Heat Biologics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 09, 2021 Heat Biologics, Inc., a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually between September 13-15, 2021 (Press release, Heat Biologics, SEP 9, 2021, https://ir.heatbio.com/news/detail/701/heat-biologics-to-present-at-the-h-c-wainwright-23rd-annual-global-investment-conference [SID1234587474]).

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Heat Biologics’ presentation will be available on-demand to registered attendees via the conference platform beginning Monday, September 13, 2021 at 7:00 AM Eastern Time.

The webcast can be accessed here and on the investor relations section of Heat Biologics’ website at View Source Management will also be participating in one-on-one meetings with qualified members of the investor community throughout the conference.

Regulus Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 9, 2021 Regulus Therapeutics Inc., a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the H.C. Wainwright 23rd Annual Global Investment Conference: An on-demand webcast presentation will be available on Monday, September 13, 2021 at 7:00 a.m. ET (Press release, Regulus, SEP 9, 2021, View Source [SID1234587490]).

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PDS Biotech Completes Enrollment of Lead-In Safety Cohort in VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer

On September 9, 2021 PDS Biotechnology Corporation, a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported that it has completed the enrollment of the lead-in safety cohort of its VERSATILE-002 Phase II study evaluating the efficacy and safety of the combination of PDS0101, a clinical stage immunotherapy to treat cancers caused by infection with the human papillomavirus (HPV), and KEYTRUDA (pembrolizumab), a checkpoint inhibitor (CPI) (Press release, PDS Biotechnology, SEP 9, 2021, View Source [SID1234587509]). The combination is being studied for the treatment of advanced human papillomavirus (HPV16)-associated head and neck cancer that has returned or spread. The trial is being conducted in collaboration with Merck & Co.

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The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm, non-randomized trial that will enroll approximately 100 patients across approximately 25 sites in the U.S. Today the study achieved an important milestone by completing the enrollment of the lead-in safety cohort. Consistent with the study design, further recruitment for the study will commence after a formal analysis by the drug monitoring committee.

VERSATILE-002 is being studied in two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group have not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including CPI therapy (CPI refractory).

The advancement of the VERSATILE-002 trial follows the previously disclosed presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting of interim data in a separate Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI). That trial is evaluating the combination of PDS0101 with two investigational immunotherapies in patients with advanced HPV-related cancers who have failed prior treatment. Objective responses measured according to RECIST 1.1 (tumor reduction of 30% or more) were reported in 83% (5/6) of HPV16-positive patients who had failed chemotherapy and radiation but were CPI naive. In CPI refractory patients, tumor reduction was reported in 58% (7/12) and objective responses in 42%. Two patients, one in each group were reported to have a complete response (no evidence of disease) at the time of reporting. Current standard of care is reported to result in objective responses of approximately 20% and 10% in CPI naïve and refractory patients respectively. More information on this study can be found on PDS Biotech’s website.

"The early data from these initial studies suggest that Versamune-based immunotherapies administered in combinations that include a checkpoint inhibitor, may have the potential to enhance the immune system’s ability to induce a more powerful and targeted anti-tumor response," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "There is an enormous unmet medical need for more effective treatment of advanced HPV-related cancers and specifically, head and neck cancer. We believe the combination of PDS0101 and KEYTRUDA has the potential to significantly improve clinical outcomes for these patients who have limited treatment options. We look forward to sharing data from this trial as they become available."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [email protected] or visit the website at View Source to learn more.

ImmunoPrecise Reports Financial Results and Recent Business Highlights for First Quarter Fiscal Year 2022

On September 9, 2021 ImmunoPrecise Antibodies, a leader in full-service therapeutic antibody discovery and development, reported financial results for first quarter fiscal year 2022, which ended July 31, 2021 (Press release, ImmunoPrecise Antibodies, SEP 9, 2021, View Source [SID1234587475]).

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First Quarter Fiscal Year 2022 Financial Summary*
• Revenues of $4.6 million, up 22%
• Research and development costs increased to $1.1 million from $309,213 in 2021
• The Company recorded a net loss of $3.2 million in the quarter
• Adjusted EBITDA** loss of $1.3M
• As of July 31, 2021, the Company held cash of $40.7M
*Expressed in Canadian dollars, unless otherwise indicated.
**For additional information on Adjusted

Dr. Jennifer Bath, CEO of ImmunoPrecise, stated, "This quarter marks an exciting leap into IPA’s major strategic initiatives to support our vision shared by the board of directors and management alike: Formidable and unabashed goals as we invest to recognize new heights of potential in our contract research, our internally-owned therapeutic assets, and new research and manufacturing services. In the previous quarters, our operational sites focused on the development of complementary revenue-generating service offerings, each of which is now resulting in new revenue streams. Under the guidance of our recently appointed CSO, Ilse Roodink, this quarter saw unprecedented investments driving later-stage pre-clinical asset development toward clinical manufacturing (PolytopeTM) and functional validation, as well as a ramp in earlier stage discovery. Our excitement around these programs is palpable yet does not overshadow our ongoing dedication to the Company’s contract research, as we celebrate numerous milestones such as our recent commercial partnership with Eurofins Discovery and ongoing push to open new doors to opportunities such as the French R&D tax credit, CIR (Crédit d’Impôt de Recherche). Our fiscal year is off to an energetic start as we continue to execute on growth strategies and focus in on initiatives around R&D investments, aggressive sales and partnering agendas, and potential acquisitions."

Recent and Fiscal 2021 Operational Highlights
• Appointed Dr. Ilse Roodink to the Role of Chief Scientific Officer and Dr. Dion Neame to the Strategic Advisory Board.
• Successfully demonstrated pre-clinical in vivo results for TATX-03 PolyTope Therapy, a four monoclonal antibody cocktail developed for the potential prevention and treatment of SARS-CoV-2. The preclinical study demonstrated potent pseudovirus, neutralizing activity against the SARS-CoV-2 Delta (B.1.617.2) variant.
• Histopathology preclinical data from TATX-03a Polytope Program confirms treatment substantially reduced bronchitis and tracheitis severity in preclinical studies.
• Completed preclinical efficacy studies for newly optimized 4-antibody cocktail (TATX-03b), showing strong in vivo therapeutic efficacy and synergy for the treatment and protection against SARS-CoV-2 infection
 o IPA’s optimized, 4-Ab cocktail (TATX-03b) shows high levels of efficacy in treating SARS-CoV-2 in the preclinical study
 o Updated mutant binding data demonstrates continued in vitro resistance against novel variants of concern, including the recently described Californian and New York variants.
• Release of publication entitled "Cornering an Ever-Evolving Coronavirus: TATX-03, a Fully Human, Synergistic, Multi-Antibody Cocktail Targeting the SARS-CoV-2 Spike Protein with in vivo Efficacy" on bioRxiv.
• Expanded partnership providing Eurofins Discovery’s global clients greater access to ImmunoPrecise’s end-to-end antibody discovery capabilities using wild type and best-in-class in vivo and in vitro antibody discovery technologies that are optimized to deeply mine antibody repertoires.
• Presented results from in vitro characterizations investigating TATX-21, a novel potential first-in-class antibody for Atherosclerosis Cardiovascular Disease (ACVD) at 2021 BIO International Convention partnering sessions.

Financial Results

Revenue
The Company achieved revenues of $4.6 million during the three months ended July 31, 2021, compared to $3.8 million in 2020, a 22% increase in its core CRO business. The Company’s strong organic revenue growth of its CRO business continues as a result of increases in both volume and financial values of client contracts as well as continued focus on the development and expansion of revenue-generating services.

Research & Development
Research and development increased to $1.1 million from $309,213 in 2020, due to the extensive R&D work the Company is undertaking, the majority attributed to the development of potential therapeutic assets in the Company’s subsidiary, Talem.

Net Loss

The Company recorded a net loss of $3.2 million during the three months ended July 31, 2021, compared to net loss of $549,318 for the three months ended July 31, 2020.

Financing Activities / Liquidity and Capital Resources
As of July 31, 2021, the Company held cash of $40.7 million and had working capital of $40.2 million.

Dynavax to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

On September 9, 2021 Dynavax Technologies Corporation, a biopharmaceutical company focused on developing and commercializing vaccines, reported that Ryan Spencer, Chief Executive Officer, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13-15, 2021 (Press release, Dynavax Technologies, SEP 9, 2021, View Source [SID1234587491]).

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The on demand presentation will be available, beginning Monday, September 13, 2021 at 7:00 a.m. E.T. and may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source