Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
might get there, if it does i will by more and sell at 10.00 again
351stang I am doing the same thing. Waiting for $6.50
as i said, would'nt hold. back in at $7.00
Not the best to follow. They are so huge they are everywhere. Baker brother better
Might be a mistake selling, as their listing on the Russel index might attract institutional investors and the mature pipeline of drugs could keep the investor interest flowing.
GLTA
Ditto 351stang!
just sold most of mine over 10.00, dont think it will hold, buy back later
and some how it still goes down
NEWS -- Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 2021 American Society of Clinical Oncology Annual Meeting
Survival benefit observed in two treatment settings of previously treated non-small lung cancer patients
DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world’s largest oncology conference showcasing the latest advancements in cancer research.
HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year’s ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO® (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:
Heat Biologics to Showcase Favorable Survival Data of HS-110 in Previously Treated Non-Small Cell Lung Cancer Patients at 2021 American Society of Clinical Oncology Annual Meeting
Survival benefit observed in two treatment settings of previously treated non-small lung cancer patients
DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting which is being held from June 4-8, 2021. This poster presentation can be viewed on Heat Biologics' website at: https://www.heatbio.com/product-pipeline/scientific-publications. The ASCO Annual Meeting is the world’s largest oncology conference showcasing the latest advancements in cancer research.
HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year’s ASCO meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO® (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:
Median overall survival (mOS) of 24.6 months was observed in previously treated, CPI naïve patients with advanced NSCLC (Cohort A, n=47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting.
mOS of 11.9 months was reported in NSCLC patients who were previously treated with CPI and whose disease had subsequently progressed (Cohort B, n=68). Published data from other studies stated median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after CPI progression.
Multiple subset analyses including injection-site reaction (ISR) and tumor PD-L1 expression were performed.
Significantly longer mOS was observed in patients with ISR compared with those without such a reaction for both Cohorts A and B.
Extended survival benefit was observed in PD-L1 positive patients in Cohort A.
A trend of improved overall survival was observed in patients with low blood tumor mutation burden in Cohort B.
Dr. Roger B. Cohen, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, commented, “HS-110 is a promising agent for treatment of incurable NSCLC. The latest data presented support further clinical evaluation in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors.”
Jeff Wolf, Chief Executive Officer of Heat, commented, “This data further reinforces the potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC. The growing body of clinical data demonstrates that HS-110 in combination with a CPI is well tolerated and has the potential to enhance survival benefit when given with a CPI. Our latest results, consistent with previously reported data, provide a strong foundation for the Company to discuss possible Phase 3 registration trial designs with the FDA and potential partners.”
About HS-110
HS-110 is a first-in-class, off-the-shelf, allogeneic cell therapy designed to utilize gp96 for immune activation against multiple tumor testis antigens. Phase 2 trial of HS-110 in combination with Bristol Myers Squibb's OPDIVO® (nivolumab) has completed enrollment in patients with incurable or metastatic NSCLC. OPDIVO® is a programmed death-1 immune checkpoint inhibitor. HS-110 has broad potential for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. Positive interim survival data has been demonstrated in two distinct treatment settings in previously treated NSCLC patients who have not been treated with CPI as well as patients who have progressed during or after previous treatment with a CPI. Combination of HS-110 and PD-(L)1 therapies may confer additional survival benefit.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as the HS-110, in combination with a checkpoint inhibitor (CPI), being a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC), HS-110 being a promising agent for treatment of incurable NSCLC, potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC, HS-110 in combination with a CPI having the potential to enhance survival benefit when given with a CPI and HS-110 being administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability of HS-110, in combination with a CPI to be utilized in multiple treatment settings of NSCLC and to improve survival benefit for patients with non-small cell lung cancer (NSCLC), the ability HS-110 to be administered in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors, Heat's vaccine platform to provide protection against COVID-19, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
investorrelations@heatbio.com
Look up the top 10 investors in heat biologics. The top two are the Vanguard Group which owns 1,034,327 shares and BlackRock Fund Advisors which owns 343,724 shares. They obviously must know something.
Heat Biologics wouldn't be building a manufacturing facility in San Antonio, Texas if nothing was happening.
Yes it is. Thank you.
GREAT NEWS! Heat Biologics announces construction of a large manufacturing facility in San Antonio, Texas! Press release in an article that appeared yesterday, May 26th, 2021 in the San Antonio Business Journal.
NEWS -- Heat Biologics Announces Promising Survival Data of HS-110 in Two Treatment Settings of Lung Cancer; Selected for Presentation at 2021 American Society of Clinical Oncology Annual Meeting
DURHAM, N.C., May 20, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that the latest data from HS-110, the Company’s lead product, has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. The ASCO Annual Meeting is the largest international conference to showcase the latest advancements in oncology.
HEAT BIOLOGICS ANNOUNCES PROMISING SURVIVAL DATA OF HS-110 IN TWO TREATMENT SETTINGS OF LUNG CANCER; SELECTED FOR PRESENTATION AT 2021 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING
DURHAM, N.C., May 20, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that the latest data from HS-110, the Company’s lead product, has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. The ASCO Annual Meeting is the largest international conference to showcase the latest advancements in oncology.
Abstract Title: Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings
Session Title: Poster Session: Lung Cancer—Non-Small Cell Metastatic
Abstract Number: 9100
Lead Author and Presenter: Roger B. Cohen, MD, Perelman School of Medicine at the University of Pennsylvania
According to ASCO, more than 5,400 abstracts were reviewed for the 2021 ASCO Annual Meeting. Additional information about the conference may be accessed at https://conferences.asco.org/am/attend .
About HS-110
HS-110 is a first-in-class, off-the-shelf, allogeneic cell therapy designed to utilize gp96 for immune activation against multiple tumor testis antigens. Phase 2 trial of HS-110 in combination with Bristol-Myers Squibb's (BMS) OPDIVO® (nivolumab) has completed enrollment in patients with incurable or metastatic NSCLC. OPDIVO® is a programmed death-1 immune checkpoint inhibitor (PD-1 inhibitor). HS-110 has broad potential for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. Positive interim survival data has been demonstrated in two distinct treatment settings in previously treated NSCLC patients who have not been treated with PD-1 inhibitor or programmed death-ligand 1 inhibitor (PD-L1 inhibitor) as well as patients who have progressed during or after previous treatment with a PD-1 or PD-L1 [PD-(L)1] inhibitor. Combination of HS-110 and PD-(L)1 therapies may confer additional survival benefit.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as the broad potential of HS-110 for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor . These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, Heat's vaccine platform to provide protection against COVID-19, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
investorrelations@heatbio.com
NEWS -- Heat Biologics Announces Multiple Presentations on PTX-35 at the Upcoming 3rd Annual Treg Directed Therapies Summit
GlobeNewswire Inc. -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that PTX-35 will be featured in several presentations and panel discussions at the 3rd Annual Treg Directed Therapies Summit on May 19-20. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells.
Heat Biologics Announces Multiple Presentations on PTX-35 at the Upcoming 3rd Annual Treg Directed Therapies Summit
DURHAM, N.C., May 19, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced that PTX-35 will be featured in several presentations and panel discussions at the 3rd Annual Treg Directed Therapies Summit on May 19-20. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells.
On Wednesday, May 19th at 4PM EDT, Heat Biologics will present: “A Novel TNFRSF25-Agonist for Regulatory T-Cell Expansion.” The presenter, Matthew Seavey, Ph.D., Heat Biologics’ Executive Director of Special Projects, plans to discuss how TNFRSF25-engagement by PTX-35 can expand regulatory T-cells in vivo and reduce disease severity in several animal models of GVHD & inflammatory disease.
On Thursday, May 20th at 3:30PM EDT, Robert B. Levy, Ph.D., Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine, will present: “Improving Outcomes of Allo-HCT: Manipulating the Regulatory Cell Compartment in vivo to Ameliorate GVHD.”
Dr. Seavey will also chair two panels, including: “Exploring Key Questions to Advance Understanding of Treg Behavior,” and “Maximizing Immune Tolerance through Generation of Antigen Specific Tregs.”
The 3rd Annual Treg Directed Therapies Summit is focused on targeting and translating Treg modifying therapies and brings together executives and leading researchers from large pharma, biotech and academia to discuss developments in Treg therapies.
About PTX-35
PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3 or DR3), a receptor that is preferentially expressed by antigen-experienced T-cells. PTX-35 is currently enrolling in a Phase 1 clinical trial for the treatment of patients with solid tumors.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as the planned presentations. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the contributions of, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, Heat's vaccine platform to provide protection against COVID-19, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
investorrelations@heatbio.com
Bought 2500 shares yesterday @$5.95. I am in this for the long haul. Things should be really happening with this stock next summer, 2022. GLTA.
I bought this during a run up last Summer (2020 AND paid 9.25 for 100 shares and this has been an absolute downward spiral .. but Hope is eternal
Don't anyone dare lose faith. This is a $50 stock.
NEWS -- Heat Biologics Appoints Anthony Manning, Ph.D. as Chief Scientific Advisor
GlobeNewswire Inc. -- Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today announced the appointment of Anthony Manning, Ph.D. as Chief Scientific Advisor. Dr. Manning will be responsible for strategic initiatives to accelerate the development of Heat Biologics’ product portfolio.
Dr. Manning brings over three decades of experience in immunology and autoimmune disease research and development. Most recently, Dr. Manning served as Chief Scientific Officer and Head of Research at Momenta Pharmaceuticals, a biotechnology company focused on biologic therapeutics to treat rare immune-mediated diseases. At Momenta, Dr. Manning provided strategic leadership to all research activities, including the discovery and development of three novel autoimmune drug candidates. Momenta was recently acquired by Johnson & Johnson for approximately $6.5 billion. Prior to Momenta, Dr. Manning served as Senior Vice President of Research and Preclinical Development at Aileron Therapeutics, where he oversaw target selection, lead identification and optimization, clinical candidate selection, and IND-enabling studies. Before Aileron, Dr. Manning served as Vice President and Head of Inflammation and Autoimmune Disease Research at Biogen, and previously served as Vice President and Global Therapy Area Head of Inflammation, Autoimmunity & Transplantation Research at Roche. Dr. Manning is a member of the Board Directors of Palatin Technologies, Inc, Chairman of the Institute for Biomedical Entrepreneurship, and an Advisor to the Harvard Medical School Therapeutics Initiative. He is an author and inventor on over 120 publications and patents relating to autoimmune disease and novel drug discovery.
Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, “We are thrilled to welcome Dr. Manning to our team. With his proven track record in the drug discovery, research and development, Dr. Manning will provide strategic leadership and invaluable insight to accelerate the development of our portfolio programs. ”
“I am excited to be joining Jeff and the team at Heat Biologics,” stated Dr. Manning. “My entire professional career has been aimed at targeting the immune system and Heat’s first-in-class pipeline holds immense promise for improving current standard of care. I look forward to working with the team to expand and advance the innovative pipeline programs.”
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as Dr. Manning offering invaluable insight as Heat advances its product pipeline.. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the contributions of Dr. Manning to Heat, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, Heat's vaccine platform to provide protection against COVID-19, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's most recent annual report on Form 10-K filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
Almost there folks, keep the faith.
It's still sub $7, keep buying, it's like taking candy from a baby.
NEWS -- Heat Biologics Provides First Quarter 2021 Business Update; Reports Continued Progress on Oncology and COVID-19 Vaccine Programs
DURHAM, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today provided financial, clinical and operational updates for the first quarter ended March 31, 2021.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We continue to make tremendous progress on our clinical programs, including both our oncology program and COVID-19 vaccine program, which we recently advanced into scale-up manufacturing. We are currently reviewing a variety of possible Phase 3 registration settings for HS-110 in combination with checkpoint inhibitors, following positive interim data from our Phase 2 trial in patients with advanced non-small cell lung cancer (NSCLC).”
“We recently announced promising new preclinical data around PTX-35, our potential first-in-class T-cell co-stimulatory antibody at the AACR Annual Meeting 2021. We are completing enrollment in our Phase 1 PTX-35 trial in patients with solid tumors and expect to share interim data later this year.”
“Finally, we have maintained a solid balance sheet with over $128 million of cash and short-term investments, which should provide us substantial runway to fund our current clinical programs and further expand our therapeutic portfolio. Moreover, we believe that upcoming catalysts and milestones have the potential to drive significant shareholder value in 2021,” concluded Mr. Wolf.
First Quarter 2021 Financial Results
Heat Biologics Provides First Quarter 2021 Business Update; Reports Continued Progress on Oncology and COVID-19 Vaccine Programs
DURHAM, N.C., May 05, 2021 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, today provided financial, clinical and operational updates for the first quarter ended March 31, 2021.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We continue to make tremendous progress on our clinical programs, including both our oncology program and COVID-19 vaccine program, which we recently advanced into scale-up manufacturing. We are currently reviewing a variety of possible Phase 3 registration settings for HS-110 in combination with checkpoint inhibitors, following positive interim data from our Phase 2 trial in patients with advanced non-small cell lung cancer (NSCLC).”
“We recently announced promising new preclinical data around PTX-35, our potential first-in-class T-cell co-stimulatory antibody at the AACR Annual Meeting 2021. We are completing enrollment in our Phase 1 PTX-35 trial in patients with solid tumors and expect to share interim data later this year.”
“Finally, we have maintained a solid balance sheet with over $128 million of cash and short-term investments, which should provide us substantial runway to fund our current clinical programs and further expand our therapeutic portfolio. Moreover, we believe that upcoming catalysts and milestones have the potential to drive significant shareholder value in 2021,” concluded Mr. Wolf.
First Quarter 2021 Financial Results
Recognized $0.5 million of grant revenue for qualified expenditures under the CPRIT and NIH grant compared to $0.9 million of grant revenue for the same period last year. The decrease in grant revenue in the current-year period primarily reflects the expected timing of completion of deliveries under the current phase of the contracts. As of March 31, 2021, we had deferred revenue of $0.09 million for CPRIT proceeds received but for which the costs had not been incurred or the conditions of the award had not been met.
Research and development expenses was $3.4 million and $2.8 million for the three months ended March 31, 2021 and 2020, respectively.
General and administrative expense was $4.8 million and $3.3 million for the three months ended March 31, 2021 and 2020. The increase was primarily due to stock compensation expense.
Net loss attributable to Heat Biologics was approximately $7.5 million, or ($0.31) per basic and diluted share for the quarter ended March 31, 2021 compared to a net loss of approximately of $6.3 million, or ($0.77) per basic and diluted share for the quarter ended March 31, 2020.
As of March 31, 2021, the Company had approximately $132 million in cash, cash equivalents and short investments.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat’s gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
For more information, please visit: www.heatbio.com, and also follow us on Twitter.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such as sharing interim data later this year from the Phase 1 PTX-35 trial in patients with solid tumors, cash and short-term investments providing Heat a substantial runway to fund Heat’s current clinical programs and further expand Heat’s therapeutic portfolio, and upcoming catalysts and milestones having the potential to drive significant shareholder value in 2021. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the timing of providing interim data from the Phase 1 PTX-35 trial in patients with solid tumors, ability of Heat's vaccine platform to provide prevention and treatment of cancer and infectious diseases, such as COVID-19, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, especially in light of COVID-19, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities and its cash and short-term investments providing significant runway to fund Heat’s current clinical programs and further expand Heat’s therapeutic portfolio, its ability to continue to maintain its listing on the Nasdaq Capital Market and its ability to retain its key scientists or management personnel, and the other factors described in Heat's annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC, and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release, and Heat undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
investorrelations@heatbio.com
(tables follow)
HEAT BIOLOGICS, INC.
Consolidated Balance Sheets
March 31, December 31,
2021 2020
(unaudited)
Current Assets
Cash and cash equivalents $ 31,156,747 $ 10,931,890
Short-term investments 100,899,984 100,842,438
Accounts receivable 103,232 177,239
Prepaid expenses and other current assets 1,718,364 1,842,620
Total Current Assets 133,878,327 113,794,187
Property and Equipment, net 967,582 676,262
Other Assets
In-process R&D 5,866,000 5,866,000
Goodwill 1,452,338 1,452,338
Operating lease right-of-use asset 1,947,192 2,035,882
Finance lease right-of-use asset 217,469 247,194
Deposits 141,201 122,779
Total Other Assets 9,624,200 9,724,193
Total Assets $ 144,470,109 $ 124,194,642
Liabilities and Stockholders' Equity
Current Liabilities
Accounts payable $ 792,545 $ 1,051,764
Deferred revenue, current portion 93,529 603,717
Operating lease liability, current portion 285,927 278,753
Finance lease liability, current portion 109,757 108,127
Accrued expenses and other liabilities 1,764,385 1,614,534
Total Current Liabilities 3,046,143 3,656,895
Long Term Liabilities
Other long-term liabilities 43,754 36,243
Derivative warrant liability 42,481 33,779
Deferred tax liability 361,911 361,911
Deferred revenue, net of current portion 237,500 237,500
Operating lease liability, net of current portion 1,227,634 1,301,636
Financing lease liability, net of current portion 132,181 160,240
Contingent consideration, net of current portion 2,255,480 2,250,844
Contingent consideration, related party - net of current portion 663,035 661,671
Total Liabilities 8,010,119 8,700,719
Stockholders' Equity
Common stock, $.0002 par value; 250,000,000 and 250,000,000 shares authorized, 25,137,410 and 22,592,500 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively 5,027 4,519
Additional paid-in capital 275,618,780 247,048,349
Accumulated deficit (138,179,663 ) (130,647,485 )
Accumulated other comprehensive loss (147,788 ) (166,056 )
Total Stockholders' Equity - Heat Biologics, Inc. 137,296,356 116,239,327
Non-Controlling Interest (836,366 ) (745,404 )
Total Stockholders' Equity 136,459,990 115,493,923
Total Liabilities and Stockholders' Equity $ 144,470,109 $ 124,194,642
HEAT BIOLOGICS INC.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
Three Months Ended
March 31,
2021 2020
Revenue:
Grant and contract revenue $ 538,645 $ 901,880
Operating expenses:
Research and development 3,406,248 2,782,506
General and administrative 4,767,645 3,270,548
Change in fair value of contingent consideration 6,000 (27,000 )
Total operating expenses 8,179,893 6,026,054
Loss from operations (7,641,248 ) (5,124,174 )
Change in fair value of warrant liability (8,702 ) (977,710 )
Investor relations expense — (66,767 )
Interest income 195,165 52,710
Other expense, net (168,355 ) (257,479 )
Total non-operating income (loss) 18,108 (1,249,246 )
Net loss before income taxes (7,623,140 ) (6,373,420 )
Income tax expense — —
Net loss (7,623,140 ) (6,373,420 )
Net loss - non-controlling interest (90,962 ) (81,314 )
Net loss attributable to Heat Biologics, Inc. $ (7,532,178 ) $ (6,292,106 )
Net loss per share, basic and diluted $ (0.31 ) $ (0.77 )
Weighted-average common shares outstanding, basic and diluted 24,199,916 8,183,154
Comprehensive loss:
Net loss $ (7,623,140 ) $ (6,373,420 )
Unrealized gain on foreign currency translation 18,268 218,804
Total comprehensive loss (7,604,872 ) (6,154,616 )
Comprehensive loss attributable to non-controlling interest (90,962 ) (81,314 )
Comprehensive loss - Heat Biologics, Inc. $ (7,513,910 ) $ (6,073,302 )
Primary Logo
Source: Heat Biologics
True you have a good point, but seize the opportunity, if you can buy sub $7 and sell + $7 why not take it. The money you make can be used for donating to caner research. Keep your core position for when the stock is $50 per share, as I have been saying and believing for a while now.
Getting close to $7, currently $6.80. Buying sub $7 is like going to an
ATM machine and making a withdrawal from an anonymous shareholders account. It's a beautiful thing. Thank you!
At $6.70 what's not to like?
Buy time again. Will get back over $7 at which point you can decide if you want to sell what you bought today.
GLTA
Back in the 7s, anything under 7 is a guaranteed profitable trade.
It baffles me the lack of interest on this board. Heat is probably one of the most undervalued stocks on the market. The potential valuation of this company is out of this world.
Everyone should be excited about this company NOW not when it is $50.
Business Development Manager
About Heat Biologics
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.
Job Description
This position is an integral member of the business development (BD) team. We are seeking a highly motivated individual with a background in biology/ immunology. The ideal candidate may be a recent graduate in a PhD program in biology / immunology who has an interest in a business career versus a research career. Prior work experience in tech transfer, biopharmaceutical industry or consulting is preferred. This individual will contribute to Heat Biologics’ corporate BD goals and objectives, support the BD and commercial strategy and alliance management functions. This position reports to the Chief of Staff and Director of Business Development and will interact directly with the company’s management team.
This position is office-based in Heat Biologics’ headquarter office in Research Triangle Park Area of North Carolina. During COVID-19, the option of working remotely is available and transition to fully office-based arrangement will be determined per company health and safety guidelines.
Responsibilities
Support all aspects of corporate development and business development activities
Contribute to corporate strategy, partnership strategy and product development strategy in collaboration with the senior management team
Support and coordinate meetings for Chief of Staff including internal and external communications
Manage BD tracking database
Monitor market intelligence and competitive landscape on therapeutics areas and targets relevant to current and future Heat Biologics pipeline portfolio
Develop and update all external presentations (including corporate, partnership, scientific and clinical presentation materials) in collaboration with the rest of the BD team
Liaise with all departments to support corporate planning and partnering activities
Qualifications
MD or PhD in one of the relevant Biological Sciences
Prior work experience in biopharmaceutical industry or major management consulting firms preferred
High energy individual with positive attitude and strong communication, facilitation and interpersonal skills
Good understanding of drug discovery and development processes preferred
Ability to interface and collaborate with internal and external cross-functional teams
Strategic thinker with good quantitative analytical abilities and ability to understand and translate complex scientific concepts into core business objectives
Working knowledge of business valuations or biostatistics a strong plus
Ability to work independently and collaboratively in a fast-paced entrepreneurial environment
Strong attention to detail
Must be able to multi-task and prioritize to management multiple projects simultaneously
Proficient in PowerPoint, Excel and Word
Travel (up to 20%) may be required
POSTED ON THEIR WEBSITE
This is a $50 stock. I said it before and will say it again. This is a $50 stock. Over $100 million in cash, 22 million shares, advanced biotech pipelines.
Load up before it gets over $7 per share.
Don't be asleep at the wheel buy this before it gets back over $7
time to get this stock back over 7 and beyond
Put my money where my mouth is and increased my position by getting some late 2021 options.
I'm getting sick and tired of the opportunity day after day after day of buying stock below $7 a share. I can't wait for everything to come to fruition. For both the sake of the stock price and to help people to better fight cancer. When that day comes it will be incredibly positive!
The sub 7s are going, going..........
Anything under $7 is a steal, guaranteed profitable trade. We have all witnessed this a few times now. Buy below 7 sell above 7 for a quick trade. Now, this time, I think you might want to hold for the big run....they are close to starting a phase III trial, plus they have a boat load of other things.
Good luck, even though you don't need it below $7.
Is the company CEO dumping stock and diluting? Price of stock is dropping on the news.
NEWS -- Heat Biologics Announces New Preclinical Data on PTX-35, Demonstrating Decreased Regulatory T-cell (Treg) Activity and Delayed Tumor Progression at American Association for Cancer Research (AACR) Annual Meeting 2021
DURHAM, NC / ACCESSWIRE / April 12, 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 reported that promising new preclinical data of PTX-35 is presented at the AACR Annual Meeting 2021.
PTX-35 is the company's first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T-cells. In a B16F10 melanoma mouse model, PTX-35 in the presence of tumor antigen supplied by Heat's HS-110 immunotherapy, resulted in decreased regulatory T-cell suppression and enhanced T effector responses. These changes were associated with delayed tumor progression.
Jeff Wolf, Chief Executive Officer of Heat, commented, "PTX-35 is designed to harness the body's natural antigen-specific immune activation. We believe our latest data suggest that PTX-35 can help overcome certain mechanisms of cancer immune evasion. We continue to advance our first-in-human Phase 1 study of PTX-35 in patients with solid tumors and look forward to sharing interim data later this year."
Details of the poster presentation are as follows:
Title: PTX-35, a Potential First-in-class Agonist, Reduced the Suppressive Activity of Regulatory T cells and Enhanced CD4+ T cell Effector Responses in the Presence of Tumor Antigens in a Murine Melanoma Model
Abstract Number: 604
Session: Modifiers of the Tumor Microenvironment
Presenter: Eric Dixon, Director of Discovery Sciences, Heat Biologics
About the AACR Annual Meeting
The 2021 AACR Annual Meeting program covers the latest discoveries across the spectrum of cancer research-from population science and prevention to cancer biology, translational, and clinical studies, as well as survivorship and advocacy-and highlights the work of the best minds in research and medicine from institutions all over the world.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system. Heat's gp96 platform is designed to activate immune responses against cancer or infectious diseases. The Company has multiple product candidates in development leveraging the gp96 platform, including HS-110, which has completed enrollment in its Phase 2 trial, and a COVID-19 vaccine program in preclinical development. In addition, Heat Biologics is also developing a pipeline of proprietary immunomodulatory antibodies and cell-based therapies, including PTX-35 and HS-130 in Phase 1 clinical trials.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectation, and assumptions and include statements such asthe latest data suggesting that PTX-35 can help overcome certain mechanisms of cancer immune evasion and sharing interim data later this year. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of PTX-35 to help overcome certain mechanisms of cancer immune evasion, the ability to provide interim data when planned, 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
mailto://investorrelations@heatbio.com
SOURCE: Heat Biologics, Inc.
View source version on accesswire.com:
https://www.accesswire.com/639842/Heat-Biologics-Announces-New-Preclinical-Data-on-PTX-35-Demonstrating-Decreased-Regulatory-T-cell-Treg-Activity-and-Delayed-Tumor-Progression-at-American-Association-for-Cancer-Research-AACR-Annual-Meeting-2021
I just read that a short squeeze can send heat bio up 1000%. can someone explain what that means. short squeeze
Yes, hopefully it is obvious by now that anything under $7 is a buy
Cantor Fitzgerald analyst Kristen Kluska initiated coverage of Heat Biologics with an Overweight rating and $22 price target. Recent positive data in the company's lead program, HS-110, highlight the strength of the company's proprietary immunotherapy platforms, said Kluska, who believes that "investors have yet to fully appreciate the potential utility of both this dataset and the versatility that Heat's platforms." Given where the stock is currently trading, she sees "significant upside" for HS-110 in NSCLC alone, but she also sees potential for expanded applications across solid tumors and COVID-19 for the company's other assets, the analyst added.
From Tradelike1 on stocktwits.
Note: $50 is still the price target regardless what Kristen Kluska says :)
Followers
|
155
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
6042
|
Created
|
01/26/15
|
Type
|
Free
|
Moderators |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |