Merger and Financial Agreements - The merger between Atlantic Coastal Acquisition Corp. II and Legacy Abpro was completed on November 13, 2024, resulting in the issuance of approximately 50 million shares of New Abpro common stock[34]. - New Abpro entered into a Standby Equity Purchase Agreement with YA II PN, Ltd. for up to $5 million, with the potential for additional share issuance under certain conditions[37]. - A Convertible Promissory Note for $3 million was issued with an 8% original issue discount, providing net proceeds of $2.755 million, maturing on November 13, 2025[39]. - The merger is accounted for as a reverse recapitalization, treating ACAB as the acquired company for financial reporting purposes[35]. - The agreement with Abpro Bio includes a $30 million equity investment and potential payments totaling approximately $540 million based on development and sales milestones[177][178]. - NJCTTQ has agreed to pay up to $405 million in milestones based on commercial approval and sales in its territory, with reciprocal low single-digit royalties[181]. Product Development and Clinical Trials - ABP-102 is designed to target HER2+ solid tumors and is expected to enter clinical trials in the first half of 2026, with a projected global HER2+ market growth to $12.1 billion by 2030 at a CAGR of 1.5%[50]. - ABP-201 is being developed for vascular diseases of the eye, with potential net sales milestones of up to $485 million and development milestones of up to $56.5 million from Abpro Bio[43]. - A Phase 1 clinical trial for ABP-201 is planned for the second half of 2026, focusing on Wet AMD, following a Phase 1/2 trial for ABP-102 in HER2+ breast and gastric cancers in the first half of 2026[64]. - Clinical trials for ABP-102 are planned to initiate in the first half of 2026, focusing on HER2+ breast and gastric cancers in partnership with Celltrion[100]. - ABP-201 is undergoing a Phase 1 clinical trial for wet age-related macular degeneration (Wet AMD) to evaluate safety and initial efficacy, with plans for a larger Phase 2 study following the identification of the maximum tolerated dose[135]. Market Potential and Competitive Landscape - The global breast cancer monoclonal antibodies market is projected to grow by USD 15 billion at a CAGR of 12.5% from 2022 to 2027, with North America expected to contribute 42% to this growth[97]. - In 2022, HER2 directed therapies generated approximately $10.3 billion in sales, with key products including PERJETA ($4.6 billion), KADCYLA ($2.3 billion), HERCEPTIN ($2.2 billion), and ENHERTU ($1.2 billion)[103]. - The global oncology therapeutics market is forecasted to reach $250 billion by 2024, growing at a CAGR of 12% from $143 billion in 2019[98]. - The global ophthalmology market is expected to grow from $51 billion in 2022 to $84 billion by 2030, at a CAGR of 6.4%[99]. - The market for DME and Wet AMD is significant, with over 94% of DME patients utilizing anti-VEGF intravitreal injections as of 2021[127]. - Eylea and Lucentis accounted for over $10.4 billion in worldwide sales in 2022, highlighting the competitive landscape for ocular therapies[133]. Technology and Innovation - The DiversImmune platform aims to generate high affinity and high specificity antibodies, addressing key bottlenecks in antibody therapeutics[75]. - The MultiMab platform allows for the construction of bi- and multi-specific antibody formats, optimizing product candidates for various diseases[80]. - ABP-102 features a dual-arm affinity-tuned construct for selective killing of HER2-high target cells, aiming to reduce "on-target, off-tumor" toxicity[51]. - The TetraBi antibody format of ABP-102 is designed to enhance therapeutic efficacy and safety by selectively activating T cells in the presence of tumor cells[52]. - ABP-201 utilizes dual inhibition of VEGF and ANG-2 to block angiogenesis, featuring four high-affinity binding sites for increased potency[56]. - The TetraBi antibody format includes an Fc region for longer circulating half-lives, potentially allowing for more convenient dosing for patients[95]. - The DiversImmune platform enables the generation of high-quality antibodies against difficult-to-target proteins, accelerating the discovery phase of new therapeutics[86]. - The B cell cloning platform isolates neutralizing antibodies to SARS-CoV-2 and other viruses, enhancing the company's therapeutic capabilities[87]. Regulatory and Compliance - The FDA's approval process for therapeutic biologics requires substantial time and financial resources, including the submission of a Biologics License Application (BLA)[202]. - The company must comply with Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs) during the development and testing of its product candidates[204]. - The FDA may refuse to accept a BLA if deemed incomplete, requiring resubmission with additional information[214]. - The Prescription Drug User Fee Act (PDUFA) mandates that each BLA must be accompanied by a significant user fee, which is adjusted annually[213]. - The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) plan for certain products, which must be submitted with the Biologics License Application (BLA) if deemed necessary[216]. - The FDA may withdraw approval if regulatory compliance is not maintained post-approval, and new issues may arise that could restrict or withdraw the product from the market[217]. - Manufacturers must register with the FDA and are subject to periodic inspections to ensure compliance with current Good Manufacturing Practices (cGMP)[218]. - The Orphan Drug Act provides a seven-year exclusive marketing period for the first approved BLA for a drug treating a rare disease affecting fewer than 200,000 individuals in the U.S.[220]. - The Affordable Care Act (ACA) introduced new Medicaid rebate calculations and increased minimum rebates, impacting manufacturers' financial obligations[230]. - The Inflation Reduction Act of 2022 will reduce Medicare Part D beneficiaries' annual out-of-pocket maximum from $7,050 to $2,000 starting January 1, 2025[230]. - Third-party payors are increasingly scrutinizing drug prices and may limit coverage to specific products on an approved formulary, affecting sales potential[223]. - Companies may need to conduct pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of products to secure reimbursement[224]. - Compliance with healthcare laws, such as the Anti-Kickback Statute and the False Claims Act, is critical to avoid significant penalties and operational disruptions[229]. - Regulatory approval processes vary by country, and delays in one jurisdiction can negatively impact approvals in others[222]. Intellectual Property - The company holds two patent families for ABP-102, with expected expiration in 2042, and one patent family for ABP-110, expiring in 2033[191][192]. - The company has a patent family for ABP-150, with pending applications expected to expire in 2041[193]. - As of December 31, 2024, the company owns one patent family for the ABP-201 product candidate, expected to expire in 2042[194]. - The company has licensed three patent families from MedImmune/AstraZeneca, with patents in these families expected to expire before the commercialization of ABP-201[195]. - One licensed patent family includes three issued U.S. patents and is expected to expire in 2025[196]. - The second licensed patent family includes two issued U.S. patents and is expected to expire in 2037[197]. - The third licensed patent family also includes two issued U.S. patents and is expected to expire in 2037[198]. - The company plans to apply for patent term extensions upon receiving FDA approval for its product candidates, depending on clinical study lengths[199].
Atlantic Coastal Acquisition Corp. II(ACABU) - 2024 Q4 - Annual Report