Core Insights - Ocean Biomedical has developed a unique oncology platform targeting CHI3L1 to activate natural immune responses against various cancers, including lung cancer, glioblastoma, prostate cancer, melanoma, and breast cancer [1][2][4] Research and Development - New research published in the Journal of Immunology reveals how CHI3L1 inhibits the body's immune responses, particularly macrophage phagocytosis, by activating two key checkpoint pathways [1] - The research indicates that inhibiting CHI3L1 can enhance adaptive immune responses and reduce cancer growth in both standard and humanized mouse models [1][4] Patent and Therapeutic Potential - Ocean Biomedical has received patent allowances for multiple cancers, including prostate, colon, rectal, ovarian, kidney, breast, glioblastoma, melanoma, and lung cancer [2] - The company aims to advance towards IND-enabling studies to develop new cancer therapeutics based on the mechanisms discovered [4] Leadership and Vision - Dr. Jack A. Elias, a leading specialist in pulmonary care and co-founder of Ocean Biomedical, emphasizes the significance of controlling CHI3L1 to manage multiple anti-cancer pathways [3] - The company is focused on addressing unmet medical needs by accelerating the transition of scientific discoveries into therapeutics [6]

Core Insights - Ocean Biomedical has received a key U.S. patent for a malaria therapeutic antibody targeting PfGARP, developed by Dr. Jonathan Kurtis, which could lead to new treatment options for malaria [1][3][8] Company Developments - The patent adds to Ocean Biomedical's portfolio of over 60 patents aimed at addressing major unmet medical needs in infectious diseases, oncology, and fibrosis, supported by over $125 million in grants [2] - The company is developing a powerful vaccine candidate for long-term malaria prevention, a therapeutic antibody for short-term prevention, and a small molecule drug for treating severe malaria [1][4] Scientific Insights - Dr. Kurtis' approach induces programmed cell death in malaria parasites, addressing the growing resistance of common malaria strains to current Artemisinin-based treatments [3][5] - The research highlights the urgent need for new anti-malarial drugs as malaria remains a leading cause of death among children, with approximately 627,000 fatalities reported in 2022 [5] Leadership Perspectives - Company leadership emphasizes the importance of Dr. Kurtis' discoveries in developing new treatment options that could save hundreds of thousands of lives, showcasing the innovative model and partnerships with research institutions [7][8]

Core Insights - Ocean Biomedical, Inc. congratulates its joint venture partner Virion Therapeutics on presenting the first human immunogenicity data for its novel HBV immunotherapy, VRON-0200, at the EASL 2024 Congress [1][2] - The Phase 1b data indicates that VRON-0200 is safe, well-tolerated, and immunogenic in most chronically HBV-infected patients after a single injection [2] - The global market for chronic HBV treatments is projected to exceed $6.5 billion by 2032, highlighting the high demand for effective therapies [3] Company Overview - Ocean Biomedical is a biopharma company focused on accelerating the development of discoveries from research institutions [8] - The company is currently developing five promising therapeutic candidates targeting various diseases, including lung cancer and malaria [8] - Virion Therapeutics specializes in T cell-based immunotherapies and has developed a robust pipeline, including VRON-0200 and VRON-0300 for advanced solid tumors [6][7] Product Insights - VRON-0200 is designed to provide a functional cure for chronic HBV infection through intramuscular injection, enhancing T cell responses that are typically exhausted in chronic infections [5] - The treatment aims to stimulate T cell responses in patients with little to no prior HBV immunity, potentially leading to improved viral control [2][5] - Unlike traditional monoclonal antibody checkpoint inhibitors, Virion's approach modifies T cell activation locally, reducing the risk of serious adverse events [2]

Core Insights - Ocean Biomedical, Inc. congratulates its joint venture partner Virion Therapeutics on presenting the first human immunogenicity data for its novel HBV immunotherapy, VRON-0200, at the EASL 2024 Congress [1][2] - The Phase 1b data indicates that VRON-0200 is safe, well-tolerated, and immunogenic in most chronically HBV-infected patients after a single injection [2] - The global market for chronic HBV treatments is projected to exceed $6.5 billion by 2032, highlighting the high demand for effective therapies [3] Company Overview - Ocean Biomedical is a biopharma company focused on accelerating the development of discoveries from research institutions [8] - The company is currently developing five promising therapeutic candidates targeting various diseases, including lung cancer and malaria [8] - Virion Therapeutics specializes in T cell-based immunotherapies and has developed a robust pipeline, including VRON-0200 and VRON-0300 for advanced solid tumors [6][7] Product Insights - VRON-0200 is designed to provide a functional cure for chronic HBV infection through intramuscular injection, enhancing T cell responses that are typically exhausted in chronic infections [5] - The treatment aims to stimulate T cell responses in patients with little to no prior HBV immunity, potentially leading to improved viral control [2][5] - Unlike traditional monoclonal antibody checkpoint inhibitors, Virion's approach modifies T cell activation locally, reducing the risk of serious adverse events [2]

Core Insights - Ocean Biomedical has received a new patent for malaria therapeutic antibody discoveries aimed at preventing and treating severe malaria, addressing the growing resistance of malaria strains to current treatments [1][4][8] - The company's innovative approach targets the blood-stage of the malaria lifecycle, which is responsible for clinical disease and death, potentially offering greater efficacy than existing vaccines and therapeutics [3][4] - Ocean Biomedical is advancing its vaccine and therapeutic antibody formulation in preparation for IND submission and first-in-human testing [3][6] Company Overview - Ocean Biomedical is a biopharma company based in Providence, Rhode Island, focused on developing therapeutics for infectious diseases, oncology, and fibrosis [2][9] - The company aims to efficiently transition new therapeutic candidates from laboratory research to clinical application, with a portfolio that includes five promising discoveries [9] Industry Context - Malaria remains a significant global health issue, being the leading cause of death among children, with approximately 627,000 fatalities reported in 2022 [4] - The emergence of drug-resistant malaria strains poses a serious threat to the effectiveness of current Artemisinin-based therapies, highlighting the urgent need for new anti-malarial drugs [4][8]

Core Insights - Ocean Biomedical has received a new patent for malaria therapeutic antibody discoveries aimed at preventing malaria infection and treating severe malaria, which is crucial given the rising resistance of malaria strains to current treatments [1][4][8] - The company's innovative approach targets the blood-stage of the malaria lifecycle, which is responsible for clinical disease and death, potentially offering greater efficacy compared to existing vaccines and therapeutics [3][4] - The patent enhances Ocean Biomedical's global patent portfolio, which focuses on addressing significant unmet medical needs in infectious diseases, oncology, and fibrosis [2] Company Developments - Dr. Jonathan Kurtis, the scientific co-founder, is leading research efforts in malaria treatment, with a focus on a "kill switch" mechanism that interrupts the malaria parasite's lifecycle [5][8] - Ocean Biomedical is in the process of optimizing its vaccine and therapeutic antibody formulation before submitting for Investigational New Drug (IND) approval and initiating first-in-human testing [3][6] - The company aims to develop five promising discoveries that could lead to life-changing outcomes in various diseases, including malaria, lung cancer, and pulmonary fibrosis [9] Industry Context - Malaria remains a significant global health threat, being the leading cause of death among children, with approximately 627,000 fatalities reported in 2022 [4] - The emergence of drug-resistant malaria strains poses a serious challenge to existing treatment methods, highlighting the urgent need for new anti-malarial drugs [4][8] - Ocean Biomedical's advancements in malaria treatment are positioned to address this critical public health issue and could potentially save tens of thousands of lives [6][8]

Financial Performance - For the three months ended September 30, 2023, the net loss was $14,087,000, compared to a net loss of $3,668,000 for the same period in 2022, representing an increase of 284%[295] - The net loss per common share for the three months ended September 30, 2023, was $(0.53), compared to $(0.16) for the same period in 2022, reflecting a deterioration in earnings[295] - The net loss for September 2023 was $14,087,000, compared to a net loss of $3,668,000 in September 2022, representing an increase of 284.5%[314] - The net loss for the nine months ended September 30, 2023, was $97.6 million, compared to a net loss of $16.4 million for the same period in 2022, representing an increase of 495%[341] - Total operating expenses for September 2023 were $2,655,000, a decrease of 16.3% from $3,173,000 in September 2022[314] Shareholder Equity and Stock - The weighted-average shares of common stock outstanding for the three months ended September 30, 2023, were 26,605,147, compared to 23,355,432 for the same period in 2022, indicating a 14% increase in shares outstanding[295] - The company had 34,149,046 shares of common stock outstanding as of November 9, 2023, up from 23,355,432 shares as of December 31, 2022, representing a 46% increase[297] - The company recognized a net impact of $50,021,000 on total stockholders' equity from the business combination, after accounting for issuance costs of $2,049,000[289] - The company has the potential to issue up to an additional 19,000,000 shares of common stock as Earnout Shares based on stock price performance, contingent on the volume-weighted average price exceeding specified thresholds[290] Liabilities and Deficits - Total current liabilities increased to $30,851,000 as of September 30, 2023, from $12,661,000 as of December 31, 2022, marking a significant rise of 143%[310] - Total liabilities rose to $76,255,000 as of September 30, 2023, compared to $12,661,000 as of December 31, 2022, indicating a substantial increase of 503%[310] - The accumulated deficit increased to $(179,199,000) as of September 30, 2023, compared to $(81,589,000) as of December 31, 2022, reflecting a worsening financial position[310] - The total stockholders' deficit increased to $(75,224,000) as of September 30, 2023, from $(61,657,000) at June 30, 2023[316] Cash Flow and Working Capital - Operating cash flows resulted in a net cash used of $8.6 million for the nine months ended September 30, 2023, compared to $960,000 for the same period in 2022[322] - The company had a working capital deficiency of $29.8 million as of September 30, 2023[327] - Total cash and restricted cash at the end of the period was $1.03 million, up from $116,000 at the end of the previous year[322] Research and Development - Research and development expenses decreased to $305,000 in September 2023 from $1,858,000 in September 2022, a reduction of 83.7%[314] - The company has incurred significant additional research and development efforts for its therapeutic products, requiring substantial capital and personnel[343] - The company anticipates moving certain preclinical product candidates into clinical trials within the next 12 to 24 months[340] Debt and Financing - The principal of remaining short-term loans outstanding was $12.1 million as of September 30, 2023[330] - The Company recognized a loss on extinguishment of debt of $1,208,000 for the nine months ended September 30, 2023, related to the issuance of 200,000 shares for extensions of the maturity date[349] - The Company issued 1,365,000 shares of common stock to the Sponsor as consideration for loans totaling $2.1 million, with interest rates of 8% and 15% per annum[365] - The Company entered into a securities purchase agreement for the sale of up to three Senior Secured Convertible Notes totaling up to $27,000,000, with the initial Note amounting to $7,560,000[410] Other Financial Obligations - The Company is required to pay Elkurt an initial license fee of $110,000 and an annual maintenance fee of $3,000, increasing to $4,000 in 2029[354] - The Company has a contractual obligation to pay Elkurt 1.5% of net sales and 25% of non-royalty sublicense income prior to the first commercial sale[355] - The Company recorded interest expense of $36,852 for the nine months ended September 30, 2023[349] Market Conditions and Future Outlook - The Company's market capitalization fell below $100,000,000 for 10 consecutive trading days, triggering the "Initial Installment Trigger Date" under the SPA, requiring installment payments to the Investor starting November 1, 2023[406] - An Equity Conditions Failure was triggered as the daily trading volume of Company shares fell below $1,500,000 during the 20 days preceding the Initial Installment Trigger Date[406] - The Company expects to continue generating operating losses for the foreseeable future, dependent on successful research and development[342]

Financial Performance - Operating loss for the three months ended June 30, 2023, was $2,680,000, a decrease from $6,900,000 in the same period of 2022[20]. - Net loss for the six months ended June 30, 2023, was $80,429,000, compared to $12,708,000 for the same period in 2022[20]. - The company reported a net loss per share of $0.49 for the three months ended June 30, 2023, compared to $0.31 for the same period in 2022[20]. - The company reported a net loss of $80,429 for the six months ended June 30, 2023, compared to a net loss of $12,708 for the same period in 2022[26]. - For the three months ended June 30, 2023, the net loss was $13,028,000, compared to a net loss of $7,333,000 for the same period in 2022, representing an increase of 77%[186]. - The net loss per common share for the six months ended June 30, 2023, was $(3.13), compared to $(0.54) for the same period in 2022, indicating a significant increase in losses per share[186]. Assets and Liabilities - Total assets increased to $20,921,000 as of June 30, 2023, compared to $1,842,000 as of December 31, 2022[18]. - Current liabilities rose to $26,679,000 from $12,661,000, reflecting a significant increase in accounts payable and accrued expenses[18]. - Cash and restricted cash at the end of the period was $2,161,000, up from $395,000 at the end of June 30, 2022[26]. - The company had a working capital deficiency of $24,517,838 as of June 30, 2023[34]. - Total accounts payable and accrued expenses increased to $14,044,000 as of June 30, 2023, compared to $11,440,000 at the end of 2022[104]. Stockholder Equity - Additional paid-in capital increased to $153,617,000 as of June 30, 2023, from $70,770,000 at the end of 2022[18]. - The total stockholders' deficit improved to $(8,401,000) as of June 30, 2023, from $(10,819,000) at the end of 2022[18]. - The company recorded a net impact of $50,021,000 on total stockholders' equity from the business combination, with cash from AHAC trust net of redemptions amounting to $52,070,000[71]. - As of June 30, 2023, the total common stock outstanding was 34,012,724 shares, an increase from 23,355,432 shares as of December 31, 2022, representing a growth of approximately 45.6%[138]. Research and Development - Research and development expenses significantly decreased to $28,000 in Q2 2023 from $3,192,000 in Q2 2022[20]. - Research and development expenses for the six months ended June 30, 2023, included stock-based compensation and other costs, with no revenue generated since inception[49][50]. - The company expects to incur losses from operations and generate negative cash flows due to anticipated expenditures related to research and development activities[34]. - The Company aims to move certain preclinical product candidates in oncology, fibrosis, and infectious disease programs into clinical stages within the next 12 to 24 months[215]. Business Combination and Financing - The business combination with Legacy Ocean was valued at approximately $240,000,000 before transaction fees[30]. - The company raised $52,070,000 from reverse recapitalization and $14,260,000 from the issuance of common stock pursuant to the Backstop Agreement[26]. - The business combination on February 14, 2023, resulted in the issuance of approximately 23,355,432 shares valued at $233,554,320 to Legacy Ocean's stockholders[68]. - The Backstop Agreement allows for the purchase of up to 8,000,000 shares of Class A common stock for up to $80,000,000, including shares from stockholders who revoked their redemption elections[75]. Debt and Interest - The Company recognized interest expenses of $24,046 and $36,852 for the three and six months ended June 30, 2023, respectively[91]. - The Company recorded a loss on extinguishment of debt of $13,595,400 for the issuance of Sponsor Extension Shares for the six months ended June 30, 2023[91]. - The deferred underwriting commissions amount to $3,150,000, with interest rates of 9% per annum and 24% per annum following an event of default[92]. Licensing and Agreements - The company has entered into multiple license agreements with Elkurt, which include milestone payments ranging from $50,000 for filing an IND to $250,000 for enrolling the first patient in a Phase 3 clinical trial[195]. - The Rhode Island License Agreement requires the company to pay an initial license fee of $110,000, due within 45 days of raising at least $10 million in equity financing or by November 1, 2023[199]. - The company is required to pay Elkurt 1.5% of net sales and 25% of all non-royalty sublicense income under the Rhode Island License Agreement upon successful commercialization[200]. Company Outlook and Concerns - The company is facing substantial doubt about its ability to continue as a going concern within one year after the date the financial statements are issued[34]. - The company has no revenue-generating ability at this point in its lifecycle and does not expect to generate revenue in the foreseeable future[49]. - The Company believes its differentiated business model will enable it to commercialize products if approved and replicate licensing partnerships with research institutions[215].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____to _____ Commission File Number: 001-40793 Ocean Biomedical, Inc. (Exact name of registrant as specified in its charter) Delaware 87-1309280 (I.R.S. Employer Identification No.) 55 Claverick St., Room 325 For the quarterly period ended March 31, 2023 Providence, RI 02903 or ☐ TRANSITION REPOR ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____to _____ Commission File Number: 001-40793 Ocean Biomedical, Inc. (Exact name of registrant as specified in its charter) | Delaware | 87-1309280 | | --- | --- | ...