Month: September 2026

Health Canada-authorized trial to evaluate efficacy and safety of two sessions of MDMA-assisted therapy in up to 100 veterans and frontline workers

VANCOUVER, British Columbia, Sept. 16, 2026 (GLOBE NEWSWIRE) — Optimi Health Corp. (NASDAQ: OPTH) (CSE: OPTI) (FSE: 8BN) (“Optimi” or the “Company“), a commercial-stage pharmaceutical manufacturer of regulated psychedelic drug products, announces plans to initiate a Health Canada-authorized Phase 3 clinical trial evaluating MDMA (3,4-methylenedioxymethamphetamine)-assisted therapy for individuals with post-traumatic stress disorder (“PTSD“). The trial is expected to begin in 2027.

The Phase 3 clinical trial is intended to enroll up to 100 participants across multiple sites in Canada, with enrollment focused on veterans and current or former frontline workers, including military, police, paramedics, firefighters and healthcare workers. Participants will receive the Company’s synthetic MDMA HCl, supplied in two dosage formats, during two supervised sessions combining MDMA and psychotherapy, spaced several weeks apart, with follow-up evaluations after the final session. The primary efficacy endpoint will be change in the Clinician-Administered PTSD Scale (CAPS-5), the standard clinician-rated instrument for assessing PTSD severity.

“On the heels of announcing our Phase 2 trial of natural psilocybin for the treatment of major depressive disorder, we are preparing to advance our synthetic MDMA into an approved Phase 3 trial in PTSD, with the goal of submitting both products for registration,” said Dane Stevens, Optimi’s Chief Executive Officer and Co-Founder. “PTSD and major depressive disorder are large, underserved markets. Millions of patients around the globe continue to struggle despite existing treatments, and veterans and frontline workers carry a disproportionate share of that burden. Psychedelic-assisted therapies have shown promise in helping patients find relief.”

Post-traumatic stress disorder is a mental health condition that can develop after experiencing or witnessing a terrifying, life-threatening, or deeply traumatic event. People with PTSD typically experience severe, persistent distress that significantly disrupts daily functioning. Worldwide, an estimated 70% of people will experience a traumatic event during their lifetime, with an estimated 3.9% of the global population developing the disorder. Many people with PTSD see limited benefit from first-line treatments such as trauma-focused psychotherapy and antidepressants, leaving a pressing need for new therapeutics.

The safety and efficacy of MDMA-assisted therapy to treat PTSD are still under investigation, and none of Optimi’s MDMA drug products have received market authorization from Health Canada. Clinics in Australia have been prescribing MDMA manufactured by Optimi since October 2024.

About Optimi Health Corp.

Optimi Health Corp. is a commercial-stage pharmaceutical company focused on manufacturing and distributing GMP-grade psychedelic drug products for mental health therapies. As a Health Canada-licensed pharmaceutical manufacturer, Optimi produces validated MDMA and botanical psilocybin drug products at its GMP-compliant facilities in British Columbia, Canada. Optimi supplies both active pharmaceutical ingredients and finished dosage forms to regulated clinical and therapeutic programs internationally, with products currently prescribed to patients in Australia under the country’s Authorized Prescriber Scheme and accessible in Canada through the Special Access Program.

For more information, please visit optimi.net.

For more information, please contact:
Dane Stevens, CEO
Optimi Health Corp.
(778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca

Investor Relations Contact:
CORE IR
ir@optimi.net

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws, including statements regarding the proposed clinical trial, the availability and enrolment of patients in the trial, the utilization of the data derived from the trial, and the ability to conduct evaluations as part of the trial, the potential benefits of MDMA, the Company’s ability to manufacture and ship products from its Canadian facility, and the Company’s positioning in the regulated psychedelic medicine market. Forward-looking statements and forward-looking information are often identified by words such as “expects,” “anticipates,” “believes,” “intends,” “plans,” “estimates,” “may,” “will,” “would,” “could,” or similar expressions. Forward-looking statements and forward-looking information are based on several assumptions and are subject to a number of known and unknown risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Accordingly, there are or will be important factors that may cause actual results to differ from expected results. These factors include those described under “Risk Factors” in the Company’s registration statement on Form F-1, as amended, and other filings with the U.S. Securities and Exchange Commission made from time to time which are available at www.sec.gov and on SEDAR+ at www.sedarplus.ca and in the Company’s continuous disclosure filings available under its SEDAR+ profile at www.sedarplus.ca. These forward-looking statements reflect current expectations of management regarding future events and speak only as of the date of this press release. Except as expressly required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. New factors emerge from time to time, and it is not possible for the Company to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement.

Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.

Notice of Annual General Meeting 2026

ANNOUNCEMENT NO. 314
16 September 2026

Notice of Annual General Meeting
Notice is hereby given of the Annual General Meeting, which will be held on Thursday 8 October 2026 at 5.30 p.m.

The general meeting will be held at Nordsjællands KonferenceCenter, Gydevang 39-41, 3450 Allerød.

Additional info
Phillip Massie Price, CFO
Telefon (+45) 81 10 06 80

About ChemoMetec A/S
ChemoMetec develops, manufactures and markets instruments for cell counting and a wide range of other measurements. ChemoMetec’s instruments are marketed to the pharmaceutical, biotech and agricultural industries worldwide. ChemoMetec’s customers include some of the world’s leading pharmaceutical companies. ChemoMetec was founded in 1997 and is listed on Nasdaq OMX Copenhagen. For further information, go to www.chemometec.com.

Attachment

• AGM agenda 2026 (English)

Milestone follows FDA clearance of MAIA’s amended investigational new drug (IND) submission highlighting improved manufacturing capabilities and efficiencies 

U.S. expansion is funded by a $2.3 million NIH grant to MAIA to support third-line treatment evaluation

CHICAGO, Sept. 16, 2026 (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 that the first U.S. patient has been dosed in its Phase 2 THIO-101 trial expansion evaluating its telomere-targeting lead candidate, ateganosine, in third-line non-small cell lung cancer (NSCLC). The U.S. Phase 2 expansion is funded by a $2.3 million grant from the National Institutes of Health (NIH) to support third-line treatment evaluation and MAIA has activated 3 sites in the U.S.

MAIA holds FDA Fast Track designation for ateganosine, a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. Prior data from THIO-101 Parts A and B show overall survival (OS) beyond 24 months in eight patients receiving ateganosine sequenced with a checkpoint inhibitor.

“We have worked diligently to advance ateganosine into the U.S. market, and dosing the first patient in the United States represents a major milestone for our ongoing Phase 2 clinical trial,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “Our collaborations with some of the nation’s top institutions and foremost oncologists further strengthen the trial as we evaluate ateganosine for patients in advanced stages of this exceedingly hard-to-treat disease. We believe the data generated through the THIO-101 program may also support a potential pathway toward FDA accelerated approval. With patients now enrolled across four continents, the study has evolved into a truly global effort focused on addressing a critical unmet need in cancer care.”

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

New data presented in Vienna highlights long-term repeat-dose modeling, mechanistic GI barrier profiling, and deconvolution of payload- and linker-dependent toxicities for complex modalities

SAN DIEGO, Sept. 16, 2026 (GLOBE NEWSWIRE) — VivoSim Labs, Inc. (NASDAQ: VIVS) (“VivoSim” or the “Company”) unveils new clinical benchmark data at the 58th Congress of the European Societies of Toxicology (EUROTOX 2026) in Vienna, Austria, demonstrating the ability of its NAMkind™ 3D human liver and intestinal platforms to predict drug toxicity across small molecules and increasingly complex therapies, including Antibody-Drug Conjugates (ADCs).

The new data strengthens VivoSim’s positioning in the growing market for human-relevant predictive toxicology and New Approach Methodologies (NAMs), as pharmaceutical companies increasingly look for better ways to identify safety risks before drug candidates enter expensive human clinical trials.

Drug-induced liver injury (DILI) and gastrointestinal (GI) toxicity remain leading causes of drug candidate attrition, while ADC therapies introduce additional safety challenges involving payload toxicity, linker behavior and off-target exposure. VivoSim’s EUROTOX findings demonstrate how its long-duration, primary human cell-based models can help identify and differentiate these risks earlier in development, successfully ranking clinical safety risks for small-molecule reference sets such as thiazolidinediones and NSAIDs, while deconvoluting complex structural toxicities in advanced ADC modalities.

NAMkind™ Targets Liver and GI Toxicity Before the Clinic

VivoSim’s NAMkind™ Liver platform supports up to 28-day liver spheroid viability, while its intestinal models maintain barrier integrity for up to three weeks, allowing researchers to evaluate repeat-dose effects that shorter-duration laboratory assays may not capture.

In studies being presented at EUROTOX, VivoSim’s repeat-dose testing framework successfully ranked clinical safety risks across small-molecule reference compounds while also distinguishing payload- and linker-dependent toxicities in ADCs. The NAMkind™ Liver platform ranked trastuzumab deruxtecan as significantly more hepatotoxic than trastuzumab emtansine in the presented testing. In the NAMkind™ Intestine model, transepithelial electrical resistance (TEER) identified mucosal barrier deterioration before overt tissue cytotoxicity, with human ileum tissue demonstrating greater sensitivity to ADC-induced toxicity than colon tissue.

The findings carry particular weight as ADC development expands across oncology and other therapeutic areas, sharpening demand for technologies capable of determining where toxicity originates and which component of a complex drug is responsible.

Moving Beyond Detecting Toxicity

The broader commercial opportunity for VivoSim goes beyond simply detecting whether a drug candidate is toxic: it lies in helping pharmaceutical developers understand why toxicity occurs and whether it is likely to matter in humans.

“As global regulators like the FDA accelerate the transition away from traditional animal testing, biopharma leaders are seeking predictive human tools that eliminate translational surprises before clinical entry,” said Keith Murphy, Executive Chairman of VivoSim Labs. “Our latest data presented at EUROTOX demonstrate that the NAMkind™ platform doesn’t just evaluate traditional small molecules with exceptional fidelity, it successfully deconvolutes the complex safety liabilities of next-generation modalities like ADCs. By identifying payload and linker toxicities early, we provide our commercial partners with the actionable intelligence needed to save years of development and millions in potential clinical failure.”

“Predicting organ-specific toxicity requires capturing the biology of chronic, repeat-dose exposure,” said Amar Sethi, M.D., Ph.D., Chief Scientific Officer of VivoSim Labs. “With our extended-culture platforms, we observe micro-architectural and functional degradation that traditional short-term assays may miss. Whether ranking clinical DILI risk across small-molecule analogs or pinpointing why trastuzumab deruxtecan exhibits distinct hepatic and ileal liabilities compared to emtansine, our multi-endpoint profiling gives biopharma teams human-relevant translational signatures to optimize compound selection and de-risk pipelines.”

FDA NAM Momentum Adds to the Opportunity

The EUROTOX presentation arrives as regulators, including the U.S. Food and Drug Administration (FDA), continue advancing frameworks for New Approach Methodologies and human-relevant alternatives to traditional animal testing.

That regulatory shift does not represent an endorsement of VivoSim specifically, but it creates a potentially favorable industry backdrop for validated technologies capable of generating predictive human safety information before clinical development.

The opportunity extends beyond detecting toxicity. If broader validation and pharmaceutical adoption follow, NAMkind™ and VitroSense™ could become part of the decision layer between drug discovery and human clinical trials, helping pharmaceutical companies determine which programs deserve additional time and development capital.

For VivoSim investors, the EUROTOX data mark a meaningful validation point in the developing commercial thesis behind NAMkind™ using 3D human biology and predictive toxicology to help pharmaceutical companies identify safety liabilities earlier, select stronger drug candidates and reduce costly failures later in development.

VivoSim’s demonstrated ability to evaluate both traditional small molecules and increasingly important complex modalities such as ADCs positions its NAMkind™ platform to broaden its applications across pharmaceutical R&D.

About VivoSim Labs

VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) Roadmap to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding the Company’s cash on hand, revenue growth guidance and the Company’s progress in marketing contract research services using NAMs models to pharmaceutical companies. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on July 14, 2026, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on August 12, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. 

Contact:
Investor Relations
info@vivosim.ai
VivoSim Labs, Inc.

Converse, Indiana, Sept. 16, 2026 (GLOBE NEWSWIRE) — First Farmers Financial Corp. (OTCQX Banks; FFMR), the parent company of First Farmers Bank & Trust Co., announced that on September 15, 2026, the Board of Directors approved a record quarterly cash dividend of $0.27 per share, payable on October 15, 2026, to shareholders of record as of September 30, 2026. This quarterly dividend represents an 8.0% increase over the $0.25 split-adjusted dividend declared in September 2025.

The timing, price, and quantity of purchases under the stock repurchase plan will be at the discretion of management and may be discontinued, suspended, or restarted at any time.  The program will be funded from current available working capital.  The Board feels the stock repurchase plan continues to provide capital management opportunities and add value for the Company’s shareholders depending upon market and business conditions.

First Farmers Financial Corp is a $3.6 billion financial holding company headquartered in Converse, Indiana.  First Farmers Bank & Trust has offices throughout Boone, Carroll, Cass, Clay, Grant, Hamilton, Howard, Huntington, Madison, Marshall, Miami, Starke, Sullivan, Tippecanoe, Tipton, Vigo and Wabash counties in Indiana and offices in Coles, Edgar, and Vermilion counties in Illinois. First Farmers Financial Corp is traded on the OTC Markets Group, Inc. “OTCQX” exchange under the ticker symbol: FFMR  

CONTACT: Tade J Powell
First Farmers Financial Corporation
765-395-3316
tade.powell@ffbt.com