HTBX Heat Biologics Inc.

7.42
+0.09  (+1%)
Previous Close 7.33
Open 7.39
52 Week Low 3.5
52 Week High 30.1
Market Cap $188,542,927
Shares 25,410,098
Float 24,301,828
Enterprise Value $76,330,446
Volume 244,614
Av. Daily Volume 2,562,668
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Drug Pipeline

Drug Stage Notes
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 data announced February 9, 2021 - median progression free survival (PFS) of 1.8 months and median overall survival (OS) of 24.6 months.
PTX-35
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced June 22, 2020.
HS-130
Solid tumors
Phase 1
Phase 1
Phase 1 initiation of dosing announced December 16, 2019.
COVID vaccine
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 trial planned.
HS-410
Bladder cancer
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - November 30, 2016.

Latest News

  1. DURHAM, NC / ACCESSWIRE / March 25, 2021 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today provided financial, clinical and operational updates for the year ended December 31, 2020.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We made tremendous progress on our clinical programs in 2020. Earlier this year, we reported positive interim data from our Phase 2 trial of HS-110, which demonstrated evidence of substantial survival benefit. We are currently evaluating possible Phase 3 registration pathways for HS-110 in combination with a checkpoint inhibitor…

    DURHAM, NC / ACCESSWIRE / March 25, 2021 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today provided financial, clinical and operational updates for the year ended December 31, 2020.

    Jeff Wolf, Chief Executive Officer of Heat, commented, "We made tremendous progress on our clinical programs in 2020. Earlier this year, we reported positive interim data from our Phase 2 trial of HS-110, which demonstrated evidence of substantial survival benefit. 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. In 2020, we initiated a Phase 1 clinical trial of our first-in-class antibody therapeutic PTX-35 in patients with solid tumors. Leveraging our proprietary gp96 platform and in response to the COVID-19 pandemic, we initiated a COVID-19 vaccine program in collaboration with the University of Miami and have advanced this program forward into scale-up manufacturing. We have a strong balance sheet with approximately $132 million of cash, which should allow us to accelerate our current clinical programs and enhance our development and manufacturing capability to expand our therapeutic portfolio. We look forward executing key milestones in our growing pipeline in 2021."

    Pipeline Highlights and Updates

    HS-110

    • In previously treated, checkpoint inhibitor naïve patients with advanced non-small cell lung cancer (NSCLC) (Cohort A, N = 47), the median overall survival (OS) observed was 24.6 months was with a median follow-up time of 19.4 months and the one-year survival rate was 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.
      • The 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 OS of 11.9 months was observed.
      • 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 progression2,3.
      • NSCLC patients whose disease progresses following checkpoint inhibitor therapy have limited treatment options4.
      • The addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy.
    • As of this data cut, there were no treatment-emergent serious adverse reactions related to HS-110.

    PTX-35

    • In June 2020, the Company initiated a first-in-human Phase 1 clinical trial evaluating 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.

    COVID-19

    • In March 2020, the Company initiated a COVID-19 vaccine program leveraging its proprietary gp96 technology platform in collaboration with University of Miami.
    • Positive preclinical data demonstrated a robust T-cell mediated immune response directed against the spike protein of SARS-CoV-2, including induction of systemic and tissue-specific memory CD8+ T-cells and tissue-resident memory CD8+ T-cells in the lung.
    • The Company has initiated manufacturing of ZVX-60 and is conducting IND-enabling activities.

    2020 Financial Results

    • As of December 31, 2020, the Company had approximately $111.8 million in cash and cash equivalents and short-term investments.
    • Research and development expenses stayed consistent at $12.9 million and $13.0 million for the years ended December 31, 2020 and December 31, 2019.
    • General and administrative expense increased approximately 59% to $14.9 million for the year ended December 31, 2020 compared to $9.4 million for the year ended December 31, 2019. The increase of $5.5 million is primarily due to the increase in personnel and stock compensation expense.
    • Net loss attributable to Heat Biologics, Inc. was $26.0 million, or ($1.63) per basic and diluted share for the year ended December 31, 2020 compared to a net loss attributable to Heat Biologics, Inc. of $20.0 million, or ($4.21) per basic and diluted share for the year ended December 31, 2019.

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

    Forward-Looking Statement

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as the Heat's strong balance sheet allowing it to accelerate its current clinical programs and enhance our development and manufacturing capability to expand its therapeutic portfolio, he addition of HS-110 to a checkpoint inhibitor to improve survival benefit for NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy, and 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. 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 NSCLC patients whose disease progressed following treatment with PD-(L)1 therapy, 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 , the ability of Heat to accelerate its current clinical programs and enhance its development and manufacturing capability to expand its therapeutic portfolio, 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 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.

    3 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.

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

    CONTACT:
    David Waldman
    +1 919 289 4017

    (tables follow)

    HEAT BIOLOGICS, INC.

    Consolidated Balance Sheets

    December 31, December 31,
    2020 2019
    Current Assets
    Cash and cash equivalents
    $ 10,931,890 $ 9,039,887
    Short-term investments
    100,842,438 5,713,922
    Accounts receivable
    177,239 34,986
    Prepaid expenses and other current assets
    1,842,620 420,328
    Total Current Assets
    113,794,187 15,209,123
    Property and Equipment, net
    676,262 559,410
    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
    2,035,882 2,287,500
    Finance lease right-of-use asset
    247,194 187,573
    Deposits
    122,779 394,637
    Total Other Assets
    9,724,193 10,188,048
    Total Assets
    $ 124,194,642 $ 25,956,581
    Liabilities and Stockholders' Equity
    Current Liabilities
    Accounts payable
    $ 1,051,764 $ 1,503,342
    Deferred revenue, current portion
    603,717 3,410,319
    Contingent consideration, current portion
    - 1,124,970
    Contingent consideration, related party - current portion
    - 454,364
    Operating lease liability, current portion
    278,753 216,832
    Finance lease liability, current portion
    108,127 49,104
    Accrued expenses and other liabilities
    1,614,534 1,676,467
    Total Current Liabilities
    3,656,895 8,435,398
    Long Term Liabilities
    Other long-term liabilities
    36,243 -
    Derivative warrant liability
    33,779 -
    Deferred tax liability
    361,911 361,911
    Deferred revenue, net of current portion
    237,500 200,000
    Operating lease liability, net of current portion
    1,301,636 1,519,574
    Financing lease liability, net of current portion
    160,240 142,667
    Contingent consideration, net of current portion
    2,250,844 1,653,197
    Contingent consideration, related party - net of current portion
    661,671 485,984
    Total Liabilities
    8,700,719 12,798,731
    Commitments and Contingencies
    Stockholders' Equity
    Common stock, $.0002 par value; 250,000,000 and 100,000,000 shares authorized, 22,592,500 and 4,826,565 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively
    4,519 965
    Additional paid-in capital
    247,048,349 118,179,635
    Accumulated deficit
    (130,647,485) (104,597,748)
    Accumulated other comprehensive loss
    (166,056) (11,250)
    Total Stockholders' Equity - Heat Biologics, Inc.
    116,239,327 13,571,602
    Non-Controlling Interest
    (745,404) (413,752)
    Total Stockholders' Equity
    115,493,923 13,157,850
    Total Liabilities and Stockholders' Equity
    $ 124,194,642 $ 25,956,581

    HEAT BIOLOGICS INC.

    Consolidated Statements of Operations and Comprehensive Loss

    Year ended
    December 31,
    2020 2019
    Revenue:
    Grant and contract revenue
    $ 2,947,969 $ 3,049,104
    Operating expenses:
    Research and development
    12,938,895 13,013,604
    General and administrative
    14,934,436 9,431,015
    Goodwill impairment loss
    - 737,000
    Change in fair value of contingent consideration
    1,199,000 613,290
    Total operating expenses
    29,072,331 23,794,909
    Loss from operations
    (26,124,362) (20,745,805)
    Change in fair value of warrant liability
    (1,012,167) -
    Investor relations expense
    (66,767) -
    Interest income
    566,718 431,824
    Other income (expense), net
    255,189 (25,557)
    Total non-operating (loss) income
    (257,027) 406,267
    Net loss before income taxes
    (26,381,389) (20,339,538)
    Income tax expense
    - (45,178)
    Net loss
    (26,381,389) (20,384,716)
    Net loss - non-controlling interest
    (331,652) (367,148)
    Net loss attributable to Heat Biologics, Inc.
    $ (26,049,737) $ (20,017,568)
    Net loss per share attributable to Heat Biologics, Inc.-
    Net loss per share attributable to Heat Biologics, Inc.-basic and diluted
    $ (1.63) $ (4.21)
    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
    15,982,568 4,754,542
    Comprehensive loss:
    Net loss
    (26,381,389) (20,384,716)
    Unrealized (loss) gain on foreign currency translation
    (154,806) 8,654
    Total comprehensive loss
    (26,536,195) (20,376,062)
    Comprehensive loss attributable to non-controlling interest
    (331,652) (367,148)
    Comprehensive loss - Heat Biologics, Inc.
    $ (26,204,543) $ (20,008,914)

    SOURCE: Heat Biologics, Inc.



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  2. DURHAM, NC / ACCESSWIRE / March 8, 2021 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced that Jeff Wolf, CEO of Heat Biologics, has been invited to present at Inaugural Emerging Growth Virtual Conference, hosted by M Vest LLC and Maxim Group LLC. The presentation will be available to all registered participants of the conference (link) on March 17th - 19th and will be posted on Heat Biologics' website (link) after March 19th.

    About Heat Biologics, Inc.

    Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies…

    DURHAM, NC / ACCESSWIRE / March 8, 2021 / Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced that Jeff Wolf, CEO of Heat Biologics, has been invited to present at Inaugural Emerging Growth Virtual Conference, hosted by M Vest LLC and Maxim Group LLC. The presentation will be available to all registered participants of the conference (link) on March 17th - 19th and will be posted on Heat Biologics' website (link) after March 19th.

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

    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/633781/Heat-Biologics-to-Participate-at-M-Vest-LLC-and-Maxim-Group-LLC-Inaugural-Emerging-Growth-Virtual-Conference

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  3. 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.



    View source version on accesswire.com:
    https://www.accesswire.com/629550/Heat-Biologics-to-Present-at-2021-BIO-CEO-Investor-Digital-Conference

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  4. 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.



    View source version on accesswire.com:
    https://www.accesswire.com/628561/Heat-Biologics-Announces-Positive-Interim-Survival-Data-from-Ongoing-HS-110-Phase-2-Non-Small-Cell-Lung-Cancer-Trial

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  5. 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.



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    https://www.accesswire.com/626151/Heat-Biologics-Announces-Publication-of-Additional-Preclinical-COVID-19-Vaccine-Results

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