PDS Biotechnology Announces Conference Call and Webcast for Fourth Quarter and Full Year 2021 Financial Results

Research, News, and Market Data on PDS Biotech

 

FLORHAM PARK, N.J., March 09, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced the Company will release financial results for the three- and twelve-month periods ended December 31, 2021, on Wednesday, March 23, 2022, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, March 23, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s website at www.pdsbiotech.com. After the live webcast, the event will be archived on PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.  

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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

electroCore Announces Changes to its Board of Directors

News and Market Data on electroCore

 

Julie Bruzzone Goldstein and Tricia Wilber to join the Board, adding significant marketing, media and brand strategy experience

ROCKAWAY, N.J., 
March 09, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the appointment of  Julie Bruzzone Goldstein and  Tricia Wilber to the company’s Board of Directors effective 
March 15, 2022. The Company also announced that effective 
March 4, 2022, Dr.  Stephen Ondra is resigning from the Board to focus on his new role as Chief Medical Advisor at MITRE, and  Michael Atieh will not be standing for re-election to the Board at the 2022 Annual General Meeting.  

“Ms. Goldstein and  Ms. Wilber are successful business leaders with proven track records, and I am pleased to welcome them to our Board,” said  Peter Cuneo, Chairman of the Board of Directors of electroCore. “As the company continues to invest in direct-to-consumer initiatives, their breadth of knowledge and experience will add significant value as we seek to expand the reach and impact of our therapies. These appointments are great additions to our Board of Directors, and we look forward to their contributions.”    

Mr. Cuneo continued, “I would like to recognize and thank  Mr. Atieh and  Dr. Ondra for their long service and myriad contributions to the Company. Their leadership and dedication, Mr. Atieh’s role as our previous Chairman, and both Directors’ service on various committees, have greatly advanced our business. Both  Mr. Atieh and  Dr. Ondra will remain available to the Company as advisors to the Chairman and CEO. We wish them continued success in their future endeavors.”

Ms. Goldstein brings to electroCore more than 30 years of leadership expertise in product, media and entertainment marketing, which spans a career in radio, television, music and theater. Ms. Goldstein’s specific expertise includes operations, sales development, advertising, and project management. She has also spearheaded many major national and international marketing campaigns. She worked as a 
Broadway producer for the musical, First Date, and served in senior marketing positions, artist development and media-sales at JIVE Records, TV Guide Television Network, RCA Records, 
Virgin Records and multiple radio stations. As a key player, her expertise around spending and strategic marketing techniques contributed to RCA’s turnaround. She received the Billboard Magazine’s Radio Promotion Director of the Year, Bertelsmann Key Management Award, and 
Virgin Records Promotion Director of the Year.  Ms. Goldstein holds a Bachelor of Arts in Communications and Social Welfare from 
California State University at Chico. 

During her distinguished career,  Ms. Wilber has been a Chief Marketing Officer, global business strategist, and board member who delivers organizational and cultural transformation for branding. She is a pioneer in new franchise models and branded partnerships.  Ms. Wilber last served as the Executive Vice President, CMO, and Managing Director of Partnerships, EMEA, the highest position in the marketing department at 
Disney, where she drove growth for Walt Disney Company’s marquee brands by leading marketing and communications for 
Disney, Pixar, Star Wars, and Marvel. Additionally, she established and led EMEA’s 40-country integrated marketing, franchise and partnership functions, including a major reorganization of the EMEA channels to boost growth and profitability by significantly reducing expenses. She served as a Director for the board of 
Euro Disney SCA, and served as a member of the board of directors of 
Magical Cruise Company, more commonly known as 
Disney Cruise Line.  Ms. Wilber holds a Bachelor of Arts in History from 
Brown University.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments including online, e-commerce, direct-to-consumer channels, telehealth portal, and cash pay initiatives; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS for the acute treatment of PTSD, stroke and hemorrhagic brain injury, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

For more information, visit www.electrocore.com.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore Announces Changes to its Board of Directors

News and Market Data on electroCore

 

Julie Bruzzone Goldstein and Tricia Wilber to join the Board, adding significant marketing, media and brand strategy experience

ROCKAWAY, N.J., 
March 09, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the appointment of  Julie Bruzzone Goldstein and  Tricia Wilber to the company’s Board of Directors effective 
March 15, 2022. The Company also announced that effective 
March 4, 2022, Dr.  Stephen Ondra is resigning from the Board to focus on his new role as Chief Medical Advisor at MITRE, and  Michael Atieh will not be standing for re-election to the Board at the 2022 Annual General Meeting.  

“Ms. Goldstein and  Ms. Wilber are successful business leaders with proven track records, and I am pleased to welcome them to our Board,” said  Peter Cuneo, Chairman of the Board of Directors of electroCore. “As the company continues to invest in direct-to-consumer initiatives, their breadth of knowledge and experience will add significant value as we seek to expand the reach and impact of our therapies. These appointments are great additions to our Board of Directors, and we look forward to their contributions.”    

Mr. Cuneo continued, “I would like to recognize and thank  Mr. Atieh and  Dr. Ondra for their long service and myriad contributions to the Company. Their leadership and dedication, Mr. Atieh’s role as our previous Chairman, and both Directors’ service on various committees, have greatly advanced our business. Both  Mr. Atieh and  Dr. Ondra will remain available to the Company as advisors to the Chairman and CEO. We wish them continued success in their future endeavors.”

Ms. Goldstein brings to electroCore more than 30 years of leadership expertise in product, media and entertainment marketing, which spans a career in radio, television, music and theater. Ms. Goldstein’s specific expertise includes operations, sales development, advertising, and project management. She has also spearheaded many major national and international marketing campaigns. She worked as a 
Broadway producer for the musical, First Date, and served in senior marketing positions, artist development and media-sales at JIVE Records, TV Guide Television Network, RCA Records, 
Virgin Records and multiple radio stations. As a key player, her expertise around spending and strategic marketing techniques contributed to RCA’s turnaround. She received the Billboard Magazine’s Radio Promotion Director of the Year, Bertelsmann Key Management Award, and 
Virgin Records Promotion Director of the Year.  Ms. Goldstein holds a Bachelor of Arts in Communications and Social Welfare from 
California State University at Chico. 

During her distinguished career,  Ms. Wilber has been a Chief Marketing Officer, global business strategist, and board member who delivers organizational and cultural transformation for branding. She is a pioneer in new franchise models and branded partnerships.  Ms. Wilber last served as the Executive Vice President, CMO, and Managing Director of Partnerships, EMEA, the highest position in the marketing department at 
Disney, where she drove growth for Walt Disney Company’s marquee brands by leading marketing and communications for 
Disney, Pixar, Star Wars, and Marvel. Additionally, she established and led EMEA’s 40-country integrated marketing, franchise and partnership functions, including a major reorganization of the EMEA channels to boost growth and profitability by significantly reducing expenses. She served as a Director for the board of 
Euro Disney SCA, and served as a member of the board of directors of 
Magical Cruise Company, more commonly known as 
Disney Cruise Line.  Ms. Wilber holds a Bachelor of Arts in History from 
Brown University.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments including online, e-commerce, direct-to-consumer channels, telehealth portal, and cash pay initiatives; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS for the acute treatment of PTSD, stroke and hemorrhagic brain injury, the potential of nVNS generally and gammaCore in particular and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

For more information, visit www.electrocore.com.

Investors:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital
or
Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

PDS Biotechnology Announces Conference Call and Webcast for Fourth Quarter and Full Year 2021 Financial Results

Research, News, and Market Data on PDS Biotech

 

FLORHAM PARK, N.J., March 09, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced the Company will release financial results for the three- and twelve-month periods ended December 31, 2021, on Wednesday, March 23, 2022, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.

The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, March 23, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s website at www.pdsbiotech.com. After the live webcast, the event will be archived on PDS Biotech’s website for six months.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.  

Our Infectimune™ -based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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

 

Lifeist Portfolio Company, Mikra, Begins Presales of CELLF™

Research, News, and Market Data on Lifeist Wellness

 

With a waitlist of over 40,000 subscribers, Mikra launches presale of innovative cellular therapeutic to help combat oxidative stress

TORONTO, March 09, 2022 (GLOBE NEWSWIRE) — Lifeist Wellness Inc. (“Lifeist” or the “Company”) (TSXV: LFST) (FRANKFURT: M5B) (OTCMKTS: NXTTF), a health-tech company that leverages advancements in science and technology to build breakthrough companies that transform human wellness, today announced a number of business updates regarding its wholly owned U.S. subsidiary, Mikra, Cellular Sciences Inc. (“Mikra”), including the commencement of presales in the U.S. for its novel cellular therapeutic compound, CELLF™, targeted at combating oxidative stress.

“Lifeist’s U.S. portfolio company Mikra is demonstrating meaningful momentum with today’s launch of presale activities for CELLF™, founded upon clear consumer research insight,” said Meni Morim, CEO of Lifeist. “We believe that Mikra has the real potential to help accelerate Lifeist’s path to profitability and value creation for shareholders, while simultaneously improving human health and wellness, and we fully support Faraaz and the team’s plan.”

Added Faraaz Jamal, COO of Lifeist and CEO of Mikra, “We are building a different type of biological sciences company. The real health crisis is not reduced longevity. Humans are living longer, but they’re not able to enjoy those extra years because they’re plagued with many chronic issues. But it’s so hard for us to evaluate longevity or health span because it requires lifetimes. Multi-omics data is the name of the game now – we’ve entered an era of precision medicine and wellness. For every product we launch, we look at how it affects you on a cellular level by mapping what gene expression pathways are triggered, positively and negatively. That way, we know that our product is actually affecting you positively at the most microscopic level: your cells.”

Mikra, Cellular Sciences has commenced its genomic and transcriptomic clinical trials to gather evidence for CELLF™ at a molecular and cellular level.

Lifeist recognizes Mikra’s potential to help accelerate the Company’s path to profitability and increasing its total addressable markets outside of Canada, through a predominantly subscription based product pipeline, differentiated through its transparent R&D pillar that pledges rigorous clinical testing, the sharing of test result data, and launching new and improved iterations of existing products. With this unique selling point, Mikra intends to drive consumer trust and capture share of a $105 billion U.S. nutraceutical market through clear distribution pathways both online and offline.

Lifeist has approved a budgetary allocation to Mikra of up to $8.5 million for the fiscal year 2022, subject to ongoing achievement of internal milestones governing each new product, and assuming reinvestment of all anticipated Mikra profits back into Mikra.

CELLF[1] Presale Commences

With a waitlist of over 40,000 subscribers and positive feedback at levels of testing, Mikra has launched presale of its innovative cellular therapeutic CELLF to help combat oxidative stress, which may manifest in symptoms such as systemic fatigue, inflammation, and brain fog.

Monthly subscriptions at www.wearemikra.com start at US$88.00 + applicable taxes, for a 30-day supply of 10ml single-serve sachets, with sales on Amazon USA targeted to commence shortly afterward. With respect to distribution in Canada, Mikra is in the process of obtaining a Natural Product Number (NPN) from Health Canada. Subject to NPN receipt, Mikra anticipates launching a Canadian retail distribution strategy in calendar Q3 2022.

Mikra’s Data-Driven Product Pipeline

Mikra subscribes to the mentality that nutraceuticals specifically meant to affect change at a cellular level should be more akin to how software and pharmaceutical companies continually improve and upgrade their products. To do so Mikra is partnering with precision clinical partners, commencing with InVivo Biosystems, to accurately evaluate CELLF on a cellular level and to better understand, with precision and speed, which human cellular pathways relate to healthy aging and performance. This insight will fuel CELLF’s data warehouse creating a pipeline of iterative and more effective versions of CELLF. Mikra intends to share publicly complete data on all trials related to CELLF, adhering to Mikra’s brand pillar of “Transparent R&D” ensuring a changelog for all subsequent versions of CELLF.

Complementing this transparent R&D approach, Mikra is in the process of establishing a scientific advisory group, composed of distinguished physicians and medical researchers to consult on CELLF iterations and new products in development.

As part of Mikra’s marketing activities, Mikra has concurrently issued a U.S. consumer facing press release found here.

About Lifeist Wellness Inc.

Sitting at the forefront of the post-pandemic wellness revolution, Lifeist leverages advancements in science and technology to build breakthrough companies that transform human wellness. Portfolio business units include: CannMart, which operates a B2B wholesale distribution business facilitating recreational cannabis sales to Canadian provincial government control boards; CannMart Labs, a BHO extraction facility for the production of high margin cannabis 2.0 products; the CannMart.com marketplace, which provides U.S. customers with access to hemp-derived CBD and smoking accessories; Australian Vapes, the country’s largest online retailer of vaporizers and accessories; Findify, a leading AI-powered search and discovery platform; and Mikra, a biosciences and consumer wellness company seeking to develop innovative therapies for cellular health.

Information on Lifeist and its businesses can be accessed through the links below:

www.lifeist.com
www.cannmart.com
www.australianvaporizers.com.au
www.wearemikra.com

Contacts

Lifeist Wellness Inc.
Meni Morim, CEO
Matt Chesler, CFA, Investor Relations
Ph: 647-362-0390
Email: ir@lifeist.com 

Neither the 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 or has in any way approved or disapproved of the contents of this press release.

Forward Looking Information

This news release contains “forward-looking information” within the meaning of applicable securities laws. All statements contained herein that are not historical in nature contain forward-looking information. Forward-looking information can be identified by words or phrases such as “may”, “expect”, “likely”, “should”, “would”, “plan”, “anticipate”, “intend”, “potential”, “proposed”, “estimate”, “believe” or the negative of these terms, or other similar words, expressions and grammatical variations thereof, or statements that certain events or conditions “may” or “will” happen.

The forward-looking information contained herein, including, without limitation, statements related to Mikra’s contribution to the Company’s anticipated path to profitability and value creation for shareholders, the anticipated therapeutic benefits of Mikra’s first product CELLF™, the anticipated budget allocated to Mikra’s development and the development of its products, the establishment of a scientific advisory group and the launch of Mikra’s Canadian retail strategy in the third quarter of this calendar year are made as of the date of this news release and is based on assumptions management believed to be reasonable at the time such statements were made, including, without limitation, that: pre-clinical trials will prove successful, the Company’s previously filed application for a patent will be granted, expectations that CELLF will gain market acceptance along with the expansion of the market for nutraceutical products, expectations that the allocated budget to Mikra will be sufficient to pursue its business strategy as anticipated and that future sales of Mikra’s products through a subscription based model is the appropriate sales model to contribute to the Company’s path to profitability, Mikra will be able to attract the distinguished medical personnel it seeks to consult on iterations of CELLF™ and new products in development, Mikra will obtain a Natural Product Number from Health Canada, in a timely manner, enabling Mikra to distribute products in Canada, management’s perceptions of the Company’s standing in the online marketplace for nutraceutical and well products, Lifeist’s beliefs regarding the expected demand for nutraceutical and wellness products and the expected growth of the nutraceutical market, the timing of product availability, as well as other considerations that are believed to be appropriate in the circumstances. While we consider these assumptions to be reasonable based on information currently available to management, there is no assurance that such expectations will prove to be correct. While we consider these assumptions to be reasonable based on information currently available to management, there is no assurance that such expectations will prove to be correct. By its nature, forward-looking information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. A variety of factors, including known and unknown risks, many of which are beyond our control, could cause actual results to differ materially from the forward-looking information in this press release. Such factors include, without limitation: unforeseen developments that would delay Mikra’s ability to launch CELLF as anticipated and in a timely manner, the risk that preclinical trials are not as successful as anticipated and do not demonstrate the expected therapeutic benefits and/or fail to strengthen the Company’s patent claim, the risk that the expected demand for nutraceutical products in general and those of Mikra in particular does not develop as anticipated, the failure to convert the current number of subscribers on the pre-sales waitlist to actual sales, the inability to attract qualified physicians and medical researchers to consult on product development, the failure to obtain the requisite Natural Product Number from Health Canada resulting in Mikra not being able to distribute products in Canada, unforeseen budgetary constraints, redeployment of capital and/or Mikra’s failure to meet internal milestones governing the development of any new product, regulatory risk, risks relating to the Company’s ability to execute its business strategy and the benefits realizable therefrom and risks specifically related to the Company’s operations. Additional risk factors can also be found in the Company’s current MD&A and annual information form, both of which have been filed under the Company’s SEDAR profile at www.sedar.com. Readers are cautioned not to put undue reliance on forward-looking information. The Company undertakes no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.

Source: Lifeist Wellness Inc.

Ayala Pharmaceuticals to Present at the 32nd Annual Oppenheimer Healthcare Conference

Research, News, and Market Data on Ayala Pharmaceuticals

 

REHOVOT, Israel and WILMINGTON, Del., March 09, 2022 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, today announced that it will present at the 32^nd Annual Oppenheimer Healthcare Conference, taking place on March 15-17, 2022. The company will also participate in one-on-one investor meetings at the conference.

Details on the presentation can be found below.

A webcast of the presentation will be available on the “Events and Presentations” section of the Ayala Pharmaceuticals website.

About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Contacts:

Investors:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com  

Ayala Pharmaceuticals:
+1-857-444-0553
info@ayalapharma.com

Tonix Pharmaceuticals Announces Appointment of Jeffrey Rosenfeld, Ph.D., as Executive Director, Genomics and Bioinformatics

Research, News, and Market Data on Tonix Pharmaceuticals

 

CHATHAM, N.J., March 09, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the appointment of Jeffrey Rosenfeld, Ph.D., as its new Executive Director, Genomics and Bioinformatics. In this role, Dr. Rosenfeld will direct Tonix’s pharmacogenomics efforts including applying artificial intelligence, genome-wide association studies and mathematical modeling techniques to the analysis of patient outcomes in Tonix’s clinical trials.

“Dr. Rosenfeld brings substantial genomics expertise to Tonix that will support our efforts in pharmacogenomics and companion diagnostics,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As we continue to advance our pipeline and programs, Dr. Rosenfeld’s abilities and his passion for genomics will support the future success of our drug development efforts.”

“I am excited to join Tonix to lead the Company’s efforts to integrate genomics with clinical trials,” said Dr. Rosenfeld. “I look forward to working closely with the team to fully realize the potential of the Company’s deep portfolio of product candidates.”

Dr. Rosenfeld has a record of achievement in genomics and bioinformatics. Over his 15-year career in genomics, he has contributed to a wide range of biological and genetic projects, including genetic association studies of schizophrenia and clinical cancer genome sequencing. Most recently, he led an effort to investigate markers for autism in paternal sperm. For the past seven years, Dr. Rosenfeld has been an Assistant Professor of Pathology and Laboratory Medicine and the Manager of the Biomedical Informatics Shared Resource at the Rutgers Cancer Institute of New Jersey. In 2013, he founded Genome Liberty which developed tools for direct-to-consumer pharmacogenomics testing. Dr. Rosenfeld earned his B.S. in Biology and M.S. in Biotechnology from the University of Pennsylvania and a Ph.D. in Biology from New York University. He completed doctoral research at the Cold Spring Harbor Laboratory.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, central nervous system (CNS) and infectious disease product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including Tonix’s lead immunology candidate TNX-1500¹, which is a humanized monoclonal antibody targeting CD40 ligand being developed for the prevention of allograft rejection and the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to start in the second half of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL², (cyclobenzaprine HCl sublingual tablets), is a small molecule drug in mid-Phase 3 development for the management of fibromyalgia, with a new Phase 3 study expected to start in the first half of 2022. TNX-102 SL is also being developed to treat Long COVID, a chronic post-COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. TNX-1300³ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Tonix’s lead vaccine program is TNX-801 (live horsepox virus for percutaneous administration) for preventing smallpox and monkeypox⁴. Horsepox is also the basis for Tonix’s recombinant pox vaccine (RPV) platform. Tonix’s lead vaccine candidates designed for COVID-19, TNX-1840 and TNX-1850⁵, are live virus vaccines in development based on the RPV platform. Finally, TNX-3500⁶ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
²TNX-102 SL is an investigational new drug and has not been approved for any indication.
³TNX-1300 is an investigational new biologic and has not been approved for any indication.
⁴TNX-801 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
⁵TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. TNX-1840 and TNX-1850 are designed to express the spike protein of SARS-CoV-2 from omicron and BA.2 variants, respectively, based on the experience from TNX-1800, which expresses the spike protein from the ancestral Wuhan strain.
⁶TNX-3500 is an investigational new drug at the pre-IND stage of development and has 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, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, 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
(212) 688-9421

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.

Avivagen Secures New Influential Customer in Mexico

Research, News, and Market Data on Avivagen

 

Ottawa, ON /Business Wire/ March 8, 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 a large, influential and industry-leading poultry producer in Mexico has placed an order for its OxC-beta Livestock™ product, through Avivagen’s Mexican consultant Meyenberg International Group.

The sale follows a successful customer evaluation trial confirming that OxC-beta^TM Livestock increased productivity, flock health, uniformity and improved skin pigmentation within its operations. This small initial order is expected to be delivered in Q2.  Based on discussions with the customer, Avivagen anticipates receiving increasingly larger orders in the coming quarters as the customer implements OxC-beta in an increasing number of its contract farms.

“This new purchase, while modest,  is continued proof that once large and reputable food producers begin to trial OxC-beta, they consistently see strong results in improved health and production,” says Kym Anthony, Chief Executive Officer, Avivagen. “We’re excited to increase our reach in Mexico, and we expect our relationship with this high-profile customer to grow over the coming months.”

The sale has twofold significance. First, this customer is a relatively large producer with the capacity to regularly use a considerable quantity of OxC-beta in its operations. Thus, they represent an important potential recurring revenue stream for Avivagen. Secondly, the company is a prominent member of ANFACA, a producer association with a large membership based in Jalisco, Mexico. The adoption of OxC-beta in their operations provides other potential customers in the region with validation of the product’s effectiveness under local conditions and will help facilitate additional new sales.

The Mexico Animal feed market is expected to expand to more than US$8 billion by 2025. Growth in the Mexico poultry industry is noted as a key driver of that growth.[i]

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 expectations for the new customer to order more and larger orders of Avivagen product, the anticipated benefits of the new customer relationship to Avivagen, 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, the new customer is under no obligation to order Avivagen products in the future and could stop ordering at any time, the benefits Avivagen anticipates from this new customer relationship may not be realized, 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

Source: Avivagen

Avivagen Secures New Influential Customer in Mexico

Research, News, and Market Data on Avivagen

 

Ottawa, ON /Business Wire/ March 8, 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 a large, influential and industry-leading poultry producer in Mexico has placed an order for its OxC-beta Livestock™ product, through Avivagen’s Mexican consultant Meyenberg International Group.

The sale follows a successful customer evaluation trial confirming that OxC-beta^TM Livestock increased productivity, flock health, uniformity and improved skin pigmentation within its operations. This small initial order is expected to be delivered in Q2.  Based on discussions with the customer, Avivagen anticipates receiving increasingly larger orders in the coming quarters as the customer implements OxC-beta in an increasing number of its contract farms.

“This new purchase, while modest,  is continued proof that once large and reputable food producers begin to trial OxC-beta, they consistently see strong results in improved health and production,” says Kym Anthony, Chief Executive Officer, Avivagen. “We’re excited to increase our reach in Mexico, and we expect our relationship with this high-profile customer to grow over the coming months.”

The sale has twofold significance. First, this customer is a relatively large producer with the capacity to regularly use a considerable quantity of OxC-beta in its operations. Thus, they represent an important potential recurring revenue stream for Avivagen. Secondly, the company is a prominent member of ANFACA, a producer association with a large membership based in Jalisco, Mexico. The adoption of OxC-beta in their operations provides other potential customers in the region with validation of the product’s effectiveness under local conditions and will help facilitate additional new sales.

The Mexico Animal feed market is expected to expand to more than US$8 billion by 2025. Growth in the Mexico poultry industry is noted as a key driver of that growth.[i]

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 expectations for the new customer to order more and larger orders of Avivagen product, the anticipated benefits of the new customer relationship to Avivagen, 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, the new customer is under no obligation to order Avivagen products in the future and could stop ordering at any time, the benefits Avivagen anticipates from this new customer relationship may not be realized, 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

Source: Avivagen

Monday, March 07, 2022

Ocugen (OCGN)
COVAXIN Pediatric EUA Declined, But Majority of Expected Market Unaffected

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

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.

FDA Has Denied The Pediatric Emergency Use Application (EUA).  Ocugen has announced that the FDA has declined its EUA for pediatric use in the ages 2 through 18 group. Although its approval would have been positive sign for full product BLA approval, we do not believe its denial will have any impact on the BLA for adult use.

BLA Application for Adult Use Is Unaffected.  Ocugen did not give details about the reasons for the denial, only saying that it will “continue working with the FDA to evaluate the the regulatory pathway for COVAXIN.” We believe the FDA is highly unlikely to approve additional COVID-19 products under Emergency Use guidelines, and that the COVAXIN pediatric indication submission will be reviewed …

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 Collaboration with Massachusetts General Hospital to Evaluate TNX-1900 (Intranasal Potentiated Oxytocin) for Treating Binge Eating Disorder

Research, News, and Market Data on Tonix Pharmaceuticals

 

An Investigator Initiated Phase 2 Clinical Trial of TNX-1900 In Patients with Binge Eating Disorder Planned for Second Half 2022

Binge Eating Disorder is Estimated to Affect 2.8 Million American Adults^1-3

Expands Uses of Tonix’s Proprietary Potentiated Oxytocin for Intranasal Administration to a Potential New Indication

CHATHAM, N.J., March 07, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement with Massachusetts General Hospital, a teaching hospital of Harvard Medical School, to evaluate TNX-1900* in an investigator initiated Phase 2 clinical trial as a potential treatment for patients with binge eating disorder. The Phase 2 clinical trial is expected to start in the second half of 2022.

“Binge eating disorder is a serious mental health condition associated with behavioral and metabolic morbidity for which there are few treatment options,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Oxytocin is a well-known natural hormone that is used therapeutically in certain other indications including as an i.v. medication for the induction of labor in pregnancy with a medical indication. We are hopeful that our proprietary intranasal dosage form will enhance its properties for use in the underserved population of patients suffering from binge eating disorder.”

TNX-1900* is also in development for the treatment of chronic migraine and is expected to enter a multi-site Phase 2 potential pivotal clinical trial for the prevention of migraine headache in chronic migraineurs in the second half of 2022.

“The binge eating disorder trial is expected to provide a rich source of data to evaluate the potential clinical benefit of TNX-1900 on binge eating disorder, which is often seen in association with other behavioral conditions such as depression, substance abuse and posttraumatic stress disorder, and is often under-diagnosed and under-treated,” said Elizabeth A. Lawson, M.D., M.M.Sc., Director, Interdisciplinary Oxytocin Research Program, Neuroendocrine Unit, Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School and principal investigator of the trial. “While available psychological and pharmacological treatments produce remission from binge eating in some cases, up to 50% of patients continue to binge, and weight loss in those with obesity is difficult to achieve and sustain. There is accumulating evidence that oxytocin may reduce food intake by acting on neural pathways involved in reward and impulse control, which have been implicated in binge eating disorder. We are excited to investigate TNX-1900 as a potential novel therapy to reduce binge eating and excess body weight in individuals with binge eating disorder.”

Dr. Lawson previously led a program of research suggesting intranasal oxytocin reduces food intake, modulates the neural circuitry driving eating behavior, and enhances impulse control in men with overweight and obesity.^4-7

The planned investigator initiated Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled study of 60 patients with binge eating disorder and obesity. The 8-week study will evaluate the efficacy and safety of TNX-1900 as a treatment for binge eating disorder and determine whether TNX-1900 reduces bingeing frequency and body weight in adults with binge eating disorder and obesity, and underlying mechanisms.

* TNX-1900 is an investigational new drug and has not been approved for any indication.

¹https://www.bingeeatingdisorder.com/hcp/patient-demographics (accessed Feb 23, 2022)
²Hudson JI, et al. (2007) [Published correction appears in Biol Psychiatry. 2012;72(2):164.] Biol Psychiatry. 61(3):348-358. doi: 10.1016/j.biopsych.2006.03.040.
³Howden LM and Meyer JA. (2011) Age and sex composition: 2010. US Census Bureau
⁴Lawson EA et al. (2015) Oxytocin reduces caloric intake in men. Obesity 23(5):950-6.  doi: 10.1002/oby.21069.
⁵Plessow F. et al. (2018) Effects of intranasal oxytocin on the blood oxygenation level-dependent signal in food motivation and cognitive control pathways in overweight and obese men. Neuropsychopharmacology 43(3):638-645.  doi: 10.1038/npp.2017.226.
⁶Kerem L et al. (2020) Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity. In J Obes 44(5):980-989. doi: 10.1038/s41366-019-0489-7.
⁷Plessow F et al. (2021) Oxytocin administration increases proactive control in men with overweight or obesity: A randomized, double blind, placebo-controlled crossover study. Obesity 29(1):56-61. doi: 10.1002/oby.23010.

About Binge Eating Disorder

Binge-eating disorder is a psychiatric illness characterized by frequent episodes of uncontrollable consumption of large amounts of food. It is the most common eating disorder and often leads to obesity-associated complications and later psychopathology¹. Binge eating disorder is characterized by increased homeostatic appetite and sensitivity to reward (including food reward), which may lead to initiation of binge episodes, and a reduced ability to control behavioral impulses and formed habits, creating an imbalance in the sensitive interplay between these bottom-up and top-down processes governing the adaptive regulation of food intake and energy balance^2-5.

¹Field AE et al. (2012) Prospective association of common eating disorders and adverse outcomes. Pediatrics, 130: e289–95.  doi: 10.1542/peds.2011-3663.
²Dawe S. & Loxton NJ, (2004) The role of impulsivity in the development of substance use and eating disorders Neurosci Biobehav Rev.  28(3):343-51. doi: 10.1016/j.neubiorev.2004.03.007.
³Giel KE et al. (2017) Food-Related Impulsivity in Obesity and Binge Eating Disorder-A Systematic Update of the Evidence. Nutrients 9(11):1170. doi: 10.3390/nu9111170.
⁴Hernandez D et al. (2019) Meal-Related Acyl and Des-Acyl Ghrelin and Other Appetite-Related Hormones in People with Obesity and Binge Eating. Obesity 27(4):629-635. doi: 10.1002/oby.22431.
⁵Schag K et al. (2013) Food-related impulsivity in obesity and binge eating disorder–a systematic review. Obes Rev.  14(6):477-95.  doi: 10.1111/obr.12017. 

About TNX-1900 and Tonix’s Potentiated Oxytocin Platform

TNX-1900 is based on a proprietary potentiated formulation of oxytocin and is currently being developed as a candidate for prophylaxis of chronic migraine, the treatment of insulin resistance¹ and related conditions.TNX-1900 is based on Tonix’s patented intranasal potentiated oxytocin formulation. Tonix is also developing a different intranasal formulation, designated TNX-2900, for the treatment of Prader-Willi syndrome. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. It was originally approved by the U.S. Food and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal form of oxytocin was marketed in the U.S. by Novartis to assist in the production of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml), but the product was withdrawn, and the New Drug Application has been discontinued. TNX-1900 and TNX-2900 are in the pre-Investigational New Drug stage and have not been approved for any indication.

¹Deblon N, et al. (2011) PLoS ONE 6(9): e25565. doi:10.1371/journal.pone.0025565
*Pitocin® is a trademark of Par Pharmaceutical, Inc.
**Syntocinon® is a trademark of BGP Products Operations GmbH

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500¹ which is a humanized monoclonal antibody targeting CD40 ligand being developed for the prevention of allograft rejection 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 includes next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. The pipeline also includes a vaccine in development to prevent smallpox. Tonix’s lead vaccine candidate for COVID-19, TNX-1800², is a live virus vaccine based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-3500³ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL⁴ , (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022. Finally, TNX-1300⁵ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first quarter of 2022.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
²TNX-1800 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication. TNX-1800 is based on TNX-801, live horsepox virus vaccine for percutaneous administration, which is in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
³TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
⁴TNX-102 SL is an investigational new drug and has not been approved for any indication.
⁵TNX-1300 is an investigational new biologic and has 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 development of TNX-1900; 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, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, 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 
(212) 688-9421

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 Collaboration with Massachusetts General Hospital to Evaluate TNX-1900 (Intranasal Potentiated Oxytocin) for Treating Binge Eating Disorder

Research, News, and Market Data on Tonix Pharmaceuticals

 

An Investigator Initiated Phase 2 Clinical Trial of TNX-1900 In Patients with Binge Eating Disorder Planned for Second Half 2022

Binge Eating Disorder is Estimated to Affect 2.8 Million American Adults^1-3

Expands Uses of Tonix’s Proprietary Potentiated Oxytocin for Intranasal Administration to a Potential New Indication

CHATHAM, N.J., March 07, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement with Massachusetts General Hospital, a teaching hospital of Harvard Medical School, to evaluate TNX-1900* in an investigator initiated Phase 2 clinical trial as a potential treatment for patients with binge eating disorder. The Phase 2 clinical trial is expected to start in the second half of 2022.

“Binge eating disorder is a serious mental health condition associated with behavioral and metabolic morbidity for which there are few treatment options,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Oxytocin is a well-known natural hormone that is used therapeutically in certain other indications including as an i.v. medication for the induction of labor in pregnancy with a medical indication. We are hopeful that our proprietary intranasal dosage form will enhance its properties for use in the underserved population of patients suffering from binge eating disorder.”

TNX-1900* is also in development for the treatment of chronic migraine and is expected to enter a multi-site Phase 2 potential pivotal clinical trial for the prevention of migraine headache in chronic migraineurs in the second half of 2022.

“The binge eating disorder trial is expected to provide a rich source of data to evaluate the potential clinical benefit of TNX-1900 on binge eating disorder, which is often seen in association with other behavioral conditions such as depression, substance abuse and posttraumatic stress disorder, and is often under-diagnosed and under-treated,” said Elizabeth A. Lawson, M.D., M.M.Sc., Director, Interdisciplinary Oxytocin Research Program, Neuroendocrine Unit, Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School and principal investigator of the trial. “While available psychological and pharmacological treatments produce remission from binge eating in some cases, up to 50% of patients continue to binge, and weight loss in those with obesity is difficult to achieve and sustain. There is accumulating evidence that oxytocin may reduce food intake by acting on neural pathways involved in reward and impulse control, which have been implicated in binge eating disorder. We are excited to investigate TNX-1900 as a potential novel therapy to reduce binge eating and excess body weight in individuals with binge eating disorder.”

Dr. Lawson previously led a program of research suggesting intranasal oxytocin reduces food intake, modulates the neural circuitry driving eating behavior, and enhances impulse control in men with overweight and obesity.^4-7

The planned investigator initiated Phase 2 clinical trial will be a randomized, double-blind, placebo-controlled study of 60 patients with binge eating disorder and obesity. The 8-week study will evaluate the efficacy and safety of TNX-1900 as a treatment for binge eating disorder and determine whether TNX-1900 reduces bingeing frequency and body weight in adults with binge eating disorder and obesity, and underlying mechanisms.

* TNX-1900 is an investigational new drug and has not been approved for any indication.

¹https://www.bingeeatingdisorder.com/hcp/patient-demographics (accessed Feb 23, 2022)
²Hudson JI, et al. (2007) [Published correction appears in Biol Psychiatry. 2012;72(2):164.] Biol Psychiatry. 61(3):348-358. doi: 10.1016/j.biopsych.2006.03.040.
³Howden LM and Meyer JA. (2011) Age and sex composition: 2010. US Census Bureau
⁴Lawson EA et al. (2015) Oxytocin reduces caloric intake in men. Obesity 23(5):950-6.  doi: 10.1002/oby.21069.
⁵Plessow F. et al. (2018) Effects of intranasal oxytocin on the blood oxygenation level-dependent signal in food motivation and cognitive control pathways in overweight and obese men. Neuropsychopharmacology 43(3):638-645.  doi: 10.1038/npp.2017.226.
⁶Kerem L et al. (2020) Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity. In J Obes 44(5):980-989. doi: 10.1038/s41366-019-0489-7.
⁷Plessow F et al. (2021) Oxytocin administration increases proactive control in men with overweight or obesity: A randomized, double blind, placebo-controlled crossover study. Obesity 29(1):56-61. doi: 10.1002/oby.23010.

About Binge Eating Disorder

Binge-eating disorder is a psychiatric illness characterized by frequent episodes of uncontrollable consumption of large amounts of food. It is the most common eating disorder and often leads to obesity-associated complications and later psychopathology¹. Binge eating disorder is characterized by increased homeostatic appetite and sensitivity to reward (including food reward), which may lead to initiation of binge episodes, and a reduced ability to control behavioral impulses and formed habits, creating an imbalance in the sensitive interplay between these bottom-up and top-down processes governing the adaptive regulation of food intake and energy balance^2-5.

¹Field AE et al. (2012) Prospective association of common eating disorders and adverse outcomes. Pediatrics, 130: e289–95.  doi: 10.1542/peds.2011-3663.
²Dawe S. & Loxton NJ, (2004) The role of impulsivity in the development of substance use and eating disorders Neurosci Biobehav Rev.  28(3):343-51. doi: 10.1016/j.neubiorev.2004.03.007.
³Giel KE et al. (2017) Food-Related Impulsivity in Obesity and Binge Eating Disorder-A Systematic Update of the Evidence. Nutrients 9(11):1170. doi: 10.3390/nu9111170.
⁴Hernandez D et al. (2019) Meal-Related Acyl and Des-Acyl Ghrelin and Other Appetite-Related Hormones in People with Obesity and Binge Eating. Obesity 27(4):629-635. doi: 10.1002/oby.22431.
⁵Schag K et al. (2013) Food-related impulsivity in obesity and binge eating disorder–a systematic review. Obes Rev.  14(6):477-95.  doi: 10.1111/obr.12017. 

About TNX-1900 and Tonix’s Potentiated Oxytocin Platform

TNX-1900 is based on a proprietary potentiated formulation of oxytocin and is currently being developed as a candidate for prophylaxis of chronic migraine, the treatment of insulin resistance¹ and related conditions.TNX-1900 is based on Tonix’s patented intranasal potentiated oxytocin formulation. Tonix is also developing a different intranasal formulation, designated TNX-2900, for the treatment of Prader-Willi syndrome. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. It was originally approved by the U.S. Food and Drug Administration as Pitocin®*, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal form of oxytocin was marketed in the U.S. by Novartis to assist in the production of breast milk as Syntocinon®** (oxytocin nasal 40 units/ml), but the product was withdrawn, and the New Drug Application has been discontinued. TNX-1900 and TNX-2900 are in the pre-Investigational New Drug stage and have not been approved for any indication.

¹Deblon N, et al. (2011) PLoS ONE 6(9): e25565. doi:10.1371/journal.pone.0025565
*Pitocin® is a trademark of Par Pharmaceutical, Inc.
**Syntocinon® is a trademark of BGP Products Operations GmbH

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500¹ which is a humanized monoclonal antibody targeting CD40 ligand being developed for the prevention of allograft rejection 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 includes next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a potential treatment for Long COVID. The pipeline also includes a vaccine in development to prevent smallpox. Tonix’s lead vaccine candidate for COVID-19, TNX-1800², is a live virus vaccine based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-3500³ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL⁴ , (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022. Finally, TNX-1300⁵ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first quarter of 2022.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.
²TNX-1800 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication. TNX-1800 is based on TNX-801, live horsepox virus vaccine for percutaneous administration, which is in development to protect against smallpox and monkeypox. TNX-801 is an investigational new biologic and has not been approved for any indication.
³TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.
⁴TNX-102 SL is an investigational new drug and has not been approved for any indication.
⁵TNX-1300 is an investigational new biologic and has 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 development of TNX-1900; 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, 2020, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, 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 
(212) 688-9421

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.

Monday, March 07, 2022

Ocugen (OCGN)
COVAXIN Pediatric EUA Declined, But Majority of Expected Market Unaffected

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

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.

FDA Has Denied The Pediatric Emergency Use Application (EUA).  Ocugen has announced that the FDA has declined its EUA for pediatric use in the ages 2 through 18 group. Although its approval would have been positive sign for full product BLA approval, we do not believe its denial will have any impact on the BLA for adult use.

BLA Application for Adult Use Is Unaffected.  Ocugen did not give details about the reasons for the denial, only saying that it will “continue working with the FDA to evaluate the the regulatory pathway for COVAXIN.” We believe the FDA is highly unlikely to approve additional COVID-19 products under Emergency Use guidelines, and that the COVAXIN pediatric indication submission will be reviewed …

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.