Onvansertib in combination with trastuzumab deruxtecan demonstrated enhanced antitumor activity, including tumor regression and apoptosis in HER2-low breast cancer models, supporting its potential for patients with limited treatment options
SAN DIEGO, Calif., April 17, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, will present new preclinical data in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22 in San Diego, California. These data highlight the potential of Cardiff’s highly specific oral PLK1 inhibitor, onvansertib, in combination with the HER2-targeted antibody-drug conjugate (ADC), trastuzumab deruxtecan (T-DXd), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models.
“These preclinical findings highlight a potential new opportunity for onvansertib, demonstrating its ability to enhance the activity of ADCs, which are becoming mainstays in oncology across multiple indications,” said Tod Smeal, Ph.D., Chief Scientific Officer of Cardiff Oncology. “By enhancing and prolonging DNA damage, this combination appears to drive greater apoptosis than either agent alone, offering a promising new approach for patients whose cancers have become resistant to standard-of-care treatments.”
Poster Presentation Highlights:
Onvansertib + T-DXd synergistically inhibited the viability of HER2-low breast cancer cell lines, including fulvestrant- and CDK4/6i-resistant cells
In the resistant triple-negative breast cancer model and two hormone receptor-positive models, the combination drove tumor regression in nearly all mice, with complete response rates up to 62%
Increased tumor regression, improved tumor growth inhibition, and extended event-free survival across models
Combination showed favorable tolerability in vivo
Following the presentation on April 19, 2026 from 2:00–5:00 PM PT, the poster titled “PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models” will be available on the Scientific Publications page of the Company’s website.
About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.
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 Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’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 candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Biotech’s long IPO drought may finally be breaking — but don’t mistake a crack in the window for a wide-open door.
This week, two biopharma companies launched roadshows that signal a cautious return of investor appetite to the public markets. GLP-1 developer Kailera Therapeutics hit the road at a $1.9 billion valuation, while proteomics company Alamar Biosciences priced at $17 per share — the top of its marketed range — and opened trading on the Nasdaq Friday with a 33% pop, valuing the company at roughly $1.53 billion. The upsized offering raised $191.3 million, a meaningful signal that institutional demand is real, not manufactured.
But the story isn’t really about IPOs. It’s about M&A.
The primary engine driving this biotech resurgence is an aggressive acquisition cycle fueled by the pharmaceutical industry’s looming patent cliff. Major drug companies are racing to backfill pipelines before blockbuster drugs lose exclusivity, and that urgency is translating into deal flow at a historic pace. According to a Stifel report, 19 biopharma M&A transactions of $1 billion or more were announced between January 1 and April 7 alone — putting the industry on pace for its second-highest annual total ever. Marquee deals include Merck’s $6.7 billion acquisition of Terns Pharmaceuticals and Eli Lilly’s $6.3 billion upfront commitment for Centessa Pharmaceuticals, both announced last month.
That M&A velocity matters beyond the deal itself. When large acquisitions close, venture investors recycle that capital back into the ecosystem — funding the next generation of companies and, critically, making investors more willing to participate in secondary offerings and IPOs. It’s a flywheel, and right now it’s spinning.
Valuations in the private markets are reflecting it. Median pre-money valuations for venture-growth biopharma companies jumped from $65 million to $247 million in 2025, according to PitchBook’s Q4 2025 Biopharma VC Trends report. And the Russell 2000 Biotech Index is up 9.7% year-to-date, outperforming the S&P 500.
That said, the numbers tell a sobering parallel story: of the six biopharma companies that have gone public since January, four are currently trading below their offer price. The market is rewarding quality — and punishing everyone else.
The threshold to go public has risen considerably since the 2020–2021 boom years, when companies with minimal patient data could attract institutional money. Today, clinical-stage companies are bringing 50 or more patients’ worth of data to the roadshow. Pre-clinical companies aren’t even in the conversation.
For small and microcap investors, this environment requires nuance. The biotech IPO window is open — but narrowly, and selectively. Companies that are scientifically de-risked, operationally sound, and well-positioned relative to M&A comps are getting deals done. Everything else is waiting.
The broader implication: as Big Pharma’s acquisition appetite grows, smaller biotech names that could plausibly become targets deserve a closer look. The deals are getting done — the question is who’s next on the list.
NORWOOD, Mass., April 15, 2026 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQB: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its first quarter 2026 financial results on May 13, 2026 after the markets close. Management will host a conference call on May 14, 2026 at 8:00 a.m. EDT to discuss financial results.
A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q1 2026 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.
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™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. The Company is also recognized for delivering exceptional customer service at our 13 Thrive Dispensary retail locations across five states. 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.
Company Contact: Howard Schacter Chief Communications Officer Email: [email protected] Phone: (781) 277-0007
Pivotal Phase 3 Trial for GEO-MVA (Mpox/Smallpox Vaccine)
Scheduled to Initiate During the Second Half of This Year
ATLANTA, GA, April 15, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigenic vaccines and immunotherapies against infectious diseases and cancer, today announced its financial results and key operational accomplishments for the year ended December 31, 2025.
“During 2025, we made significant progress advancing GEO-MVA toward late-stage clinical development, supported by regulatory alignment with the European Medicines Agency (EMA) and key manufacturing milestones,” stated David Dodd, Chairman and Chief Executive Officer of GeoVax. “We believe GEO-MVA represents a critically important opportunity to eliminate the current global supply constraint in orthopoxvirus vaccines, while supporting broader public health preparedness and biosecurity objectives. As such, we look forward to initiating the planned Phase 3 immuno-bridging study in the second half of this year, which represents the next key step in advancing GEO-MVA to regulatory approval and access, providing a critically needed supply source of MVA-vaccine.”
Mr. Dodd concluded, “As we look ahead, our priority is executing key GEO-MVA clinical and regulatory milestones, strengthening strategic partnerships, while selectively advancing other programs, addressing critical medical needs worldwide, while maximizing long-term value to shareholders and stakeholders.”
Corporate and Operational Highlights
Priority Program – GEO-MVA
GeoVax’s primary near-term strategic development focus is the advancement of GEO-MVA, its Modified Vaccinia Ankara (MVA)-based vaccine candidate targeting mpox and smallpox. GEO-MVA is the Company’s most advanced program and its most direct path to potential regulatory approval and commercialization. GEO-MVA is being developed on an expedited regulatory pathway to address a documented global supply constraint in orthopoxvirus vaccines, while supporting both public health preparedness and biosecurity needs, including diversification of supply beyond a single foreign manufacture.
During 2025, the Company achieved several key milestones, advancing GEO-MVA toward late-stage development and commercial readiness:
Regulatory Alignment: GeoVax received formal Scientific Advice from the European Medicines Agency (EMA), supporting a streamlined and accelerated development pathway for GEO-MVA, including a single Phase 3 immuno-bridging study without the need for prior Phase 1 or Phase 2 trials.
Phase 3 Readiness: The Company is preparing to initiate a pivotal Phase 3 clinical trial in the second half of 2026, representing the critical next step toward potential regulatory approval and product distribution.
Manufacturing Progress: GeoVax completed cGMP manufacturing and fill-finish of clinical-grade GEO-MVA, establishing readiness for clinical supply and potential commercialization.
GeoVax believes GEO-MVA is uniquely positioned at the intersection of:
Recurring global mpox outbreaks and evolving viral strains
Depleted government stockpiles following recent outbreaks
Policy-driven demand for diversified and domestic vaccine supply
Given these dynamics, GEO-MVA is expected to play a central role in global orthopoxvirus preparedness strategies. The Company is actively aligning GEO-MVA with public health preparedness and biosecurity procurement frameworks, including engagement with international regulatory and governmental stakeholders.
Additional Progress Across Clinical Pipeline
Beyond GEO-MVA, GeoVax continues to advance a diversified pipeline spanning infectious diseases and oncology:
GEO-CM04S1 (COVID-19 Vaccine):
Advancing through multiple Phase 2 clinical trials targeting immunocompromised populations, including stem cell transplant and CLL patients.
Data readouts expected in 2026, including from a completed booster trial in healthy adults.
Interim DSMB findings in the CLL study indicated superior immune responses versus mRNA comparator, supporting continued development.
Gedeptin® (Oncology):
Completed Phase 1/2 clinical evaluation in advanced head and neck cancer.
Entered into an exclusive license agreement with Emory University to support combination use with immune checkpoint inhibitors.
Planning Phase 2 trial for first-line treatment in locally advanced head and neck squamous cell carcinoma (2027).
2025 Full Year Financial Results
Net Loss: Net loss for the year ended December 31, 2025, was $21.5 million, or $22.40 per share, as compared to $25.0 million, or $120.46 per share, for the year ended December 31, 2024.
Revenue: For the year ended December 31, 2025, the Company reported $2.5 million of government contract revenues associated with the BARDA/RRPV Project NextGen award, compared to $4.0 million during 2024. In April 2025, GeoVax received notification that BARDA determined to terminate the contract for convenience to the government.
R&D Expenses: Research and development expenses were $18.1 million for 2025, compared to $23.7 million in 2024, with the overall decrease primarily related to discontinued costs associated with termination of the BARDA/RRPV contract, as well as lower costs for the GEO-CM04S1 clinical trials and manufacturing costs associated with the GEO-CM04S1 and Gedeptin programs.
G&A Expenses: General and administrative expenses were $6.0 million for 2025, compared to $5.4 million in 2024, with the overall increase primarily due to higher personnel costs, investor relations consulting and other programmatic expenses, patent costs, and stock-based compensation expense.
Cash Position: GeoVax reported cash balances of $3.1 million on December 31, 2025, as compared to $5.5 on December 31, 2024.
Summarized financial information is attached. Further information is included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biosecurity preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.
Exceptional measures of efficacy observed in THIO-101 Phase 2 trial to date include disease control, response rates, and survival data well above standard of care benchmarks
50,000 advanced NSCLC diagnoses in the U.S. annually
CHICAGO, April 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 it has activated the first U.S. clinical site in its Phase 2 THIO-101 expansion trial of its lead investigational therapy as a third-line (3L) treatment for non-small cell lung cancer (NSCLC).
“We are thrilled to activate the expansion of our Phase 2 THIO-101 trial in the U.S., bringing our novel treatment to our country’s broad underserved NSCLC patient population. Every year, we estimate approximately 50,000 patients resistant to chemo and CPIs alone advance to third-line NSCLC in the U.S. The medical need is extensive,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA.
The trial’s expansion into the U.S. marks a key milestone for MAIA, which is expected to open a significantly larger patient pool for evaluation of ateganosine, a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. In addition to the first location, Summit Medical Group in New Jersey, MAIA intends to open four additional sites in U.S. in 2026. The trial is ongoing in Europe and Asia with 44 active sites in 6 countries.
MAIA’s THIO-101 expansion study evaluates ateganosine in heavily pre-treated patients in 3L NSCLC who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy. Two treatment arms are being studied: ateganosine sequenced with cemiplimab (Libtayo®) and ateganosine monotherapy. Third-line treatment evaluation in the U.S. is funded by a prestigious $2.3 million grant from the National Institutes of Health (NIH).
“The activation of Summit Medical Group as our first U.S. clinical site is a landmark moment for the THIO-101 study. This is expected to further advance ateganosine as a potential best-in-class therapy for third-line NSCLC,” said Matthew Failor, MAIA’s Director of Clinical Operations. “Partnering with a premier institution like Summit should allow us to bring this highly innovative telomere-targeting approach to U.S. patients who have limited options.”
“We are proud to be the first U.S. site to offer patients access to MAIA’s innovative THIO-101 expansion trial and contribute to advancing a promising new treatment strategy in lung cancer,” added Charles J. Kim, M.D., Summit Health oncologist and principal investigator for the THIO-101 trial in New Jersey.
MAIA holds FDA Fast Track designation for its lead drug targeting advanced NSCLC. The Fast Track process is designed to facilitate development and expedite the review of drugs for serious conditions with no treatment options or limited low-efficacy therapies. If relevant criteria are met during the Fast Track process, a drug is eligible for FDA Accelerated Approval and Priority Review (FDA decision within six months).
In 2025, THIO-101 delivered exceptional efficacy data for MAIA’s lead investigational drug sequenced with a checkpoint inhibitor including disease control, response rates, and survival data well above standard of care benchmarks. MAIA recently reported overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B of the trial. The eight patients include one with survival of 33 months and four with survival over 30 months. The measures of 3L OS beyond 24 months exceed all known benchmarks for advanced NSCLC treatment. The THIO-101 treatment regimen has shown an acceptable safety profile to date in a heavily pre-treated population.
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.
TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime, is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years
TONMYA commercially launched in the U.S. in November 2025
BERKELEY HEIGHTS, N.J., April 15, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated, commercial stage biotechnology company, today announced the publication of a paper, “Steady-State Pharmacokinetic Properties of TNX-102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open-Label Trial,” in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology (ACCP). TONMYA® (cyclobenzaprine HCl sublingual tablets) was investigated under the designation TNX-102 SL. The manuscript can be accessed at https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.70060.
“TONMYA’s sublingual tablet was developed for long-term daily dosing at bedtime to target the nonrestorative sleep associated with fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Therefore, the steady-state pharmacokinetic (PK) profile at Day 20 is more relevant to the product’s indicated dosing regimen than single dose PK. The dynamic changes in cyclobenzaprine concentrations from sublingual tablet dosing over 24 hours at Day 20 are believed to provide pharmacodynamic effects on the brain owing to rapid absorption and distribution. The sublingual tablet was designed with a basifying ingredient and cyclobenzaprine–mannitol eutectic to provide transmucosal absorption to speed uptake, deliver maximum plasma levels of cyclobenzaprine during the middle of the sleep phase, and bypass first-pass liver metabolism. This study supported TONMYA’s approval for the treatment of fibromyalgia in adults by the U.S. Food and Drug Administration (FDA) and elucidates how TONMYA’s pharmacokinetic profile is consistent with long-term daily dosing at bedtime.”
Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The dynamic changes in cyclobenzaprine concentrations are magnified by the higher predicted percentage of receptors by cyclobenzaprine relative to norcyclobenzaprine occupied (i.e., 5-HT2A, α1-adrenergic, H1, and M1) during sleep hours after bedtime dosing. For example, 5-HT2A antagonism increases slow wave sleep (SWS) activity during non–rapid eye movement (NREM) sleep, and α1-adrenergic antagonism increases the time and continuity in REM sleep and reduces noradrenergic sympathetic tone, which has the potential to impair the quality of SWS.”
The publication reports findings from a single-center, randomized, open-label, multiple-dose, parallel-group pharmacokinetic study conducted in 60 healthy adult volunteers. Participants were randomized 1:1 to receive either sublingual cyclobenzaprine HCl 5.6 mg (two 2.8 mg tablets, the FDA approved dose of TONMYA for adults) or oral cyclobenzaprine HCl extended-release (ER) 30 mg capsules (AMRIX®) once daily for 20 consecutive days.
At steady state, exposure to both plasma cyclobenzaprine and norcyclobenzaprine for sublingual tablets (TNX-102 SL) 5.6 mg was substantially lower than that to the comparator listed drug, oral cyclobenzaprine HCl ER 30 mg capsules. Importantly, when exposures were normalized by dose, cyclobenzaprine bioavailability is higher for sublingual tablets at 5.6 mg relative to oral ER 30 mg capsules. Both treatments had comparable metabolic profiles of Phase I and II metabolites in human plasma. These pharmacokinetic results are consistent with the use of sublingual cyclobenzaprine HCl tablets at 5.6 mg to target nonrestorative sleep in fibromyalgia, reduce pain, and potentially improve other symptoms of the condition.
On Day 1, sublingual cyclobenzaprine was detectable within one hour of administration, with median time to peak plasma concentration (tmax) approximately three hours earlier than the oral ER capsule formulation (five vs. eight hours). At steady state on Day 20, the sublingual tmax remained two hours earlier (five vs. seven hours). The sublingual formulation demonstrated markedly higher cyclobenzaprine bioavailability when exposures were normalized by dose.
Daily morning administration of sublingual cyclobenzaprine HCl 5.6 mg over 20 days was generally safe and well tolerated. There were no serious adverse events or treatment discontinuations due to adverse events. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events with sublingual tablets occurring at rates higher than oral ER capsules were oral hypoesthesia, abnormal product taste, somnolence, back pain, and fatigue. Since TONMYA is intended for bedtime administration, the effects of somnolence are expected to be an attribute for bedtime dosing when sleepiness effects are beneficial. No metabolites unique to the sublingual route of administration were identified.
About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA® (cyclobenzaprine HCl sublingual tablets) TONMYA (cyclobenzaprine HCl sublingual tablets) is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which, compared to the immediate-release oral cyclobenzaprine, provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. The reduction in norcyclobenzaprine, a potent inhibitor of the norepinephrine transporter (NET), is thought to be key to the durability of treatment response as NET inhibition is activating and disruptive to slow wave sleep. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress reaction (ASR)/acute stress disorder (ASD), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
*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.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. 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 in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. 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.
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.
A microcap biotech is getting a new identity — and $350 million to go with it.
Galera Therapeutics (OTC: GRTX) and privately-held Obsidian Therapeutics announced today they have entered into a definitive merger agreement to combine in an all-stock transaction. The combined company will operate as Obsidian Therapeutics and plans to trade on Nasdaq under the ticker symbol OBX.
For Galera shareholders, this is a lifeline. The stock was trading at less than five cents on the OTC markets heading into this announcement. For Obsidian, it’s a calculated path to the public markets — using Galera as a vehicle to access Nasdaq without a traditional IPO.
The Deal Structure
Under the merger agreement, Galera will merge into a subsidiary of the new parent company, Gazelle Parent, Inc., while Obsidian simultaneously merges into a separate subsidiary — with both surviving as wholly owned subsidiaries of the combined parent.
Concurrent with the merger, the companies secured commitments for a private placement financing expected to generate $350 million in gross proceeds. That’s a substantial war chest for a clinical-stage biotech, and signals serious institutional conviction in Obsidian’s pipeline.
The ownership breakdown tells the real story of who’s driving this combination: pre-merger equityholders of Obsidian are expected to own approximately 53.2% of the combined company, PIPE investors approximately 45%, and Galera’s legacy shareholders approximately 1.8%. Galera’s existing stockholders are essentially getting a small equity stake in a well-funded new entity rather than facing dissolution.
Who’s Backing It
Investors in the private placement include Balyasny Asset Management, Caligan Partners, Eventide Asset Management, Nantahala Capital, Octagon Capital, Redmile, Spruce Street Capital, and Trails Edge Capital Partners. That’s a roster of credible, healthcare-focused institutional names — not speculative money.
What Obsidian Actually Does
Obsidian focuses on engineered cell and gene therapies targeting unmet medical needs, while Galera had concentrated on treatments for radiation-induced toxicities. The combined company’s primary asset is OBX-115, a TIL (tumor-infiltrating lymphocyte) cell therapy. The company expects Phase 1 NSCLC data in the first half of 2027 and topline data from a melanoma registration-enabling trial by year-end 2027, supported by the merged company’s expanded cash runway.
TIL cell therapy is an emerging but compelling approach in oncology — it extracts a patient’s own immune cells from a tumor, engineers them, and reinfuses them to fight cancer. The space has attracted significant Big Pharma attention as cell therapy continues to mature beyond CAR-T into broader tumor types.
The Bigger Picture
This transaction is a textbook example of a structure the small-cap biotech world relies on — a reverse merger into a public shell paired with a concurrent PIPE to fund the surviving entity’s operations. It avoids the cost and volatility of a traditional IPO while still achieving a Nasdaq listing and fresh capital.
Closing requires approval from Galera and Obsidian stockholders, effectiveness of a Form S-4 registration statement, receipt of the approximately $350 million in private placement proceeds, and Nasdaq approval for the new parent’s listing.
For small-cap investors, the question now is whether OBX can justify that institutional confidence when the clinical data arrives in 2027.
Highlights Critical Need for Additional MVA Vaccine Supply, Ending the Current Monopoly, Increasing Access and Supply Worldwide
ATLANTA, GA, April 14, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today highlighted the urgent challenges caused by the supply-constrained, global orthopoxvirus vaccine market and outlined the strategic positioning of its GEO-MVA vaccine candidate to address the limited supply and increasing global demand.
A Procurement-Driven Market with Recurring Global Demand
The global market for vaccines targeting mpox and smallpox (orthopoxviruses) has evolved into a recurring, procurement-driven market supported by:
National stockpile programs across the United States, Europe and allied countries
Ongoing purchasing by global health organizations and regional agencies
Outbreak-driven surge demand tied to periodic global transmission events
Recent mpox outbreaks across multiple continents, including the emergence of more virulent strains, have reinforced the need for sustained vaccine supply beyond emergency response cycles.
Single-Supplier Market Structure and Limited Surge Capacity
The current global supply of MVA vaccines, the preferred vaccine for orthopoxvirus infections due to their recognized safety for use in vulnerable populations, is concentrated with a single commercial supplier.
This market structure has contributed to:
Limited surge capacity during outbreaks
Repeated depletion of government stockpiles
Increased focus on supply chain resilience and diversification
As a result, governments and public health agencies are increasingly prioritizing:
Establishment of additional sources of MVA vaccine supply
Expansion of domestic and allied manufacturing capacity
Reduced dependence on single-source providers for critical countermeasures
An Established Market Measured in Hundreds of Millions Annually
Public disclosures and procurement activity indicate that the mpox/smallpox vaccine market:
Has generated hundreds of millions of dollars in annual procurement in recent years
Includes multiyear purchasing frameworks and forward-looking supply agreements
Is supported by both baseline stockpiling demand and outbreak-driven purchasing cycles
GeoVax believes these dynamics support a durable and expanding global market, rather than a one-time, pandemic-driven market opportunity.
GEO-MVA Positioned as a Second-Source MVA Vaccine Candidate
GeoVax’s GEO-MVA vaccine candidate is being developed to address the current supply-demand imbalance. The Company believes GEO-MVA is positioned as a potential second-source MVA vaccine, with key attributes including:
Leverages the established MVA platform, widely used for immunocompromised and high-risk populations
A defined regulatory pathway, based on immuno-bridging, to an approved MVA vaccine
Late-stage development readiness, with Phase 3 initiation planned during 2026
GeoVax believes GEO-MVA has the potential to support:
National stockpile replenishment programs
Global outbreak response efforts
Long-term preparedness and biodefense strategies
Alignment with Public Health and Biodefense Priorities
The mpox/smallpox vaccine market is increasingly shaped by the intersection of:
Public health preparedness, driven by recurring mpox outbreaks and evolving viral threats
National security and biodefense priorities, including protection against biological threats
Recent U.S. and international policy initiatives have emphasized:
Strengthening biosecurity infrastructure
Expanding domestic manufacturing capabilities
Ensuring reliable access to critical medical countermeasures
GeoVax believes GEO-MVA is positioned for both civilian and biodefense procurement channels.
Development Timeline Synchronized with Procurement Cycles
GeoVax believes its planned development timeline for GEO-MVA corresponds with:
Anticipated stockpile replenishment cycles following recent depletion
Continued global procurement activity driven by outbreak preparedness
Increasing policy emphasis on supply diversification initiatives
David Dodd, Chairman and Chief Executive Officer of GeoVax, commented, “The mpox and smallpox vaccine market is not a future construct, it is an active, procurement-driven market with recurring demand and increasing strategic importance. It is also a market currently defined by supply concentration and limited surge capacity.”
Mr. Dodd added, “We believe that, if approved, GEO-MVA, which is expected to begin a pivotal Phase 3 trial this year, is positioned to enter this market as a second-source MVA vaccine at a time when governments and global health organizations are actively seeking to diversify supply and strengthen preparedness. Our focus is on executing the next phase of development and aligning GEO-MVA with procurement frameworks that support both long-term stockpiling and rapid response capabilities.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit 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.
STAFFORD, Texas, April 14, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its financing strategy.
The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for Q1 2026 exceeded the Company’s Q1 2026 cash burn rate, leading to a Q1 2026 cash balance of approximately $10.5 million as of March 31, 2026. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial review for Q1 2026.
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
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 Methodology Continues To Improve Medicare Cost Savings. TOI announced new data from the Enhancing Oncology Model (EOM) developed by the Centers for Medicare & Medicaid Services (CMS). Data from CMS shows that during Performance Period 3, the six-month period beginning July 2024, TOI achieved cost savings of $1.8 million, equating to $6,400 per patient-episode. This compares with the Performance Period 2, from January 2024 to June 2024, in which savings were $1.1 million or $3,500 per episode.
TOI Methodology Fits Well With The EOM. The CMS Innovation Center developed the EOM as a total-cost-of-care model to improve cancer care for Medicare Fee-for-Service beneficiaries. It incentivizes oncology practices to deliver coordinated care for patients receiving chemotherapy. The EOM model has identified pharmacy, avoidable acute care, and supportive care as the three main areas for cost reduction and quality-of-care improvements.
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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).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Board member and Interim CEO Mani Mohindru, PhD, named President and Chief Executive Officer
Appoints industry veterans Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer
SAN DIEGO, April 09, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO, and that she will continue as a member of the Board. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.
“I am honored to step into the role of Chief Executive Officer at this important time for Cardiff. We have made meaningful progress advancing onvansertib in first-line RAS-mutant metastatic colorectal cancer and remain focused on delivering clinical data to support our registrational program,” said Mani Mohindru, PhD, President and Chief Executive Officer. “Building the right team to advance this promising asset is central to our strategy and to ultimately delivering a potential new therapy to patients in need.”
Dr. Mohindru continued, “We are excited to welcome Josh and Ajay to our team. Josh is a highly accomplished financial leader with a strong track record of executing complex financings and building trusted relationships across the investment community. Ajay brings deep clinical development and operational expertise, with a proven ability to advance programs from early research through late-stage development. Together, their complementary experience strengthens our ability to execute our strategic priorities.”
Josh Muntner
Mr. Muntner brings deep expertise in capital markets strategy, financial operations and supporting clinical-stage organizations through key inflection points. He is a seasoned biopharma finance executive with more than 25 years of experience spanning investment banking and corporate leadership roles, including as CFO of both private and publicly traded biotechnology companies. Previously, Mr. Muntner served as Chief Financial Officer of Imvax, Inc., where he led all finance functions, including raising $86 million in a convertible financing. Prior to that, he served as Chief Financial Officer of Mesoblast Ltd., a Nasdaq- and ASX-listed biotechnology company, where he completed multiple cross-border equity and debt financings totaling approximately $300 million and helped expand the company’s U.S. investor base. Earlier in his career, Mr. Muntner held senior roles in investment banking, completing more than 90 transactions and raising over $9 billion in equity and debt financing for life sciences companies. Mr. Muntner serves as a member of the Board Directors at Devonian Health Group Inc., a biopharmaceutical company developing immunomodulatory treatments for inflammatory diseases.
Mr. Muntner holds an MBA from the UCLA Anderson School of Management and a BFA from Carnegie Mellon University.
Ajay Aggarwal, MD, MBA
Dr. Aggarwal is a board-certified Pulmonary, Critical Care and Sleep Medicine physician with more than 15 years of experience in the pharmaceutical industry, spanning respiratory, immunology and oncology drug development. Most recently, he served as Senior Vice President and Head of Clinical Development at Aclaris Therapeutics, where he led clinical strategy and execution across multiple programs.
Prior to Aclaris, Dr. Aggarwal served as Chief Medical Officer of CereXis, Inc., a company advancing therapies for rare neurology and oncology indications. He has also held clinical leadership roles at Insmed, Inc. and AstraZeneca PLC, where he successfully advanced several compounds from preclinical stages into late-stage clinical development.
Earlier in his career, he held academic leadership roles, including Chief of Medicine at a VA Hospital, and has authored numerous peer-reviewed publications. He is a Fellow of the American College of Chest Physicians.
Dr. Aggarwal received his MBA from the Kellogg School of Management at Northwestern University and his medical degree from the All India Institute of Medical Sciences.
Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
In connection with Mr. Muntner joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 486,650 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Mr. Muntner becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of April 6, 2026, and has an exercise price of $1.58 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to Mr. Muntner’s continued employment with Cardiff Oncology on such vesting dates.
About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients. For more information, please visit https://www.cardiffoncology.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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’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 candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Strong participation in recent $33 million common stock offering highlights investor confidence in late-stage clinical momentum and commercial potential
Statistical assessments point to high probability of technical success in Phase 3 full approval trial
FDA granted Fast Track designation for dual mechanism therapy as a treatment for non-small cell lung cancer (NSCLC)
CHICAGO, April 08, 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 net proceeds from its $33 million public offering of common stock in March 2026 are expected to fully fund the Company’s ongoing pivotal Phase 3 clinical trial of its lead investigational therapy, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). Ateganosine is a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in third line (3L) NSCLC treatment.
“We are grateful for the support and confidence shown by the healthcare-dedicated investors and existing shareholders who participated in our recent offering. The $33 million raise is expected to complete the necessary funding for our pivotal Phase 3 trial through completion,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA
“Statistical assessments point to a high probability of technical success in the third-line setting if Phase 3 data is consistent with our Phase 2 trial results,” Dr. Vitoc continued. “Interim data from the Phase 3 trial, expected next year, may support a discussion with the FDA to present our case for early full commercial approval in third-line NSCLC.”
MAIA’s pivotal Phase 3 trial, THIO-104, evaluates the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors alone and chemotherapy. The global multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. Chemotherapy is the standard utilized treatment for third-line NSCLC patients.
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-104 Phase 3 Clinical Trial
THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.
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, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and (viii) the funding status for our Phase 3 trial for ateganosine, 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.
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.
New Data Added To Expand Patent Claims. Greenwich LifeSciences announced that it has filed new patent claims to expand the patent estate covering GP2, the proprietary compound in GLSI-100. The new claims add recently announced data from the Phase 3 FLAMINGO-01 trial that show the immune response and recurrence rate for non-HLA*02 patients. These claims could expand both the scope and the term of the patent estate beyond previous claims from HLA*02 patients.
Broadening Patent Protection Protects Against Competitors. Patent claims covering the immune response that results from GLSI-100 treatment could help lock out competitors trying to develop similar compounds. If a new compound were able to avoid patents covering GP2, it would be blocked by the new claims covering the immune response that follows.
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