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Release – GeoVax and CEPI Enter Agreement to Utilize CEPI Centralised Laboratory Network to Support GEO-MVA Phase 3 Trial

Posted on September 14, 2026September 14, 2026 by [email protected]

Independent Evaluation Supports GEO-MVA Pivotal Phase 3 Program

Advances GeoVax’s Strategy to Expand and Diversify MVA Vaccine Supply

ATLANTA, GA – September 14, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against high consequence infectious diseases and solid tumor cancers, today announced that it has entered into a Memorandum of Agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) providing GeoVax access to clinical trial sample testing services through the CEPI Centralised Laboratory Network in support of its planned pivotal GEO-MVA Phase 3 immune-bridging study.

The agreement represents an important step in the continued development of GEO-MVA, GeoVax’s MVA-based vaccine candidate targeting mpox and smallpox. It provides access to independent laboratory testing using standardized assays and reporting procedures established through CEPI’s global laboratory infrastructure. CEPI’s network is the largest global group of laboratories dedicated to harmonizing the immunological assessment of vaccines in development against infectious diseases with epidemic and pandemic potential. With network scientists assessing clinical trial samples using the same methods and validated assays, the possibility of variability in trial readouts is minimized, helping researchers and regulators consistently evaluate vaccine performance in clinical trials. For GeoVax, the agreement also supports a broader strategic objective: building independent scientific evidence necessary to establish GEO-MVA as a potential additional source of MVA-based mpox vaccine supply at a time when outbreaks and preparedness requirements continue to demonstrate the importance of resilient, diversified vaccine capacity.

GeoVax expects to initiate its approximately 500-participant pivotal Phase 3 immune-bridging study in the fourth quarter of 2026, with results expected in mid-2027.

Recent global mpox outbreaks have underscored the risks of constrained vaccine supply and the importance of expanding MVA vaccine capacity. GeoVax believes sustainable preparedness will increasingly require not only adequate vaccine stockpiles, but also multiple qualified sources of supply and manufacturing capacity capable of serving different regions of the world.

“Independent evaluation is an important step toward building confidence in GEO-MVA among regulators, public-health organizations, governments and potential strategic partners,” said David Dodd, Chairman and Chief Executive Officer of GeoVax. “Our agreement with CEPI provides access to a highly respected global laboratory network capable of testing and characterizing immune responses associated with GEO-MVA.”

Dodd continued, “But the larger objective extends beyond development of another mpox vaccine. The global preparedness community needs resilient MVA supply. We believe that the data produced by CEPI’s network could pave the way for an additional qualified supply source of mpox vaccine supply if we are successful in testing and licensure, reducing dependence on a single manufacturing infrastructure and ultimately enabling production capacity that can be deployed closer to the populations it is intended to protect.”

Independent Evaluation Supporting an Expanded-Source Strategy

Under the agreement, clinical samples provided by GeoVax will be evaluated through the CEPI Centralised Laboratory Network using assays specific to orthopoxviruses, the family of viruses to which mpox and smallpox belong.

The independent nature of the testing is particularly important as GeoVax advances GEO-MVA toward its pivotal Phase 3 study. Results generated through CEPI’s laboratory network will provide independently generated and standardized immunological data that will inform GeoVax’s ongoing clinical development and future regulatory interactions.

“CEPI’s Centralised Laboratory Network was set up during the COVID-19 pandemic to help reduce clinical testing differences that can emerge from independent laboratory review to instead ensure easy access and alignment to key data that could support vaccine approvals” said Dr Amy Shurtleff, Director of Laboratory Research and Innovation Department at CEPI. “It has rapidly expanded since then, with vaccine developers around the world using the service to evaluate thousands of their samples produced during trials of promising vaccine candidates against other deadly pathogens, including mpox. Our new agreement with GeoVax enables the company to access validated, high-quality mpox testing tools that could fast-track its promising GEO-MVA mpox vaccine through development and give the world further options to fight this harmful, recurring disease.”

The agreement also provides a framework under which CEPI may share anonymized summaries of sample-testing results with the World Health Organization (WHO), Gavi, the Vaccine Alliance and others to further CEPI’s mission to transform the world’s response to epidemic and pandemic threats, including diseases like mpox.

GeoVax will cover the full testing costs associated with the research carried out by CEPI’s Centralised Laboratory Network. CEPI has not provided specific funding for the development of GEO-MVA.

About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency (EMA), GeoVax is pursuing an immune-bridging development strategy that is intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.

GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply, scalable production capabilities, and a capital-efficient regulatory pathway. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional, reliable source of MVA vaccine to support biosecurity and orthopoxvirus preparedness.

About CEPI and the Centralised Laboratory Network

CEPI is an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need. Central to CEPI’s pandemic-beating plan is the ‘100 Days Mission’ to develop safe, effective and accessible vaccines against new threats in just 100 days. CEPI is seeking $2.5 billion to execute CEPI 3.0, its 2027-2031 strategy which will systematically reduce the likelihood, impact and cost of epidemics and pandemics by driving the 100 Days Mission towards an operational reality. Learn more at CEPI.net.

The Centralised Laboratory Network focuses on the assessment of vaccines against CEPI’s priority list of pathogens including Lassa, Nipah, mpox, MERS, Ebola, Chikungunya, Rift Valley fever and COVID-19.

Laboratory members also support testing of vaccines for other viral threats with epidemic or pandemic potential, like Marburg, and are on standby to help fast-track the assessment of vaccine candidates against a Disease X – a novel or as-of-yet unidentified pathogen. To date, the network has served over 60 vaccine developers to assess their vaccine candidates at all stages of developments, processing over 120,000 samples.

CEPI’s Centralised Laboratory Network members are listed here. Laboratories are selected to join the network based on their capacity, experience and scientific expertise in testing clinical samples using high-quality systems. Since its launch in 2020, CEPI has provided up to US $59 million to fund capability building and collect immunogenicity data in the network.

Data produced by members of the network is sent back to the vaccine developer. Neither CEPI nor the laboratory who assessed the samples owns the data.

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, an investigational 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 fourth quarter 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 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.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Cardiff Oncology and Nerviano Medical Sciences Amend their 2017 Exclusive License Agreement

Posted on September 14, 2026September 14, 2026 by [email protected]

Research News and Market Data on CRDF

September 14, 2026

PDF Version

Under the terms of the Amendment, all disputed issues are resolved

SAN DIEGO and NERVIANO, Italy, Sept. 14, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (NASDAQ: CRDF) (“Cardiff”) and Nerviano Medical Sciences S.r.l. (“NMS”) today announced that they have reached a settlement and amended their 2017 Exclusive License Agreement, resolving all outstanding disputes between the two companies related to the global rights for onvansertib, Cardiff’s lead PLK1 inhibitor drug candidate, and establishing an expanded collaborative framework to support onvansertib’s continued clinical development.

Cardiff and NMS have agreed to a full and mutual release of all claims asserted in the litigation pending in the U.S. District Court for the Southern District of California. Cardiff and NMS plan to jointly request dismissal of all claims with prejudice.

“This Amendment strengthens our long-term rights to onvansertib as a promising treatment for cancer, beginning with first-line RAS-mutated metastatic colorectal cancer,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “We are pleased to be entering into this agreement with NMS, which reflects our shared commitment to bringing onvansertib to patients with high unmet need.”

“We look forward to working with Cardiff to advance onvansertib into a global Phase 3 study in first-line RAS-mutated metastatic colorectal cancer and to bring this therapy to patients,” said Hugues Dolgos, PharmD, Chief Executive Officer of NMS Group S.r.l.

The Parties clarified and expanded on the royalty structure in the License Agreement. The agreement also includes development objectives related to Cardiff’s upcoming Phase 3 program, as well as rights for NMS to appoint a Board observer and join Cardiff’s Scientific Advisory Board.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated mCRC. In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC.

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. Cardiff’s 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 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.

About NMS
NMS is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative oncology therapies. Building on a long-standing heritage in cancer biology and drug discovery, NMS combines a focused clinical-stage small-molecule portfolio with a differentiated ADC platform and an active discovery engine generating first-in-class oncology programs. NMS has operations in Italy, the United States, China and Hong Kong.

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.

For more information regarding Cardiff, please visit https://www.cardiffoncology.com.

Cardiff Investor Contact:
Candice Masse
Astr Partners
[email protected]

Cardiff Media Contact:
Amy Bonanno
Lyra Strategic Advisory
[email protected]

For more information regarding NMS, please visit https://www.nervianoms.com/

NMS Media Contact:
[email protected]

Addus HomeCare to Acquire AccentCare Personal Care Division for $275 Million

Posted on September 14, 2026September 14, 2026 by cpatches

Addus HomeCare (NASDAQ: ADUS) is expanding its footprint in the home-based care market with an agreement to acquire the personal care division of AccentCare for approximately $275 million.

The transaction covers AccentCare’s personal care operations outside New York and does not include its home health or hospice businesses. The acquired operations serve an average daily census of approximately 13,700 clients across 10 states and are expected to contribute roughly $280 million in annualized revenue to Addus.

Addus said the deal would increase its revenue base by approximately 19% and is expected to be accretive to financial results. The company plans to fund the acquisition through a combination of cash on hand and borrowings under its revolving credit facility.

Expanding Scale in Personal Care

Personal care is already the largest part of Addus’ business.

Unlike skilled home health, which typically involves nurses or therapists providing medically necessary services, personal care generally helps patients with activities of daily living such as bathing, dressing, meal preparation and mobility.

Addus primarily serves elderly, chronically ill and disabled individuals who might otherwise be at greater risk of hospitalization or institutional care. Its payors include government agencies, managed care organizations, insurers and private-pay clients.

That business has also been the company’s primary growth engine. Personal care represented 78.4% of Addus revenue in the second quarter of 2026, while organic revenue in the segment increased 6.8% from a year earlier. Addus has benefited from both increased service volumes and reimbursement increases in important markets including Texas and Illinois.

The AccentCare transaction adds considerable scale to that existing operation.

More Density — and Six New States

The acquisition strengthens Addus in four states where it already has significant personal care operations: Texas, Illinois, California and Arizona.

It also adds operations in Colorado, Georgia, Minnesota, Pennsylvania, Tennessee and Washington, giving Addus entry into six additional markets through the transaction.

For a labor-intensive business like home care, geographic density can matter. Larger local operations can improve caregiver recruiting, scheduling and administrative efficiency while also making a provider more important to managed care organizations and other payors looking for partners capable of serving broad patient populations.

Addus Chairman and CEO Dirk Allison said the acquisition would deepen the company’s presence in key markets while strengthening its ability to work with managed care and value-based care partners.

After the transaction, Addus will be adding those operations to an organization that already serves roughly 62,500 consumers through 264 locations across 24 states.

Why Home-Based Care Continues to Attract Buyers

The transaction also reflects a broader consolidation trend across home-based healthcare.

The long-term investment case is relatively straightforward: the U.S. population is aging, many patients would prefer to receive care at home, and home-based services can often be less expensive than institutional settings such as skilled nursing facilities.

Those characteristics have continued to attract strategic buyers and private-equity-backed operators despite a more difficult reimbursement and labor environment. Industry data show 55 home health and hospice transactions were announced during the first half of 2026, only modestly below the 58 transactions recorded during the same period last year.

Personal care can be particularly attractive because demand is tied closely to long-term demographic trends rather than episodic medical procedures.

The business is not without challenges. Recruiting and retaining caregivers remains difficult across the industry, while reimbursement levels — particularly in Medicaid-funded programs — can have a substantial impact on margins. Buyers have consequently become more selective, placing greater emphasis on operating quality, reimbursement exposure, compliance and local market density.

That environment tends to favor larger operators with established infrastructure and access to capital.

Addus Has Been an Active Consolidator

The AccentCare deal is consistent with a strategy Addus has been pursuing for several years.

The company completed three acquisitions during 2025 and has continued adding operations in 2026, including personal care assets in Indiana. Management has repeatedly said acquisitions remain an integral component of its growth strategy, particularly where transactions allow Addus to increase density in existing markets or enter attractive new geographies.

On the company’s most recent earnings call, Allison said Addus was seeing an increased number of personal care businesses come to market as sellers became more comfortable with the reimbursement environment.

He also indicated that the company remained active in evaluating transactions, suggesting the AccentCare agreement may be part of a broader consolidation strategy rather than a one-off expansion.

The $275 million purchase price is also significant relative to the approximately $280 million in annualized revenue Addus expects to acquire, although revenue alone does not indicate the profitability or ultimate economics of the transaction.

AccentCare Narrows Its Focus

For AccentCare, the agreement represents a partial portfolio reshaping rather than an exit from home-based healthcare.

The company will retain its home health, palliative care and hospice businesses, which together form a large national post-acute care platform. AccentCare says it serves more than 200,000 patients and clients annually across more than 280 locations in 30 states and the District of Columbia.

AccentCare CEO Laura Tortorella said Addus was a natural owner for the personal care operation because of its focus and scale in the segment, while the transaction allows AccentCare to continue concentrating on its remaining care businesses.

Building a Larger Home-Care Platform

For Addus, the strategic rationale is primarily about scale.

The company is adding approximately 13,700 daily clients, $280 million of annualized revenue and a broader geographic footprint to a personal care business that already represents nearly four-fifths of its revenue.

That scale could become increasingly important as home-based healthcare evolves toward larger managed-care relationships and value-based reimbursement arrangements. Larger operators are generally better positioned to invest in technology, caregiver recruitment, compliance and administrative infrastructure while serving patients across multiple markets.

The transaction still requires regulatory approvals and customary closing conditions, and Addus has not yet provided a specific closing date.

If completed as planned, however, the AccentCare acquisition would further establish Addus as one of the larger multi-state personal care providers at a time when demographic trends, healthcare costs and patient preferences continue pushing more care into the home.

Release – GeoVax Provides Nasdaq Listing Update and Reaffirms Focus on Advancing Strategic Priorities

Posted on September 10, 2026September 10, 2026 by [email protected]

Research News and Market Data on GOVX

ATLANTA, GA – September 10, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against high-consequence infectious diseases and solid tumor cancers, today provided an update regarding its Nasdaq listing status and reaffirmed its continued focus on advancing the Company’s key development and strategic priorities.

As previously disclosed, GeoVax requested a hearing before the Nasdaq Hearings Panel (the “Panel”) to appeal the delisting determination the Company received on August 27, 2026, relating to the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The hearing has been scheduled for October 13, 2026.

The Company’s hearing request has stayed any suspension or delisting action pending the hearing and the expiration of any extension period that may be granted by the Panel following the hearing. Accordingly, GeoVax’s common stock is expected to continue to trade on The Nasdaq Capital Market under the symbol “GOVX” at least through that period. At the hearing, GeoVax intends to present its plan to regain and maintain compliance with the applicable Nasdaq listing standards.

David Dodd, Chairman and Chief Executive Officer of GeoVax, commented, “We remain committed to maintaining GeoVax’s Nasdaq listing and look forward to presenting our compliance plan to the Hearings Panel. Importantly, the Nasdaq process does not change our strategic priorities or our focus on execution. We continue to advance GEO-MVA toward its planned pivotal Phase 3 clinical program, pursue opportunities to strengthen our manufacturing and global preparedness capabilities, and engage potential strategic, funding and development partners across our portfolio.”

Mr. Dodd continued, “Our focus remains on building long-term value from GeoVax’s vaccine and immuno-oncology programs while addressing the Company’s near-term corporate and financing priorities. We believe the progress across our programs, together with the growing emphasis on vaccine supply resilience, biodefense preparedness and expanded global access, provides a strong foundation for our continued efforts.”

Continued Focus on Key Strategic Priorities

GeoVax’s priority program is GEO-MVA, an investigational 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 addressing the need for expanded orthopoxvirus vaccine supply and biodefense preparedness.

In parallel, GeoVax continues to pursue manufacturing and product innovations intended to support broader access and preparedness, while evaluating strategic partnerships and funding opportunities aligned with its development priorities.

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.

The Company also maintains a broader MVA-based vaccine platform and intellectual property portfolio addressing high-consequence infectious diseases and global health preparedness.

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 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 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 continue and 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.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – MAIA Biotechnology Delivers Oral and Poster Presentations Showcasing Next-Generation Telomere-Targeting Cancer Therapies at IRT 2026

Posted on September 10, 2026September 10, 2026 by [email protected]

Research News and Market Data on MAIA

September 10, 2026 8:15am EDT Download as PDF

Next-generation divalent agents show increased anticancer activity in preclinical in vitro and in vivo models

CHICAGO, Sept. 10, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced its presentation of a poster featuring its second-generation telomere-targeting anticancer drug candidates at the recent XXVI International Round Table on Nucleosides, Nucleotides and Nucleic Acids (IRT 2026) held in Barcelona, Spain.

MAIA’s lead drug candidate, ateganosine, is a first-in-class telomere-targeting therapy designed to selectively damage cancer-cell telomeres while activating the body’s antitumor immune response. The poster and oral presentations highlighted both ateganosine’s novel mechanism of action and MAIA’s next-generation divalent telomere-targeting drug candidates, which combine ateganosine with a complementary DNA-targeting agent in a single prodrug molecule. These next-generation candidates are designed to attack tumors through multiple mechanisms, with the goal of delivering greater efficacy than ateganosine alone.

“Our presentations at IRT 2026 reflect the continued scientific progress of our telomere-targeting platform and significant scientific interest in our research,” said Vlad Vitoc, M.D., Founder and CEO of MAIA. “Our next-generation program is designed to expand the therapeutic potential and versatility of our science and support our long-term strategy of developing differentiated therapies that address significant unmet medical needs.”

“It was an honor to participate at IRT 2026, where we shared how we are advancing our telomere-targeting platform with next-generation prodrug molecules designed to enhance antitumor activity,” said Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA. “By evaluating multiple molecular designs in complementary cell-based studies and preclinical in vivo tumor models, we have identified structural features associated with the strongest antitumor activity. These findings are helping us optimize our next-generation therapies while further validating the potential of our platform to induce durable antitumor immune responses.”

“IRT 2026 provided an important opportunity to share the progress of our next-generation telomere-targeting programs with leading researchers in the field and to discuss how these advances could translate into new therapeutic approaches for cancer,” said Victor Zaporojan, M.D., Executive Medical Director of MAIA Biotechnology. “The data presented at the conference demonstrate the breadth of our platform beyond ateganosine and reinforce our strategy of developing increasingly potent and optimized molecules that leverage telomere biology to selectively target cancer cells. We believe this work further strengthens the scientific foundation for expanding MAIA’s pipeline across multiple tumor types.”

MAIA’s presentations:

Oral: “Novel Divalent Cancer RedOx Activatable Nucleoside Prodrugs as Potent Anticancer Modalities”
Poster: “New Telomere-Targeting Dual-Pharmacophore Dinucleotide Prodrugs for Anticancer Therapy”

MAIA was a sponsor of IRT 2026. MAIA’s IRT 2026 poster is available at maiabiotech.com/publications.

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

About 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
[email protected]

Source: MAIA Biotechnology, Inc.

Released September 10, 2026

Release – GeoVax Welcomes Launch of Global Mpox Vaccine Stockpile, Highlights GEO-MVA Readiness to Support Diversified Global Supply

Posted on September 9, 2026September 9, 2026 by [email protected]

Research News and Market Data on GOVX

Gavi-funded, ICG-Coordinated Initiative Establishes Long-Term Infrastructure for Timely and Equitable Mpox Vaccine Access During Outbreaks

New Stockpile Framework Supports Sustainable Supply and Long-Term Global Preparedness

ATLANTA, GA – September 9, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today welcomed the launch of a new global mpox vaccine stockpile designed to provide countries with timely, equitable and sustainable access to vaccines during future outbreaks.

In a September 2 announcement, the World Health Organization (WHO) highlighted the initiative, which was launched on August 27 and is funded by Gavi (the Vaccine Alliance) and coordinated through the International Coordinating Group (ICG) on Vaccine Provision, whose partners include WHO, UNICEF, Médecins Sans Frontières (MSF) and the International Federation of Red Cross and Red Crescent Societies (IFRC). The stockpile is scheduled to begin operations later this month and establishes a long-term mechanism for global mpox vaccine access and outbreak response.

“Establishing a dedicated global mpox vaccine stockpile is an important step forward in moving from reactive outbreak response toward sustained preparedness,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Equitable access requires more than having vaccines available after an outbreak begins. It requires durable procurement infrastructure, sufficient vaccine supply, and the ability to rapidly deliver vaccine protection where it is needed. We applaud WHO, Gavi and the ICG partners for establishing this important mechanism and look forward to engaging with global health partners as our mpox vaccine candidate, GEO-MVA, advances toward pivotal Phase 3 evaluation and potential future supply.”

The new stockpile builds upon the Access and Allocation Mechanism established during the 2024 mpox public health emergency and responds to persistent barriers to vaccine access experienced during recent outbreaks. WHO has identified securing a robust product mix of vaccines and supplies and supporting market-shaping efforts to promote longer-term sustainable access to mpox vaccines among the stockpile’s strategic objectives. These objectives underscore the importance of reliable and diversified vaccine supply as part of sustained global preparedness.

The ICG mechanism has been used for decades to coordinate emergency vaccine supplies for epidemic-prone diseases. The addition of mpox establishes a durable framework through which international health organizations, donors, countries and vaccine manufacturers can support preparedness and rapid outbreak response.

GEO-MVA: Advancing Toward Pivotal Phase 3

GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of mpox and smallpox. The Company has completed key manufacturing, regulatory, clinical and preclinical milestones supporting planned initiation of its pivotal Phase 3 immune-bridging study in the fourth quarter of 2026.

GEO-MVA program readiness includes:

Manufacturing Readiness: GMP clinical product has been manufactured, filled, packaged and released for use in the pivotal clinical study.
Regulatory Alignment: European Medicines Agency (EMA) Scientific Advice supports an expedited immune-bridging development pathway comparing GEO-MVA with the licensed MVA-BN vaccine.
Clinical Readiness: CRO engagement and clinical-site identification are advancing in support of the targeted approximately 500-participant pivotal study.
Preclinical Support: Comparative nonclinical studies have generated orthopoxvirus-specific immune responses and neutralizing-antibody data supporting the planned immune-bridging strategy.

As the new global stockpile infrastructure develops, GeoVax believes additional qualified MVA vaccine sources can help expand supply availability, manufacturing capacity and preparedness for future outbreaks. The Company is engaging government agencies and international preparedness organizations regarding future procurement requirements and the potential role of GEO-MVA as an additional source of MVA vaccine supply.

“Creating a sustainable procurement mechanism is an important part of preparedness, but preparedness also requires sufficient and reliable vaccine supply,” Dodd continued. “Our objective with GEO-MVA is to contribute a reliable additional source of MVA vaccine capacity that can strengthen global supply resilience and provide governments and international health organizations with greater supply flexibility.”

Extending Access Through Next-Generation MVA Technologies

Beyond advancing GEO-MVA toward potential registration and supply, GeoVax is pursuing technologies intended to address additional barriers to global vaccine access and administration. These efforts include development of MVA-X, a next-generation MVA vaccine approach targeting single-dose protection; advancement of continuous-cell-line manufacturing intended to support scalable production; and evaluation of microarray-based delivery technologies that could potentially simplify vaccine administration and facilitate broader deployment.

“The launch of this global stockpile represents a significant advance in the infrastructure for equitable mpox vaccine access and outbreak response,” Dodd said. “The next challenge is ensuring that the vaccines supporting that stockpile can be manufactured at scale and deployed as efficiently and broadly as possible. Our longer-term MVA strategy is focused on that entire continuum – from expanding supply, to pursuing single-dose protection, to simplifying how vaccines may ultimately be administered in the field.”

“As GEO-MVA progresses toward pivotal Phase 3 evaluation, we look forward to working with Gavi, WHO, the ICG and other international health organizations toward the shared objective of expanding sustainable and equitable access to mpox vaccines worldwide,” Dodd added.

About GEO-MVA

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency, GeoVax is pursuing an immune-bridging development strategy intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.

GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply and scalable production capabilities. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional source of MVA vaccine supporting biosecurity and orthopoxvirus preparedness.

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 fourth quarter 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 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

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Eledon Pharmaceuticals Announces Presentation at the International Congress of The Transplantation Society

Posted on September 9, 2026September 9, 2026 by [email protected]

Research News and Market Data on ELDN

September 9, 2026

PDF Version

IRVINE, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation highlighting the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection will take place at the upcoming International Congress of The Transplantation Society in Sydney, Australia, from September 20–23, 2026.

Details of the presentation are below:

Oral Presentation

Title: Phase 2 BESTOW trial and the BESTOW EXTENSION: Evaluating the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection

Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview

Session Title: Novel immunosuppression

Session Date and Time: Tuesday, September 22, 2026, from 8:00AM to 9:00AM AEST

Session Room: Room C4.9

Presentation Time: 8:00AM AEST

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40L biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Release – Cocrystal Pharma Announces Last Subject Dosed in Phase 1b Human Challenge Study Evaluating CDI-988 for Norovirus Prevention and Treatment

Posted on September 9, 2026September 9, 2026 by [email protected]

Research News and Market Data on COCP

September 09, 2026

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No serious adverse events reported to date

Preliminary efficacy results expected in late 2026 or early 2027

MIAMI, Fla. And BOTHELL, Wash., Sept. 09, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a biotechnology company developing novel therapeutics to meet the growing global need for effective, safe antiviral treatments, today announced that the last subject has been dosed in its Phase 1b norovirus challenge study (NCT07198139) evaluating CDI-988 as both a preventive and treatment for norovirus infections.

CDI-988 is the first oral antiviral drug candidate developed for norovirus acute gastroenteritis and is designed to inhibit viral replication in all known norovirus strains. CDI-988 completed a Phase 1 clinical trial in Australia, with data showing CDI-988 was safe and well tolerated in humans, with no serious adverse events reported.

“Completion of this critical milestone brings us closer to addressing one of the most pressing unmet needs in infectious disease,” said James Sapirstein, Chief Executive Officer of Cocrystal Pharma. “Norovirus imposes an enormous burden on patients and health systems, with particular risk in settings such as hospitals, nursing homes, cruise ships, schools and military facilities. We look forward to reporting preliminary results near the end of 2026 or early 2027 and to advancing CDI-988 as a potential first-in-class oral antiviral for norovirus.”

The Phase 1b randomized, double-blind, placebo-controlled study was conducted at Emory University School of Medicine and enrolled healthy subjects ages 18-49, who were infected with the norovirus GII.2 (Snow Mountain Virus) strain and orally administered CDI-988 or placebo. The primary endpoint is efficacy versus placebo in reducing the incidence of clinical symptoms. Secondary endpoints include reduction of viral shedding and disease severity, as well as safety and pharmacokinetic profiles.

“Reaching last-subject-dosed in the first clinical trial of a direct-acting antiviral specifically targeting norovirus is a significant achievement for our team,” said Sam Lee, Ph.D., President and Chief Scientific Officer of Cocrystal Pharma. “The efficacy and safety data from this study are expected to provide a strong rationale for further clinical advancement of CDI-988.”

CDI-988 previously demonstrated favorable safety and tolerability in a Phase 1 study across all dose levels, including the highest dose of 1200 mg administered. The 1200 mg dose, established as safe in the earlier Phase 1 dose-escalation study in healthy volunteers conducted in Australia, is the dose being administered to healthy volunteers who are then infected with norovirus in the ongoing Phase 1b challenge study.

About Norovirus

With an estimated 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare’s most pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. Noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 deaths annually in children in the developing world.

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancing of CDI-988 as a potential first-in-class oral antiviral for norovirus. Words such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” and “expect,” as they relate to the Company, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, risks arising from the research into a related virus was not done in animals and was necessarily early stage, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Nicolas Johnson
Russo Partners
[email protected]
(303) 482-6405

Media Contact:
David Schull
Russo Partners
[email protected]
(858) 717-2310

SelectQuote (SLQT) – Cash Flow Inflection Takes Center Stage

Posted on August 26, 2026August 26, 2026 by [email protected]

Wednesday, August 26, 2026

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

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

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

Q4 profitability improves despite softer revenue. Fiscal fourth quarter revenue declined 7% to $321.7 million from $345.1 million in the prior-year period, while adj. EBITDA increased to $11.9 million from $2.7 million. Operating cash usage also improved sharply to $3.3 million from $37.5 million a year earlier, highlighting the company’s improving cash conversion.

Healthcare Services emerges as a key earnings driver. Healthcare Services generated Q4 revenue of $193.5 million and adj. EBITDA of $12.1 million, with SelectRx membership of approximately 109,000. Importantly, prescription utilization continues to increase even as membership growth moderates, while the Olathe facility provides capacity for more than 200,000 members and meaningful opportunity for additional operating leverage.

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*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.

Moderna Doubled Today on a Cancer Vaccine Breakthrough

Posted on August 19, 2026August 19, 2026 by [email protected]

Moderna (Nasdaq: MRNA) shares more than doubled Wednesday after the company and Merck (NYSE: MRK) announced their personalized mRNA cancer vaccine met its primary and key secondary endpoints in a pivotal Phase 3 trial, the first positive late-stage result ever recorded for an individualized neoantigen cancer therapy and for any mRNA-based cancer treatment. The rally lifted biotech stocks broadly, with investors treating the result as validation for an entirely new category of oncology treatment that has been in development for more than a decade.

The trial, called INTerpath-001, enrolled 1,137 patients with completely resected stage IIB-IV melanoma, the deadliest form of skin cancer. Patients received either the vaccine, known as intismeran autogene, alongside Merck’s Keytruda, or Keytruda alone. The combination produced statistically significant and clinically meaningful improvements in recurrence-free survival, the trial’s primary endpoint, along with a secondary measure of how long patients went without their cancer spreading to distant parts of the body. No new safety signals emerged.

How the Vaccine Actually Works

What makes intismeran genuinely novel is that it is not a single, mass-produced product. Each dose is manufactured individually based on the specific mutational fingerprint of a patient’s own tumor, sequenced from surgically removed tissue, and designed to train the immune system to recognize as many as 34 distinct targets unique to that patient’s cancer. Neoantigen vaccines built on this personalized model have been discussed as a theoretical possibility in oncology for years. This is the first randomized Phase 3 trial to actually prove the concept works in a large patient population, which is precisely why the result is being described across the biotech industry as a landmark moment rather than an incremental clinical update. Notably, the trial was stopped at its first interim analysis, meaning the question of whether the vaccine ultimately extends overall survival, not just delays recurrence, remains open and could take years to fully answer. The companies have indicated they intend to pursue regulatory filings quickly, describing a timeline measured in months rather than years.

What It Means for Smaller Biotech Companies

For investors tracking small and microcap biotech, a validation event of this scale rarely stays contained to the two companies involved. Proof that personalized, sequencing-based cancer vaccines can succeed in a randomized Phase 3 trial provides real clinical and regulatory validation for an entire mechanism, and that validation tends to lift sentiment and capital allocation across every smaller company pursuing related or adjacent immuno-oncology approaches, not just the two large caps that generated today’s headline. Smaller oncology-focused biotechs, including companies like MAIA Biotechnology, both advancing their own differentiated approaches to hard-to-treat cancers, operate in exactly the kind of therapeutic environment where a breakthrough of this magnitude tends to draw renewed institutional attention to the broader category, even when their own mechanisms differ meaningfully from Moderna and Merck’s personalized vaccine platform.

This pattern is consistent with what we detailed in our recent look at the current biotech catalyst environment, where clinical breakthroughs at any point in the sector, whether at a large pharma partnership or a clinical-stage microcap, tend to reprice risk and opportunity across the entire space rather than staying isolated to a single company’s stock.

Eledon Pharmaceuticals (ELDN) – 2Q26 Reported With Several Tegoprubart Trial Updates

Posted on August 14, 2026August 14, 2026 by [email protected]

Friday, August 14, 2026

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.

2Q Financial Results Were Within Expectations. Eledon reported a 2Q26 loss of $31.6 million or $(0.27) per share. The Operating Loss of $22.9 million was close to our estimate of $22.4 million, before a charge of $9.6 million for Changes In The Fair Value of Warrant Liabilities. The Net Loss excluding the non-cash charge would have been $22 million. Cash balance on June 30, 2026 was $ $88.8 million.

Preparations For A Global Phase 3 Trial In Kidney Transplantation Continue. During 2Q26, an End-Of-Phase 2 meeting was held with the FDA to discuss the Phase 3 trial design and requirements for a BLA submission. The Phase 3 trial has been designed to test tegoprubart against tacrolimus to prevent kidney transplant rejection. It is scheduled to begin in late 2026 with a target enrollment of about 600 patients. The Primary Endpoint will be non-inferiority based on a composite of BPAR (biopsy-proven acute rejection), graft loss, and death.

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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).

Unicycive Therapeutics (UNCY) – 2Q26 Reported As OLC Moving Forward With FDA Manufacturing Inspection

Posted on August 13, 2026August 13, 2026 by [email protected]

Thursday, August 13, 2026

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.

OLC Is Moving Forward. Unicycive reported a 2Q26 loss of $1.7 million, or $(0.06) per share. The Operating Loss of $10.1 million was offset by $8.0 million in Change In Fair Value Of Warrant Liabilities, leading to a Net Loss To Common Shareholders of $1.7 million. Importantly, the FDA has given written notice of facility inspection to one of the OLC third-party manufacturers. Assuming the inspection results are positive, Unicycive will be able to resubmit its NDA for OLC. Cash and equivalents on June 30, 2026, were $61.4 million.

The Third-Party Inspection Could Complete The Missing Part Of The NDA. In June 2026, Unicycive received a CRL (Complete Response Letter) to its NDA for OLC. The stated reason was that the required FDA inspection of one of its third-party manufacturing vendors had not been performed. The notification of an inspection is good news that could allow the NDA to be resubmitted.

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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).

NeuroSense Therapeutics Ltd. (NRSN) – NeuroSense Announces Target Date For Canadian PrimeC Approval Application

Posted on August 11, 2026August 11, 2026 by [email protected]

Tuesday, August 11, 2026

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.

Pre-Application Process Has Been Completed. NeuroSense announced that it has completed Pre-NDS meetings with Health Canada and plans to submit a New Drug Submission (NDS) for PrimeC in its ALS indication. These meetings focused on whether the data could support approval and the submission requirements. The target date is December 2026. We see this as good news that is consistent with our expectations.

We View The Canadian NDS Process As An Important Milestone For PrimeC. The NDS application will include the Phase 2b PARADIGM trial data, with additional preclinical and supporting data. The primary endpoint in the trial showed a reduction in TDP-43 (TAR DNA-binding Protein 43, a protein that drives ALS progression and deterioration). The data also showed increased median survival, improved functional assessments, biomarkers showing slower disease progression, as well as safety and tolerability. Approval would be based on Health Canada’s analysis of these data.

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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).