Abpro Holdings Announces Submission of an IND Application to Initiate a Phase 1 Clinical Trial of T cell engager ABP-102/CT-P72 for HER2-positive Cancers

Rhea-AI Summary

Abpro Holdings (Nasdaq: ABP) and co-developer Celltrion submitted an IND to the FDA on Dec 15, 2025 for ABP-102/CT-P72, a HER2 × CD3 T cell engager engineered for improved tumor selectivity.

Pending FDA clearance, the IND would enable a planned phase 1 dose-escalation and dose-expansion trial anticipated to start in 1H 2026 in patients with HER2-positive cancers including breast and gastric cancers.

Preclinical data presented at AACR and SITC 2025 showed selective activity in HER2-high tumor models and lower activity on normal-tissue–level HER2, and non-human primate studies reported tolerability, supporting a potential favorable therapeutic index.

Positive

• IND submission for ABP-102/CT-P72 received Dec 15, 2025
• Phase 1 trial planned to begin in 1H 2026 pending FDA clearance
• Preclinical selectivity in HER2-high tumor models reported at AACR and SITC 2025
• Favorable tolerability observed in non-human primate studies

Negative

• FDA authorization pending — trial start is not guaranteed
• No human clinical data available yet for ABP-102/CT-P72
• Safety and efficacy in patients remain unproven until clinical readouts

Key Figures

Planned Phase Phase 1 trial First-in-human study for ABP-102/CT-P72 in HER2-positive cancers

Trial timing 1H 2026 Anticipated start of Phase 1 trial pending FDA clearance

Quarter net loss $1.7 million Net loss for quarter ended September 30, 2025 (424B3)

9M net loss $8.5 million Net loss for nine months ended September 30, 2025 (424B3)

Cash balance $328 thousand Cash as of September 30, 2025 vs. current liabilities of $17.3M (424B3)

Stockholders’ deficit $15.6 million Stockholders’ deficit as of September 30, 2025 (424B3)

SEPA capacity $50,000,000 Potential gross proceeds from SEPA sales of Common Stock to YA (S-1)

Registered shares 9,775,017 shares Common Stock registered for resale under SEPA (S-1)

Market Reality Check

$5.87 Last Close

Volume Volume 31,602 is modestly above the 20-day average of 28,987 (relative volume 1.09x). normal

Technical Shares at $5.87 were trading below the 200-day MA of $7.70 and sit 96.19% below the 52-week high, though still 29.07% above the 52-week low.

Peers on Argus

Key biotech peers like ADAP (-17.57%), PHGE (-7.69%), and others also showed weakness, but no names appeared in the momentum scanner and no peer headlines were recorded today, pointing to stock-specific rather than coordinated sector news impact.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 09	Nasdaq extension & funding	Positive	+6.3%	Nasdaq listing extension, cost cuts, and access to up to $44M financing.
Nov 04	Preclinical data SITC	Positive	+1.1%	Positive preclinical HER2×CD3 data for ABP-102/CT-P72 presented at SITC 2025.
Nov 03	Reverse stock split	Negative	-3.6%	1-for-30 reverse split to address Nasdaq compliance and capital structure.

Pattern Detected

Limited history shows price moves generally aligning with news tone: compliance/financing and ABP-102 preclinical updates all saw modest same-direction reactions.

Recent Company History

Over recent months, Abpro focused on Nasdaq compliance and capital structure while advancing ABP-102. A 1-for-30 reverse split on Nov 3, 2025 reduced outstanding shares from ~81.2M to 2.7M. Subsequent updates highlighted a Nasdaq listing extension, cost reductions, access to up to $44M in equity financing, and positive preclinical data for ABP-102/CT-P72 presented at SITC 2025. Today’s IND submission continues that trajectory from preclinical data toward first-in-human evaluation for the same HER2×CD3 program.

Market Pulse Summary

This announcement advances ABP-102/CT-P72 from preclinical work toward a planned Phase 1 trial for HER2-positive cancers in 1H 2026, building on prior AACR and SITC data. At the same time, SEC filings show a cash position of $328 thousand, current liabilities of $17.3 million, and a stockholders’ deficit of $15.6 million, with management citing substantial doubt about going concern. Investors may watch for FDA feedback on the IND and concrete funding steps to support upcoming clinical work.

Key Terms

investigational new drug (IND) regulatory

"announced the submission of an investigational new drug (IND) application to the U.S."

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

t cell engager medical

"ABP-102/CT-P72, a HER2 × CD3 T cell engager engineered with optimized CD3"

A T cell engager is an engineered protein drug that physically links a patient’s T cell — the immune system’s attack cell — to a diseased cell so the T cell will recognize and kill it. For investors it matters because clinical trial results, manufacturing success and safety profiles determine whether the therapy becomes a widely adopted, high-value treatment or a costly failure; think of it like a matchmaker that must reliably bring soldiers to the right target without triggering friendly fire.

her2-positive medical

"phase 1 clinical trial, anticipated to begin in 1H 2026 in patients with HER2-positive cancers"

HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.

cd3 medical

"a HER2 × CD3 T cell engager engineered with optimized CD3 and HER2 binding"

CD3 is a group of proteins on the surface of T cells, the immune system’s front-line soldiers, that act like a control panel to turn those cells on and off. It matters to investors because many modern therapies work by engaging or blocking CD3 to direct T cells against cancer or dampen harmful immune reactions; success, safety and regulatory approval of CD3-targeting drugs can significantly affect a biotech company’s prospects.

pharmacokinetics medical

"study will evaluate the safety, pharmacokinetics, and preliminary efficacy of ABP-102/CT-P72"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

dose-escalation medical

"in a dose-escalation and dose-expansion format."

Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.

immuno-oncology medical

"advance for Abpro’s broader immuno-oncology pipeline."

Immuno-oncology is a field of medicine focused on using the body's immune system to fight cancer. It involves developing treatments that help the immune system recognize and attack cancer cells more effectively. For investors, advancements in immuno-oncology can signal promising new therapies that may lead to improved patient outcomes and potentially significant commercial opportunities.

AI-generated analysis. Not financial advice.

 IND submitted for ABP-102/CT-P72, a HER2 × CD3 T cell engager, with preclinical studies demonstrating enhanced HER2-high tumor selectivity and a favorable safety profile

ABP-102/CT-P72 represents Abpro’s first IND submission for a phase 1 trial in a solid tumor indication, and is being co-developed by Abpro and Celltrion, Inc.

BURLINGTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Abpro Holdings, Inc. (Nasdaq: ABP, “Abpro”), a biotechnology company developing novel breakthrough therapeutics for solid tumors, together with its co-development partner Celltrion, Inc., today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for ABP-102/CT-P72, a HER2 × CD3 T cell engager engineered with optimized CD3 and HER2 binding to improve tumor selectivity. Pending regulatory clearance, this IND will support the initiation of a phase 1 clinical trial, anticipated to begin in 1H 2026 in patients with HER2-positive cancers including breast and gastric cancers. This submission represents a significant milestone in the companies’ collaborative development of ABP-102/CT-P72 and marks an important advance for Abpro’s broader immuno-oncology pipeline.

Abpro Holdings and CELLTRION, INC. recently presented compelling preclinical results for ABP-102/CT-P72 at the American Association for Cancer Research (AACR) 2025 Annual Meeting and at the Society for Immunotherapy of Cancer (SITC) 40^th Anniversary Annual Meeting, highlighting selective activity in HER2-high tumor models and lower activity on cells with normal-tissue–level HER2 expression in preclinical studies. In non-human primates, ABP-102/CT-P72 was well tolerated. Together, these findings support the potential for a favorable therapeutic index in clinical studies.

“We are pleased to advance ABP-102/CT-P72 to IND review; this reflects the strength of our T cell engager platform and the productive collaboration between Abpro and Celltrion throughout development,” said Miles Suk, CEO of Abpro. “This milestone brings us closer to delivering a potentially highly selective therapeutic candidate for patients with HER2-positive solid tumors, including those with limited treatment options. It also underscores the momentum across our broader T-cell-engager platform as we continue to expand and advance a differentiated oncology pipeline.”

Upon FDA authorization to proceed, the planned phase 1 study will evaluate the safety, pharmacokinetics, and preliminary efficacy of ABP-102/CT-P72 in a dose-escalation and dose-expansion format. Data generated from the trial will inform dose selection and guide subsequent clinical development.

About Abpro
Abpro’s mission is to improve the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies. Abpro is advancing a pipeline of next-generation antibody therapies, for HER2+cancers, non-HER2+ gastric and liver cancer, and wet age-related macular degeneration and diabetic macular edema. These antibodies are developed using Abpro's proprietary DiversImmune^® platform. Abpro is located in Burlington, Massachusetts. For more information, please visit www.abpro.co.

Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of development programs, including the timing and availability of additional data, and expectations regarding the therapeutic benefit of Abpro’s programs, as well as strategic partnerships. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; Abpro’s ability to continue as a going concern; Abpro’s ability to achieve compliance with Nasdaq listing standards; expectations regarding the therapeutic benefit of Abpro’s programs; that final data from Abpro’s pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; Abpro’s ability to efficiently discover and develop product candidates; Abpro’s ability to obtain and maintain regulatory approval of product candidates; Abpro’s ability to maintain its intellectual property; the implementation of Abpro’s business model, including strategic plans for Abpro’s business and product candidates; and other risks identified in Abpro’s filings with the U.S. Securities and Exchange Commission (SEC) including Abpro’s most recent Annual Report on Form 10-K filed with the SEC and subsequent filings with the SEC. Abpro cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Abpro disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Abpro’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea, that specializes in researching, developing, and manufacturing innovative therapeutics that improve people's lives worldwide. Celltrion pursues sustainable growth by leveraging its experience and assets in the successful biosimilar business to develop new medicines and healthcare platform technologies. The company works with a sense of duty to advance patients' wellness and provide them with enhanced access to reliable healthcare. To accomplish this, Celltrion adheres to strong internal ethical standards in its daily operations. To learn more, please visit www.celltrion.com.

Forward-Looking Statement
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws.

These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements.

Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.

Investor and Media Contact:
Daniel Kontoh-Boateng
DKB Partners, LLC
Tel: +1-862-213-1398
dboateng@dkbpartners.net

FAQ

What did Abpro (ABP) announce on Dec 15, 2025 about ABP-102/CT-P72?

Abpro and Celltrion submitted an IND to the FDA for ABP-102/CT-P72 to support a planned phase 1 trial in HER2-positive cancers.

When is the ABP-102/CT-P72 phase 1 trial expected to start for ABP stock investors?

The company anticipates initiating the phase 1 study in 1H 2026, pending FDA clearance.

What preclinical evidence supports ABP-102/CT-P72 for HER2-positive cancers?

Preclinical results presented at AACR and SITC 2025 showed selective activity in HER2-high tumor models and lower activity on normal-tissue–level HER2.

What will the planned phase 1 ABP-102/CT-P72 trial evaluate?

The phase 1 study will evaluate safety, pharmacokinetics, and preliminary efficacy in a dose-escalation and dose-expansion format.

Does non-human primate data for ABP-102/CT-P72 show safety signals?

In non-human primates, ABP-102/CT-P72 was reported to be well tolerated in preclinical studies.