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.
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 InsightsTM, 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.
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
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.
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.
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.
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
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.
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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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.
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.
AboutdAMD 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.
AboutOCU410 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.
AboutOcugen,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 Thispressreleasecontainsforward-lookingstatementswithinthemeaningofThePrivateSecuritiesLitigationReformActof1995,including,butnot limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines,whicharesubjecttorisksanduncertainties.Wemay,insomecases,usetermssuchas “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,butnotlimitedto,therisksthatpreliminary,interimandtop-lineclinicaltrialresultsmaynotbeindicativeof,andmaydifferfrom,finalclinical data;the ability of OCU410 to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data;thatunfavorablenewclinicaltrialdatamayemergeinongoingclinicaltrialsorthroughfurtheranalysesofexistingclinicaltrialdata;thatearlier non-clinicalandclinicaldataandtestingofmaynotbepredictiveoftheresultsorsuccessoflaterclinicaltrials;andthatthatclinicaltrialdataare subject to differing interpretations and assessments, including by regulatory authorities.Theseandotherrisksanduncertaintiesaremorefully describedinourperiodicfilingswiththeSecuritiesandExchangeCommission(SEC),includingtheriskfactorsdescribedinthesectionentitled“Risk Factors”inthequarterlyandannualreportsthatwefilewiththeSEC.Anyforward-lookingstatementsthatwemakeinthispressreleasespeakonlyas ofthedateofthispressrelease.Exceptasrequiredbylaw,weassumenoobligationtoupdateforward-lookingstatementscontainedinthispress release whether as a result of new information, future events, or otherwise, after the date of this press release.
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.
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.
Tegoprubart Used For Immunosuppression In Another Transplantation Surgery. A transplant patient that received a genetically engineered pig kidney has been given tegoprubart as part of their drug regimen to prevent organ rejection. The genetically engineered pig kidney was produced by Eledon’s partner, eGenesis, with the surgery performed at Massachusetts General Hospital (MGH). We see the continued use of tegoprubart instead of tacrolimus, the standard of care, as a positive sign from the transplant community.
Tegoprubart Was Chosen Over Tacrolimus. Tegoprubart is an anti-CD40 ligand antibody that modulates the immune system and avoids the long-term toxic side effects of tacrolimus. It is currently in two human clinical trials for kidney transplantation and has been used in several recent xenotransplantation procedures. We see this choice as a sign that doctors see its clinical data as an improvement over tacrolimus.
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The AVERSA™ transdermal abuse deterrent technology is protected by a broad international intellectual property portfolio with patents already issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia
February 07, 2025 08:45 ET
ORLANDO, Fla., Feb. 07, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) on February 3, 2025 for patent application 18/369,241, “Abuse and Misuse Deterrent Transdermal Systems” which covers its Aversa™ abuse deterrent technology. The receipt of a Notice of Allowance means that the USPTO is expected to issue a U.S. patent for this application after administrative processes have been completed.
The expected issuance of this patent further expands Nutriband’s intellectual property protection in the United States for its portfolio of abuse deterrent transdermal products based on its proprietary Aversa™ abuse deterrent technology. This technology 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, with the potential to become the first and only abuse deterrent pain patch on the market.
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. The 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
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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.
Patient treated in procedure, conducted at Mass General Transplant Center and in collaboration with partner eGenesis, was recently released from hospital
Investigational therapy tegoprubart targets CD40 ligand (CD40L) with potential to improve both safety and efficacy compared to standard of care immunosuppression regimens
IRVINE, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig. The procedure was performed on January 25, 2025, by surgeons at Massachusetts General Hospital (MGH) in collaboration with our partner eGenesis. In December 2024, MGH received Food and Drug Administration (FDA) approval to proceed with this transplant and plans to perform two additional xenotransplants this year, further advancing the field of xenotransplantation. Following the successful transplant, the patient was discharged from the hospital and is now off dialysis for the first time in over two years.
“This second kidney xenotransplant conducted at MGH represents another important milestone in the effort to consider new strategies in transplantation and immunosuppression to address the global organ shortage crisis. We are grateful to the patient, the team at MGH, and our partner eGenesis for supporting tegoprubart’s central role in these landmark procedures,” said David-Alexandre C. Gros, M.D., Eledon Chief Executive Officer. “Blocking the CD40 Ligand is a critical component of the immunosuppression regimen for effective translation of organ transplant from nonhuman primates into humans. Our anti-CD40L antibody tegoprubart represents a novel approach to immunosuppression therapy with the potential to improve safety and efficacy and enable patients to live longer with their transplanted organs.”
Similar to the first-ever kidney xenotransplant, also conducted at MGH in March 2024, tegoprubart is being administered to the current patient investigationally as part of a regimen designed to prevent the body from rejecting the transplanted pig organ. Tegoprubart is designed to block CD40L and has been shown to inhibit multiple costimulatory receptors including CD40 and CD11, key components of how immune cells communicate with one another. Based on extensive prior research, tegoprubart has been observed to be generally safe and well-tolerated in multiple potential indications, including for the prevention of rejection following kidney allotransplantation.
“I would like to thank Eledon for their work supporting this historic xenotransplant. Immunosuppression presents one of the greatest challenges for transplantation in both human and non-human organs. The need for advancements in immunosuppressive medications is critical for advancing our field and improving the quality of life for transplant patients everywhere,” said Dr. Leonardo Riella, MD, PhD, Medical Director for Kidney Transplantation at Massachusetts General Hospital.
Tegoprubart was also used as a cornerstone component of the chronic immunosuppression regimen administered following the second-ever transplant of a genetically modified heart from a pig to a human, performed at the University of Maryland Medical Center in September 2023. Currently, tegoprubart is being evaluated in three global clinical studies for the prevention of organ rejection in patients receiving kidney transplants and in a separate investigator sponsored trial for the prevention of islet transplant rejection in patients with type 1 diabetes (T1D). Eledon recently announced initial data from this investigator-initiated islet transplant trial, conducted by the research team at the University of Chicago Medicine Transplant Institute, that demonstrated potentially the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus, the current standard of care for prevention of transplant rejection.
The Company plans to report updated interim clinical trial from its ongoing Phase 1b and long-term safety and efficacy extension studies in kidney transplant this summer, topline results from its Phase 2 BESTOW kidney transplant trial in the fourth quarter of 2025, and longer-term follow up results from the investigator-led islet transplant clinical trial at UChicago Medicine Transplant Institute later this year.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Strategic Progress Across COVID-19, Mpox, Oncology Therapies and AI Integration Positions GeoVax for Strong Momentum
Atlanta, GA – February 5, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined its 2025 strategic milestones and business outlook. Building on a history of delivering on key commitments, GeoVax enters 2025 with a robust pipeline, a catalyst-rich milestone schedule, and an unwavering commitment to addressing unmet medical needs on a global scale.
An Important Year Ahead for GEO-CM04S1, a Next-Generation COVID-19 Vaccine
GEO-CM04S1 continues to demonstrate potential for both immunocompromised patients and as a booster vaccine for those previously inoculated with mRNA vaccines. In 2025, the Company anticipates completion of the evaluation trial among Chronic Lymphocytic Leukemia (CLL) patients, a patient population recognized to currently have minimal COVID-19 vaccine options. Interim data reported in Q4 2024 suggest GEO-CM04S1 may offer superior immune responses to CLL patients compared to an mRNA vaccine.
GeoVax also expects to report final results from its healthy adults booster trial, offering valuable data on the vaccine’s safety and immunogenicity profile. Another pivotal milestone for GEO-CM04S1 in 2025 is the anticipated initiation of patient enrollment in the BARDA-funded Project NextGen Phase 2b trial, which will evaluate GEO-CM04S1 compared to an authorized mRNA vaccine within a 10,000-patient study. As both a booster and a primary vaccine for immune-compromised patient populations, GEO-CM04S1 remains central to GeoVax’s mission to address the ongoing and evolving challenges of COVID-19.
As part of its strategy, GeoVax will continue to explore and establish strategic partnerships and collaborations to accelerate the development, commercialization, and global accessibility of GEO-CM04S1.
GEO-MVA: Addressing Biosecurity and Global Health Gaps
GEO-MVA, a vaccine designed to combat Mpox and Smallpox, has emerged as a critical solution amid rising global biosecurity concerns. In 2025, the Company plans to initiate clinical evaluations for GEO-MVA while continuing discussions with various stakeholders regarding the opportunity to utilize GEO-MVA among underserved populations in regions including Africa. With ongoing geopolitical and logistical challenges limiting vaccine availability, GEO-MVA’s ability to offer multi-disease protection, minimal refrigeration needs, and scalability through implementation of an advanced MVA manufacturing process, GEO-MVA represents a potential transformative resource for both national biosecurity strategies and global health initiatives.
GeoVax recognizes that addressing these critical global challenges requires collaborative efforts. In 2025, the Company will actively pursue strategic partnerships with governments, NGOs, and private-sector stakeholders to maximize the impact and reach of its GEO-MVA platform.
Gedeptin: Unlocking Potential in Solid Tumor Cancer Therapy
GeoVax’s oncology program, centered around Gedeptin®, continues to progress in addressing unmet medical needs in solid tumor therapies. Following encouraging results from Phase 1 and Phase 1/2 trials, Gedeptin is advancing into a Phase 2 clinical trial in 2025, where it will be evaluated in combination with an immune checkpoint inhibitor, targeting first recurrent head and neck cancer. This trial aims to validate the potential synergy between Gedeptin’s targeted gene-directed enzyme prodrug therapy and the powerful immune responses activated by checkpoint inhibitors.
As an FDA-designated Orphan Drug for anatomically accessible oral and pharyngeal cancers, Gedeptin is strategically positioned to address not only head and neck cancers but also other solid tumor indications, such as triple-negative breast cancer, soft tissue sarcoma and melanoma. GeoVax’s clinical roadmap for Gedeptin represents a significant market opportunity, with the potential to reshape how these cancers are treated worldwide.
GeoVax remains open to collaborations with oncology leaders, academic research institutions, and industry partners to further enhance the clinical impact and commercial success of Gedeptin.
Next-Generation Manufacturing: Pioneering Scalable Vaccine Production
To amplify the value of its clinical programs, GeoVax is also focused on advancing MVA vaccine manufacturing through validation of continuous cell line manufacturing processes, ensuring consistent, high-quality vaccine production capabilities. These advancements address long-standing challenges in vaccine scalability and cost-effectiveness, positioning GeoVax as a leader in MVA-based vaccine manufacturing solutions, potentially implementing a proprietary MVA manufacturing process supporting more flexible, localized MVA manufacturing at lower production cost, specifically enabling vaccine self-sufficiency manufacturing in low-middle income regions such as Africa.
GeoVax recognizes that strong manufacturing partnerships are vital to bringing these innovations to market efficiently and cost-effectively. The Company plans to collaborate with manufacturing partners worldwide to scale up production capabilities and meet the growing global demand for MVA-based vaccines.
AI Integration: Optimizing Processes and Driving Innovation
In alignment with its 2025 objectives, GeoVax has expanded the integration of Artificial Intelligence (AI) across its vaccine development and cancer immunotherapy activities. Leveraging AI is anticipated to accelerate vaccine development, optimize cancer therapies, streamline clinical trials, and enhance manufacturing processes, potentially in the following manners:
Vaccine and Therapy Innovation: Predicting pathogen mutations and optimizing GEO-CM04S1 and Gedeptin® design, ensuring effectiveness in variant-proof vaccines and cancer therapies.
Clinical Trial Optimization: Refining patient selection, accelerating recruitment, and enhancing diversity for trials targeting high-risk and underserved populations.
Streamlined Manufacturing: Enhancing scalability and logistics, enabling efficient production and distribution, particularly in underserved regions.
Addressing a $55+ Billion Pipeline Market Opportunity
GeoVax’s pipeline addresses significant unmet and underserved medical needs worldwide in both infectious disease vaccines and oncology, representing a collective potential global market opportunity in excess of $55 billion. Each program—GEO-CM04S1, GEO-MVA, and Gedeptin—addresses significant gaps in existing treatment and prevention strategies, backed by emerging clinical data and a focus towards achieving the necessary regulatory milestones in support of product registration.
David Dodd, Chairman & CEO of GeoVax, commented: “2024 was a transformative year for GeoVax, and our focus and commitment in 2025 is unwavering, focused on critically needed unmet medical needs. Our pipeline, enriched with value-driven milestones, positions us well for successful growth and development. Collaborations and partnerships remain core to our strategy, ensuring our innovations reach those who need them most. With GEO-CM04S1, GEO-MVA, Gedeptin, our MVA manufacturing advancements, and leveraging AI to optimize our processes and drive innovation, we are prepared to make meaningful contributions to global health, delivering value to our fellow shareholders, various stakeholders and, providing compelling career development opportunities to our staff colleagues.”
For further details on GeoVax’s pipeline and strategic initiatives, please visit www.geovax.com.
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 to initiate during the first half of 2025. 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.
