Category: Health

Release – Ocugen, Inc. Announces Completion of Dosing In Subjects With Geographic Atrophy Secondary To dAMD In High-Dose Cohort Of Phase 1/2 ArMaDa Clinical Trial Of OCU410—A Novel Modifier Gene Therapy

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

July 25, 2024

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• Initiated Phase 2 clinical trial

MALVERN, Pa., July 25, 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 third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). GA affects approximately 1 million people in the United States.

“Currently, there are two FDA approved anti-complement therapies for GA, which targets only one pathway for a disease that has a multifactorial and complex etiology,” said Majda Hadziahmetovic, MD, Associate Professor of Ophthalmology, Vitreoretinal Diseases and Surgery, Duke University Eye Center, and the lead investigator for the OCU410 Phase 1/2 trial. “Though these treatments are a significant milestone, they provide limited benefits and involve a continuous regimen of multiple intravitreal injections over several years. This modifier gene therapy could potentially transform the landscape of GA treatment.”

Three subjects received a single subretinal administration of the highest dose (200 µL of 1.5×1011 vg/mL) being tested, which completed the dosing for the Phase 1 stage of the trial. The ArMaDa clinical trial for OCU410 is being performed at 14 leading retinal surgery centers across the United States.

“We are very encouraged about the potential of OCU410 as a one-time treatment option for GA,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen.

We have initiated a Phase 2 clinical trial that will assess the safety and efficacy of OCU410 in a larger group of patients who will be randomized into either of two treatment groups (medium- or high-dose) or a control group.

The Company will continue to provide clinical updates on a periodic basis.

About the Phase 1/2 ArMaDa clinical trial
The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with geographic atrophy and will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-escalation study consisting of three dose levels [low dose (2.5×1010 vg/mL), medium dose (5×1010 vg/mL), and high dose (1.5 ×1011 vg/mL)]. Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

About dry age-related macular degeneration (dAMD) and geographic atrophy (GA)
Dry age-related macular degeneration (dAMD) affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 utilizes an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of geographic atrophy.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies 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, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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

Viking’s Surprise Move in the $150 Billion Weight Loss Race

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Viking Therapeutics stock surges 20% after announcing early advancement to late-stage trials for weight loss drug
– Company’s experimental injection VK2735 shows promising results, potentially rivaling industry giants
– Decision to skip additional mid-stage trial could accelerate drug’s market entry by a year
– Viking also developing a convenient monthly injection and oral version of the drug

In a stunning turn of events, the relatively unknown biotech company Viking Therapeutics has suddenly become the talk of Wall Street. The San Diego-based firm saw its stock price soar by over 20% on Thursday, following a game-changing announcement that has investors and health enthusiasts alike sitting up and taking notice.

The catalyst for this dramatic surge? Viking Therapeutics revealed its plans to fast-track its experimental weight loss injection, VK2735, directly into late-stage trials. This bold move, which comes earlier than expected, has positioned the company as a potential dark horse in the fiercely competitive GLP-1 market, currently dominated by pharmaceutical giants Novo Nordisk and Eli Lilly.

The GLP-1 market, projected to balloon to a staggering $150 billion by the end of the decade, has been a battlefield for drug companies seeking to capitalize on the growing demand for effective weight loss solutions. Viking’s unexpected leap forward has not only caught the attention of investors but also sent ripples through the industry, with shares of both Novo Nordisk and Eli Lilly dipping more than 1% in response.

What makes Viking’s VK2735 so promising? In a phase two trial, patients receiving weekly doses of the injection lost up to 14.7% of their body weight over just 13 weeks – an impressive figure that puts it in the same league as its more established competitors. But Viking isn’t stopping there. The company is also developing a monthly injection version of VK2735, which could offer a more convenient option for patients compared to the weekly regimens of current market leaders.

Adding another layer of intrigue, Viking is simultaneously working on an oral version of VK2735. In early-stage trials, this pill form demonstrated a 3.3% weight loss compared to placebo, opening up the possibility of a non-injectable alternative in the future.

The decision to skip an additional mid-stage trial and move directly to phase three could shave off a significant amount of time from Viking’s development timeline. Analysts now estimate that this strategic move could accelerate the drug’s market entry by as much as a year, potentially launching in 2028 instead of the previously projected 2029.

Viking’s CEO, Brian Lian, expressed confidence in the company’s direction during a recent earnings call, citing positive feedback from the Food and Drug Administration as a key factor in their decision to expedite the development process. The company is now preparing for a crucial meeting with the FDA in the fourth quarter to discuss the design and timing of the phase three trial.

As Viking Therapeutics gears up for this next critical phase, the biotech world watches with bated breath. Could this underdog company be on the verge of disrupting the weight loss drug market? With its promising results and aggressive development strategy, Viking is certainly positioning itself as a formidable contender in the race to capture a slice of the lucrative GLP-1 pie.

For investors and health-conscious individuals alike, the message is clear: keep a close eye on Viking Therapeutics. This small biotech firm might just be holding the key to the next big breakthrough in weight loss treatment.

Release – Beyond “One Bug, One Drug” – Tonix Pharmaceuticals Secures Up To $34 Million In Funding From The U.S. Department Of Defense To Develop a Broad-Spectrum Antiviral

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 24, 2024 7:45am EDT

CHATHAM, NJ / ACCESSWIRE / July 24, 2024 / From anthrax to the plague, biological warfare is a real threat to U.S. forces and civilians, so much so the Pentagon budgeted about $2 billion for the country’s biological defense for the coming fiscal year. It’s also why the U.S. Department of Defense is seeking broad-spectrum antiviral drugs and teaming up with the biotech companies developing them.

That’s the case with Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), a fully integrated biopharmaceutical company. The DoD’s Defense Threat Reduction Agency (DTRA) recently inked a five-year deal with Tonix Pharmaceuticals to develop small molecule broad-spectrum antiviral agents for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Through the Other Transaction Agreement (OTA) contracting vehicle, Tonix could get as much as $34 million in funding over five years.

“Through our agreement with DTRA, our broad-spectrum antiviral research program will address the DoD’s goal of protecting U.S. forces in the event biological weapons are introduced onto the battlefield,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “This funding provides important validation for our ongoing research and current in-house capabilities and will enable Tonix to advance its antiviral discovery program.”

Stop Viruses In Their Tracks

Antiviral drugs are designed to stop a virus in its tracks by either attacking it or preventing it from spreading. In the case of Tonix’s program, the goal is to fortify the immune system so that it can protect against a range of viruses. Demand for antiviral drugs is rising along with the concerns about viruses on the battlefield. Viruses are changing, jumping back and forth between humans and animals and there’s the new risk that synthetic biology can be used maliciously, to make new viruses or to make existing viruses more virulent in what’s called “gain of function”. On the battlefield, the DoD is looking for antiviral drugs that can protect soldiers regardless of the agent. It is pouring money into different initiatives designed to react in the event of a biological attack.

Take DTRA’s Chemical and Biological Technologies Department which is sponsoring Tonix’s research. The department, which is funded out of DTRA’s approximately $1.9 billion budget for fiscal 2024, invests in medical countermeasure projects to fulfill its mission to anticipate future threats and equip the warfighter to survive, fight and win in chemical and biological contested environments.

Across the U.S. government, chemical and biological countermeasures programs have approximately $1.26 billion budgeted for fiscal 2024 and includes programs to reduce the risks to both U.S. troops and the global community from bacteria or viruses. The need to slow the spread of viruses and protect troops from biowarfare is just part of an over-all antiviral market estimated to reach $74.75 billion by 2028, growing at a CAGR of 6.19%.

Attacking The CD45 Protein

Tonix Pharmaceuticals’ program will focus on optimizing and developing TNX-4200, the company’s oral CD45 antagonist program, which is designed to have broad-spectrum efficacy against a range of viral pathogens. This broad-spectrum capability is a move beyond the previous “one bug, one drug” approach and seeks to target a broad range of deadly agents through just a single drug. Reduction of CD45 activity, a protein tyrosine phosphatase, protects animals against many viruses, including the Ebola virus. Through this funding, Tonix expects to establish the treatment’s biological activity and safety in animals and then submit an Investigational New Drug application (IND) to conduct a first-in-human phase 1 clinical study.

Tonix said it plans to leverage previous research on phosphatase inhibitors – specifically compounds that target CD45 – to optimize compounds for therapeutic intervention of biothreat agents and provide the government with a broad-spectrum medical countermeasure. The idea behind Tonix’s compound is that partial inhibition of CD45 will provide optimal antiviral protection with an acceptable safety profile. The $34 million, five-year contract will help bankroll and accelerate the development of Tonix’s host-directed antivirals which have the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response, reports the company.

Leveraging R&D Capabilities

To develop its program, Tonix plans to rely on what it says are state-of-the-art research laboratory capabilities, including a Biosafety Level 3 (BSL-3) lab and an Animal Biosafety Level 3 (ABSL-3) facility at its research and development center in Frederick, Maryland. The research center is located in Maryland’s I-270 biotech corridor and is close to the center of the U.S. biodefense research community. The research facilities will help to accelerate the development of vaccines and antiviral drugs against infectious diseases.

The threat of viruses, pandemics and biochemical attacks is increasing, driving demand for antivirals that can stop pathogens in their tracks. Tonix is betting it can deliver a single remedy to cover several viruses – and has up to $34 million to prove it.

Featured photo by api.army.mil.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-24072/

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

Important notice, please read: Certain statements in this document 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 24, 2024

Release – MAIA Biotechnology Announces New Updates From Phase 2 Trial Of Novel Cancer Treatment Agent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

July 23, 2024 4:11am EDT

  • THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments
  • 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

  • 6 patients remain on treatment following at least 12 months of therapy.
  • Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
  • Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.

“Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment,” said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. “With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options.”

  1. https://www.sciencedirect.com/science/article/pii/S0169500217304373

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

Source: MAIA Biotechnology, Inc.

Released July 23, 2024

Augmedix and Commure Join Forces in $139 Million Healthcare AI Deal

Posted on by slightbourne@noblecapitalmarkets.com

In a significant move that could reshape the landscape of healthcare technology, Augmedix, Inc. (Nasdaq: AUGX) has announced its acquisition by Commure, Inc. The all-cash transaction, valued at approximately $139 million, marks a pivotal moment in the evolution of ambient AI and medical documentation solutions.

Announced on July 19, 2024, the deal will see Augmedix stockholders receive $2.35 per share, representing a substantial premium of 169% over the company’s recent trading history. This acquisition not only provides a windfall for Augmedix investors but also signals a strong vote of confidence in the company’s innovative approach to reducing administrative burdens in healthcare.

Augmedix, a pioneer in ambient AI medical documentation, has made significant strides in liberating clinicians from time-consuming paperwork. By leveraging artificial intelligence to transform natural conversations into organized medical notes and structured data, Augmedix has been at the forefront of enhancing clinical efficiency and decision support.

Commure, the acquiring company, is no stranger to healthcare innovation. As a leading provider of technology solutions to healthcare systems, Commure has been working to streamline operations and improve patient care across hundreds of care sites. The merger with Augmedix aligns perfectly with Commure’s mission to make health the focus of healthcare by eliminating distractions and keeping providers connected to their patients.

Manny Krakaris, CEO of Augmedix, expressed enthusiasm about the deal, stating, “This proposed transaction with Commure provides certainty and a premium value for our stockholders, representing a transformative next step in Augmedix’s mission.” He emphasized the potential for scaling ambient documentation solutions and accelerating the development of innovative features and AI capabilities.

Tanay Tandon, CEO of Commure, shared a similar sentiment, highlighting the strategic importance of the acquisition. “We’re taking a huge step forward in building the health AI operating system of the future,” Tandon remarked, underlining the goal of consolidating various point solutions into a single, integrated platform for healthcare providers and operations teams.

The transaction is expected to close in late Q3 or early Q4 of 2024, subject to approval by Augmedix stockholders and other customary closing conditions. Upon completion, Augmedix will transition from a publicly-traded company to a wholly-owned subsidiary of Commure, operating as a private entity.

This merger comes at a critical time in healthcare, as the industry grapples with burnout among medical professionals and the need for more efficient, patient-focused care. By combining Augmedix’s expertise in ambient AI documentation with Commure’s broad reach and resources, the newly formed entity aims to address these challenges head-on.

The deal also reflects the growing importance of AI in healthcare. As language models and AI technologies continue to advance, their potential to transform medical practice becomes increasingly clear. This acquisition positions the combined company at the forefront of this transformation, with the potential to set new standards in healthcare IT and clinical workflow optimization.

For the healthcare community, this merger promises a future where technology works seamlessly in the background, allowing medical professionals to focus more on patient care and less on administrative tasks. It also signals a trend towards consolidation in the healthcare tech sector, as companies seek to create more comprehensive, integrated solutions.

As the healthcare industry watches this deal unfold, many will be eager to see how the combined strengths of Augmedix and Commure will translate into practical improvements for clinicians, patients, and health systems alike. With the backing of Commure’s resources and the innovative spirit of Augmedix, the future of AI-driven healthcare solutions looks brighter than ever.

Cocrystal Pharma (COCP) – CDI-988 Reaches Milestone In Phase 1 Trial For Norovirus and Coronavirus

Posted on by cpereira@noblefcm.com


Friday, July 19, 2024

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.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.

CDI-988 Completes Phase 1 SAD Trial. Cocrystal announced that CDI-988 has completed the single ascending dose stage of the Phase 1 trial for CDI-988, its oral protease inhibitor in development for norovirus and coronavirus. The trial was designed to test the safety and tolerability of CDI-988, as well as its pharmacokinetics. The results justify moving forward to the multiple ascending dose (MAD) stage, expected later in FY2024.

SAD Study Was Designed To Test Basic Safety. The SAD trial was a double-blind trial to test a single oral administration of escalating doses ranging from 100 mg to 600 mg of CDI-988. The objectives were to determine basic safety, tolerability, and pharmacokinetics including food effects. There were no serious adverse events or treatment-emergent adverse events, with no laboratory or exam abnormalities. Safety and tolerability were considered sufficient to continue to the next stage of the trial.


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Release – ZyVersa Therapeutics Announces Publication Demonstrating that Inflammasome ASC Inhibitor IC 100 Restored Retinal Structure and Function in a Retinopathy of Prematurity Animal Model

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jul 18, 2024

PDF Version

  • Publication showed that IC 100 suppressed retinal microglia activation by interfering with ASC speck formation, attenuating retinal inflammation, abnormal retinal vascularization, and retinal thinning, and it led to restored retinal function.
  • Retinopathy of Prematurity (ROP), affecting very low birth weight premature infants is a leading cause of childhood blindness worldwide.
  • ZyVersa is developing Inflammasome ASC Inhibitor IC 100 to inhibit multiple types of inflammasomes and their associated ASC specks that trigger damaging inflammation and its perpetuation and spread to surrounding tissues.

WESTON, Fla., July 18, 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, announces that acclaimed inflammasome researchers from the University of Miami Miller School of Medicine and inventors of Inflammasome ASC Inhibitor IC 100 have published a scientific paper in the peer-reviewed journal, Angiogenesis. The paper demonstrates the crucial role of inflammasome ASC and ASC specks in the development of oxygen-induced retinopathy and provides data showing that Inflammasome ASC Inhibitor IC 100 attenuates impairment of retinal structure and function.

The paper titled, “IC 100, a humanized therapeutic monoclonal anti-ASC antibody alleviates oxygen-induced retinopathy in mice,” summarizes research evaluating mouse models representative of ROP. Following is a summary of key findings:

  • ASC specks, which lead to inflammasome activation, were significantly increased in animal model retinas and colocalized with the abnormal vasculature, along with increased microglial activation indicative of retinal inflammation that leads to retinal damage and disease progression.
  • IC 100 decreased expression of inflammasome-related molecules (ASC, gasdermin D), inflammatory cytokines (IL-1β, IL-6, and TNF), and VEGF in animal model retinas.
  • Importantly, IC 100 reduced ASC speck formation and microglial activation, attenuating inflammation, abnormal vascularization, retinal thinning, and retinal dysfunction.
  • The structural and functional improvements demonstrated with IC 100 treatment correlated with corrections of hyperoxia-modulated gene pathways associated with eye development, leukocyte migration, angiogenesis, inflammation, neurogenesis, and VEGF signaling.

“We have demonstrated that IC 100 effectively treated both phases of oxygen-induced retinopathy in a mouse model that resembles ROP in preterm infants, as it decreased retinal vaso-obliteration and intravitreal vascularization,” said Dr. Shu Wu, Professor of Pediatrics at the University of Miami. “Our data suggest that IC 100 may have potential therapeutic use in the treatment of preterm infants with ROP.”

“This research highlighting that Inflammasome ASC Inhibitor IC 100 attenuated retinal inflammation, abnormal retinal vascularization, and retinal thinning leading to restored retinal function in an animal model of ROP supports the broad range of indications that IC 100 has potential to treat. ROP is the sixth indication with preclinical data demonstrating that IC 100 attenuates pathogenic inflammasome signaling pathways resulting in reduced inflammation and improved histopathological and/or functional outcomes,” stated Stephen C. Glover, ZyVersa’s Co-founder, Chairman, CEO, and President. “The other promising indications are early Alzheimer’s disease, multiple sclerosis, acute respiratory distress syndrome, spinal cord injury, and traumatic brain injury.”

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, 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 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. The lead indication for IC 100 is obesity and its associated metabolic complications. To review a white paper summarizing the mechanism of action and preclinical data for IC 100, Click Here.

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 inflammatory or kidney diseases with high unmet medical needs. We are well positioned in the rapidly emerging inflammasome space with a highly differentiated monoclonal antibody, Inflammasome ASC Inhibitor IC 100, and in kidney disease with phase 2 Cholesterol Efflux Mediator™ VAR 200. The lead indication for IC 100 is obesity and its associated metabolic complications, and for VAR 200, focal segmental glomerulosclerosis (FSGS). Each therapeutic area offers a “pipeline within a product,” with potential for numerous indications. The total accessible market is over $100 billion. 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, Media, and IR Contact:
Karen Cashmere
Chief Commercial Officer
kcashmere@zyversa.com
786-251-9641        

Release – Cocrystal Pharma Reports Favorable Results from Single-Ascending Dose Cohorts of Phase 1 Study with CDI-988, its Oral Pan-Viral Norovirus/Coronavirus Protease Inhibitor

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

JULY 18, 2024

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BOTHELL, Wash., July 18, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) today reported favorable safety and tolerability results from the single-ascending dose (SAD) cohorts of the Phase 1 study in healthy volunteers with CDI-988, its potent, oral, pan-viral protease inhibitor. CDI-988 was specifically designed and developed using Cocrystal’s proprietary structure-based drug discovery platform technology as a broad-spectrum antiviral inhibitor to a highly conserved region in the active site of 3CL viral proteases. It is being developed as the first dual, broad-spectrum antiviral for the treatment of norovirus and coronaviruses.

“Based on a novel mechanism of action and superior broad-spectrum antiviral activity, CDI-988 is a strong candidate for advancement as a first-in-class oral treatment for both noroviruses and coronaviruses. We are pleased with the encouraging safety and tolerability data from the CDI-988 Phase 1 study SAD cohorts,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are currently manufacturing drug product for the multiple-ascending dose (MAD) cohorts of this study, with subject enrollment planned to begin in the fourth quarter of this year.”

The single-center, randomized, double-blind Phase 1 study is evaluating the safety, tolerability and pharmacokinetics including a food-effect cohort of orally administered CDI-988 compared with placebo in healthy adults and is being conducted in Australia. Study participants in the SAD cohorts received CDI-988 in doses ranging from 100 mg to 600 mg. All participants completed the study with no discontinuations. There were no serious adverse events or severe treatment-emergent adverse events. No clinically significant observations were noted in laboratory assessments, physical exams or electrocardiograms.

About Norovirus
Human noroviruses are highly contagious, constantly evolving, extremely stable in the environment and associated with debilitating illness. Symptoms include vomiting and diarrhea, with or without nausea and abdominal cramps. Norovirus infection can be much more severe and prolonged in specific risk groups including infants, children, the elderly and people with immunodeficiency. In the U.S. alone, noroviruses are responsible for an estimated 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, according to the CDC. The NIH estimates the annual burden of noroviruses to the U.S. at $10.6 billion. Outbreaks occur most commonly in semi-closed communities such as nursing homes, hospitals, cruise ships, schools, disaster relief sites and military settings. To date, no antiviral treatment or vaccine is approved for norovirus infections.

Coronaviruses Including COVID-19 and Variants
Coronaviruses (CoV) are a family of viruses that historically have been associated with a wide range of symptoms, ranging from no symptoms at all to more severe disease that includes pneumonia, acute respiratory distress syndrome (ARDS), kidney failure and death. By targeting the viral replication enzymes and protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including SARS-CoV-2 and its variants, ARDS and Middle East Respiratory Syndrome (MERS). The ability of an asymptomatic individual to transmit infection heightened the public health challenge of COVID-19.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses, and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential efficacy of CDI-988 against coronaviruses and noroviruses, the results of the CDI-988 Phase 1 trial for the antiviral treatment of coronaviruses and noroviruses, the expected timing of the CDI-988 MAD cohorts of the study, including estimated subject enrollment in the fourth quarter of fiscal year 2024, and the potential market for such product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to obtain regulatory authority for and proceed with clinical trials including the recruiting of volunteers and procuring materials for the MAD cohorts CDI-988 Phase 1 study by our clinical research organizations and vendors, the results of such studies, our collaboration partners’ technology and software performing as expected, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes, and potential development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

# # #

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Source: Cocrystal Pharma, Inc.

Released July 18, 2024

Release – The United States Eventing Association Names Zomedica’s PulseVet(R) as the Official Shock Wave of the USEA

Posted on by aweinsoff@channelchek.com

News Research and Market Data on ZOM

Zomedica will sponsor a variety of high-profile events within the USEA

ANN ARBOR, MI / ACCESSWIRE / July 17, 2024 / Zomedica Corp. (NYSE American:ZOM) (“Zomedica” or the “Company”), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, is honored to announce that the United States Eventing Association, Inc. (USEA), a leading equestrian sports organization, has named PulseVet as the “Official Shock Wave of the USEA” for 2024. As part of its partnership with the USEA, PulseVet Shock Wave is also a “Gold Sponsor” of the USEA American Eventing Championships, “Bronze Sponsor” of the USEA Classic Series, and “Contributing Sponsor” of the USEA EA21 Program, the USEA Annual Meeting and Convention, and the USEA Adult Team Championships.

Zomedica’s PulseVet system is a world leader in veterinary electro-hydraulic shock wave technology for the treatment of a wide variety of conditions in equine, canine, and feline patients. The high-energy sound waves stimulate cells and release healing growth factors in the body that reduce inflammation, increase blood flow, and accelerate bone and soft tissue development. PulseVet’s technology is used in conditions including tendon and ligament healing, bone healing, osteoarthritis, chronic pain, and wound healing.

Zomedica CEO Larry Heaton commented, “We are excited to engage with USEA as the Official Shock Wave of their organization. Zomedica is committed to helping veterinarians provide the best possible care for horses at every level of training and competition, from rehabilitation to maintaining peak performance.”

“We are grateful to Zomedica for partnering with U.S. Eventing as its newest sponsor. Keeping our equine partners healthy and happy is a top priority, and we are thankful to have a brand committed to the same goals. Our event horses are a part of the family, and we are glad that the PulseVet shock wave device is focused on keeping them in top shape,” stated USEA CEO Rob Burk.

“As a long-time member, I am thrilled to partner with the USEA and help educate all those who enjoy the sport of eventing,” Zomedica’s Senior Product Manager of Therapeutics, Courtney Calnan, commented. “Eventing requires our equine teammates to be an ultimate athlete. I’m excited for the members of USEA to learn how the PulseVet system can help their partners feel their best.”

PulseVet’s electro-hydraulic shock wave technology has been clinically proven to treat tendon, ligament, and muscle injuries; osteoarthritis; degenerative joint disease; navicular syndrome; chronic back and neck pain; fractures; and wounds. Electro-hydraulic shock wave continues to be the most researched type of shock wave in the veterinary industry. The total addressable market for PulseVet devices in the US is estimated at $1 billion, with additional recurring revenue of $150 million annually for related consumables.

About the United States Eventing Association

The USEA is a non-profit 501(c)(3) educational organization committed to providing eventing enthusiasts with a competitive level suited to their individual skills. By assisting and educating competitors, event organizers, and officials; maintaining responsible safety standards; and registering qualified competitions and clinics, the USEA offers a strong and continuous training opportunity for an ever-expanding field of world-class competitors. Just as importantly, the USEA provides a means for all riders, regardless of age or ability, to experience the thrill of eventing. To learn more, visit www.useventing.com.

About Zomedica

Zomedica is a leading equine and companion animal healthcare company dedicated to improving animal health by providing veterinarians innovative therapeutic and diagnostic solutions. Our gold standard PulseVet® shock wave system, which accelerates healing in musculoskeletal conditions, has transformed veterinary therapeutics. Our suite of products also includes the Assisi® Loop line of therapeutic devices and the TRUFORMA® diagnostic platform, the TRUVIEW™ digital cytology system, and the VetGuardian® no-touch monitoring system, all designed to empower veterinarians to provide top-tier care. In the aggregate, their total addressable market in the U.S. exceeds $2 billion. Headquartered in Michigan, Zomedica employs approximately 150 people and manufactures and distributes its products from its world-class facilities in Georgia and Minnesota. An NYSE American company, Zomedica grew revenue 33% in 2023 to $25 million and maintains a strong balance sheet with approximately $91 million in liquidity as of March 31, 2024. Zomedica is advancing its product offerings, leveraging strategic acquisitions, and expanding internationally as we work to enhance the quality of care for pets, increase pet parent satisfaction, and improve the workflow, cash flow and profitability of veterinary practices. For more information visit www.zomedica.com.

Follow Zomedica

Cautionary Note Regarding Forward-Looking Statements

Except for statements of historical fact, this news release contains certain “forward-looking information” or “forward-looking statements” (collectively, “forward-looking information”) within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.

Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company’s products, the Company’s ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.

Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the expected market and Zomedica’s share of such market, continued growth of sales, the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work including the development of new cartridges; uncertainty as to the timing and results of verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, or other requirements for our products in the Middle East, Africa and India, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, particularly in the Middle East, Africa and India; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.

The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.

Investor Relations Contact:
Zomedica Investor Relations
investors@zomedica.com
1-734-369-2555

SOURCE: Zomedica Corp.

Release – Tonix Pharmaceuticals, Set to File an NDA for Tonmya for the Management of Fibromyalgia, is Planning Expected Launch in 2H 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

July 17, 2024 8:00am EDTDownload as PDF

CHATHAM, NJ / ACCESSWIRE / July 17, 2024 / With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA – Tonix’s Tonmya and one from another U.S. company – there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

Fibromyalgia Landscape

According to an opportunity analysis commissioned by Tonix and carried out by Eversana for Tonix’s drug, Tonmya™, fibromyalgia affects around 2.7 million diagnosed and treated patients in the United States. Despite the high prevalence of this condition, the treatment landscape has remained largely stagnant for over 15 years. The last approved medication was approved in 2009, and two earlier ones were approved in 2008 and 2007.

Despite widely reported side effects and tolerability issues, the two biggest selling fibromyalgia drugs generated combined peak sales of approximately $5 billion each. Both are now generic. A big difference about the fibromyalgia market today is that the condition is widely accepted. Before the heydays of the two blockbusters, many doctors doubted the existence of fibromyalgia due to the lack of visible physical signs and specific diagnostic tests. Many believe that fibromyalgia was overlooked because it affects mostly women.

Tonix will be competing for a slice of a global market that was valued at over $3 billion in 2023 and is expected to grow at a compound annual growth rate of 3.8% from 2024 to 2030.

Tonix Enters the Ring with Tonmya

Tonmya is a new therapeutic class and unlike the three currently approved fibromyalgia drugs, which are involved in the uptake of both serotonin and norepinephrine or are more specific for norepinephrine than serotonin. The other new drug candidate heading for FDA approval is very specific for norepinephrine and does not affect serotonin.

Tonmya (also known as TNX-102 SL) is a non-opioid, non-addictive sublingual tablet designed for bedtime use. Tonmya is a sublingual formulation of cyclobenzaprine hydrochloride, which has improved sleep quality in clinical studies. Sleep quality is different than sleep quantity – or the amount of time spent asleep. By focusing on sleep quality, Tonmya is different from conventional sleep drugs. Traditional sleep aids like Ambien® fail to manage the type of sleep disturbances that exacerbate fibromyalgia symptoms.

In the latest Phase 3 trial, Tonmya showed a statistically significant improvement in fibromyalgia pain with a p-value of 0.00005. Tonix reports that statistically significant results were also seen in improving sleep quality, reducing depression and fatigue and improving overall fibromyalgia symptoms and function. Tonmya was well tolerated and the most common adverse events were transient sensations in the mouth corresponding with the disintegration of the tablets under the tongue.

Tonmya has been conditionally accepted by FDA as a trade name for the management of fibromyalgia. Tonix says it will file a new drug application (NDA) with the FDA in the second half of this year and has completed both manufacturing and multi-disciplinary-focused pre-NDA meetings with FDA.

As the anticipated NDA filing and FDA approval dates for Tonmya and a second new drug draw near, a battle in the fibromyalgia market heats up. Tonix Pharmaceuticals, with its innovative approach and promising clinical trial results, could be well positioned to disrupt a market long dominated by a few large players.

Click here for more information on Tonix Pharmaceuticals: https://redingtonvirtual.com/tnxp-aw-2407/

*Tonmya is an investigational new drug and is not approved for any indication

Investor Contact

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

Important notice, please read: Certain statements in this document 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All 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. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Tonix Pharmaceuticals Holding Corp. for investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.

SOURCE: Tonix Pharmaceuticals Holding Corp.

View the original press release on accesswire.com

Released July 17, 2024

Release – Unicycive Therapeutics Granted Patent On UNI-494 To Treat Acute Kidney Injury By The United States Patent And Trademark Office (USPTO)

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

July 17, 2024 7:03am EDT Download as PDF

ENSURES INTELLECTUAL PROPERTY PROTECTION UNTIL 2040

LOS ALTOS, Calif., July 17, 2024 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced the issuance of U.S. Patent No. 12,036,211 by the United States Patent and Trademark Office (USPTO) for UNI-494.

The patent, valid until 2040, secures protection of a method of treating a disease or a condition selected from acute kidney injury or contrast induced nephropathy by administering the UNI-494 compound. The UNI-494 compound covered in the method of use claims is not limited to a particular salt, dose or type of administration. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease.

“We are pleased to receive this patent from the USPTO, which ensures intellectual property protection for many years to come,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “This Method of Use patent for UNI-494 is an important component of our strategy to become a leader in the development of drugs that target kidney disease. UNI-494 is currently in an ongoing Phase 1 clinical trial and recently received Orphan Drug Designation in Delayed Graft Function, a form of acute kidney injury. This patent helps protect our approach and expands our portfolio as we look to develop novel treatments for kidney diseases.”

About UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive is currently conducting a Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom that is expected to complete in the second half of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined on the basis of increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.

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Source: Unicycive Therapeutics, Inc.

Released July 17, 2024

Release – GeoVax to Raise Approximately $3.1 Million of Gross Proceeds in Offering Priced At-the-Market

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, July 11, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it has entered into a definitive securities purchase agreement with a certain institutional investor for the purchase and sale of 1,085,000 shares of the Company’s common stock (or common stock equivalents) at a price of $2.86 per share in a registered direct offering priced at-the-market under Nasdaq rules.

In addition, in a concurrent private placement, the Company will issue to the investor warrants to purchase up to 2,170,000 shares of common stock. The warrants have an exercise price of $2.86 per share, will be exercisable immediately following the date of issuance and will have a term of five years following the date of stockholder approval.

Roth Capital Partners is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from this offering are expected to be approximately $3.1 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. The closing of the offering is expected to occur on or about July 12, 2024, subject to the satisfaction of customary closing conditions.

The shares in the offering described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-277585) previously filed with the Securities and Exchange Commission (the ”SEC”) and declared effective by the SEC on March 13, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, relating to the offering that will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting Roth Capital Partners, LLC at 888 San Clemente Drive, Newport Beach CA 92660, by phone at (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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®, which recently completed enrollment 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.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. 

Company Contact: Investor Relations Contact: Media Contact:
info@geovax.com                         austin.murtagh@precisionaq.com                        sr@roberts-communications.com 
678-384-7220 212-698-8696 202-779-0929

Unicycive Therapeutics (UNCY) – Patient Survey Data From Pivotal Trial Shows Patients Prefer OLC

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, July 11, 2024

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.

Pivotal Trial Included A Patient Satisfaction Survey. In late June, Unicycive released safety, efficacy, and dosing data from its Pivotal trial for OCL. As discussed on our Research Note on June 26, over 90% of the patients were able to reach target serum phosphate levels. The trial included a pre-specified patient survey asking about ease of use, satisfaction, and overall preference that shows patients prefer OLC over their current phosphate binders. We see this as an important point that could make it the best treatment in a $1 billion drug category.

We Consider Patient Preference To Be A Strong Point. OLC was developed as an improved formulation of Fosrenol (lanthanum citrate) that would require fewer and smaller pills. This was intended to improve compliance and maintain phosphate levels in the proper range. The Pivotal study for the NDA application showed sufficient safety, tolerability, and effective dose levels, with a pre-specified patient survey to collect post-treatment opinions.


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