OCUGEN ANNOUNCES PUBLICATION OF POSITIVE RESULTS OF COVID-19 VACCINE TRIAL FOR CHILDREN 2-18 IN THE LANCET INFECTIOUS DISEASES

June 21, 2022

Ocugen’s partner Bharat Biotech’s Phase 2/3 study of COVAXIN™ (BBV152) in 526 children showed safety, efficacy, and superior response to that shown in adults

Ocugen has North American commercialization rights for COVAXIN™

MALVERN, Pa., June 21, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced the publication of positive pediatric Phase 2/3 study results in children aged 2–18 years for the COVID-19 vaccine COVAXIN™ (BBV152) in The Lancet Infectious Diseases (“The Lancet”). COVAXIN™ is developed and manufactured by Ocugen’s partner Bharat Biotech International Limited (“Bharat Biotech”), a global leader in vaccine innovation based in Hyderabad, India, and is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

The Lancet article, entitled “Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2–18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study,” which was authored by Dr. Krishna Mohan Vadrevu, Siddharth Reddy, MSc, and others, was published on June 16, 2022.

Ocugen has commercial rights for COVAXIN™ throughout North America and COVAXIN™ has emergency use authorization in Mexico for adults. Ocugen is continuing to explore pediatric emergency use authorization in Mexico. This data demonstrates that the same dose is effective in both pediatrics and adults (ages two and older) and would be an ideal option as the majority of Americans are looking for traditional vaccine options. Ocugen is continuing its effort to bring this vaccine to the North American Market.

“We congratulate Bharat Biotech on the publication of the COVAXIN™ pediatric data in this prestigious peer-reviewed medical journal,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. “Not only is this a strong validation of the work they are doing, but it is a very encouraging development in the effort to contain this pandemic, which needs a greater variety of vaccine options to combat the multiple COVID-19 variants. We believe the distinct features of COVAXIN™ offer benefits that could help improve public health.”

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “We are glad to have Ocugen as a valuable partner to help bring COVAXIN™ to North America. Safety of the vaccine is critical for children, and we are glad to share that COVAXIN™ has proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children, for primary immunization and booster doses, making COVAXIN™ a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India.”

The low reactogenicity might make COVAXIN™ more acceptable in pediatric populations than the more reactogenic mRNA vaccines as Bharat Biotech’s pediatric Phase 2/3 study had no serious adverse events, deaths, or withdrawals due to an adverse event including no cases of Guillain-Barré syndrome, thromboembolic events, myocarditis, or pericarditis, or other adverse events of special interest being observed to date. We believe COVAXIN™ will be a valuable tool in the global immunization effort as it can be stored at 2–8°C, which is standard vaccine storage conditions. Follow-up studies to assess pediatric effectiveness are underway, but this study suggests that similar efficacy, measured by the ability of a vaccine to prevent disease, might be anticipated in children based on the observation of superior immunogenicity, measured by the ability of a vaccine to produce an immune response, as compared to adults.

The open-label, non-randomized study was conducted in six hospitals in India and included 526 healthy children. Two doses of COVAXIN™ were administered 28 days apart in three groups according to their ages, two to six years, six to 12 years, and 12 to 18 years. The results were compared with those from adults who participated in a previously reported Phase 2 study. The study is registered with the Clinical Trials Registry, India (CTRI/2021/05/033752) and ClinicalTrials.gov (NCT04918797).

About COVAXIN™ (BBV152)
The COVID-19 vaccine candidate BBV152, known as COVAXIN™ outside the United States, is a whole-virion inactivated COVID-19 vaccine candidate that applies the same Vero cell manufacturing platform, which has been used in the production of polio vaccines for decades. COVAXIN™ was co-developed with Ocugen’s partner, Bharat Biotech, in collaboration with the Indian Council of Medical Research – National Institute of Virology. COVAXIN™ has been granted Emergency Use Listing by the World Health Organization based on a submission by Bharat Biotech. COVAXIN™ is formulated uniquely such that the same dosage can be administered to adults and children alike, making it truly a universal vaccine. COVAXIN™ is a ready to use liquid vaccine stored at 2-8°C with a 12-month shelf life and multi dose vial policy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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, but are not limited to, statements about COVAXIN™ efficacy, safety, and immunogenicity in children aged 2-18 years, Ocugen’s ability to expand emergency use authorization for COVAXIN™ in Mexico to include children aged 2-18 years, Ocugen’s intention to continue its effort to bring COVAXIN™ to the North American Market, and the potential advantages of COVAXIN™ over other vaccines. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. 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.

Contacts:
Tiberend Strategic Advisors, Inc.
Jonathan Nugent / Daniel Kontoh-Boateng (Investor Relations)
jnugent@tiberend.com
dboateng@tiberend.com

Bill Borden (Media)
bborden@tiberend.com

 

 

Tuesday, June 21, 2022

Avivagen Inc. (VIVXF)
Waiting for Upturn in End Markets

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.

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.

Q2 Results. Avivagen reported revenue of $88,438 (all figures are in Canadian $), down from $159,614 the prior year and below our estimate of $400,000. Net loss for the quarter was at $1.3 million or $0.02 per share, an increase over the prior year’s $2.2 million or $0.04 per share, and better than our estimate of a loss of $1.4 million or $0.03 per share. The decrease in revenue was due to lower sales of OxC-Beta, with the net loss decrease due to an adjustment on the Company’s ACOA liabilities.

Modest OxC-beta Sales. During 2Q22, Avivagen sold just 925 kilograms of OxC-beta Livestock, down from 2,550 kg in 1Q22. Nearly half, or 400 kgs, was sold in Brazil, Other sales were made in Thailand, 150 kgs, Taiwan, 350 kgs, and Mexico, 25 kgs. The average price of OxC-Beta per kilogram was $102.27 in the quarter from a previous $106.33 in 1Q22….

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. 

Tonix Pharmaceuticals Announces Ribbon-Cutting Ceremony for its Advanced Development Center (ADC) for Vaccine Programs in Massachusetts

Research, News, and Market Data on Tonix Pharmaceuticals

The ADC is
Expected to Accelerate Clinical-Scale Manufacturing of Live Virus Vaccines,
Including Vaccines for Monkeypox, Smallpox and COVID-19

Internal Manufacturing
Capabilities Expected to Support U.S. Pandemic Preparedness

CHATHAM, N.J., June 16, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced it will hold a ribbon-cutting ceremony at the Company’s 45,000 square foot clinical-scale manufacturing facility in the New Bedford Business Park in North Dartmouth, Massachusetts on June 21, 2022 at 1:00 pm ET. The new facility houses Tonix’s Advanced Development Center (ADC) for accelerated research, development and analytical capabilities, as well as the production of clinical trial quality vaccines for infectious diseases, including monkeypox, smallpox and COVID-19 as well as other infectious diseases for pandemic preparedness. The ceremony marks the formal opening of the New Bedford site.

U.S. Representative Bill Keating; the mayor of New Bedford, Mass., Jon Mitchell; Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals; and other prominent community members and employees plan to attend the event.

The ADC includes single-use bioreactors and purification suites with equipment for Good Manufacturing Practice (GMP) production of vaccines for clinical trials, including the capability of producing sterile vaccines in glass bottles. The ADC is Biosafety Level 2 (BSL-2). At full capacity, the facility can employ up to 70 researchers, scientists, manufacturing and technical support staff.

“Tonix Pharmaceuticals is making good on their promise to bring jobs to the New Bedford area, and we should be proud to host this new facility that has the potential to impact lives all over the world,” said Congressman Bill Keating. “Thanks to the hard work of Tonix, the town of Dartmouth and City of New Bedford, this facility opening further cements the role that the South Coast is playing in biotech. The continued private and public sector investments in our region are paying dividends, and the ribbon-cutting for this facility serves as yet another positive indicator of continued economic growth on the South Coast.”

“The addition of Tonix Pharmaceuticals to the growing biotech community in Greater New Bedford is a strong indicator of the quality of the region’s workforce. We have the talent to compete in a variety of sectors,” said Jon Mitchell, Mayor of the City of New Bedford.

“The opening of our new manufacturing facility in the New Bedford Business Park is a significant milestone for Tonix and we are excited to be part of the growing biotech industry in the South Coast region of Massachusetts,” stated Dr. Lederman. “The ADC greatly enhances our ability to progress our pipeline of vaccines for infectious diseases, including monkeypox, smallpox and COVID-19. We believe that the recombinant pox virus platform technology underlying our key vaccines in development, TNX-801, TNX-1840 and TNX-1850, coupled with our capabilities at the Tonix R&D Center (RDC) for research and development, will be rapidly deployable for addressing potential novel or emerging pathogens, with simplified distribution and administration, relative to modified mRNA-based vaccines. Our goal is to be able to design and test new recombinant pox virus vaccines against novel pathogens within the 100 days of recognition of a potential emerging pandemic threat, consistent with the criteria set forth by the White House Office of Science and Technology Policy. With high quality people, systems and processes, we intend to be a center of excellence for vaccine development.”

The facility is located in the New Bedford Business Park in a section of the park that is located in the Town of Dartmouth, Massachusetts. The two municipalities work together to accommodate businesses located in the Dartmouth portion of the park as the roads are inaccessible through Dartmouth and municipal services are provided by the City of New Bedford.

Tonix
Pharmaceuticals Holding Corp.¹

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 expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that Phase 2 ready and has been granted Breakthrough Therapy Designation by the FDA. 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All 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)
Westwicke/ICR

peter.vozzo@westwicke.com

(443) 213-0505

 

Ocugen, Inc. Announces Issuance of U.S. Patent for Treating Retinal Degenerative Diseases Using Gene Therapy

Research, News, and Market Data on Ocugen

ISSUANCE OF U.S.
PATENT NO. 11,351,225 FURTHER ENHANCES OCUGEN’S GENE THERAPY INTELLECTUAL
PROPERTY PORTFOLIO

MALVERN, Pa., June 13, 2022 (GLOBE NEWSWIRE) — Ocugen,
Inc. (NASDAQ:OCGN), a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals, and vaccines, today announced that on June 7, 2022, the United States Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 11,351,225, which is directed to methods for preventing or treating an ocular disease or disorder associated with a retinal degenerative disease.

U.S. Patent No. 11,351,225 (the “‘225 Patent”) covers the use of a nuclear hormone receptor gene, such as NR2E3, RORA, NUPR1, and 
NR2C1, in treating retinal degenerative diseases as well as reducing the risk of developing such diseases. Additional issued claims pertain to using a nuclear hormone receptor gene to treat retinitis pigmentosa, age-related macular degeneration, and inherited retinal degenerative diseases. The ‘225 Patent contains 18 claims and expires in March 2034.

“We are pleased to have been granted this new U.S. patent through our exclusive license agreement with The Schepens Eye Research Institute, an affiliate of Harvard Medical School. We believe this patent significantly validates our modifier gene therapy platform developed by Dr. Neena Haider and augments our growing global patent portfolio,” commented Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.

This newly allowed patent is exclusive to Ocugen and is the latest U.S. patent issued in connection with Ocugen’s gene therapy program for treating retinal degenerative diseases.

About Ocugen,
Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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 statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. 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.

Contact
Tiberend
Strategic Advisors, Inc.
Jonathan Nugent / Daniel Kontoh-Boateng (Investors)
jnugent@tiberend.com
dboateng@tiberend.com

Dave Schemelia (Media)

dschemelia@tiberend.com

Onconova Therapeutics Announces Key Management Promotions

News and Market Data on Onconova Therapeutics

Mark Guerin promoted to Chief
Operating Officer and Chief Financial Officer

Dr. Adar Makovski Silverstein
promoted to Senior Director and Head of Corporate Development

NEWTOWN, Pa., June 13, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Mark Guerin was appointed Chief Operating Officer in addition to his current role as Onconova’s Chief Financial Officer (CFO), and that Dr. Adar Makovski Silverstein was appointed Senior Director and Head of Corporate Development. Avi Oler, Senior Vice President, Corporate Development and General Counsel, will be leaving the Company on June 17, 2022, to pursue another opportunity outside of the biotechnology sector.

“Mark and Adar have consistently displayed the skills needed to excel in their new roles and functions and I congratulate them on the recognition of the value they bring to Onconova,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “Expanding their responsibilities will allow us to maximize their talents and further benefit from Mark’s financial and operational expertise, as well as Adar’s scientific and business development acumen. I look forward to our continued work together as we advance towards key milestones expected across our pipeline later this year. I’d also like to thank Avi for his contributions to Onconova and wish him the best in his future endeavors.”

Mr. Guerin has worked in numerous roles at Onconova since he joined the Company in September 2013 following its initial public offering (IPO) in July 2013 and has served as Onconova’s Chief Financial Officer since September 1, 2016. Prior to joining Onconova, Mr. Guerin served as Vice President of Finance and CFO of Cardiokine, Inc. through its filing of a New Drug Application and sale to Cornerstone Therapeutics. Prior to joining Cardiokine, Mr. Guerin was Director, Financial Reporting and Internal Controls at Barrier Therapeutics, Inc., including during its IPO and follow-on offering. Mr. Guerin started his career at Coopers & Lybrand in Philadelphia. He received his bachelor’s degree in Accounting from DeSales University and has earned the CPA, CMA, and CFM professional certifications.

Dr. Makovski Silverstein joined Onconova in December 2021 from Amgen, where she worked as Sr. Licensing Associate, Business Development, External R&D. At Amgen, Dr. Makovski Silverstein was responsible for evaluating external scientific opportunities across all therapeutic areas and managing processes within business development and cross functional teams. Prior to her time at Amgen, Dr. Makovski Silverstein interned as a member of the Research Program Management Team at Regeneron. She also worked as a marketing analyst graduate student consultant at Roche Sequencing Solutions. Dr. Makovski Silverstein earned her Ph.D. in Biotechnology from Bar-Ilan University in Israel and completed a post-doctoral fellowship at the City of Hope in Duarte, California.

About Onconova Therapeutics

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

For more information, please visit www.onconova.com.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “encouraging,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Mark Guerin
Onconova Therapeutics, Inc.
267-759-3680

ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200

bmackle@lifesciadvisors.com

Ocugen, Inc. to Present at BIO International Convention 2022

Research, News, and Market Data on Ocugen

MALVERN, Pa., June 09, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, today announced that Michael Shine, Ocugen’s Senior Vice President, Commercial, will present at the 2022 BIO International Convention being held in San Diego, California, from June 13-16, 2022.

The Company presentation, which is scheduled for Monday, June 13, at 4:45 p.m. PT in Meeting Room 1 of the San Diego Convention Center, will focus on Ocugen’s robust clinical pipeline, including its COVID-19 vaccine candidate, COVAXIN™ (BBV152), its modifier gene therapy programs, and its new cell therapy program, NeoCart^®.

About
Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals and vaccines that improve health and offer hope for people and global communities. We are making an impact through courageous innovation, taking science in new directions in service of patients. Our breakthrough modifier gene therapy platform has the potential to treat multiple diseases with one drug and we are advancing research in other therapeutic areas to offer new options for people with unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

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 statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or results to
differ materially from our current expectations. 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.

Contact
Tiberend Strategic Advisors,
Inc.
Jonathan Nugent / Daniel Kontoh-Boateng (Investor)
jnugent@tiberend.com
dboateng@tiberend.com

Dave Schemelia (Media)
dschemelia@tiberend.com

Friday, June 10, 2022

Filament Health (FLHLF)
Collaboration Formed To Develop Additional Botanical Compounds

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

Filament Forms Collaboration With Jaguar Health.  Filament and Jaguar Health (JAGX, $0.35, Not Rated) have signed a Letter of Intent to develop botanical compounds for psychiatric uses.  We believe Filament’s expertise in extraction and manufacturing technologies fits well with Jaguar’s extensive research in botanical compounds. 

Research Collaboration Will Develop Products For Out-licensing.  The collaboration intends to develop psychoactive compounds for use in mental health indications, such as attention deficit hyperactivity disorder (ADHD), social anxiety disorder, and related conditions. The companies plan to license commercialization rights to drug candidates developed under the collaboration with an equal profit split….

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. 

Friday, June 10, 2022

Avivagen Inc. (VIVXF)
What Can the Completion of Safety Studies Mean?

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.

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.

Safety Studies. Avivagen completed a series of safety evaluations based on the oxidized beta-carotene (OxBC), a critical active ingredient in the OxC-beta product line. Results of the Avivagen-initiated toxicology study, conducted following standardized and internationally recognized protocols, provided further evidence of the safety and effectiveness of OxBC and the OxC-beta product line for use in human and animal applications.

Confidence. The toxicology test allows Avivagen to reinforce the safeness of OxC-beta through providing more formal evidence in support of regulatory approval and additional adoption in jurisdictions and applications. We believe the studies show confidence in the OxC-beta line and with the positive toxicology results, the Company adds another feather to its cap in marketing the feed additive to other countries for expansion….

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. 

Avivagen Announces Successful Completion of Formal Safety and Toxicology Evaluation of Fully Oxidized Beta-Carotene (OxBC)

Research, News, and Market Data on Avivagen

Ottawa, ON /Business Wire/ June 9, 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 that it has completed a series of important safety evaluations of fully oxidized beta-carotene (OxBC), the proprietary and critical active ingredient in the company’s highly-regarded OxC-betaTM product line. Results of the Avivagen-initiated toxicology study, conducted following standardized and internationally recognized protocols, provided further evidence of the safety and effectiveness of OxBC and the OxC-betaTM product line for use in human and animal applications.

Based on previously conducted scientific testing, OxBC and Avivagen’s OxC-betaTM product line have achieved self-affirmed GRAS status in the United States and have already secured regulatory approval in a number of other important food and feed markets, including China, Brazil, Philippines, Mexico, Taiwan, New Zealand, Thailand, Vietnam, Australia, and Malaysia.

“Through extensive internal and third-party testing, and both regulatory evaluation and customer trial and adoption of our OxC-beta line around the globe, the safety of OxBC as an active ingredient supporting a wide range of beneficial uses for humans and animals has been shown again and again,” says Kym Anthony, Chief Executive Officer, Avivagen. “Already more than than 35 million livestock animals have seen enhanced health and productivity thanks to the OxBC ingredient, and over 82,000 dogs and 3,300 humans have enjoyed the benefits of OxBC products. As expected, proactively participating in this toxicology assessment has provided further evidence of the safety and effectiveness of our OxC-betaTM line and presents a valuable indicator of the significant commercialization opportunities for our technology as we continue to expand approvals and adoptions in new markets worldwide.”

While there have been zero reports of product-related adverse events from OxBC or OxC-betaTM to date, the present toxicology tests were initiated by Avivagen to further reinforce OxBC’s applicability as a very safe ingredient in a wide range of products and provide further formal evidence to support continued regulatory approval and adoption in both new jurisdictions and product applications. Toxicology testing consisted of three separate studies, all of which are conducted in animals, typically rats. The first test demonstrated that in rats the maximum tolerated single oral dose of OxBC and the LD50 were 5,000 and 30,079 mg/kg body weight, respectively. The second test, a 14-day, repeat-dose acute oral toxicity test demonstrated an initial No Observable Adverse Effect Level (NOAEL) of OxBC of 1,250 mg/kg body weight. In the third and final test, no mortality or morbidity was observed for administration by oral gavage of OxBC up to 1875 mg/kg body weight once daily in male and female Sprague Dawley rats for 90 consecutive days followed by a 28-day recovery period. There were no treatment-related adverse effects on body weight, feed consumption, hematology, coagulation, hormonal, and clinical chemistry parameters and organ weights. No gross pathological abnormalities nor adverse histopathological findings were observed. The NOAEL was determined to be 1875 mg/kg body weight. These findings strongly support the safety of OxBC, especially considering the NOAEL value exceeds by several thousand times the daily level of approximately 0.5 mg/kg body weight of OxBC used in supplementing livestock, canines, felines and humans.

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.

Tonix Pharmaceuticals Announces Data Presentations Involving TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Kidney and Heart Allograft Transplantation in Animal Models at the 2022 American Transplant Congress

Research, News, and Market Data on Tonix Pharmaceuticals

Research Directed by Faculty of the Center for Transplantation Sciences, Massachusetts General Hospital

CHATHAM, N.J., June 09, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from three oral presentations at the 2022 American Transplant Congress (ATC) by faculty at the Center for Transplantation Sciences, Massachusetts General Hospital. The data involve studies of Tonix’s TNX-1500 (Fc-modified anti-CD40L monoclonal antibody) product candidate in development for the prevention of organ transplant rejection. The molecular target of TNX-1500 is CD40-ligand (CD40L), which is also known as CD154. Copies of the presentations are available under Scientific
Presentations on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

The presentations titled, “Long-Term Rejection Free Renal Allograft Survival with Fc-Modified
Anti-CD154 Antibody Monotherapy in Nonhuman Primates,” “TNX-1500, an Fc-modified Anti-CD154 Antibody, Prolongs Nonhuman Primate
Cardiac Allograft Survival,” and “Novel Targetable Pathways in Costimulation Pathway Blockade” include data demonstrating that TNX-1500 showed activity in preventing organ rejection and was well tolerated in non-human primates. Blockade of CD40L with TNX-1500 monotherapy consistently and safely prevented pathologic alloimmunity in a non-human primate cardiac allograft model without clinical thrombosis.

“There remains a significant need for new treatments with improved activity and tolerability to prevent organ transplant rejection,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “To date, there has not been a humanized anti-CD40L antibody that can effectively prevent transplant rejections with acceptable level of tolerability. TNX-1500 is a third generation anti-CD40L mAb that has been designed by protein engineering to decrease Fc?RII binding and to reduce the potential for thrombosis. The animal studies found that TNX-1500 retains activity to prevent rejection and preserve graft function. We believe TNX-1500 has the potential for treating and preventing organ transplant rejection.”

About Tonix
Pharmaceuticals Holding Corp.¹

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 expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally, 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All 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) 799-8599

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 June
9, 2022

Tonix Pharmaceuticals Announces Presentation of Licensed Antiviral Drug Technology at the 4th Symposium of the Canadian Society for Virology

Research, News, and Market Data on Tonix Pharmaceuticals

Oral Presentation Describes Activity of Wnt/?-Catenin Signaling Pathway Inhibitors Against SARS-CoV-2 in Cell
Culture and in an Animal Model

CHATHAM, N.J., June 08, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Tom Hobman, Ph.D., Professor, Department of Cell Biology, University of Alberta, presented data from his laboratory at The University of Alberta as a keynote presentation at the 4th Symposium of the Canadian Society for Virology held in Edmonton, Alberta, Canada on June 5, 2022. The oral presentation titled, “The
virus-host Interface: A treasure trove of novel antiviral targets,” includes research sponsored by Tonix Pharmaceuticals focused on the development and testing of Wnt/?-Catenin signaling pathway inhibitors as broad-spectrum antivirals against SARS-CoV-2 and other emerging viruses. Tonix has previously announced that it exercised an option to license the antiviral technology platform A copy of the presentation is available on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

“We are excited by the progress of Professor Hobman and his colleagues at The University of Alberta on the further testing of Wnt/?-Catenin signaling pathway inhibitors as broad-spectrum antivirals,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “Professor Hobman presented data showing that three different Wnt/?-Catenin inhibitor drug candidates decreased lung infection in an animal model of SARS-CoV-2 infection. The set of Wnt/?-Catenin inhibitors tested by Professor Hobman include drugs that have been previously studied in humans for other indications including one drug that is FDA approved. Professor Hobman believes that reducing ?-Catenin levels with Wnt-inhibitor drugs induces peroxisome proliferation and enhances the interferon response. Previously, SARS-CoV-2 was shown to be sensitive to inhibition by interferon². Professor Hobman reported that Wnt/?-Catenin inhibitor and peroxisome inducing drugs also inhibit Zika virus (ZIKV) and Mayaro (MAYV) virus in cell culture. Tonix is excited to have sponsored Professor Hobman’s research involving Wnt/?-Catenin signaling pathway inhibitors as broad-spectrum antivirals and to have licensed the technology. We look forward to working with Professor Hobman to try to bring one or more of these candidate drugs to clinical testing.”

About Tonix
Pharmaceuticals Holding Corp.¹

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 expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally, 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All of Tonix’s
product candidates are investigational new drugs or biologics and have not been approved
for any indication.
²Lokugamage, K. G. et al., (2020). Journal of
virology, 94 (23), [e01410]. https://doi.org/10.1128/JVI.01410-20

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) 799-8599

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.

Tonix Pharmaceuticals Announces Presentation on TNX-801 Vaccine Protection Against Monkeypox at the 4th Symposium of the Canadian Society for Virology

Research, News, and Market Data on Tonix Pharmaceuticals

Poster Presentation Includes Preclinical Data from Tonix’s Program to Develop a Vaccine for Monkeypox and Smallpox

CHATHAM, N.J., June 08, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that Ryan Noyce, Ph.D., and David Evans, Professor, Department of Cell Biology, University of Alberta, together with scientists from Tonix presented data from a research collaboration between Tonix Pharmaceuticals and The University of Alberta in a poster presentation at the 4th Symposium of the Canadian Society for Virology held in Edmonton, Alberta, Canada on June 5, 2022. Copies of the poster are available on the Tonix Pharmaceuticals corporate website at www.tonixpharma.com.

The poster titled, “Synthetic
Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox,” describes data from animals vaccinated with TNX-801¹ to protect against monkeypox. The poster presentation reports that all animals (eight of eight) vaccinated with TNX-801 were fully protected with sterilizing immunity from a challenge with intra-tracheal monkeypox. The vaccinations with TNX-801 were well tolerated. Synthetic horsepox virus is the basis for the Company’s TNX-801 vaccine in development to protect against monkeypox and smallpox and for the Company’s Recombinant Pox Virus (RPV) platform to protect against other pathogens, including SARS-CoV-2.

“Our research work, in collaboration with Dr. Noyce and Professor Evans at The University of Alberta, shows that vaccination with TNX-801 has the ability to protect against monkeypox infection,” said Seth Lederman, M.D., President and Chief Executive Officer. “Monkeypox infection of humans was rare during the time people were vaccinated to protect against smallpox. After the eradication of smallpox, vaccination with live-virus vaccinia was stopped in most of the world. Monkeypox cases have been rising in Africa for several years. Very recently a strain of monkeypox from West Africa has caused clusters of monkeypox cases in many countries outside of Africa. We believe that vaccination with live-virus vaccines like TNX-801 has the potential to control monkeypox again.”

About TNX-801,
TNX-1840 and TNX-1850

TNX-801 is a live virus vaccine based on synthesized horsepox^2,3. Tonix is developing TNX-801 for percutaneous administration as a vaccine to protect against monkeypox and smallpox. Tonix has previously reported positive data from a monkeypox challenge study in non-human primates⁴. Tonix is also developing TNX-1840 and TNX-1850 (horsepox-based live virus vaccines) for the prevention of COVID-19. TNX-1840 and TNX-1850 are designed to express the spike protein from the omicron and BA.2 variants of SARS-CoV-2, respectively. Tonix has previously reported positive data from a SARS-CoV-2 challenge study in non-human primates in which animals were vaccinated with TNX-1800, a horsepox-based vaccine expressing spike protein from the Wuhan strain⁵. Tonix’s TNX-801 was synthesized² based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763. Molecular analysis of DNA sequences suggests that TNX-801 is closer than modern smallpox vaccines to the vaccine discovered and disseminated by Dr. Edward Jenner in 1798^6-8. For example, recent studies^9,10 have shown approximately 99.7% colinear identity between TNX-801 and the circa 1860 U.S. smallpox vaccine VK05.¹¹ The small plaque size in culture of TNX-801 appears identical to the U.S. Centers for Disease Control publication of the natural isolate¹². Relative to vaccinia, horsepox has substantially decreased virulence in mice². Dr. Edward Jenner invented vaccination in 1798 and the procedure was called “vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum material was initially obtained from lesions on the udders of cows affected by a mild disease known as cowpox. However, Dr. Jenner suspected that cowpox originated from horses⁸. Subsequently, Dr. Jenner and others immunized against smallpox using material directly obtained from horses. The use of vaccines from horses was sometimes called ‘equination’ from the Latin ‘equus’ which means ‘horse’¹³. Equination and vaccination were practiced side-by-side in Europe
^13,14.

About the
Recombinant Pox Virus (RPV) Platform

Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses. Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) manufacturable at scale, and (7) ability to provide direct antigen presentation. Relative to vaccinia, horsepox has substantially decreased virulence in mice². Horsepox-based vaccines are designed to be single dose, vial-sparing vaccines, that can be manufactured using conventional cell culture systems, with the potential for mass scale production and packaging in multi-dose vials. Tonix’s TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged, or “bifurcated” needle. The major cutaneous reaction or “take” to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization’s (WHO) accelerated smallpox eradication program that successfully eradicated smallpox in the 1960’s. The “take” is a measure of functional T cell immunity validated by the eradication of smallpox, a respiratory-transmitted disease caused by variola.

About
Monkeypox and Smallpox

Monkeypox¹⁵ and smallpox
¹⁶ are diseases in humans called by the monkeypox and smallpox (or variola) viruses, respectively. Monkeypox and variola are closely related orthopox viruses. Vaccination against smallpox with live virus vaccines based on horsepox or vaccinia protects against monkeypox. After routine smallpox vaccination was stopped in about 1970, monkeypox has become a growing problem in Africa. Recently approximately 300 cases have been identified outside of Africa.¹⁷ Smallpox is considered eradicated, but there are concerns about malicious reintroduction.

About Tonix
Pharmaceuticals Holding Corp.¹

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 expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA. Finally, 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 second half of 2022. 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 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 second half of 2022. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox called TNX-801, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-1850, which are live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform.

¹All of Tonix’s
product candidates are investigational new drugs or biologics and have not been
approved for any indication.
²Noyce RS, et
al. (2018) PLoS One. 13(1):e0188453
³Tulman ER, et
al. (2006) J Virol. 80(18):9244-58.PMID:16940536
⁴Noyce, RS, et
al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects
Macaques from Monkeypox* Presented as a poster at the American Society of
Microbiology BioThreats Conference – January 29, 2020, Arlington, VA.
(https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf)
⁵Tonix Press
Release March 16, 202a
https://ir.tonixpharma.com/news-events/press-releases/detail/1255/tonix-pharmaceuticals-reports-positive-covid-19-vaccine
⁶Schrick L et
al. N Engl J Med. (2017) 377:1491.
⁷Qin et al. J. Virol. 89:1809
(2015).
⁸Jenner E. “An
Inquiry Into the Causes and Effects of the Variolae Vaccinae:
A Disease Discovered in Some of the Western Counties of England, Particularly
Gloucestershire, and Known by the Name of the Cow Pox.” London: Sampson Low,
1798.
⁹Brinkmann A et
al, Genome Biology (2020) 21:286 https://doi.org/10.1186/s13059-020-02202-0
¹⁰Duggan A et
al. Genome Biology (2020) 21:175 https://doi.org/10.1186/s13059-020-02079-z
¹¹Tonix press
release. Dec 4, 2020
https://ir.tonixpharma.com/news-events/press-releases/detail/1236/vaccine-genome-researchers-report-99-7-colinear-identity
¹²Trindale GS et
al. Viruses (2016) (12). Pii: E328. PMID:27973399
¹³Esparza E, et
al Vaccine. (2017) 35(52):7222-7230.
¹⁴Esparza J et
al. Vaccine. (2020); 38(30):4773-4779.
¹⁵www.cdc.gov/poxvirus/monkeypox/about.html
¹⁶www.cdc.gov/smallpox/research/
¹⁷Mandavilli, A.
The New York Times. May 26, 2020. “Who is protected against monkeypox”

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) 799-8599

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.

Wednesday, June 08, 2022

PDS Biotechnology Corp (PDSB)
Conference Call Clarifies Data and Mechanism of PDS0101

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted 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.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

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

PDS Held A Conference Call Following ASCO Data Presentations.  On June 7, PDS management held a conference call to discuss the full data from its presentations at the American Society for Clinical Oncology (ASCO) meeting on June 5 and 6.  The presentations were from the Phase 2 VERSATILE-002 trial testing PDS0101 in head and neck cancer and the Phase 2 Triple Combination trial testing PDS0101 with two immune modulating drugs in multiple tumor types.

Two Trials Presented Data At ASCO.  PDS0101 was developed using the PDS Versamune technology to stimulate an immune response to HPV16, an immune marker found on human papilloma virus (HPV) related cancers.  The VERSATILE-002 trial tested PDS0101 the combination with Merck’s pembrolizumab (Keytruda), using the checkpoint inhibitor to make the tumor recognizable to the immune system along with PDS0101 to improve the immune response and kill the tumor cells….

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.