Category: Health

Release – GeoVax Reports Positive Interim Data from Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

  • Last updated: 06 February 2024 14:12
  • Created: 06 February 2024 13:33
  • Hits: 134

Results Demonstrate Potential Protective Immunity

Against Multiple SARS-CoV-2 Variants

Atlanta, GA, February 6, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.

The study is designed to evaluate the safety and immunogenicity of two GEO-CM04S1 dose levels. The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year. To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations. The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses. Consolidated data from all subjects tested one-month post-vaccination, documented statistically significant increases in neutralizing antibody responses against multiple SARS-CoV-2 variants, ranging from the original Wuhan strain through Delta and Omicron XBB 1.5; additional testing against the JN.1 variant is underway.

GEO-CM04S1 is a next-generation Covid-19 vaccine based on GeoVax’s MVA viral vector platform, which supports the presentation of multiple vaccine antigens to the immune system in a single dose. GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce both antibody and T cell responses to those parts of the virus less likely to mutate over time. The more broadly functional engagement of the immune system is designed to protect against severe disease caused by continually emerging variants of Covid-19. Vaccines of this format should not require frequent and repeated modification or updating. These latest findings lend support to previously published findings in cell transplant patients of the ability of GEO-CM04S1 to stimulate functional antibody responses against a broad array of evolving SARS-CoV-2 virus variants (Chiuppesi et al, Vaccines, Sept 2023).

Kelly McKee, Jr., MD, MPH, GeoVax Chief Medical Officer, stated, “There is a critical need to address the recognized shortcomings of currently approved SARS-CoV-2 vaccines. Annual (or even more frequent) vaccination in a seemingly never-ending race to keep pace with this rapidly evolving virus is an unsustainable strategy. GEO-CM04S1 continues to demonstrate the ability to elicit broadly reactive functional antibodies in conjunction with robust and durable T-cell responses, offering the prospect of a next-generation solution to address these shortcomings.”

“We are thrilled by these data and our investigational vaccine designed to protect against severe disease caused by emerging variants of Covid-19,” said David Dodd, GeoVax Chairman and CEO. “These interim data reinforce our resolve to bring our expertise in the development of innovative vaccines to address critical public health needs using new approaches and technologies. We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1.”

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.

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 paige.kelly@sternir.com sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – MustGrow Receives Registration Approval for TerraSante™ in Oregon State

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MGROF

  • MustGrow has received The State of Oregon Agriculture approval to commence sales of TerraSanteTM, an organic biofertility product, in Oregon State.
  • MustGrow’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to this Registration.
  • Mustard-derived TerraSanteTM focuses on soil microbiome health, nutrient/water use efficiencies, and plant yields.

SASKATOON, Saskatchewan, Canada, February 6, 2024 – MustGrow Biologics Corp. (TSXV:MGRO) (OTC:MGROF) (FRA:0C0) (the “Company” or “MustGrow”) is pleased to announce receipt of The State of Oregon Agriculture Fertilizer Registration Certificate for its mustard plant-based TerraSanteTM, an organic biofertility product.  TerraSanteTM’s recently-awarded organic compliance certification from the USDA National Organic Program (OMRI Listed®) will apply to TerraSanteTM product sales in Oregon State.

TerraSanteTM product sales may now commence in Oregon State, with a sales and marketing commercialization strategy already underway with BioAg Product Strategies for the 2024 planting season.  In addition to Oregon State and recently-awarded Washington State, further state-level registrations are progressing in other key U.S. states.

In 2021, Oregon State recorded $5.0 billion USD in agriculture production on 16 million acres of farmland and contributed $2.6 billion USD in agriculture exports.(1) Agriculture plays a critical role in the state’s economy, generating 13% of the state’s gross product and $30 billion USD in wages.(1)  Oregon farmers grow a wide variety of fruits and vegetables, including potatoes, tomatoes, strawberries, wine-making grapes, cherries, pears, and apples.  Oregon farmers are regarded for their innovative commitment to sustainable agriculture with a rising trend toward organic and sustainable farming practices.(2) MustGrow believes its organic TerraSanteTM product will position Oregon farmers to meet increasing demand for organic, local, and healthy produce.

The MustGrow organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide, which are currently under development with four global partners: Bayer, Sumitomo Corporation, Janssen PMP, and NexusBioAg.  These four partnered programs continue to achieve performance milestones and expand globally in scope and investment.

TerraSanteTM for Soil and Ecological Health

MustGrow’s soil amendment and biofertility development programs focus on soil microbiome health, nutrient and water use efficiencies, and plant yields.  Soil is a farmer’s most valuable asset, and MustGrow’s mustard plant-based technologies are being developed with the intention to improve not only the health of the soil, but also the surrounding ecological environment.

As an organic biofertilizer in soluble mixable form, TerraSanteTM contains nutritious plant proteins and carbohydrates that feed soil microbes, potentially improving beneficial microbial activity and ensuring long-term sustainable soil health. These targeted micro-communities have been shown to work to improve nutrient availability, which can potentially increase plant vigor and yields, while reducing plant stress. TerraSanteTM has the potential to improve crop nutrient uptake and, hence, overall crop performance. There are no artificial additives or preservatives used during its manufacturing.

To learn more about TerraSanteTM, visit www.mustgrow.ca.

Sources:

(1) https://www.oregon.gov/oda/shared/documents/publications/administration/boardreport.pdf
(2) https://farmloans.com/general-farm-news/how-oregon-farming-plays-a-key-role-in-the-agriculture-industry/

About MustGrow

MustGrow is an agriculture biotech company developing organic biocontrol and biofertility products by harnessing the natural defense mechanism and organic materials of the mustard plant to sustainably protect the global food supply and help farmers feed the world. MustGrow and its leading global partners — Bayer, Janssen PMP (pharmaceutical division of Johnson & Johnson), Sumitomo Corporation, and Univar Solutions’ NexusBioAg — are developing mustard-based organic solutions for applications in biocontrol to potentially replace harmful synthetic chemicals in preplant soil treatment and weed control, to postharvest disease control and food preservation. Bayer has a commercial agreement to develop and commercialize MustGrow’s biocontrol soil applications in Europe, Africa, and the Middle East. Concurrently, with new formulations derived from food-grade mustard, the Company is pursuing the adoption and use of its first registered and OMRI Listed® product, TerraSanteTM, in key U.S. states.  Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection and yield enhancements. Pending regulatory approval, MustGrow’s patented liquid technologies could be applied through injection, standard drip or spray equipment, improving functionality and performance features.  MustGrow has approximately 51.5 million basic common shares issued and outstanding and 54.2 million shares fully diluted.  For further details, please visit www.mustgrow.ca.

Contact Information

Corey Giasson
Director & CEO
Phone: +1-306-668-2652
info@mustgrow.ca

MustGrow Forward-Looking Statements

Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: the commencement of TerraSanteTM product sales in Oregon State; the progress of state-level registrations of TerraSanteTM products in other states; whether the TerraSanteTM product will position Oregon farmers to meet increasing demand for organic, local, and healthy produce; whether MustGrow’s organic biofertility product will complement the Company’s existing biocontrol programs in preplant soil fumigation, postharvest food preservation, and bioherbicide; whether MustGrow’s four partnered programs will continue to achieve performance milestones and expand globally in scope and investment; whether targeted micro-communities can increase plant vigor and yields, while reducing plant stress; and the potential for TerraSanteTM to improve crop nutrient uptake and, hence, overall crop performance. Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include market receptivity to investor relations activities as well as those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2022 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.

Neither the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.

© 2024 MustGrow Biologics Corp. All rights reserved.

Novo Holdings Announces Catalent Acquisition

Posted on by cpatches

In a strategic move aimed at addressing the soaring demand for its revolutionary weight-loss drug, Wegovy, Novo Holdings, the parent company of Novo Nordisk, has disclosed plans to acquire contract drug maker Catalent for $11.5 billion in cash. This acquisition is poised to fortify Novo Nordisk’s production capabilities in response to the extraordinary demand for innovative weight loss and diabetes medications.

Novo Holdings will acquire Catalent for $11.5 billion in cash. As part of the deal, Novo Nordisk will purchase three Catalent fill-finish sites, bolstering the production of Wegovy and other crucial medications. The acquisition is strategically driven by the exceptional demand for Wegovy and Ozempic over the past year.

Novo anticipates that the deal will have a low single-digit percentage negative impact on operating profit growth in 2024 and 2025. The terms include the acquisition of all outstanding shares of Catalent for $63.50 per share in cash, representing a premium of 16.5% to the company’s last trading price. Novo will also assume Catalent’s debt, bringing the total enterprise value of the deal to $16.5 billion.

The acquisition is expected to gradually increase Novo’s filling capacity, with notable effects expected from 2026 onwards. The three fill-finish sites, located in Italy, Belgium, and Bloomington, Indiana, will play a crucial role in supporting Novo Nordisk’s expanding drug portfolio.

In the growing obesity drug market, Novo Nordisk faces competition from Eli Lilly’s Zepbound. Analysts estimate that the obesity drug market could reach $100 billion by the end of the decade, highlighting the immense potential for companies in this sector.

The acquisition aligns seamlessly with Novo Holdings’ strategy of investing in established life science companies with significant long-term potential. Catalent’s expertise in enabling pharmaceutical, biotech, and consumer health partners is in harmony with Novo Holdings’ commitment to improving health and sustainability.

The merger is anticipated to close by the end of calendar year 2024, subject to customary closing conditions, Catalent stockholder approval, and regulatory approvals. Catalent’s Board unanimously recommends that stockholders vote in favor of the merger, following an evaluation of value-maximizing alternatives.

Kasim Kutay, CEO of Novo Holdings, expressed excitement about the partnership with Catalent and emphasized their commitment to supporting Catalent’s growth and mission to develop products that enhance lives.

Novo Holdings’ acquisition of Catalent represents a strategic move to strengthen production capabilities and meet the escalating demand for transformative medications like Wegovy. As the merger progresses, it not only positions Novo Nordisk for continued success in the competitive pharmaceutical landscape but also aligns with Novo Holdings’ broader mission of investing in high-quality life sciences companies for the betterment of society and the planet. The industry will be closely watching the outcome of this significant acquisition, anticipating positive impacts on Novo Nordisk’s product development and market position.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Biotech IPO Market Off to a Strong Start in 2024

Posted on by cpatches

The biotech sector is witnessing a dynamic start to the year 2024, with companies such as Alto Neuroscience (ANRO) and Fractyl Health (GUTS) surpassing expectations in their initial public offerings (IPOs).

Alto Neuroscience’s Upsized IPO

Alto Neuroscience today announced the pricing of its upsized IPO, offering 8,040,000 shares of common stock at $16.00 per share. The aggregate gross proceeds are estimated to be approximately $128.6 million. This figure exceeds Alto’s earlier projection of $89 million to $103 million, showcasing strong investor confidence. The shares, traded under the ticker symbol ANRO, are set to commence trading on the NYSE, with the offering expected to close on February 6.

The substantial funds raised will propel Alto’s research and development efforts, primarily supporting the advancement of its lead asset, ALTO-100. This oral small molecule inhibitor of BDNF is currently undergoing a Phase II study for major depressive disorder. Additionally, the IPO proceeds will contribute to the progress of Alto’s other depression asset, ALTO-300, and the Phase I PDE4 asset, ALTO-101, targeted at neurodegenerative and neuropsychiatric conditions.

Fractyl Health’s Successful Debut

In a parallel success story, Fractyl Health has announced the pricing of its IPO, offering 7,333,333 shares of common stock at $15.00 per share. The total gross proceeds amount to approximately $110.0 million, surpassing the initial expectation of $99 million. Fractyl Health, trading under the ticker symbol GUTS on the Nasdaq Global Market, is scheduled to debut on Friday, with the IPO closing on February 6.

The lead product candidate for Fractyl, named Revita, is an outpatient endoscopic procedural therapy utilizing hydrothermal ablation to remodel the dysfunctional duodenal lining and restore metabolic health. Revita is currently in a pivotal study for insulin-treated type 2 diabetes, with anticipated data release in the fourth quarter of 2024.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Positive Industry Trends

Alto Neuroscience and Fractyl Health’s successful IPOs follow in the footsteps of CG Oncology, which recently announced an upsized IPO of $380 million, and ArriVent Biopharma, following suit with its own $175 million offering. These developments underscore the current investor enthusiasm and optimism surrounding biotech companies, indicating a positive trajectory for the sector in 2024.

The robust performance of Alto Neuroscience and Fractyl Health in the IPO market exemplifies the strong start for the biotech sector in 2024. These successful offerings not only provide these companies with the necessary capital for their innovative projects but also reflect a broader trend of confidence and interest from investors in the biotech industry. As the year progresses, these companies and their groundbreaking initiatives will undoubtedly be closely watched by industry insiders and investors alike.

Cigna Unloads Medicare Assets for $3.7B, Ups Investments in Core Segments

Posted on by slightbourne@noblecapitalmarkets.com

Health insurer Cigna announced Wednesday it is divesting its Medicare Advantage, Medicare Part D, and other Medicare operations to Health Care Service Corporation (HCSC) in a $3.7 billion cash deal.

Cigna said the sale will streamline its business to focus on growing its health services and benefits platforms. Proceeds will also fund share repurchases, with the transaction expected to be accretive to adjusted earnings per share in 2025.

Refocusing the Portfolio

The sale includes Cigna’s Medicare Advantage plans, Medicare Part D prescription drug plans, Cigna Supplemental Benefits, and the CareAllies health support services unit.

With HCSC taking over these businesses, Cigna can direct more investment and resources toward expanding its Evernorth health services division and Cigna Healthcare commercial health benefits segment.

Evernorth provides pharmacy benefits management, specialty pharmacy, and health technology solutions. Cigna Healthcare offers employer-sponsored group health plans as well as individual plans.

While Cigna sees Medicare as an attractive market, the segment required outsized focus and capital relative to its size within Cigna’s broader portfolio. The sale unlocks value and simplifies operations.

Gaining Scale and Capabilities

For HCSC, the transaction accelerates growth in Medicare, where the company has over 1 million members currently across 7 states. Adding Cigna’s Medicare customers and capabilities will expand HCSC’s geographic reach and enhance its product portfolio.

The businesses being acquired generated around $5.5 billion in 2022 revenues for Cigna. So the deal provides HCSC with meaningful membership and revenue growth in Medicare and immediate scale.

Cigna built a significant presence in Medicare through organic growth and acquisitions like HealthSpring in 2011. HCSC gains these customer relationships and infrastructure with the purchase.

Focusing on What Cigna Does Best

Cigna has been optimizing its portfolio under CEO David Cordani to concentrate on its core competencies. Last year, Cigna sold its international life, accident, and supplemental benefits businesses.

The Medicare sale continues this strategic focus on areas where Cigna has differentiated capabilities and growth opportunities. Evernorth provides unique pharmacy solutions and analytics. Cigna Healthcare leverages the company’s strong employer and health plan expertise.

The transaction value of $3.7 billion represents about 10 times Medicare Advantage customer revenue and 16 times Medicare Part D customer revenue. This appears a solid price for Cigna to unlock capital from non-core assets.

Financial Benefits

Cigna expects the deal will be 5-10% accretive to adjusted EPS in 2025 once completed. The company reaffirmed its 2024 outlook and long-term 10-13% annual EPS growth target.

Proceeds from the divestiture will primarily fund share buybacks, representing an attractive return of capital for investors. Cigna previously had around $7.5 billion remaining on its buyback authorization.

The deal is expected to close in the first quarter of 2025 after securing necessary regulatory clearances. There is no financing condition, providing transaction certainty.

Overall, the sale highlights Cigna’s disciplined portfolio approach to drive shareholder value. Consolidating its focus while monetizing Medicare strengthens Cigna’s growth trajectory in targeted segments. For HCSC, the deal accelerates its diversification into a key government market.

Cadrenal Therapeutics (CVKD) – Peer-Reviewed Journal Reviews Uses of DOAC Drugs, Pointing To The Need For Tecarfarin

Posted on by cpereira@noblefcm.com


Thursday, February 01, 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.

New Article Discusses Uses and Contraindicated Patient Groups. An article in the Journal of the American College of Cardiology titled “When Direct Oral Anticoagulants Should Not Be Standard Treatment: JACC State-of-the-Art Review” summarized indications where DOAC drugs are commonly used, indications where they should not be used, and indications where efficacy is uncertain. The paper identifies conditions that tecarfarin is being developed to treat and supports the need we see for the drug.

DOAC Drugs Are Not For All Patients. The Direct Oral Anticoagulants (DOAC) drugs are anticoagulants that act on one specific protein in the clotting cascade. The class includes Eliquis (apixaban), Xarelto (rivaroxaban), Savaysa (edoxaban), and Pradaxa (dabigatran). Although these are effective in many conditions, some clinical trials have shown adverse findings and conditions where they should not be used.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Cardinal Health Bolsters Specialty Offering With $1.2 Billion Acquisition

Posted on by slightbourne@noblecapitalmarkets.com

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

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

Expanding Service Offerings

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

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

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

Supporting Independent Physicians

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

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

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

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Enhanced Analytics and Insights

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

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

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

Driving Growth in Key Areas

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

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

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

Strong Cultural and Strategic Fit

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

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

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

Release – Cadrenal Therapeutics Highlights Publication of Peer-Reviewed Article Supporting Need for New Anticoagulation Therapy for Patients with Certain Medical Conditions

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

31 Jan, 2024, 09:00 ET

PONTE VEDRA, Fla., Jan. 31, 2024 /PRNewswire/ — Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a novel Vitamin K Antagonist (VKA) for unmet needs in anticoagulation (blood thinning) therapy, cited today a recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, “When Direct Oral Anticoagulants Should Not Be Standard Treatment” by Antoine Bejjani, MD, et.al. The article examines the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed.

Consistent with the evolving evidence documenting the need for VKA-based anticoagulant therapy, while simultaneously recognizing the deficiencies of the available VKA anticoagulants (such as warfarin), this latest peer-reviewed journal publication highlights:

  • For most patients, DOACs are preferred over existing Vitamin K Antagonists [warfarin] for stroke prevention in atrial fibrillation (AFib) and venous thromboembolism treatment.
  • However, randomized controlled trials indicate that DOACs may not be as efficacious or as safe in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome (APS), and AFib associated with end-stage kidney disease (ESKD).
  • Their [DOACs] efficacy is uncertain for conditions such as left ventricular thrombus, and for patients with AFib or venous thrombosis who have ESKD.

“This expert review provides an assessment of the available evidence regarding DOACs, detailing not only when they have demonstrated efficacy and safety, but also when the DOACs have failed and therefore should not be the standard of care,” commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “These critical gaps in anticoagulation therapy, such as for patients with left ventricular assist devices (LVADs), thrombotic APS, and those with AFib and ESKD, highlight and support the need for the advancement of our tecarfarin development program to serve these patients.”

Further information on the article is available at https://www.jacc.org/doi/epdf/10.1016/j.jacc.2023.10.038.

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

Safe Harbor Statement

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

For more information, please contact:

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

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

SOURCE

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jan 31, 2024

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

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

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

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

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

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

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

To read the article, Click Here.

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

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

About Inflammasome ASC Inhibitor IC 100

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

About ZyVersa Therapeutics, Inc.

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

Cautionary Statement Regarding Forward-Looking Statements

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

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

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

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

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

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

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on TNXP

January 31, 2024 7:00am EST

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

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

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

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

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

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

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

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

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

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

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

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

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

Tonix Pharmaceuticals Holding Corp.*

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

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

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

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

Forward Looking Statements

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 January 31, 2024

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

Posted on by slightbourne@noblecapitalmarkets.com

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

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

Strategic Focus on TIGIT

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

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

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

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

Quemliclustat Now Solo Arcus Program

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

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

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

Extends Arcus Cash Runway

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

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

Gilead Building a Powerhouse

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

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

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

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

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

noble capital markets emerging growth virtual healthcare equity conference

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Release – GeoVax Announces 1-for-15 Reverse Stock Split to Regain Compliance with Nasdaq Minimum Bid Requirement

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Atlanta, GA, January 29, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the Company’s Board of Directors has approved a reverse stock split of its issued and outstanding shares of common stock, par value $0.001 per share (the “Common Stock”), at a ratio of 1-for-15. The Company is effecting the reverse split to regain compliance with the $1.00 minimum bid price required for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The reverse stock split was approved by the Company’s stockholders at a meeting held January 16, 2024.

The reverse stock split will become effective on January 30, 2024 (the “Effective Date”), and the Common Stock is expected to begin trading on the split-adjusted basis on the Nasdaq Stock Exchange (“Nasdaq”) at the market open on January 31, 2024. Following the reverse split, the Common Stock will continue to trade under the symbol “GOVX”, and the Company’s publicly traded warrants will continue to trade under the symbol “GOVXW”.

On the Effective Date, every 15 issued and outstanding shares of the Company’s Common Stock will be converted automatically into one share of the Company’s Common Stock without any change in the par value per share. The total number of issued and outstanding shares of Common Stock will therefore be reduced proportionately from 29,757,823 shares to approximately 1,983,855 shares. On the Effective Date, the publicly traded warrants will be adjusted to require fifteen (15) warrants to be exercised to receive one (1) share of common stock at a price of $75 per share.

Immediately after the reverse stock split, each stockholder’s percentage ownership interest in the Company and proportional voting power will remain unchanged, except for minor changes and adjustments that will result from the rounding up of any fractional shares to the next whole number of shares. The rights and privileges of the holders of shares of Common Stock will be substantially unaffected by the reverse stock split.

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.

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                paige.kelly@sternir.com                sr@roberts-communications.com 
678-384-7220 212-698-8699 202-779-0929

Release – Unicycive Therapeutics Announces Both An Oral And Poster Presentation To Be Delivered On UNI-494 At The Upcoming AKI And CRRT Conference

Posted on by aweinsoff@channelchek.com

January 29, 2024 7:03am EST 

NEW PRECLINICAL DATA ON UNI-494 IN ACUTE KIDNEY INJURY

LOS ALTOS, Calif., Jan. 29, 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 that two presentations related to UNI-494 will be presented at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024 taking place March 12-15, 2024, in San Diego, CA.

Shalabh Gupta, MD, Chief Executive Officer of Unicycive, commented, “We are looking forward to presenting data on the efficacy of our second clinical stage program UNI-494 in animal models of delayed graft function, a manifestation of acute kidney injury (AKI) that occurs during kidney transplantation resulting in loss of kidney function. We are also presenting a poster describing our ongoing Phase 1 clinical trial design for UNI-494 in healthy volunteers. Based on the results from this trial, we will determine the best path forward for the program. While our primary focus is on advancing our lead drug, OLC (Oxylanthanum Carbonate) towards a New Drug Application submission, we continue to build a body of data on UNI-494 as it progresses through its first clinical trial.”

  
Title:Intravenous Administration of UNI-494 Ameliorates Acute Kidney Injury in Rat Model of Delayed Graft Function
Lead Author:Satya Medicherla, Ph.D.
Type:Oral Presentation
Date/Time:Tuesday, March 12, 2024 / 5:30 – 7:30 p.m. PT
  
Title:UNI-494 Phase I Safety, Tolerability and Pharmacokinetics: Trial in Progress
Lead Author:Guru Reddy, PH.D.
Type:Poster
Date/Time:March 12th from 5:30 – 7:30 p.m. PT and March 13th from 6:00 – 8:00 p.m. PT
  

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 this year. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide.

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 late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn 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, 2022, 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.

Released January 29, 2024