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Release – MAIA Biotechnology Announces Design for Expansion of THIO-101 Phase 2 Trial in Advanced Non-Small Cell Lung Cancer

Posted on February 26, 2025February 26, 2025 by aweinsoff@channelchek.com

February 26, 2025 8:47am EST Download as PDF

Expansion study to enroll patients in the U.S. and select countries in Europe and Asia
Multiple milestones attainable for 2025

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA,” the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced the trial design for the expansion of its THIO-101 pivotal Phase 2 trial in non-small cell lung cancer (NSCLC). Following successful outcomes to date in THIO-101, the expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy.

The THIO-101 study in 3L will enroll up to 48 patients with two arms: Arm 1, continuing the evaluation of THIO sequenced with Libtayo^®(cemiplimab); and Arm 2, evaluating THIO as a monotherapy, to further gain experience of THIO in the contribution of components. Treatment cycles for patients in both arms will administer THIO on 3 consecutive days, followed by immune activation on day 4. Arm 1 will administer Libtayo on day 5. The Company plans to enroll an additional 100 patients for the registration phase of the trial. MAIA expects to conduct the trials in the U.S. and select countries in Europe and Asia.

MAIA recently announced an amended clinical supply agreement with Regeneron to include the expansion portion of THIO-101. Under terms of the amended agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients including the additional patients in the expansion and potentially, the registration studies.

“We are excited to start the expansion arm of our THIO-101 trial which is designed to determine overall response rates in third line NSCLC. We expect to have new patients enrolled in the coming weeks,” said Vlad Vitoc, M.D., CEO of MAIA. “Through THIO-101 to date, THIO has delivered unprecedented disease control, response, and survival results. Continued efficacy and safety data generated by our study could support an FDA NDA submission directly, particularly as we plan to seek an accelerated approval of THIO in the U.S.

“We have multiple milestones that we believe are attainable for 2025 and we look forward to keeping our shareholders and investors well informed of our progress on value creation,” Dr. Vitoc added.

As of January 15, 2025, data indicated that Median Overall Survival (OS) in third-line treatment was reached at 16.9 months, with 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 population¹.

________________________________
¹	Details on safety can be found on the previously announced SITC 2024 presentation available on MAIA’s website.

About THIO
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 (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO 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. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial
THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo^®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250226839348/en/

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

Source: MAIA Biotechnology, Inc.

Released February 26, 2025

Release – MAIA Biotechnology Announces Non-Brokered Private Placement of Approximately $1.43 Million

Posted on February 25, 2025February 25, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 24, 2025 4:30pm ESTDownload as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 952,300 shares of common stock at a purchase price of $1.50 per share, in a non-brokered private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.85 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to Company directors participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 26, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $1.43 million, prior to offering expenses payable by the Company. The Company closed a private placement of approximately $2.7 million on February 24, 2025 and the aggregate gross proceeds from both private placements are expected to be $4.1 million, prior to deducting offering expenses payable by the Company. The Company intends to use the combined net proceeds received from the two private placements to fund the starting cost for Part C of the Phase 2 THIO -101 clinical trial and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act or applicable state securities laws and do not have registration rights. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities issued in the Private Placement will be “restricted securities” under the U.S. Securities Act.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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 THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward-Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward-looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; (viii) the completion of the offering and (ix) the satisfaction of customary closing conditions related to the offering, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250224819364/en/

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

Source: MAIA Biotechnology, Inc.

Released February 24, 2025

Release – GeoVax Highlights the Role of MVA-Based Vaccines in Advancing Public Health Preparedness

Posted on February 24, 2025February 24, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

Last updated: 24 February 2025
Created: 24 February 2025
Hits: 46

Recent Studies Support Diversified Vaccine Strategies, Aligning with GeoVax’s MVA-Based GEO-CM04S1 for Enhanced Protection, Particularly for Immunocompromised Populations

ATLANTA, GA, February 24, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company specializing in immunotherapies and vaccines, today reaffirms the critical role that mRNA vaccines have played in combating the COVID-19 pandemic and highlights the growing recognition of the need for complementary vaccine platforms, particularly for immunocompromised patients and those requiring broader, more durable immunity.

The rapid development and deployment of mRNA vaccines were pivotal in mitigating the initial impact of the pandemic, offering a timely and effective response. However, the scientific literature continues to underscore the importance of a diversified vaccine strategy directed towards enhanced durability and expanded protection against variants for populations that may not mount a sufficiently strong immune response to a single vaccine platform. GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidates, such as GEO-CM04S1 (COVID-19), may complement other existing vaccine platforms by addressing specific challenges.

Building a More Resilient Vaccine Landscape

Recent scholarly analyses, including research from leading experts⁽¹⁾ and a strategic review by the Biomedical Advanced Research and Development Authority (BARDA)⁽²⁾, stress the importance of broadening vaccine portfolios beyond mRNA. These publications highlight areas where alternative vaccine platforms, such as viral-vector and live-attenuated vaccines, may provide advantages in durability, cellular immunity, and accessibility.

GeoVax’s MVA-based vaccines may offer an alternative approach, by utilizing a well-established vaccine vector, particularly in high-risk populations. Unlike current mRNA COVID-19 vaccines, GEO-CM04S1 expresses both the Spike (S) and Nucleocapsid (N) antigens, to elicit a broader immune response. This enhanced immunogenicity may be especially valuable for immunocompromised individuals, including transplant recipients and cancer patients, who often exhibit suboptimal responses to mRNA vaccines.

GeoVax’s MVA-based COVID-19 vaccine can serve as an important addition to the global immunization strategy by offering:

Enhanced Immune Response: The inclusion of both Spike and Nucleocapsid antigens in GEO-CM04S1 is intended to elicit a more comprehensive immune response, potentially reducing the need for frequent boosters.
Durability and Broader Variant Protection: Studies suggest measures of T-cell responses induced by GEO-CM04S1 elicit protection against emerging variants, minimizing the need for frequent reformulation.
Better Suitability for Immunocompromised Populations: Clinical trials demonstrate that GEO-CM04S1 elicits robust T-cell responses in patients unable to generate adequate antibody responses to conventional (spike-only) COVID-19 vaccines. This is critical for individuals with immune systems compromised by disease (eg cancers, genetic defects) or immunosuppressive therapies.
Scalability and Global Accessibility: GeoVax is further addressing vaccine availability with plans to transition manufacturing to a Next-Generation MVA manufacturing platform, with the potential for improved production efficiency and reduced costs, facilitating global distribution.

A Proven Technology with a Strong Safety Record

MVA was originally developed as a safer smallpox vaccine. MVA-based vaccines have been safely administered for decades. MVA’s extensive track record aligns with the U.S. Department of Health and Human Services’ (HHS) emphasis on vaccine safety, durability, and transparency. The well-documented safety and efficacy of MVA-based vaccines positions them as an important complement to existing mRNA-based approaches.

Government and Industry Support for Diversified Vaccine Strategies

Under BARDA’s $5 billion Project NextGen initiative, GeoVax was awarded a contract to conduct a 10,000-participant Phase 2b clinical trial evaluating an Omicron-updated version of GEO-CM04S1 in a comparison format against an approved mRNA COVID-19 vaccine. This study aims to validate the value of multi-antigen MVA-based COVID-19 vaccines in long-term pandemic preparedness and protection against future health threats.

Positioning for the Future of Vaccine Innovation

“The success of mRNA vaccines in responding to COVID-19 has been remarkable, but the evolving nature of infectious diseases calls for a diversified, complementary approach to immunization,” said David Dodd, Chairman & CEO of GeoVax. “Our MVA-based vaccines offer enhanced protection for those who need it most, including immunocompromised patients and populations requiring longer-lasting immunity. We are committed to advancing vaccine innovation in collaboration with public and private stakeholders.”

As the industry moves towards a more integrated and diversified vaccine ecosystem, GeoVax’s MVA-based vaccines should provide a scalable, durable, and globally accessible solution that enhances the existing landscape, ensuring broader protection for all populations.

References:

Plotkin, S. A., Robinson, J. M., Fitchett, J. R. A., & Gershburg, E. (2024). Vaccine development should be polytheistic, not monotheistic. Clinical Infectious Diseases, 79(6), 1518–1520. https://doi.org/10.1093/cid/ciae460
Parish, L. A., Rele, S., Hofmeyer, K. A., Luck, B. B., & Wolfe, D. N. (2025). Strategic and technical considerations in manufacturing viral vector vaccines for the Biomedical Advanced Research and Development Authority threats. Vaccines, 13(73). https://doi.org/10.3390/vaccines13010073

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers. The company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin^® combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. For more information about the current status of our clinical trials and other updates, visit our website: www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

austin.murtagh@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – Nutriband Receives Certificate of Registration for Trademark covering Pharmaceutical and Product Research and Development

Posted on February 21, 2025February 21, 2025 by aweinsoff@channelchek.com

Research News and Market Data on NTRB

February 21, 2025 07:00 ET

ORLANDO, Fla., Feb. 21, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ: NTRB) (NASDAQ:NTRBW), a developer of transdermal pharmaceutical products, today announced that it received the Certificate of Registration from the United States Patent and Trademark Office (USPTO) on Feb 18, 2025, for trademark registration Number 7,692,920, covering the mark “Nutriband™.” The Trademark registration covers Goods/Services: Class: 042 Product research and development, scientific research and development; biochemical research and development; pharmaceutical research and development.

The Nutriband™ trademark is integral to the commercialization of the Company’s platform technology AVERSA which can be incorporated into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. Nutriband’s lead product under development is AVERSA™ Fentanyl, an abuse deterrent fentanyl transdermal system.

Nutriband, in partnership with Kindeva Drug Delivery, is progressing towards completing the scale-up of the commercial manufacturing process for AVERSA™ Fentanyl, the first product under the AVERSA Platform that the company intends to submit for FDA approval.

According to a market analysis report by Health Advances, AVERSA™ Fentanyl has the potential to reach peak annual U.S. sales of $80 million to $200 million. This reflects the significant impact that AVERSA™ technology could have on the market for abuse deterrent pharmaceutical products.

About AVERSA™ Technology

Nutriband’s AVERSA™ abuse deterrent transdermal technology is designed to incorporate aversive agents into transdermal patches, deterring abuse by making the experience unpleasant. This technology is especially significant for drugs like fentanyl, which have a high potential for abuse. AVERSA™ aims to ensure that these essential medications remain accessible to patients who need them while enhancing their safety profiles. The AVERSA™ technology is supported by a robust intellectual property portfolio, with patents granted in the United States and several other countries including Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.

About Nutriband Inc.

Nutriband Inc. is primarily engaged in developing a portfolio of transdermal pharmaceutical products. The Company’s lead product in development is an abuse deterrent fentanyl patch that incorporates AVERSA™ technology. This technology can be integrated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites, or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024 and Forms 10-Q, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

For more information, contact:

Nutriband Inc.
Phone: 407-377-6695
Email: info@nutriband.com

Release – Ocugen to Host Conference Call on Wednesday, March 5, 2025 at 8:30 A.M. ET to Discuss Business Updates and Fourth Quarter and Full Year 2024 Financial Results

Posted on February 21, 2025February 21, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 21, 2025

PDF Version

MALVERN, Pa., Feb. 21, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s fourth quarter and full year 2024 financial results and provide a business update at 8:30 a.m. ET on Wednesday, March 5, 2025.

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

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 5045393
Webcast: Available on the events section of the Ocugen investor site.

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health 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 treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

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

Release – Unicycive Therapeutics Announces the Publication of Preclinical Data on Synergies Between Oxylanthanum Carbonate and Tenapanor in American Society of Nephrology Journal Kidney360

Posted on February 20, 2025February 20, 2025 by aweinsoff@channelchek.com

Research News and Market Data on UNCY

February 20, 2025 7:00am EST Download as PDF

Combination therapy with oxylanthanum carbonate plus tenapanor led to greater reductions in urinary phosphate excretion than either drug alone

LOS ALTOS, Calif., Feb. 20, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced the publication of preclinical data describing the benefits of combination treatment of oxylanthanum carbonate (OLC) and tenapanor on phosphate management in the American Society of Nephrology (ASN) journal, Kidney360.

The publication, entitled “Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rats,” examines the potential synergistic benefits of a combination of OLC, a phosphate binder, with tenapanor, a sodium/hydrogen exchanger 3 (NHE3) inhibitor, on urinary phosphate excretion. Data demonstrated sizeable reductions in urinary phosphate excretion (a proxy for intestinal phosphate absorption) in response to both OLC monotherapy and the combination of OLC with tenapanor.

“With approximately 75% of patients receiving maintenance dialysis failing to meet serum phosphate targets set by international Kidney Disease Improving Global Outcomes (KDIGO) guidelines, we must explore new approaches to improve control of hyperphosphatemia” said Glenn M. Chertow, M.D., M.P.H., Professor of Medicine, Stanford University School of Medicine. “Based on the results of this pre-clinical study, we believe that OLC, an investigational phosphate binder, when used alone or in combination with tenapanor, could improve control of hyperphosphatemia in patients receiving maintenance dialysis who are either unresponsive to currently available phosphate binders or intolerant to their associated adverse effects, high pill burden, and poor palatability.”

“We’re excited by these preclinical data showing a synergistic treatment effect from the combination of OLC and tenapanor. OLC, with its low pill burden and more palatable formulation, could complement tenapanor, significantly enhancing patient adherence and clinical outcomes,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Further studies in patients with end-stage kidney disease and hyperphosphatemia will be required to understand the most effective and best tolerated OLC-containing regimens, as we aim to improve long-term control of hyperphosphatemia and prevent its myriad complications.”

Key Findings:

Treatment with tenapanor alone (0.15 mg/kg) led to 12.5% lower mean urinary phosphate excretion compared to the vehicle in rats fed a high phosphorus diet.
A pooled analysis of monotherapy with OLC (0.75%, 1.5%, and 3%) demonstrated a 17.7% reduction in urinary phosphate excretion compared to vehicle.
Treatment with tenapanor in combination with OLC demonstrated a more pronounced 41.3% reduction in urinary phosphate excretion compared to vehicle.
The combination of OLC and tenapanor was synergistic and statistically significant (p=0.009 for 0.75% OLC + tenapanor and p=0.010 for 1.5% OLC + tenapanor).

About Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.¹ The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.² Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.³

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.⁴

Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

¹Reason Research, LLC 2022 survey. Results here.
² Fortune Business Insights^TM, Hyperphosphatemia Treatment Market, 2023-2030
³ US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
⁴ Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.

Investor Contacts:

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com

Media Contact:

Rachel Visi
Real Chemistry
redery@realchemistry.com

SOURCE: Unicycive Therapeutics, Inc.

Source: Unicycive Therapeutics, Inc.

Released February 20, 2025

Release – Mpox Clade 1 in the U.S. Highlights the Need for Vaccine Supply Diversification

Posted on February 19, 2025February 19, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GeoVax Advances GEO-MVA to Strengthen U.S. and Global Readiness

ATLANTA, GA, February 19, 2025 – The confirmation of a fourth case of Clade 1 Mpox in New York underscores the urgent need for a stronger and more diversified vaccine supply chain. GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, is calling for immediate action to expand vaccine production and ensure timely distribution.

The spread of Clade 1 Mpox, a highly virulent and transmissible strain with a fatality rate ranging from 3% – 10%, is raising alarms across the public health community. While the virus has been a persistent threat in Africa, its increasing presence in Europe and the United States signals a critical moment in the fight against the disease. Over the last 4 months, confirmed cases of Clade 1 Mpox have been reported in California, Georgia, New Hampshire, and New York. However, the nation remains heavily dependent on a single non-U.S. vaccine manufacturer of the preferred Mpox vaccine, based on Modified Vaccinia Ankara (MVA), leaving the U.S. and global markets vulnerable to supply chain disruptions, limited accessibility, and potential vaccine shortages at a time when demand is surging.

Current Supply Chain Inadequate for Global Mpox Response

The current reliance on a single supplier for the preferred Mpox vaccine presents numerous challenges, particularly as the outbreak grows:

Supply chain instability – Depending on a single foreign manufacturer introduces geopolitical and logistical risks that could delay vaccine availability during critical outbreaks.
Insufficient production capacity – African health agencies have requested 20 million doses in 2025 to curb the spread of the virus, yet only 2–5 million doses are expected to be available.
High costs and limited access – At as much as $270 per dose in the U.S., the preferred product for vaccination against Mpox can be prohibitively expensive for many, creating a barrier to widespread vaccination efforts.
Inability to respond swiftly to emerging strains – Current stockpiles, which were depleted during the 2022 outbreak, are likely inadequate to combat the increasing spread of Clade 1, leaving public health officials struggling to contain the outbreak.

GeoVax’s GEO-MVA: A Critical Additional-Source Solution

In response to these pressing concerns, GeoVax is advancing development of GEO-MVA, an alternative MVA based vaccine in the fight against Mpox. GeoVax is also further addressing vaccine availability with plans to transition manufacturing of GEO-MVA, once authorized, to an advanced MVA manufacturing platform with the potential to offer significant advantages over the currently utilized Chicken Embryo Fibroblast (CEF) manufacturing platform, a complicated manufacturing process highly dependent on the availability of Specific Pathogen Free (SPF) chicken eggs. GEO-MVA’s innovative MVA production process, once implemented, should enable:

Scalability for global demand – Rapid, high-volume manufacturing to meet urgent vaccination needs.
Flexibility to utilize existing vaccine manufacturing facilities vs need to construct new ones.
Lower cost and increased accessibility – The advanced technology behind GeoVax’s MVA manufacturing platform should help reduce production costs, making vaccination programs more affordable worldwide.
Eliminate the need for SPF eggs whose availability can be negatively impacted by supply disruptions such as those related to avian flu outbreaks.
Strengthening U.S. biosecurity – Unlike the current MVA vaccine, which is produced overseas, GEO-MVA can be manufactured within the U.S., reducing reliance on foreign supply chains.
Enhanced pandemic preparedness – A diversified vaccine supply ensures greater resilience in response to future outbreaks, preventing disruptions in availability.

GeoVax has established strategic partnerships with OXB (France) and ProBioGen (Berlin) to support production scale up, while also actively engaging with U.S. and international health agencies to potentially expedite regulatory approvals and secure funding to bring GEO-MVA to market and eventually transition production to the next generation MVA manufacturing process. GeoVax recently completed cGMP (current Good Manufacturing Practice) manufacturing of the GEO-MVA drug substance and is currently in the process of fill-finish, with anticipated availability of clinical vialed material by mid-year.

A Call to Action: Strengthening the Global Response

With the growing threat of Clade 1 Mpox, it is imperative to diversify vaccine manufacturing capabilities and ensure the U.S. and global health agencies have access to multiple suppliers. GeoVax urges policymakers and regulators to take decisive action:

Increase federal funding and policy support to expedite the availability of GEO-MVA as an alternative Mpox vaccine.
Expedite regulatory approvals to bring GEO-MVA to market as quickly as possible.
Enhance collaboration with global health organizations to ensure equitable vaccine distribution, particularly in underserved regions.

“We cannot afford to wait for another pandemic-level crisis before addressing vaccine shortages and supply chain vulnerabilities,” said David Dodd, Chairman & CEO of GeoVax. “The emergence of Clade 1 Mpox in the U.S. is a clear warning sign. Immediate action is needed to strengthen vaccine supply and access. GEO-MVA, along with our efforts towards establishing our next generation MVA manufacturing platform, represents critical solutions to ensure we are better prepared for future outbreaks.”

About GeoVax

Forward-Looking Statements

Company Contact:

info@geovax.com

678-384-7220

Investor Relations Contact:

austin.murtagh@precisionaq.com

212-698-8696

Media Contact:

sr@roberts-communications.com

202-779-0929

Release – MAIA Biotechnology Announces Private Placement of $2,715,000

Posted on February 18, 2025February 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on MAIA

February 18, 2025 3:44pm EST Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

About MAIA Biotechnology, Inc.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; (viii) the completion of the offering and (ix) the satisfaction of customary closing conditions related to the offering, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250218383990/en/

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

Source: MAIA Biotechnology, Inc.

Released February 18, 2025

Release – GeoVax Pledges Continued Support for Vaccine Innovation, Transparency, and Public Health

Posted on February 18, 2025February 18, 2025 by aweinsoff@channelchek.com

Research News and Market Data on GOVX

GeoVax’s Vaccine Development Programs Align with Anticipated HHS Focus on Vaccine Safety, Diversification and Domestic Biosecurity

ATLANTA, GA, February 18, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in vaccine and immunotherapy development, congratulates Robert F. Kennedy, Jr. on his confirmation as Secretary of the U.S. Department of Health and Human Services (HHS). RFK Jr.’s appointment provides a significant opportunity for healthcare innovation, transparency, and public trust, reinforcing national priorities such as vaccine safety, diversified vaccine platforms, and strengthened domestic manufacturing. GeoVax stands ready to support these initiatives by delivering next-generation vaccines and advanced vaccine manufacturing technology that enhance biosecurity, public health resilience, and vaccine confidence.

GeoVax’s Commitment to a Robust, Transparent and Secure Vaccine Future

GeoVax’s mission aligns closely with the new administration’s policy priorities, particularly in reducing reliance on foreign pharmaceutical supply chains, increasing vaccine safety and durability, and ensuring access for underserved populations. The Company’s proprietary Modified Vaccinia Ankara (MVA) platform offers a promising alternative to other vaccine technologies such as mRNA, providing broad-spectrum, durable immunity across multiple infectious diseases via a recognized safe vaccine platform.

Key initiatives supporting the goals for vaccine safety and transparency include:

Diversified Vaccine Development – GeoVax’s GEO-CM04S1, a next-generation COVID-19 vaccine, and GEO-MVA, a dual-purpose Mpox and smallpox vaccine, align with the advocacy for alternative vaccine platforms beyond mRNA. These vaccines are designed to offer long-term immunity with a well-documented safety profile.
Transparency as a Pillar of Public Trust – As David Dodd, Chairman and CEO of GeoVax, has emphasized, restoring trust in vaccines requires clear communication, open regulatory processes, and full transparency regarding safety, efficacy, and potential risks. GeoVax supports the call for greater industry accountability and public engagement, ensuring that vaccine development aligns with the highest standards of ethical science.
Strengthening U.S. Biosecurity – GeoVax’s anticipated domestic vaccine manufacturing capabilities reinforce the bipartisan legislative commitment to reducing dependence on foreign pharmaceutical supply chains, thereby enhancing national pandemic preparedness.
Ethical Vaccine Development & Public Confidence – GeoVax embraces open regulatory processes, rigorous safety standards, and public access to data, ensuring confidence in its vaccines. These principles align with the call for increased scrutiny and transparency in vaccine development and approval.
Equitable Access & Global Preparedness – With cost-effective, scalable technology that does not require ultra-cold storage, GeoVax’s vaccines are well-suited for domestic and global distribution, ensuring broad access to critical immunizations, particularly for immunocompromised and underserved communities.

David Dodd: “Transparency is the Key to Restoring Vaccine Trust”

Reflecting on the challenges of vaccine hesitancy, David Dodd has been a vocal advocate for transparency in vaccine development and regulatory processes. In a recent op-ed, he emphasized: “Trust in vaccines has become a critical battleground for public health. Addressing public concerns openly and honestly is the only way to bridge the growing divide between science and skepticism. Transparency is a necessity, not an option. GeoVax remains committed to clear communication, scientific integrity, and ensuring that public confidence in vaccines is based on facts, not fear.” (https://www.genengnews.com/topics/translational-medicine/a-call-to-action-building-vaccine-trust-through-transparency/)

This perspective directly supports the stated goals of strengthening public trust, reducing regulatory opacity, and ensuring vaccine safety through independent oversight. GeoVax’s proactive approach to transparent vaccine development is a model for responsible biotech leadership.

A New Era for U.S. Healthcare and Pandemic Preparedness

RFK Jr.’s confirmation as HHS Secretary provides a renewed opportunity in support of vaccine diversification, transparency, and strategic biomanufacturing initiatives. GeoVax’s innovative vaccine pipeline supports these goals, positioning the Company as a vital partner in safeguarding national and global public health.

GeoVax’s vaccine development strategy builds upon successful national initiatives, such as Operation Warp Speed and Project NextGen, by prioritizing pandemic preparedness and biosecurity resilience. Through continued engagement with federal agencies and global health organizations, the Company seeks to accelerate vaccine development, expand domestic manufacturing, and enhance pandemic response efforts.

David Dodd, Chairman and CEO of GeoVax, stated: “Secretary Kennedy’s confirmation presents an opportunity to redefine public health with greater emphasis on safety, accessibility, and innovation. GeoVax proudly supports the commitment to reducing dependence on foreign pharmaceutical supply chains, diversifying vaccine technology, and restoring trust in public health solutions. We stand ready to collaborate with HHS and other healthcare stakeholders to advance a safer, more resilient healthcare future.”

About GeoVax

Forward-Looking Statements

Company Contact:	Investor Relations Contact:	Media Contact:
info@geovax.com	austin.murtagh@precisionaq.com	sr@roberts-communications.com
678-384-7220	212-698-8696	202-779-0929

Nutriband Inc. (NTRB) – Nutriband Extends Partnership Agreement To Include Post-Approval Financial Terms

Posted on February 14, 2025February 14, 2025 by cpereira@noblefcm.com

Friday, February 14, 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.

Previous Agreements Have Been Extended. Nutriband and its partner, Kindeva, have amended their development and commercialization agreement covering AVERSA Fentanyl, the abuse-deterrent transdermal fentanyl patch in development. The amendments include cost sharing and royalties on product sales. We see this as a sign that both parties are optimistic for the future of the product.

Agreement Provides For Development Cost Sharing and Royalty Payments. Nutriband and Kindeva first collaborated on a feasibility study to determine the efficacy of the AVERSA abuse-deterrent technology and its manufacturing requirements. The next agreement covered the development of manufacturing processes for commercial-scale production. The new revisions cover sharing of development costs and royalty payments on sales.

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Release – Nutriband and Kindeva formalize exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments

Posted on February 13, 2025February 13, 2025 by aweinsoff@channelchek.com

Research News and Market Data on NTRB

Nutriband is partnering with Kindeva Drug Delivery to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch.

ORLANDO, Fla., Feb. 13, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed an addendum to the Commercial Development and Clinical Supply Agreement for its lead product, Aversa™ Fentanyl, that it has in place with its partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.

Nutriband and Kindeva have revised their agreement to formalize their exclusive product development partnership and long-term commitment based on shared development costs in exchange for milestone payments.

Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants.

Nutriband’s abuse-deterrent transdermal technology consists of a proprietary aversive agent coating that employs taste aversion to deter the oral abuse of and accidental exposure to transdermal opioid and stimulant patch products.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

AVERSA Fentanyl has the potential to be the world’s first abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach peak annual US sales of $80 million to $200 million.1

1 Health Advances Aversa Fentanyl market analysis report 2022

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words “believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Form 10-K for the year ended January 31, 2024, filed May 1, 2024, the Forms 10-Q’s filed subsequent to the Form 10-K in 2024, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Release – Ocugen, Inc. Announces Dosing Completion in the Phase 2 ArMaDa Clinical Trial for OCU410—a Multifunctional Modifier Gene Therapy for the Treatment of Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Posted on February 12, 2025February 12, 2025 by aweinsoff@channelchek.com

Research News and Market Data on OCGN

February 12, 2025

PDF Version

Completed Phase 2 enrollment with randomization of 51 subjects into treatment and control arms
Phase 1/2 study (N=60) demonstrated favorable safety and tolerability profile with no serious adverse events related to OCU410, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization

Subjects showed considerably slower lesion growth (44%) from baseline in treated eyes versus untreated fellow eyes at 9 months in follow-up data from the Phase 1 study
Clinically meaningful 2-line (10-letter) improvement in visual function (LLVA) in treated eyes compared to untreated eyes was noted in the Phase 1 portion of the trial
Preservation of retinal tissue at 9 months around GA lesions of treated eyes with a single injection of OCU410 in Phase 1 compared favorably to published data on a leading FDA-approved complement inhibitor given monthly or every other month at the same time points

MALVERN, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that dosing is complete, ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410—a novel multifunctional modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). Age-related macular degeneration (AMD) affects 1 in 8 people 60 years and older. The global prevalence of dAMD is 266 million worldwide and by 2050 more than 5 million Americans may suffer from this incurable condition. Today, GA – the later stage of dAMD – affects approximately 2-3 million people in the United States (U.S.) and Europe.

There are limited options for patients with dAMD in the U.S. and current therapies involve frequent (monthly or every other month) injections and have unwanted side effects that can affect vision. These therapies are not approved in Europe, leaving approximately 2 million patients with no therapeutic option.

“Dosing completion is a major accomplishment for our OCU410 program,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “Based on the multifunctional effect of our modifier gene therapy, the profound unmet medical need, limited treatment options, and the fact that it is designed as a one and done treatment, we believe OCU410 can be a potential blockbuster therapy and the gold standard for treating GA worldwide. The data from this trial will help us design a future pivotal Phase 3 study planned for 2026 and enable our commercial strategy for Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings as soon as 2028.”

“The preliminary efficacy and safety data from the Phase 1/2 study are highly encouraging, demonstrating the potential of OCU410 to improve both structural and functional outcomes,” said Lejla Vajzovic, MD, FASRS, Director of the Duke Surgical Vitreoretinal Fellowship Program and Professor of Ophthalmology, Pediatrics and Biomedical Engineering with Tenure at Duke University Eye Center. “I look forward to the Phase 2 results and believe a one-time gene therapy could reshape the treatment landscape, offering a transformative option for patients.”

GA is a multifactorial disease with a complex etiology that involves genetic and environmental factors. The current treatment options for GA in the U.S. are limited to those targeting a single mechanism—the complement pathway—requiring frequent intravitreal injections, either monthly or every other month. By contrast, OCU410 is a multifunctional modifier gene therapy, which targets multiple pathways associated with GA.

“Given the safety concerns associated with currently approved GA treatments, the encouraging safety and tolerability profile of OCU410 offers a promising treatment option,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “With Phase 2 enrollment now complete, OCU410 has the potential to be a one-time treatment, reducing the burden of frequent injections, improving patient compliance, and ultimately enhancing quality of life.”

In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD will be assessed. Fifty-one (51) patients were randomized 1:1:1 into either of two treatment groups (medium or high dose) or a control group. In the treatment groups, subjects received a single subretinal 200-µL administration of 5 x 10¹⁰ vector genomes (vg)/mL (medium dose) or 1.5 x 10¹¹ vg/mL (high dose), while the control group remained untreated.

The ArMaDa clinical trial for OCU410 is being performed at 14 leading retinal surgery centers across the U.S.

About the Phase 1/2 ArMaDa clinical trial
The ArMaDa Phase 1/2 clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases. Phase 1 is a multicenter, open label, dose-escalation study consisting of three dose levels [low dose (2.5×10¹⁰ vg/mL), medium dose (5×10¹⁰ vg/mL), and high dose (1.5 ×10¹¹ vg/mL)]. Phase 2 is a randomized, outcome assessor-blinded, dose-expansion study in which subjects were randomized in a 1:1:1 ratio to either the medium dose or high dose OCU410 treatment groups or to an untreated control group.

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the portion of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function, and central vision impairment. dAMD accounts for 85-90% of all AMD cases.

About OCU410
OCU410 utilizes an adeno-associated virus (AAV) platform for the retinal delivery of the RORA (ROR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role as well as inhibiting the complement system in both in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ 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 treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 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 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 preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical 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

Novartis to Acquire Anthos Therapeutics in $3.1 Billion Deal

Posted on February 12, 2025February 12, 2025 by slightbourne@noblecapitalmarkets.com

Key Points:
– Novartis has agreed to acquire Anthos Therapeutics for up to $3.1 billion, expanding its presence in the cardiovascular space.
– Anthos’ lead drug candidate, abelacimab, has demonstrated significant potential in reducing bleeding risks compared to current anticoagulants.
– The acquisition highlights the success of Blackstone Life Sciences’ investment strategy in building and scaling innovative biopharmaceutical companies.

Novartis has entered into a definitive agreement to acquire Anthos Therapeutics, a clinical-stage biopharmaceutical company specializing in innovative therapies for cardiometabolic diseases, for up to $3.1 billion. The deal, announced by Blackstone Life Sciences and Anthos, represents a major step forward in the development of abelacimab, a next-generation Factor XI inhibitor designed to prevent strokes and blood clots with superior safety benefits.

Anthos was founded in 2019 as a collaboration between Blackstone Life Sciences and Novartis, securing exclusive global rights from Novartis to develop, manufacture, and commercialize abelacimab. The acquisition reflects Novartis’ confidence in abelacimab’s potential to become a leader in the growing class of Factor XI anticoagulants, which aim to reduce the risk of major bleeding while maintaining strong stroke prevention efficacy.

“Abelacimab has the potential to be an important treatment option for the millions of patients globally with atrial fibrillation at high risk of stroke, and we could not have more conviction in the potential of this asset,” said Bill Meury, Chief Executive Officer of Anthos. “With its deep roots in the cardiovascular space, Novartis is especially well positioned to advance abelacimab’s clinical development and bring this innovative product to healthcare providers and patients.”

The drug has already demonstrated promising results in the AZALEA-TIMI 71 trial, where abelacimab showed a 62% reduction in major bleeding or clinically relevant non-major bleeding compared to rivaroxaban (Xarelto), a 67% reduction in major bleeding, and an 89% reduction in gastrointestinal bleeding. These impressive findings prompted the Independent Data Monitoring Committee to discontinue the study early due to clear clinical benefits. The results were recently published in the New England Journal of Medicine.

Anthos is currently conducting three phase 3 clinical trials for abelacimab: LILAC-TIMI 76 for patients with atrial fibrillation at high risk of stroke or systemic embolism, and ASTER and MAGNOLIA for patients with cancer-associated thrombosis. Data from these trials are expected in the second half of 2026, and Novartis is expected to continue these efforts to bring abelacimab to market.

Blackstone Life Sciences has played a crucial role in Anthos’ growth, investing in its development, assembling a world-class team, and designing the clinical plan. “This transaction is an affirmation of Blackstone Life Sciences’ ownership investment strategy, where we seek to find innovative products and build companies around them to meet unmet patient needs,” said Dr. Nicholas Galakatos, Global Head of Blackstone Life Sciences.

The acquisition deal includes an upfront payment of $925 million, with additional payments contingent on meeting regulatory and commercial milestones. The transaction is expected to close in the first half of 2025, pending regulatory approvals.