Abpro Holdings (NASDAQ: ABP) discloses IND filing for HER2 therapy

Rhea-AI Filing Summary

Abpro Holdings, Inc. disclosed that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to initiate a phase 1 clinical trial of its T cell engager candidate ABP-102/CT-P72 for HER2-positive cancers. This marks a step toward first-in-human testing of the therapy, subject to regulatory review.

The update comes via a current report that references a company press release containing further details and includes the release as an exhibit. The company notes that this information is being furnished rather than filed under securities laws, which limits how it is incorporated into other regulatory documents.

Insights

Biotech industry analyst

Abpro moves its HER2-directed T cell engager toward first human testing.

Abpro Holdings reports that it has submitted an IND application to the U.S. Food and Drug Administration for ABP-102/CT-P72, a T cell engager targeting HER2-positive cancers. An IND submission is the formal request to begin a phase 1 clinical trial, typically focused on safety and initial biological signals in humans.

This step indicates the company has completed sufficient preclinical work and compiled data to seek regulatory clearance to test the drug in people, but it does not imply that the FDA has accepted the application or that dosing has begun. The attached press release, referenced as an exhibit, is positioned as the primary source for additional details on the planned trial design and development plans.

Future progress will depend on the FDA’s response to the IND and on subsequent clinical results once a phase 1 trial is underway. Subsequent company disclosures and regulatory communications will clarify whether the trial proceeds as proposed and how the program evolves over time.

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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): December 15, 2025

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 December 15, 2025, Abpro Holdings, Inc. (the “Company”) issued a press release announcing that the Company submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a phase 1 clinical trial of T cell engager ABP-102/CT-P72 for HER2-positive cancers. A copy of the press release is attached hereto as Exhibit 99.1 hereto and is incorporated into this Item 7.01 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 December 15, 2025
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: December 15, 2025

2

FAQ

What did Abpro Holdings (ABP) disclose about ABP-102/CT-P72?

Abpro Holdings disclosed that it submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration to initiate a phase 1 clinical trial of its T cell engager ABP-102/CT-P72 for HER2-positive cancers.

Which disease area is targeted by Abpro Holdings ABP-102/CT-P72 candidate?

The T cell engager candidate ABP-102/CT-P72 is intended for the treatment of HER2-positive cancers, according to the companys disclosure.

What stage of development is ABP-102/CT-P72 entering based on this Abpro (ABP) update?

Abpro is seeking to move ABP-102/CT-P72 into a phase 1 clinical trial, as the company has submitted an IND application to enable first-in-human testing, subject to FDA review.

How did Abpro Holdings communicate the IND submission to investors?

The company reported the IND submission in a current report and referenced a related press release, which is included as Exhibit 99.1 and incorporated into the disclosure by reference.

Does the Abpro Holdings disclosure state that the FDA has approved the IND for ABP-102/CT-P72?

No. The disclosure states that the company has submitted an IND application to the FDA to initiate a phase 1 trial; it does not state that the IND has been accepted or approved.

What exhibit is attached to Abpro Holdings current report about the IND submission?

The report lists Exhibit 99.1 as a press release dated December 15, 2025, which provides additional information on the IND submission.