NightHawk Biosciences Inc (NHWK)

[Paulness]

NEWS -- Heat Biologics (“NightHawk Biosciences”) Completes Acquisition of Elusys Therapeutics

• Elusys becomes wholly-owned biodefense subsidiary of NightHawk
• Plans to expand ANTHIM® distribution abroad

DURHAM, N.C., April 20, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (NYSE American: HTBX) (to be renamed “NightHawk Biosciences”), a fully-integrated biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today announced it has completed the acquisition of Elusys Therapeutics, Inc. a commercial-stage biodefense company and developer of ANTHIM® (obiltoxaximab), a treatment for inhalation anthrax. ANTHIM® is approved for use in the U.S. and Canada, and under the brand name Obiltoxaximab SFL in Europe and the United Kingdom.

Nighthawk acquired all outstanding shares of Elusys, which will continue to operate as a wholly-owned subsidiary of NightHawk. No stock or warrants were issued in connection with the acquisition, and Elusys had no outstanding term debt.

The strategic acquisition of Elusys significantly expands the Company’s role in the biodefense space, complementing NightHawk’s RapidVax® platform, which is designed to target emerging biological threats. Pursuant to this acquisition, NightHawk also announced it plans to migrate manufacturing of ANTHIM® to its planned 500,000 square foot Scorpion biomanufacturing facility in Manhattan, Kansas, which is being constructed to support development of commercial-scale biologics and large molecules.

To date, Elusys has been awarded over $350 million in research and development grants, contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) and the U. S. Strategic National Stockpile (SNS). Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM® to the SNS - the government’s repository of critical medical supplies for biodefense preparedness.

Jeff Wolf, CEO of NightHawk, commented, “We are excited to announce the closing of this transformative acquisition, which provides us with a solid foothold in the biodefense space. Elusys has an established a successful track record collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. We plan to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax®, our “plug and play” platform designed for rapid development and delivery of new vaccines. In addition, we look forward to leveraging our new Kansas facility, which will enable us to manufacture these therapies internally and therefore benefit from significant operating synergies, as well as enhanced oversight, quality control, and speed to market. We are also exploring opportunities to expand ANTHIM® distribution abroad. This transaction is perfectly aligned with our overall vision to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently.”

David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction, and a member of NightHawk’s Biothreat Advisory Board, commented, “This transaction is extremely timely, given the global uncertainty and unprecedented threats from foreign nations and rogue actors. Anthrax is one of the most significant biological warfare threats facing our country, with real potential for mass casualties. ANTHIM® represents a key medical countermeasure for the treatment of inhalation Anthrax.”

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. Blank Rome LLP acted as legal counsel to Heat. Elusys was advised by RBC Capital Markets, LLC. Additional details on the transaction are outlined in Company’s Form 8-K, which will be filed with the Securities and Exchange Commission and will be available on the Company’s website.

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.

About Heat Biologics, Inc. / NightHawk Biosciences, Inc.

Heat Biologics (to become “NightHawk Biosciences”) is a fully-integrated biopharmaceutical company focused on the development of new drugs from discovery through biomanufacturing. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.

For more information on the Company and is subsidiaries, please visit: https://www.nighthawkbio.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 plans to migrate manufacturing of ANTHIM® to the planned 500,000 square foot biomanufacturing facility in Manhattan, Kansas, plans to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax, leveraging the new Kansas facility to enable Heat to manufacture therapies internally, expected benefit to be derived from significant operating synergies, as well as enhanced oversight, quality control, and speed to market, exploring opportunities to expand ANTHIM® distribution abroad and establishing a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability to migrate manufacturing of ANTHIM® to the Manhattan, Kansas facility, the ability to expand ANTHIM® sales beyond the U.S., the ability to leverage Elusys’ existing relationships and distribution channels as a launching pad for RapidVax , the ability to expand ANTHIM® distribution abroad, the ability to derive benefit from operating synergies, as well as enhanced oversight, quality control, and speed to market, the ability to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently, 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, 2021, 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
[phone]
mailto://[e-mail]

[bige777]

A company doesn't form a partnership to build a 500,000 square foot giant building with a university, have a production facility under works in Texas, and top-notch research doctors working on first-in-class products if it is a joke. I've been waiting for 4 years for this company to develop real traction. The old saying Rome wasn't built in a day applies IMHO.

[351stang]

never does, this company is junk. name change, what the hell is that going to do, i could change my name to, does'nt change who i am

[Spike5]

Haha what a joke it didn’t even last a day

[Paulness]

NEWS -- Heat Biologics Announces Planned Name Change to NightHawk Biosciences, Reflecting Company’s Evolution, Therapeutic Pipeline Expansion, Vertical Integration and New Biodefense Capabilities

Key Corporate Updates Announced Via Livestream Event from Manhattan, Kansas, available for replay at https://Nighthawkbio.com

DURHAM, N.C., April 19, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, today announced that it is changing the name of the Company to NightHawk Biosciences, Inc., effective May 3, 2022, to better reflect the Company’s evolution, including expansion of its therapeutic pipeline, the vertical integration of capabilities from drug discovery to manufacturing and commercialization, as well as the Company’s new biodefense capabilities. In connection with the name change, the Company’s ticker will change to “NHWK,” effective May 3, 2022. The livestream event, held at the Purple Masque Theatre at Kansas State University in Manhattan, Kansas and other locations, is available on the Company’s new website at: https://NightHawkBio.com.

NightHawk will focus on rapid and efficient drug development through its integrated ecosystem of subsidiary companies, which includes Skunkworx Bio (Skunkworx), Heat Biologics (Heat), Pelican Therapeutics (Pelican), Scorpion Biological Services (Scorpion) and Elusys Therapeutics (Elusys). The Company believes this fully-integrated ecosystem enables a more rapid delivery of medical innovations with increased quality and efficiency.

During the event, the Company announced several key corporate developments, including:

• Discovery subsidiary Skunkworx continues to make progress across a variety of infectious disease, biodefense and oncology-related indications, with an intended public announcement of these programs set to occur later this year.
• Scorpion is expected to host the grand opening of its San Antonio facility following completion of construction in Q3, 2022.
• PTX-35 is nearing final enrollment in its last cohort of its Phase 1 solid tumor trial, and just recently announced a presentation of new data at the American Association of Cancer Research (AACR).
• A planned research collaboration with Kansas State University’s Biosecurity Research Institute on its RapidVax biodefense program.
• Expanded efforts by biodefense Elusys Therapeutics to support international sales of ANTHIM® (obiltoxaximab). 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. Additional details are available at https://anthim.com/
• Richard Myers, who previously served as the Chairman of the Joint Chiefs of Staff before serving as President of Kansas State University, will become Chairman of NightHawk’s BioThreat Advisory Board.

Jeff Wolf, Chief Executive Officer of NightHawk, commented, “Over the past 18 months, we’ve built a powerful drug discovery engine in our SkunkWorx subsidiary. We’ve been building our Scorpion subsidiary to deliver world-class biomanufacturing. And we announced the acquisition of Elusys Therapeutics, a biodefense company, which we intend to grow into a biodefense powerhouse.”

Mr. Wolf added, “The pandemic highlighted the fact that the development of new drugs is tremendously slow, encumbered, and expensive. These are enormous barriers to American progress. We believe the solution is full integration of discovery, preclinical testing and manufacturing, optimized to quickly and efficiently deliver drugs to the people who need them.”

Mr. Wolf continued, “The NightHawk model represents a new way of thinking and is designed to combine speed and agility with the full-integration of discovery, development and manufacturing. We are excited to continue to build and enhance this ecosystem under the NightHawk banner.”

About Heat Biologics / NightHawk Biosciences, Inc.

Heat Biologics (to become “NightHawk Biosciences”) is a fully-integrated biopharmaceutical company focused on the development of new drugs from discovery through manufacturing. The Company leverages its integrated ecosystem of subsidiaries to accelerate the creation of novel therapies that arm the immune system, breaking through barriers that prolong traditional drug development. This empowers us to bring our ideas to life with efficient control, superior quality, and uncharacteristic agility.

For more information on the Company and is subsidiaries, please visit: https://www.nighthawkbio.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 planned name change, the fully-integrated ecosystem enabling a more rapid delivery of medical innovations with increased quality and efficiency, Skunkworx’s continued progress across a variety of infectious disease, biodefense and oncology-related indications, with an intended public announcement of these programs set to occur later this year, the grand opening of Scorpion’s San Antonio facility following completion of construction in Q3, 2022, a planned research collaboration with Kansas State University’s Biosecurity Research Institute on its RapidVax biodefense program, Richard Myers becoming Chairman of NightHawk’s BioThreat Advisory Board, growing Elysus into a biodefense powerhouse, the solution to barriers to development of new drugs being a full integration of discovery, preclinical testing and manufacturing, optimized to quickly and efficiently deliver drugs to the people who need them. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to enable a more rapid delivery of medical innovations with increased quality and efficiency, the ability to integrate discovery, preclinical testing and manufacturing, and optimize such integration to quickly and efficiently deliver drugs to the people who need them, the contributions to be derived from Richard Myers and NightHawk’s BioThreat Advisory Board, the ability to complete construction of, and open, Scorpion’s San Antonio facility in Q3, 2022, Skunkworx’s ability to continue progress across a variety of infectious disease, biodefense and oncology-related indications, the contributions to be derived from the collaboration with the Kansas State University’s Biosecurity Research Institute , Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities 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 most recent annual report on Form 10-K for the year ended December 31, 2021 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
[phone]
mailto://[e-mail]

[Paulness]

NEWS -- Heat Biologics’ Scorpion Subsidiary Announces Planned Development of New Kansas Commercial/Biodefense Biomanufacturing Facility

• 500,000+ square foot facility to support commercial-scale biomanufacturing
• Livestreaming ceremony with Governor Laura Kelly Live from Manhattan, Kansas today at 11:00am ET/ 10:00am CT today at https://www.kansascommerce.gov/projectannouncement-4-18-22/

DURHAM, N.C., April 18, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (Heat) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, today announced a planned development partnership of its Scorpion Biological Services subsidiary with a private developer, the State of Kansas and local and university affiliates, to support the development of a new biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas. Manhattan is the home of Kansas State University (K-State), its Biosecurity Research Institute (BRI), and the National Bio and Agro-Defense Facility (NBAF).

The Company intends to utilize the new 500,000+ square foot facility for large molecule and biologics manufacturing, with a particular focus on biodefense. In addition to servicing the Company’s own product pipeline, it plans to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to provide third-party manufacturing services on a fee-for-service basis. Once fully operational, the new facility is expected to employ more than 500 individuals.

The facility is expected to have a billion-dollar economic impact within the State of Kansas. According to Emergen Research, the current demand for biologics is rapidly growing, with an expected market size reaching $567 billion by 2028.

The design and engineering of the facility is being led by CRB Group, a nationally recognized firm focused on designing and building biomanufacturing facilities, with Realty Trust Group (RTG), a leading healthcare/ life sciences real estate advisory and development firm, serving as the lead developer on the project.

Later today, the Company will host a ceremony with Kansas Governor Laura Kelly and Lt. Governor David Toland. Also attending the event will be US Senator Jerry Moran, former K-State President General Richard Myers and current K-State President Richard Linton, among others. The event will be held in Manhattan, Kansas, at 11:00 AM Eastern Time / 10:00 AM Central Time on April 18, 2022, and will be live streamed here: https://www.kansascommerce.gov/projectannouncement-4-18-22/

“We are thrilled and excited that Scorpion has chosen Kansas for this game-changing facility that will have a massive positive impact in our state,” said Governor Laura Kelly. “Being in the center of the country, with quick access to either coast, there is no better state for Scorpion to locate in order to address potential threats to public health.”

David Halverson, President of Heat’s Scorpion subsidiary, noted, “We are very excited to break ground on this new facility. There is a strong demand for world-class biomanufacturing, which we expect to continue well into the future. We intend to help fill that demand with our San Antonio, Texas and Manhattan, Kansas facilities. The 500,000 square foot Manhattan facility is being designed to service up to 144,000 liters across 48 bioreactors–powered by an excellent Kansas workforce. We're looking forward to rapidly growing and expanding Scorpion, and Manhattan is the perfect location for our newest facility.”

Jeff Wolf, Chief Executive Officer of Heat, commented, “Today, we are very proud to unveil our plans for our newest biomanufacturing facility in Manhattan, Kansas. With a model that starts with discovery at our Skunkworx subsidiary in North Brunswick, New Jersey and ends with commercial scale manufacturing here in Manhattan, this facility represents the next stage in our evolution, designed to enable us to combine speed and agility with the full-integration of discovery, development and manufacturing.”

Mr. Wolf added, “The COVID pandemic and recent geopolitical events highlight the urgent need for rapid response to potential biological threats, natural or man-made. Among other intended uses, we believe this facility should enable us to effectively scale production of ANTHIM®, an anthrax antitoxin, for use against a potential anthrax attack per our Elusys acquisition, as well as RapidVax®, a rapid plug-and-play programmable vaccine designed to target a comprehensive range of emerging biological threats.”

Mr. Wolf continued, “Today’s announcement is a major milestone, enhancing our domestic production of vital biologics to protect Americans from deadly disease. We appreciate the tremendous bipartisan support for this initiative, and we are extremely grateful to the State of Kansas and their officials for their hard work in bringing this project to fruition.”

About Scorpion Biological Services

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 experts in bioanalytics, cell biology, virology, translational biology, biomanufacturing, and drug development. Scorpion’s services are designed to support a myriad of biologic drugs from conception through clinical trials and commercial production, 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 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 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 planned development of a new Kansas, commercial/biodefense biomanufacturing facility, Scorpion’s intended use of the facility for large molecule and biologics manufacturing, with a particular focus on biodefense, plans to operate as a full-service Contract Development and Manufacturing Organization (CDMO) to provide third-party manufacturing services on a fee-for-service basis, the facility employing more than 500 individuals once fully operational, the facility having a billion-dollar economic impact within the State of Kansas, the current demand for biologics rapidly growing with an expected market size reaching $567 billion by 2028, the Kansas facility servicing up to 144,000 liters across 48 bioreactors, y, the facility enabling Heat to combine speed and agility with the full-integration of discovery, development and manufacturing, the facility enabling Heat to effectively scale production of ANTHIM® and RapidVax®, the strong demand for world-class biomanufacturing continuing well into the future, Heat helping to fill the demand for world-class biomanufacturing with its San Antonio, Texas and Manhattan, Kansas facilities, rapidly growing and expanding Scorpion. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to develop a new 500,000+ square foot biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas in partnership with the State of Kansas and local and university affiliates as planned, Heat’s ability to employ more than 500 individuals at the facility, the ability of the facility to service up to 144,000 liters across 48 bioreactors Heat’s ability to combine speed and agility with the full-integration of discovery, development and manufacturing at the facility, Heat’s ability to scale production of ANTHIM® and RapidVax®, Heat’s ability to fill the demand for world-class biomanufacturing with its San Antonio, Texas and Manhattan, Kansas facilities, Heat’s ability to rapidly grow and expand Scorpion, Heat’s ability to successfully consummate the merger of Elusys, Heat's ability to provide further near-term updates on its biodefense efforts, execute on key upcoming milestones and drive shareholder value, Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities 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 most recent annual report on Form 10-K for the year ended December 31, 2021 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
[phone]
mailto://[e-mail]

[Paulness]

NEWS -- Heat Biologics’ Announces Planned Investor and Media Livestream Event to Discuss Latest Developments

DURHAM, N.C., April 14, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system and novel biodefense assets, today announced it plans to host an investor and media livestream event on Tuesday, April 19, 2022 at 10:30 AM Eastern Time to discuss the latest developments. The event will be broadcast at: https://vimeo.com/event/2027558/fc6de52c31

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.

Media and Investor Relations Contact
David Waldman
[phone]
mailto://[e-mail]

[Paulness]

NEWS -- Heat Biologics Unveils Enhanced Allogeneic Cell Manufacturing Process

• New 3-D process designed to increase yield and improve operating efficiency for rapid and scalable manufacturing of HS-110, gp-96 based cell therapies and other cellular products

DURHAM, N.C., March 25, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, today unveiled enhanced allogeneic cell therapy manufacturing capabilities through its Scorpion Biological Services subsidiary.

Jeff Wolf, Chief Executive Officer of Heat, commented, “We are excited to rollout our new 3-D allogeneic cell manufacturing capabilities to replace our current 2-D HS-110 manufacturing. This new process is designed to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization. We plan to implement these processes for the manufacturing of our own therapies, including HS-110, as well as provide these services to other biopharma companies on a fee-for-service basis through our Scorpion subsidiary. One of the greatest challenges to broad adoption of cell therapies has been the time and cost of production. We believe these capabilities will help position Scorpion as a leading contract development and manufacturing organization (CDMO), as we advance our mission to become a fully-integrated biopharmaceutical company.”

Wolf continued, “We are incorporating these manufacturing changes into our clinical and commercial plans for HS-110 and plan to discuss these changes with the FDA during our Type C meeting scheduled for next quarter. We have received positive industry feedback on our new 3-D process, as well as the clinical results of our Phase 2 trial of HS-110, and plan to accelerate discussions with potential partners following our FDA interaction. We then plan to resubmit a Type B meeting request, including clinical setting and selection of the checkpoint inhibitor to be used in combination with HS-110, in collaboration with a potential partner.”

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 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 new process increasing yield, improving operating efficiency, as well as providing both a rapid and scalable solution to support Phase 3 trials and commercialization; plans to implement processes for the manufacturing of Heat’s own therapies, including HS-110, as well as provide these services to other biopharma companies on a fee-for-service basis through our Scorpion subsidiary, the capabilities helping position Scorpion as a leading contract development and manufacturing organization (CDMO), Heat’s mission to become a fully-integrated biopharmaceutical company, plans to discuss manufacturing changes with the FDA during Heat’s Type C meeting scheduled for next quarter, plans to accelerate discussions with potential partners following our FDA interaction and plans to resubmit a Type B (“End of Phase 2 Meeting”) meeting request, including clinical setting and selection of the checkpoint inhibitor to be used in combination with HS-110, in collaboration with a potential partner. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to become a fully-integrated biopharmaceutical company and offer manufacturing capabilities to other biopharma companies and utilize them for Heat’s own therapies, the ability to meet with the FDA as planned, Heat’s ability to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization; the ability to Heat’s ability to successfully consummate the merger of Elusys, Heat's ability to provide further near-term updates on its biodefense efforts, execute on key upcoming milestones and drive shareholder value, Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities 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 most recent annual report on Form 10-K for the year ended December 31, 2021 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
[phone]
mailto://[e-mail]

[cheynew]

Heat Biologics Unveils Enhanced Allogeneic Cell Manufacturing Process

New 3-D process designed to increase yield and improve operating efficiency for rapid and scalable manufacturing of HS-110, gp-96 based cell therapies and other cellular products

DURHAM, N.C., March 25, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, today unveiled enhanced allogeneic cell therapy manufacturing capabilities through its Scorpion Biological Services subsidiary.

Jeff Wolf, Chief Executive Officer of Heat, commented, “We are excited to rollout our new 3-D allogeneic cell manufacturing capabilities to replace our current 2-D HS-110 manufacturing. This new process is designed to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization. We plan to implement these processes for the manufacturing of our own therapies, including HS-110, as well as provide these services to other biopharma companies on a fee-for-service basis through our Scorpion subsidiary. One of the greatest challenges to broad adoption of cell therapies has been the time and cost of production. We believe these capabilities will help position Scorpion as a leading contract development and manufacturing organization (CDMO), as we advance our mission to become a fully-integrated biopharmaceutical company.”

Wolf continued, “We are incorporating these manufacturing changes into our clinical and commercial plans for HS-110 and plan to discuss these changes with the FDA during our Type C meeting scheduled for next quarter. We have received positive industry feedback on our new 3-D process, as well as the clinical results of our Phase 2 trial of HS-110, and plan to accelerate discussions with potential partners following our FDA interaction. We then plan to resubmit a Type B meeting request, including clinical setting and selection of the checkpoint inhibitor to be used in combination with HS-110, in collaboration with a potential partner.”

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: 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 new process increasing yield, improving operating efficiency, as well as providing both a rapid and scalable solution to support Phase 3 trials and commercialization; plans to implement processes for the manufacturing of Heat’s own therapies, including HS-110, as well as provide these services to other biopharma companies on a fee-for-service basis through our Scorpion subsidiary, the capabilities helping position Scorpion as a leading contract development and manufacturing organization (CDMO), Heat’s mission to become a fully-integrated biopharmaceutical company, plans to discuss manufacturing changes with the FDA during Heat’s Type C meeting scheduled for next quarter, plans to accelerate discussions with potential partners following our FDA interaction and plans to resubmit a Type B (“End of Phase 2 Meeting”) meeting request, including clinical setting and selection of the checkpoint inhibitor to be used in combination with HS-110, in collaboration with a potential partner. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to become a fully-integrated biopharmaceutical company and offer manufacturing capabilities to other biopharma companies and utilize them for Heat’s own therapies, the ability to meet with the FDA as planned, Heat’s ability to increase yield, improve operating efficiency, as well as provide both a rapid and scalable solution to support Phase 3 trials and commercialization; the ability to Heat’s ability to successfully consummate the merger of Elusys, Heat's ability to provide further near-term updates on its biodefense efforts, execute on key upcoming milestones and drive shareholder value, Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, the ability of Heat's therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat's ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat's ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat's ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities 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 most recent annual report on Form 10-K for the year ended December 31, 2021 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
[phone]
[e-mail]

[Paulness]

NEWS -- Heat Biologics Announces Appointment of Greg Burel, Former Director of the Strategic National Stockpile, to its Biothreat Advisory Board and as Senior Advisor to the Company

Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing novel biodefense assets and first-in-class therapies to modulate the immune system, announces the appointment of Greg Burel, former Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR) Director of the Strategic National Stockpile (SNS), to the Company’s Biothreat Advisory Board and as a senior advisor to the Company.

Mr. Burel served as the Director of SNS from March 2007 to January 2020. In this role, Mr. Burel directed the nation’s premier medical materiel preparedness and response organization charged with delivering critical medical assets to the site of a national emergency. In addition, his prior service includes senior management roles with increasing responsibility with the Federal Emergency Management Agency (FEMA) and the General Services Administration (GSA). Mr. Burel recently retired after nearly 38 years of federal service in January of 2020.

Mr. Burel stated, “I am excited to support and help advance Heat’s biodefense initiatives. The COVID pandemic has only reinforced the urgent need for a rapid, safe, and effective response to potential biological threats. Moreover, current geopolitical events highlight the need for an effective response to biological weapons. For this reason, it is essential to have effective therapies that can be stockpiled in advance, and then rapidly customized, manufactured, and deployed to address imminent and future threats.”

Jeff Wolf, Chief Executive Officer of Heat, commented, “We are honored to welcome Greg to our Biothreat Advisory Board, given his decades of experience preparing for and responding to public health threats, including pandemics, chemical and biological agents and more. In addition to his role with the advisory board, he will also serve as a senior advisor and consultant to the Company, where he will provide strategic advice, support outreach initiatives for our core biodefense programs. He will also support our anthrax initiative and the development and rollout of RapidVax®, our novel cellular vaccine designed for rapid “plug and play” programming and stockpiling against emerging known and unknown biological threats. We look forward to leveraging his deep expertise as we seek to grow our biodefense portfolio in the US and abroad.”

In addition to Mr. Burel, current members of the Biothreat Advisory Board include former US Senator Mark Pryor; 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 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 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 leveraging Mr. Burel’s deep expertise as Heat seeks to grow its biodefense portfolio in the US and abroad. These statements are subject to leverage Mr. Burel’s expertise and to grow its biodefense portfolio, Heat’s ability to successfully consummate the merger of Elusys, 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 most recent annual report on Form 10-K for the year ended December 31, 2021 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
[phone]
mailto://[e-mail]

[Paulness]

NEWS -- Heat Biologics Provides Year-End 2021 Business Update

DURHAM, N.C., March 14, 2022 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (NYSE American: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, today provided strategic, financial, and operational updates for the year ended December 31, 2021.

Jeff Wolf, Chief Executive Officer of Heat, commented, “2021 was a transformative year for Heat as we progress our strategic evolution to become a fully-integrated biopharmaceutical company. On the clinical front, we presented favorable survival data at The American Association of Cancer Research (AACR) of HS-110 in combination with checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC). We recently submitted meeting requests to the FDA for separate Type B (“End of Phase 2 Meeting”) and Type C (Phase 3 “CMC Readiness Meeting”) meetings to receive feedback on our proposed trial design and regulatory path forward. We anticipate these meetings will be scheduled for the second quarter of 2022. Following these meetings, we should be in a better position to advance potential strategic discussions regarding this program.”

“In September, based on our positive review of the Phase 1 data generated to date, we announced additional dose levels for our Phase 1 clinical trial evaluating the safety of PTX-35 monotherapy in patients with solid tumors and look forward to reporting the results of this trial later this year. We also recently announced new data demonstrating a single dose of the preclinical version of PTX-35 (mPTX-35), was able to expand regulatory T cells (Tregs) and significantly improve disease and graft survival outcome in a model of pancreatic islet allotransplantation for the treatment of diabetes.”

“We continued to make great strides towards becoming a fully integrated biotech capable of driving innovations from discovery through delivery. With the formation of Skunkworx Bio, we have ramped up our in-house discovery of biologics for our preclinical and clinical development efforts.”

“Our biomanufacturing and analytical team at Scorpion Biological Services broke ground on a new facility in San Antonio, Texas, designed to decrease our dependence on third-party CDMOs, reducing costs and accelerating timelines. In addition to supporting our own internal operations, we intend to offer manufacturing services to other biopharma companies on a fee-for-service basis. These efforts reinforce our goal of maximizing efficiency of drug development to expedite the delivery of novel immune activating therapies.”

“At the World Vaccine Conference, we announced our new biosecurity/biodefense initiative led by RapidVax®, a novel vaccine platform designed to enable an accelerated response and long-lasting immunological memory against a wide variety of infectious agents. RapidVax is designed to utilize a common unprogrammed vaccine base that can be manufactured in bulk, stockpiled, and rapidly customized upon identification of a biological threat to enable an accelerated time to clinic that can harness shared development, clinical safety, and manufacturing synergies. Our gp96-based cellular vaccines have previously demonstrated prophylactic protection in animal models against a range of diseases, including malaria, HIV/SIV, Zika and SARS-CoV-2 in multiple DOD and NIH-funded studies. Since launching this program, we have filed patents to protect our proprietary technology and have established our new Biothreat Advisory Board, which includes highly renowned individuals in the fields of biosecurity and biodefense, to guide the development of our programs.”

“In addition to our internal biodefense initiatives, we announced a definitive merger agreement to acquire Elusys Therapeutics, a commercial-stage biodefense company and the manufacturer of ANTHIM® (obiltoxaximab), which is approved for the treatment of inhalation anthrax in the U.S., Canada, Europe. Since announcing this acquisition, Elusys completed the first phase of a contract for $50 million with an option to procure up to an additional $31 million of ANTHIM by the first half of 2023. Given the growing global uncertainty, we believe the risks of anthrax and other biological threats are more present than ever. This acquisition is aligned with our strategy to take a leading role in the biodefense market.”

2021 Financial Results

• Recognized $2.1 million of grant and contract revenue, primarily for qualified expenditures under the CPRIT grant for the year ended December 31, 2021 compared to $2.9 million for the year ended December 31, 2020. 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 December 31, 2021, we had a grant receivable balance of $1.3 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award had been met. We continue our efforts to secure future non-dilutive grant funding to subsidize ongoing research and development costs.
• Research and development expense was $18.8 million and $12.9 million for the years ended December 31, 2021 and 2020, respectively. The increase was primarily due to manufacturing and patient costs for PTX-35, consulting expenses in our clinical and CMC groups, and a $2.4 million impairment of IPR&D.
• General and administrative expense was $16.8 million and $14.9 million for the years ended December 31, 2021 and 2020. The increase was primarily due to the increase in salaries, D&O insurance expense, and legal fees.
• Net loss attributable to Heat Biologics was approximately $35.1 million, or ($1.41) per basic and diluted share for the year ended December 31, 2021 compared to a net loss of approximately of $26.0 million, or ($1.63) per basic and diluted share for the year ended December 31, 2021.
• As of December 31, 2021, the Company had approximately $96.4 million in cash, cash equivalents and short term investments.

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 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 anticipated FDA meetings being scheduled for the second quarter of 2022 and following these meetings being in a better position to advance potential strategic discussions, reporting results of the Phase 1 clinical trial evaluating the safety of PTX-35 monotherapy in patients with solid tumors later this year, offering manufacturing capabilities to other biopharma companies, decreasing the dependence on third-party CDMOs reducing costs and accelerating timelines and maximize the efficiency of drug development to expedite the delivery of novel immune activating therapies, RapidVax® enabling an accelerated response and long-lasting immunological memory against a wide variety of infectious agents and the risks of anthrax and other biological threats being more present than ever. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including Heat’s ability to offer manufacturing capabilities to other biopharma companies and decrease dependence on third-party CDMOs, reduce costs and accelerate timelines, the ability to maximize the efficiency of drug development to expedite the delivery of novel immune activating, the ability of RapidVax® to enable an accelerated response and long-lasting immunological memory against a wide variety of infectious agents, Heat’s ability to leverage its gp96 platform for its new biosecurity/biodefense initiative, Heat's ability to reduce development costs, accelerate development timelines and ensure the highest levels of quality control, Heat’s ability to successfully consummate the merger of Elusys, Heat's ability to provide further near-term updates on its biodefense efforts, execute on key upcoming milestones and drive shareholder value, Heat's ability to augment its clinical programs and enhance and expand its therapeutic pipeline, 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 most recent annual report on Form 10-K for the year ended December 31, 2021 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
[phone]
mailto://[e-mail]

[oltimer]

That may be true but Iam still buying. With what they have going on it will take off one of these days. I am in no hurry. You should take a look atSXOOF======GLTU

[351stang]

unfortunately still the same company

[Paulness]

NEWS -- Heat Biologics Announces Planned Transfer to the NYSE American

DURHAM, N.C., Feb. 02, 2022 (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, announced today that it plans to change its listing from the Nasdaq Capital Market to the NYSE American stock exchange.

“We are pleased to announce our listing on the NYSE American, a global leader in listings for a range of sectors, including life sciences and technology,” said Jeff Wolf, Chairman and Chief Executive Officer of Heat. “As our company continues to grow and execute on upcoming milestones, we believe our stockholders will benefit from the broad exposure and international reach of this exchange.”

Heat expects to commence trading as an NYSE American-listed company when markets open on Monday, February 14, 2022. The Company’s common stock will continue to trade under its existing “HTBX” symbol. The Company will continue to trade on the Nasdaq Capital Market until the close of market on Friday, February 11, 2022.

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.

Forward-Looking Statements

This release includes forward-looking statements that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as "may", "will", "aim", "will likely result", "believe", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", "seek to", "future", "objective", "goal", "project", "should", "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the Company's current expectations about its future plans and performance and includes statements regarding the timing of the change of its listing to the NYSE American stock. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company's most recent annual report on Form 10-K filed with the SEC and other subsequent filings with the SEC for a further discussion of these risks and uncertainties. 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
[phone]
mailto://[e-mail]

[oltimer]

Looks like they have done something right for a change by going to the NYSE====

[Paulness]

This new item does relate to HTBX as follows:

"As previously announced, Elusys has executed a definitive merger agreement with Heat Biologics, Inc. (NASDAQ: HTBX), 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."

[Paulness]

NEWS -- Elusys Therapeutics Finalizes HHS Contract to Deliver ANTHIM®, Its Treatment for Inhalation Anthrax, to the U.S. Department of Health and Human Services

Completed first phase of contract for $50 million; HHS options to procure up to $31 million of ANTHIM by the first half of 2023

Reaffirms ANTHIM as an important medical countermeasure in the U.S. government’s strategy to maintain sufficient quantities of anthrax anti-toxin to effectively respond to an anthrax emergency

PARSIPPANY, N.J., Jan. 31, 2022 (GLOBE NEWSWIRE) -- Elusys Therapeutics, Inc. (Elusys) announced today that it has finalized a contract with the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) for the continued supply of ANTHIM (obiltoxaximab), an anthrax antitoxin, for use against a potential anthrax attack.

“Elusys is pleased to continue its successful track record of supplying a critical medicine to treat the deadly effects of anthrax exposure,” said Elizabeth Posillico, president and chief executive officer of Elusys. “ANTHIM is a key therapeutic in the U.S. government’s preparedness strategy to protect the U.S. population against natural and man-made biothreats.”

The contract for the procurement of ANTHIM consists of a base period of performance, valued at $50 million, which has been fulfilled. The contract includes options valued up to $31 million. If all options are exercised, the total contract value will be $80,864,000 with completion of the contract expected by the first half of 2023. Contract 75A50121C00073 is funded by HHS ASPR.

As previously announced, Elusys has executed a definitive merger agreement with Heat Biologics, Inc. (NASDAQ: HTBX), 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.

About ANTHIM

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.

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.

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.

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.

CONTACT:
Elizabeth Posillico
Elusys Therapeutics, Inc.
t: 973.808.0222
e: mailto://[e-mail]

[351stang]

another wonderful day in heat land

[351stang]

4 more pennies, yippie

[351stang]

biggest pos in my portfolio

[bige777]

Press release dated January 12th, 2022 in Globe Newswire. "Mr. Wolf further noted we are also making significant process with HS-110 and expect to file for an end of phase 2 meeting with the FDA this quarter. Our goal for this meeting is to discuss potential Phase 3 registration pathways for HS-110. Although this submission is taking longer than expected, we believe we have prepared a very comprehensive package and look forward to the FDA's feedback." Very good outlook for 2022. By the end of the year hoping for double-digit price, maybe even $20!

[Biotechgrowth]

Strong update from HTBX

Let the CEO know how you feel about the recent acquisition, all of the insider buys (none), promises kept on scheduling (yes, scheduling is all) which are delayed/suspended, and a pipeline stuck in first gear if it ever was there.

Investor Relations - 917.349.1485

[wolfjr]

Easy volume

[wolfjr]

Zacks in the house!

https://s27.q4cdn.com/906368049/files/News/2022/Zacks_SCR_Research_01132022_HTBX_Vandermosten.pdf

[Paulness]

NEWS -- Heat Biologics Announces New PTX-35 Preclinical Data in Organ Transplantation and Provides Update on HS-110

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 promising new preclinical data regarding PTX-35 has been accepted for publication in the American Journal of Transplantation and is available at: https://onlinelibrary.wiley.com/doi/epdf/10.1111/ajt.16940.

Key Findings:

• A single dose of the preclinical version of PTX-35 (mPTX-35), was able to expand regulatory T cells (Tregs) and significantly improve disease and graft survival outcomes.
• Chemically induced pancreatic failure (a model for type-1 diabetes) could be partially reversed when mice were transplanted with beta-cell islet allografts and treated with mPTX-35.
• Disease protection in preclinical models was correlated with a significant expansion of Tregs and protection of the allograft, resulting in euglycemia and a graft survival benefit.
• Long-term surviving grafts showed a marked increase in Treg infiltration which directly correlated with mPTX-35 agonist activity.

PTX-35 is a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be manipulated to expand regulatory T-cell subsets. 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.

Dr. James Shapiro, Professor in the Department of Surgery and Clinical Islet Transplant Program at the University of Alberta, Edmonton, Canada, commented, “The study demonstrated that a single dose of PTX-35 enabled prolonged graft survival in a mouse model of pancreatic islet allotransplantation. Additionally, PTX-35 could contribute to achieving lasting immunological tolerance in organ transplantation.”

Jeff Wolf, Chief Executive Officer of Heat, commented, “We are very encouraged by these results showing pronounced Treg expansion and significantly prolonged graft survival compared to control. PTX-35 has the potential to modulate immunological responses and may facilitate minimization of post-transplant immunosuppression, which supports further clinical evaluation in the context of inflammatory disease. Similar preclinical results have also been previously demonstrated for bone marrow, corneal and cardiac transplantation using these and other TNFRSF25 agonists.”

Mr. Wolf further noted, “We are also making significant progress with HS-110 and expect to file for an End of Phase 2 meeting with the FDA this quarter. Our goal for this meeting is to discuss potential Phase 3 registration pathways for HS-110. Although this submission is taking longer than expected, we believe we have prepared a very comprehensive package and look forward to the FDA’s feedback.”

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 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 partially reversing chemically induced pancreatic failure (a model for type-1 diabetes) when mice were transplanted with beta-cell islet allografts and treated with mPTX-35, PTX-35 contributing to achieving lasting immunological tolerance in organ transplantation, the potential of PTX-35 to modulate immunological responses and facilitate minimization or withdrawal of immunosuppression post-transplant, which supports further clinical evaluation in the context of inflammatory disease, expected filing for HS-110 for an End of Phase 2 meeting with the FDA this quarter, and the potential Phase 3 registration pathways for HS-110. 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, 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 including a Phase 3 registration pathway for HS-110 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
[phone]
mailto://[e-mail]

[351stang]

ONLY 4999 MORE PENNYS TO GO

[wolfjr]

It’s making moves!

[wolfjr]

$50 +

[351stang]

wow nothing more can be said

[bige777]

With everything that $HTBX has going on I truly think this is oversold IMHO.

[Tim696969]

Does anyone feel this will rally in January?

[351stang]

when i do make a profit on htbx, and i will, it will be the last time i buy this turd

[351stang]

what a POS

[Paulness]

NEWS -- Heat Biologics Announces Planned Acquisition of Elusys Therapeutics

• Elusys' ANTHIM® is approved for the treatment of inhalation anthrax in the U.S., Canada, Europe and the United Kingdom

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
[phone]
mailto://[e-mail]

[351stang]

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

[bige777]

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.

[wolfjr]

$50+

[351stang]

maybe we will see .25 again, what junk

[351stang]

this is a joke,good news and still going down. 3s coming.wolf is a joke, this might as well be a penny stock

[351stang]

still dreaming i see

[wolfjr]

$50+

[Digging For Pennies]

Great news today!

[Paulness]

NEWS -- Heat Biologics Unveils RapidVax®, A Novel Cellular Vaccine Platform Targeting Known and Unknown Emerging Biological Threats

• Designed for rapid “plug and play” programming and stockpiling against emerging infectious agents and viral mutations
  
  
• Emergence of Omicron and other COVID-19 variants underscores the need for a rapid, safe, and effective response to potential biological threats
  
  
• RapidVax Presentation at the 2021 World Vaccine & Immunotherapy Congress West Coast and World Antiviral Congress 2021

DURHAM, N.C., Nov. 30, 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 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 presentationposter 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: 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, 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
[phone]
mailto://[e-mail]

[crudeoil24]

Revenues are lower yoy. My cousins three bay auto repair shop has higher yearly revenues than HTBX.

[crudeoil24]

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,

[cheynew]

Heat Biologics Unveils RapidVax®, A Novel Cellular Vaccine Platform Targeting Known and Unknown Emerging Biological Threats
November 30 2021 - 07:30AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook

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
[phone]
[e-mail]

[351stang]

winner

[wolfjr]

Due for some news. $10 +

[351stang]

getting pretty close to that $4.50 mark, pretty shitty

[bige777]

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.