PDS Biotechnology Welcomes Matthew Hill as Chief Financial Officer

 

FLORHAM PARK, N.J., Oct. 06, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced that Matthew Hill will join PDS Biotech as its Chief Financial Officer (CFO) effective as of October 18, 2021, to lead the company’s financial strategy through its next phase of growth.

Mr. Hill brings more than 25 years of experience in finance and operational leadership roles for life science companies. He is joining PDS Biotech after spending the last several years at Strata Skin Sciences (Nasdaq: SSKN) as their Chief Financial Officer, where he led the financial vision and strategy for the medical device company. Prior to joining Strata Skin Sciences, he held CFO roles at several companies, including Velcera prior to its acquisition by the Perrigo Company, and EP Medsystems prior to its acquisition by St. Jude Medical, where he also served as the VP of Operations. Mr. Hill holds a Bachelor of Science in accounting from Lehigh University.  

“Given the promise of the Versamune^® platform in oncology, I’m excited to bring my experience with life science companies to PDS Biotech’s next chapter. PDS has achieved significant milestones in the last year and I am energized to contribute my expertise and leadership to direct PDS Biotech’s financial strategy to facilitate its next phase of growth,” said Hill.

“We are focused on developing and commercializing novel and more effective treatments for cancer,” said PDS Biotech President and CEO Dr. Frank Bedu-Addo. “Matt’s extensive experience with growth-stage healthcare and life science companies will provide PDS Biotech with solid financial leadership and I look forward to working closely with Matt to fulfill the promise demonstrated thus far of bringing novel oncology products to the market.”

Mr. Hill will replace Seth Van Voorhees in the role of CFO.   Dr. Bedu-Addo continued, “On behalf of our board of directors, we would like to thank Seth for his service to the company and wish him continued success in his future endeavors.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers.   To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s or monitoring committees’ or other third parties’ interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment, significance of milestones, and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

	Image Credit: Pixabay (Pexels)

Nobel Prize: How Chili Peppers Helped Researchers Uncover How Humans Feel Pain

 

Think about how often we feel a touch, or sense temperature. Perhaps it’s the warmth we feel when we hold a coffee cup or the comfort we feel when hugging a loved one – these sensations are integral to our everyday lives and how we interact with our world. These sensations are all part of our somatosensory system, which is responsible for many different sensations – including temperature, touch, body position and movement, pain and itch. Some might say that the combined effects of our somatosensory system are the very essence of what it is to connect to the world around us and to experience it.

But until the late 1990s, little was known about how the body actually senses temperature and pressure. This is why the 2021 Nobel prize in physiology or medicine was jointly awarded to David Julius and Ardem Patapoutian, whose independent research uncovered the receptors which allow us to sense touch and temperature.

 

This article was republished with permission from  The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of   Francis McGlone, Professor in Neuroscience, Liverpool John Moores University

 

The discoveries made by Julius and Patapoutian help solve questions many people have been asking for years – showing us how these stimuli are converted into nerve signals at a molecular level. These discoveries may also have important implications for developing treatments for a variety of different conditions, including chronic pain, in the future.

 

 

A Bit of Spice

Both researchers began working on this topic in the 1990s but were looking at it in different ways. Julius and his colleagues at the University of California were looking at a rather unconventional compound known as capsaicin, which is the chemical that causes the burning sensation we feel when we touch or eat chili peppers. While researchers already knew capsaicin activated nerve cells that caused pain sensations, Julius sought to uncover which sensors in the nerve endings actually respond to the heat from this compound.

Using lab-grown neurons – humans nerve cells – Julius and his team created a library of millions of DNA strands that corresponded to genes in the sensory neurons that react to pain, heat, and touch. This eventually led them to identify a single gene that was responsible for making cells sensitive to capsaicin. The gene allows cells to build a protein called TRPV1 which leads to these receptors perceiving the heat from capsaicin as painful.

This was the first of many more temperature-sensing receptors Julius and his lab discovered. Using menthol, Julius identified TRPM8, a receptor shown to be activated by cold. He also used the chemical found in wasabi to identify TRPA1, which is triggered by pain. Julius’s TRPV1 discovery was a breakthrough that allowed further research into how temperature induces electrical signals in the nervous system.

 

 Their discoveries may lead to new treatments for managing pain.

 

Patapoutian, from the Scripps Research Institute in California, uncovered the mechanisms which underpin our sense of touch. Patapoutian’s research first began when he and his team identified a type of cell that gave off an electrical signal when it was poked with a micropipette. But to understand more about these pressure-sensitive cells, Patapoutian and his team first needed to identify which receptor was responsible.

They started with 72 candidate genes, inactivating them one by one until they found that the single gene responsible for creating the protein which responds to pressure on cell membranes – known as Piezo1. This discovery then led them to find a second gene, called Piezo2, which functions similarly.

This decades-long search now means researchers understand the mechanisms underpinning our sense of touch. Piezo1 and Piezo2 both work to initiate an electrical signal that travels between cells and to the brain when our skin or internal organs are touched or feel pressure.

 

The Importance of These Senses

Mammals are the only organisms that have the ability to generate and maintain our internal body temperature. If our blood temperature falls below 27? we’re in critical condition. It’s essential for survival to be able to sense temperature changes in our environment in order to maintain our core body temperature. It tells us that we should put a coat on if it’s cold outside, or not to touch a hot stove door so we don’t get hurt.

Julius’s discovery of the temperature-sensitive receptors in our nerves means we now know how changes in our environment’s temperature is detected. Discovering both the receptors that detect heat – TRPV1 – and cold – TRPM8 – now means we may have targets for drugs to treat inflammation, itch, pain, and cold allodynia (increased sensitivity to cold temperatures).

Our sense of touch is also extremely important to us for a number of reasons – not least of which is because it allows us to enjoy a hug. Being able to detect a mechanical stimulus – the sense we call touch – is important to every tissue and cell in our body. It means that the body can monitor blood flow, a full stomach, or when our bladder is full.

Patapoutian’s research means that we now understand which receptors allow us to sense touch, which could have many implications for future treatments. Researchers are already targeting the proteins Patapoutian discovered for the treatment of pain conditions.

 

Suggested Reading:

Opportunities in the Rapidly Growing Pain Management Sector

Stem Cells Role in the Anti-Aging Business

Therapeutic Research Advanced by Stem Cell Science

Improving Mortality Rates Through Genetic Research

 

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PDS Biotechnology Welcomes Matthew Hill as Chief Financial Officer

 

FLORHAM PARK, N.J., Oct. 06, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced that Matthew Hill will join PDS Biotech as its Chief Financial Officer (CFO) effective as of October 18, 2021, to lead the company’s financial strategy through its next phase of growth.

Mr. Hill brings more than 25 years of experience in finance and operational leadership roles for life science companies. He is joining PDS Biotech after spending the last several years at Strata Skin Sciences (Nasdaq: SSKN) as their Chief Financial Officer, where he led the financial vision and strategy for the medical device company. Prior to joining Strata Skin Sciences, he held CFO roles at several companies, including Velcera prior to its acquisition by the Perrigo Company, and EP Medsystems prior to its acquisition by St. Jude Medical, where he also served as the VP of Operations. Mr. Hill holds a Bachelor of Science in accounting from Lehigh University.  

“Given the promise of the Versamune^® platform in oncology, I’m excited to bring my experience with life science companies to PDS Biotech’s next chapter. PDS has achieved significant milestones in the last year and I am energized to contribute my expertise and leadership to direct PDS Biotech’s financial strategy to facilitate its next phase of growth,” said Hill.

“We are focused on developing and commercializing novel and more effective treatments for cancer,” said PDS Biotech President and CEO Dr. Frank Bedu-Addo. “Matt’s extensive experience with growth-stage healthcare and life science companies will provide PDS Biotech with solid financial leadership and I look forward to working closely with Matt to fulfill the promise demonstrated thus far of bringing novel oncology products to the market.”

Mr. Hill will replace Seth Van Voorhees in the role of CFO.   Dr. Bedu-Addo continued, “On behalf of our board of directors, we would like to thank Seth for his service to the company and wish him continued success in his future endeavors.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers.   To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s or monitoring committees’ or other third parties’ interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment, significance of milestones, and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Cocrystal Pharma Receives Australian Regulatory Clearance to Initiate Phase 1 Study of CC-42344 for the Treatment of Pandemic and Seasonal Influenza

 

BOTHELL, Wash., Oct. 06, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of coronaviruses, influenza, hepatitis C viruses and noroviruses, announces receipt of clearance from an Australian Human Research Ethics Committee (HREC) to initiate a Phase 1 trial with its orally administered PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A.

The Phase 1 randomized, double-blind, placebo-controlled study is expected to enroll 56 healthy volunteers at a single site in Australia. The study is designed to assess the safety, tolerability and pharmacokinetics of CC-42344.

CC-42344 binds to a highly conserved PB2 site of influenza polymerase complex and exhibits a novel mechanism of action that inhibits viral replication. In preclinical testing, CC-42344 demonstrated excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu^® and Xofluza^®-resistant strains, as well as favorable pharmacokinetic and drug-resistance profiles.

“The need for a novel, broad-spectrum, oral antiviral for pandemic and seasonal influenza A is clear as current approved influenza treatments are partially effective and are prone to viral resistance,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “We discovered CC-43244 using our proprietary structure-based drug discovery platform technologies. CC-43244 is specifically designed to be effective against pandemic and seasonal influenza A strains and emerging avian influenza viruses.”

“Our decision to conduct the Phase 1 trial in Australia was due to favorable regulatory policies and a clinical trial environment that aligns with our strategy for rapid, cost-efficient and high-quality clinical development,” added James Martin, Cocrystal’s CFO and co-interim CEO. “We are delighted to begin our first clinical study with CC-42344 as a treatment for this major global health concern.”

The World Health Organization (WHO) estimate there are approximately 1 billion cases of influenza annually worldwide, resulting in 3 million to 5 million cases of severe illness and 290,000 to 650,000 deaths. The Center for Disease Control (CDC) estimates that since 2010 influenza has resulted in 9 million to 45 million illnesses in the U.S. annually, resulting in 140,000 to 810,000 hospitalizations and 12,000 to 61,000 deaths.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C virus and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding conducting the Phase 1 study of CC-42344 in Australia and our strategy with respect to clinical development. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy, on our collaboration partners, CROs, CMOs, and on our Company, including raw material and test animal shortages and other supply chain disruptions, the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, possible delays resulting from the lockdowns in Australia, potential delays related to the manufacturing of the drug for the study, the results of clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Source: Cocrystal Pharma, Inc.

Avivagen to Hold Webcast to Discuss Landmark Deal with AB Vista

 

• AB Vista becomes the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand
• Webcast to take place Wednesday, October 6th, 2021, at 10:30 a.m. EST

Ottawa, ON /Business Wire/ October 4, 2021/ Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce it will be holding a webcast on Wednesday, October 6th at 10:30 A.M. EST to discuss its recent sales agreement with AB Vista that was announced on Friday, October 1, 2021.

The webcast will commence with remarks by Avivagen CEO Kym Anthony, followed by a Q & A session.  To access the live webcast, visit this link to the event. Please pre-register questions with Investor Relations ahead of time. Following the live webcast, an archived version of the call will be available on Avivagen’s website.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about beta-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

For more information: Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

 

FLORHAM PARK, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer. 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

“Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North 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 info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s or monitoring committees’ or other third parties’ interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment, significance of milestones, and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

 

FLORHAM PARK, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer. 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

“Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North 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 info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s or monitoring committees’ or other third parties’ interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment, significance of milestones, and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Avivagen to Hold Webcast to Discuss Landmark Deal with AB Vista

 

• AB Vista becomes the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand
• Webcast to take place Wednesday, October 6th, 2021, at 10:30 a.m. EST

Ottawa, ON /Business Wire/ October 4, 2021/ Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce it will be holding a webcast on Wednesday, October 6th at 10:30 A.M. EST to discuss its recent sales agreement with AB Vista that was announced on Friday, October 1, 2021.

The webcast will commence with remarks by Avivagen CEO Kym Anthony, followed by a Q & A session.  To access the live webcast, visit this link to the event. Please pre-register questions with Investor Relations ahead of time. Following the live webcast, an archived version of the call will be available on Avivagen’s website.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about beta-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

For more information: Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Monday, October 04, 2021

Lineage Cell Therapeutics (LCTX)
Full OpRegen Data Presentation Details Patients Improvements

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Data Presented At Medical Meeting. Lineage presented an update from its Phase 1/2a clinical trial at the Annual Scientific Meeting of the Retina Society. This was the full presentation of the data announced in mid-September. The patient data showed continued improvement and maintenance of effect from the OpRegen treatments.


Presentation Provided Longer Post-Treatment Data.  The OpRegen Phase 1/2a is an open-label trial with three cohorts of 12 patients treated to establish safety, then a fourth cohort of 12 patients to determine efficacy. The presentation had more patients followed to longer treatment assessment times than previous seen. The presentation also detailed the treatment and methods of analysis for the …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

AB Vista and Avivagen Strike OxC-beta™ Supply Agreement in the United States, Brazil and Thailand

 

• Eight-year agreement expected to increase OxC-Beta™ access and adoption in the largest feed production markets worldwide
• AB Vista to become exclusive distributor for use with poultry, swine, ruminants and aquaculture in United States, Brazil and Thailand
• AB Vista and Avivagen to collaborate on development efforts

Ottawa, ON/Business Wire/ October 1, 2021/ Leading global animal nutrition technology company AB Vista and Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”) today announced they have entered into a transformative supply agreement that is expected to expand the adoption and use of OxC-beta™ in a number of high-value feed production markets worldwide. The landmark eight-year deal will see AB Vista become the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand.

AB Vista is a global animal nutrition technology company supplying feed additives, nutrition expertise and analytical services to animal feed and protein producers.

“This is a truly transformative partnership for Avivagen, and one that stands to benefit not only us and AB Vista but feed and livestock producers in the Americas and Asia as well,” says Kym Anthony, Chief Executive Officer, Avivagen Inc. “We’ve had a lot of interest from potential partners for OxC-beta™, but AB Vista’s expertise and track record set it apart. With their industry-leading technical knowledge and know-how we are confident that this agreement will drive considerable adoption of OxC-beta™ and growth for Avivagen over the better part of the next decade.”

As a part of the agreement AB Vista and Avivagen will also collaborate on future development efforts, including advancing opportunities for OxC-beta™ use for aquaculture purposes (such as shrimp production). Aquaculture represents a new category for OxC-beta™ use, following considerable success with poultry, swine and ruminants in markets worldwide.

“We pride ourselves on bringing pioneering, high-value products and services to  the global animal feed market. We believe OxC-beta™ could be one of the next great innovations and advancements in animal nutrition, and we’re excited to be able to deliver this great product to our customers,” says Juan Ignacio Fernandez, Managing Director, AB Vista.

“Based on the extensive technical data supporting the role OxC-beta™ can have in reducing production reliance on antibiotics, we are confident our customers in the United States, Brazil and Thailand will have high demand for such a differentiated product.”

The United States and Brazil represent the world’s second and third largest feed production markets, accounting for nearly 300 million metric tonnes of feed produced in 2020[1]. More than one-quarter of 2021 international feed tonnage was produced in these two markets alone.

About AB Vista
AB Vista is a global feed additive business bringing pioneering products and technical services to the poultry, swine, ruminant and aquaculture sectors. Since its launch in 2005 the company has become a highly respected global player with top three market share positions in its core segments. The business uses its innovative product research, technical services and nutrition expertise to gather global insights that can be used to provide new ways of thinking to feed compounders, integrators and pre-mixers. With over 25 years’ experience in the NIR field and a global network of laboratories able to analyse feed samples, AB Vista provides the tools and expertise to allow its customer to better balance their ingredients. AB Vista is headquartered in the UK, with regional offices located in the USA, Brazil, Singapore, Spain, India, China, Germany and Finland.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the term of the agreement with AB Vista, expections as to expansion and adoption of products, Avivagen’s expectations as to future growth and results, the anticipated benefits of this agreement to Avivagen and others, future collaboration, future product development, Avivagen’s expectations as to growth in demand for Avivagen’s products,   the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, the supply agreement could be terminated prior to 8 years for a number of reasons, Avivagen’s products may not be adopted at the rate anticipated, Avivagen may not benefit from the supply agreement as anticipated, future collaboration and product development may not occur or may not be successful in developing viable products, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

AB Vista – a division of AB Agri Ltd
Lynsey Wickens
3 Woodstock Court, Blenheim Road, Marlborough Business Park,
Marlborough, Wiltshire, SN8 4AN
t +44 (0)1672 517662

e-mail: lynsey.wickens@abvista.com

[1] 2021 Alltech Global Feed Survey: https://www.petfoodindustry.com/articles/9973-th-annual-alltech-global-feed-survey-estimates-world-feed-production-increased-1

Pain Management Market to Grow to $81.9 Billion by 2026

 

“No pain, no gain” is a motivational gym saying heard for years. Investors have found the saying also applies to portfolio gains.  The pain management industry is rapidly growing and now provides an even broader spectrum of publicly traded opportunities. Why? Reduced opioid use has opened a path for inventive new therapeutics to become the new go-to where an opioid would have been prescribed previously.  Estimates on the potential for the industry were just released in a report by Zion Market Research. The report demonstrates the pain management therapeutics industry is expected to amass earnings of about $81.9 billion by 2026. This is an increase of $16.3 billion over 2019 earnings.

Background:

Treatment of chronic pain has a large base as a major healthcare service. This base provides a solid footing for the business of pain management therapeutics.  Pain-relieving drugs such as opioids have provided help to patients with severe pain, but their usage should be short-term in duration or to treat pain in the terminally ill. New protocols based on this reality leave many sufferers that had relied on addictive pharmaceuticals needing new alternatives.

Primary pharmaceutical segments in Pain Management:

• Anesthetics
• NSAIDS
• Anticonvulsants
• Antidepressants
• Anti-migraine agents
• Non-narcotic analgesics

Major uses for which they are indicated include: 

• Neuropathic Pain
• Arthritic Pain
• Cancer pain
• Post-operative Pain
• Chronic Back Pain
• Fibromyalgia
• A migraine

Market
Growth Dynamics

As the number of patients affected with chronic pain increases among an aging population, and opioid prescriptions come under more scrutiny, medical treatments, including non-pharmacologic therapies, and interventional pain treatments, have increased. The pain management therapeutics market is expected to continue its accelerated growth over the next couple of years. This is expected to translate into a $16.3 billion expansion of industry earnings over the next few years, according to the Zion report.  Additionally, they expect, growth in the number of surgeries along with an increase in automotive accidents and sports injuries. This will also serve to lift this market involved in helping sufferers.

Expansion
Prospects

The anticipated growth of pain management therapeutics within North American healthcare is expected to happen on several fronts. Players include the nimble, creative growth companies as well as the huge established names. Large companies involved in the segment include Novartis AG, Purdue Pharma L.P., AstraZeneca Plc., Mallinckrodt Pharmaceuticals, GlaxoSmithKline Plc., Teva Pharmaceutical Industries Ltd., Pfizer Inc., Depomed, Inc., Johnson & Johnson Services, Inc., Endo International Plc., Merck & Co., Inc., and Abbott Laboratories. These are big corporations where successful individual products aren’t as impactful to the bottom line or stock price movement.

The smaller more nimble prospects are worth learning about. There are a number of them that have developed solutions that are just now becoming adopted and substituted for old methods of treatment. Below is a list of six companies in this space that may be worth becoming familiar with:

NanoVibronix
Inc. (NAOV)  is engaged in manufacturing of noninvasive biological response-activating devices which target wound healing and pain therapy, without the assistance of medical professionals. The primary products of the company include WoundShield which is patch-based therapeutic ultrasound device to help regenerate tissue and healing by using ultrasound to increase local capillary perfusion and tissue oxygenation; PainShield which is a disposable patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures; and UroShield which is an ultrasound-based product designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain. Most of the company’s revenue comes from the U.S. $NAOV is listed on the Nasdaq exchange.

Bioelectronics Corp. (BIEL) is an electroceutical company. It develops wearable, neuromodulation devices to safely mitigate neurological diseases. Its product line includes Actipatch Musculoskeletal Pain Therapy, Allay menstrual pain therapy, Smart insole heel pain therapy and Recovery RX post-operative and Chronic wounds therapy. The company sells its products to wholesale distributors, directly to hospitals and clinics, and consumers. $BIEL trades OTC.

 

 

Baudax Bio Inc.
(BXRX) is a Pharmaceutical company. The company develops and commercialize products for hospital and related acute care settings. Products in its pipeline include two novel neuromuscular blocking agents, or NMBAs, and a related proprietary chemical reversal agent and Dex-IN. $BXRX is listed on the Nasdaq exchange.

Virpax
Pharmaceuticals Inc. (VRPX) is a preclinical stage biopharmaceutical company. The company is focused on developing pharmaceutical product candidates for pain management. Its product portfolio includes Topical metered-dose spray, Liposomal in Hydrogel encapsulation, and Enkephalin Intranasal spray. $VRPX is listed on the Nasdaq exchange.

Heron
Therapeutics Inc. (HRTX) is a commercial-stage biotechnology company. It’s focused on improving the lives of patients by developing treatments that address some of the unmet patient needs. The company’s product portfolio consists of SUSTOL and CINVANTI. Its pipeline product is HTX-011. $HRTX is listed on the Nasdaq exchange.

Medx Health
Corp. (MDXHF) is engaged in the development, manufacturing, and marketing of skin-related screening tools and phototherapy devices for pain relief and tissue repair. Its two main product lines are; SIAscopy, a medical device technology that is used to scan skin for suspicious moles and lesions; and Phototherapeutic medical devices, which use light energy in lower-level laser and LED to provide effective treatment of pain and tissue damage in the rehabilitation market. It derives key revenue from the sale of Phototherapeutic lasers. Its product portfolio includes SIAscopy, MoleMate, SIMSYS, MedX Home System, Rehab Portable Laser, Debtal Laser Console System and others. The company sells its products internationally, of which prime revenue is generated in Canada and the US. $MDXHF trades OTC.

Take-Away

Heightened awareness of the risks associated with prescribing opioids coupled with an aging populous is providing opportunities for companies to develop new methods to minimize suffering; this includes medical devices to treat or assess causes, and novel medicines. Investors could benefit from growing their awareness of this therapeutic space and individual companies operating in the pain management sector.

There is usually no better way to understand a company than letting management explain the products and their uses. A virtual conference with management from the above six companies will take place on October 6. There is no cost to register or attend some or all of the sessions.

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 Sources:

https://www.zionmarketresearch.com/news/pain-management-therapeutics-market

https://channelchek.vercel.app/news-channel/New_Developments_in_Pain_Management___a_NobleCon_Online_Investor_Event___Presenting_Companies

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AB Vista and Avivagen Strike OxC-beta™ Supply Agreement in the United States, Brazil and Thailand

 

• Eight-year agreement expected to increase OxC-Beta™ access and adoption in the largest feed production markets worldwide
• AB Vista to become exclusive distributor for use with poultry, swine, ruminants and aquaculture in United States, Brazil and Thailand
• AB Vista and Avivagen to collaborate on development efforts

Ottawa, ON/Business Wire/ October 1, 2021/ Leading global animal nutrition technology company AB Vista and Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”) today announced they have entered into a transformative supply agreement that is expected to expand the adoption and use of OxC-beta™ in a number of high-value feed production markets worldwide. The landmark eight-year deal will see AB Vista become the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand.

AB Vista is a global animal nutrition technology company supplying feed additives, nutrition expertise and analytical services to animal feed and protein producers.

“This is a truly transformative partnership for Avivagen, and one that stands to benefit not only us and AB Vista but feed and livestock producers in the Americas and Asia as well,” says Kym Anthony, Chief Executive Officer, Avivagen Inc. “We’ve had a lot of interest from potential partners for OxC-beta™, but AB Vista’s expertise and track record set it apart. With their industry-leading technical knowledge and know-how we are confident that this agreement will drive considerable adoption of OxC-beta™ and growth for Avivagen over the better part of the next decade.”

As a part of the agreement AB Vista and Avivagen will also collaborate on future development efforts, including advancing opportunities for OxC-beta™ use for aquaculture purposes (such as shrimp production). Aquaculture represents a new category for OxC-beta™ use, following considerable success with poultry, swine and ruminants in markets worldwide.

“We pride ourselves on bringing pioneering, high-value products and services to  the global animal feed market. We believe OxC-beta™ could be one of the next great innovations and advancements in animal nutrition, and we’re excited to be able to deliver this great product to our customers,” says Juan Ignacio Fernandez, Managing Director, AB Vista.

“Based on the extensive technical data supporting the role OxC-beta™ can have in reducing production reliance on antibiotics, we are confident our customers in the United States, Brazil and Thailand will have high demand for such a differentiated product.”

The United States and Brazil represent the world’s second and third largest feed production markets, accounting for nearly 300 million metric tonnes of feed produced in 2020[1]. More than one-quarter of 2021 international feed tonnage was produced in these two markets alone.

About AB Vista
AB Vista is a global feed additive business bringing pioneering products and technical services to the poultry, swine, ruminant and aquaculture sectors. Since its launch in 2005 the company has become a highly respected global player with top three market share positions in its core segments. The business uses its innovative product research, technical services and nutrition expertise to gather global insights that can be used to provide new ways of thinking to feed compounders, integrators and pre-mixers. With over 25 years’ experience in the NIR field and a global network of laboratories able to analyse feed samples, AB Vista provides the tools and expertise to allow its customer to better balance their ingredients. AB Vista is headquartered in the UK, with regional offices located in the USA, Brazil, Singapore, Spain, India, China, Germany and Finland.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the term of the agreement with AB Vista, expections as to expansion and adoption of products, Avivagen’s expectations as to future growth and results, the anticipated benefits of this agreement to Avivagen and others, future collaboration, future product development, Avivagen’s expectations as to growth in demand for Avivagen’s products,   the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, the supply agreement could be terminated prior to 8 years for a number of reasons, Avivagen’s products may not be adopted at the rate anticipated, Avivagen may not benefit from the supply agreement as anticipated, future collaboration and product development may not occur or may not be successful in developing viable products, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

AB Vista – a division of AB Agri Ltd
Lynsey Wickens
3 Woodstock Court, Blenheim Road, Marlborough Business Park,
Marlborough, Wiltshire, SN8 4AN
t +44 (0)1672 517662

e-mail: lynsey.wickens@abvista.com

[1] 2021 Alltech Global Feed Survey: https://www.petfoodindustry.com/articles/9973-th-annual-alltech-global-feed-survey-estimates-world-feed-production-increased-1

Thursday, September 30, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Reports 3Q21 Results; Pipeline Remains Strong

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

3Q21 Results. Avivagen reported revenue of $505,866 in the quarter, down from $612,530 last year. We had estimated revenue of $1.0 million. The majority of the miss comes from a 3.5 million tonne order shipped in the quarter for which the revenue has yet to be recognized. We estimate the delayed revenue to be in the $375,000 range. Net loss for the quarter was $1.5 million, or $0.03 per share versus a net loss of $787,424, or $0.02 per share, in 3Q20. We had forecast a net loss of $1.1 million, or $0.02 per share.


Pipeline.  The pipeline continues to expand, with management calling it “the strongest pipeline in Avivagen history. During the quarter, the Company secured a new customer win in Western Mexico, recorded its first order from Brazil and secured the first order with a major swine and poultry producer in Thailand. We expect OxC-beta to further penetrate the livestock feed market …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision.