Ocean Biomedical Advances Malaria Vaccine Research with New NIH Funding and Expedited Development Pathway

Ocean Biomedical (NASDAQ: OCEA) announced today that its Scientific Co-founder, Dr. Jonathan Kurtis, MD, PhD, and his research team have received additional significant funding from the National Institutes of Health (NIH) to advance their groundbreaking malaria vaccine research. In parallel, recent U.S. Food and Drug Administration (FDA) Guidance on lipid-encapsulated vaccines may offer an expedited development pathway for their innovative approach.

Malaria remains a devastating global health challenge, claiming the lives of over 500,000 children annually in sub-Saharan Africa. Despite hundreds of vaccine development efforts, few have succeeded, largely due to ineffective target selection strategies. Dr. Kurtis and his team have taken a novel approach by studying naturally occurring immune responses in children who have developed resistance to malaria.

Through longitudinal studies of children frequently exposed to infected mosquitoes, the researchers identified a unique protein—glutamic acid-rich protein (GARP)—on the surface of malaria-infected red blood cells. Notably, children who naturally resisted severe malaria were found to have developed antibodies against GARP. This discovery, supported by multiple NIH and non-governmental grants, has paved the way for vaccine development.

With the support of a $4.6 million non-governmental Foundation grant, Dr. Kurtis’ team is now testing three vaccine candidates in non-human primates. These candidates aim to block the malaria parasite’s ability to enter and exit red blood cells. The research also explores the feasibility of using lipid-encapsulated messenger ribonucleic acid (mRNA) technology as a delivery mechanism.

Building on clinical data from millions of individuals who received lipid-encapsulated mRNA vaccines, the FDA has issued new guidance that could facilitate a faster transition to first-in-human trials. Ocean Biomedical intends to leverage this opportunity, with a potential to initiate human trials as early as 4Q 2025.

In December 2024, Dr. Kurtis secured an additional $3.5 million NIH grant to further identify vaccine targets to protect against severe malaria in children. Commenting on this milestone, Dr. Kurtis stated:

“We are thrilled to receive this additional funding and are encouraged by the emerging data from our human cohort studies. FDA’s new guidance for lipid-encapsulated vaccines will bring us closer to translating years of research into a potential breakthrough malaria vaccine.”

Dr. Chirinjeev Kathuria, Chairman and Co-founder of Ocean Biomedical, added:

“Dr. Kurtis’ work continues to gain significant validation, reinforcing our confidence in the potential of our patented technology. We look forward to further exploring the GARP pathway to develop a vaccine that could have a transformative impact on global health.”

About Dr. Jonathan Kurtis

Dr. Kurtis is the Chair of the Department of Pathology and Laboratory Medicine at the Warren Alpert Medical School of Brown University, the Director of Laboratories at the Center for International Health Research, and the Executive Director of the MD/PhD Program at Brown University. He is also a co-founder of Ocean Biomedical.

Malaria Mortality in Sub-Saharan Africa :

Statement : "Malaria remains a devastating global health challenge, claiming the lives of over 500,000 children annually in sub-Saharan Africa."

Citation : According to UNICEF, in 2022, there were 249 million malaria cases globally, leading to 608,000 deaths, with 76% of these deaths occurring in children under 5 years of age. This translates to over 1,000 child deaths daily, many of which are in sub-Saharan Africa. UNICEF DATA

About Ocean Biomedical

Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world’s toughest problems, for the people who need it most.

To learn more, visit www.oceanbiomedical.com .

Forward-Looking Statements

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The announced discoveries were based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that this treatment will prove safe or effective in humans, and that any clinical benefits of this treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away.

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) risk that the Company may not be able to execute its growth strategies; (v) risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; (vi) risk that the Company may not be able to develop and maintain effective internal controls; (vii) the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; (viii) the ability to develop, license or acquire new therapeutics; (ix) the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that the Company experiences difficulties in managing its growth and expanding operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Company’s business; (xii) the risk of cyber security or foreign exchange losses; (xiii) the risk that the Company is unable to secure or protect its intellectual property.

The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and its subsequent Quarterly Reports on Form 10-Qs, and which are described in the “Risk Factors” sections thereof, and other documents to be filed by the Company from time to time with the SEC and which are and will be available at www.sec.gov . These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements.

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