Category: Health

Release – ZyVersa Therapeutics Highlights Data from Review Article Published in Nature Reinforcing IC 100’s Rationale for Inhibiting ASC and ASC Specks to Attenuate Damaging Inflammation Associated with Various Conditions, Including Obesity and Its Complications

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Feb 28, 2024

PDF Version

  • Obesity, which affects over 1.9 billion people worldwide, is a state of low-grade chronic inflammation that causes an array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, dyslipidemia, and even cancer.
  • The article summarizes data demonstrating that inflammasome activation in fat tissue triggers cell death, known as pyroptosis. Pyroptosis results in systemic release of inflammatory cytokines, IL-1β and IL-18, and ASC specks, which perpetuates and spreads inflammation to other tissues leading to the metabolic disturbances associated with obesity.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100, designed to inhibit formation of multiple types of inflammasomes and their associated ASC specks to attenuate initiation and perpetuation of damaging inflammation.

WESTON, Fla., Feb. 28, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, highlights data published in Nature reinforcing IC 100’s rationale for inhibiting ASC and ASC Specks to attenuate damaging inflammation associated with various conditions, including obesity and its complications.

Studies dating back to 2011 have implicated a pathogenic role for inflammasome activation in initiation of obesity and its metabolic complications. Authors of the review paper published in Nature titled, “Cell death and inflammation during obesity: Know my methods, WAT(son),” reviewed 111 papers, which demonstrated that the state of low-grade chronic inflammation in obesity combined with activated macrophages in adipose tissue result in a vicious cycle of inflammation, cell death, and metabolic dysbalance that together cause metabolic syndromes. This also promotes a pro-tumorigenic microenvironment that induces or supports tumor growth in cancers linked to obesity such as breast, liver, and colon carcinomas.

The authors concluded, “There is no question that macrophage-inflammasome activation triggers systemic inflammation during obesity and it is one of the main culprits of metabolic syndromes.” To read the article, Click Here.

“Obesity, a well-established risk factor for array of different metabolic disorders, including insulin resistance, type 2 Diabetes, hypertension, cardiovascular disease, and cancer, has reached pandemic proportions, and may affect up to two-thirds of the adult population in developed countries,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO and President. “The research published in Nature demonstrates that inflammasome activation in fat tissue triggers cell death. Cell death results in systemic release of inflammatory cytokines, IL-1β and IL-18, and ASC specks, which can perpetuate and spread inflammation to other tissues leading to the metabolic disturbances associated with obesity. This provides support for Inflammasome ASC Inhibitor IC 100 as a potential therapeutic option. By inhibiting ASC, IC 100 blocks formation of NLRP3 and other types of inflammasomes to block initiation of the inflammatory cascade. Likewise, IC 100 uniquely inhibits ASC specks to attenuate spread and perpetuation of damaging inflammation.” 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, IR, and Media Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641

Veradigm Bets on AI, Acquires ScienceIO for $140M

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare technology firm Veradigm announced a deal this week to purchase artificial intelligence (AI) startup ScienceIO for $140 million in cash. The acquisition provides Veradigm with advanced AI capabilities to derive insights from its health data assets.

Chicago-based Veradigm offers data platforms and software solutions for healthcare stakeholders including providers, insurers, and pharmaceutical companies. The company claims its network covers over 400,000 healthcare providers and 200 million patients.

ScienceIO, founded in 2019, has developed AI models and platforms specifically for healthcare applications. Its natural language processing models can extract information from complex medical text and records.

Powered by this AI, Veradigm aims to launch next-generation analytics products that enhance clinical decision-making and improve patient outcomes across its customer base.

Accelerating Growth Through AI

The merger agreement comes as Veradigm looks to reposition itself as a high-growth data analytics leader. Management believes integrating ScienceIO’s technology is key to that transformation.

In the press release, Veradigm Interim CEO Yin Ho said the acquisition “will be able to provide more highly differentiated and advanced products to provider, payer and life sciences customers.”

The company’s Executive Chairman Greg Garrison also called the deal “a natural next step in the strategy…to drive continued growth across our business units.”

Veradigm plans to leverage ScienceIO’s platform to build custom natural language processing models trained on its own proprietary health data. Running advanced analytics on its comprehensive provider and patient dataset will uncover previously untapped insights.

The focus will be developing AI-enabled offerings while ensuring full compliance with healthcare data privacy regulations. This will likely necessitate keeping modeling and computation on Veradigm’s controlled systems rather than via public cloud services.

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Near-Term Growth and Long-Term Potential

Incorporating ScienceIO’s technology throughout its product portfolio will help accelerate new feature development, per Veradigm management. Enhanced offerings could then drive near-term revenue growth.

But the larger potential impact is establishing Veradigm as a leader in next-generation intelligent healthcare systems. AI-powered analytics promise to transform areas like clinical diagnostics, patient risk assessment, and treatment decision support.

Veradigm highlighted that its unique combination of data breadth and advanced analytics can lead to “higher quality, lower cost care for patients.” This goal aligns with the current shift towards value-based care in the healthcare sector.

The transaction is expected to close within weeks, subject to customary closing conditions. ScienceIO’s team will likely join Veradigm’s existing technology group.

Plans for integrating operations and migrating customers to enhanced AI offerings will be critical during the post-merger integration process. Realizing the promised growth synergies rapidly will demonstrate the strategic logic of the deal.

What Competition and Customers Can Expect

For competitors, Veradigm gaining potent AI abilities raises the stakes in the race to provide smarter healthcare analytics tools. AI-driven insight platforms are seen as a major battleground in the industry.

The deal pressures other players to advance their own AI or seek technology acquisitions to keep pace. Industry titans like Optum and IQVIA have already been aggressive on the M&A front, snapping up emerging analytics firms.

Ultimately, it’s healthcare payers and providers that need to see material improvements from AI adoption. They will expect Veradigm’s new data products to deliver actionable insights that improve patient outcomes and the bottom line.

If Veradigm can successfully integrate ScienceIO’s capabilities across its client verticals, it will cement its positioning as a partner that can drive impact from healthcare data analytics.

But the company must also tread carefully, as the sensitive nature of health data makes privacy preservation paramount. Responsible data usage and ethics around AI will determine customer and public perception.

Release – MAIA Biotechnology Appoints Leading Immuno-Oncology Scientist DR. Remus Vezan as Scientific Advisor

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 27, 2024 10:30am ESTDownload as PDF

  • New Scientific Advisory Board member played instrumental role in FDA approval and commercialization of multiple blockbuster products

CHICAGO, IL, Feb. 27, 2024 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the appointment of immuno-oncology leader Remus Vezan, M.D., Ph.D., to its Scientific Advisory Board (SAB).

With over 20 years of academic and biopharmaceutical industry experience, Dr. Vezan is a highly regarded leader in drug development of novel therapeutic modalities, including cell and gene therapies, and played a pivotal role in the development and approval of CAR-T cell products TECARTUS® and YESCARTA® (Gilead), and kinase inhibitor IMBRUVICA® (AbbVie). Dr. Vezan currently serves as Vice President, Global Clinical Development at BeiGene.

“Dr. Vezan holds vast experience in guiding oncology assets through all stages of development, from research to clinical strategies and registration. His extensive engagement with the regulatory agencies to maximize clinical and commercial opportunities has been instrumental in garnering multiple FDA and global approvals for novel therapies including biologics and CAR-T cell products,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “It is a pleasure to welcome Remus to the MAIA franchise, where he will provide valued guidance along our pathway to approval and commercialization of our lead candidate THIO.”

Previously, as executive director of clinical development at Kite Pharma (Gilead Sciences), Dr. Vezan was primarily responsible for managing and overseeing the clinical development of CART-cell products, including axi-cell/YESCARTA®, the first CART-cell therapy approved for relapsed/refractory B-cell lymphoma, and brexu-cell/TECARTUS®, the first CART-cell therapy approved for mantle cell lymphoma and adult acute lymphoblastic leukemia. Earlier, Remus served as Medical Director at Pharmacyclics, an AbbVie Company, where he was the clinical lead for IMBRUVICA® in lymphoplasmacytic lymphomas.

Dr. Vezan’s therapeutic expertise includes both hematology and oncology, with various treatment modalities including next generation small molecules and adaptive cellular therapies (CAR-T, NK, autologous, allogeneic).

Dr. Remus Vezan commented, “It is my pleasure and privilege to join MAIA as scientific advisor and support the efforts of the MAIA team in advancing the clinical development of its first-in-class telomere targeting agent. THIO is a next generation asset with the potential to provide meaningful clinical benefit to many patients with malignancies.”

Dr. Vezan completed his medical training (M.D. and Ph.D.) at the University of Medicine and Pharmacy Cluj, Romania, and University of Bern, Switzerland. He holds multiple medical and scientific affiliations including the American Society of Hematology (ASH), the European Hematology Association (EHA), and the American Society of Clinical Oncology (ASCO). His work has appeared in numerous scientific papers and publications.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Attachment

MAIA BIOTECHNOLOGY, INC.
REMUS VEZAN, M.D., PH.D. – SCIENTIFIC ADVISOR TO MAIA BIOTECHNOLOGY

Source:

Released February 27, 2024

Release – Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

February 27, 2024 8:00am ESTDownload as PDF

Tonix plans to File a Clinical Trial Notification (CTN) in Japan and Investigational New Drug (IND) application in China to support a registration-enabling Asian Phase 3 study without dosage adjustment based on U.S. registrational Phase 3 data

Tonmya’s market exclusivity is supported by issued patents in Japan, China, Hong Kong and Taiwan; cyclobenzaprine is a new chemical entity in Japan and China

New Drug Application (NDA) submission to the U.S. FDA for the approval of Tonmya for the management of fibromyalgia planned for second half of 2024

CHATHAM, N.J., Feb. 27, 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, announced positive results from its clinical pharmacokinetic (PK) bridging study of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key pharmacokinetic parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.

This study characterized the PK profile and dose proportionality of Tonmya following administration in 20 healthy volunteers of documented Japanese or Chinese ancestry, and compared these findings to an existing PK dataset conducted under similar conditions in Caucasian volunteers.

“This bridging study is an important first step as we begin evaluating the potential for approval and marketing Tonmya in Japan and China. The results show a similar pharmacokinetic profile in ethnic Japanese and Chinese volunteers with a Caucasian comparator group,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “As a result, we believe that these data, with supporting results recently reported from the positive Phase 3 RESILIENT study, are the only clinical data needed to support regulatory filings in Japan and China.”

Dr. Lederman continued, “With patents issued in Japan, China, Hong Kong and Taiwan expected to provide market exclusivity into 2034, we believe that Tonmya would be a welcome addition to the therapeutic options for fibromyalgia patients in East Asia and an attractive asset for the right development and commercialization partners in these markets. Cyclobenzaprine is an NCE in both of these countries. We plan to meet with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) to seek agreement on the development of Tonmya in Japan and China, respectively.”

About the Asia Bridging Study

The study was a randomized, single-dose, open-label, 2-way, crossover study design in ethnic Japanese (N=10) and Chinese (N=10) healthy male and female volunteers. The primary objective of the study was to characterize the PK profile and dose proportionality of Tonmya following administration of 2.8 mg and 5.6 mg (one and two 2.8 mg tablets) under fasting conditions in Japanese and Chinese volunteers, and to retrospectively compare these PK data with existing PK data of both cyclobenzaprine and norcyclobenzaprine from a prior Phase 1 study in Caucasian volunteers dosed under the same conditions. Safety and tolerability were also assessed. A 2.8 mg or 5.6 mg dose (2 X 2.8 mg tablet) of Tonmya was administered sublingually in the morning under fasted conditions. Blood samples were collected pre-dose and up to 15 days post-dose for analyte measurements, with a 28-day washout between periods. The primary PK endpoints were the total amount of cyclobenzaprine and metabolite norcyclobenzaprine in the blood (expressed as the area under the curve (AUC0-T)) and maximum concentration (expressed as Cmax).

Study Results

Pharmacokinetics
Ethnic Japanese and Chinese volunteers were considered comparable on PK parameters for cyclobenzaprine following a 2.8 mg and 5.6 mg dose of Tonmya, and dose proportionality was demonstrated in both samples. Given that the similarity in PK profile between Japanese and Chinese volunteers was confirmed, the PK data from the two ethnic groups were pooled for the comparison between Asian (n=20) and Caucasian (n=16) volunteers. The PK parameters of cyclobenzaprine for Japanese, Chinese, and Caucasian groups were similar, with geometric mean ratios falling within the 90% confidence interval.

Safety

  • Tonmya was shown to be safe and well-tolerated at doses up to 5.6 mg as single sublingual administrations in healthy adult Japanese and Chinese volunteers.
  • The incidence of adverse events (AEs) and investigational product-related AEs was low. No volunteer discontinued due to an AE.
  • No clinically significant abnormal findings in laboratory parameters, ECGs, or other safety assessments were noted during the study. No severe AEs and no deaths were reported during the study.

Issued Patents in Japan, China, Hong Kong and Taiwan

EUTECTIC FORMULATIONS









CountryPatent NumberExpected Expiry
ChinaZL 201480024011.103/14/2034
ChinaZL201910263541.603/14/2034
Hong KongHK121872703/14/2034
Japan631054203/14/2034
Taiwan R.O.C.I66182503/14/2034
TRANSMUCOSAL ABSORPTION







Japan625945206/14/2033
Taiwan R.O.C.I59082006/14/2033
Taiwan R.O.C.I68366006/14/2033
Taiwan R.O.C.I64242906/14/2033
Hong Kong120936106/14/2033

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

Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual 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 submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia.

*Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya, a product candidate for which two positive Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase) a biologic designed to treat cocaine intoxication with Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg 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 27, 2024

Schwazze (SHWZ) – A Management Change

Posted on by cpereira@noblefcm.com


Monday, February 26, 2024

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

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

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

CEO Steps Away. Friday, Schwazze announced Nirup Krishnamurthy’s resignation as Schwazze Chief Executive Officer and as a member of the Board of Directors, effective February 20, 2024, due to personal reasons. In his place, Forrest Hoffmaster, the Company’s Chief Financial Officer, has been appointed to the additional role of interim CEO.

Forrest Hoffmaster. Mr. Hoffmaster joined the Company in January 2023, bringing over 30 years of executive experience in finance and operations for both public and private companies. Prior to Schwazze, Mr. Hoffmaster served as CEO of New Seasons Market, a specialty gourmet food retailer, where he navigated the company through one of the most disruptive periods in the retail grocery industry. Under his leadership, Mr. Hoffmaster implemented a focused growth and cost optimization program, enabling the company to grow EBITDA by over 30% in two years. Prior to New Seasons Market, Forrest held leadership positions with other leading grocers, including Whole Foods Market and H-E-B.


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Release – Ocugen, Inc. Announces Dosing Completion Of Subjects With Stargardt In Cohort 1 Of Phase 1/2 Clinical Trial Evaluating The Safety And Efficacy Of OCU410ST

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 22, 2024

PDF Version

MALVERN, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease. Stargardt disease is an orphan blindness disease that affects approximately 35,000 people in the United States alone.

“This is an important clinical milestone for our first-in-class, potential one-time therapy for the treatment of Stargardt disease,” said Dr. Arun Upadhyay, Chief Scientific Officer and Head of R&D at Ocugen. “Although Stargardt is one of the most common inherited retinal diseases, there remains no treatment option to address this condition. OCU410ST provides hope to these patients who may eventually lose their vision.”

Up to 10 leading retinal surgery centers across the United States are participating in the GARDian clinical trial. In the first cohort, 3 subjects received 200L single subretinal administration of the low dose (3.75×1010 vg/mL) of OCU410ST.

“I am very pleased to participate in this study and to offer a novel modifier gene therapy option to my patients,” said Benjamin Bakall, MD, PhD, Director of Clinical Research at Associated Retina Consultants and Clinical Assistant Professor at the University of Arizona, College of Medicine—Phoenix. “Until now, we have not had any effective treatment that can prevent the vision loss in patients with Stargardt disease. Now, I believe that this approach can offer a new therapeutic option to address the disease itself.”

The GARDian clinical trial will assess the safety of unilateral subretinal administration of OCU410ST in subjects with Stargardt disease and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose ranging study consisting of three dose levels [low dose (3.75×10E10 vg/mL), medium dose (7.5×10E10 vg/mL), and high dose (2.25×10E11 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which adult and pediatric subjects will be randomized in a 1:1:1 ratio to either one of two OCU410ST dose groups or to an untreated. The Company will continue to provide clinical updates.

About Stargardt Disease

Stargardt disease is a genetic eye disorder that causes retinal degeneration and vision loss. Stargardt disease is the most common form of inherited macular degeneration. The progressive vision loss associated with Stargardt disease is caused by the degeneration of photoreceptor cells in the central portion of the retina called the macula.

Decreased central vision due to loss of photoreceptors in the macula is the hallmark of Stargardt disease. Some peripheral vision is usually preserved. Stargardt disease typically develops during childhood or adolescence, but the age of onset and rate of progression can vary. The retinal pigment epithelium (RPE), a layer of cells supporting photoreceptors, is also affected in people with Stargardt disease.

About OCU410ST

OCU410ST utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. It represents Ocugen’s modifier gene therapy approach, which is based on Nuclear Hormone Receptor (NHR) RORA that regulates pathway links to Stargardt disease such as lipofuscin formation, oxidative stress, compliment formation, inflammation, and cell survival networks.

About Ocugen, Inc.

Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release. 

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

MAIA Biotechnology (MAIA) – THIO-101 Patient Enrollment Completed Ahead Of Schedule

Posted on by cpereira@noblefcm.com


Friday, February 23, 2024

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Enrollment In THIO-101 Has Been Completed. MAIA announced that it has completed enrollment of the Part B of the Phase 2 THIO-101 clinical trial. Allowing time for patient follow-up and analysis, the preliminary data announcement is expected in 2H24. This is ahead of schedule, shortening our expected development timeframe.

Optimal Dose Selection Allowed Earlier Completion. The THIO-101 trial was designed with several stages. Part A was a lead-in to verify the safety seen in earlier trials. Part B was designed to find the optimal dose, with patients receiving doses of 60mg, 180mg, or 360mg. In December 2023, the 180mg dose was selected and new patients were only enrolled at 180mg. This allowed Part B to reach the target enrollment ahead of schedule.


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*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. 

Release – MAIA Biotechnology Completes Enrollment In THIO-101 Phase 2 Clinical Trial for Non-Small Cell Lung Cancer 

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 22, 2024 10:30am EST

  • Topline data expected in second half of 2024
  • THIO-101 will be the first completed clinical study of a telomere targeting agent in the field of cancer drug discovery and treatment

CHICAGO, IL, Feb. 22, 2024 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that enrollment is now complete in its Phase 2 THIO-101 go-to-market clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC).

The trial reached the enrollment target of 41 patients for the 180mg/dose on February 19, 2024. As of the latest data available for the trial, 79 patients had received either 60mg (24 patients), 180mg (41 patients) or 360mg (14 patients). The original trial design targeted up to 182 patients, including all patients in the safety lead-in and 41 patients in each of the 3 tested doses (60mg, 180mg, and 360mg). Following the selection of 180 mg/cycle as the optimal dose in December 2023, all patients were subsequently enrolled at the 180mg/cycle dose and trial enrollment was completed ahead of schedule.

“Enrollment in our Phase 2 THIO-101 trial has been strong from the start. With excellent results across all doses and our selection of the optimal dose in December 2023, we enrolled the necessary number of patients in the Simon 2-stage design to achieve our trial endpoints earlier than expected,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “THIO-101 preliminary data has demonstrated unprecedented rates of disease control and response to date, and we look forward to the long-term efficacy results as we continue to monitor the enrolled patients in the upcoming months. As the only direct telomere targeting agent currently undergoing clinical development in the field of cancer, we believe THIO holds a time-to-market advantage and strong potential to become a new standard of care for NSCLC.”

The main objectives of the THIO-101 trial are to evaluate the safety, tolerability, and preliminary clinical efficacy of THIO in patients with advanced NSCLC who have experienced disease progression or relapse after initial treatments with an immune CPI alone or in combination with chemotherapy.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo®) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact

+1 (872) 270-3518
ir@maiabiotech.com

Primary Logo

Source: MAIA Biotechnology, Inc.

Released February 22, 2024

Release – GeoVax to Report 2023 Financial Results and Provide Corporate Update on February 29, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, February 22, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report 2023 financial results on Thursday, February 29, 2024, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Dial-in numbers:

Domestic:          (800) 715-9871

International:    +1 (646) 307-1963

Conference ID:  3926207

Webcast:

A webcast of the live call may be accessed here and on the Events page of the GeoVax website. A webcast replay of the call will be available for three months via the same link as the live webcast approximately two hours after the end of the call.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation Covid-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized Covid-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable Covid-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information, visit our website: www.geovax.com.

Company Contact:                  Investor Relations Contact:                  Media Contact:
info@geovax.com paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – GoHealth to Announce Fourth Quarter and Year End 2023 Results on March 14, 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Feb 22, 2024 at 8:00 AM EST

CHICAGO, Feb. 22, 2024 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its fourth quarter and full year 2023 financial results on the morning of March 14, 2024.

Chief Executive Officer, Vijay Kotte, and Chief Financial Officer, Jason Schulz, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.

A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company. Enrolling in a health insurance plan can be confusing for customers, and the seemingly small differences between plans can lead to significant out-of-pocket costs or lack of access to critical medicines and even providers. GoHealth combines cutting-edge technology, data science and deep industry expertise to match customers with the healthcare policy and carrier that is right for them. Since its inception, GoHealth has enrolled millions of people in Medicare plans and individual and family plans. For more information, visit https://www.gohealth.com.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Release – ZyVersa Therapeutics Publishes New White Paper Detailing the Role of Inflammasomes and ASC Specks in Neurological Diseases, and Data Supporting Inflammasome ASC Inhibitor IC 100 as a Potential Therapeutic Option

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Feb 22, 2024

PDF Version

  • Neurological diseases, which affect up to 16 million people over 18 years old in the US, are the leading cause of physical and cognitive disability.
  • A growing body of evidence supports that activation of more than one type of inflammasome contributes to development of common neurological diseases, and that extracellular ASC specks are involved in disease progression.
  • The white paper summarizes the preclinical research of leading inflammasome experts, Drs. Robert W. Keane and Juan Pablo de Rivero Vaccari at University of Miami Miller School of Medicine, demonstrating that Inflammasome ASC Inhibitor IC 100 crosses the blood brain barrier, and that it displays strong pharmacologic and mechanistic proof-of-concept in a variety of neurological conditions.

WESTON, Fla., Feb. 22, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with inflammatory and renal diseases who have significant unmet medical needs, announces availability of a new white paper titled, “Inflammasome ASC Inhibitor IC 100, Promising Therapeutic Potential For Neurological Diseases.” The white paper highlights data demonstrating that activation of more than one type of inflammasome and associated release of ASC specks leads to development and progression of common neurological diseases. The white paper then summarizes data from preclinical research led by Drs. Robert W. Keane and Juan Pablo de Rivero Vaccari at the University of Miami Miller School of Medicine demonstrating strong pharmacologic and mechanistic proof-of-concept for Inflammasome ASC Inhibitor IC 100 in animal models and tissue cultures representative of a variety of neurological conditions: multiple sclerosis, age-related inflammation, Alzheimer’s disease, traumatic brain injury, and spinal cord injury. Drs. Keane, de Rivero Vaccari, and their colleagues currently have research underway in Parkinson’s disease that was funded through a grant with the Michael J. Fox Foundation. To access a copy of the white paper, Click Here.

“We are excited about the potential of targeting multiple inflammasome pathways and ASC specks with Inflammasome ASC Inhibitor I00 to control the damaging inflammation contributing to neurological diseases that negatively impact the quality of life in millions of people,” said Stephen C. Glover, Co-founder, Chairman, CEO, and President of ZyVersa. “We are nearing completion of our preclinical program for IC 100 and expect to file an IND in the fourth quarter of 2024, with plans to initiate a phase 1 clinical trial in early 2025.”

About Inflammasome ASC Inhibitor IC 100

IC 100 is a novel humanized IgG4 monoclonal antibody that inhibits the inflammasome adaptor protein ASC. IC 100 attenuates 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, and 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 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 developed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system in patients with glomerular 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        

Ocugen (OCGN) – Ocugen Clinical Showcase Meeting Details OCU400 and Potential Gene Therapy Breakthroughs

Posted on by cpereira@noblefcm.com


Thursday, February 22, 2024

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Presentations Focused On OCU400. Ocugen held an investor meeting to present details of its gene therapy programs and clinical progress. The presentations included a review of the “Master Regulatory Gene” technology, OCU400 clinical results, and plans for the Phase 3 clinical trial. Next, a panel including the inventor of the technology, two doctors who have treated patients, and a patient discussed their experiences with OCU400.

Important Milestones Are Ahead. The presentations started with a review of the product pipeline progress during 2023 and the milestones ahead in 2024. These included milestones in the clinical trials for OCU400, OCU410, OCU410ST, and NeoCart. The company reiterated its goal of forming a partnership for OCU400 during the coming year. We have not included any up-front payments, milestones, or sales royalties in our models at this time.


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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. 

Novavax Stock Surges Over 20% on Positive Gavi Settlement

Posted on by slightbourne@noblecapitalmarkets.com

Shares of vaccine maker Novavax jumped over 20% on Thursday after the company announced it had reached a settlement agreement with Gavi, the Vaccine Alliance. The settlement resolves a dispute between the two organizations over a canceled COVID-19 vaccine order and provides a boost to the small cap pharmaceutical company.

In May 2021, Novavax signed an advance purchase agreement with Gavi for 350 million doses of its COVID vaccine. Gavi is a public-private global health partnership focused on increasing access to immunization in lower-income countries. It was planning to distribute Novavax’s shots globally through the COVAX initiative.

However, in 2022, Novavax terminated the agreement due to Gavi’s failure to procure any of the planned vaccine doses. Gavi sought a refund on $700 million in advance payments it had made to Novavax, but the company claimed these payments were non-refundable.

The dispute went to arbitration, with Gavi demanding full repayment of the $700 million in 2023. This presented a major financial risk for the small cap Novavax, which has a market capitalization under $5 billion.

Under the new settlement, Novavax will pay Gavi a total of up to $475 million, but in installments over 5 years. An initial $75 million payment has already been made. The remaining payments of $80 million annually through 2028 can potentially be reduced based on any future Novavax vaccine orders Gavi makes.

Gavi also has the option to order discounted Novavax vaccines over the next 5 years using “vaccine credits” provided under the settlement terms. This means that if demand arises, Novavax has the opportunity to supply more of its shots to Gavi for use in lower-income countries.

The flexible settlement terms are highly positive for Novavax’s business outlook. Instead of facing a risky $700 million payment in 2023, the company can spread payments over time while potentially recouping some of the amounts through future vaccine orders.

Many analysts viewed the Gavi arbitration as one of the largest overhangs on the beaten-down stock. Resolving this dispute eliminates a major uncertainty just as Novavax is struggling with low demand for its COVID vaccine. It also ensures Novavax can still participate in serving lower-income markets through partnerships like COVAX.

As a small cap player in the competitive vaccine space, Novavax relies heavily on such partnerships. The Gavi settlement provides the company with much-needed cash flow relief and keeps the door open to future deals. Novavax can now focus its resources on boosting sales and advancing other vaccines in its pipeline.

All told, the settlement comes as a major win for Novavax and its investors. While risks remain for the small vaccine developer, removing the Gavi arbitration cloud and securing continued market access is the optimistic boost Novavax needed right now. The company still faces challenges but has bought itself more time to strategically get back on track.

Take a look at more small cap biotech companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.