Friday, January 28, 2022

Helius Medical Technologies (HSDT)(HSM:CA)
Terminating Research Coverage

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

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

Gregory Aurand, Senior Research Analyst, Noble Capital Markets, Inc.

Termination of Research Coverage. We are terminating research coverage of Helius Medical Technologies due to a reallocation of resources. Effective upon termination of coverage, investors should no longer rely on any of our prior research, financial estimates, or ratings for the Company.

This 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. 

Thursday, January 27, 2022

Avivagen Inc. (VIVXF)(VIV:CA)
Names A President, Reports Fiscal 2021 Results

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.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

4Q21 Results. Avivagen’s management reported revenue of $368,504 (all figures in Canadian $) in the quarter, up from $287,897 last year, but down from our estimated revenue of $1.4 million. The miss is mostly due to a Philippines order that will be recognized in the first quarter of fiscal 2022. Net loss for the quarter was $1.4 million, or $0.03 per share versus a net loss of $1.2 million, or $0.03 per share, in 4Q20. We had forecasted a net loss of $993,00, or $0.02 per share.


FY21 Results.  Revenue for the 2021 fiscal year was reported at $1.3 million, a $0.1 million increase over the prior year’s $1.2 million. Operating loss for the year totaled $4.1 million compared to a loss of $3.4 million in fiscal 2020, due to an increase in finance cost and increasing operational expenses. Net loss was reported at $6.4 million or $0.12 per share, versus a $4.8 million loss, or …

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. 

Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program

Research, News, and Market Data on Cocrystal Pharma

Novel broad-spectrum oral lead candidates CDI-988 and CDI-873, discovered using Cocrystal’s antiviral drug discovery platform, demonstrate superior in vitro potency against SARS-CoV-2 and activity against all variants of concern including Omicron

Clinical trials with oral program and CDI-45204 inhalation/pulmonary-delivered COVID-19 antiviral candidates expected to begin in 2022

BOTHELL, Wash., Jan. 27, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19. CDI-988 and CDI-873 target a highly conserved region in the active site of SARS-CoV-2 main (3CL) protease required for viral RNA replication. Cocrystal plans to initiate a first-in-human trial with one selected candidate as soon as possible this year.

Although CDI-988 and CDI-873 are chemically differentiated, both exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against current variants of concern including Omicron. In preclinical studies, both candidates demonstrated a favorable safety profile and pharmacokinetic properties supportive of daily oral dosing. Additionally, CDI-988 and CDI-873 were specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology.

“We are excited to have discovered two lead COVID-19 oral antiviral candidates that both demonstrate highly encouraging preclinical efficacy and safety data,” said Sam Lee, Cocrystal’s President and interim co-CEO. “We plan to continue evaluating both CDI-988 and CDI-873 for clinical development, while we are also rapidly advancing our inhalation/pulmonary SARS-CoV-2 lead candidate CDI-45205 toward clinical development. The objective of our multipronged strategy is to offer highly potent and safe antiviral therapeutics for hospitalized patients, as well as for those not requiring hospitalization, including for prophylactic use to provide protection to uninfected individuals who may become exposed. We expect one oral candidate in addition to our inhalation/pulmonary candidate to advance into clinical trials this year.”

“Cocrystal is focused on rapidly advancing COVID-19 therapeutic candidates with multiple routes of administration. The newly emerging Omicron variant continues to rapidly spread worldwide with breakthrough infection even in people who are fully vaccinated, demonstrating a critical need for effective antiviral therapy for COVID-19. We are very pleased to have two lead oral candidates, giving us a potential edge in the anticipated large oral delivery therapeutic market. In addition to initiating two COVID-19 trials in 2022, we anticipate completion of our influenza CC-42344 Phase 1 study this year,” said James Martin, Cocrystal’s CFO and interim co-CEO.

Earlier this month Cocrystal received guidance from the U.S. Food and Drug Administration (FDA) for further development of CDI-45205 in response to the Company’s pre-Investigational New Drug (IND) briefing package. The Company believes the FDA’s response clarifies the pathway for a planned Phase 1 study and provides direction for a subsequent Phase 2 study.

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with the Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About CC-42344
CC-42344 is a novel oral PB2 inhibitor that has shown excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as strains resistant to Tamiflu^® and Xofluza^™. CC-42344 also has favorable pharmacokinetic and drug-resistance profiles. Cocrystal has completed preclinical IND-enabling studies with CC-42344 and has received clearance from the Australian Human Research Ethics Committees (HREC) to initiate a Phase 1 clinical trial with subject enrollment expected to begin in the first quarter of 2022. The World Health Organization (WHO) estimates 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 Centers for Disease Control and Prevention (CDC) estimates that between October 1, 2019 and April 4, 2020, there were between 39 million and 56 million cases of influenza in the U.S., resulting in 410,000 to 740,000 hospitalizations and 24,000 to 62,000 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 influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses 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 our plans to commence clinical trials for our COVID-19 antiviral candidates in 2022, our further development of CDI-45205, the potential efficacy of our antiviral product candidates against existing and new variants of COVID-19, our anticipated completion of the Phase 1 study for our influenza CC-42344 product candidate in 2022, the anticipated continued need for therapeutic antiviral treatment and our potential advantages in the market for such products. 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 arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract research organizations (CROs) and future CROs and contract manufacturing organizations, the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, the presence of new lockdowns in Australia, the impact of the COVID-19 pandemic including new variants on the national and global economy, the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating development in our COVID-19 program and potential delays related to the FDA’s review of our submissions, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, and 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.

Ocugen, Inc. Signs Letter of Intent to Acquire Vaccine Manufacturing, R&D Hub in Ontario, Canada

Research, News, and Market Data on Ocugen

• Dormant Vaccine Manufacturing site currently owned by an affiliate of Liminal BioSciences intended to bring new capabilities to Ocugen’s medicine portfolio of Canadian and U.S. companies
• COVAXIN™ (BBV152), if approved, to be the first product manufactured in new upgraded facility
• New facility includes potential for manufacturing for breakthrough gene therapies and serve as R&D hub
• Site development, refurbishment and manufacturing intended to bring significant new regional economic opportunities

MALVERN, Pa., Jan. 27, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing breakthrough gene therapies and vaccines, announced that it has signed a non-binding letter of intent (LOI) with Liminal BioSciences, Inc. a Canadian public company with shares listed on NASDAQ   for the acquisition of their manufacturing site in Belleville, Ontario, for an undisclosed amount.

This site would enable Ocugen to expand its manufacturing and research and development capabilities to support its pipeline. This includes the manufacture of COVAXIN™ (BBV152), the company’s COVID-19 vaccine candidate, which was submitted to Health Canada for regulatory review by Ocugen’s Canadian affiliate, Vaccigen Ltd. This vaccine manufacturing facility has the potential to help Canada in its efforts to control the current and future pandemics for all Canadians.

“We believe establishing a manufacturing and R&D hub for our biotechnology platform is the right investment and next evolution of our business. This site, after transformation into a state-of-the-art hub, with the support of the regional talent pool can help bring our innovative products – from vaccines to our modifier gene therapy assets – to the patients we will serve globally,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc.

“We’re here to deliver to Canadians medical innovation that is going to make a difference in their lives. It’s also our intent to bring new opportunities for employment to the Belleville community that over time may bring significant economic growth to Ontario,” commented Dr. Ajay Potluri, Chief Executive Officer, Vaccigen Ltd.

“We are excited to see Ocugen’s plans to repurpose our dormant vaccine manufacturing facility and create vaccine manufacturing capacity in Canada. We thank Minister Champagne and his team at Innovation Science Economic Development (ISED) Canada who facilitated the introduction to Ocugen and Vaccigen.,” said Alek Krstajic, Chairman of the Board, Liminal BioSciences.

“We believe this could be an exciting opportunity for everyone involved, Liminal BioSciences, Ocugen, the province of Ontario, and most of all, the people of Canada, and we’re pleased to help facilitate this event by potentially selling a dormant vaccine manufacturing facility which is non-core to Liminal Biosciences and could be strategic to Ocugen,” said Peter Thomson, whose company, Thomvest, is a majority shareholder of Liminal BioSciences.

Completion of the proposed transaction is subject to finalization of due diligence investigations by the parties, the negotiation and execution of definitive transaction agreements and other customary closing conditions including certain funding requirements. There can be no assurance that a definitive agreement will be entered into or that the proposed transaction will be consummated. 

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S, currently under review by the U.S. Food and Drug Administration for emergency use authorization (EUA) for children 2-18 years of age. Additionally, an Investigational New Drug application (IND) is being discussed with the agency to support an immunobridging study among U.S. participants. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 200 million doses having been administered to adults and children outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Vaccigen Ltd.
Vaccigen Ltd. is the Canadian affiliate of Ocugen, Inc. We are working every day to make a difference in the lives of Canadians, starting with the commercialization of a COVID-19 vaccine. In the future, we will work to bring innovation against blindness derived from the assets within Ocugen’s gene therapy platform. Our goal is to be here for the health of all Canadians during this public health crisis and for the future. Learn more at www.vaccigen.ca.

About Liminal BioSciences Inc.
Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from fibrotic or inflammatory diseases that have a high unmet medical need.

Liminal BioSciences has active business operations in Canada and the United Kingdom.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about our non-binding letter of intent with Liminal BioSciences (Liminal) to acquire Liminal’s manufacturing site in Belleville, Ontario, including the anticipated terms of the potential acquisition, which are non-binding and subject to change, the potential manufacturing capability of such site, the potential regional economic opportunities that could result from our plans to further develop and refurbish the site following its acquisition, and the value of such site to our product pipeline, stockholders and the Canadian population, and are subject to risks and uncertainties that could cause actual results to differ materially from those express or implied by such statements, including, among other things, the risk that we may not be able to successfully negotiate and execute a definitive purchase agreement for the acquisition on acceptable terms, if at all, and the ultimate terms and timing for closing of the transactions contemplated thereby; the risk that we will not be able to successfully close the acquisition; risks associated with the planned development and refurbishing of the manufacturing site, including that the expected costs for such development will be greater than currently contemplated or that the planned development will take longer than expected or fail to be completed on a timely basis, if at all; and the risk that we will not be able to scale production for such site to adequately support manufacturing of our product candidates or the other products that are currently or may in the future be manufactured at such site. In addition, our business is subject to numerous other risks and uncertainties, including, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that Health Canada does not accept our new drug submission (NDS) for COVAXIN™ or that we may not be able to adequately respond to or resolve the deficiencies noted by Health Canada with respect to our NDS, for which we are preparing responses; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the U.S. Food and Drug Administration (FDA) could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for Emergency Use Authorization (EUA) of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com

PDS Biotech Announces Preclinical Data for PDS0202 Universal Influenza Vaccine

Research, News, and Market Data on PDS Biotech

PDS0202 (Infectimune™ + COBRA Influenza Antigens) neutralized multiple strains of the flu and provided effective protection against infection in preclinical studies

FLORHAM PARK, N.J., Jan. 27, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced preclinical data for its universal flu vaccine, which was shown to be effective against multiple strains of the influenza virus.

Due to the existence of multiple strains of flu, a new seasonal flu vaccination is usually developed to provide protection against the strains predicted to be prevalent in an upcoming flu season. As a result, the protective efficacy of the current vaccines varies widely from season to season. PDS Biotechnology is developing a new generation of flu vaccines with the potential to provide long-lasting, and broad protection against multiple strains of the virus. We believe that the successful development of a universal flu vaccine could eliminate the need to create a vaccine to protect against each year’s predicted variants. According to the World Health Organization, influenza causes 3 to 5 million cases and approximately 290,000 to 650,000 deaths each year.

PDS0202 combines PDS Biotech’s proprietary Infectimune™ technology with proprietary COBRA (Computationally Optimized Broadly Reactive Antigens) designed by renowned influenza expert Dr. Ted Ross. PDS Biotech announced an agreement with the University of Georgia to license the COBRA antigens.

The NIAID-sponsored preclinical work was performed by Dr. Jerold Woodward at the University of Kentucky College of Medicine and Dr. Ted Ross at the University of Georgia, in collaboration with PDS Biotech. Dr. Ted Ross is Principal Investigator at the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Center (CIVICs) located at the University of Georgia. The studies demonstrated the ability of PDS0202 to promote robust induction of broadly neutralizing influenza -specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T-cells, as well as long-lasting memory T-cells. This well characterized and robust immune response to the COBRA antigens suggests strong potential for broad and long-term protection against multiple strains of influenza.

“We are excited by the highly promising preclinical results generated in collaboration with Drs. Woodward and Ross,” said Dr. Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “The COBRA antigens provide an innovative approach to generating broadly effective immune responses against influenza, which when combined with our Infectimune™ platform may provide effective neutralization and protection against infection. The data suggest that PDS0202, has the potential to overcome the well documented limitations faced in developing a universal influenza vaccine.”

“The novel mechanisms by which the PDS Biotech-patented lipids activate critical immunological pathways may allow us to develop a new generation of vaccines that could be more effective in protecting us from infectious pathogens like influenza and Covid-19,” stated Jerold Woodward, Ph.D., Professor of Immunology at the University of Kentucky, College of Medicine.

“The preclinical results show the potential for PDS0202 to be effective in preventing viral invasion of the lungs by multiple strains of the influenza virus,” stated Ted Ross, Ph.D., Professor, and Director of the Center for Vaccines and Immunology, University of Georgia. “We look forward to seeing the PDS0202-COBRA vaccine in future human trials.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

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 HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. 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 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 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 (including, without limitation, any preclinical results or data), 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.

Investor Contact:

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

ProMIS Neurosciences Appoints Internationally Recognized Neuroscientist Dr. Cheryl Wellington to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

TORONTO, Ontario and CAMBRIDGE, Mass., Jan. 27, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, announced today that it has appointed Dr. Cheryl Wellington to its scientific advisory board (SAB).

Dr. Cheryl Wellington, Professor of Pathology and Laboratory Medicine at the University of British Columbia (UBC), has built an internationally recognized research program that focuses on neurological diseases, with a particular emphasis on Alzheimer’s Disease (AD) and Traumatic Brain Injury (TBI). 

“We are delighted to welcome Dr. Wellington to the ProMIS SAB,” stated Dr. Neil Cashman, ProMIS’ Chief Scientific Officer. “In addition to her outstanding contributions to the understanding of AD and TBI, we are duly impressed by her research group that is one of the most experienced in North America on ultrasensitive blood-based biomarker tests for a number of neurological and neurodegenerative conditions, including Alzheimer’s disease.”

The emerging ability to measure biomarkers such as NfL (neurofilament light chain), P-tau (phosphorylated tau protein) and GFAP (glial fibrillary acidic protein) in blood samples as opposed to cerebrospinal fluid (CSF) offers several advantages such as its relatively non-invasive nature, lower risk of complications and ease with which blood draws can be repeated on a regular basis. These advantages make blood-based biomarkers ideal tools in AD clinical trials to assist in diagnosis and monitoring of patient progress on therapy.

Commenting on her appointment to the ProMIS SAB, Dr. Wellington stated: “ProMIS’s approach to targeting the root cause of many brain diseases is of exceptional interest and importance. I am honored to join the Scientific Advisory Board to advise and assist in their programs.”

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting misfolded proteins such as toxic misfolded oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF
Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

	Image Credit: MIT News

An All-In-One Approach to Diabetes Treatment

Anne Trafton | MIT News Office

Before consuming a meal, many people with diabetes need to inject themselves with insulin. This is a time-consuming process that often requires estimating the carbohydrate content of the meal, drawing blood to measure blood glucose levels, and then calculating and delivering the correct insulin dose.

Those steps, which typically must be repeated for every meal, make it difficult for many patients with diabetes to stick with their treatment regimen. A team of MIT researchers has now come up with a new approach to streamline the process and help
patients maintain healthy glucose levels.

“Any intervention that makes it easier for patients to receive therapy can have an enormous impact, because there are multiple barriers that have to do with time, inconvenience, dexterity, or learning and training,” says Giovanni Traverso, the Karl van Tassel Career Development Assistant Professor of Mechanical Engineering at MIT and a gastroenterologist at Brigham and Women’s Hospital. “If we’re able to overcome those barriers through the implementation of new engineering solutions, it will make it easier for patients to receive that therapy.”

Traverso and his colleagues designed two different devices that can simplify the process of calculating and injecting the correct dose of insulin. One, which combines many of the existing steps into a single device, could be used in patients in the near future. Their second prototype incorporates flexible electronics onto the surface of a needle so that the blood measurement and insulin delivery can happen through the same needle. This could eventually make the process of managing diabetes even more streamlined.

All In One Device

Diabetes affects 34 million people in the United States and more than 400 million people worldwide. Patients with diabetes often use two types of insulin to control their blood sugar levels: long-acting insulin, which helps control glucose levels over a 24-hour period, and short-acting insulin, which is injected at mealtimes. Patients first measure their blood glucose levels with a glucose meter, which requires pricking their finger to draw blood and placing a drop of blood onto a test strip. They must also estimate how many carbohydrates are in their meal and combine this information with their blood glucose levels to calculate and inject the proper insulin dose.

Existing technologies such as continuous blood glucose monitors and insulin pumps can help with some parts of this process. However, these devices are not widely available, so most patients must rely on finger pricks and syringes.

“Every day, many patients need to do this complicated procedure at least three times,” Huang says. “The main goal of this project is to try to facilitate all of these complex procedures and also to eliminate the requirement for multiple devices. We also used a smartphone camera and deep learning to create an app that identifies and quantifies food content, which can aid in carbohydrate counting.”

The research team devised two different types of “all-in-one” devices, both of which incorporate the new smartphone app. Patients first take a picture of the food, and the app can then estimate the volume of food and the amount of carbohydrates, based on nutrient information from a USDA database.

The first all-in-one device that the researchers designed consolidates many of the existing tools that patients use now, including a lancet for drawing blood and glucose test strips. Once the blood glucose measurement is taken, the device conveys the information to the smartphone app via Bluetooth, and the app calculates the correct insulin dose. The device also includes a needle that injects the correct amount of insulin.

“What our device is doing is automating the procedures to prick the skin, collect the blood, calculate the glucose level, and do the computation and insulin injection,” Huang says. “The patient no longer needs a separate lancing device, glucose meter, and insulin pen.”

Many of the components included in this device are already FDA-approved, but the device has not been tested in human patients yet. Tests in pigs showed that the system could accurately measure glucose levels and dispense insulin.

A Single Jab

For their second device, the researchers wanted to come up with a system that would require just one needle prick. To achieve that, they designed a novel glucose sensor that could be incorporated into the same needle that is used for insulin injection.

“The idea would be that if we can integrate the glucose sensor directly onto the surface of the insulin delivery needle, we would only need one stick for the patient, which minimizes pain and also makes the whole process easier to administer,” You says.

The researchers designed a flexible electronic sensor that can be attached to the needle and measure glucose levels in the interstitial fluid, just below the surface of the skin. Once the needle penetrates the skin, it takes between five and 10 seconds to measure the glucose levels. This information is transmitted to the smartphone app, which calculates the insulin dose and delivers it through the inserted needle.

In tests in the pigs, the researchers showed that they could accurately measure glucose levels with this system, and that glucose levels dropped after insulin injection.

Because this device uses a novel type of glucose sensor, the researchers expect that it will require further development to get to a point where it could be tested in patients. They have filed for patents on both of the systems described in the new study and hope to work with companies to further develop them.

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This article originally appeared in MIT News on January 20, 2022 and has been Shared with Permission

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ProMIS Neurosciences Appoints Internationally Recognized Neuroscientist Dr. Cheryl Wellington to its Scientific Advisory Board

News and Market Data on ProMIS Neurosciences

TORONTO, Ontario and CAMBRIDGE, Mass., Jan. 27, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers implicated in the development of neurodegenerative diseases, announced today that it has appointed Dr. Cheryl Wellington to its scientific advisory board (SAB).

Dr. Cheryl Wellington, Professor of Pathology and Laboratory Medicine at the University of British Columbia (UBC), has built an internationally recognized research program that focuses on neurological diseases, with a particular emphasis on Alzheimer’s Disease (AD) and Traumatic Brain Injury (TBI). 

“We are delighted to welcome Dr. Wellington to the ProMIS SAB,” stated Dr. Neil Cashman, ProMIS’ Chief Scientific Officer. “In addition to her outstanding contributions to the understanding of AD and TBI, we are duly impressed by her research group that is one of the most experienced in North America on ultrasensitive blood-based biomarker tests for a number of neurological and neurodegenerative conditions, including Alzheimer’s disease.”

The emerging ability to measure biomarkers such as NfL (neurofilament light chain), P-tau (phosphorylated tau protein) and GFAP (glial fibrillary acidic protein) in blood samples as opposed to cerebrospinal fluid (CSF) offers several advantages such as its relatively non-invasive nature, lower risk of complications and ease with which blood draws can be repeated on a regular basis. These advantages make blood-based biomarkers ideal tools in AD clinical trials to assist in diagnosis and monitoring of patient progress on therapy.

Commenting on her appointment to the ProMIS SAB, Dr. Wellington stated: “ProMIS’s approach to targeting the root cause of many brain diseases is of exceptional interest and importance. I am honored to join the Scientific Advisory Board to advise and assist in their programs.”

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting misfolded proteins such as toxic misfolded oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). The Company’s proprietary target discovery engine is based on the use of two complementary computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF
Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

PDS Biotech Announces Preclinical Data for PDS0202 Universal Influenza Vaccine

Research, News, and Market Data on PDS Biotech

PDS0202 (Infectimune™ + COBRA Influenza Antigens) neutralized multiple strains of the flu and provided effective protection against infection in preclinical studies

FLORHAM PARK, N.J., Jan. 27, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced preclinical data for its universal flu vaccine, which was shown to be effective against multiple strains of the influenza virus.

Due to the existence of multiple strains of flu, a new seasonal flu vaccination is usually developed to provide protection against the strains predicted to be prevalent in an upcoming flu season. As a result, the protective efficacy of the current vaccines varies widely from season to season. PDS Biotechnology is developing a new generation of flu vaccines with the potential to provide long-lasting, and broad protection against multiple strains of the virus. We believe that the successful development of a universal flu vaccine could eliminate the need to create a vaccine to protect against each year’s predicted variants. According to the World Health Organization, influenza causes 3 to 5 million cases and approximately 290,000 to 650,000 deaths each year.

PDS0202 combines PDS Biotech’s proprietary Infectimune™ technology with proprietary COBRA (Computationally Optimized Broadly Reactive Antigens) designed by renowned influenza expert Dr. Ted Ross. PDS Biotech announced an agreement with the University of Georgia to license the COBRA antigens.

The NIAID-sponsored preclinical work was performed by Dr. Jerold Woodward at the University of Kentucky College of Medicine and Dr. Ted Ross at the University of Georgia, in collaboration with PDS Biotech. Dr. Ted Ross is Principal Investigator at the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Center (CIVICs) located at the University of Georgia. The studies demonstrated the ability of PDS0202 to promote robust induction of broadly neutralizing influenza -specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T-cells, as well as long-lasting memory T-cells. This well characterized and robust immune response to the COBRA antigens suggests strong potential for broad and long-term protection against multiple strains of influenza.

“We are excited by the highly promising preclinical results generated in collaboration with Drs. Woodward and Ross,” said Dr. Lauren V. Wood, MD, Chief Medical Officer of PDS Biotech. “The COBRA antigens provide an innovative approach to generating broadly effective immune responses against influenza, which when combined with our Infectimune™ platform may provide effective neutralization and protection against infection. The data suggest that PDS0202, has the potential to overcome the well documented limitations faced in developing a universal influenza vaccine.”

“The novel mechanisms by which the PDS Biotech-patented lipids activate critical immunological pathways may allow us to develop a new generation of vaccines that could be more effective in protecting us from infectious pathogens like influenza and Covid-19,” stated Jerold Woodward, Ph.D., Professor of Immunology at the University of Kentucky, College of Medicine.

“The preclinical results show the potential for PDS0202 to be effective in preventing viral invasion of the lungs by multiple strains of the influenza virus,” stated Ted Ross, Ph.D., Professor, and Director of the Center for Vaccines and Immunology, University of Georgia. “We look forward to seeing the PDS0202-COBRA vaccine in future human trials.”

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

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 HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. 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 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 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 (including, without limitation, any preclinical results or data), 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.

Investor Contact:

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

Ocugen, Inc. Signs Letter of Intent to Acquire Vaccine Manufacturing, R&D Hub in Ontario, Canada

Research, News, and Market Data on Ocugen

• Dormant Vaccine Manufacturing site currently owned by an affiliate of Liminal BioSciences intended to bring new capabilities to Ocugen’s medicine portfolio of Canadian and U.S. companies
• COVAXIN™ (BBV152), if approved, to be the first product manufactured in new upgraded facility
• New facility includes potential for manufacturing for breakthrough gene therapies and serve as R&D hub
• Site development, refurbishment and manufacturing intended to bring significant new regional economic opportunities

MALVERN, Pa., Jan. 27, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing breakthrough gene therapies and vaccines, announced that it has signed a non-binding letter of intent (LOI) with Liminal BioSciences, Inc. a Canadian public company with shares listed on NASDAQ   for the acquisition of their manufacturing site in Belleville, Ontario, for an undisclosed amount.

This site would enable Ocugen to expand its manufacturing and research and development capabilities to support its pipeline. This includes the manufacture of COVAXIN™ (BBV152), the company’s COVID-19 vaccine candidate, which was submitted to Health Canada for regulatory review by Ocugen’s Canadian affiliate, Vaccigen Ltd. This vaccine manufacturing facility has the potential to help Canada in its efforts to control the current and future pandemics for all Canadians.

“We believe establishing a manufacturing and R&D hub for our biotechnology platform is the right investment and next evolution of our business. This site, after transformation into a state-of-the-art hub, with the support of the regional talent pool can help bring our innovative products – from vaccines to our modifier gene therapy assets – to the patients we will serve globally,” said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder, Ocugen, Inc.

“We’re here to deliver to Canadians medical innovation that is going to make a difference in their lives. It’s also our intent to bring new opportunities for employment to the Belleville community that over time may bring significant economic growth to Ontario,” commented Dr. Ajay Potluri, Chief Executive Officer, Vaccigen Ltd.

“We are excited to see Ocugen’s plans to repurpose our dormant vaccine manufacturing facility and create vaccine manufacturing capacity in Canada. We thank Minister Champagne and his team at Innovation Science Economic Development (ISED) Canada who facilitated the introduction to Ocugen and Vaccigen.,” said Alek Krstajic, Chairman of the Board, Liminal BioSciences.

“We believe this could be an exciting opportunity for everyone involved, Liminal BioSciences, Ocugen, the province of Ontario, and most of all, the people of Canada, and we’re pleased to help facilitate this event by potentially selling a dormant vaccine manufacturing facility which is non-core to Liminal Biosciences and could be strategic to Ocugen,” said Peter Thomson, whose company, Thomvest, is a majority shareholder of Liminal BioSciences.

Completion of the proposed transaction is subject to finalization of due diligence investigations by the parties, the negotiation and execution of definitive transaction agreements and other customary closing conditions including certain funding requirements. There can be no assurance that a definitive agreement will be entered into or that the proposed transaction will be consummated. 

About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S, currently under review by the U.S. Food and Drug Administration for emergency use authorization (EUA) for children 2-18 years of age. Additionally, an Investigational New Drug application (IND) is being discussed with the agency to support an immunobridging study among U.S. participants. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 200 million doses having been administered to adults and children outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in more than 20 countries, and emergency use authorization is in process in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.

About Vaccigen Ltd.
Vaccigen Ltd. is the Canadian affiliate of Ocugen, Inc. We are working every day to make a difference in the lives of Canadians, starting with the commercialization of a COVID-19 vaccine. In the future, we will work to bring innovation against blindness derived from the assets within Ocugen’s gene therapy platform. Our goal is to be here for the health of all Canadians during this public health crisis and for the future. Learn more at www.vaccigen.ca.

About Liminal BioSciences Inc.
Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from fibrotic or inflammatory diseases that have a high unmet medical need.

Liminal BioSciences has active business operations in Canada and the United Kingdom.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about our non-binding letter of intent with Liminal BioSciences (Liminal) to acquire Liminal’s manufacturing site in Belleville, Ontario, including the anticipated terms of the potential acquisition, which are non-binding and subject to change, the potential manufacturing capability of such site, the potential regional economic opportunities that could result from our plans to further develop and refurbish the site following its acquisition, and the value of such site to our product pipeline, stockholders and the Canadian population, and are subject to risks and uncertainties that could cause actual results to differ materially from those express or implied by such statements, including, among other things, the risk that we may not be able to successfully negotiate and execute a definitive purchase agreement for the acquisition on acceptable terms, if at all, and the ultimate terms and timing for closing of the transactions contemplated thereby; the risk that we will not be able to successfully close the acquisition; risks associated with the planned development and refurbishing of the manufacturing site, including that the expected costs for such development will be greater than currently contemplated or that the planned development will take longer than expected or fail to be completed on a timely basis, if at all; and the risk that we will not be able to scale production for such site to adequately support manufacturing of our product candidates or the other products that are currently or may in the future be manufactured at such site. In addition, our business is subject to numerous other risks and uncertainties, including, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; the risk that Health Canada does not accept our new drug submission (NDS) for COVAXIN™ or that we may not be able to adequately respond to or resolve the deficiencies noted by Health Canada with respect to our NDS, for which we are preparing responses; the risk that we may not resolve the current clinical hold on COVAXIN™ in the near term or at all, or that the U.S. Food and Drug Administration (FDA) could make other decisions that adversely impact our ability to advance the development of COVAXIN™ in the United States, and the implications that this clinical hold may have for our request for Emergency Use Authorization (EUA) of COVAXIN for pediatric use, including the timing and scope of any such authorization; risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the data and results from the preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India, will be accepted by the FDA or otherwise sufficient to support our EUA submission or planned BLA submission, assuming the clinical hold is lifted; the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support an EUA or BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit to the FDA; whether and when a BLA for COVAXIN™ will be submitted to or approved by the FDA; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com

Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program

Research, News, and Market Data on Cocrystal Pharma

Novel broad-spectrum oral lead candidates CDI-988 and CDI-873, discovered using Cocrystal’s antiviral drug discovery platform, demonstrate superior in vitro potency against SARS-CoV-2 and activity against all variants of concern including Omicron

Clinical trials with oral program and CDI-45204 inhalation/pulmonary-delivered COVID-19 antiviral candidates expected to begin in 2022

BOTHELL, Wash., Jan. 27, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19. CDI-988 and CDI-873 target a highly conserved region in the active site of SARS-CoV-2 main (3CL) protease required for viral RNA replication. Cocrystal plans to initiate a first-in-human trial with one selected candidate as soon as possible this year.

Although CDI-988 and CDI-873 are chemically differentiated, both exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against current variants of concern including Omicron. In preclinical studies, both candidates demonstrated a favorable safety profile and pharmacokinetic properties supportive of daily oral dosing. Additionally, CDI-988 and CDI-873 were specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology.

“We are excited to have discovered two lead COVID-19 oral antiviral candidates that both demonstrate highly encouraging preclinical efficacy and safety data,” said Sam Lee, Cocrystal’s President and interim co-CEO. “We plan to continue evaluating both CDI-988 and CDI-873 for clinical development, while we are also rapidly advancing our inhalation/pulmonary SARS-CoV-2 lead candidate CDI-45205 toward clinical development. The objective of our multipronged strategy is to offer highly potent and safe antiviral therapeutics for hospitalized patients, as well as for those not requiring hospitalization, including for prophylactic use to provide protection to uninfected individuals who may become exposed. We expect one oral candidate in addition to our inhalation/pulmonary candidate to advance into clinical trials this year.”

“Cocrystal is focused on rapidly advancing COVID-19 therapeutic candidates with multiple routes of administration. The newly emerging Omicron variant continues to rapidly spread worldwide with breakthrough infection even in people who are fully vaccinated, demonstrating a critical need for effective antiviral therapy for COVID-19. We are very pleased to have two lead oral candidates, giving us a potential edge in the anticipated large oral delivery therapeutic market. In addition to initiating two COVID-19 trials in 2022, we anticipate completion of our influenza CC-42344 Phase 1 study this year,” said James Martin, Cocrystal’s CFO and interim co-CEO.

Earlier this month Cocrystal received guidance from the U.S. Food and Drug Administration (FDA) for further development of CDI-45205 in response to the Company’s pre-Investigational New Drug (IND) briefing package. The Company believes the FDA’s response clarifies the pathway for a planned Phase 1 study and provides direction for a subsequent Phase 2 study.

About CDI-45205
CDI-45205 is among a group of protease inhibitors obtained by Cocrystal under an exclusive license agreement with the Kansas State University Research Foundation (KSURF) in 2020. CDI-45205 and several analogs showed potent in vitro activity against the SARS-CoV-2 Delta (India/B.1.617.2), Gamma (Brazil/P.1), Alpha (United Kingdom/B.1.1.7) and Beta (South African/B.1.351) variants, surpassing the activity observed with the original Wuhan strain. CDI-45205 has also shown good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. Preclinical research demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in mice infected with MERS-CoV-2.

About CC-42344
CC-42344 is a novel oral PB2 inhibitor that has shown excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as strains resistant to Tamiflu^® and Xofluza^™. CC-42344 also has favorable pharmacokinetic and drug-resistance profiles. Cocrystal has completed preclinical IND-enabling studies with CC-42344 and has received clearance from the Australian Human Research Ethics Committees (HREC) to initiate a Phase 1 clinical trial with subject enrollment expected to begin in the first quarter of 2022. The World Health Organization (WHO) estimates 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 Centers for Disease Control and Prevention (CDC) estimates that between October 1, 2019 and April 4, 2020, there were between 39 million and 56 million cases of influenza in the U.S., resulting in 410,000 to 740,000 hospitalizations and 24,000 to 62,000 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 influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses 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 our plans to commence clinical trials for our COVID-19 antiviral candidates in 2022, our further development of CDI-45205, the potential efficacy of our antiviral product candidates against existing and new variants of COVID-19, our anticipated completion of the Phase 1 study for our influenza CC-42344 product candidate in 2022, the anticipated continued need for therapeutic antiviral treatment and our potential advantages in the market for such products. 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 arising from supply chain disruptions on our ability to obtain products including raw materials and test animals as well as similar problems with our vendors and our current contract research organizations (CROs) and future CROs and contract manufacturing organizations, the ability of our CROs to recruit volunteers for, and to proceed with, clinical trials, the presence of new lockdowns in Australia, the impact of the COVID-19 pandemic including new variants on the national and global economy, the duration of presently discovered COVID-19 variants and our ability to treat new variants, the cooperation of the FDA in accelerating development in our COVID-19 program and potential delays related to the FDA’s review of our submissions, our collaboration partners’ technology and software performing as expected, the results of future preclinical and clinical trials, and 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 Announces CEO Update to Shareholders

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ January 26, 2022 /– Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Company”), 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, announces a CEO update to shareholders.

To our shareholders,

2021 was a year of challenge for all industries, with the global feed production industry no exception. With higher input costs that could not be passed along to consumers, ongoing COVID-19 pandemic concerns and worldwide supply chain challenges, many producers experienced financial difficulties and retrenchment, impacting every supplier they do business with – including Avivagen[i].

However, it appears that the environment is now becoming more favourable. After a period of delays numerous important Avivagen customers tell us they expect to ramp up activities in 2022. In turn, purchases of OxC-beta^TM Livestock are anticipated to scale up, reaching volumes more in line with previous expectations. We’re seeing continued progress with trials and regulatory processes, and discussions with prospective customers, potential distribution partners and stakeholders worldwide are advancing.

We feel we are in the early days of resuming our growth plans and we are excited for what is on the horizon. Given developments in the broader market and within our Company, we feel now is a suitable time to provide and update on the recent progress that has been made and our outlook on the months and year ahead.

New leadership for a new stage of growth
As a part of our ongoing commitment to building the best possible team for the future of our business, we recently announced the appointment of Jamie Nickerson to the role of President, effective January 25, 2022. Jamie has been a core member of the Avivagen team for 15 years, most recently becoming the main contact with  many of our most important and lucrative relationships and developing new applications for our OxC-beta^TM product as Vice President of Business Development and Innovation.  Few understand the Avivagen science, value proposition, market and business opportunity as completely as Jamie, making him the perfect individual to lead the next phase of growth for the Company.

This year we established important new relationships through our Mexico-based partner, Meyenberg International Group that will help spearhead expansion efforts in Central and South America. We also added Mr. Lesley Nernberg as a technical sales and marketing consultant with the goal of accelerating the adoption of OxC-beta^TM Livestock in multiple Asian markets.

Strategic partnerships and regulatory milestones
This fall we announced a transformative supply agreement with AB Vista to expand marketing and sale of OxC-beta^TM Livestock in high value markets such the United States, Brazil and Thailand. Trials with several AB Vista customers are already underway and we expect sales from this partnership to start and grow steadily throughout 2022. We also continue to seek similar strategic partnerships in additional major global feed markets.

We have continued our efforts to expand regulatory approval for use of our products and are expecting approvals for livestock use in both Vietnam and China over the coming months. In anticipation of these approvals, we have initiated discussions with both prospective customers and distributors in both markets.  Our previously announced distribution partner for Philippines, Inphilco, has successfully registered their own branded OxC-beta-based product and are beginning trials with several of its local customers. We are actively working towards new regulatory approvals in five key regions in South America and expect other regulatory developments for both companion animals (Vivamune) and humans.

Growing recognition from the scientific community
A recent analysis published in the Lancet, an international medical journal, reports that antibiotic resistance kills more than one million people each year– proving the critical need for safe and suitable alternatives to antibiotics[ii]. Concurrently, there has a marked increase in both the recognition and acceptance of our technology, due in part to a number of papers appearing in top-tier scientific publications – including several reaffirming the safety and utility of using OxC-beta^TM Livestock as an alternative to antibiotics in broilers, sows and cows. These include:

• Kang, M., Oh, J.Y., Cha, S.Y., Kim, W.I., Cho, H.S., Jang, H.K., 2018. Efficacy of polymers from spontaneous carotenoid oxidation in reducing necrotic enteritis in broilers. Poultry Sci. 97, 3058-3062 doi: 10.3382/ps/pey180.
• Chen, J., Chen, J., Zhang, Y., Lv, Y., Qiao, H., Tian, M., Cheng, L., Chen, F., Zhang, S., Guan, W., 2020. Effects of maternal supplementation with fully oxidised ?-carotene on the reproductive performance and immune response of sows, as well as the growth performance of nursing piglets. Brit. J. Nutr., 1-9 doi: 10.1017/S0007114520002652.
• Riley, W.W., Nickerson, J.G., Burton, G.W., 2021. Effect of Oxidized ?-Carotene on the Growth and Feed Efficiency of Broilers. Poultry Sci., 101088 doi: https://doi.org/10.1016/j.psj.2021.101088.
• Burton, G.W., Mogg, T.J., Riley, W.W., Nickerson, J.G., 2021. Beta-Carotene oxidation products – Function and safety. Food Chem. Toxicol. 152, 112207 doi: 10.1016/j.fct.2021.112207.
• Mogg, T.J., Burton, G.W., 2021. The ?-carotene–oxygen copolymer: its relationship to apocarotenoids and ?-carotene function. Can. J. Chem. 99, 751-762 doi: 10.1139/cjc-2021-0006.
• McDougall, S., 2021. Evaluation of fully oxidised ?-carotene as a feed ingredient to reduce bacterial infection and somatic cell counts in pasture-fed cows with subclinical mastitis. N.Z. Vet. J., 1-9 doi: 10.1080/00480169.2021.1924091.

Positive customer developments signal opportunity in 2022 and beyond
A tough economic environment led many feed producers in markets worldwide to scale back in 2021, a reality that directly impacted our key relationships in Mexico in particular. However, customers such as Industrias Melder and Tranformadora appear to be entering 2022 on much stronger footing, meaning significant commercial agreements previously secured could resume shortly. Additionally, successful trials have been completed with large and well-known dairy and poultry producers in Mexico which we expect should result in new orders placed within the coming weeks. We have also secured a number of smaller but important agreements in Asia that will diversify our customer base and product applications over the coming years. In the companion animal space, our Vivamune dog chews have been successfully introduced in Taiwan and our OxC-beta product is being used as a cornerstone ingredient in a premium dog food brand.

A new look for Avivagen
Our recently relaunched website could be seen as a marker for the next phase of Avivagen as a company, as we build off of the foundational success achieved to date and enter a period of new leadership and growth over the coming months and years. We have seen early success in numerous key markets, and with growing recognition from the scientific community and regulatory authorities we believe Avivagen is poised to grow that number. We have established important and lucrative relationships in many of the largest feed-producing markets in the world and secured expert support to help us develop new relationships that will enable growth in our livestock, companion animal and human nutrition businesses.

After two years of global uncertainty there are brighter and healthier days on the horizon.

None of this would be possible without the partnership and support of our shareholders. I thank you for your continued confidence in Avivagen, its leadership and its vision as we move into the next phase of growth.

Sincerely,

Kym Anthony
Chief Executive Officer

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 thatproduct 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 Avivagen’s expectation that customers will ramp up activities in 2022, expected growth in demand and orders for Avivagen’s products, the timing, outcomes and potential benefits of trials and regulatory processes underway, the potential for regulatory approval in additional jurisdictions, the expectations that current partner and customer discussions will result in agreements and orders that are beneficial to Avivagen, the expected resumption of orders and shipments to customers in Mexico, Avivagen’s ability to diversify its customer base in the future and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are 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 industry and Avivagen’s customers may not rebound as quickly as expected, COVID or another event outside their control could impact customer and partner buying decisions, demand may not increase or stay at the same levels for Avivagen products, trials may not be completed or the results of trials may not result in benefits to Avivagen, 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 as growth promoters in livestock feeds 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
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Avivagen Announces Appointment of James Nickerson as President

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ January 25, 2022 /– 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 excited to announce the appointment of James  (“Jamie”) Nickerson, PhD as President of Avivagen. The appointment will be effective immediately.

“Jamie has been one of the most important members of Avivagen since the early days of the organization. His impressive track record contributing to both the science behind our offerings, as well as the growth of the business surrounding them, makes him the perfect individual to lead the next phase of growth for our company,” says Kym Anthony, Chief Executive Officer of Avivagen. “I look forward to working closely with Jamie as he establishes himself in the role and assumes leadership of Avivagen during this exciting and important stage of the company’s success.”

Currently Mr. Nickerson holds the role of Vice President of Business Development and Innovation for Avivagen. In this role he has been crucial in identifying and establishing a number of the strategic and  important customer and distribution partner relationships that are core to Avivagen’s ongoing growth and global expansion. He has also been central in finding new applications for the company’s OxC-beta™  product in both the animal and human nutrition fields.

Upon joining Avivagen in 2007, Mr. Nickerson established Avivagen’s Charlottetown biological research facility and directed the research and development program as senior research biologist. Over the next 15 years he held progressively senior roles within the company, including Director of Biology and Director of Commercialization Science, prior to taking over Business Development and Innovation responsibilities. During this period he also co-authored six scientific papers on Avivagen’s oxidized carotenoid technology platform, and is listed as an author on seven patents relating to the company’s product.

“I’ve been proud to be a part of the Avivagen journey for the past 15 years and am very excited to have the opportunity to lead this exciting next phase of the company,” said Mr. Nickerson. “We have laid the foundation to become an important global player in the future of both animal and human nutrition at a time when antibiotic effectiveness is waning in both areas. There is a bright future ahead for Avivagen, and I look forward to working closely with our team, our customers, our partners and our shareholders to take full advantage of the opportunities at hand.”

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 future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are 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, 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 as growth promoters in livestock feeds 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
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.