Abpro Holdings, Inc.

Abpro Holdings, Inc. is a biotechnology company focused on developing next-generation antibody therapeutics for severe and life-threatening diseases, primarily in immuno-oncology, ophthalmology, and infectious disease. The company leverages its proprietary DiversImmune® and MultiMab™ antibody discovery and engineering platforms to develop novel antibodies both independently and through collaborations. The company's common stock, previously listed on Nasdaq, was delisted effective February 23, 2026, and now trades on the OTC Pink Limited Market under the symbol "ABPO." The company's management has concluded that uncertainties around its ability to raise additional capital, combined with its cash on hand, raise substantial doubt about its ability to continue as a going concern.

The core business model revolves around the discovery and engineering of novel antibody therapeutics using its proprietary DiversImmune® and MultiMab™ platforms. Revenue generation is primarily expected from milestone payments and future royalties under collaboration agreements, as the company has not yet generated product sales. Primary customer segments include global biopharmaceutical companies and non-profit and government research institutions through strategic partnerships. The company's platforms are designed to generate high-affinity and high-specificity antibodies and combine them into multi-specific antibody constructs with the goal of improved efficacy, safety, and dosing regimens.

The company's two lead product candidates, ABP-102 and ABP-201, utilize its next-generation tetravalent antibody format, or TetraBi antibody format, which binds to two different targets with two distinct binding sites per target. ABP-102 is an immuno-oncology TetraBi antibody targeting HER2 and CD3 for HER2+ solid tumors, including breast and gastric cancers. It is being developed through a worldwide strategic partnership with Celltrion Inc., from which Abpro received an initial milestone payment of $2.0 million ⁴ in 2022 and is eligible for net sales milestone payments of up to $1.75 billion ⁵ and development milestone payments of up to $4.0 million ⁶. The U.S. FDA cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72 on January 6, 2026, enabling the initiation of a Phase 1 clinical trial. The global HER2+ market is forecast to grow to $12.1 billion ⁷ by 2030, at a CAGR of 1.5% ⁸.

ABP-201 is a TetraBi antibody designed to simultaneously inhibit VEGF and ANG-2 for vascular diseases of the eye, such as diabetic macular edema (DME) and wet age-related macular degeneration (Wet AMD). It is being developed through a territorial partnership with Abpro Bio, a subsidiary of Abpro Bio Co. Ltd, granting exclusive development and commercialization rights in specific regions including China, Japan, South Korea, Southeast Asia, the Middle East, and the Commonwealth of Independent States. Abpro is potentially eligible for net sales milestones of up to $485 million ⁹ and development milestones of up to $56.5 million ¹⁰ under this agreement. In 2022, the combined worldwide sales of Eylea and Lucentis, current standard-of-care treatments, exceeded $10.5 billion ¹¹. Abpro holds an 82% ¹² ownership interest in its consolidated subsidiary, AbMed, through which ABP-201 is held.

For the fiscal year ended December 31, 2025, the company reported no material revenues ¹³. Total operating expenses were $8.452 million ¹⁴, resulting in a loss from operations of $8.452 million ¹⁵. Net loss for the year was $2.892 million ¹⁶, compared to a net loss of $7.232 million ¹⁷ in 2024. Basic and diluted EPS was $(1.30) ¹⁸. As of December 31, 2025, cash was $67 thousand ¹⁹, and the accumulated deficit was $119.0 million ²⁰. Total current liabilities were $9.345 million ²¹.

Comparing 2025 to 2024, research and development services revenue decreased by $0.2 million ²² (100%) ²³ from $183 thousand ²⁴ in 2024 to $0 ²⁵ in 2025. Research and development expenses decreased by $2.0 million ²⁶ (67%) ²⁷ to $989 thousand ²⁸ in 2025 from $2.983 million ²⁹ in 2024, primarily due to a reduction in personnel. General and administrative expenses increased by $0.3 million ³⁰ (5%) ³¹ to $7.463 million ³² in 2025 from $7.121 million ³³ in 2024, mainly due to increased costs of operating as a public company. Other income, net, increased to $5.560 million ³⁴ in 2025 from $2.689 million ³⁵ in 2024, driven by the derecognition of a $4.4 million ³⁶ liability for excise taxes payable and a $3.3 million ³⁷ derecognition of Mabwell liability, partially offset by $1.1 million ³⁸ in interest expenses and an $0.8 million ³⁹ loss on the change in fair value of embedded derivative liability.

Significant operational developments during the period include the FDA clearance of the IND application for ABP-102 / CT-P72 on January 6, 2026, enabling the initiation of a Phase 1 clinical trial. The company also utilized its Standby Equity Purchase Agreement (SEPA) with YA II PN, Ltd., issuing 881,472 ⁴⁰ shares of common stock in 2025 from the conversion of two convertible notes totaling $5.0 million ⁴¹ in principal, and raising approximately $1.0 million ⁴² in net proceeds from the sale of 152,377 ⁴³ shares of common stock under advance notices between July and December 2025. In January and February 2026, an additional 3,162,785 ⁴⁴ shares were issued for net proceeds of approximately $6.7 million ⁴⁵. The company furloughed its Chief Medical Officer, Robert J. Markelewicz, Jr., M.D., M.M.Sc., effective September 30, 2025, with his employment terminated on November 30, 2025. Miles Suk was appointed CEO effective March 3, 2025.

Management expects to incur operating losses and negative cash flows from operations for the foreseeable future as the company advances its product candidates. The future viability of the company is largely dependent on its ability to raise additional capital to finance its operations, with plans to seek additional funding through equity and debt financings, collaboration agreements, and research grants. The company's cash of $67 thousand ⁴⁶ as of December 31, 2025, is not sufficient to allow operations for at least 12 months from the financial statements' issuance date.

The company plans to aggressively advance its lead product candidates, ABP-102 and ABP-201, into the clinic. Clinical trials for ABP-102 are expected to initiate in the first half of 2026, focusing on HER2+ breast and gastric cancers, in conjunction with its Korean collaborator, Celltrion. The Phase 1 clinical study for ABP-102 / CT-P72 will be led by Celltrion. For ABP-201, Phase 1 clinical trials are planned for the second half of 2027 for the treatment of Wet AMD, contingent on securing appropriate funding. IND-enabling studies are underway for both lead product candidates in preparation for final GLP toxicity studies and GMP manufacturing for IND filing.

The company intends to rapidly follow ABP-102 with a broad pipeline of CD3-targeting T-cell engagers, leveraging its optimized TetraBi antibody format to target highly expressed antigens on diverse tumor types. ABP-110, targeting GPC3 on hepatocellular carcinoma, and ABP-150, targeting Claudin 18.2 on gastric cancer, are currently in pre-clinical development. Clinical trials for ABP-110 are expected to initiate in the first half of 2027, and for ABP-150 in the first half of 2027. The company may also extend this "pipeline in a format" strategy to other immune cell targets, including CD137 and CD47. The global liver cancer therapeutics market is projected to reach $12.9 billion ⁴⁷ by 2030, and the global gastric cancer market is projected to reach $13.1 billion ⁴⁸ by 2029.

Operationally, the company plans to continue investing in its DiversImmune® and MultiMab™ platforms to maintain its competitive advantage, expanding its collection of high-affinity and high-specificity antibody building blocks and applying its "fit for purpose" antibody engineering approach. The company aims to build on the success of existing immuno-oncology or cell therapies by focusing on simpler, more accessible, and less expensive approaches for large populations of cancer patients. The company does not have, and does not currently plan to acquire or develop, the infrastructure, facilities, or capabilities to manufacture cGMP bulk drug substance or filled drug product for human clinical trials, intending to utilize third-party contract manufacturing organizations (CMOs) for these needs. The company will hire additional research and development personnel as funding becomes available.

The company plans to continue exploring and executing strategic collaborations, similar to its existing partnerships with Celltrion, Abpro Bio, and Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd (NJCTTQ). These partnerships are sought to provide near-term economic benefits while retaining product rights to key strategic markets. The company also aims to build a fully integrated discovery-to-commercial antibody therapeutics company by complementing its discovery and development strengths with clinical expertise and commercial capabilities as product candidates advance into clinical development.

Management has explicitly flagged several structural headwinds and execution risks. The company is in breach of its license agreement with MedImmune/AstraZeneca relating to ABP-201, which could lead to termination of the agreement, although management believes it does not need the licensed intellectual property for ABP-201's development. The company also faces intense competition from multinational pharmaceutical and biotechnology companies with significantly greater financial, clinical, and marketing resources. The market may not be receptive to product candidates based on its novel therapeutic modality, and there is no guarantee of generating revenue from sales or licensing. The company will need substantial additional funds to advance development, and failure to obtain this capital could force delays, reductions, or termination of operations.

Geographic, regulatory, and macro factors identified as constraints include the delisting of the company's common stock from Nasdaq effective February 23, 2026, with trading now on the OTC Pink Limited Market, which may result in reduced liquidity and increased volatility. The company has appealed this delisting. Furthermore, the U.S. government's One Big Beautiful Bill Act (OBBBA), signed into law on July 4, 2025, is expected to reduce coverage availability and increase reimbursement pressure, potentially limiting the addressable reimbursed patient population and adversely affecting pricing, coverage, and utilization of pharmaceutical products, even for FDA-approved products.

The company faces substantial doubt about its ability to continue as a going concern due to ongoing operating losses and a lack of financing commitments, with an accumulated deficit of $119.0 million ⁴⁹ as of December 31, 2025. Drug development is a highly uncertain undertaking, and all product candidates are in early stages of development, with none having been tested in human subjects, posing a high risk of failure or delays. The company is in breach of its license agreement with MedImmune/AstraZeneca relating to ABP-201, which could lead to termination of the license. Intense competition from multinational pharmaceutical and biotechnology companies with greater resources could render the company's products obsolete or non-competitive. The market may not be receptive to its novel therapeutic modality, and the company may not generate any revenue from product sales or licensing. The company will need substantial additional funds to advance product candidates, and failure to obtain such capital could force delays, reductions, or termination of operations. The company relies on third-party manufacturers and clinical trial partners, and their failure to perform could delay development. Cybersecurity threats could disrupt operations, though no material incidents have occurred to date. The company's common stock was delisted from Nasdaq effective February 23, 2026, and now trades on the OTC Pink Limited Market, which may result in reduced liquidity and increased volatility. The One Big Beautiful Bill Act (OBBBA), enacted in July 2025, is expected to reduce healthcare coverage availability and increase reimbursement pressure, potentially limiting the addressable reimbursed patient population and adversely affecting pricing and utilization of pharmaceutical products. The company has identified material weaknesses in its internal controls over financial reporting, specifically inadequate existing control to ensure timely identification and evaluation of contractual obligations and a failure to design and maintain formal written policies and procedures regarding internal controls over financial reporting.

Management's message to shareholders conveys a commitment to developing next-generation antibody therapeutics despite significant financial and operational challenges. They explicitly state that uncertainties around the ability to raise additional capital, combined with current cash on hand, raise substantial doubt about the company's ability to continue as a going concern. The company expects to incur substantial operating losses and negative cash flows for the foreseeable future. Management plans to initiate clinical trials for ABP-102 in the first half of 2026 and for ABP-201 in the second half of 2027, contingent on securing appropriate funding. The three strategic priorities emphasized are: aggressively advancing lead product candidates ABP-102 and ABP-201 into the clinic; rapidly following ABP-102 with a broad pipeline of CD3-targeting T-cell engagers and leveraging this approach to other immune cell targets; and continuing to explore and execute strategic collaborations while building a fully integrated discovery-to-commercial antibody therapeutics company.