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NEWS -- Heat Biologics Announces Planned Acquisition of Elusys Therapeutics
DURHAM, N.C., Dec. 21, 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, today announced it has executed a definitive merger agreement to acquire Elusys Therapeutics, a commercial-stage biodefense company and the manufacturer of ANTHIM® (obiltoxaximab) Injection, pursuant to which Elusys will merge into a wholly owned subsidiary of Heat. The acquisition is expected to close during the first quarter of 2022 and is subject to customary closing conditions. ANTHIM is approved for use in the U.S. and Canada, and in Europe and the United Kingdom under the brand name Obiltoxaximab SFL.
The strategic acquisition of Elusys is intended to enhance Heat’s immunotherapy portfolio and further position Heat to take a lead role in the biodefense space. The addition of ANTHIM, together with Heat’s previously announced RapidVax® platform designed to target emerging biological threats, would significantly expand the company’s infectious disease product portfolio. To date, Elusys has been awarded over $350 million in research and development contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR), the National Institute of Allergy and Infectious Disease (NIAID), and the Department of Defense (DOD).
Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM to the U.S. Strategic National Stockpile (SNS)—the government’s repository of critical medical supplies for biowarfare preparedness. Following the closing of this acquisition, Elusys will continue to operate as a wholly owned subsidiary of Heat. Under the terms of the merger agreement with Elusys, Heat will acquire all outstanding shares of Elusys. No stock or warrants will be issued in connection with the acquisition, and Elusys has no outstanding debt.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are excited to announce the signing of a definitive merger agreement for this transformative planned acquisition of Elusys. This is an important step in realizing our vision to develop and commercialize new biopharmaceuticals and vaccines for the global biodefense market. Anthrax represents one of the most significant biological warfare threats facing our country and Elusys has established a successful track record in collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. Following this acquisition, we look forward to further strengthening the ongoing collaboration with the U.S. government. Our goal is to expand global sales and leverage our capabilities to supply ANTHIM worldwide.”
“Additionally, we recently unveiled our RapidVax® program, a new cellular vaccine platform targeting known and unknown biological threats. This platform is designed for rapid “plug and play” to deliver new vaccines and to enable the stockpiling of medical countermeasures against emerging infectious agents and biological threats. We plan to leverage our proprietary discovery platform, clinical, regulatory, and manufacturing capabilities to accelerate the development and commercialization of new programs for global biodefense. This transaction will significantly expand our product portfolio and complements our ongoing efforts in the space,” concluded Mr. Wolf.
Elizabeth Posillico, CEO of Elusys, stated, “This transaction begins an exciting new chapter for Elusys, and I am grateful to our team for their important contributions to the successful development and commercialization of ANTHIM. Heat brings significant core expertise and resources to accelerate the production and distribution of ANTHIM. I am very pleased that following the closing of the merger certain key members of the Elusys team will continue to manage and support the ANTHIM program. I believe Heat’s Biothreat Advisory Board, which includes leading global experts on biodefense, will facilitate the expansion of the product’s potential worldwide.”
David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction and a member of Heat’s Biothreat Advisory Board, further noted, “Anthrax is the deadliest bioterrorism threat to ever hit American soil, and that threat continues to this day from foreign state actors and others. It has been used as a weapon around the world with significant potential for mass casualties. Inhalation anthrax is the most serious form and can kill quickly if not treated immediately. ANTHIM is a key medical countermeasure for treatment of inhalation Anthrax and is currently stockpiled at strategic locations throughout the US as part of SNS. I and my fellow Biothreat Advisory Board members look forward to working with Elusys to expand the supply of ANTHIM globally to meet this deadly threat.”
A special committee of Heat’s Board of Directors negotiated and approved the transaction and Cassel Salpeter & Co. provided a fairness opinion in connection with the transaction. Additional details on the transaction are outlined in Company’s Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission and will be available on the Company’s website.
Elusys was advised by RBC Capital Markets, LLC.
About ANTHIM
Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.
ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.
Indications and Usage
ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.
IMPORTANT SAFETY INFORMATION Including BOXED WARNING
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.
To see the complete prescribing information for ANTHIM, click here (https://anthim.com/assets/pdfs/ANTHIM-prescribing-information.pdf).
About Elusys Therapeutics
Elusys, based in Parsippany, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. ANTHIM®(obiltoxaximab) Injection, the company’s monoclonal antibody (mAb) anthrax antitoxin, received market clearance by the U.S. Food and Drug Administration (FDA) in March 2016. In July 2020, Health Canada approved ANTHIM’s New Drug Submission (NDS) for the treatment of inhalation anthrax. ANTHIM has also received marketing approved in the E.U. and the U.K., under the trade name of Obiltoxaximab SFL. For more information, please visit https://www.elusys.com.
About Heat Biologics, Inc.
Heat Biologics is a biopharmaceutical company focused on developing first-in-class therapies and vaccines 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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://www.heatbio.com, and also follow us on Twitter.
Forward Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, and include statements regarding the proposed acquisition of Elusys by Heat, closing the transaction during the first quarter of 2022, further strengthening the ongoing collaboration with the U.S. government following the closing of the merger, expanding global sales and leveraging Heat’s capabilities to supply ANTHIM worldwide, and plans to leverage Heat’s RapidVax® proprietary discovery platform and clinical, regulatory, and manufacturing capabilities to accelerate the development and commercialization of new programs for global biodefense. These forward-looking 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. Important factors that could cause actual results to differ materially from current expectations include, among others, the risk associated with Heat and Elusys’s ability to satisfy the conditions to consummate the proposed merger, the timing of the closing of the proposed merger, the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Merger Agreement between Elusys and Heat, unanticipated difficulties or expenditures relating to the proposed Merger, the response of customers and competitors to the announcement of the proposed Merger, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed Merger, whether the combined business of Heat and Elusys will be successful, Heat’s and Elusys’ ability to maintain license agreements, the continued maintenance and growth of Heat’s and Elusys’ patent estate, Heat’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, the ability to initiate clinical trials and if initiated, the ability to complete them on time and achieve the desired results and benefits continuing enrollment as expected, the ability to obtain regulatory approval 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 the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of Heat’s, developments by competitors that render such products obsolete or non-competitive, and other factors described in Heat’s annual report on Form 10-K for the year ended December 31, 2020, subsequent quarterly reports on Form 10-Qs and any other filings Heat makes with the SEC. Heat can give no assurance that the conditions to the Merger will be satisfied. The information in this presentation is provided only as of the date presented, and Heat undertakes no obligation to update any forward-looking statements contained in this presentation on account of 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
I've been here for many years also, it's disappointing for sure. i think we can still see 10 to 12 dollars this year coming up, just keep buying on dips
I have been invested in this company since 2017. I am surprised that the stock price has dropped this much. I really do believe the stock is very oversold. Looking forward to putting Christmas behind us and to the new year.
maybe we will see .25 again, what junk
this is a joke,good news and still going down. 3s coming.wolf is a joke, this might as well be a penny stock
still dreaming i see
NEWS -- Heat Biologics Unveils RapidVax®, A Novel Cellular Vaccine Platform Targeting Known and Unknown Emerging Biological Threats
Revenues are lower yoy. My cousins three bay auto repair shop has higher yearly revenues than HTBX.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are excited to unveil RapidVax, a potentially disruptive approach that leverages our vast experience developing our gp96 platform in both cancer and infectious disease. Heat has treated over 250 patients using its gp96 platform in multiple oncology clinical trials. Furthermore, our gp96-based cellular vaccines demonstrated prophylactic protection in mice and primate models against a range of infectious threat agents, including malaria, HIV/SIV, Zika and SARS-CoV-2 in multiple DOD and NIH-funded studies. The emergence of COVID-19 variants, such as Omicron, further highlights the urgent need for a novel cellular vaccine platform designed to provide a rapid, safe, and effective response to biological threats. We also look forward to leveraging the relationships, experience,
Heat Biologics Unveils RapidVax®, A Novel Cellular Vaccine Platform Targeting Known and Unknown Emerging Biological Threats
November 30 2021 - 07:30AM
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Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today unveiled its new RapidVax® cellular vaccine platform at the 2021 World Antiviral Congress. RapidVax is designed as a rapid programmable vaccine to target a comprehensive range of emerging biological threats. Heat is showcasing a poster presentation highlighting RapidVax at the World Vaccine & Immunotherapy Congress West Coast and World Antiviral Congress, November 30 to December 2, 2021.
RapidVax is designed to enable an accelerated response to a wide variety of infectious agents by providing a flexible “plug and play” vaccine platform that can be stockpiled in advance, and then rapidly customized, manufactured, and deployed to address imminent and future biological threats. This platform has the potential to shorten the timelines needed to develop and test novel vaccines against emerging infectious agents.
David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction and a member of Heat’s Biothreat Advisory Board, commented, “Neutralizing the threat of biological weapons or emerging infectious diseases has been elusive due to the number of potential agents and the timeline required to develop viable vaccines. The current COVID-19 pandemic has underscored societal risks and vulnerabilities to battle biological threats, whether by an intentional attack, accidental release, or naturally occurring infectious disease. RapidVax aims to provide a proven, safe, vaccine strategy that can be quickly engineered and adapted to address emerging biological threats.”
RapidVax leverages the immune-activating properties of heat shock protein gp96, a danger-signal associated protein. This protein normally chaperones activation peptides to antigen-presenting cells under cellular stress. These peptide-gp96 complexes then stimulate antigen cross-presentation, leading to a broad array of innate and adaptive immune responses to confer cellular and humoral immunity against a wide range of pathogens. RapidVax also co-expresses a potent T-cell costimulatory molecule, OX40L, which contributes to the generation of long-lasting T-cell memory and B-cell neutralizing antibody production via the development of T follicular helper cells upon enhanced stimulation of professional antigen-presenting cells.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are excited to unveil RapidVax, a potentially disruptive approach that leverages our vast experience developing our gp96 platform in both cancer and infectious disease. Heat has treated over 250 patients using its gp96 platform in multiple oncology clinical trials. Furthermore, our gp96-based cellular vaccines demonstrated prophylactic protection in mice and primate models against a range of infectious threat agents, including malaria, HIV/SIV, Zika and SARS-CoV-2 in multiple DOD and NIH-funded studies. The emergence of COVID-19 variants, such as Omicron, further highlights the urgent need for a novel cellular vaccine platform designed to provide a rapid, safe, and effective response to biological threats. We also look forward to leveraging the relationships, experience, and knowledge across our Biothreat Advisory Board as we advance the RapidVax platform.”
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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 regarding, RapidVax enabling an accelerated response to a wide variety of infectious agents and potentially shortening the timelines to develop and test novel vaccines against emerging infectious agents, RapidVax providing a proven, safe, vaccine strategy that can be quickly engineered and adapted to address emerging biological threats, and leveraging the relationships, experience, and knowledge across Heat’s Biothreat Advisory Board as it advances the RapidVax platform. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of RapidVax to enable an accelerated response to a wide variety of infectious agents and potentially shortening the timelines to develop and test novel vaccines against emerging infectious agents, the ability of RapidVax to provide a proven, safe, vaccine strategy that can be engineered and adapted to address emerging biological threats, Heat’s ability to leverage the relationships, experience, and knowledge across Heat’s Biothreat Advisory Board as it advances the RapidVax platform, 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
getting pretty close to that $4.50 mark, pretty shitty
Without any positive news I think the slow bleed is going to continue for a while. Phase 2 finished in February, I thought they were going to go into phase 3 quickly. I don't understand what the delay is.
this has turned out to be a real turd lately
NEWS -- Heat Biologics Appoints Paul Tebbey as Senior Vice President of Product Development and Portfolio Strategy
DURHAM, N.C., Oct. 06, 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, today announced the appointment of Paul Tebbey, Ph.D. as Senior Vice President of Product Development and Portfolio Strategy.
Dr. Tebbey is a pharmaceutical development strategy leader with over 25 years of healthcare and management experience across the biotechnology and pharmaceutical sectors at companies such as Abbvie, Baxter, Centocor/Johnson & Johnson and Wyeth/Pfizer. Dr. Tebbey’s research, development and commercial launch experiences include novel monoclonal antibodies (STELARA® first-in-IL-12/23 class, REMICADE® & HUMIRA® anti-TNF mAbs), complex vaccines (PREVNAR® novel conjugated vaccine, influenza and respiratory syncytial virus), biosimilars as well as targeted oncolytic small molecules (VENCLEXTA®). Dr. Tebbey received a Ph.D. in Microbiology and Immunology from East Carolina University School of Medicine where his research focused on T lymphocyte cell signaling, immunosuppression and transformation and completed his postdoctoral studies at Vanderbilt University focusing on the regulation of gene expression. Dr. Tebbey’s publications include over 40 peer-reviewed articles that span immunology, immune-mediated and infectious diseases, clinical trial design as well as pharmaceutical strategy planning and brand success.
Jeff Wolf, Chief Executive Officer of Heat, commented, “Paul’s background and proven track record will help advance our current and planned clinical programs, as well as our extensive ongoing R&D and emerging biosecurity initiatives.”
Paul Tebbey further noted, “I am excited to join Heat Biologics at this exciting time. Heat has developed a robust clinical platform spanning both oncology and infectious diseases. On the R&D front, I look forward to helping advance numerous, value-driving clinical programs as well as Skunkworx, which is utilizing integrated computational and bioinformatic analysis with the goal of accelerating the speed and reducing the costs associated with drug development.”
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://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 Dr. Tebbey’s background and proven track record helping advance Heat’s current and planned clinical programs, as well as its extensive ongoing R&D and emerging biosecurity initiatives and Dr. Tebbey helping advance numerous, value-driving clinical programs as well as Skunkworx, which is utilizing integrated computational and bioinformatic analysis with the goal of accelerating the speed and reducing the costs associated with drug development. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability to successfully integrate Dr. Tebbey into the management team and derive the anticipated contributions from Dr. Tebbey, 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
mailto://investorrelations@heatbio.com
We’ll see big daddy!
not that i want it to but i think it has more of a chance hitting $4.50 than it does $45.00, if so you should pay me a $1000.00
got my sell order in for $45.00 time will tell
Okay. Get it ready. $100 dollar bills
ill give a $1000.00 if this hits $45.00 within a year, cant hold $6.50
With everything $htbx is doing why does the stock price remain stagnant in the low 6s? Makes no sense.
NEWS -- Heat Biologics CEO to Present at the Cantor Fitzgerald Global Healthcare Conference on September 29th
September 15 2021 - 07:30AM
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 Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting at the Cantor Fitzgerald Global Healthcare Conference being held virtually between September 27-30, 2021.
Presentation Details:
Date: Wednesday, September 29, 2021
Time: 9:20 AM ET / 6:20 AM PT
Webcast: Cantor Global Healthcare Conference (https://wsw.com/webcast/cantor12/register.aspx?conf=cantor12&page=htbx&url=https://wsw.com/webcast/cantor12/htbx/2096220)
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://www.heatbio.com, and also follow us on Twitter.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
NEWS -- Heat Biologics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference
DURHAM, N.C., Sept. 09, 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 Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually between September 13-15, 2021.
Heat Biologics' presentation will be available on-demand to registered attendees via the conference platform beginning Monday, September 13, 2021 at 7:00 AM Eastern Time.
The webcast can be accessed here (https://journey.ct.events/view/1a62ca3e-9da6-4fc1-970c-4211c9f86cbc) and on the investor relations section of Heat Biologics' website at https://ir.heatbio.com/. Management will also be participating in one-on-one meetings with qualified members of the investor community throughout the conference.
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://www.heatbio.com, and also follow us on Twitter.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
how do you come up with that number and do you have a time frame
NEWS -- Heat Biologics to Provide Corporate Update
Heat Biologics, Inc. (“Heat”) (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced CEO Jeff Wolf will host a conference call on Thursday, September 2nd at 11:00 A.M. Eastern Time to provide an update on the Company’s activities.
The conference call may be accessed by dialing 844-602-0380 for U.S. callers or +1 862-298-0970 for international callers. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2768/42602 or on the Company’s website at https://ir.heatbio.com/.
An audio replay of the call will be available through September 16, 2021, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 42602.
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://www.heatbio.com, and also follow us on Twitter.
Media and Investor Relations Contact
David Waldman
+1 919 289 4017
mailto://investorrelations@heatbio.com
NEWS -- Heat Biologics Unveils Skunkworx Bio, New Drug Discovery Subsidiary
Developing a new era of precision medicines using a unique and proprietary drug discovery platform
DURHAM, N.C., Aug. 26, 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, today announced the launch of its wholly-owned subsidiary, Skunkworx Bio, Inc. (“Skunkworx”), focused on the development of a drug discovery paradigm to enable rapid drug development.
Skunkworx’s unique, highly diverse, proprietary libraries of “Pocket Biologics” are used to identify miniature proteins which bind to critical domains of druggable targets. The Skunkworx approach aims to enable rapid drug discovery and validation of new innovative therapeutics utilizing advanced computational methods and bioinformatics to further enhance target precision. Skunkworx has successfully identified agonists and antagonists for a number of targets and is in the process of progressing several of these assets through preclinical studies.
Matt Seavey, Ph.D., Skunkworx’s Executive Director of Scientific Operations, commented, “Our unique process flips the paradigm of drug discovery, as it enables us to rapidly identify novel drug targets to determine if a target is druggable. By utilizing this approach, we have been able to identify lead targets and already have several promising programs underway.”
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are extremely proud to launch Skunkworx, an innovative platform to accelerate the path from discovery to preclinical development. Skunkworx augments Heat’s emerging drug development ecosystem designed to efficiently move new biologic programs from discovery into the clinic. New programs will be discovered through Skunkworx, developed at Heat and manufactured at Scorpion Biological Services, Heat’s wholly owned manufacturing subsidiary. This integrated platform is focused on driving innovation by rapidly accelerating the drug development process. We look forward to working with Skunkworx to advance a wide repertoire of drugs across a wide variety of indications, including biosecurity applications, an area of growing importance.”
About Skunkworx Bio.
Skunkworx Bio is developing a new era of precision medicines where “Biology drives Innovation.” The Company’s “Pocket Biologics” are therapeutics derived from its antibody and small protein libraries. Skunkworx has integrated computational and bioinformatic analysis to its biology-based drug discovery paradigm. The goal is to “accelerate” the time from discovery to moving its drug leads into formal preclinical development. For more information, please visit: https://www.skunkworx.bio.
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://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 Skunkworx’s approach aiming to enable rapid drug development and validation of new precision therapeutics, utilizing advanced computational methods and bioinformatics to further enhance their target precision, Skunkworx, as a potentially revolutionary drug discovery company, the Skunkworx platform accelerating the path from discovery to preclinical, Skunkworx enabling Heat to efficiently move new biologic programs from discovery into the clinic and advancing a wide repertoire of drugs across the spectrum of oncology, inflammation, infectious diseases, and other indications, including biosecurity applications, an area of growing importance.. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Skunkworx to enable rapid drug development and accelerate the path from discovery to preclinical and to enable Heat to efficiently move new biologic programs from discovery into the clinic and advancing a wide repertoire of drugs across the spectrum of oncology, inflammation, infectious diseases, and other indications, including biosecurity applications, an area of growing importance, 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
mailto://investorrelations@heatbio.com
Heat Biologics Unveils Skunkworx Bio, New Drug Discovery Subsidiary
Developing a new era of precision medicines using a unique and proprietary drug discovery platform
DURHAM, N.C., Aug. 26, 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, today announced the launch of its wholly-owned subsidiary, Skunkworx Bio, Inc. (“Skunkworx”), focused on the development of a drug discovery paradigm to enable rapid drug development.
Skunkworx’s unique, highly diverse, proprietary libraries of “Pocket Biologics” are used to identify miniature proteins which bind to critical domains of druggable targets. The Skunkworx approach aims to enable rapid drug discovery and validation of new innovative therapeutics utilizing advanced computational methods and bioinformatics to further enhance target precision. Skunkworx has successfully identified agonists and antagonists for a number of targets and is in the process of progressing several of these assets through preclinical studies.
Matt Seavey, Ph.D., Skunkworx’s Executive Director of Scientific Operations, commented, “Our unique process flips the paradigm of drug discovery, as it enables us to rapidly identify novel drug targets to determine if a target is druggable. By utilizing this approach, we have been able to identify lead targets and already have several promising programs underway.”
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are extremely proud to launch Skunkworx, an innovative platform to accelerate the path from discovery to preclinical development. Skunkworx augments Heat’s emerging drug development ecosystem designed to efficiently move new biologic programs from discovery into the clinic. New programs will be discovered through Skunkworx, developed at Heat and manufactured at Scorpion Biological Services, Heat’s wholly owned manufacturing subsidiary. This integrated platform is focused on driving innovation by rapidly accelerating the drug development process. We look forward to working with Skunkworx to advance a wide repertoire of drugs across a wide variety of indications, including biosecurity applications, an area of growing importance.”
About Skunkworx Bio.
Skunkworx Bio is developing a new era of precision medicines where “Biology drives Innovation.” The Company’s “Pocket Biologics” are therapeutics derived from its antibody and small protein libraries. Skunkworx has integrated computational and bioinformatic analysis to its biology-based drug discovery paradigm. The goal is to “accelerate” the time from discovery to moving its drug leads into formal preclinical development. For more information, please visit: www.skunkworx.bio.
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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 regarding Skunkworx’s approach aiming to enable rapid drug development and validation of new precision therapeutics, utilizing advanced computational methods and bioinformatics to further enhance their target precision, Skunkworx, as a potentially revolutionary drug discovery company, the Skunkworx platform accelerating the path from discovery to preclinical, Skunkworx enabling Heat to efficiently move new biologic programs from discovery into the clinic and advancing a wide repertoire of drugs across the spectrum of oncology, inflammation, infectious diseases, and other indications, including biosecurity applications, an area of growing importance.. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Skunkworx to enable rapid drug development and accelerate the path from discovery to preclinical and to enable Heat to efficiently move new biologic programs from discovery into the clinic and advancing a wide repertoire of drugs across the spectrum of oncology, inflammation, infectious diseases, and other indications, including biosecurity applications, an area of growing importance, 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
NEWS -- Heat Biologics Announces Addition of Former US Senator Mark Pryor to Biothreat Advisory Board
DURHAM, N.C., Aug. 23, 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, announces the addition of Mark Pryor, former US Senator from the State of Arkansas, to the Company’s Biothreat Advisory Board.
Former US Senator Mark Pryor currently serves with the premier law firm, Brownstein Hyatt Farber Schreck. He is a former two-term U.S. senator and Arkansas attorney general. During his 12 years representing Arkansas in the Senate, he worked across the aisle to pass more than 70 pieces of legislation on a range of critical issues, including homeland security and defense. Sen. Pryor served on several high-profile committees during his tenure, including Appropriations; Armed Services; Commerce, Science and Transportation; Homeland Security and Governmental Affairs.
Jeff Wolf, Chief Executive Officer of Heat, commented, “As a leader on the Armed Services as well as the Homeland Security and Governmental Affairs committees, Senator Pryor brings unique expertise in policy and government affairs to our biothreat efforts. We look forward to leveraging Senator Pryor’s knowledge as we advance our new biothreat initiatives.”
Senator Pryor joins David Lasseter, Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction; Former US Representative Jack Kingston, who also serves as the Secretariat of the Alliance for Biosecurity; Andrew C. Weber, Former Assistant Secretary of Defense for Nuclear, Chemical & Biological Defense Programs; and Dr. Gregory Koblentz, Associate Professor at George Mason University and leading expert on chemical and biological weapons.
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 a Phase 2 trial, various infectious disease/biological threat programs in preclinical development and 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: https://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 the contributions to be made by Mark Pryor the advisory board and leveraging Senator Pryor’s knowledge as Heat advances its new biothreat initiatives. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat to successfully develop a new biosecurity/biodefense initiative and benefit from the contributions of the advisory board, 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
mailto://investorrelations@heatbio.com
NEWS -- Heat Biologics Announces New Additions to Biothreat Advisory Board
DURHAM, N.C., Aug. 19, 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, announces the following additions to its newly formed Biothreat Advisory Board: Andrew C. Weber, Former Assistant Secretary of Defense for Nuclear, Chemical & Biological Defense Programs; and Dr. Gregory Koblentz, Associate Professor at George Mason University and leading expert on chemical and biological weapons. These individuals join David Lasseter, Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and Former US Representative Jack Kingston, who also serves as the Secretariat of the Alliance for Biosecurity.
Jeff Wolf, Chief Executive Officer of Heat, commented, “We are delighted to announce the addition of these highly renowned individuals in the fields of biosecurity and biodefense to our biothreat advisory board. As the former Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs, Mr. Weber has deep insight into the potential threats facing our nation and best potential avenues for developing effective solutions. Professor Koblentz is one of the leading global thought leaders in the field of chemical and biological weapons.”
Andy Weber is a Senior Fellow at the Council on Strategic Risks’ Janne E. Nolan Center on Strategic Weapons. He is also a member of the Council on Foreign Relations. Mr. Weber has dedicated his professional life to countering nuclear, chemical, and biological threats and to strengthening global health security. Mr. Weber’s decades of U.S. government service included five-and-a-half years as the Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs. He was a driving force behind reducing biological weapons threats, and destroying Libyan and Syrian chemical weapons stockpiles. In addition, he coordinated U.S. leadership of the international Ebola response for the Department of State.
Dr. Gregory D. Koblentz is an Associate Professor and Director of the Biodefense Graduate Program at George Mason University's Schar School of Policy and Government. He is also an Associate Faculty at the Center for Security Policy Studies at George Mason and a member of the Scientists Working Group on Chemical and Biological Security at the Center for Arms Control and Non-Proliferation in Washington, DC. He has published widely on issues related to the proliferation of nuclear, biological, and chemical weapons and has briefed the UN Security Council on the threat of non-state actors acquiring and using weapons of mass destruction.
“We are very enthusiastic about our efforts in the biodefense space,” added Wolf. “Our Biothreat Advisory Board brings deep insight and relationships that we expect will be instrumental in advancing our new biothreat initiatives. We look forward to providing more details as developments unfold.”
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, various infectious disease/biological threat programs in preclinical development and 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: https://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 the contributions to be made by the advisory board, the Board bringing deep insight and relationships that will be instrumental in advancing our new biothreat initiatives and providing more details as developments unfold. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat to successfully develop a new biosecurity/biodefense initiative and benefit from the contributions of the advisory board, 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
mailto://investorrelations@heatbio.com
NEWS -- Heat Biologics Announces Formation of Biothreat Advisory Board
Heat Biologics Announces Formation of Biothreat Advisory Board
Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, David Lasseter, and Former US Representative Jack Kingston, join newly formed Board
DURHAM, N.C., Aug. 18, 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, announces it has commenced development of a new biosecurity/biodefense initiative. The Company also announces it has formed an advisory board to support this initiative. Joining the new advisory board are David Lasseter, Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and Former US Representative Jack Kingston.
Jeff Wolf, Chief Executive Officer of Heat, commented, “This biosecurity/biodefense initiative was initially conceived as a result of our research following the COVID-19 pandemic. We recognized the need for versatile and timely response solutions to protect the U.S. against known or unknown future biological threats and embarked on the development of a platform to address this issue. I am pleased to welcome both David Lasseter and Representative Jack Kingston to our newly formed board of advisors. As Former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction (WMD), Mr. Lasseter had direct oversight over the country’s biological defense programs. During his tenure in Congress, Rep. Kingston was a leading member of the House Appropriations Committee and the Defense Appropriations Subcommittee, and is currently Secretariat of The Alliance for Biosecurity. I believe their expertise will be invaluable to our initiative and I look forward to providing further details as we roll out this highly differentiated approach.”
David F. Lasseter was the Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction where he was responsible for, among other issues, all strategies and policies concerning preventing the proliferation of WMD and WMD-related materials; the United States Department of Defense (DoD) Cooperative Threat Reduction Program; and Chemical, Biological, Radiological and Nuclear (CBRN) defense. Prior to this, Mr. Lasseter worked for United Technologies Corporation as the lead defense government relations professional. He has served as a Congressional chief of staff, military legislative assistant, and counsel. He is also a Marine Corps intelligence officer in the reserve component. Mr. Lasseter received his undergraduate degree from the University of Georgia and a juris doctor from the University of Alabama.
Former US Representative Jack Kingston is a Principal at Squire Patton Boggs, a premier, full-service global law firm that helps clients address public policy challenges in legislatures and regulatory agencies around the world. He also serves as Secretariat for The Alliance for Biosecurity, which promotes a stronger, more effective partnership between government, the biopharmaceutical industry, and other stakeholders in seeks to advance their shared goal of developing critically needed medical countermeasures. The Alliance also seeks to develop sound public policy proposals that could bolster national efforts to rapidly develop, produce, stockpile, and distribute medical countermeasures. In Congress, Rep. Kingston earned a reputation as an effective legislator with a keen ability to resolve complex matters by reaching across the aisle. Rep. Kingston’s leadership of the largest domestic appropriations subcommittee and his senior position on the defense appropriations subcommittee give him a deep understanding of the policy and financial challenges global clients face. In addition, Rep. Kingston assists with strategic counseling for the firm’s leadership in defense related issues and other specialty areas. Rep. Kingston served Georgia's 1st Congressional District in Southeast Georgia from 1993 to 2015. He also served as vice-chairman of the House Republican Conference, the sixth-ranking post among House Republicans, from 2002 to 2006.
David Lasseter further noted, “Time is of the essence when responding to a pandemic or biological threat. I look forward to working closely with Heat to advance their unique and proprietary biodefense initiative to rapidly address urgent national security needs.”
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, various infectious disease/biological threat programs in preclinical development and 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 regarding the contributions to be made by the advisory board, the expertise of David Lasseter and Jack Kingston being invaluable to Heat’s biosecurity/biodefense initiative and providing further details as we roll out our new biosecurity/biodefense initiative. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability of Heat to successfully develop a new biosecurity/biodefense initiative and benefit from the contributions of the advisory board, 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
NEWS -- Heat Biologics Provides Second Quarter 2021 Business Update
DURHAM, N.C., Aug. 11, 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, today provided financial, clinical and operational updates for the second quarter ended June 30, 2021.
Jeff Wolf, Chief Executive Officer of Heat, commented, “This quarter we achieved several meaningful clinical, research and business milestones. First, we presented favorable survival data of HS-110 in previously treated non-small cell lung cancer (NSCLC) patients at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Based on these results, we believe HS-110, in combination with a checkpoint inhibitor (CPI), holds significant potential to improve survival benefit for patients with non-small cell lung cancer. We are continuing to evaluate possible Phase 3 registration pathways with the FDA and potential partners. At the same time, we are exploring a variety of paths forward related to our infectious disease efforts. We look forward to providing further near-term updates.”
“This quarter we also announced the groundbreaking for our biomanufacturing/bioanalytic facility in San Antonio, TX and the expansion of our current research and development (R&D) facilities at our corporate headquarters in Morrisville, NC. This expansion will support enhanced R&D capabilities including in-house synthesis and production of antibodies and other drugs/reagents, as well as an expanded vivarium for onsite pre-clinical studies. We believe that this expansion will allow us to accelerate R&D timelines and generate cost savings on research and development by bringing more of our development activities in-house.”
“Moreover, we have maintained a strong balance sheet with approximately $122.5 million of cash, cash equivalents and short-term investments which should allow us to augment our clinical programs as well as enhance and expand our therapeutic pipeline.”
Second Quarter 2021 Financial Results
NEWS -- Heat Biologics Announces Groundbreaking for New San Antonio Facility
Groundbreaking ceremony to be streamed live
DURHAM, N.C., Aug. 09, 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, today announced it will be hosting a groundbreaking ceremony for the launch of its new planned San Antonio biomanufacturing/bioanalytic facility. The Company also announced it has received approval for an estimated $1.0 million in tax abatements from the City of San Antonio and Bexar County.
The opening ceremony will be streamed live at 11AM ET /10AM CT today, at: https://www.facebook.com/GreaterSATX/
The Company’s wholly owned subsidiary, Scorpion Biological Services, plans to build a large molecule bioanalytical research and manufacturing facility in San Antonio. Anticipated activities include the development of in-house immuno-assays and biomarkers, a Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) laboratory, and cGMP manufacturing capabilities.
Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, “We appreciate the tremendous support from the San Antonio community as we expand our biomanufacturing and bioanalytic capabilities. We expect this facility to shorten our development and manufacturing timelines and reduce costs for these services which we would have otherwise outsourced to third-party contractors. In addition to supporting our own internal operations, we plan to leverage these capabilities to support other biopharma companies.”
“Our diverse medical and bioscience community has come together to form an ecosystem that’s cooperative and supportive — one that drives innovation to improve lives — and that’s attractive to startups, established corporations, and talent. We are committed to supporting Scorpion as they grow their operations in our community,” said San Antonio Mayor Ron Nirenberg.
About Scorpion Biological Services, Inc.
Scorpion Biological Services, Inc. is working to expand the reach of precision medicine to more people within multiple therapeutic areas that are untreatable or treatment-resistant today. Its team is comprised of renowned experts in bioanalytics, cell biology, virology, translational biology, biomanufacturing, and drug development. Scorpion’s new facility is expected to be able to support a myriad of biologic drugs from conception through clinical trials and beyond, to bring new drugs to market faster and more reliably.
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, various infectious disease programs in preclinical development and 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: https://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 plans of Scorpion Biological Services to build a large molecule bioanalytical research and manufacturing facility in San Antonio, anticipated activities including the development of in-house immuno-assays and biomarkers, a Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) laboratory, and cGMP manufacturing capabilities, the facility shortening Heat’s development and manufacturing and reducing costs for services Heat would have otherwise outsourced to third-party contractors, leveraging the facilities capabilities to support the activities of other biopharma companies and the new facility being able to support a myriad of biologic drugs from conception through to clinical trials and beyond, to bring new drugs to market faster and more reliably. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability to build a facility with capabilities to develop in-house immuno-assays and biomarkers, a Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) laboratory, and cGMP manufacturing capabilities, the ability of the facility to shorten Heat’s development and manufacturing and reduce costs for services Heat would have otherwise outsourced to third-party contractors and the ability to leverage the facilities capabilities to support the activities of other biopharma companies, including a myriad of biologic drugs from conception through to clinical trials and beyond, to bring new drugs to market faster and more reliably, the 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
mailto://investorrelations@heatbio.com
Heat Biologics Announces Groundbreaking for New San Antonio Facility
Groundbreaking ceremony to be streamed live
DURHAM, N.C., Aug. 09, 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, today announced it will be hosting a groundbreaking ceremony for the launch of its new planned San Antonio biomanufacturing/bioanalytic facility. The Company also announced it has received approval for an estimated $1.0 million in tax abatements from the City of San Antonio and Bexar County.
The opening ceremony will be streamed live at 11AM ET /10AM CT today, at: https://www.facebook.com/GreaterSATX/
The Company’s wholly owned subsidiary, Scorpion Biological Services, plans to build a large molecule bioanalytical research and manufacturing facility in San Antonio. Anticipated activities include the development of in-house immuno-assays and biomarkers, a Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) laboratory, and cGMP manufacturing capabilities.
Jeff Wolf, Chief Executive Officer of Heat Biologics, commented, “We appreciate the tremendous support from the San Antonio community as we expand our biomanufacturing and bioanalytic capabilities. We expect this facility to shorten our development and manufacturing timelines and reduce costs for these services which we would have otherwise outsourced to third-party contractors. In addition to supporting our own internal operations, we plan to leverage these capabilities to support other biopharma companies.”
“Our diverse medical and bioscience community has come together to form an ecosystem that’s cooperative and supportive — one that drives innovation to improve lives — and that’s attractive to startups, established corporations, and talent. We are committed to supporting Scorpion as they grow their operations in our community,” said San Antonio Mayor Ron Nirenberg.
About Scorpion Biological Services, Inc.
Scorpion Biological Services, Inc. is working to expand the reach of precision medicine to more people within multiple therapeutic areas that are untreatable or treatment-resistant today. Its team is comprised of renowned experts in bioanalytics, cell biology, virology, translational biology, biomanufacturing, and drug development. Scorpion’s new facility is expected to be able to support a myriad of biologic drugs from conception through clinical trials and beyond, to bring new drugs to market faster and more reliably.
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, various infectious disease programs in preclinical development and 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 regarding plans of Scorpion Biological Services to build a large molecule bioanalytical research and manufacturing facility in San Antonio, anticipated activities including the development of in-house immuno-assays and biomarkers, a Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) laboratory, and cGMP manufacturing capabilities, the facility shortening Heat’s development and manufacturing and reducing costs for services Heat would have otherwise outsourced to third-party contractors, leveraging the facilities capabilities to support the activities of other biopharma companies and the new facility being able to support a myriad of biologic drugs from conception through to clinical trials and beyond, to bring new drugs to market faster and more reliably. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability to build a facility with capabilities to develop in-house immuno-assays and biomarkers, a Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) laboratory, and cGMP manufacturing capabilities, the ability of the facility to shorten Heat’s development and manufacturing and reduce costs for services Heat would have otherwise outsourced to third-party contractors and the ability to leverage the facilities capabilities to support the activities of other biopharma companies, including a myriad of biologic drugs from conception through to clinical trials and beyond, to bring new drugs to market faster and more reliably, the 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
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Source: Heat Biologics
Go to Yahoo Finance for the news====I am having trouble with my computer.
$1.5m + ?
Partnership news ?
Phase 3 results ?
Covid 19 vaccine update ?
$25 - $45 pps???
Let’s gooooo
ANYBODY
Want to guess what is going to happen this week? ====Earning are due out this week======
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