Category: Healthcare

Nutriband (NTRB) – Manufacturing Milestone Allows Development To Move Forward As Expected

Posted on by slightbourne@noblecapitalmarkets.com


Friday, June 20, 2025

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

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

Preparing For AVERSA Fentanyl Clinical Testing. Nutriband and its partner Kindeva announced that it has completed commercial manufacturing processes and scale-up for AVERSA Fentanyl, its abuse-deterrent fentanyl patch. This allows the company begin manufacturing clinical supplies and filing the IND (Investigational New Drug application) for the Phase 1 clinical study within the timeframe we anticipated. Only a single Phase 1 study is needed to file the application for marketing approval.

Manufacturing Completion Is A Significant Milestone. This scale-up is a significant step that demonstrates the ability to apply Kindeva’s transdermal patch technology for commercial scale production of AVERSA Fentanyl patches. We expect the IND filing to be completed shortly, with clinical testing to follow as expected.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

MAIA Biotechnology (MAIA) – Roche Forms Supply Agreement For THIO Combination Studies

Posted on by slightbourne@noblecapitalmarkets.com


Friday, June 20, 2025

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 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.

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.

MAIA Makes Its Third Supply Agreement. MAIA announced that it has entered a supply agreement with Genentech/Roche to test THIO (ateganosine) in combination with Tecentriq (atezolizumab, Roche’s PD-L1 checkpoint inhibitor) for the treatment of several hard-to-treat cancers. MAIA now has supply agreements to test THIO in combination with checkpoint inhibitors from three global pharmaceutical companies, which we see as an indicator of interest for future partnerships.

PD-1 or PD-1L? That Is The Question. Checkpoint inhibitors block the interaction of the surface proteins PD-1 (programmed death receptor-1) with PD-1L (the programed death receptor-1 ligand). When the PD-1 receptor binds to the PD-1L ligand, it inhibits the immune response. Checkpoint inhibitors are monoclonal antibody drugs against PD-1 or PD-L1 that block this interaction, allowing cancer cells to be recognized by a patient’s immune system and killed.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

GoHealth (GOCO) – Noble Virtual Conference Highlights

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, June 18, 2025

Patrick McCann, CFA, Research Analyst, Noble Capital Markets, Inc.

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

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

Highlights from Noble’s Emerging Growth Virtual Conference. Vijay Kotte, CEO, presented at Noble’s Virtual Equity conference June 4 & 5th. Mr. Kotte highlighted the company’s proprietary technology, consumer-centric Medicare policy platform, and gave an update on recent developments. A rebroadcast is available here.

Purpose-built technology. Mr. Kotte emphasized the company’s use of proprietary machine learning tools alongside licensed agents to tailor recommendations to each consumer’s needs. With Medicare beneficiaries typically choosing from 40–50 plans, this technology plays a key role in efficiently identifying the most suitable options.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Lilly Acquires Verve to Advance One-Time Gene Therapy for Heart Disease

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Lilly acquires Verve Therapeutics to develop one-time gene editing treatments for cardiovascular disease.
– Verve’s VERVE-102 targets the PCSK9 gene to lower cholesterol with a single dose.
– Deal strengthens Lilly’s position in cardiometabolic and genetic medicine sectors.

In a move set to transform the landscape of cardiovascular care, Eli Lilly and Company (NYSE: LLY) announced its acquisition of Verve Therapeutics, Inc. (Nasdaq: VERV), a clinical-stage biotechnology firm focused on gene editing treatments for atherosclerotic cardiovascular disease (ASCVD). The transaction, valued at up to $1.3 billion, is aimed at accelerating the development of groundbreaking one-time treatments that could offer lifelong benefits to patients with high cardiovascular risk.

Verve’s lead program, VERVE-102, is a promising in vivo gene editing therapy targeting the PCSK9 gene—an established regulator of LDL cholesterol levels. Currently in a Phase 1b clinical trial, VERVE-102 has been granted Fast Track designation by the FDA and is designed for individuals with heterozygous familial hypercholesterolemia (HeFH) and certain forms of premature coronary artery disease. If successful, the treatment could eliminate the need for chronic medication by permanently modifying liver DNA to lower harmful cholesterol levels.

“This acquisition marks a bold step toward shifting cardiovascular care from lifelong therapy to one-time cures,” said Ruth Gimeno, Lilly’s Group VP of Diabetes and Metabolic Research and Development. “Combining Lilly’s global scale with Verve’s scientific innovation positions us to lead the next generation of cardiometabolic treatment.”

The purchase agreement includes an upfront cash payment of $10.50 per share—totaling approximately $1.0 billion—along with an additional contingent value right (CVR) worth up to $3.00 per share, tied to future clinical milestones. If all conditions are met, the total deal value could reach $1.3 billion. The acquisition represents a 113% premium over Verve’s 30-day average stock price prior to the announcement.

Founded just seven years ago, Verve has rapidly built a pipeline of one-time gene editing therapies aimed at the three core lipid-related drivers of ASCVD: low-density lipoproteins, triglycerides, and lipoprotein(a). In addition to VERVE-102, Verve is advancing VERVE-201 (targeting ANGPTL3 for refractory hypercholesterolemia) and VERVE-301 (targeting LPA for lipoprotein(a)-related risks).

“Joining Lilly is the natural next step in our mission to bring one-time gene editing treatments to people with cardiovascular disease,” said Dr. Sekar Kathiresan, co-founder and CEO of Verve. “Lilly’s world-class capabilities will significantly accelerate our clinical development and commercial reach.”

The deal is expected to close in Q3 2025, pending customary regulatory approvals and the successful tendering of Verve shares. Several major shareholders, including co-founders and investors affiliated with GV (formerly Google Ventures), have already agreed to tender approximately 17.8% of Verve’s outstanding stock.

For Lilly, this acquisition reinforces its strategic commitment to expanding in cardiometabolic and genetic medicine sectors—areas already central to its long-term growth strategy. As the race to develop durable, gene-based solutions for chronic illnesses intensifies, the Verve acquisition could position Lilly at the forefront of an entirely new therapeutic paradigm.

Ocugen (OCGN) – Stargardt Disease Program Moves To Phase 2/3 Trial

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 17, 2025

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

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

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

OCU410ST Cleared To Begin Confirmatory Trial. Ocugen announced that the FDA has approved its IND amendment to allow OCU410ST to begin its Phase 2/3 pivotal confirmatory trial. This will become the second Ocugen product to move into a Phase 2/3 confirmatory trial, and keeps the company on schedule to meet its goal of submitting three BLAs in the three years between 2026-28.

Brief Description of Stargardt Disease. Stargardt disease is a rare autosomal recessive disease caused by mutations in the ABCA4 gene in the retina. Progressive loss of photoreceptor cells in the retina typically starts at a young age, leading to blindness. Ocugen has received Orphan Drug designation and Rare Pediatric Disease Designation (RPDD) for diseases associated with ABCA4 diseases, including Stargardt, retinitis pigmentosa 19, and cone-rod dystrophy 3.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

GeoVax Labs (GOVX) – EMA Allows GEO-MVA To Leapfrog To Phase 3 Trial In EU

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 17, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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

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

GEO-MVA Gets An Accelerated Pathway To European Approval. GeoVax announced that it has received guidance from the EMA (European Medicines Agency) that provides an accelerated path to approval for GEO-MVA, its modified vaccinia ankara (MVA) based vaccine for smallpox/Mpox. It will only be required to conduct immune-bridging and toxicity studies before moving directly to Phase 3. This cuts several years from development time and saves many millions of dollars in clinical expenses.

Only Phase 3 Will Be Needed. The Committee for Medicinal Products for Human Use (CHMP) of the EMA stated that only requirements before beginning a Phase 3 study will be a non-clinical immuno-bridging and toxicity studies. No Phase 1 or Phase 2 studies are required. An MAA regulatory application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine (Imvanex or Jynneos, from Bavarian Nordic). The proposed endpoints of the study would be demonstration of immunogenicity to show non-inferiority.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Supernus Pharmaceuticals Acquires Sage Therapeutics in $795M Deal, Boosting Neuropsychiatric Pipeline

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Supernus to acquire Sage for up to $12.00 per share, combining upfront cash and milestone-based CVRs.
– Deal adds FDA-approved ZURZUVAE® for postpartum depression to Supernus’ growing CNS portfolio.
– Transaction expected to be accretive by 2026, with $200M in annual cost synergies forecast.

Supernus Pharmaceuticals (NASDAQ: SUPN) has announced a strategic acquisition of Sage Therapeutics (NASDAQ: SAGE) in a deal worth up to $795 million, signaling a bold expansion into the neuropsychiatric space. This all-cash transaction, set to close in Q3 2025, brings to Supernus a key commercial asset—ZURZUVAE® (zuranolone)—as well as access to Sage’s central nervous system (CNS) discovery platform.

The proposed deal includes an upfront payment of $8.50 per share in cash, representing approximately $561 million, and a non-tradable contingent value right (CVR) worth up to an additional $3.50 per share. The CVR milestones are tied to commercial performance of ZURZUVAE in the U.S. and its future launch in Japan.

This acquisition is a transformative step for Supernus, best known for CNS products such as Qelbree®, GOCOVRI®, and ONAPGO™. With the addition of ZURZUVAE—the first and only FDA-approved oral treatment for postpartum depression—the company further solidifies its footprint in the growing neuropsychiatry market. Supernus CEO Jack Khattar stated that the move “adds a fourth growth product” and “diversifies our sources of future growth.”

ZURZUVAE was developed by Sage and commercialized in partnership with Biogen. Under the collaboration, Supernus will recognize revenue equal to 50% of U.S. net sales. In 2024, that share amounted to $36.1 million, with $13.8 million already reported in Q1 2025—indicating an accelerating ramp that Supernus is now positioned to capitalize on.

From a financial perspective, the deal is expected to be significantly accretive starting in 2026, supported by estimated annual cost synergies of up to $200 million. Supernus will fund the transaction entirely through its existing cash reserves, avoiding equity dilution or new debt issuance. For investors, this adds a layer of financial discipline and long-term earnings potential.

Sage’s leadership, including CEO Barry Greene, called the deal the result of a comprehensive strategic review aimed at maximizing shareholder value. Greene highlighted the company’s mission in brain health and praised the Sage team’s work in delivering two first-in-class therapies for postpartum depression.

In terms of integration, Sage’s R&D pipeline and commercial operations will fold into Supernus’ existing infrastructure—a move expected to streamline costs and accelerate product development. The combined entity will also benefit from a strengthened CNS platform and expanded market reach.

While the deal is subject to customary closing conditions, including regulatory approvals and a majority tender of Sage’s outstanding shares, both companies anticipate a smooth closing process. Supernus plans to provide revised financial guidance following deal completion in Q3.

This acquisition reflects a strategic shift in mid-cap biopharma, where clinical differentiation and near-term revenue growth are prioritized. For small- and micro-cap investors, it also signals continued consolidation in the CNS space—where innovation, reimbursement potential, and strong commercialization strategy drive M&A activity.

Unicycive Therapeutics (UNCY) – FDA Finds Deficiencies At Third-Party Manufacturing Subcontractor – Approval Could Be Delayed

Posted on by slightbourne@noblecapitalmarkets.com


Wednesday, June 11, 2025

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

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

Approval May Come After The PDUFA Date Of June 28. Unicycive announced that an FDA inspection has found deficiencies with the cGMP (certified Good Manufacturing Practice) compliance at a third-party manufacturing subcontractor. The company’s product, OLC, is manufactured by a contract manufacturer with other subcontractors. The deficiency does not involve the active pharmaceutical compound (APC) and may be related to final finishing and packaging operations.

Good News and Bad News. The FDA stated that the manufacturing deficiencies must be resolved before product label discussions can proceed. We interpret this to mean that the FDA review of the clinical data has been completed, the manufacturing inspection was conducted, and product labeling remains as the final step before approval. Although the manufacturing deficiencies have stopped the labeling discussion, we expect NDA approval when corrected.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Concentra Biosciences to Acquire Elevation Oncology in Strategic Biotech Merger

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Concentra Biosciences is acquiring Elevation Oncology for $0.36 per share in cash plus a CVR tied to future financial milestones.
– Elevation’s board supports the deal; insiders holding 5.1% have committed to tender their shares.
– Shareholders could earn additional payouts based on net cash reserves and proceeds from potential asset sales.

In a strategic move within the biotech sector, Concentra Biosciences has announced plans to acquire Elevation Oncology, a clinical-stage oncology firm known for its targeted cancer therapies. The transaction, which was unveiled Monday, values Elevation at $0.36 per share in cash. In addition to the upfront payment, shareholders will receive a contingent value right (CVR) tied to future financial outcomes.

This acquisition marks a significant shift for Elevation Oncology, which has focused its efforts on developing precision treatments for solid tumors with limited current treatment options. The deal aligns with Concentra’s expansion strategy in oncology innovation, particularly in addressing high-need patient populations.

Under the terms of the agreement, Elevation stockholders will receive a cash payout of $0.36 per share, with an additional CVR providing potential future compensation. The CVR includes two main components: shareholders could benefit from any closing cash above $26.4 million and from a share of future net proceeds related to the disposition of EO-1022, a clinical asset, if sold within a year of closing. The CVR will remain active for up to five years following the merger.

Elevation’s board of directors has unanimously backed the agreement, emphasizing that the proposed terms serve the best interest of shareholders. A wholly owned subsidiary of Concentra is expected to begin a formal tender offer by June 23, 2025. For the acquisition to proceed, a majority of Elevation’s outstanding shares must be tendered, and at least $26.4 million in net cash must remain on hand after deducting liabilities, transaction costs, and specific payments.

Support for the deal is already emerging. Elevation’s leadership and certain insiders, who collectively own about 5.1% of the company’s shares, have signed agreements to support and tender their holdings. If all conditions are met, the merger is expected to finalize by July 2025.

The acquisition arrives at a pivotal moment for Elevation Oncology. The company has faced challenges navigating the complex landscape of cancer drug development and commercialization. Partnering with Concentra provides a pathway to both secure value for current shareholders and potentially advance EO-1022 and other clinical assets under stronger financial and operational support.

Legal counsel for Elevation Oncology is being provided by Fenwick & West LLP, while Gibson, Dunn & Crutcher LLP is advising Concentra.

This merger is part of a broader trend in the biotech sector, where companies with innovative pipelines seek strategic partnerships or acquisitions to accelerate growth and mitigate risk. For Concentra, the deal expands its reach into solid tumor therapeutics—a market with both high clinical need and strong commercial potential.

As the healthcare sector continues to evolve, this acquisition underscores the importance of collaboration in bringing forward novel cancer treatments and delivering shareholder value in a highly competitive and capital-intensive industry.

Take a moment to take a look at Noble Capital Markets’ Biotechnology and Life Sciences Research Analyst Robert Leboyer’s coverage list.

MAIA Biotechnology (MAIA) – THIO Update Shows Another Increase In Overall Survival

Posted on by slightbourne@noblecapitalmarkets.com


Friday, June 06, 2025

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 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.

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 THIO-101 Update Presented AT ASCO. MAIA presented updated data from its THIO-101 trial showing median overall survival increased as more patients advanced through treatment. Data presented showed a median overall survival of 17.8 months for patients receiving the combination of THIO and the PD-1 inhibitor, Libtayo (cemiplimab, a checkpoint inhibitor from Regeneron), an increase from 16.9 months reported in January 2025.

Survival Improved As More Patients Completed The Study. Updated data was presented at the American Society for Clinical Oncology (ASCO) 2025 Annual Meeting, with more patients treated for longer periods. The median overall survival reported was 17.8 months compared with the expected survival of 5.8 months for standard of care therapy. This was an improvement from 16.9 months (n=22 patients) reported in January 2025 and 10.6 months (n=19 patients) reported in August 2024.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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. 

Release – MAIA Biotechnology Announces New Responder in Non-Small Cell Lung Cancer Phase 2 Clinical Trial

Posted on by slightbourne@noblecapitalmarkets.com

June 05, 2025 11:10am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced a new partial response (PR) was identified in a patient after 20 months of treatment in its Phase 2 THIO-101 clinical trial evaluating ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy. A partial response is defined as a decrease in tumor size of at least 30%.

“The patient remained on treatment and we observed stable disease for more than twenty months before the partial response was identified, highlighting the efficacy, safety and low toxicity of the treatment. Extended-term responses like this are not often seen in heavily pretreated patients in hard-to-treat diseases such as NSCLC, where the prognosis for the advanced-stage of the disease is typically poor,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “We confirmed this response with a second scan, and we are highly confident that ateganosine could become an outstanding therapeutic alternative for third-line NSCLC patients.”

THIO-101 third line (3L) data cutoff from May 15, 2025, showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine in parts A and B of the trial. At the data cutoff, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.1

MAIA has announced the trial design for an expansion of its THIO-101 pivotal Phase 2 trial in NSCLC to assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous CPI treatment and chemotherapy.

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.

1 Girard N, et al. J Thorac Onc 2009;12:1544-1549.

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

Source: MAIA Biotechnology

Released June 5, 2025

Release – MAIA Biotechnology Announces Positive Efficacy Update for Phase 2 THIO-101 Clinical Trial in Non-Small Cell Lung Cancer

Posted on by slightbourne@noblecapitalmarkets.com

June 05, 2025 8:04am EDT

Median overall survival (OS) from ateganosine (THIO) treatment extends to 17.8 months in latest data

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, ateganosine (THIO), sequenced with Regeneron’s immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy.

As of May 15, 2025, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis continues to demonstrate a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population.1 Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.2-3

“It is gratifying to see that our treatment further extends lives for these hard-to-treat patient populations, especially in third-line NSCLC treatment where patients are most resistant to therapy,” said MAIA Chairman and CEO Vlad Vitoc, M.D. “This new benchmark of 17.8 months median OS is nearly triple the recognized SOC data for third-line NSCLC found in medical literature. We believe this is a substantial indicator of the potential ateganosine has to shift the NSCLC treatment landscape.”

MAIA’s multiple potential regulatory pathways for ateganosine could provide accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.

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.

1Details on safety can be found on the previously announced ASCO 2025 poster available on MAIA’s website.
2Girard N, et al. J Thorac Onc 2009;12:1544-1549.
3A.T. Freeman et al. Curr Oncol. 2020 May 1;27(2):76–82

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

Source: MAIA Biotechnology, Inc.

Released June 5, 2025

Release – Ocugen, Inc. Announces Signing of Binding Term Sheet for the License of OCU400 Modifier Gene Therapy for Retinitis Pigmentosa in Korea

Posted on by slightbourne@noblecapitalmarkets.com

June 5, 2025

PDF Version

  • Upfront fees and near-term development milestone payments totaling up to $11 million
  • Sales milestones of $150 million or more in first 10 years of commercialization
  • Royalties equaling 25% of net sales
  • Ocugen to manufacture and supply OCU400

MALVERN, Pa., June 05, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the signing of a binding term sheet to negotiate and enter into a licensing agreement with a well-established leader in the pharmaceutical and healthcare sector in Korea, for exclusive Korean rights to OCU400—Ocugen’s novel modifier gene therapy for retinitis pigmentosa (RP).

Pursuant to the term sheet, under the license agreement Ocugen will receive upfront license fees and near-term development milestones equaling up to $11 million. The Company will be entitled to sales milestones of $1 million for every $15 million of net sales in Korea in addition to a royalty of 25% on net sales of OCU400 generated by Ocugen’s partner. Additionally, Ocugen will manufacture commercial supply of OCU400 under terms of a supply agreement.

There are an estimated 15,000 individuals in the Republic of Korea with RP. OCU400 provides the opportunity for our partner to help thousands of patients and become a leader in gene therapy in Korea.

“This regional licensing agreement is aligned with our business development strategy to partner with well-established companies in their respective countries and regions—leveraging their networks and know-how to treat as many RP patients as possible,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “A regional approach preserves Ocugen’s rights to larger geographies to maximize total patient reach while also generating return for our shareholders.”

Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 60 days.

Ocugen is currently advancing OCU400 through Phase 3 clinical development with a target Biologics License Application filing of mid-2026.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene therapies to address major blindness diseases and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the terms of the definitive license and timing of a definitive agreement or if a definitive agreement will be executed at all or the anticipated benefits to Ocugen of the definitive license agreement, qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that a definitive agreement for the license will be delayed or not executed at all, or that, if executed, it will not be on terms described above, the risk that contemplated license agreement, if executed, will not lead to the current anticipated benefits to Ocugen, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 to perform in humans in a manner consistent with nonclinical or preclinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com