Biopharmaceutical Archives - Page 10 of 26

Release – YS Biopharma Announces Appointment of New Directors

Posted on February 14, 2024February 14, 2024 by aweinsoff@channelchek.com

GAITHERSBURG, Md., Feb. 14, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (Nasdaq: YS) (“YS Biopharma” or the “Company”, and together with its subsidiaries, “YS Group”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced the appointment of six new members to its Board of Directors (the “Board”), effective February 13, 2024. The six new directors are: Dr. Yuntao Cui; Dr. Jin Wang; Mr. Henry Chen; Mr. Haitao Zhao; Mr. Pierson Yue Pan; and Ms. Brenda Chunyuan Wu.

In addition to the new appointments, the Board has elected Dr. Ajit Shetty, who had served as the Company’s Interim Chairperson of the Board since December 9, 2023, as Chairperson of the Board, effective February 13, 2024.

Dr. Yuntao Cui has over 15 years of law-related work experience, and has previously worked as a Senior Lawyer at Zhong Lun Law Firm, one of the top law firms in China, and as General Manager of Legal Affairs at Wanda Group, a top conglomerate in the real estate, finance, and hospitality industries. Dr. Cui is currently a Senior Vice President and General Counsel at Juventas Cell Therapy Ltd., a leading immune cell therapy company. Dr. Cui holds a JD from Renmin University of China.

Dr. Jin Wang is Founding Partner and CEO of Manhattan Capital Investment Consulting Group (“MCG”), and has managed the venture capital investment fund Nuokang Venture Fund since 2014. Dr. Wang has more than 27 years of experience finding, building, and strategizing for biotech companies, including his co-founding and angel investment in leading medical professional networking and service firm DXY. Dr. Wang previously worked as an analyst and Asia/Greater China Regional Director for Paramount Capital Investment, LLC, and co-founded the Sino-American Pharmaceutical Professionals Association (“SAPA”) in 1993. Dr. Wang holds a PhD in Biomedical Science from Worcester Polytechnic Institute.

Mr. Henry Chen is the CEO of Monument Pacific Development Corp., a California-based company dedicated to developing, managing, and operating residential and commercial properties in Northern and Southern California. Mr. Chen received his MBA from the University of California, Berkeley’s Hass School of Business in 2012, and a Bachelor of Laws in Business Administration and Management from the Beijing University of Chemical Technology in 2005.

Mr. Haitao Zhao has served as a Partner of the Shanxi Tie Niu law firm since 2016, where he is responsible for handling corporate law related to intellectual property protection, corporate internal governance, and financing-related legal services. Previously, Mr. Zhao worked as an Attorney for the Beijing Ding En law firm from 2012-2016. He holds an MA in International Law from Shanxi University.

Mr. Pierson Yue Pan has served as a Vice President of Monument Pacific Development Corp. since 2018. Previously, Mr. Pan worked as Vice President of Project Development at real estate developer Propriis from 2012-2018, and as General Manager of the Africa Market with the China Civil Engineering Construction Company Nigeria Limited from 2004-2011. Mr. Pan holds an MBA from the University of California, Berkeley’s Hass School of Business.

Ms. Chunyuan (Brenda) Wu currently serves as the CFO of YS Group, a position she has held since December 31, 2020. Previously, Ms. Wu served as CFO of YS Group Biopharma from 2018-2020, and as Financial Controller for the same company from 2013-2018. Ms. Wu has also previously worked as a Senior Auditor at Ernst & Young. Ms. Wu holds degrees in Accounting and Finance from Washington State University.

Dr. Ajit Shetty, Chairperson of the Board of Directors of the Company, commented, “We are pleased to welcome each of our new directors to the Board. Each of these talented individuals brings valuable expertise in various aspects of corporate governance, legal affairs, business management, and strategic decision-making. We expect that their diverse experience and commitment to success will serve our company well going forward.”

About YS Biopharma

YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit investor.ysbiopharm.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “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. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of the Company, the development progress of all product candidates, the progress and results of all clinical trials, the Company’s ability to source and retain talent, and the cash position of the Company following the closing of the Business Combination. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.

These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from those expressed or implied by these forward-looking statements. Although YS Biopharma believes that it has a reasonable basis for each forward-looking statement contained in this press release, YS Biopharma cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. In addition, there are risks and uncertainties described in the documents filed by YS Biopharma from time to time with the U.S. Securities and Exchange Commission (“SEC”). These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, the outcome of any potential litigation, government or regulatory proceedings, the sales performance of the marketed vaccine product and the clinical trial development results of the product candidates of YS Biopharma, and other risks and uncertainties, including those included under the heading “Risk Factors” in the post-effective amendment No. 2 to Form F-1 filed with the SEC on January 23, 2024 which became effective on January 25, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

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SOURCE YS Biopharma Co., Ltd.

Release – Tonix Pharmaceuticals Announces Engagement of Rho as CRO to Support Submission of New Drug Application to the FDA for Approval of Tonmya™ for the Management of Fibromyalgia

Posted on February 13, 2024February 13, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 13, 2024 8:00am ESTDownload as PDF

Tonmya™ is a potential new first-line therapy, non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials

New Drug Application (NDA) submission to the FDA planned for second half of 2024

Fibromyalgia is a chronic pain condition affecting approximately 10 million U.S. adults that typically persists for years or decades

CHATHAM, N.J., Feb. 13, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it has engaged Rho, Inc. (Rho), a global contract research organization (CRO), to support Tonix’s preparation and planned submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.

“We are excited by our most recent positive Phase 3 study results of Tonmya and look forward to Rho’s support in preparing our NDA,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We intend to meet with the FDA in the first half of this year and to submit our NDA in the second half of the year. We believe we have completed all development work required for the NDA, including CMC requirements and the completion of two positive Phase 3 studies.”

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the Company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.

“We are delighted in our continued support of Tonix and their Tonmya program,” said Tara Gladwell, President and COO at Rho. “We are hopeful that this work may result in a new treatment for the millions of Americans that suffer from this debilitating, chronic disorder.”

About Fibromyalgia

Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6 million to 12 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

About Tonmya™ (also known as TNX-102 SL)

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of CBP-HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

About Rho

Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. Since 1984, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho’s therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on LinkedIn.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to reduce the severity of acute stress reaction and the frequency of acute stress disorder and posttraumatic stress disorder. This trial is being sponsored by the University of North Carolina and received funding support from the U.S. Department of Defense. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA and received funding from the National Institute on Drug Abuse (NIDA). A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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; risks related to the failure to successfully market any of our products; 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, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, 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.

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released February 13, 2024

Gilead Sciences Acquires CymaBay Therapeutics for $4.3 Billion in Cash

Posted on February 13, 2024February 13, 2024 by slightbourne@noblecapitalmarkets.com

Gilead Sciences announced Monday that it will acquire clinical-stage biotech CymaBay Therapeutics for $4.3 billion, gaining seladelpar, an investigational treatment for primary biliary cholangitis (PBC) that is currently under FDA priority review.

PBC is a progressive autoimmune disease that damages the bile ducts in the liver, causing bile acid buildup that can lead to irreversible scarring and liver failure. An estimated 130,000 Americans live with PBC, which mostly affects women over 40.

CymaBay’s seladelpar is an oral selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that targets metabolic and inflammatory pathways involved in PBC. Data from late-stage studies demonstrate seladelpar’s potential as a best-in-class therapy for second-line PBC patients who don’t respond adequately to first-line treatment with ursodeoxycholic acid (UDCA).

The drug received breakthrough therapy and orphan drug designations from the FDA and EMA based on positive mid-stage results. In December 2022, CymaBay submitted a new drug application to the FDA, which was granted priority review last month. An approval decision is expected by August 14, 2024.

According to the phase 3 RESPONSE trial, seladelpar achieved significant improvements in reducing alkaline phosphatase levels and relieving itch symptoms compared to placebo. Nearly 62% of patients on seladelpar attained a biochemical response versus 20% on placebo.

Gilead aims to leverage its extensive experience in developing treatments for liver diseases like hepatitis C and nonalcoholic steatohepatitis (NASH) to advance seladelpar. The deal expands Gilead’s presence in the PBC space, complementing its existing medicine Ocaliva, which is approved as a second-line option.

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“We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” commented Gilead CEO Daniel O’Day. “Building on the strong R&D work by the CymaBay team, we have the potential to address a significant unmet need for people with PBC.”

Under the terms of the agreement, Gilead will commence a tender offer to acquire all outstanding CymaBay shares at $32.50 per share in cash, representing a 27% premium over the stock’s closing price on February 9. Following the tender offer, Gilead will mop up any untendered shares via a second-step merger at the same price.

The deal is anticipated to close in the first quarter of 2024, subject to customary closing conditions and regulatory clearances. Once the transaction is completed, CymaBay will become a wholly owned subsidiary of Gilead.

Gilead expects the buyout will boost its top-line revenue growth, while being neutral to earnings per share in 2025 before turning significantly accretive thereafter.

For CymaBay, the takeover marks the culmination of years of effort advancing seladelpar into late-stage testing and regulatory review. “Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead can apply its expertise to bring seladelpar as quickly as possible to people with PBC,” noted CymaBay CEO Sujal Shah.

The profitable exit provides a major return for CymaBay investors, as the purchase price represents a substantial premium over the stock’s pre-announcement valuation. CymaBay shares have languished below $4 for much of the past two years.

Gilead has actively pursued M&A to augment its pipeline and product portfolio across therapeutic areas like oncology, inflammation, and antivirals. The company faces looming patent expiries on flagship HIV medicines. New growth drivers like seladelpar could help offset that impact.

PBC currently affects a relatively small patient population, but analysts project seladelpar could generate peak annual sales above $1 billion. Gilead likely sees potential to expand seladelpar’s utility to other cholestatic liver diseases.

Nonetheless, the deal does carry risks for Gilead. Seladelpar’s broad mechanism regulating gene expression raises safety concerns about potential side effects. Patients in late-stage testing experienced elevations in low-density lipoprotein cholesterol.

By acquiring CymaBay outright, Gilead shoulders all future R&D costs rather than opting for a partnership deal to share expenses. If seladelpar encounters any regulatory or commercial setbacks, Gilead lacks an immediate fallback option for its PBC program.

But with priority review underway and approval expected within six months, Gilead moved aggressively to lock up rights to a promising PBC candidate. Adding seladelpar provides another growth avenue beyond HIV and bolsters Gilead’s mission of delivering transformative medicines for underserved diseases.

Release – Tonix Pharmaceuticals Announces FDA IND Clearance for DoD Funded Trial of TNX-102 SL for the Reduction of Acute Stress Reaction and Prevention of PTSD

Posted on February 12, 2024February 12, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 12, 2024 8:00am ESTDownload as PDF

Bedtime TNX-102 SL improves sleep quality in PTSD and is also being developed for the management of fibromyalgia for which NDA preparation is ongoing

Investigator-Initiated OASIS Trial at UNC is a Phase 2 180-patient, randomized, placebo-controlled trial in acute trauma patients following motor vehicle collisions

One-third of emergency department visits in the U.S. (40-50 million patients per year) involve evaluation after trauma exposures

CHATHAM, N.J., Feb. 12, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the Phase 2 investigator-initiated OASIS trial to evaluate TNX-102 SL¹ in reducing the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD). The trial is sponsored by The University of North Carolina (UNC) Institute for Trauma Recovery and supported by a $3 million grant from the U.S. Department of Defense (DoD).

“No medication is currently available at or near the point-of-care to treat patients suffering from traumatic events and support long-term health,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “There is an unmet need for treating ASR after traumatic events such as civilian motor vehicle collisions or warfighter experiences in forward bases or in theater. Previous trials of TNX-102 SL in PTSD suggested activity on sleep and stress related symptoms in the first several weeks of treatment.^2,3 The study is motivated by the observation that the symptoms of ASR and PTSD are similar and by the hypothesis that TNX-102 SL’s effect on sleep quality may reduce ASR symptoms.”

The Optimizing Acute Stress Reaction Interventions with TNX-102 SL (OASIS) trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients presenting to the emergency department (ED) after a motor vehicle collision. The trial will enroll approximately 180 trauma survivors at ED study sites around the U.S. Participants will be randomized in the ED to receive a two-week course of either TNX-102 SL 5.6 mg or placebo.

The OASIS trial will build upon a foundation of knowledge and infrastructure developed through the UNC-led, $40 million AURORA initiative. AURORA is a major national research initiative to improve the understanding, prevention, and recovery of individuals who experience a traumatic event. AURORA is supported by funding from the National Institutes of Health (NIH), leading brain health nonprofit One Mind, private foundations, and partnerships with leading tech companies such as Mindstrong Health and Verily Life Sciences, the healthcare arm of Alphabet, the parent company of Google.

“This innovative clinical trial and partnership will help address the need for safe and effective therapies to treat acute trauma,” said Samuel McLean, M.D., Professor of Psychiatry and Emergency Medicine at the UNC School of Medicine at UNC, School of Medicine, and lead principal investigator of the proposed study. “ASR and posttraumatic stress symptoms are common among civilian motor vehicle collision survivors. The AURORA initiative, which has collected thousands of data points from motor vehicle collisions, has allowed us to better investigate the correlation between motor vehicle collisions and the emergence of acute stress disorder or PTSD symptoms. In OASIS, we will test a pharmacological intervention in the immediate aftermath of trauma that has potential for fast relief of stress symptoms, improvement in coping and functioning, and preclusion of escalation to more severe conditions, ASD in the short term and PTSD thereafter.”

Acute and chronic stress disorders can affect both civilian and military populations. According to the National Center for PTSD, in the U.S. about 60% of men and 50% of women experience at least one trauma in their lives.⁴ In the U.S. alone, one-third of emergency department visits (40-50 million patients per year) involve evaluation after trauma exposures, and in a 2014 study involving 3,157 US veterans, 87% reported exposure to at least one potentially traumatic event during their service.⁵ Moreover, as many as 500,000 U.S. troops who served in wars between 2001 and 2015 were diagnosed with PTSD.⁶

About Tonmya™ (also known as TNX-102 SL)

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia. TNX-102 SL is also in development for fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of cyclobenzaprine HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

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

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) has not been approved for any indication; (Tonmya™ is conditionally approved by FDA for the management of fibromyalgia)
Sullivan GM, et al. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974.
Parmenter ME, et al. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic stress disorder. Psychiatry Res. 2024 (In Press). https://doi.org/10.1016/j.psychres.2024.115764
Goldstein RB, et al. Soc Psychiatry Psychiatr Epidemiol. 2016. 51(8):1137-48
Wisco BE, et al. J Clin Psychiatry. 2014. 75(12):1338-46
Thompson M. Time. 2015;185(12):40-3

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039

Source: Tonix Pharmaceuticals Holding Corp.

Released February 12, 2024

Release – YS Biopharma Announces US$40 Million Private Placement Financing

Posted on February 9, 2024February 9, 2024 by aweinsoff@channelchek.com

Research News and Market Data on YS

GAITHERSBURG, Md., Feb. 9, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma”) along with its subsidiaries (“YS Group” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that it has entered into a share purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Purchaser”) for the private placement of 95,269,762 ordinary shares of the Company, par value US$0.00002 per share (the “Shares”) at a purchase price of $0.41986 per Share (the “Private Placement”) for an aggregate of US$40 million in proceeds.

Dr. David Shao, Director, President, and CEO of the Company, commented, “We are proud to announce the US$40 million private placement, exclusively through the issuance of ordinary shares. Through equity financing, without issuance of any warrants or options, we empower our investors with direct ownership, aligning their interests with the interests of existing shareholders striving for the long-term success of YS Biopharma. This infusion of capital significantly improves and strengthens our balance sheet. It bolsters our cash position, enhances liquidity, and provides additional financial resources to support our core operations and business growth.”

The Shares being purchased are exempted from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) pursuant to Regulation S promulgated thereunder. The Private Placement was made after the dismissal of the injunction order granted by the Grand Court of the Cayman Islands dated December 22, 2023. The Purchase Agreement contains customary representations, warranties and covenants of the Company and the Purchaser, and customary indemnification provisions for a transaction of this type. The Company also granted the Purchaser customary registration rights with respect to the Shares. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale of these securities would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “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. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of the Company, the development progress of all product candidates, the progress and results of all clinical trials, the Company’s ability to source and retain talent, and the cash position of the Company. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma’s management and are not predictions of actual performance.

YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Company’s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.

Investor Relations Contact

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

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SOURCE YS Biopharma Co., Ltd.

AstraZeneca Shares Drop Despite Strong 2024 Outlook

Posted on February 9, 2024February 9, 2024 by slightbourne@noblecapitalmarkets.com

Shares of pharmaceutical giant AstraZeneca fell over 6% despite the company projecting double-digit growth for 2024. Investors were disappointed by AstraZeneca missing Q4 earnings expectations due to rising costs. However, smaller healthcare firms may offer more upside potential.

AstraZeneca reported fourth quarter core earnings per share of $1.45, below analyst estimates of $1.50. Higher research and development costs weighed on profits. Meanwhile, total revenue edged above expectations at $12.02 billion.

The company expects low double-digit percentage increases in both total revenue and core earnings per share in 2024. This robust guidance is driven by AstraZeneca’s oncology and rare disease drugs.

However, shares dropped as investors focused on the earnings miss and product mix in the latest quarterly results. While AstraZeneca maintains a strong long-term outlook, its scale and mature product portfolio limit rapid growth.

This has led some investors to turn their attention to younger healthcare companies in search of higher growth potential. Smaller biotechs and emerging medtech firms can offer more upside, albeit with higher risk.

For example, cancer immunotherapy developer Silverback Therapeutics went public in late 2020 and has seen its stock price triple over the last year. The company is advancing treatments that harness the body’s immune system to fight cancer.

Other high-growth areas include digital health, where newly public firms like GoodRx are disrupting pharmacy and drug pricing. And healthcare tech provider Oak Street Health has surged over 200% since its 2020 IPO.

These younger healthcare firms tend to have higher volatility compared to big pharmas like AstraZeneca. But their focus on new innovations and faster growth in underpenetrated markets make them appealing for growth-oriented investors.

However, due diligence is required as many of these stocks go on to underperform or even fail. Factors like clinical trial results, regulatory approvals, and market adoption can make or break emerging health stocks.

Diversification across multiple companies can help mitigate the risk. Investing in a healthcare-focused ETF is one method to gain diversified exposure to both mature drugmakers and higher-growth emerging stocks.

Additionally, many biotech and medtech IPOs have been impacted by the 2022/2023 bear market. This offers an opportunity for investors to buy promising stocks at lower valuations.

Overall, AstraZeneca maintains a healthy long-term outlook supported by its deep pipeline of new drugs. But near-term headwinds like rising costs and the latest earnings miss dragged shares lower.

This illustrates how even strong incumbent firms face challenges sustaining rapid growth. For investors seeking higher growth potential, carefully selected emerging healthcare stocks can provide more upside.

However, realizing this potential requires thorough due diligence. Not all emerging companies succeed, making diversification and patience key when investing in new healthcare names. But buying into the right stocks early can result in tremendous gains over the long-term.

The health sector’s constant innovation ensures exciting new companies will continue disrupting incumbents. While mature pharmas like AstraZeneca play a key role in the market, fast-growing upstarts are where outsized returns often lie.

Release – Cadrenal Therapeutics Appoints Jeff Cole as Chief Operating Officer In Advance Of Tecarfarin Phase 3 Pivotal Trial

Posted on February 8, 2024February 8, 2024 by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Feb. 8, 2024 — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, today announced the appointment of Jeff Cole to the newly created position of Chief Operating Officer. In this role, Mr. Cole will be responsible for the Company’s manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.

Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company. This includes senior executive roles at both private and publicly-traded companies such as Espero BioPharma, Valeant Pharmaceuticals International (now Bausch Health Companies), and Legacy Pharmaceuticals. Mr. Cole co-founded Espero, a biopharmaceutical company focusing on the late-stage development and commercialization of medicines to treat cardiovascular diseases, and served as Board Director, President, and Chief Financial Officer where he was responsible for the company’s supply chain, commercialization, and multiple licensing and M&A transactions.

“Jeff is an extremely accomplished pharmaceutical operations executive with a deep understanding of product development, manufacturing, and commercialization. His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.

While at Valeant, Mr. Cole held roles of increasing responsibility, including as General Manager, Vice President of Corporate Development, and Chief Financial Officer of North America, where revenue more than tripled during his tenure. As General Manager at Valeant, Mr. Cole managed a division of U.S. prescription and OTC products across multiple therapeutic areas with responsibility for product development, supply, and commercial operations. Prior to the pharmaceutical industry, Mr. Cole served as Principal in the Financial Management Consulting practice at PricewaterhouseCoopers.

“I am excited to be joining the team at Cadrenal at a pivotal time when demand is increasing for a new anticoagulation therapy to address the unmet needs for patients with left ventricular assist devices (LVADs), antiphospholipid syndrome (APS), and those with end-stage kidney disease (ESKD) and atrial fibrillation (AFib),” added Jeff Cole. “I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups.”

Mr. Cole holds an MBA with honors from the University of Michigan and a BS in accounting from the University of Southern California.

ABOUT CADRENAL THERAPEUTICS, INC.

Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with certain medical conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: www.cadrenal.com.

Safe Harbor Statement

Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the Mr. Cole’s experience serving the Company well as it advances its tecarfarin clinical program and evaluates partnering opportunities and leveraging Mr. Cole’s experience to advance tecarfarin to the market and help underserved patient groups. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the expected contribution from Mr. Cole and the ability to advance tecarfarin with patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
858-337-0766
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

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SOURCE Cadrenal Therapeutics, Inc.

Cardinal Health Bolsters Specialty Offering With $1.2 Billion Acquisition

Posted on February 1, 2024February 1, 2024 by slightbourne@noblecapitalmarkets.com

Cardinal Health announced Wednesday that it will acquire Specialty Networks for $1.2 billion in cash, strengthening the healthcare giant’s services for specialty physician practices. Specialty Networks provides technology-enabled group purchasing, practice management solutions, and data analytics to over 11,500 specialty providers across key areas like urology, rheumatology, and gastroenterology.

The deal enhances Cardinal Health’s capabilities in strategically important specialty areas while expanding its platform serving independent physicians. Here are some key details on the acquisition:

Expanding Service Offerings

Specialty Networks gives Cardinal Health new clinical and economic services to offer specialty physicians and practices. Its analytics platform, PPS Analytics, taps into electronic medical records, imaging systems, and other data sources to generate insights improving patient care and outcomes.

Cardinal gains Specialty Networks’ expertise optimizing specialty practice operations and finance. And through group purchasing relationships Specialty Networks facilitates, Cardinal Health can provide access to discounted products and services.

The combined specialty offerings will aim to boost efficiency, revenues, and coordination of care for specialty providers. This strengthens Cardinal’s value proposition as a distribution and services partner.

Supporting Independent Physicians

A key aspect is Specialty Networks’ focus on independent and community-based specialty practices. With over 1,200 physician practice customers, it expands Cardinal’s reach and understanding of this critical healthcare segment.

The medical landscape is increasingly consolidated, making it more vital for Cardinal Health to support independent practices’ success. Specialty Networks’ experience and technology assets aid in this aim.

Cardinal Health can also leverage Specialty Networks’ physician expertise and relationships to accelerate development of its Navista Network. This network assists independent community oncologists with practice solutions and clinical trials access.

Enhanced Analytics and Insights

Specialty Networks’ rich specialty patient data and analytics capabilities will enhance Cardinal’s offerings. Its PPS Analytics platform mines electronic records and images using artificial intelligence to generate diagnostic and treatment insights.

Cardinal gains access to millions of longitudinal specialty patient data points. This strengthens its real-world evidence and insights for biopharma partners on the safety, efficacy and use of therapies.

The specialty data and analytics also aid population health management and value-based care initiatives. And they support Cardinal’s direct provider services like improved medication adherence programs.

Driving Growth in Key Areas

Specialty Networks expands Cardinal’s presence and cross-selling opportunities in strategic specialty therapeutic areas:

Urology – large patient population with ongoing and acute care needs
Rheumatology – fast growing with new advanced treatments
Gastroenterology – increasing prevalence of GI diseases

These are growth priorities where Specialty Networks strengthens Cardinal’s advantages. The deal accelerates Cardinal’s specialty growth plans through enhanced resources and newly integrated offerings.

Strong Cultural and Strategic Fit

Cardinal Health and Specialty Networks share a mission to bring value to physician practices while improving patient outcomes. Keeping Specialty Networks’ management team intact ensures continuity of its culture and physician focus.

The companies also have experience collaborating, as Specialty Networks is already a Cardinal Health specialty GPO partner. This makes integration of the businesses more seamless.

The acquisition is expected to be accretive to Cardinal’s non-GAAP earnings per share within 12 months post closing. Specialty Networks gives Cardinal Health a stronger specialty platform and differentiated assets to better serve practices and patients. Combining specialized expertise and technologies, the deal creates benefits for physicians and Cardinal Health alike.

Release – ZyVersa Therapeutics Highlights Publication Indicating That Inflammasome NLRP3-Mediated Inflammation in Obese Children Leads to Insulin Resistance and Risk of Complications Such as Type 2 Diabetes

Posted on January 31, 2024January 31, 2024 by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jan 31, 2024

Insulin resistance (IR), a common feature of childhood obesity which affects 15 million children and adolescents, is the main driver of obesity-related metabolic complications such as Type 2 diabetes, hypertension, and premature heart disease.

This study demonstrated that NLRP3 inflammasome activation was highest in obese children with the worst metabolic profile (higher serum glucose levels, a late insulin response to glucose tolerance tests, adverse serum lipid profiles, and higher oxidative stress (based on ROS levels).
ZyVersa is developing Inflammasome ASC Inhibitor IC 100 which inhibits NLRP3 and other types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.

WESTON, Fla., Jan. 31, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics (Nasdaq: ZVSA, or “ZyVersa”), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases, highlights an article published in the peer-reviewed Journal of Translational Medicine supporting that NLRP3 activation is associated with a pathologic inflammatory response in obese children with insulin resistance and increased risk of developing metabolic complications. Inflammation and oxidative stress, which are closely related pathophysiological processes, one of which can be easily induced by the other, are key drivers for developing metabolic complications, such as type 2 diabetes and cardiovascular disease, in this population.

In the paper titled, “Altered insulin secretion dynamics relate to oxidative stress and inflammasome activation in children with obesity and insulin resistance,” the authors conducted a case-controlled study of 132 children who were either lean or obese. The obese group was segmented into those with or without insulin resistance, and those with insulin resistance were segmented into those with an early and late insulin response to glucose as determined by an oral glucose tolerance test (OGTT).

The researchers reported the following key findings in Children with obesity, insulin resistance, and increased risk of metabolic complications:

Higher levels of NLRP3 and its effector proteins (active IL-1β, caspase-1, and gasdermin D) in peripheral blood mononuclear cells (PBMCs) and serum compared to the other groups studied, indicative of NLRP3 activation and an inflammatory response.
Higher levels of uric acid versus the other groups, a well-known trigger of NLRP3 activation.
Increased levels of oxidative stress and oxidative damage versus the other groups.

The authors concluded, “It is insulin response to an OGTT that identifies children with obesity suffering oxidative stress, and inflammasome activation more specifically. Uric acid could be mediating this pathological inflammatory response by activating NLRP3 in peripheral blood mononuclear cells.”

To read the article, Click Here.

“Childhood obesity, which has increased more than 8-fold over the last 40 years, is an alarming health problem today due to the increased risk for developing type 2 diabetes, early heart disease, and other co-morbidities,” commented Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The research published in the Journal of Translational Medicine points to a significant role for inflammasome-mediated inflammation and oxidative stress in development of metabolic complications in obese children. ZyVersa is developing Inflammasome ASC Inhibitor IC 100 designed to inhibit NLRP3 and other types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of inflammation, which may have therapeutic potential to alleviate metabolic complications of childhood obesity with early intervention.”

To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 was designed to attenuate both initiation and perpetuation of the inflammatory response. It does so by binding to a specific region of the ASC component of multiple types of inflammasomes, including NLRP1, NLRP2, NLRP3, NLRC4, AIM2, Pyrin. Intracellularly, IC 100 binds to ASC monomers, inhibiting inflammasome formation, thereby blocking activation of IL-1β early in the inflammatory cascade. IC 100 also binds to ASC in ASC Specks, both intracellularly and extracellularly, further blocking activation of IL-1β and the perpetuation of the inflammatory response that is pathogenic in inflammatory diseases. Because active cytokines amplify adaptive immunity through various mechanisms, IC 100, by attenuating cytokine activation, also attenuates the adaptive immune response.

About ZyVersa Therapeutics, Inc.

ZyVersa (Nasdaq: ZVSA) is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs for patients with renal and inflammatory diseases who have significant unmet medical needs. The Company is currently advancing a therapeutic development pipeline with multiple programs built around its two proprietary technologies – Cholesterol Efflux Mediator™ VAR 200 for treatment of kidney diseases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management’s intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc (“ZyVersa”) uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa’s plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa’s planned preclinical and clinical trials; the timing of the availability of data from ZyVersa’s preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa’s plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa’s product candidates; ZyVersa’s commercialization, marketing and manufacturing capabilities and strategy; ZyVersa’s ability to protect its intellectual property position; and ZyVersa’s estimates regarding future revenue, expenses, capital requirements and need for additional financing.

New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Corporate and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Media Contacts
Tiberend Strategic Advisors, Inc.
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

Dave Schemelia
dschemelia@tiberend.com
609-468-9325

Release – Tonix Pharmaceuticals Announces Research Indicating Pre-Existing Fibromyalgia-Type Symptoms May Increase the Risk of Developing Long COVID

Posted on January 31, 2024January 31, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

January 31, 2024 7:00am EST

Retrospective observational study of electronic medical records of more than 90 million people living in the U.S.

Long COVID shares symptoms with chronic overlapping pain disorders like fibromyalgia and appears mechanistically related

Tonix is studying TNX-102 SL for both the management of fibromyalgia and management of fibromyalgia-type Long COVID.

CHATHAM, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates and currently focused on preparing a New Drug Application (NDA) for Tonmya (formerly TNX-102 SL, sublingual cyclobenzaprine HCl) for the management of fibromyalgia, today announced the online publication of a research paper in the Journal Pain. The article titled, “Chronic Overlapping Pain Conditions Increase the Risk of Long COVID Features, Regardless of Acute COVID Status,” by Bergmans, et al.¹, found that patients with pre-existing chronic overlapping pain conditions (COPCs) had an increased risk of being diagnosed with symptoms of Long COVID¹. Faculty at the University of Michigan directed the research. Commentary on the article titled, “A step towards better understanding chronic overlapping pain conditions” by Fitzcharles, et al,² is in the same issue of the journal.

COPCs include fibromyalgia, chronic fatigue syndrome, migraine headache, irritable bowel syndrome, endometriosis and low back pain. The TriNetX Analytics platform was used to extract anonymized electronic health record data from more than 91 million people in the U.S. These findings showed that: (1) in addition to COVID, prolonged pain may occur after recovery from viral infections like influenza, (2) people with pre-existing pain are at risk for exacerbation of their pain after viral illness, (3) pre-existing COPCs increase the risk of Long COVID, and (4) COPCs and Long COVID likely result from the same or similar brain processes, and Long COVID can be conceptualized as a new onset COPC or an exacerbation of a pre-existing COPC.

“These results contribute to a growing body of evidence that most symptoms of Long COVID are at least partly driven by central nervous system mechanisms rather than persistent exposure to the SARS-CoV-2 virus,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Tonix is studying TNX-102 SL for the management of fibromyalgia (conditionally approved by U.S. Food and Drug Administration as “Tonmya”) and for fibromyalgia-type Long COVID. Fibromyalgia is already recognized as a COPC. The new paper adds to the growing body of evidence that many cases of Long COVID should be viewed in the COPC framework, rather than in a purely post-infectious disease perspective.”

Dr. Lederman continued, “In the post-pandemic era, in which COVID is endemic and repeated bouts are common, it will be important to learn if appropriate management of fibromyalgia may reduce the risk of developing Long COVID. Moreover, since fibromyalgia symptoms like widespread pain were risk factors for COVID even without a diagnosis of fibromyalgia, these findings suggest that earlier diagnosis and management of fibromyalgia may be advised.”

“The magnitude of Long COVID risk conferred by a pre-existing COPC was comparable with, if not larger than, that for sex and acute COVID hospitalization status, which are known risk factors for Long COVID,”^2,3 said Rachael Bergmans, M.P.H, Ph.D., Research Assistant Professor at the University of Michigan Medical School Department of Anesthesiology, Chronic Pain and Fatigue Research Center (CPFRC) and lead author of the paper. “These findings are consistent with previous research where pre-existing chronic pain conditions including fibromyalgia, back pain, and migraine increase the risk of Long COVID.”^2-4

Tonmya* has shown positive results in two Phase 3 clinical trials for the management of fibromyalgia. Tonix plans to submit an NDA to the U.S. Food and Drug Administration in the second half of 2024 under the 505(b)(2) regulatory pathway for Tonmya for the management of fibromyalgia.

About Tonmya™ (formerly known as TNX-102 SL)

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

¹Bergmans RS, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003110
²Fitzcharles M-A, et al. PAIN. 2023. DOI: 10.1097/j.pain.0000000000003129
³Subramanian A, et al. Nat Med. 2022. 28(8):1706-1714.
⁴ Galal I, et al. Egypt J Bronchol. 2021. 15(1):10.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace^® SymTouch^® (sumatriptan injection) 3 mg and Tosymra^® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released January 31, 2024

Gilead Deepens Arcus Ties With $320M Investment to Accelerate Cancer Immunotherapy Pipeline

Posted on January 31, 2024January 31, 2024 by slightbourne@noblecapitalmarkets.com

Gilead Sciences and biotech partner Arcus Biosciences announced Tuesday an amended collaboration to accelerate development of their cancer immunotherapy programs, along with a $320 million equity investment by Gilead.

The deal builds on the companies’ 2020 partnership and boosts Gilead’s ownership in Arcus to 33% through an additional stake purchase at $21 per share. Gilead also gains a third seat on Arcus’ board, having their Chief Commercial Officer Johanna Mercier join as a director.

Strategic Focus on TIGIT

A key change is prioritizing late-stage studies for the anti-TIGIT antibody domvanalimab, the lead candidate from the collaboration. Arcus CEO Terry Rosen stated the partners want to “leverage their strengths and focus on efficiently advancing novel combinations.”

Domvanalimab is progressing in Phase 3 for non-small cell lung cancer and gastric/GEJ cancer. By accelerating these pivotal studies, expected to fully enroll by year-end, the drug could reach approval sooner if successful.

However, they are discontinuing the ARC-10 Phase 3 lung cancer trial to devote resources to the other domvanalimab studies targeting greater unmet need.

This streamlining highlights the companies’ faith in TIGIT’s potential but the necessity to optimize their most promising assets. TIGIT is an emerging immunotherapy target and domvanalimab a next-gen asset, so focusing late-stage research is prudent.

Quemliclustat Now Solo Arcus Program

Meanwhile, the planned Phase 3 study of Arcus’ CD73 inhibitor quemliclustat in pancreatic cancer will become an Arcus-only program, no longer jointly developed.

Again the theme is concentrating human capital and financial resources where they can make the biggest difference. For smaller Arcus, independence for some programs provides flexibility.

Arcus can also now fully control projects beyond domvanalimab and their PD-1 drug zimberelimab, which Gilead has options to license. This benefits Arcus’ broader pipeline and product vision.

Extends Arcus Cash Runway

Importantly, the $320 million cash infusion lengthens Arcus’ funding horizon until 2027 by their estimates. This enables advancing Phase 3 quemliclustat and AB154 studies plus potential commercial launch activities without financing concerns.

Any biotech developing novel drugs without revenue benefits immensely from having ample cash reserves. This partly protects Arcus from market volatility and general biotech funding challenges.

Gilead Building a Powerhouse

For Gilead, the enhanced Arcus alliance adds another pillar to their ambitions cancer franchise. The pharma giant has been aggressively wheeling and dealing to expand in oncology, now a key growth area.

Recent moves include the $21 billion Immunomedics acquisition and purchases of companies like Tango Therapeutics, Dragonfly Therapeutics, and Epizyme. The Arcus pact leverages access to next-generation immunotherapy science and pipeline.

Gilead is constructing a vertically integrated oncology player combining in-house and external innovation. Scale and synergies across R&D, manufacturing, and commercialization can accelerate targeted therapies to patients.

With collaborators like Arcus doing the early lifting, Gilead can then optimize late-stage studies and apply their regulatory expertise to reach approvals more quickly.

Overall the amended Arcus agreement highlights Gilead’s commitment to cancer and immunology while bolstering their presence in cutting-edge research like TIGIT inhibition. With the investment and restructuring, Gilead strengthens ties to Arcus’ science while keeping the biotech funded and focused. For both, it’s a win-win accelerating cancer drugs to market.

noble capital markets emerging growth virtual healthcare equity conference

Release – Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya™ as Trade Name for TNX-102 SL for the Management of Fibromyalgia

Posted on January 29, 2024January 29, 2024 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

January 29, 2024 7:00am EST

Results from two positive Phase 3 studies point to Tonmya’s (TNX-102 SL) potential as a new first-line medicine for chronic use in managing fibromyalgia, a debilitating condition suffered by 6-12 million adults in the U.S.

New Drug Application (NDA) submission to the FDA planned for second half of 2024 under the 505(b)(2) regulatory pathway

CHATHAM, N.J., Jan. 29, 2024 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, Tonmya™, for the Company’s drug product candidate TNX-102 SL for the management of fibromyalgia.

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the Company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. Tonix plans to have a pre-NDA meeting with U.S. Food and Drug Administration (FDA) in the first half of 2024 and to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya for the management of fibromyalgia.

“We are very pleased with the FDA’s conditional acceptance of Tonmya as the brand name for TNX-102 SL,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “With this acceptance, we remain excited for what we believe is an important opportunity to offer the first FDA-approved drug for fibromyalgia patients in more than a decade.”

About Tonmya™ (formerly known as TNX-102 SL)

Tonmya is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is designed for daily administration at bedtime with a proposed mechanism of improving sleep quality in fibromyalgia. Tonmya provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A-serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic cholinergic receptors, Tonmya is in development as a daily bedtime treatment for fibromyalgia, fibromyalgia-type Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary Tonmya composition. These patents are expected to provide Tonmya, upon NDA approval, with U.S. market exclusivity until 2034/2035. In addition, Tonix has pending but not issued U.S. patent applications directed to the transmucosal absorption of CBP-HCl, with U.S. market exclusivity expected until 2033, for treating depressive symptoms in fibromyalgia, with U.S. market exclusivity expected until 2032, and for treating pain in fibromyalgia with U.S. market exclusivity expected until 2041.

Tonix Pharmaceuticals Holding Corp.^*

Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for Tonmya, which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of Tonmya for the management of fibromyalgia in the second half of 2024. TNX-102 SL is being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.

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

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

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

Forward Looking Statements

Investor Contact

Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
443-213-0495

Source: Tonix Pharmaceuticals Holding Corp.

Released January 29, 2024

Science 37 to be Acquired by eMed in Deal to Expand Virtual Clinical Trials

Posted on January 29, 2024January 29, 2024 by slightbourne@noblecapitalmarkets.com

Clinical research company Science 37 announced Monday that it has entered into a definitive agreement to be acquired by telehealth provider eMed in a deal valued at approximately $38 million. Under the agreement, eMed will commence a tender offer to purchase all outstanding shares of Science 37 stock for $5.75 per share in cash, representing a 21.3% premium over Science 37’s share price last week.

The deal will allow eMed to leverage Science 37’s remote clinical trial capabilities and proprietary Metasite technology platform to expand patient access and accelerate enrollment for clinical studies. Science 37’s decentralized clinical trial model enables patients to participate from home via telehealth, rather than having to travel to physical trial sites.

This acquisition comes at a pivotal time, as the biotech industry embraces virtual and hybrid trial designs in the wake of the COVID-19 pandemic. Science 37 was an early pioneer in decentralized trials, giving the company a first-mover advantage. According to Science 37 CEO David Coman, “eMed provides the greatest value to our stockholders, customers, patients, and employees. Stockholders will receive a premium, trial sponsors will gain greater access to patients, faster enrollment, and confidence in the Company’s capital position.”

For eMed, the deal significantly expands its digital healthcare footprint, adding Science 37’s network of telehealth investigators, coordinators, and software platform to its existing suite of at-home diagnostics and virtual care services. eMed was an early mover as well, having developed the first at-home COVID-19 test kit in 2020. Since then, the company has expanded into at-home testing and treatment for flu, UTIs, and other conditions.

The combined resources of both companies will provide end-to-end support for decentralized clinical trials, from patient recruitment to at-home sample collection to telemedicine visits. This could be a game-changer in improving patient diversity in trials and enabling studies focused on rare diseases or targeted therapies.

According to Science 37’s latest financial update, the company expects approximately $58-59 million in revenue for 2023 and over $50 million in cash reserves as of December 31, 2023. The company projected 2023 revenue of $50-60 million.

Science 37’s board of directors unanimously approved the acquisition deal with eMed. Major Science 37 shareholders, including Redmile Group, LLC, have also agreed to tender their shares in support of the acquisition.

The deal is expected to close in Q1 2024, pending tender of a majority of outstanding Science 37 shares and satisfaction of other customary closing conditions. Once completed, Science 37 will become a privately held subsidiary of eMed.

This Science 37 acquisition comes on the heels of eMed’s parent company, Evernow Inc., raising $100 million in Series B funding last March. The current deal highlights continued investor appetite for telehealth and digital health companies that are expanding access to care.

In fact, Noble Capital Markets will be hosting a Virtual Healthcare Conference from on April 17-18, 2024, featuring presentations from emerging growth companies in the healthcare sector. The conference will provide a platform for companies to showcase their innovations in digital health, telemedicine, medical devices and more.

The Science 37 and eMed deal also demonstrates the growing intersection between telehealth and clinical research. Other companies like Medable and Excelya are exploring how hybrid and decentralized trials can boost patient recruitment and retention. By meeting patients where they are, virtual trials enable more representative, diverse study populations.

While some industry experts say a hybrid approach will become the standard, decentralized trials are still a relatively new model. This acquisition provides eMed with a first-mover advantage, but expect other digital health companies to underscore their clinical trial offerings moving forward. In the meantime, all eyes will be on eMed and Science 37 as they pioneer the next generation of virtual clinical research.