[8-K] Abpro Holdings, Inc. Reports Material Event

Abpro Holdings, Inc. reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, its lead multispecific antibody oncology program.

Rhea-AI Filing Summary

Abpro Holdings, Inc. reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, its lead multispecific antibody oncology program. The therapy is being co-developed with Celltrion, Inc., and this clearance allows clinical studies of the candidate to begin under the IND. The update was shared via a press release furnished under a Regulation FD disclosure.

Insights

Biotech and regulatory affairs analyst

FDA IND clearance lets Abpro and Celltrion begin clinical testing of their lead oncology antibody.

The company reports that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for ABP-102 / CT-P72, described as its lead multispecific antibody oncology program, co-developed with Celltrion, Inc.. IND clearance is the formal authorization needed to start clinical evaluation of a new drug candidate in humans in the United States.

Because this program is identified as the lead oncology asset, the regulatory milestone can be important for Abpro’s development pipeline, shifting the project from purely preclinical work into the clinical stage governed by the IND. The involvement of Celltrion as a co-development partner may also shape future funding, development responsibilities, and commercialization paths, although specific economic terms are not detailed here.

The company communicated this development in a press release furnished under Regulation FD on January 6, 2026. Subsequent disclosures in future company filings can provide more detail on clinical trial design, timelines, and any early safety or activity signals as the ABP-102 / CT-P72 program progresses.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Accepted by SEC EDGAR 01/06/2026 - 07:06 AM Learn about SEC filing dates

false 0001893219 0001893219 2026-01-06 2026-01-06 0001893219 ABP:SharesOfCommonStockParValue0.0001PerShareMember 2026-01-06 2026-01-06 0001893219 ABP:WarrantsEachWholeWarrantExercisableForOneShareOfCommonStockAtExercisePriceOf114.90Member 2026-01-06 2026-01-06 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

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 of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

100 Summit Drive Burlington, 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)

1

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

2