Tag: Biotechnology

Release – Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Operating and Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

March 20, 2025

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Tegoprubart used as a key component of immunosuppression regimen in the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital

Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

Topline results from Phase 2 BESTOW trial of tegoprubart in kidney transplantation expected in fourth quarter of 2025

Proceeds from oversubscribed $85 million underwritten offering extend cash runway to end of 2026

IRVINE, Calif., March 20, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2024 operating and financial results and reviewed recent business highlights.

“We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients. Tegoprubart was a cornerstone immunosuppression component in recent historic procedures including kidney xenotransplant and islet transplants in patients with type 1 diabetes,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The results from these landmark studies together with the encouraging allograft kidney transplant clinical data we have shared continue to reinforce tegoprubart’s broad potential to protect transplanted organs and cells, regardless of the transplant type and the organ source. We are entering 2025 from a position of balance sheet strength and we are on track to deliver on multiple key milestones in the coming months, including topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.”

Fourth Quarter 2024 and Recent Business Highlights

  • Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human in a study conducted at Massachusetts General Hospital. Following the successful transplant on January 25, 2025, the patient was discharged from the hospital without need for continued treatment with dialysis for the first time in over two years.
  • Reported positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first in human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard for care for prevention of transplant rejection.
  • Completed an oversubscribed, underwritten offering of common stock and pre-funded warrants for total gross proceeds of $85.0 million and net proceeds of approximately $79.5 million after deducting underwriting discounts, commissions, and offering expenses. The offering, which priced at a premium, included participation from both new and existing investors.

Anticipated Upcoming Milestones

  • Summer 2025: Report updated interim clinical data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.
  • 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
  • 2025: Report updated interim clinical data from the investigator-led clinical trial with UChicago Medicine for pancreatic islet transplantation in subjects with type 1 diabetes.

Fourth Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments totaled $140.2 million as of December 31, 2024 compared to $78.2 million at September 30, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.

Research and development (R&D) expenses for the fourth quarter of 2024 were $17.9 million, including $2.7 million of non-cash stock-based compensation expense, compared to $7.1 million, including $0.3 million of non-cash stock-based compensation expense, for the comparable period in 2023.

General and administrative expenses for the fourth quarter of 2024 were $6.8 million, including $3.9 million of non-cash stock-based compensation expense, compared to $3.3 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2023.

Net loss for the fourth quarter of 2024 was $44.6 million, or $0.64 per basic share, compared with a net loss of $30.1 million, or $1.00 per basic share, for the comparable period in 2023. Both periods included a non-cash loss from changes in the fair value of warrant liabilities, totaling $20.9 million in 2024 and $20.5 million in 2023.

Full Year 2024 Financial Results

Research and development (R&D) expenses for the year ended December 31, 2024 were $52.0 million, including $4.3 million of non-cash stock-based compensation expense, compared to $30.3 million, including $1.5 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b, Phase 2 BESTOW and Phase 2 open-label extension trials for kidney transplantation, an increase in manufacturing costs for drug substance and drug product clinical trial supply, an increase in stock-based compensation expense and employee compensation and benefits related to increased headcount.

General and administrative expenses for the year ended December 31, 2024 were $18.6 million, including $8.8 million of non-cash stock-based compensation expense, compared to $12.7 million, including $5.0 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by an increase in stock-based compensation expense, professional services and employee compensation and benefits.

Net loss for the year ended December 31, 2024 was $36.2 million, or $0.75 per basic share, compared with a net loss of $116.5 million, or $4.73 per basic share, in 2023. The 2024 net loss included a non-cash gain of $30.9 million from changes in the fair value of warrant liabilities, whereas the 2023 net loss included a non-cash loss of $76.2 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, the company would have recorded a net loss of $67.1 million for the year ended December 31, 2024 and a net loss of $40.3 million for the year ended December 31, 2023.

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 the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. 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 sites, 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
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

View Full Release Here.

Release – MAIA Biotechnology Announces Publication of Peer-Reviewed Study Featuring Potency and Potential of Novel THIO Prodrug

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

March 20, 2025 9:20am EDT Download as PDF

  • Novel THIO dimer shows promise as a new compound with a dual mechanism of action for enhancing standard cancer treatments and overcoming resistance

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announces the publication of preclinical data for its lead proprietary telomere-targeting THIO dimer in the peer-reviewed scientific journal Naunyn-Schmiedeberg’s Archives of Pharmacology.

In a preclinical study, THIO and its new described dimer form were found to be potent inhibitors of Glutathione S-transferase Pi (GSTP1), a key enzyme implicated in cancer progression and chemoresistance and a highly important factor for the detoxification of cancer cells. The findings suggest that the dimerized form of THIO could enhance chemotherapeutic efficacy by effectively targeting GSTP1 and reducing drug resistance. The article, titled “Investigation of the inhibitory effects of the telomere-targeted compounds on glutathione S-transferase P1,” was published on February 15, 2025.

“The esteemed Archives of Pharmacology has published our first peer-reviewed paper about the unique potential of the lead molecule in our second-generation THIO program,” said Vlad Vitoc, M.D., CEO of MAIA. “Preclinical findings illuminate the superior GSTP1 binding affinity and inhibitory potency of this novel prodrug and support continued development of this new strategy for cancer therapy.”

MAIA’s second generation research and discovery platform seeks to identify new telomere-targeting THIO-like compounds with potentially improved specificity towards cancer cells relative to normal cells and with potentially increased anticancer activity. More than 80 THIO-like compounds have been developed as part of the second-generation telomere targeting program.

“Our manuscript highlights the potential of THIO’s dimer as a potent GSTP1 inhibitor and a promising new strategy for enhancing cancer treatment and overcoming drug resistance,” said Chief Scientific Officer Sergei Gryaznov, Ph.D. “Further exploration of the combinatorial effects of THIO with standard chemotherapeutic agents could provide valuable insights for optimizing standard cancer treatment protocols. These efforts could pave the way for novel, targeted strategies in cancer therapy, offering new hope in the fight against drug-resistant cancers.”

About Naunyn–Schmiedeberg’s Archives of Pharmacology

Naunyn–Schmiedeberg’s Archives of Pharmacology, founded in 1873, is the oldest existing pharmacological journal and a dedicated platform for new and significant information on drug action and toxicity of chemical compounds. The peer-reviewed scientific journal covers all fields of experimental and clinical pharmacology as well as toxicology and includes studies in neuropharmacology and cardiovascular pharmacology and those describing drug actions at the cellular, biochemical and molecular levels.

About Ateganosine

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

Source: MAIA Biotechnology, Inc.

Released March 20, 2025

Tonix Pharmaceuticals Holdings (TNXP) – Fourth Quarter Reported As Tonmya PDUFA Approaches

Posted on by cpereira@noblefcm.com


Thursday, March 20, 2025

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

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.

Fourth Quarter Reported With Product Development Updates. Tonix reported 4Q Net Loss to Common Shareholders of $22.1 million or $(9.77) per share and $130.0 million or $(176.60) per share for FY2024. Total Product sales were $10.1 million with Gross Margin averaging 23% for the full year. The company ended FY2024 with $98.8 million in cash then raised $46.3 million in 1Q25. Including our expected loss for 1Q25, we estimate cash on March 31 to be around $125 million and believe the company has sufficient operating funds into FY2026.

Preparations For Tonmya Are In Progress. Tonix has been assigned a PDUFA date of August 15, 2025, the statutory date for the FDA to answer its NDA for Tonmya (TNX-102 SL). We believe the Phase 3 trials justify approval for fibromyalgia and anticipate broad use for relief of its multiple symptoms. Based on its patient population of over 10 million patients, we believe Tonmya could be a significant revenue generator for Tonix.


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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. 

Release – MAIA Biotechnology Receives USAN Council Approval for “Ateganosine” as Nonproprietary Name for Anticancer Agent THIO

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

March 19, 2025 11:00am EDT Download as PDF

  • Nonproprietary drug name approval marks essential step in FDA approval process

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the United States Adopted Names (USAN) Council has approved “ateganosine” as the nonproprietary (generic) name for its lead molecule THIO, a telomere-targeting anticancer agent in clinical development as a first-in-class treatment for advanced non-small cell lung cancer (NSCLC).

The USAN Council is responsible for selecting standardized, informative and unique nonproprietary (generic) drug names. It is made up of experts from the American Medical Association (AMA), the U.S. Pharmacopeial Convention (USP) and the U.S Food and Drug Administration (FDA).

“The designation of a new nonproprietary name for THIO is a key step along our development and regulatory pathway as we move forward with Phase 2 and 3 clinical trials,” said Vlad Vitoc, M.D., CEO of MAIA. “We chose a name inspired by the mechanism of action of our molecule: altering telomeric guanosine of the cancer cells. The generic name ateganosine is a unique and consistent identity that will support clear communication between healthcare providers, patients and researchers.”

Generic drug names are used in product information, drug regulation, labelling and prescribing as for promotional materials and scientific literature.

MAIA will retain the name THIO in its clinical trial designations (THIO-101, THIO-102, THIO-103, THIO-104).

About Ateganosine

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

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

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

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

Source: MAIA Biotechnology, Inc.

Released March 19, 2025

Gyre Therapeutics, Inc. (GYRE) – 4Q24 Reported With Hydronidone (F351) Data Coming In 2Q25

Posted on by cpereira@noblefcm.com


Wednesday, March 19, 2025

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.

Net Income Was Within Expectations. Gyre Therapeutics reported 4Q24 Net Income Attributable to Common Shareholders of $(0.1) million or $(0.00) per share and FY2024 Net Income of $12.1 million, or $0.14 per basic share and $0.05 per fully diluted share. Revenues were $105.8 million in FY2024 with gross margins of 96.3%, consistent with our revenue estimates of $101.4 million and 96.2% gross margins. As of December 31, 2024, cash on hand was $51.2 million. Separately, results of the Phase 3 clinical trial for Hydronidone will be announced in 2Q25.

Hydronidone Data Announcement Pushed To 2Q25. In its quarterly press release, the company stated that data from the Phase 3 clinical trial for Hydronidone will be announced in 2Q25, although we had expected the data in 1Q25. We do not see this as a significant delay, as it extends the timeframe by 2 to 14 weeks. We believe this can still allow for regulatory filing in China during FY2025.


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. 

Release – Data and Safety Monitoring Board Reviews Cohort 1 Safety Data and Approves Dosing Cohort 2 in the Clinical Trial of OCU200—a Novel Fusion Protein for Diabetic Macular Edema

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 18, 2025

PDF Version

  • OCU200 has a very favorable safety and tolerability profile
  • No serious adverse events related to the study drug have been reported
  • Dosing of the second cohort has been approved

MALVERN, Pa., March 18, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial recently convened and reviewed safety data following dosing of the first cohort in the dose-escalation portion of the Phase 1 study and approved continuation of dosing in the second cohort. OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin, with the potential to treat diabetic macular edema (DME).

“OCU200 is given intravitreally,” said Peter Chang, MD, FACS, Co-President and Partner of the Massachusetts Eye Research and Surgery Institution (MERSI). “No serious adverse events related to OCU200 have been reported to date.”

The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). All subjects will receive two doses six weeks apart, and patients will be followed for up to 6 months.

“It is encouraging that we have successfully completed dosing in the low dose cohort for OCU200, a novel biologic that has a very favorable safety and tolerability profile,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “There remains a considerable unmet medical need for the 30% to 40% of DME patients who do not respond to current anti-VEGF therapies. OCU200 holds the promise of potentially benefiting all DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) patients.”

Approximately 12 million people in the United States and 130 million people worldwide are affected by DME, DR, or wet AMD. Patients affected by them share common symptoms, such as blurriness in vision and progressive vision loss, as the diseases progress. The formation of fragile and leaky new blood vessels leads to fluid accumulation in and around the retina, causing damage to vision.

OCU200 has the potential to change the treatment landscape for DME, DR, and wet AMD with its unique mechanism of action, binding the active component—tumstatin—to integrin receptors on active endothelial cells that play a crucial role in disease pathogenesis.

OCU200 brings an innovative biologic candidate to Ocugen’s ophthalmology portfolio targeting blindness diseases. The Company intends to complete the Phase 1 OCU200 clinical trial in the second half of 2025 and to provide preliminary safety and efficacy updates throughout the year.

About OCU200

OCU200 is a recombinant fusion protein that consists of two parts connected by a linker: tumstatin, the active component, acts as an anti-inflammatory, anti-VEGF agent by binding to integrin receptors; and transferrin, which targets the drug to the choroid and retina by binding transferrin receptors on endothelial cells. These features will potentially enable OCU200 to reduce the vascular permeability, inflammation, and neovascularization that drive the pathophysiology of DME, DR, and wet AMD at a significantly lower dose compared to currently approved therapies.

About Ocugen, Inc.

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

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 benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU200 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

Release – Gyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GYRE

March 17, 2025

PDF Version

Data from pivotal Phase 3 trial in CHB-associated liver fibrosis expected in Q2 2025

Commercial launch in the PRC of generic nintedanib for the treatment of IPF and avatrombopag maleate tablets for the treatment of CLD-associated thrombocytopenia expected in 2025

Initiation of U.S. Phase 2 trial of F351 in MASH-associated liver fibrosis expected in 2025

Full year 2025 total revenue guidance of $118 to $128 million

SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update.

“2025 is shaping up to be a pivotal year for Gyre across both our commercial-stage and clinical-stage portfolios. We plan to expand and enhance our commercial product offerings through the additions of nintedanib for IPF, SSc-ILD and PF-ILD, as well as avatrombopag for CLD-associated thrombocytopenia and chronic idiopathic thrombocytopenia (“ITP”). Given our proven track record and extensive sales and marketing platform, we are confident in our ability to successfully launch and expand these two products in the PRC,” said Han Ying, Ph.D., Chief Executive Officer of Gyre Therapeutics. “In parallel, we expect to share topline data from our pivotal Phase 3 trial in CHB-associated liver fibrosis in the second quarter of 2025, which will help inform our U.S. Phase 2 proof-of-concept trial of F351 in MASH-associated liver fibrosis.”

Full Year 2024 Business Highlights and Upcoming Milestones

Commercial-Stage Updates

  • ETUARY (Pirfenidone) sales update: For the year ended December 31, 2024, Gyre Pharmaceuticals generated $105.0 million primarily in sales of ETUARY.
  • Nintedanib: In May 2024, Gyre Pharmaceuticals executed a comprehensive agreement with Jiangsu Wangao Pharmaceuticals Co., Ltd. to obtain the drug registration certificate for and became the marketing authorization holder of nintedanib, the other product approved for the treatment of treatment of idiopathic pulmonary fibrosis (“IPF”). In addition, it has also been approved for the treatment of SSc-ILD and PF-ILD. Gyre Pharmaceuticals plans to initiate commercialization of the nintedanib product in the PRC in 2025.
  • Avatrombopag: In June 2024, Gyre Pharmaceuticals received approval from China’s National Medical Products Administration (“NMPA”) for avatrombopag maleate tablets for the treatment of thrombocytopenia associated with chronic liver disease (“CLD”) and chronic idiopathic thrombocytopenia (“ITP”) in adult patients undergoing elective diagnostics procedures or therapy. Gyre Pharmaceuticals plans to begin commercialization of avatrombopag in 2025.

Pipeline Development Updates

F351 (Hydronidone):

  • All patients completed 52-week pivotal Phase 3 trial in chronic hepatitis B (“CHB”)-associated liver fibrosis in the PRC. In October 2024, Gyre Pharmaceuticals announced the last patient completed the 52-week pivotal Phase 3 trial. The trial is evaluating 248 patients with CHB-associated liver fibrosis in the PRC with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one stage after taking F351 in combination with entecavir. Gyre expects to report topline data in the second quarter of 2025.
  • Plans to initiate a Phase 2 clinical trial in metabolic dysfunction-associated steatohepatitis (“MASH”)-associated liver fibrosis in 2025. Pending the results from the pivotal Phase 3 trial in CHB-associated liver fibrosis, Gyre intends to initiate a Phase 2 proof-of-concept trial in the U.S. to evaluate F351 for the treatment of MASH-associated liver fibrosis in 2025.

F573:

  • F573 is a caspase inhibitor and a potential Category 1 new drug for the treatment of acute/acute on-chronic liver failure (“ALF/ACLF”). Completion of the Phase 2 clinical trial of F573 as a treatment for ALF/ACLF is expected by the end of 2026.

F230:

  • F230, a selective endothelin receptor agonist for the treatment of pulmonary arterial hypertension (“PAH”), is expected to begin a Phase 1 trial in 2025.

F528:

  • F528, a novel anti-inflammation agent with the potential to modify the progression of chronic obstructive pulmonary disease (“COPD”), is undergoing preclinical studies as a potential first-line therapy for the treatment of COPD. Gyre plans to submit an IND application in 2026.

Corporate Updates

  • In January 2025, appointed Ping Zhang to the Company’s Board of Directors as the lead independent director and member of the Nominating Committee. In addition, Ying Luo, Ph.D., resigned as Chairman and member of the Board of Directors of Gyre and Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the People’s Republic of China (“PRC”), to focus on other responsibilities at GNI Group Ltd. Songjiang Ma has been appointed Chairman of the Board of Directors of Gyre Pharmaceuticals.

Financial Results

Cash Position

As of December 31, 2024, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $51.2 million.

Financial Results for the Three Months Ended December 31, 2024

  • Revenues: Revenues for the three months ended December 31, 2024 were $27.9 million, compared to $27.1 million for the same period in 2023. The $0.8 million increase was primarily driven by a $1.0 million increase in ETUARY’s revenue and a $0.2 million decrease in generic drug revenue. The growth in ETUARY sales was attributed to the active expansion of the IPF treatment market, increased market penetration, and a stronger focus on ETUARY sales. To support future revenue growth, Gyre Pharmaceuticals plans to commercially launch two new products, nintedanib and avatrombopag, in 2025, which will be supported by its extensive sales and marketing platform in the PRC.
  • Cost of Revenues: For the three months ended December 31, 2024, cost of revenues was $1.2 million, compared to $1.3 million for the same period in 2023. The $0.1 million decrease was primarily driven by a $0.2 million decrease in generic drug cost due to the decrease in sales and a $0.1 million decrease in factory stoppage loss due to factory renovation in 2023, offset by a $0.2 million increase due to the increase of ETUARY’s cost due to the increase in sales.
  • Selling and Marketing Expense: For the three months ended December 31, 2024, selling and marketing expense was $16.9 million, compared to $16.5 million for the same period in 2023. The increase was primarily driven by a $2.1 million increase in promotion expense and conference expenses, offset by a $1.1 million decrease in selling and marketing payroll costs, a $0.3 million decrease in stock-based compensation expense and a $0.3 million decrease in travel and miscellaneous expenses.
  • Research and Development Expense: For the three months ended December 31, 2024, research and development expense was $3.7 million, compared to $4.6 million for the same period in 2023. The decrease was primarily driven by a $0.5 million decrease in pre-clinical and clinical research expenses and a $0.5 million decrease in stock-based compensation expense, offset by a $0.1 million increase in miscellaneous expense.
  • General and Administrative Expense: For the three months ended December 31, 2024, general and administrative expense was $5.5 million, compared to $10.1 million for the same period in 2023. The decrease was primarily driven by a $5.8 million decrease in stock-based compensation cost, offset by a $0.8 million increase in the functional and administrative department’s personnel cost and a $0.4 million increase in professional expense, including legal and consulting fees.
  • Income (Loss) from Operations: For the three months ended December 31, 2024, income from operations was $0.7 million, compared to $91.1 million loss from operation for the same period in 2023. The increase in income from operations was driven primarily by acquired in-process research and development expense recognized in the fourth quarter of 2023 and there was no such expense in the same period in 2024.
  • Net Income (Loss): For the three months ended December 31, 2024, net income was $0.6 million, compared to $101.0 million net loss for the same period in 2023.
  • Non-GAAP Adjusted Net Income: For the three months ended December 31, 2024, non-GAAP adjusted net income was $1.1 million, compared to $2.1 million for the same period in 2023. The decrease was primarily driven by the costs of being a public company for three months in 2024, as compared to two months in 2023.

Financial Results for the Full Year Ended December 31, 2024

  • Revenues: Revenues for the full year ended December 31, 2024 were $ 105.8 million, compared to $113.5 million for the same period in 2023. The $7.7 million decrease was primarily driven by a $7.1 million decrease in ETUARY’s revenue and a $0.6 million decrease in generic drug revenue as a result of decreased sales volumes. The decrease in ETUARY and generic drug sales volumes was due to fluctuations in the Chinese economy that significantly affected demand for anti-fibrosis drugs and decreasing healthcare spending generally. To support future revenue growth, Gyre plans to commercially launch two new products, nintedanib and avatrombopag, in 2025, which will be supported by Gyre Pharmaceuticals’ extensive sales and marketing platform across the PRC.
  • Cost of Revenues: For the full year ended December 31, 2024, cost of revenues was $3.9 million, compared to $4.6 million for the same period in 2023. The $0.7 million decrease was primarily driven by a $0.5 million factory stoppage loss due to factory renovation in 2023, which did not occur in 2024, and a $0.2 million decrease due to decreased sales volumes.
  • Selling and Marketing Expense: For the full year ended December 31, 2024, selling and marketing expense was $57.5 million, compared to $61.2 million for the same period in 2023. The decrease was primarily driven by a $2.4 million decrease in conference costs and promotion expense due to decreased sales activities, a $0.9 million decrease in selling and marketing payroll costs due to the decrease of sales of ETUARY in 2024, a $0.3 million decrease in share base compensation expense, and a $0.1 million decrease in miscellaneous expenses.
  • Research and Development Expense: For the full year ended December 31, 2024, research and development expense was $12.0 million, compared to $13.8 million for the same period in 2023. The decrease was primarily from Gyre Pharmaceuticals, and was driven by a $0.3 million decrease in materials and utilities, a $1.3 million decrease in pre-clinical research expense due to several research and development projects advancing to the clinical trials stage or reaching the application phase in 2024, and a $0.4 million decrease in staff cost due to reduced headcount, and a $0.5 million decrease in stock-based compensation, related to options being fully vested in 2023, which did not occur in 2024, This overall decrease was partially offset by a 0.7 million increase in general research and development expense from Gyre Therapeutics due to increased consulting fees.
  • General and Administrative Expense: For the full year ended December 31, 2024, general and administrative expense was $16.1 million, compared to $14.7 million for the same period in 2023. The increase was primarily driven by costs associated with being a public company, including a $1.9 million increase in professional expense, a $2.1 million increase in miscellaneous expenses and a $3.0 million increase in the functional and administrative department’s personnel cost, offset by a $5.6 million decrease in stock-based compensation cost.
  • Income (loss) from Operations: For the full year ended December 31, 2024, income from operations was $16.2 million, compared to $67.2 million loss for the same period in 2023. The increase in income from operations was driven primarily by acquired in-process research and development expense recognized in 2023 and there was no such expense in the same period in 2024.
  • Net Income (loss): For the full year ended December 31, 2024, net income was $17.9 million, compared to $85.5 million net loss for the same period in 2023.
  • Non-GAAP Adjusted Net Income: For the full year ended December 31, 2024, non-GAAP adjusted net income was $16.9 million, compared to $25.4 million for the same period in 2023. The decrease was primarily driven by a $7.7 million decline in revenue and a $1.1 million increase in operating expenses. Despite these changes, the gross profit margin remained consistent.

Full Year 2025 Financial Guidance

For the full year 2025, the Company expects to generate revenues of $118 to $128 million, representing growth of 11.3% to 20.8% over 2024 revenue, primarily driven by the anticipated commercial launches of nintedanib and avatrombopag and sales of ETUARY.

 Guidance Range
  
Total Revenue$118 to $128 million
  

Please note the following regarding the total revenue guidance:

  • Guidance assumes a constant foreign currency exchange rate.
  • Guidance assumes no significant economic disruption or downturn.

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating the Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

About Hydronidone (F351)

F351 is a structural analogue of the approved anti-fibrotic (IPF) drug Pirfenidone and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet).

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.0 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC, initiation of Gyre’s Phase 2 trial in the U.S. for F351 for the treatment of MASH-associated liver fibrosis, timing of completion of Gyre’s Phase 2 clinical trial in the PRC of F573 for ALF/ACLF, initiation of Phase 1 trial of F230 for the treatment of PAH and IND submission of F528 in COPD, the expectations regarding commercial launch of nintedanib and avatrombopag maleate tablets, interactions with regulators, expectations regarding future product sales, and Gyre’s financial position and cash resources. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 27, 2024 and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

For Investors:
Stephen Jasper
stephen@gilmartinir.com

View Full Release Here.

Release – GeoVax to Report Fourth Quarter and Full Year 2024 Financial Results and Provide Corporate Update on March 27, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GeoVax to Host Conference Call at 4:30 PM ET

Atlanta, GA, March 17, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancer and infectious diseases, today announced that it will report 2024 financial results on Thursday, March 27, 2025, after the close of U.S. markets. Following the release, management will host a live conference call and webcast, including Q&A, at 4:30 p.m. ET to provide a corporate update and discuss financial results.

Conference Call Details

To access the live conference call, participants may register here. The live audio webcast of the call will be available under “Events and Presentations” in the Investor Relations section of the GeoVax website at geovax.com/investors. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on GeoVax’s website approximately two hours after the conference call and will remain available for at least 90 days following the event.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) 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, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Cadrenal Therapeutics (CVKD) – FY2024 Report Reviews A Pivotal Year For Tecarfarin

Posted on by cpereira@noblefcm.com


Friday, March 14, 2025

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.

FY2024 Was A Productive Year. Cadrenal reported a 4Q24 loss of $4.2 million or $(2.55) per share and FY2024 loss of $10.7 million or $(8.73) per share. An important development discussed in our Research Note on March 5 was Cadrenal’s announcement of a collaborative agreement with Abbott (ABT, Not Rated) for support of its pivotal trial testing tecarfarin in patients with left ventricular assist (LVAD) devices. Cash and equivalents on December 31 were $10.0 million.

Tecarfarin Is In Development For Several Patient Populations With Coagulation Needs. Many patients that are at risk for cardiovascular events (stroke, embolism, deep vein thrombosis) take anticoagulants in the direct oral anticoagulant class (DOACs, such as Eliquis or Xarelto). However, there are several patient populations that must take warfarin, an older drug, due to lack of efficacy or high bleeding risk. Tecarfarin is being developed to replace warfarin in these populations. Cadrenal has Orphan Drug designation from the FDA for implanted mechanical devices (LVADs) and prevention of systemic thromboembolism in end-stage kidney disease (ESKD) and atrial fibrillation (AFib).


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Release – Unicycive to Highlight Patient Reported Outcomes Data at Upcoming Medical Meetings Showing Oxylanthanum Carbonate Reduced Pill Burden and Improved Adherence in Treatment of Hyperphosphatemia

Posted on by aweinsoff@channelchek.com

Research News and Market Data on UNCY

March 13, 2025 7:00am EDT Download as PDF

LOS ALTOS, Calif., March 13, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. These data will be presented at three medical meetings, including the 2025 Annual Dialysis Conference (ADC), March 13-16, 2025, National Kidney Foundation (NKF) Spring Clinical Meetings, April 10-13, 2025, and the 2025 American Nephrology Nurses Association (ANNA) National Symposium, being held on May 1-4, 2025.

Unicycive’s investigational drug OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. If approved, OLC may provide patients and their physicians with a welcome new option to control hyperphosphatemia. The New Drug Application (NDA) for OLC was accepted by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.

“Despite the availability of several approved phosphate binders, hyperphosphatemia remains uncontrolled in 75% of people in the U.S. on dialysis due to challenges of insufficient potency, pill burden and unpalatable formulations. There is a critical need for more effective solutions,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Innovative solutions such as OLC that improve phosphate control and minimize pill size and count have the potential to significantly improve adherence, empowering those on dialysis to manage their treatment more effectively.”

Unicycive abstracts to be presented at the upcoming medical meetings include:

ADC

  • Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: A-6870
  • Presentation Details: Friday, March 14, 5:30-7:30 p.m. PT
  • Presenting Author: Doug Jermasek

NKF Spring Clinical Meetings

  • Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: G-018
  • Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
  • Presenting Author: Guru Reddy, PhD
  • Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients – Poster #: G-297
  • Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
  • Presenting Author: Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities

ANNA

  • Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients
  • Presentation Details: Friday, May 2, starting at 8:45 a.m. PT

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

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. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

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Source: Unicycive Therapeutics, Inc.

Released March 13, 2025

Mallinckrodt and Endo Announce $6.7B Merger to Create Specialty Pharma Giant

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Mallinckrodt and Endo will combine to form a diversified pharmaceutical powerhouse.
– The merger will create a company with $3.6 billion in projected 2025 revenue and $1.2 billion in adjusted EBITDA.
– The new entity will focus on branded specialty pharmaceuticals while planning to separate its generics and sterile injectables business.

Pharmaceutical companies Mallinckrodt and Endo have agreed to merge in a $6.7 billion deal that will create a new powerhouse in the specialty medication market, the companies announced Thursday.

The stock-and-cash transaction, expected to close in the second half of 2025, combines Mallinckrodt’s rare disease portfolio with Endo’s sterile injectables business, positioning the merged entity to compete more effectively in high-margin specialty pharmaceutical segments.

Shares of both companies jumped on the news, with Mallinckrodt stock up 7.2% and Endo shares surging 12.3% in morning trading.

Under the terms of the agreement, Endo shareholders will receive $80 million in cash while maintaining a 49.9% stake in the combined company. Mallinckrodt shareholders will hold the remaining 50.1% interest, with Mallinckrodt serving as the parent company.

The merged firm projects $3.6 billion in revenue for 2025 with $1.2 billion in adjusted EBITDA. Management expects to achieve $150 million in annual cost synergies by the third year post-merger, with $75 million realized in the first year.

Goldman Sachs is providing $900 million in committed financing to support the transaction. The combined company will operate with a net leverage ratio of approximately 2.3x, giving it significant financial flexibility for future growth initiatives.

Siggi Olafsson, CEO of Mallinckrodt, will lead the combined entity. The companies emphasized that the complementary nature of their businesses would maximize operational efficiencies while maintaining focus on innovation.

A key component of the merger strategy involves the eventual separation of the combined sterile injectables and generics businesses. While these operations will initially be integrated, management plans to spin off this unit as a standalone company, pending board approval and market conditions.

The core branded specialty pharmaceuticals business will focus on rare diseases and hospital-based therapies, areas where both companies have established market positions. With 17 manufacturing facilities and 30 distribution centers predominantly in the United States, the company will employ approximately 5,700 people worldwide.

According to Endo’s interim CEO Scott Hirsch, the merger will leverage complementary strengths and create immediate scale advantages in key therapeutic areas. The planned separation of the generics business aims to further sharpen focus on high-growth specialty markets.

The Mallinckrodt-Endo merger comes amid increasing consolidation in the pharmaceutical sector as companies look to gain scale and portfolio diversification.

Analysts at Morgan Stanley noted that the deal makes strategic sense for both companies, particularly given the challenges they’ve faced individually in recent years. The combined entity will have greater resources to invest in R&D and a stronger position in negotiations with payers and hospital systems.

However, some analysts expressed caution about integration risks and the ambitious timeline for the planned business separation. Healthcare analysts at JP Morgan pointed out that executing a merger of this scale while simultaneously preparing for a business spinoff creates significant operational complexity. The management team will need to carefully balance these priorities to deliver the promised synergies.

The combined company will be listed on the New York Stock Exchange following the transaction’s completion.

Take a moment to take a look at Noble Capital Markets’ Biotechnology Research Analyst Robert Leboyer’s coverage list.

Bristol Myers Squibb to Acquire 2seventy Bio in $286 Million All-Cash Deal

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– BMS is acquiring 2seventy bio for $5.00 per share, an 88% premium to its last closing price.
– The deal strengthens BMS’s cell and gene therapy portfolio, particularly in multiple myeloma treatment.
– The acquisition comes amid increased M&A activity in biotech, signaling confidence in the sector’s long-term potential.

Bristol Myers Squibb (BMY) has announced a definitive agreement to acquire 2seventy bio (TSVT) in an all-cash deal valued at approximately $286 million. This acquisition further strengthens BMS’s foothold in the oncology space, particularly through its access to Abecma, an FDA-approved CAR T-cell therapy for multiple myeloma. The deal is expected to close in the second quarter of 2025, pending regulatory approvals and shareholder consent.

BMS’s acquisition of 2seventy bio aligns with its broader strategy to expand its presence in the high-growth cell and gene therapy market. 2seventy bio has focused exclusively on Abecma, a treatment developed in collaboration with BMS, to extend and improve the lives of patients with relapsed or refractory multiple myeloma. With this acquisition, BMS will take full control of Abecma’s commercialization and development, streamlining operations and potentially accelerating future advancements.

Chip Baird, CEO of 2seventy bio, emphasized the significance of the transaction, stating: “This acquisition ensures Abecma continues to reach patients in need while maximizing value for our stakeholders.” BMS, with its expansive resources and global reach, is well-positioned to drive further innovation in the cell therapy space.

The biotech sector has seen a resurgence in M&A activity, with pharmaceutical giants seeking to bolster their pipelines amid ongoing scientific advancements and a challenging regulatory landscape. The acquisition of 2seventy bio comes at a time when investors are looking for signs of stability in biotech, and deals like this reinforce confidence in the sector’s long-term growth potential.

The broader biotechnology sector, as measured by the iShares Biotechnology ETF (IBB), has posted gains year-to-date, reflecting renewed investor interest in the space. As larger pharmaceutical companies look to capitalize on cutting-edge therapies, small and mid-cap biotech firms with promising assets are becoming increasingly attractive acquisition targets. The deal values 2seventy bio at a significant premium, rewarding shareholders with an 88% increase from its prior trading price. However, it also raises questions about the long-term independence of innovative biotech firms. While consolidation can lead to greater efficiency and resource allocation, it may also reduce competition and limit the number of standalone biotech companies driving early-stage innovation.

For BMS, the acquisition is a strategic move to reinforce its oncology pipeline amid growing competition in the CAR T-cell therapy space. With this deal, BMS is betting on continued demand for personalized cell-based therapies and positioning itself to lead in this evolving field. Biotech acquisitions are often driven by the need for pharmaceutical companies to secure new revenue streams as patents on existing drugs expire. By acquiring 2seventy bio, BMS gains a competitive advantage in the high-value oncology segment, ensuring its ability to remain a dominant force in the industry.

Bristol Myers Squibb’s acquisition of 2seventy bio represents a significant development in the biotech sector. As M&A activity accelerates, the deal underscores the importance of targeted therapies in oncology and highlights the ongoing push by pharmaceutical giants to secure cutting-edge treatments. For investors, this acquisition may serve as a signal that biotech remains a strong sector, with potential for both innovation and consolidation in the years ahead.

Gyre Therapeutics, Inc (GYRE) – Initiation of Coverage: Focused On Fibrosis

Posted on by cpereira@noblefcm.com


Tuesday, March 11, 2025

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.

We Are Initiating Coverage Of Gyre Therapeutics With An Outperform Rating. Gyre Therapeutics is a pharmaceutical company developing drugs for inflammatory diseases that lead to fibrosis. It currently markets Etuary (pirfenidone) in China for idiopathic pulmonary fibrosis. The lead drug in the pipeline is Hydronidone, a new molecule derived from pirfenidone, that is in a Phase 3 clinical trial in China. The data announcement is expected to report Phase 3 clinical trial results in March 2025.

Hydronidone Was Developed To Improve Efficacy and Side Effects. Hydronidone is a structural analogue of pirfenidone that was developed to improve efficacy with a more tolerable side effect profile. It is in Phase 3 trial in China for fibrosis of the liver after hepatitis B (HBV) infections. Hydronidone targets steps in the Transforming Growth Factor (TGF)-ß1 pathway as well as the downstream genes and liver cells it activates to produce fibrotic tissue. Data from the Phase 3 in China will be used to design a Phase 2a trial in the US, expected to begin in late FY2025.


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