Tonix Pharmaceuticals Initiates Enrollment in Phase 2 PREVAIL Study of TNX-102 SL for the Treatment of Long COVID

Research, News, and Market Data on Tonix Pharmaceuticals

August 22, 2022 7:00am EDT

Results from Planned Interim Analysis Expected
First Half 2023

Long COVID Afflicts More Than 30% of Patients
Following Infection with SARS-CoV-2, the Virus that Causes COVID-19, and is
Expected to be a Global Health Burden

Concerning Rate of Opioid Use Observed in Long
COVID Patients with Multi-Site Pain

CHATHAM, N.J., Aug. 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 2 PREVAIL study of TNX-102 SL¹ as a potential treatment for a subset of patients with Long COVID syndrome (Long COVID) whose symptoms overlap with fibromyalgia. Long COVID is known officially as Post-Acute Sequelae of COVID-19 (PASC)².

“We are pleased to be starting a Phase 2 clinical study in this indication which is a growing problem and for which no drug is currently approved. We believe Long COVID, characterized by multi-site pain, fatigue and sleep disturbance, has features of central sensitization syndromes similar to fibromyalgia. Fibromyalgia is considered one of the clusters of chronic overlapping pain conditions that have much in common with Long COVID,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Findings from our retrospective observational database study in over 50,000 Long COVID patients showed that more than 40% of Long COVID patients in the sample have fibromyalgia-like multi-site pain symptoms, suggesting that we should be able to recruit a robust cohort of participants to test the effects of TNX-102 SL in treating this condition. Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia. We recognize the need to better understand and develop treatment for Long COVID.”

“This retrospective observational database study also revealed the rate of opioid use in Long COVID patients,” said Greg Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Opioid use was noted in 36% of Long COVID patients with multi-site pain symptoms relative to 19% of Long COVID patients without multi-site pain. In those with multi-site pain, opioid use increased to 39% of patients when fatigue was present, and 50% when insomnia was present. We look forward to continuing to progress this study with the goal of developing a non-addictive, centrally acting analgesic which potentially treats not only pain but also the sleep disturbance and fatigue that are common in Long COVID.”

About the Phase 2 PREVAIL
Study

The Phase 2 PREVAIL study is 14-week double-blind, randomized, multicenter, placebo-controlled study to evaluate the efficacy and safety of TNX-102 SL taken daily at bedtime in patients with multi-site pain associated with post-acute sequelae of SARS-COV-2 infection (PASC). The trial is being conducted at approximately 30 sites in the U.S. and is expected to enroll approximately 470 patients (235 per arm) who will be randomized in a 1:1 ratio to treatment with TNX-102 SL or placebo tablets. The primary efficacy endpoint will be changed from baseline in the weekly average of daily self-reported worst pain intensity scores at the Week 14 endpoint. Key secondary efficacy endpoints include change from baseline in self-reported scores for sleep disturbance, fatigue and cognitive function. An interim analysis is expected to be completed after the first 50% of enrolled patients have completed the study for the purpose of possible sample size re-estimation or to stop the study early for efficacy, currently anticipated in the first half of 2023.

For more information, see ClinicalTrials.gov Identifier: NCT05472090.

About Long COVID or
Post-Acute Sequelae of COVID-19 (PASC)

Although most people recover from COVID-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long COVID. These individuals experience a constellation of disabling symptoms long past the time of recovery from acute COVID-19. Most Long COVID patients who have been studied appear to have cleared the SARS-CoV-2 infection from their systems. The symptoms of Long COVID can include fatigue, sleep disorders, multi-site pain, fevers, shortness of breath, cognitive impairment described as “brain fog” or memory disturbance, gastrointestinal symptoms, anxiety, and depression. Long COVID can persist for many months and can range in severity from mild to incapacitating. Several cohort studies have reported that persistence of symptoms following SARS-CoV-2 infection occurs in more than 30% of patients.^3-5 While typically associated with moderate or severe COVID-19, Long COVID can occur after mild COVID-19 or even after asymptomatic SARS-CoV-2 infection. Patients with Long COVID are sometimes referred to as “long-haulers”. Long COVID is a chronic disabling condition that is expected to result in a significant global health and economic burden.^4-7 In response to the urgent need for therapies that address Long COVID, Congress awarded $1.15 billion to the National Institutes of Health to study Long COVID in December 2020.⁸ While the vaccines available in the U.S. through either FDA approval or under Emergency Use Authorization have been shown to prevent acute COVID, their ability to prevent Long COVID is unknown. There is currently no approved drug for the treatment of Long COVID.

¹TNX-102 SL is an
investigational new drug and has not been approved for any indication.

²Feb. 24, 2021 – White
House COVID-19 Response Team press briefing; Feb 25, 2021 – policy brief from
the World Health Organization on long COVID.

³Harris, H, et
al. Tonix data on file. 2022

⁴Briggs, A, and Vassall,
A. (2021) “Count the cost of disability caused by COVID-19.” Nature
593(7860): 502-505.

⁵Nittas V, et al. (2022)
“Long COVID Through a Public Health Lens: An Umbrella Review.” Public
Health Rev. 43:1604501. Published 2022 Mar 15. doi:10.3389/phrs.2022.1604501

⁶Davis, HE., et al. (2021)
“Characterizing long COVID in an international cohort: 7 months of
symptoms and their impact.” EClinicalMedicine 38: 101019.

⁷Martin C, et al. (2021)
“A model framework for projecting the prevalence and impact of Long-COVID in
the UK.” PLoS One. 16(12):e0260843. Published 2021 Dec
2. doi:10.1371/journal.pone.0260843

⁸The NIH provision of
Title III Health and Human Services, Division M–Coronavirus Response and
Relief Supplemental Appropriations Act, 2021, of H.R. 133, The Consolidated
Appropriations Act of 2021. The bill was enacted into law on 27 December 2020,
becoming Public Law 116-260.

About TNX-102 SL

TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the serotonin-5-HT2A, ?1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors, TNX-102 SL is in clinical development as a daily bedtime treatment for Long COVID, fibromyalgia, PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The U.S. Patent and Trademark Office (USPTO) has issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in these patents are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035.

Tonix Pharmaceuticals
Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the first quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the fourth quarter of 2022. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first half of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.

^*All
of Tonix’s product candidates are investigational new drugs or
biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking
Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)

Tonix Pharmaceuticals
investor.relations@tonixpharma.com

(862) 904-8182

Olipriya Das, Ph.D. (media)

Russo Partners
Olipriya.Das@russopartnersllc.com

(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com

(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released
August 22, 2022

Image Credit: NIH

Tissue Model Reveals Key Players in Liver Regeneration

Anne Trafton | MIT News
Office

The human liver has amazing regeneration capabilities: Even if up to 70 percent of it is removed, the remaining tissue can regrow a full-sized liver within months.

Taking advantage of this regenerative capability could give doctors many more options for treating chronic liver disease. MIT engineers have now taken a step toward that goal, by creating a new liver tissue model that allows them to trace the steps involved in liver regeneration more precisely than has been possible before.

The new model can yield information that couldn’t be gleaned from studies of mice or other animals, whose biology is not identical to that of humans, says Sangeeta Bhatia, the leader of the research team.

“For years, people have been identifying different genes that seem to be involved in mouse liver regeneration, and some of them seem to be important in humans, but they have never managed to figure out all of the cues to make human liver cells proliferate,” says Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and of Electrical Engineering and Computer Science at MIT and a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science.

The new study, which appears this week in the Proceedings of the National Academy of Sciences, has identified one molecule that appears to play a key role, and also yielded several other candidates that the researchers plan to explore further.

The lead author of the paper is Arnav Chhabra, a former MIT graduate student and postdoc.

Regeneration on a Chip

Most of the patients who need liver transplants suffer from chronic illnesses such as viral hepatitis, fatty liver disease, or cancer. However, if researchers had a reliable way to stimulate the liver to regenerate on its own, some transplants could be avoided, Bhatia says. Or, such stimulation might be used to help a donated liver grow after being transplanted.

From studies in mice, researchers have learned a great deal about some of the regeneration pathways that are activated after liver injury or illness. One key factor is the reciprocal relationship between hepatocytes (the main type of cell found in the liver) and endothelial cells, which line the blood vessels. Hepatocytes produce factors that help blood vessels develop, and endothelial cells generate growth factors that help hepatocytes proliferate.

Another contributor that researchers have identified is fluid flow in the blood vessels. In mice, an increase in blood flow can stimulate the endothelial cells to produce signals that promote regeneration.

To model all of these interactions, Bhatia’s lab teamed up with Christopher Chen, the William F. Warren Distinguished Professor of Biomedical Engineering at Boston University, who designs microfluidic devices with channels that mimic blood vessels. To create these models of “regeneration on a chip,” the researchers grew blood vessels along one of these microfluidic channels and then added multicellular spheroid aggregates derived from liver cells from human organ donors.

The chip is designed so that molecules such as growth factors can flow between the blood vessels and the liver spheroids. This setup also allows the researchers to easily knock out genes of interest in a specific cell type and then see how it affects the overall system.

Using this system, the researchers showed that increased fluid flow on its own did not stimulate hepatocytes to enter the cell division cycle. However, if they also delivered an inflammatory signal (the cytokine IL-1-beta), hepatocytes did enter the cell cycle.

When that happened, the researchers were able to measure what other factors were being produced. Some were expected based on earlier mouse studies, but others had not been seen before in human cells, including a molecule called prostaglandin E2 (PGE2).

The MIT team found high levels of this molecule, which is also involved in zebrafish regeneration, in their liver regeneration system. By knocking out the gene for PGE2 biosynthesis in endothelial cells, the researchers were able to show that those cells are the source of PGE2, and they also demonstrated that this molecule stimulates human liver cells to enter the cell cycle.

Human-Specific Pathways

The researchers now plan to further explore some of the other growth factors and molecules that are produced on their chip during liver regeneration.

“We can look at the proteins that are being produced and ask, what else on this list has the same pattern as the other molecules that stimulate cell division, but is novel?” Bhatia says. “We think we can use this to discover new human-specific pathways.”

In this study, the researchers focused on molecules that stimulate cells to enter cell division, but they now hope to follow the process further along and identify molecules needed to complete the cell cycle. They also hope to discover the signals that tell the liver when to stop regenerating.

Bhatia hopes that eventually researchers will be able to harness these molecules to help treat patients with liver failure. Another possibility is that doctors could use such factors as biomarkers to determine how likely it is that a patient’s liver will regrow on its own.

“Right now when patients come in with liver failure, you have to transplant them because you don’t know if they’re going to recover on their own. But if we knew who had a robust regenerative response, and if we just needed to stabilize them for a little while, we could spare those patients from transplant,” Bhatia says.

The research was funded in part by the National Institutes of Health, the National Science Foundation Graduate Research Fellowship Program, Wellcome Leap, and the Paul and Daisy Soros Fellowship Program.

Reprinted with the permission  MIT News http://news.mit.edu/

Virtual Roadshow – August 23 Lineage Cell Therapeutics – Brian M. Culley, CEO Join Lineage Cell Therapeutics CEO Brian M. Culley for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level Register Now

Suggested Content

The Gene Therapy Space May be Blossoming

Covid-19 Vaccine and Healthcare Responsibility to Begin Falling on the Patient

Monkeypox Treatments and Vaccines are Creating Investor Opportunities

Is Biotech’s Outperformance Reaching a New Stage of Development?

Stay up to date. Follow us:

Image Credit: The Focal Project (Flickr)

Sixteen Years After the Human Genome Project Completion, Regenerative Medicine May Hit its Stride

Bluebird Bio’s performance this past week shows what the power of FDA approval can do when a biotech company gets the green light. Not only did investors enjoy a 51.7% increase in the gene therapy company’s stock price, but patients can now overcome a severe genetic disease. Gene therapies and regenerative medicine are now beginning to blossom, 16 years after the last human chromosome was mapped, completing the human genome project. Quite a few specialized biotech companies have been started within the past 16 years, and many have a product pipeline in various stages of FDA approval. Below is information on Bluebird and two other public companies involved in genetic medicine that you may want to pay attention to.

Source: Koyfin

Bluebird Bio (BLUE)

Bluebird Bio’s blood disorder gene therapy was approved a few days earlier than anticipated. The approval of Zynteglo is exciting for those whose lives will be changed by the gene therapy, investors that have had confidence in the surrounding science, and of course, everyone working at Bluebird bio. Congratulations.

A downside to the FDA approval is that the therapy for betibeglogene autotemcel (beti-cel), will initially cost $2.8 million for those receiving it. More positively, the pediatric and adult patients that will benefit have been requiring ongoing red blood cell transfusions. Zynteglo is a one-time gene therapy, so those afflicted can receive transfusion independence.

Lineage Cell Therapeutics (LCTX)

Lineage Cell Therapeutics is a clinical-stage biotech company developing new cellular therapies for degenerative retinal diseases, neurological conditions associated with demyelination, and helping the body fight cancer. At the company’s core are two proprietary technology platforms: cell replacement and cell and drug delivery. Its cell replacement platform creates new cells and tissues with its pluripotent and progenitor cell technologies. The company’s cell and drug delivery programs are based upon its proprietary HyStem cell and drug delivery matrix technology.

There is no better way for any investor to develop an understanding of a biotech company in the regenerative medicine or gene therapy space than to have its products and pipeline explained to them by the CEO. Channelchek and Noble Capital Markets have arranged for an online interactive roadshow (bring your questions) for interested investors to attend. This will be held on Tuesday (August 23). More information is available here.

Miromatrix (MIRO)

Miromatrix is a company that may one day eliminate waitlists for organ transplants. The company claims to lead the development of bioengineered organs for transplantation with over 118 issued patents worldwide. The technology is able to be applied across many of needs. Specifically, they are currently focused on creating transplantable kidneys (MiroKidney) and livers (MiroLiver) with expectations to also bioengineer other critical organs like lungs, pancreas, and heart.

The decellularization technology is supported through pre-clinical and animal studies that the FDA cleared in previously commercialized matrix products. The company’s bioengineered organs have the potential to eliminate ongoing therapies and prolong life. They also are expected to reduce costs across many areas of the healthcare system. 

Take Away

The FDA approval of Zynteglo for Bluebird Bio and the stock performance was a reminder this week of the potential for companies in the regenerative medicine space to make a difference. It has been 16 years since the human genome project was completed. Many of these companies were started shortly after; perhaps their research and development are about to pay off.

Explore more companies like BLUE, LCTX, and MIRO by registering for Channelchek and exploring under the “COMPANY Data” tab.

Paul Hoffman

Managing Editor, Channelchek

Virtual Roadshow – August 23 Lineage Cell Therapeutics – Brian M. Culley, CEO Join Lineage Cell Therapeutics CEO Brian M. Culley for this exclusive corporate presentation, followed by a Q & A session moderated by Robert LeBoyer, Noble’s senior research analyst, featuring questions taken from the audience. Registration is free and open to all investors, at any level Register Now

Suggested Content

Stem Cell-Derived Retinal Pigment Epithelium Cells – Vision for the Future

Preventing the Immune System from Rejecting Gene Therapy

Pros and Cons of FDA Funded in Part by Companies

Cells that Can be Produced from Stem Cells

Source

https://en.wikipedia.org/wiki/Human_Genome_Project#History

https://www.zynteglo.com/

Stay up to date. Follow us:

Avivagen Announces New Dairy Customer in Mexico

Research, News, and Market Data on Avivagen

• Family-owned dairy business with established reputation for high-quality products turning to OxC-beta^TM to support quality of milk
• Order procured through Meyenberg International, Avivagen’s Mexican distribution partner

Ottawa, ON /Business Wire/ August 19, 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 pleased to announce it has secured a promising new customer in the Mexican dairy industry.  The agreement will see the customer order 220 kg/month of OxC-beta^TM over a three-month period, beginning in September 2022.

“This new agreement represents the continued expansion of OxC-beta™ use within the dairy industry, a key growth market for Avivagen due to its size and positive economics,” said Kym Anthony, Chief Executive Officer, Avivagen Inc. “Mexico remains an important geographic region for us. We are excited about the potential for this first dairy order in the country to lead to others in this vital industry.”

The new customer, based in the Jalisco State region of Mexico, is a thirty-year old, family-owned business with a history of supplying high quality dairy products. The order follows a thorough assessment by the customer of numerous trials previously conducted in Mexico with OxC-beta™, resulting in higher quality milk and yields across a range of important metrics.

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, Vietnam 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, the potential for additional orders for
Avivagen’s products, future shipments 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.  Orders may be cancelled for many
reasons 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.

Friday, August 19, 2022

MustGrow Biologics Corp. (MGROF)
Extending an Agreement

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.

Sumitomo Extension. MustGrow announced Wednesday that the Company has extended the option with Sumitomo for exclusive testing with MustGrow’s technology on potatoes and bananas in North, Central, and South America. The Company did not disclose the length of the extension.

Positive Results. During Sumitomo’s use of MustGrow’s mustard-based products for preplant soil fumigation, bioherbicide, and postharvest and food preservation, Sumitomo’s efforts have shown positive levels of efficacy in comparison to certain synthetic chemical standards. With the extension, Sumitomo will to continue to drive all field development, along with regulatory and market assessment work for commercialization. We believe this to be a testament to the safeness and efficacy of MustGrow’s technology and believe this to be a step forward towards seeing top-line revenue….

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.