Category: Health

Release – YS Biopharma Announces Changes to its Board Committees

Posted on by aweinsoff@channelchek.com

Research News and Market Data on YS

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GAITHERSBURG, Md., Jan. 8, 2024 /PRNewswire/ — YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma” or the “Company“), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that the Company’s Board of Directors (the “Board“) has approved Ms. Rui Yu as the new Chairperson of its Audit Committee, as a member of its Compensation Committee, and as a member of the Nominating and Corporate Governance Committee on January 7, 2024 (Beijing Time), with immediate effect. Ms. Yu currently serves as a partner at Oceanpine Capital, a position she has held since 2021. Prior to that, she served as a managing director at China Renaissance Group and vice president and head of China healthcare research at Gerson Lehman Group. Ms. Yu received her Bachelor of Science degree from Guangdong Pharmaceutical University, her Master of Science degree from the University of Missouri School of Medicine, and her MBA from the University of Chicago Booth School of Business with concentrations in finance, accounting and entrepreneurship.

   

Accordingly, the membership of each Board Committee will be as follows:

Audit Committee

Rui Yu (Chairperson), Viren Mehta, and Shaojing Tong

Compensation Committee

Viren Mehta (Chairperson), Ajit Shetty, Shaojing Tong, and Rui Yu

Nominating and Corporate Governance Committee

Ajit Shetty (Chairperson), Viren Mehta, Rui Yu, and Yi Zhang

About YS Biopharma

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

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

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SOURCE YS Biopharma Co., Ltd.

Annual JPMorgan Conference Attracts Investors Seeking Insights Into Biotech’s Promising Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

The buzz in biotech circles is building as the industry prepares to descend on San Francisco for the annual JPMorgan Healthcare Conference running January 8th through 11th. The high-profile event represents a prime opportunity for investors to gain valuable insights into the sector’s most promising up-and-comers.

Now in its 42nd year, the JPMorgan conference attracts leading biotech and pharmaceutical companies along with institutional investors, analysts, and dealmakers. Presenting firms range from massive big pharma players to small emerging growth biotechs.

Nearly 500 companies are slated to present this year, most running 30-minute Q&A sessions. These tightly packed presentations offer a wealth of intel for those looking to separate promising science from speculative hype.

The event also facilitates crucial networking and dealmaking. With so many industry leaders gathered in one place, the conference often catalyzes partnerships, financing deals, and even M&A activity.

For investors, the information bonanza can heavily influence trading decisions in the year ahead. The majority of presenting firms see significant stock volatility around their presentations as analysts and investors digest new details.

This is especially true for micro-cap biotechs developing novel platforms. The conference represents their best shot at introducing promising science to a captive audience.

Noble Capital Markets analyst Robert LeBoyer will be at the JPMorgan conference seeking hidden gems among early-stage drug developers to add to his coverage universe. His focus areas include oncology, rare diseases, and molecular diagnostics.

The four-day gathering kicks off Monday evening with keynote presentations from industry luminaries like Eli Lilly CEO Dave Ricks and CVS Health Executive Vice President Karen Lynch.

But the real action gets going Tuesday morning when company presentations start at 7:30am local time. With non-stop panels running through Thursday afternoon, the schedule stays jam-packed.

Much of the focus tends to fall on clinical trial data reveals and pipeline updates for major drug development programs. However, digging into the schedules of micro-cap presenters can pay off big for enterprising analysts and investors.

These small companies are often where the next generation of groundbreaking therapies get their start. Wall Street has seen many cases where a small or microcap biotech makes waves at JPMorgan only to become a mammoth player years later.

For instance, cancer therapy innovator Mirati Therapeutics has skyrocketed from a $200 million micro-cap at the 2012 conference to now boast a $10 billion valuation. The company’s promising clinical data updates year after year built significant investor enthusiasm.

Success stories like Mirati help explain why the JPMorgan conference receives such massive interest despite its insider feel. Registering to attend requires an invitation, and getting meetings with management teams can prove challenging given packed schedules.

But resourceful attendees find ways to build productive agendas even without formal presentations. The four-day stretch offers countless sidebar conversations and impromptu meetups.

The healthcare sector faces no shortage of complex challenges, from surging costs to ageing populations across the developed world. But the constant flow of biopharmaceutical innovation provides reason for long-term optimism.

Conferences like JPMorgan offer a window into the relentless progress companies of all sizes are making against the world’s most pressing health needs. For investors, finding the next breakthrough drug before it makes headlines could lead to substantial upside. That’s why analysts like LeBoyer eagerly make the trek each year.

The scope of the JPMorgan Healthcare Conference mirrors the diverse breadth of the wider industry. Oncology, rare diseases, neurology, infectious diseases – no area with unmet needs goes overlooked.

Both science and business play equal roles at a conference ultimately aimed at facilitating capital flows into the most promising research. The progress showcased reflects the entwinement of noble medical advancement and shrewd financial investment.

In that sense, JPMorgan offers the ideal backdrop for launching promising biotech companies into the public markets. The conference’s elevated stage has introduced scores of now-large firms over the years, and 2024 will undoubtedly add to that list.

For a list of emerging growth biotech companies, take a look at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Release – Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2024 Outlook

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

January 4, 2024

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Reported updated data from ongoing Phase 1b trial in kidney transplantation demonstrating tegoprubart treatment successfully prevented kidney transplant rejection and was generally safe and well-tolerated 

Dosed first participants in Phase 2 BESTOW trial in kidney transplantation 

Tegoprubart dosed in second-ever pig to human xenotransplant procedure

IRVINE, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced a summary of 2023 accomplishments and provided guidance for anticipated upcoming 2024 milestones.

2023 Key Highlights

  • Reported updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation. Data from 11 trial participants demonstrated that tegoprubart was generally safe and well-tolerated in patients undergoing kidney transplantation, with aggregate mean estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m2 at all reported time points after 90 days post-transplant. Amended the Phase 1b trial protocol to add a second cohort, now allowing enrollment of up to 24 trial participants who are undergoing kidney transplantation.
  • Dosed first participants in Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation.
  • Dosed tegoprubart in second-ever transplant of genetically modified heart from a pig to a human.
  • Completed financing of up to $185 million, with $35 million in upfront funding and additional aggregate financing of up to $105 million, subject to achieving clinical development milestones, volume weighted share price levels, and trading volume conditions, as well as up to an additional $45 million upon exercise of warrants. If all commitments are met, the financing is expected to be sufficient to fund the Company through the completion of the Phase 2 BESTOW trial, subject to the achievement of specified milestones, including clinical development enrollment targets.
  • Partnered with the University of Chicago Transplantation Institute to secure financing from the Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance to fund an investigator sponsored study in pancreatic islet cell transplantation in participants with type 1 diabetes. Tegoprubart treatment will be evaluated for the prevention of transplant rejection.
  • Strengthened leadership team with appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer and strengthened board of directors with appointment of Allan Kirk, M.D., Ph.D. and James Robinson.

“Eledon made significant progress in 2023 on multiple fronts, highlighted by the presentation of the first clinical evidence of tegoprubart’s potential to prevent organ rejection while producing robust improvements in eGFR and maintaining a favorable safety profile. We were also honored to play an important role in the second-ever transplant of a genetically modified heart from a pig to a human with the use of tegoprubart as part of the patient’s cornerstone immunosuppressive regimen,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “In the coming year, we look forward to building upon the promising results from our tegoprubart kidney transplant Phase 1b trial, generating additional long-term data from the Phase 1b extension study, and completing enrollment in our Phase 2 BESTOW trial.”

Anticipated 2024 Milestones

  • First half of 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation.
  • First half of 2024: Dose the 12th participant in the Phase 2 BESTOW trial. Upon the dosing of the 12th participant, the Company will have completed both clinical development milestones related to the second financing tranche from the private placement announced on May 1, 2023.
  • End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for CD40 Ligand, a well-validated biological target within the costimulatory CD40/CD40L cellular pathway. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Release – GeoVax Announces Gedeptin® Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors

Expanded Development for Monotherapy and Combination Therapy Anticipated

Atlanta, GA, January 4, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study evaluating Gedeptin® in patients suffering from advanced head and neck cancer.

Kelly McKee, MD, MPH, GeoVax’s Chief Medical Officer stated, “Completion of this trial will be a significant milestone in our Gedeptin clinical development program. Allowing time for the maximum number of cycles of Gedeptin therapy and patient follow-up, we expect to complete the study by the third quarter of this year. In the interim, we are in active discussions with advisors on protocol development in support of a follow-on Phase 2 or Phase 2/3 trial among patients with advanced head and neck cancer in whom current therapeutic options are suboptimal.  Our intent is to discuss this follow-on protocol with the FDA, in conjunction with a complete review of the results of the current trial, to ensure alignment with the regulator’s expectations.  We expect that such discussions will include addressing the opportunity and basis for an expedited approval pathway.”

Dr. McKee continued, “Demonstrating the safety, tolerability, and stabilization or shrinkage of injected tumors in patients receiving multiple cycles of Gedeptin opens the door to advancing this promising therapeutic in additional patients with advanced head and neck cancer as well as in patients with other solid tumor types and at multiple points in their therapeutic journey.”

David Dodd, GeoVax’s Chairman and CEO, commented, “We believe that the successful completion of the current trial, in conjunction with earlier findings from the completed Phase 1 first-in-human trial and preclinical investigations, provide a sound rationale for proceeding with further Gedeptin investigations.  These will include adjustments to the Gedeptin treatment regimen and combination with immune checkpoint inhibitors in advanced head and neck cancer as well as for additional cancerous and non-cancerous tumor indications. These advances represent a significant potential opportunity for GeoVax to improve the performance of immune checkpoint inhibitors and/or introduce Gedeptin as a treatment option in patients with earlier-stage disease.”

About Gedeptin®

Gedeptin is a novel patented product/technology for the treatment of solid tumors through a gene therapy strategy known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a very toxic antitumor compound in situ.

The ongoing Phase 1/2 trial (ClinicalTrials.gov Identifier: NCT03754933) is evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible for injection and no curable treatment options. The protocol entails up to five treatment cycles, each consisting of three intratumoral injections of Gedeptin over two days followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. A completed Phase 1 dose-ranging study demonstrated that treating a tumor with a single cycle of Gedeptin, followed by fludarabine infusions, was well tolerated, with evidence of a reduction in tumor size in patients with solid tumors.

A previously reported interim data review demonstrated:

  • No dose limiting toxicities or serious adverse events (SAEs) are definitively attributable to treatment. Additionally, no adverse events above grade 3 severity have been reported.
  • Up to 5 cycles of Gedeptin treatment have been administered without limiting sequelae. Intratumoral expression of the PNP transgene by RT-PCR has been established in treated tumors studied to date.
  • Impairment of tumor growth (i.e., “stable disease” using RECIST 1.1 evaluation criteria) in targeted lesions was seen in 5 of 7 patients; tumor response assessment in one patient remains under study.

The current study is being funded in part by the FDA pursuant to its Orphan Products Clinical Trials Grants Program.  The FDA has also granted Gedeptin orphan drug status for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland, and other oral cavities.

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 – Cocrystal Pharma Provides an Update on the Clinical Development of its Novel, Broad-Spectrum Antiviral Investigational Candidates

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

JANUARY 04, 2024

BOTHELL, Wash., Jan. 04, 2024 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) provides an update on the clinical development of its oral first-in-class pan-norovirus and pan-coronavirus dual protease inhibitor CDI-988 and its oral PB2 inhibitor CC-42344 for the treatment of pandemic and seasonal influenza A. CDI-988 and CC-42344 were specifically designed and developed using Cocrystal’s unique structure-based drug discovery technology platform to be effective on a broad range of viruses causing these diseases.

“We are encouraged that the preliminary data of the ongoing Phase 2a and Phase 1 studies showed CC-42344 and CD-988 were well-tolerated with favorable safety profiles,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We see great promise with both of these drug candidates as potential effective oral treatments for highly contagious, pandemic viruses, while also providing significant market opportunities for Cocrystal.”

CDI-988 targets a highly conserved region in the active site of the main 3CL protease required for viral RNA replication for pandemic norovirus and coronaviruses, including SARS-CoV-2. CDI-988 is being evaluated for safety and pharmacokinetics in a randomized, double-blinded, placebo-controlled Phase 1 study in healthy subjects being conducted in Australia. The Company reports favorable preliminary data from the single-ascending dose cohorts of the clinical study. Cocrystal expects to report topline results from the Phase 1 study this year.

CC-42344 binds to a highly conserved PB2 site of the influenza A polymerase complex and exhibits a novel mechanism of action that inhibits viral replication. A randomized, double-blind, placebo-controlled Phase 2a clinical study with CC-42344 is underway in the United Kingdom. The Company reports favorable tolerability and safety in the first cohort of the Phase 2a influenza A challenge study and expects to report topline results from the Phase 2a clinical study this year. In 2022 Cocrystal reported favorable safety and tolerability results in the healthy volunteer Phase 1 study with CC-42344 conducted in Australia.

About Norovirus

Although norovirus is a worldwide public health problem, there are no effective treatments or vaccines. Norovirus afflicts an estimated 685 million people annually at an estimated societal cost of $60 billion. About 200 million cases are seen among children under 5 years old, leading to an estimated 50,000 child deaths every year, mostly in developing countries, according to the Centers for Disease Control and Prevention (CDC). CDI-988 in vitro studies showed potent broad-spectrum antiviral activity against a panel of pandemic GII.4 norovirus proteases, which have caused the majority of norovirus outbreaks worldwide since 2002, and a favorable pharmacokinetic property targeting the gastrointestinal tract.

About COVID-19
COVID-19 hospitalizations have recently increased in the U.S. with the new JN.1 variant responsible for about 20% of these cases. Driven by the anticipated emergence of new COVID-19 variants, the global COVID-19 therapeutics market is estimated to exceed $16 billion by the end of 2031. The ability of someone with no symptoms to transmit infection to another person has heightened the public health challenge of COVID-19. CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against variants of concern. By targeting the viral replication protease, Cocrystal believes it is possible to develop an effective treatment for all coronaviruses, including COVID-19 and its variants, as well as for Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

About Seasonal Influenza
Each year there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually.

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 promise and potential of the two product candidates, the clinical development of CC-42344 as a product candidate for oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A and the Phase 2a study for such product candidate, CC-988 as a product candidate for dual oral antiviral inhibitor for the treatment of coronavirus and norovirus and the Phase 1 study for such product candidate, the potential efficacy and clinical benefits of, and market for, such product candidates, and the expected results and topline data from these clinical trials in 2024. 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 proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, and the results of such studies. 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, 2022. 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

# # #

Source: Cocrystal Pharma, Inc.

Released January 4, 2024

Release – ZyVersa Therapeutics Announces Equity Research Coverage Initiated by Noble Capital Markets

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jan 4, 2024

PDF Version

  • ZyVersa is developing two proprietary product platforms targeting renal and inflammatory diseases.
  • Cholesterol Efflux MediatorTM VAR 200, designed to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression.
  • Inflammasome ASC Inhibitor IC 100, designed to inhibit multiple inflammasome pathways to attenuate initiation and perpetuation of damaging inflammation pathogenic in numerous inflammatory diseases.

WESTON, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that Noble Capital Markets has initiated company-sponsored equity research coverage. To obtain a copy of the full report authored by Noble Capital Markets’ Senior Research Analyst Robert LeBoyer, as well as news and advanced market data on ZyVersa Therapeutics, please go to Channelchek.com.

About ZyVersa Therapeutics, Inc.

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the kidneys’ filtration system. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. ZyVersa’s pipeline also includes proprietary inflammasome ASC inhibitor IC 100 that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different CNS and other inflammatory diseases. For more information, please visit www.zyversa.com.

About Noble Capital Markets

Noble Capital Markets, Inc. was incorporated in 1984 as a full-service SEC / FINRA registered broker-dealer, dedicated exclusively to serving underfollowed small/microcap companies through investment banking, wealth management, trading & execution, and equity research activities. Over the past 37 years, Noble has raised billions of dollars for these companies and published more than 45,000 equity research reports. For more information, please visit www.noblecapitalmarkets.com or email: contact@noblecapitalmarkets.com.

About Channelchek

Channelchek (.com) is a comprehensive investor-centric portal – featuring more than 6,000 emerging growth companies – that provides advanced market data, independent research, balanced news, video webcasts, exclusive c-suite interviews, and access to virtual road shows. The site is available to the public at every level without cost or obligation. Research on Channelchek is provided by Noble Capital Markets, Inc., an SEC / FINRA registered broker-dealer since 1984. For more information, go to www.channelchek.com or email: contact@channelchek.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. A discussion of these and other factors, including risks and uncertainties with respect to ZyVersa, is set forth in ZyVersa’s filings with the Securities and Exchange Commission, including ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.

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
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

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

Goldman Sachs Throws Weight Behind Life Sciences’ Hottest Startups with $650M Fund

Posted on by slightbourne@noblecapitalmarkets.com

Goldman Sachs Asset Management (GSAM) has raised $650 million for its inaugural life sciences private equity fund, West Street Life Sciences I, reflecting the firm’s bullish outlook on the high-growth potential in the sector.

The fund exceeded its original fundraising target and ranks as one of the largest-ever first-time private life sciences growth funds. GSAM secured commitments from a diverse group of institutional, strategic, and high net worth investors, including meaningful capital from Goldman’s own employees.

“We are in a golden-era of innovation in the life sciences, where technological breakthroughs are creating new approaches to diagnosing and treating disease,” said Amit Sinha, head of GSAM’s Life Sciences Investing Group. “We believe the current environment provides an attractive opportunity for investing in the next generation of leading life sciences companies.”

GSAM’s entrance into life sciences PE highlights the wave of investor interest into the sector, as rapid scientific and technological advancements transform healthcare. The strategy will focus on high-growth investment opportunities in early to mid-stage therapeutic companies developing innovative drugs and treatments, as well as life sciences tools and diagnostics companies.

Specifically, the fund will target several key themes that GSAM believes will drive significant growth, including precision medicine, genetic medicine, cell therapy, immunotherapy, synthetic biology, and artificial intelligence. By leveraging GSAM’s global platform and Advisory Board of seasoned life sciences experts, the fund aims to identify the most promising companies in these emerging areas.

The Life Sciences Investing Group at the helm of managing the fund was established in 2021 and is led by Amit Sinha. The team brings decades of combined experience investing in life sciences and will tap into GSAM’s broader resources and expertise to source deals and create value.

According to Marc Nachmann, global head of Asset & Wealth Management at Goldman Sachs, “Life sciences represents one of the most exciting areas in the private investing landscape, with advances in technology transforming healthcare at an unprecedented pace. We have a long history of partnering with companies in this space and look forward to bringing the full resources of Goldman Sachs to world-class management teams who are driving progress in the industry.”

The new fund has already made 5 investments totaling approximately $90 million into high-potential life sciences startups. The deals include companies using precision medicine, immunotherapy, and artificial intelligence to develop new therapies in oncology, neurology, rare diseases, and other areas.

One portfolio company, MOMA Therapeutics, is pioneering novel therapeutics targeting mitochondrial diseases, which lack effective treatments. Another investment, Nested Therapeutics, is developing a new modality of antibody therapeutics focused on hard-to-drug intracellular protein targets.

Overall, the launch of West Street Life Sciences I demonstrates Goldman Sachs’ confidence in the booming life sciences sector and its commitment to funding innovation. With its deep expertise, global resources, and strategic focus on cutting-edge healthcare technologies, GSAM is positioning itself to capitalize on the most promising opportunities. The new fund is a bellwether for the growing intersection of finance, biotech, and next-gen medicine.

Take a moment to take a look at emerging biotech companies by looking at Noble Capital Markets’ Senior Research Analyst Robert LeBoyer’s coverage universe.

Release – GeoVax Announces Issuance of Malaria Vaccine Patent

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

 

Patent Covers Multiple Component Vaccine for Both Prevention and Treatment

Atlanta, GA, January 3, 2024 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11,857,611 to GeoVax, pursuant to the Company’s patent application No. 17/726,254 titled “Compositions and Methods for Generating an Immune Response to Treat or Prevent Malaria.”

The claims granted by the patent generally cover compositions comprising GeoVax’s modified vaccinia Ankara (MVA) vector expressing Plasmodium antigens and methods of inducing an immune response to malaria utilizing the compositions. The compositions and methods covered in the claims are useful both prophylactically and therapeutically and may be used to prevent and/or treat malaria.

David Dodd, GeoVax President and CEO, commented, “During 2023, there were the first cases of locally transmitted malaria reported in the United States in 20 years, with cases reported in Florida, Maryland and Texas. Worldwide, there are over 600,000 deaths annually attributed to malaria. This patent represents a potentially significant advance against a most critical deadly threat worldwide. While our focus and priority is to support our clinical-stage programs, we also remain strongly committed to improving public health worldwide and developing vaccines against global public health threats, such as malaria, as a part of our long-term vision for the company.”

According to data from the World Health Organization, globally, malaria causes 227 million infections and 619,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection. Most of these vaccines are based on individual proteins that induce immune responses targeting only one stage of the malaria parasite’s life cycle. GeoVax’s MVA-VLP malaria vaccine candidates incorporate antigens derived from multiple stages of the parasite’s life cycle and are designed to induce an immune response with durable functional antibodies and CD4+ and CD8+ T cell responses, all hallmarks of an ideal vaccine-induced immune response.

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 – ZyVersa Therapeutics CEO, Stephen C. Glover, Issues Letter to Shareholders Providing Outlook for 2024

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ZVSA

Jan 3, 2024

PDF Version

WESTON, Fla., Jan. 03, 2024 (GLOBE NEWSWIRE) — ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of patients with renal and inflammatory diseases who have unmet medical needs, announces that Stephen C. Glover, Co-Founder, Chairman, Chief Executive Officer, and President, has issued a Letter to Shareholders providing a corporate outlook with anticipated milestones for 2024. The full text of the letter follows.

A MESSAGE FROM OUR PRESIDENT AND CHIEF EXECUTIVE OFFICER

To my fellow shareholders,

Like so many in the biotech and pharmaceutical industry, we are looking forward to 2024 with great optimism for improved conditions in the financial markets and a milestone-rich year in the development of our lead renal and anti-inflammatory therapeutic candidates, which is expected to drive value for our shareholders. Our renal and inflammatory disease pipelines each have potential to address multiple indications. Combined, our two proprietary product platforms target a global total addressable market of around $75 billion.

On the financial front, various market watchers are seeing signals that the biotech and pharma investment environment is set to trend positively in 2024. Capital is again starting to flow to companies that are seeking to innovate through differentiated technologies or novel mechanisms of action. Near the end of 2023, we began to witness an increase in financings and an uptick in M&A across multiple sectors from inflammatory diseases to oncology. These were driven by investors targeting high upside opportunities and large pharma seeking to re-energize their product pipelines. Our team at ZyVersa shares this optimism, anticipating improved conditions as we focus our efforts on developing innovative, disease-modifying treatments to help improve patients’ quality of life.

We are looking forward to an active first quarter of this new year, including initiation of our first clinical trial for our Cholesterol Efflux MediatorTM VAR 200. VAR 200 is designed to ameliorate renal lipid accumulation that damages the kidney’s filtration system. Currently there are no approved treatments that target lipid accumulation, which is known to contribute to structural damage, proteinuria, and progression of kidney disease. The current standard of care addresses glomerular hypertension and inflammation.

We are on schedule to initiate our Phase 2a clinical trial with VAR 200 in patients with diabetic kidney disease (DKD) in the first quarter of 2024. This will be an open label trial for real-time data reads. Initial data is anticipated to be available mid-year. DKD represents a significant area of unmet need, as it is the leading cause of end-stage kidney disease, requiring dialysis or kidney transplant for survival. Although substantial progress has been made in slowing progression of DKD with introduction of ACE inhibitors, ARBs, and most recently SGLT2 inhibitors, patients are still progressing to end-stage renal disease. We are optimistic that the protection against kidney injury, fibrosis, and disease progression that was demonstrated with VAR 200 in animal models of three different kidney diseases will translate to humans. Data from our initial Phase 2a trial will not only provide proof-of-concept for VAR 200 in renal patients, it will also provide valuable insights for designing future trials with VAR 200 in other planned renal indications, including two rare kidney diseases, focal segmental glomerulosclerosis (FSGS) and Alport syndrome.

We are equally excited about our progress in the development of our proprietary Inflammasome ASC Inhibitor IC 100, which is designed to block initiation and perpetuation of damaging inflammation that contributes to a multitude of inflammatory diseases. A growing body of scientific literature reinforces the central role of multiple types of inflammasomes in the development and progression of inflammatory diseases, and we continue to report on these developments as they are published. By inhibiting Inflammasome ASC rather than a sensor molecule such as NLRP3, IC 100 targets multiple types of inflammasome pathways (including NLRP3, NLRP1, and AIM2), which is expected to provide better control of damaging inflammation and its perpetuation.

The IC 100 preclinical program is nearing completion and IND submission is planned for the fourth quarter of 2024, with Phase 1 trial initiation expected shortly thereafter.

Two Platforms, Singular Vision

We view 2024 as a potentially transformative year for ZyVersa based on the value-building milestones that we expect to achieve over the next 12 to 15 months. I look forward to working with my leadership team and fellow Board members to execute a business and clinical strategy that has potential to position ZyVersa as a leading and innovative company developing transformative drugs for underserved patients with renal and inflammasome-mediated inflammatory diseases.

Though our platforms are independent from each other, our mission is singular – to develop drug therapies that can restore health and improve quality of life for patients living with the often debilitating symptoms of renal and inflammatory diseases. We look forward to embarking on what we believe will be a productive 2024. We thank you for your continued support.

Sincerely,
Stephen C. Glover
Co-Founder, Chairman, Chief Executive Officer, and President
ZyVersa Therapeutics

About ZyVersa Therapeutics, Inc.

ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes phase clinical stage Cholesterol Efflux MediatorTM VAR 200 in development to alleviate damaging accumulation of cholesterol and lipids in the filtering system of the kidneys. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. ZyVersa’s pipeline also includes proprietary inflammasome ASC inhibitor IC 100 that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different 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. A discussion of these and other factors, including risks and uncertainties with respect to ZyVersa, is set forth in ZyVersa’s filings with the Securities and Exchange Commission, including ZyVersa’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.

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.

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

Media Contacts
Casey McDonald
cmcdonald@tiberend.com
646-577-8520

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

ZyVersa Therapeutics, Inc. (ZVSA) – Novel Therapies For Renal Diseases and Inflammation

Posted on by cpereira@noblefcm.com


Wednesday, January 03, 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.

Initiating Coverage With An Outperform Rating. ZyVersa Therapeutics is a biotechnology company focused on renal and inflammatory diseases. Its lead product, VAR 200, is in development to reduce renal cholesterol and lipid accumulation in the kidney. These accumulations damage the kidney and lead to loss of filtration in kidney diseases. Its second product in development, IC 100, is an inflammasome inhibitor to inhibit the inflammation that contributes to many chronic diseases.

Renal Diseases. Accumulation of renal cholesterol and lipids in the kidney leads to cellular damage that starts a decline in filtration function and leakage of protein into the urine. VAR 200 was developed to reduce levels of cholesterol and lipids in renal cells to reduce the damage, scarring, and disease progression. The first clinical trial in diabetic kidney disease (DKD) is planned for early 2024.


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Bristol Myers Squibb $4.1B RayzeBio Buyout

Posted on by slightbourne@noblecapitalmarkets.com

Pharma giant Bristol Myers Squibb (BMY) announced Tuesday that it will acquire clinical-stage biotech RayzeBio for $4.1 billion, continuing Bristol’s strategy of deals to refresh its drug pipeline amid upcoming patent expirations.

RayzeBio is developing a novel targeted radiotherapy called RYZ101 to treat multiple types of cancer. The company’s technology combines tumor-targeting antibodies with radioactive isotope payloads that selectively damage cancer cells’ DNA when delivered.

RYZ101 is currently in Phase 3 testing for treating metastatic castration-resistant prostate cancer. Early clinical data showed promising results with the drug demonstrating tumor response rates of 44-55%.

Bristol gains full rights to RYZ101 and RayzeBio’s broader platform for linking radioisotopes to cancer-fighting proteins. The deal gives Bristol a potential new blockbuster cancer treatment as competition intensifies in the immuno-oncology space.

Shoring Up the Cancer Business

Bristol already markets leading cancer immunotherapies Opdivo and Yervoy. However, Opdivo faces patent expiration in 2028/2031, forcing Bristol to find new long-term growth drivers.

The RayzeBio deal comes right after Bristol announced the $13.1 billion acquisition of schizophrenia drug developer Karuna Therapeutics last Friday. Karuna’s lead drug KarXT could generate peak annual sales of over $3 billion, analysts project.

These acquisitions help future-proof Bristol’s business as its top-selling drugs face new competition. Blood thinner Eliquis, which makes up over 30% of Bristol’s revenue, will see biosimilar rivals by 2026. Cancer drug Revlimid, acquired in Bristol’s 2019 buyout of Celgene, faces generics soon too.

“We are focused on strengthening our portfolio through a combination of internal programs and targeted business development,” said Bristol Myers CEO Giovanni Caforio. The RayzeBio and Karuna deals “complement our existing pillars of growth,” he added.

Betting Big on Radio-Pharmaceuticals

In addition to RYZ101’s potential, Bristol gains RayzeBio’s expertise with radio-pharmaceuticals. Attaching radioactive particles to antibodies allows them to precisely pinpoint tumor cells and kill them via DNA damage.

RayzeBio’s technology overcomes past challenges with radio-drugs such as lack of tumor specificity and rapid decay of radioisotopes. Linking radioisotopes to robust antibodies circumvents these issues and improves the drugs’ efficacy.

Analysts see radio-pharmaceuticals as an emerging trend in oncology. Radio-immunotherapies like RayzeBio’s could complement immuno-oncology drugs that activate the immune system against cancer.

By acquiring RayzeBio’s platform, Bristol can expand development of new radio-drug conjugates across its oncology pipeline. Bristol may also look to license out the technology to other companies given the heightened industry interest.

An Expensive Acquisition

Bristol is paying a huge premium to acquire RayzeBio before the biotech can prove RYZ101’s efficacy in late-stage testing. The $4.1 billion price tag works out to $62.50 per share, more than double RayzeBio’s prior closing price.

But Bristol likely wanted to preempt competition for the promising biotech asset. Amgen and Novartis are also developing radio-pharmaceutical drugs for cancer. And RayzeBio would have commanded an even higher valuation had RYZ101 succeeded in Phase 3.

Bristol expects the acquisition will reduce its adjusted earnings by about 13 cents per share in 2024. But Bristol maintained its existing profit guidance for 2022 and 2023, implying confidence the long-term benefits outweigh the near-term costs.

The company plans to finance the purchase using new debt. Bristol’s strong cash flows should allow it to service the additional debt load as it waits for RYZ101 to potentially reach the market around 2025.

Conclusion: Bolstering Its Firepower

The back-to-back deals for Karuna Therapeutics and RayzeBio showcase Bristol Myers Squibb’s strategy to acquire new therapies and drug platforms that can drive growth over the next decade. While expensive, these acquisitions reduce Bristol’s reliance on aging blockbuster drugs facing patent cliffs.

Gaining Karuna’s potential multi-billion dollar schizophrenia medicine and RayzeBio’s cutting-edge radio-pharmaceutical technology gives Bristol valuable new firepower to deploy in the fiercely competitive pharma market. If successful, the deals will ensure Bristol Myers remains an industry leader as it confronts upcoming challenges from biosimilar and generic competition.

Take a moment to take a look at emerging growth biotechnology companies by looking at Noble Capital Markets Senior Research Analyst Robert LeBoyer’s coverage universe.

Bristol Myers Drops $14 Billion to Acquire Karuna Therapeutics, Gaining Schizophrenia Drug

Posted on by slightbourne@noblecapitalmarkets.com

Pharmaceutical giant Bristol Myers Squibb made a bold move into neuroscience today, announcing the $14 billion acquisition of clinical-stage biotech Karuna Therapeutics. The massive deal provides Bristol Myers with Karuna’s lead drug candidate, KarXT, a potential new treatment for schizophrenia and other psychiatric disorders.

KarXT could be the first drug in its class approved for schizophrenia in decades. The market for schizophrenia drugs is estimated at over $7 billion globally. If approved, KarXT is projected to achieve multi-billion dollar peak sales. Bristol Myers is betting the experimental medicine could transform treatment for millions struggling with serious mental illness.

This acquisition is the latest in a wave of big pharma interest in the emerging neuroscience space. Companies are eager to find new approaches to historically hard-to-treat psychiatric conditions like schizophrenia, depression and Alzheimer’s disease.

Smaller biotechs like Karuna have led the charge, developing novel therapies targeting neurological mechanisms of psychiatric disorders. But larger players like Bristol Myers have taken notice of the promise of these new technologies.

Karuna’s KarXT combines xanomeline, a novel muscarinic receptor agonist, with trospium chloride, an FDA-approved muscarinic receptor antagonist. Early clinical results show this approach reduces side effects and improves efficacy compared to current schizophrenia drugs.

Take a look at other emerging growth biotechnology companies by taking a look at Noble Capital Markets’ Senior Research Analyst Robert Leboyer’s coverage list.

In late-stage clinical trials, KarXT demonstrated statistically significant and clinically meaningful improvements in schizophrenia symptoms. Patients experienced rapid reductions in hallucinations and delusions with far fewer problematic side effects like sedation.

Based on positive Phase 3 data, Karuna submitted a New Drug Application for KarXT in schizophrenia in mid-2022. The FDA accepted the application and set a PDUFA goal date of September 2023 for a potential approval.

Clearly Bristol Myers feels confident about KarXT’s chances, agreeing to pay $28.5 billion upfront in cash to finalize the acquisition. Karuna shareholders will also be eligible for up to $3.5 billion in milestone payments if KarXT reaches certain commercial goals.

For Bristol Myers, the move signals a push into neuroscience and psychiatric disease, an area it has not traditionally emphasized. But the company likely sees major growth potential, given the prevalence of mental illness and the need for better treatments.

Almost 3% of the U.S. population suffers from schizophrenia. Another 17% experience some other mental illness like depression, bipolar disorder or PTSD. Existing drugs fail to adequately manage symptoms for many patients and carry tolerability issues that lead to poor compliance.

Doctors and patients are eagerly awaiting novel therapies like KarXT that balance safety and efficacy. Karuna is also exploring KarXT’s potential in dementia-related psychosis and other indications beyond schizophrenia.

The lucrative deal builds on other recent big-ticket acquisitions for Bristol Myers as the company looks to expand its portfolio. Earlier this year, Bristol Myers acquired cancer biotech Turning Point Therapeutics for $3.2 billion and the oncology company MyoKardia for $13 billion.

But the Karuna purchase represents Bristol Myers’ biggest bet yet on the emerging neuroscience space. It’s the second largest biopharma acquisition announced in 2022 after Pfizer’s $43 billion buyout of cancer drugmaker Seagen.

Other large pharmaceutical companies have also signed deals to access neuropsychiatric drug candidates. AbbVie recently acquired an option to purchase Alector’s experimental Alzheimer’s therapy for up to $2.2 billion. And Eli Lilly collaborated with NextCure on novel immuno-oncology approaches for treating mental illness.

As more novel mechanisms like KarXT arrive, expect growing competition among pharma giants to capture market share. Bristol Myers struck first with today’s monumental acquisition, but likely won’t be the last looking to neuroscience for future growth.

Release – Ocugen Gains FDA Alignment on Key Aspects of OCU400—Modifier Gene Therapy—Pivotal Phase 3 Study Design

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

December 21, 2023

MALVERN, Pa., Dec. 21, 2023 (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 the Company received alignment from FDA on key aspects of the Phase 3 clinical trial design to assess the safety and efficacy of OCU400 in patients with RHO and other gene mutations associated with Retinitis Pigmentosa (RP).

“This news brings us even closer to fulfilling our mission to bring our first-in-class, gene-agnostic therapies to market and provide access to patients globally,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We look forward to beginning the Phase 3 clinical trial, which we plan to initiate in early 2024.”

During a multidisciplinary meeting with FDA, based on preliminary results from an ongoing Phase 1/2 study, Ocugen received alignment on key aspects of the Phase 3 study design—including the study endpoint, patient enrollment strategy, and study duration of one year. The Phase 3 clinical trial will enroll a broader group of RP patients, including patients with the most common RHO gene mutation, based on OCU400’s potentially gene-agnostic mechanism of action.

With orphan drug and RMAT designations in place for OCU400, FDA’s alignment on key aspects of the Phase 3 study design positions Ocugen to confidently move forward in pursuing product development and licensure for OCU400.

Currently there are approximately 110,000 patients in the United States with RP and 1.6 million patients globally. Of these patients, more than 10% have the RHO genetic mutation. Advancing OCU400 to Phase 3 clinical development will be an important step toward addressing unmet needs in the RP patient community.

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 patient’s 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.

Cautionary Note on 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 therapeutic and clinical benefits of our product candidates, expectations for clinical trial timing and results, anticipated timing of clinical trial updates and expectations for timing and outcome of regulatory interactions, 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; that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities; that receipt of orphan drug and RMAT designations may not lead to faster development or regulatory review; and that regulatory authorities may disagree with additional aspects of our clinical trial designs or may not approve our future IND applications on the anticipated timeline or at all. 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
IR@ocugen.com