Category: Health

Release – Cadrenal Therapeutics Announces Clinical Trial Initiation Plans for Tecarfarin in Patients with End-Stage Kidney Disease (ESKD) Transitioning to Dialysis

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

Advances knowledge about the use of tecarfarin in patients with severe kidney impairment, including dialysis

Pivotal step forward in pursuit of ESKD + Atrial Fibrillation (AFib) registration trial

Addresses a critical current treatment gap in patients with ESKD

PONTE VEDRA, Fla. – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company focused on developing transformative therapeutics that specifically address limitations of current anticoagulation therapy, today announced clinical trial initiation plans for its lead late-stage drug candidate, tecarfarin, in patients with ESKD who are transitioning to dialysis. Enrollment is planned to begin later this year and will include patients with and without atrial fibrillation (AFib).

Patients with severe kidney disease are already at high risk for thrombotic cardiovascular events such as myocardial infarction and stroke, along with a much greater risk of AFib and venous thromboembolism compared to subjects with normal kidney function. When ESKD patients require dialysis, their transition period comes with even greater risk of myocardial infarction, stroke, and a substantial increase in mortality.

“There is a critical need for safe, effective anticoagulants for use in ESKD patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “Tecarfarin’s orphan drug and fast-track designations in ESKD patients with AFib underscore this need, and we are excited to advance this program. This study will be an important step forward for the continued development of tecarfarin in ESKD and in other areas with real opportunities to improve patient outcomes with a potentially better vitamin K antagonist.”

Currently, there is limited evidence supporting the use of anticoagulant therapy in dialysis patients. Dialysis patients are often excluded from clinical trials due to their high underlying risk profile, and studies of direct oral anticoagulants (DOACs) in this patient population have not provided clear answers. Furthermore, a recent Phase 2 trial of chronic hemodialysis patients sponsored by a global company showed no benefit from the new class of Factor XI inhibitors in maintaining vascular access graft patency. To date, no prospective studies have examined the benefit of oral anticoagulation in preventing thrombotic events at the time of dialysis initiation.

“Initiating dialysis carries substantial excess risk of cardiovascular events and mortality, and to date, this risk has not been sufficiently addressed. Tecarfarin, a next-generation Vitamin K antagonist with a unique metabolism pathway that is not significantly affected by kidney impairment, has potential promise in this area of unmet need,” said Wolfgang Winkelmayer, Professor of Medicine and Chief of Nephrology at Baylor College of Medicine in Houston, Texas.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing transformative therapeutics to address limitations of current anticoagulation therapy specifically. Cadrenal’s lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that is designed to address unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of managing Vitamin K antagonists and where DOACs remain inadequate or unproven.

Tecarfarin received Orphan Drug Designation (ODD) and fast-track status for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease and atrial fibrillation (ESKD+AFib). The company also received ODD for the prevention of thromboembolism and thrombosis in patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs). The company has submitted an Orphan Drug Designation Request to the US FDA for patients with chronic kidney disease who have an implanted mechanical heart valve (and consequently require lifelong anticoagulation with a VKA) who also have genetic predisposition to impaired CYP2C9 metabolism, and resulting associated challenges with achieving reliable degrees of anticoagulation with the long-term use of warfarin.

Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit https://www.cadrenal.com/and connect with us on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding initiation of clinical trial for tecarfarin in patients with ESKD transitioning to dialysis; initiation of registration trial in patients with ESKD and AFib, developing transformative therapeutics to specifically address limitations of current anticoagulation therapy; addressing a critical current treatment gap in patients with ESKD; enrollment in the planned clinical trial beginning later this year; the planned study being an important step forward for the continued development of tecarfarin in ESKD; improving patient outcomes with a potentially better vitamin K antagonist; tecarfarin offering potential promise in patients initiating dialysis; addressing the unmet needs in anticoagulation therapy; and Cadrenal’s ability to pursue business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to specifically address limitations of current anticoagulation therapy; the ability to address a critical current treatment gap in patients with ESKD; the ability to advance an innovative solution to address the unmet needs in anticoagulation therapy; the ability to initiate and successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Corporate and Investor Relations

Paul Sagan

LaVoieHealthScience

(617) 865-0041

psagan@lavoiehealthscience.com

Media

Andrew Korda

LaVoieHealthScience

(617) 865-0043

akorda@lavoiehealthscience.com

Ocugen (OCGN) – 2Q25 Reported With All Three Trials On Schedule

Posted on by slightbourne@noblecapitalmarkets.com


Monday, August 04, 2025

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

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

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

Product Updates All Three Trials Are On Schedule. Ocugen reported a 2Q25 loss of $14.7 million or $(0.05) per share. During the quarter, the clinical trials made progress to keep the products on schedule for 3 BLA filings beginning in 2026. The quarter also included a licensing agreement covering OCU400 in South Korea and the reverse merger to form OthroCellix, a new company focused on regenerative medicine.

OrthoCellix Has Been Formed To Develop NeoCart. Ocugen and Carisma Therapeutics, Inc. announced a reverse merger that will create a new company developing regenerative cellular therapies.  As discussed in our Research Note on June 24, NeoCart  cellular therapy is outside its main focus. The transaction is expected to close in September-October with the new company valued at $150 million. The Phase 3 pivotal trial is expected to begin in FY2025.


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Release – Ocugen Provides Business Update with Second Quarter 2025 Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

August 1, 2025

PDF Version

Conference Call and Webcast Today at 8:30 a.m. ET

  • Initiated dosing in OCU410ST Phase 2/3 GARDian3 pivotal confirmatory clinical trial
  • Actively dosing patients in OCU400 Phase 3 liMeliGhT clinical trial and on track for 2026 BLA filing
  • OrthoCellix reverse merger intended to unlock the value of NeoCart/regenerative cell therapies and enable the Company to focus capital on modifier gene therapy platform
  • Signed binding term sheet for exclusive Korean rights to OCU400 with upfront fees and near-term development milestone payments totaling up to $11 million

MALVERN, Pa., Aug. 01, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported second quarter 2025 financial results along with a business update.

“While our modifier gene therapy clinical trials advance—now with two in late-stage—we are securing strategic partnerships and evolving the business to support three successful Biologics License Application (BLA) filings over the next three years,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “We have also made important appointments to our Board of Directors, Retina Scientific Advisory Board, and Leadership Team to provide the Company with scientific and strategic know-how to bring us closer to delivering paradigm-changing gene therapies to millions of people with blindness diseases.”

In June, the Company announced a proposed reverse merger with OrthoCellix, a wholly-owned subsidiary, and Carisma Therapeutics, Inc. to create a Nasdaq-listed, late clinical-stage regenerative cell therapy company with a first-in-class technology platform, focused on orthopedic diseases. The combined company will focus on the development of OrthoCellix’s NeoCart® technology for the treatment of articular knee cartilage defects. Previously, NeoCart® received Regenerative Medicine Advanced Therapy (RMAT) designation and concurrence from the U.S. Food and Drug Administration (FDA) on a single, confirmatory Phase 3 clinical trial to enable submission of a BLA.

Aligned with Ocugen’s business development strategy to pursue regional partnerships for OCU400, the Company signed a binding term sheet to negotiate and enter into a licensing agreement with a well-established leader in the pharmaceutical and healthcare sector in Korea for exclusive Korean rights to OCU400. Pursuant to the term sheet, under the license agreement, in addition to the upfront and milestone fees, the Company will be entitled to sales milestones of $1 million for every $15 million of net sales in Korea in addition to a royalty of 25% on net sales of OCU400 generated by Ocugen’s partner. Ocugen will manufacture commercial supply of OCU400 under terms of a supply agreement. A regional approach preserves Ocugen’s rights to larger geographies to maximize total patient reach while also generating return for shareholders.

Following the FDA’s agreement to proceed with a Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST for Stargardt disease, the agency granted Rare Pediatric Disease Designation (RPDD) to OCU410ST in May. This designation underscores the urgent need to address Stargardt disease, which remains a significant unmet medical need. Stargardt disease is an inherited retinal disorder that typically presents in childhood and affects approximately 100,000 people in the U.S. and Europe combined, and approximately 1 million globally. Currently, there is no FDA-approved treatment available for Stargardt disease.

The OCU410ST Phase 2/3 GARDian3 clinical trial is progressing well with the first patient dosed in July after FDA clearance in June. The GARDian3 clinical trial builds upon encouraging results and positive data from the Phase 1 GARDian trial, which demonstrated 48% slower lesion growth at 12-month follow-up in evaluable treated eyes compared to untreated eyes. Additionally, evaluable treated eyes showed a statistically significant (p=0.031) and clinically meaningful improvement of nearly 2-line/9-letter gain in best corrected visual acuity (BCVA) at 12-month follow-up when compared to untreated eyes.

Positive preliminary efficacy and safety data from the OCU410 Phase 1 ArMaDa clinical trial at 12 months demonstrated no drug-related serious adverse events (SAEs), 23% slower geographic atrophy (GA) lesion growth in treated eyes versus fellow eyes after a single injection, and 2-line/10-letter gain in visual acuity in treated eyes when compared to untreated fellow eyes. Preliminary results from ongoing Phase 2 clinical trial (N=31), 6-month interim analysis, demonstrated a 27% slower lesion growth and preservation of retinal tissue. These data support the potential for OCU410 to provide a one-time treatment for life for the 2-3 million people in the U.S. & EU combined who suffer from GA.

Patients are actively being recruited in the United States and Canada for the OCU400 Phase 3 liMeliGhT clinical trial, which remains on track for BLA and MAA submissions in 2026. This is the only broad retinitis pigmentosa (RP) gene-agnostic trial to address multiple genetic mutations with a single therapeutic approach. In addition, the European Medicines Agency has granted eligibility to submit the OCU400 Marketing Authorization Application (MAA) through the centralized procedure, based on the current study design and statistical analysis plan.

Regarding the Company’s inhaled vaccines portfolio, the National Institute of Allergy and Infectious Diseases (NIAID) intends to initiate the Phase 1 clinical trial for OCU500 in the third quarter of 2025.

In addition to the notable leadership appointments, Ocugen welcomed the National Security Commission on Emerging Biotechnology (NSCEB) and U.S. Rep. Chrissy Houlahan to its manufacturing facility as part of the NSCEB’s Biotech Across America events, highlighting biotech innovation in Pennsylvania. Rep. Houlahan subsequently announced the bipartisan BIOTech Caucus to build greater awareness and understanding of biotechnology among lawmakers and support transformative advances in healthcare. Dr. Musunuri supports the formation of this very important bipartisan BIOTech Caucus that includes senior congressional leaders such as Rep. Pete Sessions in addition to local leaders, which will prioritize biotechnology at the national level to ensure U.S. leadership globally.

“The meaningful progress Ocugen is making across its novel modifier gene therapy platform, along with strategic leadership changes and significant external alliances are evidence of a strong first half of 2025,” said Dr. Musunuri. “We look forward to providing critical program updates and data in the coming months.”

Modifier Gene Therapy Platform—a Novel First-in-Class Platform

  • OCU400 for RP – On track to complete enrollment in support of BLA/MAA filings in 2026. Data and Safety Monitoring Board (DSMB) convened and found no SAEs related to OCU400 and recommended to continue study dosing as planned.
  • OCU410ST for Stargardt Disease – FDA granted RPDD for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3. FDA cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST and dosing has been initiated.
  • OCU410 for GA – Phase 1 data at 12 months demonstrates reduced lesion growth, preservation of retinal tissue, and—most importantly—a positive effect on the functional visual measure of low luminance visual acuity (LLVA). Interim Phase 2 data at 6 months demonstrated very encouraging results consistent with Phase 1 data.

Ophthalmic Biologic Product

  • OCU200 – DSMB approved continuation of dosing in the third cohort and the Company intends to complete the Phase 1 clinical trial in the second half of 2025.

Second Quarter 2025 Financial Results

  • The Company’s cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, compared to $58.8 million as of December 31, 2024, providing cash runway into the first quarter of 2026. The Company had 292.2 million shares of common stock outstanding as of June 30, 2025.
  • Total operating expenses for the three months ended June 30, 2025 were $15.2 million and included research and development expenses of $8.4 million and general and administrative expenses of $6.8 million. This compares to total operating expenses for the three months ended June 30, 2024 of $16.6 million that included research and development expenses of $8.9 million and general and administrative expenses of $7.7 million.
  • Ocugen reported a $0.05 net loss per common share for the three months ended June 30, 2025, compared to a $0.06 net loss per common share for the three months ended June 30, 2024.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s executive leadership team will host the call, which will be open to all listeners. There also will be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 9627149
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. 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, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; Ocugen’s financial condition and expected cash runway into the first quarter of 2026, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, and Ocugen’s negotiations regarding the license agreement with a Korean partner and Ocugen’s potential merger transaction regarding the OrthoCellix business, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities; that a definitive agreement for the license with a Korean partner will be delayed or not executed at all, or that, if executed, it may not be on terms anticipated; that the OrthoCellix merger transaction may not close or, if closed, may not result in the benefits anticipated. These and other risks and uncertainties are more fully described in our annual and 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

View full release here.

Release – MariMed’s Products to Enter Pennsylvania Market Through a Management Services and Licensing Agreement with TILT Holdings

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MRMD

July 31, 2025 7:30am EDT Download as PDF

NORWOOD, Mass., July 31, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed,” “the Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, today announced a strategic agreement with TILT Holdings (“TILT”) (CBOE: TILT) (OTCPK: TLLTF) that will expand the distribution of the Company’s award-winning portfolio of medical marijuana products to Pennsylvania.

On July 30, 2025, Standard Farms, LLC (“Standard Farms”), a wholly owned subsidiary of TILT, entered into a Management Services Agreement (the “MSA”) with MariMed Advisors, Inc., a Delaware corporation and wholly owned subsidiary of MariMed (the “Manager”). Under the terms of the MSA, effective September 1, 2025, MariMed will assume the day-to-day management of TILT’s Standard Farms cultivation and processing facility in White Haven, Pennsylvania. Standard Farms will remain the sole permit holder. As Manager, MariMed will provide comprehensive management services to Standard Farms, including oversight of budgeting, financial planning, and compliance with applicable laws, and will maintain quality management programs. The Manager will also be responsible for advising on accounting, managing business bank accounts, and ensuring compliance with tax and licensing requirements. In addition, Standard Farms intends to produce and distribute MariMed’s award-winning brands in Pennsylvania, the fifth most populous state in the country, pursuant to a licensing arrangement with MariMed.

Pursuant to the MSA, which has an initial term of four years, MariMed will receive a management fee of 12.5% of Standard Farm’s gross revenue.

“We are thrilled to bring our brands to consumers in the great state of Pennsylvania, a strong medical marijuana market that is likely to become the next cannabis adult-use market,” said Jon Levine, MariMed’s Chief Executive Officer. “These agreements align with our ‘Expand the Brand’ strategy, a top priority initiative that is driving us toward becoming the leading consumer packaged goods company in medical marijuana. We will continue to identify opportunities to expand the distribution of our brands into new, high-growth markets and deeper in our existing markets.”

“We are excited to partner with the MariMed team and to support their expansion,” said TILT Chief Executive Officer, Tim Conder. “We are eager to work closely with MariMed through this MSA agreement, providing their trusted and high-quality branded products to medical marijuana patients throughout Pennsylvania. These brands lead in other markets, and we expect similar success here. Our team has done a tremendous job building a foundation of quality and trust with patients under the Standard Farms banner, and we expect this foundation to be the right launching pad for MariMed. We view this partnership as another positive step forward in the strategic review process we have been conducting over the past few quarters.”

ABOUT MARIMED
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

ABOUT TILT
TILT is dedicated to helping cannabis businesses build their brands. Through a diverse portfolio of companies providing technology, hardware, cultivation and production, TILT services brands and cannabis retailers across North America, South America, Israel and the European Union. TILT’s core business is Jupiter Research LLC, a wholly-owned subsidiary and leader in the vaporization segment focused on hardware design, research, development and manufacturing. Jupiter recently received EU medical device certification for Europe’s first handheld liquid inhalation device. Additionally, TILT operates Commonwealth Alternative Care, Inc., Inc. in Massachusetts, and Standard Farms Ohio, LLC in Ohio and is the permit holder of record for Standard Farms LLC in Pennsylvania. TILT is headquartered in Scottsdale, Arizona. For more information, visit www.tiltholdings.com.

IMPORTANT CAUTION REGARDING FORWARD-LOOKING STATEMENTS:

The information in this release contains “forward-looking” statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which are subject to several risks and uncertainties. All statements other than statements of historical facts contained in this release, including without limitation statements regarding projected financial results for 2025, including anticipated openings of dispensaries and facilities, timing of regulatory approvals, plans and objectives of management for future operations, are forward-looking statements. Without limiting the foregoing, the words “anticipates”, “believes”, “estimates”, “expects”, “expectations”, “intends”, “may”, “plans”, and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on our current beliefs and assumptions regarding our business, timing of regulatory approvals, the ability to obtain new licenses, permits, business prospects and strategic growth plan, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated in these forward-looking statements due to various risks, uncertainties, and other important factors, including, among others, reductions in customer spending, our ability to recruit and retain key personnel, and disruptions from the integration efforts of acquired companies.

These factors are not intended to be an all-encompassing list of risks and uncertainties that may affect our business and results of operations. These statements are not a guarantee of future performance and involve risk and uncertainties that are difficult to predict, including, among other factors, changes in demand for the Company’s services and products, changes in the law and its enforcement, and changes in the economic environment. Additional information regarding these and other factors can be found in our reports filed with the U.S. Securities and Exchange Commission. In providing these forward-looking statements, the Company expressly disclaims any obligation to update these statements publicly or otherwise, whether as a result of new information, future events or otherwise, except as required by law.

All trademarks and service marks are the property of their respective owners.

TILT Company Contact:
Lynn Ricci, VP of Investor Relations & Corporate Communications
TILT Holdings Inc.
lricci@tiltholdings.com

MariMed Company Contact:
Howard Schacter, Chief Communications Officer
Email: hschacter@marimedinc.com
Phone: (781) 277-0007

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Source: MariMed Inc.

Released July 31, 2025

Eledon Pharmaceuticals (ELDN) – Abstract From A Single Patient Is Not A Safety Concern

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, July 31, 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 Look Forward To Data At The World Transplant Congress. Eledon is scheduled to present interim data from its Phase 1b study at the World Transplant Congress (WTC), to be held August 2 to 6. We have also seen an abstract discussing a single patient in the Phase 2 BESTOW trial that had an unrelated fungal infection. While we do not consider the abstract to be significant, it may have raised safety concerns for investors.

WTC Abstract From One Patient May Have Been Misinterpreted. The abstract discusses “a unique case of pulmonary mucomycosis” in a patient enrolled in the Phase 2 BESTOW trial. Four weeks after receiving a kidney transplant and the tegoprubart regimen, he developed fever due to a rare fungal infection that was treated and resolved. “The patient remained on tegoprubart infusions and showed evidence of clinical improvement, without evidence of rejection or infection at follow-up visits”, stated the abstract.


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Release – Eledon Pharmaceuticals to Host a Conference Call to Discuss Updated Data from the Ongoing Phase 1b Trial of Tegoprubart in Kidney Transplantation Being Presented at the World Transplant Congress 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on ELDN

July 30, 2025

PDF Version

IRVINE, Calif., July 30, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that the company will host a conference call and webcast on Wednesday, August 6, 2025 at 4:30 p.m. ET to discuss updated clinical data from its ongoing open-label Phase 1b study evaluating tegoprubart for the prevention of rejection in subjects undergoing kidney transplantation. These data, from approximately 30 kidney transplant recipients, are being presented at the World Transplant Congress (WTC) in San Francisco, CA on August 6, 2025.

To join the conference call, please dial 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. The conference ID is 34575. Registration for the live webcast can be found here and available on the “Events” section of Eledon’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.

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

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

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Source: Eledon Pharmaceuticals, Inc.

Release – MustGrow Announces Non-Brokered LIFE Offering of up to $3 Million, Proposed Repricing of Warrants, and Shares for Debt Settlement Offer to Debentureholders

Posted on by aweinsoff@channelchek.com

Research News and Market Data MGROF

Jul 30, 2025 | News Releases

SASKATOON, Saskatchewan, Canada, July 30, 2025 – MustGrow Biologics Corp. (TSXV: MGRO; OTC: MGROF; FRA: 0C0) (the “Company” or “MustGrow“), is pleased to announce the following: (i) a non-brokered private placement of up to 4,285,715 units of the Company (each, a “Unit“) at a price of $0.70 per Unit for gross proceeds of up to $3,000,000 (the “LIFE Offering“); (ii) the proposed repricing of outstanding share purchase warrants issued pursuant to its January 16, 2025 private placement (the “Warrant Repricing“); and (iii) its intention to offer shares for debt settlement to all holders of unsecured convertible debentures issued pursuant to its January 16, 2025 private placement (the “Shares for Debenture Debt Settlement“).

LIFE Offering

Each Unit will consist of (i) one common share of the Company (a “Share“); and (ii) one common share purchase warrant (a “Warrant“). Each whole Warrant will be exercisable for a period of 60 months from the Closing Date (defined below) and will entitle the holder thereof to purchase one additional Share (a “Warrant Share“) at an exercise price of $0.90 per Warrant Share.

The Company intends to use the net proceeds raised from the LIFE Offering for inventory production for its mustard-derived organic biofertility product TerraSanteTM, inventory for agricultural products to sell via its Canadian distribution platform NexusBioAg, and working capital and general corporate purposes.

Subject to the rules and policies of the TSX Venture Exchange (the “TSXV“), the securities issuable from the sale of Units to Canadian resident subscribers will not be subject to a hold period under applicable Canadian securities laws. Insiders and certain consultants that participate in the LIFE Offering would be subject to a four-month hold period pursuant to applicable policies of the TSXV.

There is an offering document related to the LIFE Offering that can be accessed under the Company’s profile at www.sedarplus.ca and on the Company’s website at www.MustGrow.ca. Prospective investors should read this offering document before making an investment decision.

It is expected that closing of the LIFE Offering will take place on or about August 21, 2025 or such other date(s) as may be determined by the Company (the “Closing Date“). Closing of the LIFE Offering is subject to certain conditions including, but not limited to, receipt of all necessary approvals, including the approval of the TSXV.

The Units sold pursuant to the LIFE Offering will be offered in Canada pursuant to the listed issuer financing exemption from the prospectus requirement available under Part 5A of National Instrument 45-106 – Prospectus Exemptions as modified by Coordinated Blanket Order 45-935 Exemptions from Certain Conditions of the Listed Issuer Financing Exemption (the “LIFE Exemption“), in the United States pursuant to available exemptions from the registration requirements of the United States Securities Act of 1933 (the “1933 Act”), as amended, and in certain other jurisdictions outside of Canada and the United States provided that no prospectus filing or comparable obligation arises in such other jurisdiction.

As consideration for services, certain eligible finders may receive (i) an aggregate cash fee equal up to 6.0% of the gross proceeds of the LIFE Offering from investors introduced to the Company by the finder; and (ii) non-transferable common share purchase warrants (the “Finder’s Warrants“) representing up to 6.0% of the aggregate number of Shares forming part of the Units issued to investors introduced to the Company by the finder. Each Finder’s Warrant will entitle its holder to purchase one Share (a “Finder Warrant Share“) at a price of $0.90 per Share for a 60-month period. The Finder Warrants and any Finder Warrant Shares issuable upon exercise thereof will be subject to a statutory hold period expiring four months and one day following the date of issue in accordance with applicable Canada securities laws.

Warrant Repricing

The Company intends to reprice an aggregate of 1,721,610 outstanding common share purchase warrants (the “Warrants“) issued pursuant to its January 16, 2025 private placement. The Warrants have an exercise price of $1.90 and an expiry date of January 16, 2030.

Provided the Company receives Warrant Amendment Approval (defined below), the Warrants will be deemed to be amended to adjust their exercise price to $0.90 per Share (the “Amended Warrants“). The Amended Warrants will also be amended to include an acceleration provision whereby, if for any ten (10) consecutive trading days (the “Premium Trading Days“) following the completion of the Warrant Repricing the closing price of the Company’s Shares exceeds $1.08, the Amended Warrants’ expiry date will be accelerated such that holders will have thirty (30) calendar days to exercise the Amended Warrants (if they have not first expired in the normal course) (the “Acceleration Clause“). The activation of the Acceleration Clause will be announced by press release and the 30-day period will commence seven (7) days after the last Premium Trading Day.

The Warrant Repricing is subject to the prior consent of all Warrantholders and the approval of the TSXV (“Warrant Amendment Approval“). The Company intends to issue an updating news release upon receipt, if any, of Warrant Amendment Approval.

Shares for Debenture Debt Settlement

The Company intends to offer a shares for debt settlement to all holders of unsecured convertible debentures issued pursuant to its January 16, 2025 private placement (the “Debentures“), to settle the outstanding principal amount owing under the Debentures, in the aggregate amount of up to $2,585,000 in consideration for: (i) the issuance of up to an aggregate of up to approximately 3,692,860 Shares (the “Settlement Shares“) at a deemed price of $0.70 per Settlement Share, and (ii) a cash payment of all accrued and unpaid interest up to the date of issuance of the Settlement Shares.

The Settlement Shares will be subject to a statutory hold period expiring four months and one day from the date of issuance, in accordance with applicable securities laws and TSXV policies.

Closing of the Shares for Debenture Debt Settlement is subject to the execution of definitive settlement documentation with any accepting holders of Debentures and the approval of the TSXV. The Company intends to issue an updating news release upon closing of the Shares for Debenture Debt Settlement.

MI 61-101 Compliance

It is anticipated that: (i) insiders of the Company may participate in the LIFE Offering, and any Units issued to insiders will be subject to a four month hold period pursuant to applicable policies of the TSXV; (ii) insiders of the Company may participate in the Warrant Repricing (subject to the rules and policies of the TSXV); and (iii) insiders of the Company may participate in the Shares for Debenture Debt Settlement, and any Settlement Shares issued to insiders will be subject to a four month hold period pursuant to applicable policies of the TSXV.

The issuance of Units to any insiders, the participation of any insiders in the Warrant Repricing, and the issuance of Settlement Shares to any insiders will be considered a “related party transaction” within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61- 101“). In respect of any such insider participation, the Company expects to rely on exemptions from the formal valuation requirements of MI 61-101 pursuant to section 5.5(a) and the minority shareholder approval requirements of MI 61-101 pursuant to section 5.7(1)(a), as the fair market value of the transaction, insofar as it involves interested parties, does not exceed 25% of the Company’s market capitalization.

Not an Offer to Sell or Solicitation in the US

This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful. The securities have not been and will not be registered under the 1933 Act, or any state securities laws and may not be offered or sold within the United States or to, or for account or benefit of, U.S. Persons (as defined in Regulation S under the 1933 Act) unless registered under the 1933 Act and applicable state securities laws, or an exemption from such registration requirements is available.

About MustGrow

MustGrow Biologics Corp. is a fully-integrated provider of innovative biological and regenerative agriculture solutions designed to support sustainable farming. The Company’s proprietary and third-party product lines offer eco-friendly alternatives to restricted or banned synthetic chemicals and fertilizers. In North America, MustGrow offers a portfolio of third-party crop nutrition solutions, including micronutrients, nitrogen stabilizers, biostimulants, adjuvants and foliar products. These products are synergistically distributed alongside MustGrow’s wholly-owned proprietary products and technologies that are derived from mustard and developed into organic biocontrol and biofertility products to help replace banned or restricted synthetic chemicals and fertilizers. Outside of North America, MustGrow is focused on collaborating with agriculture companies, such as Bayer AG in Europe, the Middle East and Africa, to commercialize MustGrow’s wholly-owned proprietary products and technologies. The Company is dedicated to driving shareholder value through the commercialization and expansion of its intellectual property portfolio of approximately 112 patents that are currently issued and pending, and the sales and distribution of its proprietary and third-party product lines through NexusBioAg. MustGrow is a publicly traded company (TSXV-MGRO) and has approximately 52.4 million common shares issued and outstanding and 59.4 million shares fully diluted. For further details, please visit www.mustgrow.ca.

Contact Information

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

MustGrow Forward-Looking Statements

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

Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Forward-looking statements in this press release, including statements about: certain proposed financing transactions and the intended use of proceeds, and are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include: risks relating to the Company’s ability to complete the proposed financing transactions on the terms and timeline contemplated herein, or at all, including the receipt of final approvals from the TSXV and satisfaction of other closing conditions, and those risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2024 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available on SEDAR+ at www.sedarplus.ca. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.

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

© 2025 MustGrow Biologics Corp. All rights reserved.

Release – GeoVax Urges Immediate Action on Pandemic Preparedness as Biodefense Gaps Expose Fragile Supply Chains

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

With Mpox spreading globally, COVID-19 variants evading immunity, and bipartisan leaders demanding U.S.-based solutions, GeoVax calls for urgent investment in domestic manufacturing and vaccine diversification

Atlanta, GA – July 30, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies, today renewed its call for decisive U.S. action on pandemic preparedness and biodefense. With escalating outbreak risks, public health system strain, and growing bipartisan consensus for domestic solutions, GeoVax underscored the urgent need to modernize the nation’s countermeasure infrastructure and end foreign vaccine dependency.

“The warning signs are multiplying,” said David Dodd, Chairman and CEO of GeoVax. “We are facing the global expansion of virulent Mpox strains, immune-evasive COVID variants, and a national stockpile reliant on outdated, offshore platforms. Pandemic readiness must be built at home – with modern, American-made solutions and proactive government-industry leadership.”

GeoVax’s Domestic Platform for Emerging and Endemic Threats

GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine platform anchors two front-line candidates:

  • GEO-MVA for Mpox/smallpox, designed to protect against both Clade I and II Mpox strains.
  • GEO-CM04S1, a multi-antigen, next-generation COVID-19 vaccine targeting the 40 million U.S. immunocompromised through robust, durable, antibody and T-cell–driven immune protection.

The vaccine candidates are supported by Phase 2 clinical data (GEO-CM04S1) and favorable clinical development guidance from the European Medicines Agency (GEO-MVA) and current development plans include the implementation of an advanced MVA continuous avian cell line manufacturing process for U.S.-based, scalable production.

New Health Threats Demand Immediate Preparedness

  • Mpox: The World Health Organization maintains Mpox as a Public Health Emergency of International Concern. Clade I outbreaks have now spread to numerous continents, including sustained transmission in China and wastewater detection in the U.S. New data from the Democratic Republic of the Congo confirmed vertical transmission during pregnancy, raising fresh concerns for maternal and neonatal health.
  • COVID-19: The NB.1.8.1 (“Nimbus”) variant continues to gain dominance, prompting updated CDC guidance recommending boosters for vulnerable groups, including older adults and the immunocompromised. However, mRNA vaccine uptake remains low in these populations, reinforcing the need for broader, longer-lasting immunity options like GEO-CM04S1.

Alarmingly, the Strategic National Stockpile (SNS) remains overly dependent on a single foreign supplier for Mpox/smallpox MVA vaccine, which is reportedly unable to supply the current estimated global needs.  Most concerning, the U.S. government has had to continuously shift MVA vaccine from the SNS, which is primarily intended for biosecurity purposes, resulting in a vicious cycle of SNS replenishment, followed by further reduction of the SNS as Mpox outbreaks continue.

“The cost of delay is steep, and the status quo is unacceptable,” said Dodd. “The United States needs increased MVA vaccine competition – not complacency and dependency on a foreign, monopolistic supplier.”

Bipartisan Momentum and Federal Mandate for Action

Policymakers across the aisle are rallying behind a more secure biodefense posture:

  • At BIO 2025, Administration for Strategic Preparedness and Response (ASPR) Chief of Staff Mark O’Neill emphasized the need for onshoring, platform diversification, and public-private partnerships to strengthen domestic pandemic response capabilities.
  • In Congress, Democrats and Republicans alike are advancing legislation to reduce foreign dependency and prioritize U.S.-based manufacturing and procurement for pandemic countermeasures.

“GeoVax supports and welcomes this emerging consensus,” Dodd added. “We’re aligned with ASPR and BARDA priorities – and we’re ready to deliver. Swift, decisive government action is needed.”

Preparedness Requires Investment – Before the Next Crisis

More than 120 nations have signed the new WHO Pandemic Agreement, and the U.S. is scaling its biodefense footprint through mobile biocontainment units, genomic surveillance, and expanded diagnostics. Yet, without domestically produced, next-generation vaccines and a diversified stockpile, those efforts will fall short.

“We commend HHS, BARDA, ASPR, and congressional leaders for sounding the alarm,” concluded Dodd. “Now is the time to fund, procure, and manufacture domestically – before the next emergency hits.”

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, 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:

info@geovax.com

678-384-7220

Investor Relations Contact:

geovax@precisionaq.com

212-698-8696

Media Contact:

Jessica Starman

media@geovax.com 

Release – GeoVax Accelerates Development of GEO-MVA Vaccine Amid Expanding Global Mpox Crisis and Reaffirmed WHO Emergency Designation

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOVX

    EMA Scientific Guidance, Global Surge in Clade I Mpox, and Aid Shortfalls Drive Urgent Need for Scalable, Equitable Vaccine Solutions

    Atlanta, GA – July 29, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced an expedited development strategy for its GEO-MVA Mpox vaccine candidate, following newly reaffirmed global emergency status by the World Health Organization (WHO), a record-setting surge in Mpox cases across Africa, and recent favorable scientific advice from the European Medicines Agency (EMA) supporting an expedited development path for GEO-MVA.

    These developments reinforce the urgent global need for diversified, scalable vaccine platforms amid critical shortages and growing international spread of more virulent Mpox strains.

    Global Mpox Cases Surge Beyond 2024 Totals; Africa’s Health Systems Overwhelmed

    More than 21,000 confirmed Mpox cases have been reported in 13 African countries so far in 2025 – exceeding the total case count for all of 2024 – with numbers expected to double by year-end. Sierra Leone, Malawi, and the Democratic Republic of the Congo (DRC) are among the most heavily impacted, with healthcare systems under severe strain due to significant U.S. and European aid reductions.

    Only 700,000 Mpox vaccine doses have been administered across 11 countries, and key nations like Sierra Leone are still awaiting most of their requested supply. In the DRC alone, over 60,000 suspected cases and nearly 1,800 deaths have been reported. The crisis is being further complicated by armed conflict, collapsing infrastructure, and the emergence of Clade I and Clade 1a Mpox variants, which exhibit greater severity and transmissibility.

    Global Spillover and WHO Emergency Status Highlight Urgency

    The WHO’s International Health Regulations (IHR) Emergency Committee reconvened on July 5, 2025, and officially reaffirmed Mpox as a Public Health Emergency of International Concern (PHEIC). The WHO’s Situation Report #55, released July 11, underscores the worsening multi-country outbreak and mounting strain on surveillance, laboratory, and response systems.

    International spread is accelerating. Clade I Mpox cases have now been confirmed in China, the United Kingdom, Italy, and the United States. U.S. health officials have identified five travel-related Clade I cases since late 2024, including a confirmed case in Massachusetts in June 2025, while wastewater testing confirms silent community transmission.

    The CDC continues to emphasize surveillance efforts – including wastewater and diagnostic testing – but warns that current tools are insufficient to contain a broader outbreak without expanded vaccine access and supply.

    EMA Guidance Supports Expedited GEO-MVA Pathway

    GeoVax has received favorable scientific advice from the European Medicines Agency (EMA) regarding the development of GEO-MVA. The EMA guidance supports a streamlined regulatory pathway, enabling GeoVax to pursue expedited development and potential conditional approval of GEO-MVA as an additional Mpox vaccine candidate in the EU. This guidance strengthens the GEO-MVA development program’s relevance to global procurement programs, including those of WHO and UNICEF.

    GeoVax Response: Acceleration, Scalability, and Equitable Access

    In light of these developments, GeoVax is implementing a comprehensive, expedited development strategy:

    • Clinical Development Acceleration: Finalizing fill-finish manufacturing and initiating human trials to evaluate safety and immunogenicity against both Clade I and Clade II variants. Regulatory planning includes immuno-bridging studies for global deployment.
    • Advanced MVA Manufacturing Platform: Development is underway for GEO-MVA’s production using a continuous avian cell line system, enabling rapid, large-scale, and cost-effective production – addressing a key shortfall of the incumbent egg-based method.
    • International Collaboration: Engaging health authorities, NGOs, and regional partners across Africa to ensure vaccine readiness and coordinated deployment to underserved and high-risk populations.
    • Policy Engagement: Advocating for vaccine platform diversification and calling on governments and international donors to break the global reliance on a single supplier for Mpox vaccines.

    David Dodd, Chairman & CEO of GeoVax, commented: “With Mpox cases rapidly rising across Africa and the WHO reaffirming global emergency status, the world must act urgently. The emergence of Clade I across multiple continents and the persistent lack of vaccine access underscore the need for scalable and diversified solutions. GEO-MVA is designed to meet this moment – leveraging our regulatory momentum from the EMA, efforts to accelerate implementation of our continuous manufacturing platform and an unwavering commitment to equitable access. We stand ready to be part of the solution, both scientifically and humanely.”

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, 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:

    info@geovax.com

    678-384-7220

    Investor Relations Contact:

    geovax@precisionaq.com

    212-698-8696

    Media Contact:

    Jessica Starman

    media@geovax.com 

    GeoVax Labs (GOVX) – 2Q25 Reported With MVA and Gedeptin Trial Updates

    Posted on by slightbourne@noblecapitalmarkets.com


    Tuesday, July 29, 2025

    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.

    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.

    GeoVax Reports 2Q25 Financials With Updates Trials For MVA and Gedeptin. GeoVax reported a 2Q25 loss of $5.4 million or $(0.35) per share. Revenues of $0.9 million were for work performed under the BARDA contract prior to its cancellation in April 2025. During the quarter, the EMEA communicated that the GEO-MVA vaccine in development for smallpox/Mpox could skip Phase 1 and 2, then receive approval based on Phase 3 immune markers. The company also amended its trial plans for Gedeptin in HNSCC.

    GEO-MVA Phase 3 Is Expected To Begin In 2H26. As discussed in our Research Note on June 17,GeoVax received Scientific Advice (SA) from the EMA for GEO-MVA smallpox/Mpox vaccine stating the Phase 1 and 2 studies would not been needed. An MAA will only require a single Phase 3 immuno-bridging trial comparing the immune response in healthy volunteers receiving GEO-MVA against the approved vaccine. The study is expected to begin in 2H26.


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    Release – DLH to Announce Fiscal 2025 Third Quarter Financial Results

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on DLH

    July 28, 2025

    PDF Version

    ATLANTA, July 28, 2025 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading provider of science research and development, systems engineering and integration, and digital transformation and cyber security solutions to federal agencies, will release financial results for the fiscal third quarter ended June 30, 2025 on August 6, 2025 after the market closes. DLH will then host a conference call for the investment community at 10:00 a.m. Eastern Time the following day, August 7, 2025, during which members of senior management will make a brief presentation focused on the financial results and operating trends. A question-and-answer session will follow.  

    Interested parties may listen to the conference call by dialing 888-347-5290 or 412-317-5256. Presentation materials will also be posted on the Investor Relations section of the DLH website prior to the commencement of the conference call. A digital recording of the conference call will be available for replay two hours after the completion of the call and can be accessed on the DLH Investor Relations website or by dialing 877-344-7529 and entering the conference ID 1191990.

    About DLH
    DLH (NASDAQ: DLHC) enhances technology, public health, and cyber security readiness missions through science, technology, cyber, and engineering solutions and services. Our experts solve some of the most complex and critical missions faced by customers today, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 2,400 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of technology, innovation, and world-class expertise, to improve lives across the globe. For more information, visit www.DLHcorp.com.

    INVESTOR RELATIONS
    Contact: Chris Witty
    Phone: 646-438-9385
    Email: cwitty@darrowir.com

    Release – GeoVax Announces Research Program to Evaluate Needle-Free, Self-Administered GEO-MVA Vaccine Using Vaxxas Microarray Patch Technology

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on GOVX

    Study Aims to Validate Thermostable, Self-Administered MVA-Vaccine Platform for Pandemic Preparedness and Global Immunization

    Atlanta, GA – July 28, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced the initiation of a research program to evaluate the immunogenicity and stability of GEO-MVA delivered via Vaxxas’ proprietary high-density microarray patch (HD-MAP) platform in preclinical models.

    The proof-of-concept study, conducted at the University of Queensland (UQ) under a research agreement between GeoVax and UniQuest Pty Limited (UQ’s commercialization company), will assess the immune responses, delivery efficiency, and thermostability of GEO-MVA formulated and dried onto HD-MAPs for administration in mice. HD-MAPs offer a needle-free, skin-targeted delivery approach with the potential to enhance immunogenicity and enable distribution without refrigeration.

    “This program represents a potential major step forward in our strategy to expand the versatility of GeoVax’s MVA platform and meet global needs for more accessible, ruggedized, and effective vaccines,” said David Dodd, Chairman and CEO of GeoVax. “Demonstrating that GEO-MVA can be delivered via HD-MAP could lead to more potent immune responses at lower doses, greater thermostability, and eliminate the need for needles – a very compelling profile for both routine immunization and rapid deployment during outbreaks.”

    If successful, the study results will support the development of a thermostable, needle-free GEO-MVA vaccine for pandemic response, biodefense stockpiling, and immunization programs in low- and middle-income countries.

    The HD-MAP platform offers several potential advantages over traditional needle-and-syringe delivery, including:

    • Self-administration in the home, pharmacy, or vaccination hubs;
    • Increased patient acceptance, especially among needle-phobic individuals;
    • Higher immunogenicity, enabling dose-sparing;
    • Thermostability, reducing cold chain reliance;
    • Elimination of sharps waste and needle-stick injuries;
    • Faster deployment in emergency settings with minimal training requirements.

    The Vaxxas HD-MAP platform has demonstrated enhanced immunogenicity in multiple animal model and clinical studies and is being advanced in partnerships with leading pharmaceutical, government entities and foundations. GeoVax recently received favorable scientific advice from the European Medicines Agency (EMA) regarding the development of GEO-MVA. The EMA guidance supports a streamlined regulatory pathway, enabling GeoVax to pursue potential expedited development and approval pathways for GEO-MVA as an additional Mpox vaccine candidate in the EU.

    The current study is supported by GeoVax and conducted by researchers led by A/Prof David Muller and Dr. Chris McMillan at the University of Queensland.

    About GeoVax

    GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine 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®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, 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:

    info@geovax.com

    678-384-7220

    Investor Relations Contact:

    geovax@precisionaq.com

    212-698-8696

    Media Contact:

    Jessica Starman

    media@geovax.com 

    Release – MAIA Biotechnology Receives FDA’s Fast Track Designation for Ateganosine as a Treatment for Non-Small Cell Lung Cancer

    Posted on by aweinsoff@channelchek.com

    Research News and Market Data on MAIA

    July 28, 2025 8:01am EDTDownload as PDF

    Potential first-to-market small molecule telomere targeting agent targets a $34 billion NSCLC treatment market

    Latest data in pivotal Phase 2 THIO-101 clinical trial shows median overall survival of 17.8 months

    CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) for the treatment of non-small cell lung cancer (NSCLC). Ateganosine is currently being evaluated in a pivotal Phase 2 THIO-101 clinical trial evaluating its anti-tumor activity when followed by a checkpoint inhibitor.

    Ateganosine is a first-in-class small molecule that compromises telomere structure and function in cancer cells, leading to rapid tumor cell elimination and specific immune memory. Through telomerase-mediated action, ateganosine reverses intrinsic or acquired resistance to immune checkpoint inhibitors (ICIs).

    “FDA’s Fast Track Designation recognizes ateganosine’s potential as a new therapeutic paradigm in cancer treatment science. Ateganosine is the first and only anticancer treatment of its kind that we are aware of in clinical development,” stated MAIA Chairman and CEO Vlad Vitoc, M.D. “If we are successful in the Fast Track regulatory pathway, ateganosine could qualify for accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year. If approved, ateganosine would have a first-to-market competitive position within a $34 billion NSCLC treatment market with significant unmet medical need.”

    NSCLC represents one of the largest global oncology indications. The market was valued at $34.1B in 2024 and is projected to reach $68.8B by 2033 with a projected CAGR of 8.1%.1

    “This is an important milestone for MAIA’s clinical development program. Ateganosine has demonstrated robust preclinical efficacy and superior clinical median overall survival compared to other FDA-approved treatments for NSCLC patients with prior disease progression on platinum-based chemotherapy and anti-PD-(L)1 antibody. Additionally, advanced NSCLC is a devastating disease that clearly meets the criteria for a serious condition with unmet medical need. Both are key criteria for the Fast Track designation,” said K. Robinson Lewis, Vice President, Head of Regulatory and Quality at MAIA. “We intend to utilize the incentives of the Fast Track Program to expedite the development and review of ateganosine and bring patient access sooner.”

    The FDA Fast Track is a process designed to facilitate development and expedite the review of drugs for treating serious conditions and filling an unmet medical need, as in providing a therapy where none exists or which may be potentially better than available therapy. If relevant criteria are met during the Fast Track process, a drug will be eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).

    MAIA’s most recent data from the pivotal Phase 2 THIO-101 clinical trial of ateganosine as of May 15, 2025 showed median overall survival (OS) of 17.8 months in a heavily pre-treated population. As of the data cut-off date, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown overall survival of 5 to 6 months.

    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 of 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 THIO-101 Phase 2 Clinical Trial

    THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

    About MAIA Biotechnology, Inc.

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

    Forward Looking Statements

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

    _____________________________
    1 Custom Market Insights, Global NSCLC Drug Market Size Likely to Surpass at a CAGR of 8.1% By 2033, Apr. 2024

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

    Source: MAIA Biotechnology, Inc.

    Released July 28, 2025