnostic test

    Completed enrollment in Phase 2 non-small cell lung cancer trial

    Reports over $25 million of cash and short-term investments as of March 23, 2020

    DURHAM, NC / ACCESSWIRE / March 30, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today provided financial, clinical and operational updates for the year ended December 31, 2019.

    Jeff Wolf, Chief Executive Officer of Heat Biologics…

    Provides update on development of gp96 vaccine for preventing infection from the SARS-CoV-2 coronavirus that causes COVID-19

    Reports progress on development of COVID-19 30-minute point of care diagnostic test

    Completed enrollment in Phase 2 non-small cell lung cancer trial

    Reports over $25 million of cash and short-term investments as of March 23, 2020

    DURHAM, NC / ACCESSWIRE / March 30, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today provided financial, clinical and operational updates for the year ended December 31, 2019.

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "2019 was an exciting year for Heat, as we advanced our therapeutic pipeline. This past November, we presented additional positive top line Phase 2 data of HS-110 plus BMS checkpoint inhibitor nivolumab (Opdivo®) in advanced NSCLC lung cancer patients at the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy. We are highly encouraged by the data as we advance partnership and collaboration discussions. Earlier this year, we announced dosing the first patient in a Phase 1 clinical trial of our co-stimulatory HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care, which marks a key milestone for Heat."

    "We recently announced plans to develop a vaccine for preventing infection from the SARS-CoV-2 coronavirus that causes COVID-19 utilizing our robust gp-96 vaccine platform in collaboration with the University of Miami. Heat's gp96 platform has undergone rigorous testing as a vaccine against SIV/HIV, malaria, zika and other infectious diseases in numerous National Institutes of Health (NIH) and Department of Defense (DOD)-funded mice and primate trials and has been tested in over 300 patients in multiple NIH and Heat-funded oncology trials. We believe this platform has the potential to provide broad protection against COVID-19, and possible future mutations of COVID-19 or other coronaviruses. We are encouraged by the prospects for this program and are moving forward with our partners to advance this vaccine as quickly as possible."

    "Earlier this month we also announced a collaboration with the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test. The new paper-based test is being designed to provide a read-out in a fraction of the time required for most other tests, have no technical hardware requirements, have low cost of goods, be easily manufactured at scale, and provide binary readout if the patient is positive for a disease within 30 minutes. Unfortunately, current diagnostic tests, are in short supply and often take days for results. This diagnostic is being designed for early detection to provide critical and time-sensitive information to help curb the spread of the disease."

    Mr. Wolf concluded, "We share our sympathies to those individuals and families impacted by COVID-19 and are committed to helping find solutions to this global pandemic. I'd like to thank all of the Heat and University of Miami professionals that have worked tirelessly to advance our therapeutic and diagnostic platforms. Importantly, we have over $25 million of cash and short-term investments as of March 23, 2020, which should put us on a solid financial footing as we advance our programs. Moreover, we believe that upcoming catalysts and milestones have the potential to drive significant shareholder value."

    2019 Financial Results

    • Research and development expenses decreased by 20% to $13.0 million for the year ended December 31, 2019 compared to $16.2 million for the year ended December 31, 2018. The variance of approximately $3.2 million is primarily due to reduced clinical trial expenses related to HS-110 patient enrollment completion.
    • General and administrative expense increased approximately 36% to $9.5 million for the year ended December 31, 2019 compared to $7.0 million for the year ended December 31, 2018. The variance of $2.5 million is primarily due to the increase in personnel and stock compensation expense.
    • Net loss attributable to Heat Biologics was approximately $20.0 million, or ($0.60) per basic and diluted share for the year ended December 31, 2019 compared to a net loss of approximately $15.7 million, or ($0.90) per basic and diluted share for the year ended December 31, 2018.
    • As of December 31, 2019, the Company had approximately $14.8 million in cash, cash equivalents and short-term investments.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 developing a vaccine for treating or preventing infection from the SARS-CoV-2 coronavirus that causes COVID-19 utilizing Heat's robust gp-96 vaccine platform in collaboration with the University of Miami, the platform having the potential to provide broad protection against COVID-19, and possible future mutations of COVID-19 or other coronaviruses, moving forward with Heat's partners to advance this vaccine to clinical trials as quickly as possible, the new paper-based test providing a read-out in a fraction of the time required for most other tests, having no technical hardware requirements, low cost of goods, being easily manufactured at scale, and providing binary readout if the patient is positive for a disease within 30 minutes,upcoming catalysts and milestones having the potential to drive significant shareholder value, and cash being sufficient to advance Heat's programs. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test that provides a read-out in a fraction of the time required for most other tests, have no technical hardware requirements, low cost of goods, be easily manufactured at scale, and provide binary readout if the patient is positive for a disease within 30 minutes, the ability of Heat's vaccine platform to provide protection against 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, 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

    HEAT BIOLOGICS INC.
    Consolidated Balance Sheets

    December 31,
    2019
    2018
    Current Assets
    Cash and cash equivalents
    $ 9,039,887 $ 22,154,251
    Short-term investments
    5,713,922 5,570,027
    Accounts receivable
    34,986 28,538
    Prepaid expenses and other current assets
    420,328 961,317
    Total Current Assets
    15,209,123 28,714,133
    Property and Equipment, net
    559,410 643,146
    Other Assets
    In-process R&D
    5,866,000 5,866,000
    Goodwill
    1,452,338 2,189,338
    Operating lease right-of-use asset
    2,287,500 -
    Finance lease right-of-use asset
    187,573 -
    Deposits
    394,637 351,220
    Total Other Assets
    10,188,048 8,406,558
    Total Assets
    $ 25,956,581 $ 37,763,837
    Liabilities and Stockholders' Equity
    Current Liabilities
    Accounts payable
    $ 1,503,342 $ 974,619
    Deferred revenue, current portion
    3,410,319 1,032,539
    Contingent consideration, current portion
    1,579,334 1,187,000
    Operating lease liability, current portion
    216,832 -
    Finance lease liability, current portion
    49,104 -
    Accrued expenses and other liabilities
    1,676,467 1,678,051
    Total Current Liabilities
    8,435,398 4,872,209
    Long Term Liabilities
    Other long-term liabilities
    - 213,724
    Deferred tax liability
    361,911 316,733
    Deferred revenue, net of current portion
    200,000 200,000
    Operating lease liability, net of current portion
    1,519,574 -
    Financing lease liability, net of current portion
    142,667 -
    Contingent consideration, net of current portion
    2,139,181 1,918,225
    Total Liabilities
    12,798,731 7,520,891
    Stockholders' Equity
    Common stock, $.0002 par value; 100,000,000 shares authorized, 33,785,999 and 32,492,144 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively
    6,757 6,499
    Additional paid-in capital
    118,173,843 114,883,135
    Accumulated deficit
    (104,597,748 ) (84,580,180 )
    Accumulated other comprehensive loss
    (11,250 ) (19,904 )
    Total Stockholders' Equity - Heat Biologics, Inc.
    13,571,602 30,289,550
    Non-Controlling Interest
    (413,752 ) (46,604 )
    Total Stockholders' Equity
    13,157,850 30,242,946
    Total Liabilities and Stockholders' Equity
    $ 25,956,581 $ 37,763,837

    HEAT BIOLOGICS INC.
    Consolidated Statements of Operations and Comprehensive Loss

    Year ended
    December 31,
    2019
    2018
    Revenue:
    Grant and licensing revenue
    $ 3,049,104 $ 5,793,849
    Operating expenses:
    Research and development
    13,013,604 16,233,014
    General and administrative
    9,431,015 7,025,212
    Goodwill impairment loss
    737,000 -
    Change in fair value of contingent consideration
    613,290 495,936
    Total operating expenses
    23,794,909 23,754,162
    Loss from operations
    (20,745,805 ) (17,960,313 )
    Interest income
    431,824 265,752
    Other (expense) income, net
    (25,557 ) 117,780
    Total non-operating income
    406,267 383,532
    Net loss before income taxes
    (20,339,538 ) (17,576,781 )
    Income tax (expense) benefit
    (45,178 ) 985,488
    Net loss
    (20,384,716 ) (16,591,293 )
    Net loss - non-controlling interest
    (367,148 ) (857,439 )
    Net loss attributable to Heat Biologics, Inc.
    $ (20,017,568 ) $ (15,733,854 )
    Net loss per share attributable to Heat Biologics, Inc.-
    Net loss per share attributable to Heat Biologics, Inc.-basic and diluted
    $ (0.60 ) $ (0.90 )
    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
    33,281,817 17,485,461
    Other comprehensive loss:
    Net loss
    (20,384,716 ) (16,591,293 )
    Unrealized gain on foreign currency translation
    8,654 146,121
    Total other comprehensive loss
    (20,376,062 ) (16,445,172 )
    Comprehensive loss attributable to non-controlling interest
    (367,148 ) (857,439 )
    Comprehensive loss
    $ (20,008,914 ) $ (15,587,733 )

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/583087/Heat-Biologics-Provides-Year-End-Business-Update

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  30. Test being designed to provide rapid, point-of-care diagnosis within 30 minutes

    DURHAM, NC / ACCESSWIRE / March 23, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today reported that it is collaborating with the University of Miami to develop a proprietary UM COVID-19 point-of-care diagnostic test.

    The new, patient-friendly test will require a simple pharyngeal throat swab to deliver on-the-spot results on a paper strip in under 30 minutes. In contrast, current tests for COVID-19 usually rely on the use of expensive thermal-cyclers, with results in five to six hours or require…

    Test being designed to provide rapid, point-of-care diagnosis within 30 minutes

    DURHAM, NC / ACCESSWIRE / March 23, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of novel therapeutic and prophylactic vaccines, including one for coronavirus COVID-19, today reported that it is collaborating with the University of Miami to develop a proprietary UM COVID-19 point-of-care diagnostic test.

    The new, patient-friendly test will require a simple pharyngeal throat swab to deliver on-the-spot results on a paper strip in under 30 minutes. In contrast, current tests for COVID-19 usually rely on the use of expensive thermal-cyclers, with results in five to six hours or require blood draws to detect antibodies, indicative of previous exposure. Preliminary research suggests the new test is specific to the novel coronavirus, with no cross-reaction to previous coronavirus subtypes. The test is designed to enable cost-effective manufacturing amenable for mass production and deployment around the world.

    Sylvia Daunert, PharmD, MS, PhD, Chair of Biochemistry and Molecular Biology at the University of Miami Miller School of Medicine, who along with Sapna Deo, MS, PhD, and Jean-Marc Zingg, PhD, both also faculty at the Miller School, developers of the test, stated, "Our lab has tremendous experience developing accurate and easily-usable tests for infectious diseases such as HPV and Zika. Unlike tests that detect antibodies (IgG and IgM method), which can take weeks to manifest, our test is being developed to utilize molecular recognition and amplification of the target virus. This should allow for much earlier detection-within a couple days of exposure-providing critical and time-sensitive information to help curb the spread of the disease."

    Dr. Daunert added, "Additionally, our test is designed to provide a read-out in a fraction of the time required for most other tests, has no technical hardware requirements, and offers high sensitivity and a simple binary paper readout that can tell the healthcare provider if the patient is positive for a disease within 30 minutes. I am very excited to collaborate with Heat Biologics in order to bring our expertise to bear in fighting this pandemic."

    Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, "We are honored to work with Dr. Daunert and the University of Miami to develop this exciting new platform for early and quick diagnosis of COVID-19. Her lab has developed multiple bioassays against similar diseases, and we are eager to utilize these tools in the war against COVID-19. Importantly, we believe this point of care diagnostic will address many of the challenges facing existing tests, including time to readout and cost. We look forward to providing further updates on this platform in the near future."

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat Biologics has also launched a program in collaboration with the University of Miami to develop a vaccine designed to protect against the COVID-19 Coronavirus. Heat has numerous other pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 new, patient-friendly test will require only a paper-based swab procedure, and is being designed to deliver on-the-spot results in under 30 minutes, preliminary research suggests the new test should be highly specific, with no cross-reaction to coronavirus subtypes, the test is designed to enable cost-effective manufacturing amenable for mass production and deployed around the world, the test should allow for much earlier detection-within a couple days of exposure-providing critical and time-sensitive information to help curb the spread of the disease, the test is designed to provide a read-out in a fraction of the time required for most other tests, has no technical hardware requirements, and offers high sensitivity and a simple binary paper readout that can tell the healthcare provider if the patient is positive for a disease within 30 minutes, this point of care diagnostic will address many of the challenges facing existing tests, including time to readout and cost and Heat developing a novel vaccine platform for use against COVID-19. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat together with researchers at the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test that allows for earlier detection, is highly specific, with no cross-reaction to coronavirus subtypes, offers high sensitivity and a simple binary paper readout that can tell the healthcare provider if the patient is positive for a disease within 30 minutes and that enables cost-effective manufacturing amenable for mass production and deployed around the world,, the ability of Heat's vaccine platform to provide protection against 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, 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 for the year ended December 31, 2018 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/582037/Heat-Biologics-and-University-of-Miami-Developing-Proprietary-COVID-19-Diagnostic-Test-Under-Collaborative-Research-Agreement

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  31. DURHAM, NC / ACCESSWIRE / March 16, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines including one for coronavirus COVID-19, today announced that it has accepted an invitation to join the Alliance for Biosecurity, a DC-based coalition of pharmaceutical and biotechnology companies that works to ensure medical countermeasures are available to protect public health and improve the prevention and treatment of severe infectious diseases, including coronavirus COVID-19.

    The Alliance for Biosecurity has a track record of securing advanced public-private partnerships to address biosecurity threats and of securing funding for firms working to address…

    DURHAM, NC / ACCESSWIRE / March 16, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines including one for coronavirus COVID-19, today announced that it has accepted an invitation to join the Alliance for Biosecurity, a DC-based coalition of pharmaceutical and biotechnology companies that works to ensure medical countermeasures are available to protect public health and improve the prevention and treatment of severe infectious diseases, including coronavirus COVID-19.

    The Alliance for Biosecurity has a track record of securing advanced public-private partnerships to address biosecurity threats and of securing funding for firms working to address these challenges.

    "We look forward to becoming an active member of the Alliance for Biosecurity, as we work to obtain government support for our novel COVID-19 vaccine," said Heat Biologics CEO, Jeff Wolf. "The efforts of the Alliance for Biosecurity will be instrumental as we advance our COVID-19 vaccine into later stages of development."

    "We look forward to supporting Heat Biologics efforts to advance their novel vaccine platform for use against COVID-19," said retired Congressman Jack Kingston, who serves as the Secretariat of the Alliance.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    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 regarding obtaining government support for Heat's novel COVID-19 vaccine, the efforts of the Alliance for Biosecurity being instrumental to advancing Heat's COVID-19 vaccine into later stages of development, and Heat developing a novel vaccine platform for use against COVID-19. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability to obtain government support for Heat's novel COVID-19 vaccine, the contribution of Alliance for Biosecurity to advancing Heat's COVID-19 vaccine into later stages of development , the ability of Heat's vaccine platform to provide protection against 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, 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 for the year ended December 31, 2018 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/580805/Heat-Biologics-Invited-to-Join-The-Alliance-for-Biosecurity

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  32. NEW YORK, NY / ACCESSWIRE / March 5, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients' immune systems against cancer, today announced that it will be presenting at the Spring Investor Summit being held on March 25th-26th in New York City.

    The Spring Investor Summit will take place at the Essex House, featuring over 500 registered executives and investors.

    About Heat Biologics

    Heat Biologics is a clinical-stage biopharmaceutical company developing novel therapeutics designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the…

    NEW YORK, NY / ACCESSWIRE / March 5, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients' immune systems against cancer, today announced that it will be presenting at the Spring Investor Summit being held on March 25th-26th in New York City.

    The Spring Investor Summit will take place at the Essex House, featuring over 500 registered executives and investors.

    About Heat Biologics

    Heat Biologics is a clinical-stage biopharmaceutical company developing novel therapeutics designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system.

    The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors.

    To register as a presenting company: please contact Cassandra Miller ()

    To request complimentary investor registration: please visit our website at www.microcapconf.com

    News Compliments of ACCESSWIRE

    FOR MORE INFORMATION

    Please visit: www.microcapconf.com

    Or, contact Cassandra Miller at

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
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  33. Heat's gp96 vaccine platform activates CD8 T cells, antigen presenting cells and natural killer cells, and induces mucosal immunity which could make it an ideal vaccine for COVID-19

    Vaccine designed to induce a multi-epitope specific CD8 T-cell response, which is crucial for protection against potential future mutations of COVID-19

    DURHAM, NC / ACCESSWIRE / March 5, 2020 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines, announced today a strategic collaboration with the University of Miami Miller School of Medicine to support the development of a vaccine leveraging Heat's proprietary gp96 platform designed to target the SARS-CoV-2 coronavirus that causes…

    Heat's gp96 vaccine platform activates CD8 T cells, antigen presenting cells and natural killer cells, and induces mucosal immunity which could make it an ideal vaccine for COVID-19

    Vaccine designed to induce a multi-epitope specific CD8 T-cell response, which is crucial for protection against potential future mutations of COVID-19

    DURHAM, NC / ACCESSWIRE / March 5, 2020 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines, announced today a strategic collaboration with the University of Miami Miller School of Medicine to support the development of a vaccine leveraging Heat's proprietary gp96 platform designed to target the SARS-CoV-2 coronavirus that causes COVID-19.

    Clinical and preclinical studies suggest that Heat's gp96-based vaccines may be utilized to target COVID-19. Heat has treated more than 300 patients to date with its gp96-based therapeutic vaccines. Results from these studies together with positive outcomes in NIH and DOD-funded mouse and primate studies against SIV/HIV 1-2, malaria and zika, demonstrate that gp96 vaccines express a broad range of antigens and stimulate a robust systemic immune response, culminating in humoral and cell mediated responses in different organs including the gut, reproductive tract, liver and lungs.

    Heat's COVID-19 vaccine will utilize Heat's gp96 platform to generate open docking sites for the insertion of multiple SARS-CoV-2 antigens. Heat anticipates that its novel approach should activate a potent immune response, without the disadvantages of possible genomic integration of foreign DNA or viral vector instability possible with attenuated viral vaccines. This approach is designed to induce a multi-epitope specific memory CD8 T-cell response that protects against multiple, distinct coronavirus strains across diverse human populations and against potential future mutations of SARS-CoV-2 and other coronavirus.

    Heat's COVID-19 program emerged from the same laboratory that originally developed Heat's gp96 platform technology, and will be developed at the University of Miami Miller School of Medicine under the direction of Natasa Strbo, M.D., D.Sc., research assistant professor of microbiology and immunology, who has spent many years advancing the gp96 platform as a vaccine against HIV, malaria, zika and other infectious diseases.

    Mucosal immunity and airway memory T-cell responses are crucial in the protection against respiratory viruses such as SARS-CoV-2, since these areas are the first to encounter the virus. Importantly, Heat's gp96-based vaccines have demonstrated effectiveness in the induction of mucosal immunity. Dr. Strbo and her team have developed a gp96 vaccine against SIV (the primate equivalent of HIV) that has been shown to induce a dramatic antigen-specific immune response in the mucous membranes. Treated primates (rheusus macaques) were 73 percent less likely to acquire a particularly virulent form of the SIV virus*. These data support broader use of the vaccine platform against other viruses attacking the mucosal tissues, such as COVID-19 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3594107).

    "T-cell immune responses play a crucial role in protection against coronaviruses and facilitation of coronavirus clearance. It is noteworthy to mention that not antibodies, but only SARS-CoV-specific memory T-cells persisted up to 11 years post-recovery," said Dr. Strbo. "Therefore, an effective coronavirus vaccine should induce neutralizing antibodies and elicit specific memory CD8 T cell responses. Currently, gp96 is the most efficient agent known to mediate antigen cross-presentation at femto-molar concentrations of antigen. Heat's gp96 vaccine platform has unique properties that enable it to activate antigen presenting cells, natural killer cells and T cells, which could make it an ideal vaccine for SARS-CoV-2."

    Heat's wholly-owned subsidiary, Zolovax, Inc., will focus on the development of the COVID-19 vaccine. Under the terms of the research collaboration, University of Miami will develop and test one or more vaccine constructs utilizing Heat's gp-96 vaccine backbone to express antigens associated with COVID-19.

    "We are excited about our collaboration with the University of Miami to develop a gp96-based vaccine designed to prevent the spread of COVID-19," said Jeff Wolf, CEO of Heat. "gp96 is a powerful vaccine platform that has been shown to induce a potent immune response, which may protect against COVID-19 and other highly-virulent infectious diseases. We look forward to advancing this important program"

    * Novel vaccination modality provides significant protection against mucosal infection by highly pathogenic SIV, J Immunol. 2013 Mar 15; 190(6): 2495-2499.

    Additional published studies (Strbo et al 2013 Cutting Edge J Immunol Selinger et al 2014, Vaccari et al Nature Medicine 2016 and 2018) support the feasibility of the gp96-Ig cell secreted-based vaccine platform.

    About Heat's gp96-based therapeutic platform

    Heat shock protein gp96 is a chaperone protein found in all human cells. It is a potent immune adjuvant that has the role of "molecular warning system" or more specifically, gp96 has demonstrated a clinical ability to induce immunity against antigens from the cell it came from. gp96 is naturally tethered to the cell and is normally released only during necrosis or cell death.

    Heat's proprietary gp96 vaccine platform reprograms live cells to continually secrete antigens of interest bound to the gp96, thus activating a robust T-cell response against those antigens. Heat's gp96 platform was developed by Dr. Eckhard Podack at the University of Miami and has undergone rigorous testing in numerous NIH and DOD-funded mice and primate trials as a vaccine against HIV, malaria and other infectious diseases, and has been tested on over 300 patients in numerous NIH and Heat-funded oncology trials.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    Forward Looking Statements

    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 regarding Heat developing a vaccine designed to protect against COVID-19 coronavirus, Heat's gp96-based vaccines targeting COVID-19, Heat's gp96 platform generating open docking sites for the insertion of multiple SARS-CoV-2 antigens, Heat's gp96 platform activating a potent immune response, without the disadvantages of possible genomic integration of foreign DNA or viral vector instability possible with attenuated viral vaccines, Heat's approach inducing a multi-epitope specific memory CD8 T-cell response that protects against multiple, distinct coronavirus strains across diverse human populations and against potential future mutations of SARS-CoV-2 and other coronavirus, and Heat's gp96 protecting against COVID-19 and other highly-virulent infectious diseases. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's platform to provide protection against COVID-19 coronavirus, and possible future mutations of COVID-19 or other coronaviruses, the ability of the gp96 platform to activate a potent immune response, without the disadvantages of possible genomic integration of foreign DNA or viral vector instability possible with attenuated viral vaccine, the issuance of a patent to Heat for use of Heat's technology platform for treating or preventing infection with the SARS-CoV-2 virus that causes coronavirus disease 2019 (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, 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 for the year ended December 31, 2018 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/579232/Heat-Biologics-Announces-Research-Collaboration-with-University-of-Miami-to-Develop-Vaccine-Designed-to-Protect-Against-COVID-19-Coronavirus

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  34. DURHAM, NC / ACCESSWIRE / March 4, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines, today announced that Jeff Wolf, Founder and CEO of Heat Biologics, is scheduled to appear today on several segments during the 4:00 PM to 6:30 PM Eastern Time news hours on ABC11-WTVD to discuss the Company's newly launched program to develop a coronavirus vaccine, using its immune activating gp96 vaccine platform, to protect against the SARS-CoV-2 coronavirus that causes COVID-19.

    The segments will be available on abc11.com and the ABC11 Facebook page: https://www.facebook.com/ABC11/.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing…

    DURHAM, NC / ACCESSWIRE / March 4, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutic vaccines, today announced that Jeff Wolf, Founder and CEO of Heat Biologics, is scheduled to appear today on several segments during the 4:00 PM to 6:30 PM Eastern Time news hours on ABC11-WTVD to discuss the Company's newly launched program to develop a coronavirus vaccine, using its immune activating gp96 vaccine platform, to protect against the SARS-CoV-2 coronavirus that causes COVID-19.

    The segments will be available on abc11.com and the ABC11 Facebook page: https://www.facebook.com/ABC11/.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer and other diseases using its proprietary gp96 platform to activate CD8+ "Killer" T-cells. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer with its gp96-based HS-110 therapeutic vaccine. HS-110 is the company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/579095/Heat-Biologics-CEO-to-Appear-Today-on-ABC11-WTVD-to-Discuss-the-Companys-Newly-Launched-Program-to-Develop-a-Vaccine-to-Protect-Against-SARS-CoV-2-Coronavirus-that-Causes-COVID-19

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  35. DURHAM, NC / ACCESSWIRE / January 21, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients' immune systems against cancer, today announced the closing of its previously announced underwritten public offering consisting of 20,000,000 shares of Common Stock together with Warrants to purchase 10,000,000 shares of Common Stock at a combined price to the public of $0.35. The gross proceeds to the Company from this offering are approximately $7,000,000, before deducting underwriting discounts, commissions and other offering expenses. The Warrants have an exercise price of $0.385, are exercisable upon issuance and expire 14 months…

    DURHAM, NC / ACCESSWIRE / January 21, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients' immune systems against cancer, today announced the closing of its previously announced underwritten public offering consisting of 20,000,000 shares of Common Stock together with Warrants to purchase 10,000,000 shares of Common Stock at a combined price to the public of $0.35. The gross proceeds to the Company from this offering are approximately $7,000,000, before deducting underwriting discounts, commissions and other offering expenses. The Warrants have an exercise price of $0.385, are exercisable upon issuance and expire 14 months from the date of issuance. Heat Biologics, Inc. has granted the underwriters a 45-day option to purchase up to 3,000,000 additional shares of Common Stock and/or additional Warrants to purchase up to 1,500,000 shares of Common Stock to cover over-allotments, if any.

    A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

    Brookline Capital Markets, a division of Arcadia Securities, LLC and Maxim Group LLC are acting as co-managers for the offering.

    A registration statement on Form S-1 (File No. 333-234105) relating to these securities has been filed with the U.S. Securities and Exchange Commission ("SEC") and became effective on January 16, 2020 and is available on the SEC's website located at http://www.sec.gov. This offering is being made only by means of a prospectus. Electronic copies of the final prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Heat Biologics

    Heat Biologics is a clinical-stage biopharmaceutical company developing novel therapeutics designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system.

    Forward Looking Statements

    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. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions and the other factors described in Heat's 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/573691/Heat-Biologics-Inc-Announces-Closing-of-7000000-Public-Offering

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  36. DURHAM, NC / ACCESSWIRE / January 16, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients' immune systems against cancer, today announced the pricing of an underwritten public offering consisting of 20,000,000 shares of Common Stock together with Warrants to purchase 10,000,000 shares of Common Stock at a combined price to the public of $0.35. The gross proceeds to the Company from this offering are expected to be approximately $7,000,000, before deducting underwriting discounts, commissions and other offering expenses. The Warrants will have an exercise price of $0.385, will be exercisable upon issuance and will expire 14…

    DURHAM, NC / ACCESSWIRE / January 16, 2020 / Heat Biologics, Inc. ("Heat") (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specializing in the development of therapeutics designed to activate patients' immune systems against cancer, today announced the pricing of an underwritten public offering consisting of 20,000,000 shares of Common Stock together with Warrants to purchase 10,000,000 shares of Common Stock at a combined price to the public of $0.35. The gross proceeds to the Company from this offering are expected to be approximately $7,000,000, before deducting underwriting discounts, commissions and other offering expenses. The Warrants will have an exercise price of $0.385, will be exercisable upon issuance and will expire 14 months from the date of issuance. Heat Biologics, Inc. has granted the underwriters a 45-day option to purchase up to 3,000,000 additional shares of Common Stock and/or additional Warrants to purchase up to 1,500,000 shares of Common Stock to cover over-allotments, if any. The offering is expected to close on Tuesday, January 21, 2020, subject to customary closing conditions.

    A.G.P./Alliance Global Partners is acting as the sole book-running manager for the offering.

    Brookline Capital Markets, a division of Arcadia Securities, LLC and Maxim Group LLC are acting as co-managers for the offering.

    A registration statement on Form S-1 (File No. 333-234105) relating to these securities has been filed with the U.S. Securities and Exchange Commission ("SEC") and became effective on January 16, 2020 and is available on the SEC's website located at http://www.sec.gov. This offering is being made only by means of a prospectus. Electronic copies of the prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: . Before investing in this offering, interested parties should read in their entirety the prospectus and the other documents that Heat Biologics, Inc. has filed with the SEC that are incorporated by reference in such prospectus, which provides more information about Heat Biologics, Inc. and such offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Heat Biologics

    Heat Biologics is a clinical-stage biopharmaceutical company developing novel therapeutics designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system.

    Forward Looking Statements

    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 regarding the proposed public offering and anticipated closing. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including market conditions, whether the proposed offering is completed, the satisfaction of customary closing conditions related to the proposed offering and the other factors described in Heat's 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

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/573285/Heat-Biologics-Inc-Prices-7000000-Public-Offering

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  37. First allogeneic, off-the-shelf cell therapy approach that enhances T-cell activation through localized OX40-mediated co-stimulation of dormant immune signals

    DURHAM, NC / ACCESSWIRE / December 16, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutics designed to activate patients' immune systems against cancer, today announced that the Company has dosed the first patient in the first Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care.

    HS-130 is Heat's allogeneic cell line engineered to locally secrete the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator…

    First allogeneic, off-the-shelf cell therapy approach that enhances T-cell activation through localized OX40-mediated co-stimulation of dormant immune signals

    DURHAM, NC / ACCESSWIRE / December 16, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company specialized in the development of therapeutics designed to activate patients' immune systems against cancer, today announced that the Company has dosed the first patient in the first Phase 1 clinical trial of HS-130, in combination with HS-110, for patients with advanced solid tumors refractory to standard of care.

    HS-130 is Heat's allogeneic cell line engineered to locally secrete the extracellular domain of OX40 ligand fusion protein (OX40L-Fc), a key costimulator of T cells, designed to augment antigen-specific CD8+ T cell response. HS-130 was manufactured by utilizing the Company's proprietary process to reprogram a live, genetically modified cancer cell line. In multiple preclinical models, these responses have demonstrated improved efficacy and safety using OX40L-Fc via cell-based delivery compared to systemic delivery of an OX40 agonist antibody in combination with HS-110.

    The first-in-human study is expected to enroll up to 30 patients under the supervision of lead investigator Dr. Rachel Sanborn, Director of the Phase 1 Clinical Trials Program at the Earle A. Chiles Research Institute, a division of Providence Cancer Institute in Portland, Oregon. In this study, patients will receive escalating doses of HS-130 in combination with HS-110. The objectives of the study are to evaluate patient safety and to determine the optimal dose for a subsequent Phase 2 trial.

    Jeff Wolf, Heat's CEO, commented, "We are pleased to announce the initiation of this combination study, which marks a key milestone for Heat as we advance our latest asset into clinical development. We look forward to sharing clinical proof of concept data to enable the development of a new generation of allogeneic therapy drug candidates in 2020."

    About HS-110

    HS-110 is designed by engineering gp96-Fc to deliver more than 70 cancer testis antigens to stimulate the patients' immune system and activate a robust cytotoxic T cell response. HS-110 has completed enrollment in a Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®) or with Merck's pembrolizumab (Keytruda®) (NCT 02439450).

    About HS-130

    HS-130 is designed with the same parent cell line as HS-110 but is engineered to secrete OX40L-Fc fusion protein, a potent inducer of antigen-specific CD8+ T cell proliferation. The first-in-human study aims to evaluate the safety and dose-response of HS-130 in combination with HS-110 in patients with advanced solid tumors (NCT04116710).

    About Heat Biologics, Inc.

    Heat Biologics is a clinical-stage biopharmaceutical company developing novel therapeutics designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. Pelican Therapeutics, Inc., a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system. For more information, please visit www.heatbio.com.

    Forward Looking Statements

    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 regarding the expected enrollment of up to 30 patients in the first in human study, the sharing of clinical proof of concept data to enable the development of a new generation of allogeneic therapy drug candidates in 2020 . 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 to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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 for the year ended December 31, 2018 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.

    Reference

    Fromm G, de Silva S, Giffin L, Xu X, Rose J, Schreiber TH. Gp96-Ig/Costimulator (OX40L, ICOSL, or 4-1BBL) Combination Vaccine Improves T-cell Priming and Enhances Immunity, Memory, and Tumor Elimination. Cancer Immunol Res. 2016 Sep 2;4(9):766-78.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/570328/Heat-Biologics-Announces-First-Patient-Dosed-in-the-First-Phase-1-Trial-of-HS-130

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  38. Prospectively Defined PD-L1 Positive Patients Achieved Median Overall Survival of 42 Months

    DURHAM, NC / ACCESSWIRE / November 20, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), presented additional positive Phase 2 interim top line data from Cohort A of the Company's Phase 2 trial of its T-cell activating cell-based therapy, HS-110, in combination with Opdivo® (nivolumab) in advanced non-small cell lung cancer (NSCLC) at a poster session at the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy on November 19, 2019 available at https://www.heatbio.com/technology/scientific-publications. Cohort A enrolled only previously treated patients who have never received a checkpoint inhibitor (CPI).

    The…

    Prospectively Defined PD-L1 Positive Patients Achieved Median Overall Survival of 42 Months

    DURHAM, NC / ACCESSWIRE / November 20, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), presented additional positive Phase 2 interim top line data from Cohort A of the Company's Phase 2 trial of its T-cell activating cell-based therapy, HS-110, in combination with Opdivo® (nivolumab) in advanced non-small cell lung cancer (NSCLC) at a poster session at the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy on November 19, 2019 available at https://www.heatbio.com/technology/scientific-publications. Cohort A enrolled only previously treated patients who have never received a checkpoint inhibitor (CPI).

    The Company reported median overall survival (mOS) of 16.9 months with 50% of patients censored with median follow up of 17 months. This compares favorably to the 12.2 months mOS reported in the Checkmate 057[i] study with Bristol-Myers Squibb's nivolumab (Opdivo®) alone in a similar patient population. The Company also reported an objective response rate (ORR) per iRECIST of 22%, and a disease control rate (DCR) of 48%, with tumor shrinkage observed in 46% of patients.

    Moreover, mOS of patients experiencing dermal injection site reactions (ISR) was 42.1 months. Statistically significant improvement in progression-free survival (PFS) and mOS was observed compared to those without ISR (Hazard Ratio = 0.51, p=0.042 and Hazard Ratio = 0.14, p <0.0001, respectively).

    Jeff Hutchins, Ph.D., Heat's Chief Scientific and Operating Officer commented, "The data from Cohort A is extremely encouraging and builds upon our recently announced data in Cohort B, a population consisting of patients who previously progressed on a checkpoint inhibitor and were re-challenged with HS-110 plus nivolumab. Of special interest in Cohort A is a prospectively defined subset of PD-L1 positive patients who achieved a median overall survival of 42.1 months (95% CI; 15.8 - 42.1). This is particularly compelling when compared to overall survival rates in published literature of 1st or 2nd line checkpoint inhibitor monotherapy."

    Highlights for Cohort A patients are presented below:

    • Median Overall Survival of 16.9 months (50% of patients still alive with median follow up of 17 months)
      • Median overall survival of ISR positive patients was 42.1 months (95% CI; 15.8 - 42.1) vs. an ISR negative mOS of 5.9 months (95% CI; 1.4 - 11.6) (Hazard Ratio = 0.14, p <0.0001)
      • A prospectively defined analysis of PD-L1 negative vs. PD-L1 positive showed a difference in mOS of 16.9 months (95% CI; 5.5 - unk) to 42.1 months (95% CI; 1.6 - 42.1), respectively
    • Objective Response Rate by iRECIST of 22% and DCR of 48%
    • Tumor shrinkage in 46% of patients
    • Patients who achieved stable disease or better showed statistically significant decreases in peripheral blood T cell subsets from baseline while on combination treatment

    Jeff Wolf, Heat's CEO, commented, "We are strongly encouraged by this latest data release and believe the data from both Cohorts A and B will be helpful as we advance partnership and collaboration discussions."

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. HS-110 is the Company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells to attack cancer. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®) or with Merck's pembrolizumab (Keytruda®). Pelican Therapeutics, a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    Forward Looking Statements

    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, expectations and assumptions and include statements such as: the belief that the data from both Cohorts A and B will be helpful as we advance partnership and collaboration discussions and the potential benefits of our product candidates. These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, 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 to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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 retain its key scientists or management personnel, and the other factors described in Heat's Annual Report on Form 10-K and 10-K/A for the year ended December 31, 2018 and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release and the company 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.

    Investor Relations Contact
    David Waldman
    +1 919 289 4017

    [i] Brahmer, J., Reckamp, K.L., Baas, P. et al, Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N. Engl. J. Med. 2015;373:123-135

    SOURCE: Heat Biologics, Inc.

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  39. DURHAM, NC / ACCESSWIRE / November 18, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer, today announced that top line data from its ongoing Phase 2 trial of HS-110 will be presented at the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy.

    The poster, titled "Viagenpumatucel-L (HS-110) plus nivolumab in previously-treated patients with advanced non-small cell lung cancer (NSCLC)," will be presented starting at 4:30PM Eastern Time on November 19, 2019.

    The AACR Special Conference on Tumor Immunology and Immunotherapy is being held at the Boston Marriott Copley Place in Boston on…

    DURHAM, NC / ACCESSWIRE / November 18, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer, today announced that top line data from its ongoing Phase 2 trial of HS-110 will be presented at the American Association for Cancer Research (AACR) Special Conference on Tumor Immunology and Immunotherapy.

    The poster, titled "Viagenpumatucel-L (HS-110) plus nivolumab in previously-treated patients with advanced non-small cell lung cancer (NSCLC)," will be presented starting at 4:30PM Eastern Time on November 19, 2019.

    The AACR Special Conference on Tumor Immunology and Immunotherapy is being held at the Boston Marriott Copley Place in Boston on November 17-20, 2019.

    About AACR Special Conference on Tumor Immunology

    The AACR Special Conference on Tumor Immunology and Immunotherapy is designed to integrate multidisciplinary facets of basic cancer immunology and immunotherapy to broaden our understanding of ways to harness the immune system to treat cancer. The hallmark of this series is also to encourage the effective exchange of ideas between basic cancer immunologists, nonimmunologists, and clinical oncologists in order to develop approaches that translate to outcomes. This year's program will feature international leaders in the field, who will expand our knowledge of the microbiome, adverse immunologic events, imaging and other new technologies, genetics and epigenomics of immuno-oncology, and immunologic signaling pathways. These world-renowned oncologists and researchers will offer their insights on novel cell therapies, biomarkers, vaccines, and adjuvants, all in the pursuit of understanding tumor evolution and creating better treatments.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. HS-110 is the Company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells to attack cancer. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®) or with Merck's pembrolizumab (Keytruda®). Pelican Therapeutics, a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    Media and Investor Relations Contact

    David Waldman
    +1 919 289 4017

    SOURCE: Heat Biologics, Inc.

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  40. Reported Positive Phase 2 Interim Data in Advanced Non-Small Cell Lung Cancer Patients

    MORRISVILLE, NC / ACCESSWIRE / November 15, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient's immune system against cancer, today reported financial and clinical updates for the third quarter ended September 30, 2019.

    Jeff Wolf, Heat's CEO, commented, "We remain encouraged by the positive top line data from our Phase 2 trial for HS-110 in advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor, Opdivo® (nivolumab) and with Merck's anti-PD-1 checkpoint inhibitor Keytruda® (pembrolizumab), which completed enrollment in July…

    Reported Positive Phase 2 Interim Data in Advanced Non-Small Cell Lung Cancer Patients

    MORRISVILLE, NC / ACCESSWIRE / November 15, 2019 / Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing therapeutics designed to activate a patient's immune system against cancer, today reported financial and clinical updates for the third quarter ended September 30, 2019.

    Jeff Wolf, Heat's CEO, commented, "We remain encouraged by the positive top line data from our Phase 2 trial for HS-110 in advanced non-small cell lung cancer (NSCLC) in combination with Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor, Opdivo® (nivolumab) and with Merck's anti-PD-1 checkpoint inhibitor Keytruda® (pembrolizumab), which completed enrollment in July 2019. We recently presented a subset of this data in a poster presentation at The Society of Immunotherapy of Cancer's (SITC) 34th Annual Meeting, in which we reported that 61% of patients in our Phase 2 Cohort B achieved disease stabilization per iRECIST, a patient population whose disease had progressed following prior checkpoint inhibitor therapy. Based on this data, we look forward to advancing our clinical trials and intend to aggressively explore all options for the future development of HS-110, including possible collaboration and licensing opportunities."

    "We ended the quarter with approximately $15.0 million in cash, cash equivalents and short-term investments. We believe we are well funded to advance our clinical activities though additional major milestones and continue to manage expenses accordingly."

    Third Quarter 2019 Financial Results

    • Research and development expenses decreased to $3.1 million for the quarter ended September 30, 2019 compared to $4.4 million for the quarter ended September 30, 2018. The decrease of approximately $1.3 million is due to the lower PTX-35 expense for 2019, primarily reflecting decreased manufacturing costs, offset by increased Phase 2 trial expenses, including outsourced clinical trial support services and payments to investigator sites.
    • General and administrative expense increased to $2.0 million for the quarter ended September 30, 2019 compared to $1.6 million for the quarter ended September 30, 2018. The $0.4 million increase is primarily attributable to increased personnel costs, including stock-based compensation expense.
    • Net loss attributable to Heat Biologics was approximately $6.2 million, or ($0.18) per basic and diluted share for the quarter ended September 30, 2019 compared to a net loss of approximately $3.7 million, or ($0.16) per basic and diluted share for the quarter ended September 30, 2018.
    • As of September 30, 2019, the Company had approximately $15.0 million in cash, cash equivalents and short-term investments with an additional $6.9 million in grant funds from Cancer Prevention Research Institute of Texas (CPRIT) that it expects to receive after filing an IND for PTX-35.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. HS-110 is the Company's first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells to attack cancer. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®) or with Merck's pembrolizumab (Keytruda®). Pelican Therapeutics, a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

    Forward Looking Statements

    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, expectations and assumptions and include statements such as: looking forward to advancing Heat's clinical trials, the intention to aggressively explore all options for the future development of HS-110, including possible collaboration and licensing opportunities, being well funded to advance Heat's clinical activities through additional major milestones and continuing to manage expenses accordingly, and the expected receipt of an additional $6.9 million in grant funds from CPRIT after filing the IND for PTX-35 These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, 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 to enroll patients and complete the clinical trials on time and achieve desired results and benefits, 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 retain its key scientists or management personnel, and the other factors described in Heat's Annual Report on Form 10-K and 10-K/A for the year ended December 31, 2018 and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release and the company 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

    September 30,
    2019
    December 31,
    2018
    (unaudited)
    Current Assets
    Cash and cash equivalents
    $ 9,334,421 $ 22,154,251
    Short-term investments
    5,683,446 5,570,027
    Accounts receivable
    37,300 28,538
    Prepaid expenses and other current assets
    734,788 961,317
    Total Current Assets
    15,789,955 28,714,133
    Property and Equipment, net
    609,916 643,146
    Other Assets
    In-process R&D
    5,866,000 5,866,000
    Goodwill
    1,452,338 2,189,338
    Right-of-use asset
    347,153 -
    Deposits
    386,284 351,220
    Total Other Assets
    8,051,775 8,406,558
    Total Assets
    $ 24,451,646 $ 37,763,837
    Liabilities and Stockholders' Equity
    Current Liabilities
    Accounts payable
    $ 1,944,333 $ 974,619
    Deferred revenue
    - 1,032,539
    Contingent consideration, current portion
    1,477,000 1,187,000
    Operating lease liability, current portion
    91,068 -
    Accrued expenses and other liabilities
    1,281,911 1,678,051
    Total Current Liabilities
    4,794,312 4,872,209
    Long Term Liabilities
    Contingent consideration
    2,356,515 1,918,225
    Deferred tax liability
    361,911 316,733
    Deferred revenue, net of current portion
    200,000 200,000
    Operating lease liability, net of current portion
    259,222 -
    Other long-term liabilities
    306,235 213,724
    Total Liabilities
    8,278,195 7,520,891
    Commitments and Contingencies
    Stockholders' Equity
    Common stock, $.0002 par value; 100,000,000 shares authorized, 33,334,124 and 32,492,144 shares issued and outstanding at September 30, 2019 (unaudited) and December 31, 2018, respectively
    6,822 6,499
    Additional paid-in capital
    117,836,082 114,883,135
    Accumulated deficit
    (101,261,124 ) (84,580,180 )
    Accumulated other comprehensive loss
    52,230 (19,904 )
    Total Stockholders' Equity- Heat Biologics, Inc.
    16,634,010 30,289,550
    Non-Controlling Interest
    (460,559 ) (46,604 )
    Total Stockholders' Equity
    16,173,451 30,242,946
    Total Liabilities and Stockholders' Equity
    $ 24,451,646 $ 37,763,837

    Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)

    Three Months Ended,
    September 30,
    Nine months Ended,
    September 30,
    2019 2018 2019 2018
    Revenue:
    Grant and licensing revenue
    $ 6,439 $ 1,840,009 $ 1,049,988 $ 3,735,713
    Operating expenses:
    Research and development
    3,129,356 4,403,759 9,725,744 10,756,485
    General and administrative
    1,993,136 1,585,600 7,201,196 4,727,105
    Goodwill impairment loss
    737,000 - 737,000 -
    Change in fair value of contingent consideration
    502,000 114,838 728,290 665,936
    Total operating expenses
    6,361,492 6,104,197 18,392,230 16,149,526
    Loss from operations
    (6,355,053 ) (4,264,188 ) (17,342,242 ) (12,413,813 )
    Interest income
    97,415 83,509 373,060 131,306
    Other (expense) income, net
    (73,275 ) 31,704 (80,539 ) 153,500
    Total non-operating income
    24,140 115,213 292,521 284,806
    Net loss before income taxes
    (6,330,913 ) (4,148,975 ) (17,049,721 ) (12,129,007 )
    Income tax benefit (expense)
    - 225,389 (45,178 ) 665,080
    Net loss
    (6,330,913 ) (3,923,586 ) (17,094,899 ) (11,463,927 )
    Net loss - non-controlling interest
    (136,315 ) (265,024 ) (413,955 ) (668,219 )
    Net loss attributable to Heat Biologics, Inc.
    $ (6,194,598 ) $ (3,658,562 ) $ (16,680,944 ) $ (10,795,708 )
    Net loss per share attributable to Heat Biologics, Inc.-basic and diluted
    $ (0.18 ) $ (0.16 ) $ (0.50 ) $ (0.75 )
    Weighted-average number of common shares used in net loss per share attributable to Heat Biologics, Inc.-basic and diluted
    33,650,829 23,143,952 33,255,535 14,359,429
    Other comprehensive loss:
    Net loss
    $ (6,330,913 ) $ (3,923,586 ) $ (17,094,899 ) $ (11,463,927 )
    Unrealized gain on foreign currency translation
    63,711 39,377 72,134 110,648
    Total other comprehensive loss
    (6,267,202 ) (3,884,209 ) (17,022,765 ) (11,353,279 )
    Comprehensive loss attributable to non-controlling interest
    (136,315 ) (265,024 ) (413,955 ) (668,219 )
    Comprehensive loss
    $ (6,130,887 ) $ (3,619,185 ) $ (16,608,810 ) $ (10,685,060 )

    SOURCE: Heat Biologics, Inc.

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