8-K
Abpro Holdings, Inc. (ABPO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): January 6, 2026
Abpro Holdings, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41224 | 87-1013956 |
|---|---|---|
| (State or other jurisdiction <br><br>of incorporation) | (Commission File Number) | (I.R.S. Employer<br><br>Identification No.) |
| 100 Summit DriveBurlington, MA | 01803 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
1-800-396-5890
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
|---|---|---|
| Shares of Common Stock, par value $0.0001 per share | ABP | The Nasdaq Stock Market LLC |
| Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $114.90 | ABPWW | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure
On January 6, 2026, Abpro Holdings, Inc. (the “Company”) issued a press release announcing that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, the Company’s lead multispecific antibody oncology program, which is being co-developed with Celltrion, Inc. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.
The information in this Item 7.01 of this Current Report on Form 8-K, including the exhibit, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated January 6, 2026 |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ABPRO HOLDINGS, INC. | ||
|---|---|---|
| By: | /s/ Miles Suk | |
| Name: | Miles Suk | |
| Title: | Chief Executive Officer | |
| Dated: January 6, 2026 |
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Exhibit 99.1
Abpro and Celltrion, Inc. Announce U.S. FDAIND Clearance for Lead Multispecific Antibody Cancer Candidate ABP-102 / CT-P72
FDA clearance enables initiation of Abpro’sfirst clinical-stage solid tumor program
Clinical trial anticipated to commence in thefirst half of 2026 through Abpro’s global collaboration with Celltrion
BURLINGTON,Mass. and INCHEON, South Korea — January 6, 2026 — Abpro Holdings, Inc. (Nasdaq: ABP), a biotechnology company developing next-generation antibody therapeutics for solid tumors, today announced, together with its co-development partner Celltrion, Inc., that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, Abpro’s lead multispecific antibody oncology program.
The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors**.** The Phase 1 clinical study will be led by Celltrion as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.
“This IND clearance marks an important step for Abpro as we advance our lead solid tumor program into clinical evaluation,” said Miles Suk, CEO of Abpro. “ABP-102 / CT-P72 represents our first clinical-stage T-cell engager program in oncology, and we believe its differentiated design has the potential to translate into a meaningful therapeutic profile for patients with HER2-positive cancers.”
Soo Young Lee, Executive Vice President and Head of New Drug Division at Celltrion, Inc. added, “Based on preclinical data generated to date, we see meaningful potential in ABP-102 / CT-P72 as a next-generation HER2-targeted T-cell engager. We are pleased to support its clinical advancement and to continue working closely with Abpro as the program moves into Phase 1 development.”
ABP-102 / CT-P72 is a multispecific HER2 × CD3 T-cell engager engineered to selectively target HER2-overexpressing tumor cells while engaging cytotoxic T cells, with optimized binding designed to enhance tumor selectivity and limit activity in normal HER2-low tissues. This design is intended to direct immune activity toward cancer cells while seeking to minimize damage to healthy tissue, addressing a key safety challenge that has limited the use of T-cell engagers in solid tumors.
In preclinical studies, ABP-102 / CT-P72 demonstrated robust antitumor activity in HER2-high tumor models, including dual xenograft models containing both HER2-high and HER2-low tumors, with selective efficacy for HER2-high tumors.
The optimized CD3 binding of ABP-102 / CT-P72, functionally linked with HER2-high selectivity, is intended to mitigate excessive immune activation and reduce the risk of cytokine release syndrome. Non-human primate toxicology studies showed the candidate was well tolerated at doses up to 80 mg/kg, with no significant adverse effects observed, supporting a differentiated therapeutic index.
Additional preclinical evaluations demonstrated activity in tumor models representing resistance to existing HER2-directed therapies, highlighting the potential to address areas of unmet medical need. Preclinical data sets for ABP-102 / CT-P72 have been presented at major scientific meetings, including the 2025 Annual Meeting of the American Association for Cancer Research and the 2025 Annual Meeting of the Society for Immunotherapy of Cancer.
Following IND clearance, Abpro and Celltrion plan to initiate a global Phase 1 clinical trial in the first half of 2026, subject to final site activation and regulatory processes. The study is expected to include dose-escalation and dose-expansion cohorts and will inform future clinical development strategies.
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 (AMD) and diabetic macular edema (DME). 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 preclinical 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.
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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 Statements
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
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