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Release – GeoVax Connects IDSA Guidance on COVID-19 Vaccination for Immunocompromised Patients with Recent Clinical Data for GEO-CM04S1

Posted on October 29, 2025October 29, 2025 by aweinsoff@channelchek.com

IDSA’s Recommendations Reinforce GeoVax’s Phase 2 Findings: Robust T-Cell Responses, Cross-Variant Durability, and Favorable Safety Profile in Vulnerable Populations

Atlanta, GA — October 29, 2025 — GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today emphasized how its recently presented Phase 2 clinical data for GEO-CM04S1, first reported at the World Vaccine Congress Europe 2025, align with the new Infectious Diseases Society of America (IDSA) guidelines prioritizing vaccination for immunocompromised individuals.

The IDSA guidance, issued October 17, 2025, concluded that existing COVID-19 vaccines provide only moderate and short-lived protection for immunocompromised patients – with effectiveness against hospitalization ranging from 33% to 56% and waning within two months. The panel called for new vaccine strategies tailored to vulnerable populations, including cancer patients, transplant recipients, and individuals receiving immunosuppressive therapies.

“Immunocompromised Americans are not a niche,” said David A. Dodd, Chairman & CEO of GeoVax. “They are cancer patients, transplant recipients, people with autoimmune disease, and those living with HIV – one in eight adults. They include family members, colleagues and neighbors. Yet mainstream vaccine approaches, heavily centered on mRNA, continue to leave them without durable protection. The new IDSA guidelines reinforce the urgent need for alternatives like GeoVax’s GEO-CM04S1.”

World Vaccine Congress – Data Provide Clinical Reinforcement

At the World Vaccine Congress Europe 2025 in Amsterdam, GeoVax scientific leaders presented new interim data from ongoing Phase 2 studies of GEO-CM04S1, the company’s multi-antigen, MVA-based COVID-19 vaccine designed for immunocompromised populations.

Key findings included:

Robust T-cell responses to both Spike and Nucleocapsid antigens, exceeding responses seen with mRNA boosters.
Broad, cross-variant immunity, including activity against Omicron subvariants.
Favorable safety profile, with only mild-to-moderate adverse events such as injection site reactions, fatigue, and myalgia; no vaccine-related serious adverse events reported.
In patients with hematologic malignancies post-transplant or CAR-T therapy, breakthrough infections were mild-to-moderate, underscoring the vaccine’s protective potential in highly vulnerable groups.

“These results, together with IDSA’s updated guidance, reinforce the critical need for vaccine platforms that move beyond antibody-only strategies,” said Dodd. “GEO-CM04S1 is designed to provide balanced immunity – antibodies plus durable T-cell responses – which are essential for the immunocompromised patients who remain most vulnerable despite existing vaccination campaigns. The convergence of these guidelines and our clinical findings underscores GEO-CM04S1’s potential to address one of the most critical gaps in COVID-19 prevention.”

GEO-CM04S1: A Vaccine Designed for the Immunocompromised

GeoVax’s GEO-CM04S1 is a multi-antigen, Modified Vaccinia Ankara (MVA)-based COVID-19 vaccine designed to elicit both antibody (humoral) and T-cell (cellular) immune responses. This dual-pathway activation is particularly important for patients who often fail to mount sufficient antibody responses with current mRNA vaccines, including cancer patients on chemotherapy, transplant recipients, and those receiving immunosuppressive therapies.

Key GEO-CM04S1 features include:

Multi-antigen breadth (Spike + Nucleocapsid proteins) – a design intended to provide broader immunologic coverage and to remain relevant as the virus continues to evolve.
Durable cellular immunity, critical where antibody responses are weak.
Alignment with IDSA priorities for transplant, cancer, autoimmune, and HIV patients.

Ongoing trials include Phase 2 studies as a primary vaccine for immunocompromised individuals, including post-transplant and hematologic cancer patients; and, as a booster for patients with chronic lymphocytic leukemia (CLL).

Interim results across these studies consistently demonstrate that GEO-CM04S1 can generate broader, more durable protection than mRNA vaccines, while maintaining a strong safety profile.

Breaking the Single-Platform Dependence

While mRNA vaccines were pivotal in the early pandemic response, their limitations in durability, breadth, and performance in immunocompromised populations highlight the risks of relying on a single platform. GEO-CM04S1 demonstrates how multi-antigen, T-cell–driven approaches can better protect high-risk populations and strengthen pandemic preparedness.

“Protecting the over 40 million immunocompromised Americans is both a moral imperative and a national security necessity,” added Dodd. “With positive clinical data and alignment with IDSA guidance, GeoVax is delivering a differentiated vaccine platform designed to serve those who need it most.”

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

Media Contact:

Jessica Starman

media@geovax.com

Unicycive Therapeutics (UNCY) – Resubmission For Approval Expected Before Year-End 2025

Posted on October 29, 2025October 29, 2025 by slightbourne@noblecapitalmarkets.com

Wednesday, October 29, 2025

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

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Unicycive Expects To Resubmit Its Application Before YE2025. Unicycive announced plans to resubmit its application for OLC (oxylanthanum carbonate) approval before the end of 2025. This follows a meeting with the FDA to identify and resolve issues that resulted in the Complete Response Letter (CRL) in June 2025. This timeframe is consistent with our expectations for resubmission. We continue to expect OLC to be approved by mid-2026.

Resubmission Announcement Follows An FDA Meeting. In early June 2025, Unicycive announced that a manufacturing inspection found deficiencies at a contract manufacturer’s facility. These inspections were one of the last steps toward approval of the New Drug Application (NDA), but the findings stopped the review process. Following the announcement, the company received a CRL on its PDUFA date of June 30, 2025.

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Release – Unicycive Therapeutics Provides Update from FDA Type A Meeting and Expects to Resubmit OLC NDA Before Year-End

Posted on October 28, 2025October 28, 2025 by aweinsoff@channelchek.com

Research News and Market Data on UNCY

October 28, 2025 7:05am EDT Download as PDF

Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC

LOS ALTOS, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the Company or Unicycive), today announced an update from its meeting with the U.S. Food and Drug Administration (FDA) and timing of the resubmission of its New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) following receipt of a Complete Response Letter (CRL) on June 30, 2025. The Type A FDA meeting was held to discuss the resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor. No other concerns have been identified to the Company, including pre-clinical, clinical, or safety data submitted as part of the NDA. Following receipt of the official meeting minutes from the Type A meeting and engaging in discussions with its third-party manufacturing vendor, the Company plans to resubmit the NDA for OLC by year-end.

“We are grateful for the highly constructive feedback and detailed meeting minutes we received from the FDA and look forward to resubmitting the NDA as we advance OLC toward potential approval,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Following our interactions with the FDA, we are very encouraged about the potential for a swift resolution of the issue raised in our CRL and we believe we are now on track to resubmit our NDA before the end of the year, which could lead to a PDUFA date in the first half of 2026. With over $42 million on our balance sheet as of September 30, we have a cash runway into 2027, enabling us to work through the regulatory approval process and continue to advance preparations for potential OLC commercialization while focusing on our mission to deliver improved treatment options for patients with hyperphosphatemia on dialysis.”

About Oxylanthanum Carbonate (OLC)
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. 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). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.¹ Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. 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.

¹Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145. Epub 2023 Jun 29. PMID: 37229723; PMCID: PMC10371371.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers.

Preliminary Financial Information
The preliminary financial information included in this press release is unaudited and is subject to completion of the Company’s quarter-end closing procedures and further financial review. Actual results may differ from these estimates as a result of the completion of quarter-end closing procedures, review adjustments and other developments that may arise between now and the time such financial information for the period is finalized. As a result, these estimates are preliminary, may change and constitute forward-looking information and, as a result, are subject to risks and uncertainties. These preliminary estimates should not be viewed as a substitute for full financial statements prepared in accordance with United States generally accepted accounting principles, and they should not be viewed as indicative of our results for any future period. The Company’s independent registered public accountants have not audited, reviewed, compiled, or performed any procedures with respect to these estimated financial results and, accordingly, do not express an opinion or any other form of assurance with respect to these preliminary estimates.

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; risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to our ability to file an NDA before the end of 2025, risk that we do not get a PDUFA date in the first half of 2026; the accuracy of our cash on hand at September 30, 2025 and risk that our cash runway does not extend into 2027. 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, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:

Layne Litsinger
Real Chemistry
llitsinger@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

Source: Unicycive Therapeutics, Inc.

Released October 28, 2025

The Beachbody Company (BODI) – Strong Brands To Flex Toward Growth

Posted on October 28, 2025October 28, 2025 by slightbourne@noblecapitalmarkets.com

Tuesday, October 28, 2025

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Initiating with an Outperform rating. After years of revenue declines, we believe that the company is on the cusp of a swing toward revenue growth, offering a breakout opportunity for a stock that has been range-bound. We are initiating coverage with an Outperform rating and a $12 price target.

Well-recognized brands with growth potential. The company has established brands in workout videos, such as Insanity and P90x, and nutritional supplements, including Shakeology, Beachbar, and Beachbody Performance. Such strong brands are expected to support the company’s revenue growth initiatives as it expands distribution of its products into mass merchants.

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Release – MAIA Biotechnology Presents Trial in Progress Poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Posted on October 27, 2025October 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 27, 2025 10:45am EDT Download as PDF

First five patients in Part C (expansion) of THIO-101 Phase 2 clinical trial enrolled in Taiwan and Turkey

CHICAGO, Oct. 27, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its recent attendance at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The Conference, held October 22-26, 2025, in Boston, MA, was hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NIC), and the European Organisation for Research and Treatment of Cancer (EORTC).

MAIA’s Sr. Medical Director, Victor Zaporojan, M.D., presented a Trial in Progress poster titled “A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress.”

Dr. Zaporojan stated, “It was a pleasure to engage with many oncologists and scientists at the AACR-NCI-EORTC Conference and share updates from Part C of our expanded Phase 2 trial. As enrollment continues, we’re seeing a safety profile well aligned with Parts A and B, and momentum is building. Our expert investigators are eager to bring this opportunity to more patients in more countries as new sites come online in the weeks ahead.”

MAIA also announced that it has enrolled five patients from Taiwan and Turkey in the expansion phase of its THIO-101 Phase 2 trial. Screening for the trial is ongoing in Europe and Asia. With multi-continental trial locations, MAIA investigators can draw from a significantly larger patient pool for its third-line studies of ateganosine.

Dr. Saadettin Kiliçkap, Scientific Advisor to MAIA and key investigator for THIO-101 Part C in Turkey, commented, “It’s exciting to see ateganosine develop into what could be a promising treatment option for the large and underserved NSCLC patient population in our region. Lung cancer remains a major public health challenge here—it is the most common cancer and the leading cause of cancer-related death, particularly among men. While public health efforts have helped reduce incidence in men, rates among women continue to rise. Our medical community would welcome a breakthrough therapy that could meaningfully extend and improve the quality of life for patients with late-stage NSCLC.”

Dr. Kiliçkap has served as principal or sub-investigator in more than 100 national and international multi-center phase 2 and phase 3 clinical studies, many of which were related to lung cancer. His research focuses on medical oncology and cancer epidemiology, including solid tumors such as lung cancer, breast cancer, melanoma, and gastrointestinal system cancers, as well as targeted therapies and immunotherapy.

The high prevalence of smoking, compounded by air pollution, is the key driver of NSCLC in Turkey. A 2018 study reported that tobacco smoking accounted for 89.6% of lung cancer cases in Turkey.¹ Subsequent research in 2019 suggested that prolonged exposure to ambient air pollution—particularly PM2.5 particulate matter—may have contributed to around 15% of lung cancer-related deaths, highlighting a significant additional risk when combined with smoking.²

MAIA’s Trial in Progress poster is available at maiabiotech.com/publications.

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.

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

¹ Tobacco Induced Diseases, 14th Annual Conference of the International Society for the Prevention of Tobacco Induced Diseases (TID)
² Department of Public Health, Trakya University, Faculty of Medicine, Türkiye

Source: MAIA Biotechnology, Inc.

Released October 27, 2025

Novartis’ $12 Billion Avidity Acquisition Strengthens Its Rare Disease Pipeline Amid Pharma Tariff Uncertainty

Posted on October 27, 2025October 27, 2025 by slightbourne@noblecapitalmarkets.com

Swiss pharmaceutical giant Novartis AG announced plans to acquire Avidity Biosciences for approximately $12 billion in cash, a move aimed at deepening its focus on rare and neuromuscular diseases while navigating an increasingly complex U.S. trade and regulatory landscape.

Under the terms of the agreement, Avidity shareholders will receive $72 per share, representing a 46% premium to the company’s most recent closing price. The acquisition, expected to close later this year pending regulatory approval, underscores Novartis’ aggressive strategy to expand its biotech capabilities and offset upcoming patent expirations on several of its blockbuster therapies.

The deal also includes the formation of a new spin-off company, Spinco, which will house Avidity’s early-stage precision cardiology programs. Spinco is expected to operate as an independent, publicly traded firm, led by Avidity’s current Chief Program Officer, Kathleen Gallagher.

Headquartered in San Diego, Avidity Biosciences has gained attention for pioneering a new class of RNA-based therapeutics that directly target muscle tissue. Its lead candidate, Del-zota, is being developed to treat a rare subtype of Duchenne muscular dystrophy (DMD), a debilitating genetic disorder that leads to progressive muscle weakness. Avidity is also advancing two other promising treatments for serious neuromuscular diseases, all of which leverage its proprietary antibody oligonucleotide conjugate (AOC) platform.

For Novartis, this acquisition offers a timely expansion into rare disease treatments — a sector experiencing growing investor interest due to high unmet medical needs and favorable regulatory incentives. The move is consistent with Novartis’ 2024 acquisition of Kate Therapeutics, another biotech developing gene therapies for muscle diseases, as well as its 2025 deals with Anthos Therapeutics and Regulus Therapeutics, collectively strengthening its position in genetic and cardiovascular medicine.

The rare disease market has become an increasingly competitive frontier for pharmaceutical innovation. Analysts note that Novartis’ acquisition spree is partly driven by its looming patent cliff, as flagship drugs such as Entresto, Xolair, and Cosentyx approach the end of their exclusivity periods. By acquiring companies like Avidity, Novartis not only diversifies its revenue base but also positions itself at the forefront of next-generation therapeutics that could define the next decade of biotech innovation.

The acquisition also carries strategic geopolitical undertones. With the Trump administration imposing 39% tariffs on Switzerland earlier this year, Swiss-based pharmaceutical companies face heightened uncertainty over U.S. trade policy. Expanding operations through American biotech acquisitions helps Novartis maintain a strong U.S. presence and mitigate risks tied to international tariffs.

For small-cap investors, the transaction reinforces an ongoing trend in the life sciences sector: large-cap pharma companies are increasingly looking to buy innovation rather than build it in-house. Early-stage biotech firms with validated technologies, particularly in RNA, gene therapy, and rare disease research, continue to attract premium valuations in acquisition deals.

Ultimately, Novartis’ acquisition of Avidity Biosciences is more than just a growth strategy — it’s a signal of where the pharmaceutical industry is heading. With advances in RNA therapeutics and genetic medicine accelerating, investors can expect more high-value takeovers in the months ahead as established players race to secure the next generation of life-changing treatments.

Release – Cocrystal Pharma Receives NIH SBIR Award to Advance its Influenza Inhibitor Program

Posted on October 27, 2025October 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on COCP

October 27, 2025

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BOTHELL, Wash., Oct. 27, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc . (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received a Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID). This approximately $500,000 award will support the Company’s development of a novel, oral, broad-spectrum antiviral candidate for the treatment of influenza A and B infections. Cocrystal plans to utilize these funds to characterize lead candidate molecules that inhibit the target of the essential function of the influenza polymerase complex.

“This award provides non-dilutive funding to advance our influenza A/B program targeting potent, broad-spectrum drugs toward the path of clinical development,” said Sam Lee, PhD, Cocrystal President and co-CEO. “We appreciate the funding and confidence from NIH, which further validates our structure-based drug discovery platform technology in developing new antiviral treatments.”

The NIH/NIAID Phase I award is designed to assess the scientific, technical and commercial potential of early-stage programs. Successful completion of Phase I may qualify the recipient eligible to apply for a larger Phase II award, which provides additional substantial funding to continue development.

“We have prioritized the pursuit of government and military funding to advance our antiviral pipeline while building shareholder value,” said James Martin, Cocrystal CFO and co-CEO. “This is an important milestone as we continue our work to secure additional non-dilutive capital.”

The research is supported by the National Institute of Allergy and Infectious Diseases of the NIH under award number 75N93025C00038. The content of this news release is solely the responsibility of Cocrystal and does not necessarily represent the official views of the NIH.

About Influenza

Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Each year, there are approximately 1 billion cases of seasonal influenza worldwide, 3-5 million severe illnesses and up to 650,000 deaths. On average, about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for an estimated $11.2 billion in direct and indirect costs in the U.S. annually.

Cocrystal Pharma’s Structure-Based Drug Discovery Platform Technology

Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancement of Cocrystal’s influenza A/B development program. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, the risks and uncertainties arising from the U.S. government shutdown in October 2025 which may delay or prevent us from receiving funds described in this press release, potential manufacturing and research delays arising from raw materials and labor shortages and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future contract research organizations (CROs) and contract manufacturing organizations (CMOs), the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of the studies we undertake including any adverse findings or delays, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by governmental authorities and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop and our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

Source: Cocrystal Pharma, Inc.

Released October 27, 2025

Release – Tonix Pharmaceuticals Presented Data on Tonmya™ (Cyclobenzaprine HCl Sublingual Tablets) at the 2025 American College of Rheumatology (ACR) Convergence

Posted on October 27, 2025October 27, 2025 by aweinsoff@channelchek.com

Research News and Market Data on TNXP

October 27, 2025 7:00am EDT Download as PDF

Tonmya demonstrated significant reduction in fibromyalgia pain compared with placebo in the Phase 3 RESILIENT study

Treatment was well tolerated with minimal effects on weight or blood pressure and discontinuation rate of 19% vs. placebo of 20.8%

Data support the potential of Tonmya as a well-tolerated, centrally acting, non-opioid analgesic and therapeutic option for adults with fibromyalgia

CHATHAM, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated commercial biotechnology company presented data on Tonmya™, which was investigated as TNX-102 SL, at the 2025 American College of Rheumatology (ACR) Convergence, held October 24–29, 2025, in Chicago, Illinois. A copy of the Company’s presentation, titled “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

“Fibromyalgia is a debilitating condition that impacts more than 10 million adults in the U.S., and existing treatments are limited by tolerability and side effects,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at ACR highlight Tonmya’s ability to provide clinically meaningful pain reduction while remaining well-tolerated, reinforcing its value as a differentiated, centrally-acting non-opioid treatment for fibromyalgia.”

The data presented at ACR come from RESILIENT, a 14-week randomized, double blind, placebo controlled trial at 34 U.S. sites, with 456 intent-to-treat participants who met the 2016 American College of Rheumatology criteria for fibromyalgia. Treatment with Tonmya resulted in a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) versus placebo, along with significant improvements in sleep quality and fatigue as well as the symptoms and function domains of the Fibromyalgia Impact Questionnaire. In an exploratory analysis, among female participants, Tonmya was associated with improvements in sexual function in total score and across multiple subscales of the Changes in Sexual Functioning Questionnaire (CSFQ-14) versus placebo. Tonmya was well tolerated, with minimal impact on weight and blood pressure, no adverse sexual side effects and a low rate of adverse event-related discontinuations (6.1% on Tonmya, 3.5% on placebo). The most common adverse events were mild and self-limited oral cavity reactions that rarely led to study withdrawal.

“The results from RESILIENT further support Tonmya’s role as an innovative treatment option that addresses chronic and widespread pain, one of the most burdensome symptoms of fibromyalgia,” added Gregory M. Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “Tonmya’s favorable tolerability profile and unique formulation designed for bedtime sublingual administration offer patients and clinicians an important advancement in care.”

Tonmya was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults.

Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

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

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

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: Tonix Pharmaceuticals Holding Corp.

Released October 27, 2025

Release – MAIA Biotechnology Details 30-Month Patient Survival in Ongoing Phase 2 Clinical Trial in Non-Small Cell Lung Cancer

Posted on October 23, 2025October 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

October 23, 2025 8:36am EDT Download as PDF

Outstanding measure of efficacy relative to high-risk cancers with limited treatment options

CHICAGO, Oct. 23, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from a recent presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany. Starting October 19, 2025, MAIA showcased two e-posters at ESMO detailing its ongoing Phase 2 and Phase 3 clinical trials of ateganosine in non-small cell lung cancer (NSCLC).

“The posters showcased at ESMO 2025 featured exceptional extended survival in third-line NSCLC patients. In addition, as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding measure relative to many of the high-risk cancers,” said MAIA CEO Vlad Vitoc, M.D. “Very few options exist for patients who are refractory or resistant to immune checkpoint inhibitors (ICI). We believe that a survival of over two years is a clear signal of ateganosine’s role in effectively targeting and eliminating NSCLC tumor cells.”

The THIO-101 patient with 30-month survival received therapy every three weeks, and concluded treatment upon reaching the maximum treatment duration of 2 years based on protocol requirements.

MAIA’s newest posters featured at ESMO 205 are now available on MAIA’s website at maiabiotech.com/publications.

Presentation 1: A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress
Presentation 2: A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress

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.

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

Source: MAIA Biotechnology, Inc.

Released October 23, 2025

Release – Ocugen to Host Webcast on Wednesday, November 5 at 8:30 A.M. ET to Discuss Business Updates and Third Quarter 2025 Financial Results

Posted on October 23, 2025October 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

October 23, 2025

PDF Version

MALVERN, Pa., Oct. 23, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s third quarter 2025 financial results and provide a business update at 8:30 a.m. ET on Wednesday, November 5, 2025.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 3029428
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, 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. 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 – MariMed To Expand Brand Distribution To New York

Posted on October 23, 2025October 23, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MRMD

October 23, 2025 7:30am EDT Download as PDF

NORWOOD, Mass., Oct. 23, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed,” “the Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, today announced a licensing agreement with Farm 2 Hand, LLC (“Farm 2 Hand”), a New York State cannabis license holder, that will introduce the Company’s top-selling portfolio of products throughout New York State. Terms of the agreement were not disclosed.

Farm 2 Hand intends to manufacture and distribute a variety of MariMed’s edibles products as permitted under New York regulations. Those are initially expected to include Betty’s Eddies™ fruit chews; Bubby’s Baked™ baked goods; and InHouse™ gummies. The products will be produced in a new kitchen that MariMed will design and equip for Farm 2 Hand at Farm 2 Hand’s Bronx production facility.

“Expanding the availability of our brands to the Empire State and its $6 billion total addressable market marks a significant step forward in our plan to own top-selling cannabis brands across the U.S.,” said MariMed CEO Jon Levine. “The addition of New York to our distribution footprint will help drive wholesale revenue and being in the nation’s top media and influencer market will also help increase national awareness for our brands.”

The Company expects its products will be available to New York’s 500+ dispensaries in 2026, following the build-out of the kitchen and regulatory approval.

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.

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.

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

Source: MariMed Inc.

Released October 23, 2025

The Oncology Institute, Inc. (TOI) – Highlights From Noble’s Virtual Conference

Posted on October 23, 2025October 23, 2025 by slightbourne@noblecapitalmarkets.com

Thursday, October 23, 2025

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

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.

TOI Is Addressing The Unsustainable Cost Trend In Oncology. The Oncology Institute manages medical clinics that have improved outcomes and patient satisfaction while reducing the cost of cancer treatment. Dr. Daniel Virnich, CEO, and Rob Carter, CFO, highlighted the benefits of the company’s hybrid model of employed physicians and contracted independent community oncologists. The video of the company’s presentation may be viewed here.

Differentiated Competitive Advantage. TOI distinguishes itself from competitors in the value-based oncology field through its ownership of clinical assets (employed physicians and clinics). This provides greater control over care delivery compared to pure utilization management firms (such as Evolent’s New Century Health) or care navigation models (such as Thyme Care). This control enables higher compliance with value-based prescribing pathways, better integration of ancillary services, and more predictable and significant cost savings for payers.

Get the Full Report

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

Nutriband (NTRB) – Highlights From Noble’s Virtual Conference

Posted on October 23, 2025October 23, 2025 by slightbourne@noblecapitalmarkets.com

Thursday, October 23, 2025

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

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Nutriband Is Developing Transdermal Abuse-Deterrent Technologies. Nutriband has developed abuse-deterrent technology for dermal patch drug delivery. Serguei Melnik, Interim CEO, and Irina Gram, Director, highlighted the company’s platform, known as AVERSA, and its focus on patches containing FDA-approved drugs. The presentation may be viewed here.

Lead Product & Market Opportunity. The lead product, AVERSA Fentanyl, is an abuse-deterrent fentanyl patch. Upon approval, the FDA could mandate such technology for all fentanyl patches, the same way it required opioid pills to have abuse-deterrents. Market analysis by Advanced Health projects annual sales of $200 million for the branded AVERSA Fentanyl. If the abuse-resistant patch were mandated and replaced generic patches, sales could reach $800 million. A patch with improved safety and abuse-deterrence could reverse the decline in fentanyl prescriptions caused by reluctance to prescribe a drug with known abuse potential.

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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).