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Recent press releases and 8-K filings for ABP.
Abpro Holdings and Celltrion Announce FDA IND Clearance for Cancer Candidate ABP-102 / CT-P72
ABP
New Projects/Investments
Product Launch
- Abpro Holdings, Inc. and co-development partner Celltrion, Inc. announced on January 6, 2026, that the U.S. FDA cleared the Investigational New Drug (IND) application for their lead multispecific antibody cancer candidate, ABP-102 / CT-P72.
- This clearance enables the initiation of a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors.
- The clinical trial is anticipated to commence in the first half of 2026 and will be led by Celltrion as part of their joint strategic collaboration.
- Preclinical data for ABP-102 / CT-P72 showed robust antitumor activity in HER2-high tumor models and was well tolerated in non-human primate toxicology studies, indicating potential for a differentiated therapeutic profile.
Jan 6, 2026, 12:06 PM
Abpro Holdings Submits IND for Phase 1 Clinical Trial of ABP-102/CT-P72
ABP
New Projects/Investments
- Abpro Holdings, Inc. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ABP-102/CT-P72 on December 15, 2025.
- This IND aims to initiate a Phase 1 clinical trial for patients with HER2-positive cancers, including breast and gastric cancers.
- The Phase 1 clinical trial is anticipated to begin in the first half of 2026 (1H 2026), pending regulatory clearance.
- ABP-102/CT-P72 is a HER2 × CD3 T cell engager being co-developed by Abpro and Celltrion, Inc..
- Preclinical studies for ABP-102/CT-P72 demonstrated enhanced HER2-high tumor selectivity and a favorable safety profile.
Dec 15, 2025, 12:16 PM
Abpro Holdings Receives Nasdaq Listing Extension
ABP
Delisting/Listing Issues
New Projects/Investments
- Abpro Holdings (ABP) has been granted an extension by the Nasdaq Hearings Panel to regain full compliance with Nasdaq listing requirements.
- The company's compliance roadmap includes a reverse stock split, which took effect on November 3, a market transfer application, and a planned capital strategy to increase stockholders' equity.
- Abpro has access to up to $44 million in equity financing to fund operations and achieve long-term financial milestones.
- The company has achieved an estimated ~60% reduction in operating expenses versus the prior year through disciplined streamlining.
- Its lead antibody candidate, ABP-102, developed in partnership with Celltrion, is on track for first-in-human trials in 2026.
Dec 9, 2025, 12:00 PM
Abpro and Celltrion to Present Preclinical Data for CT-P72/ABP-102 at SITC 2025
ABP
New Projects/Investments
Product Launch
- Abpro Holdings, Inc. and Celltrion, Inc. will present new preclinical data for their co-developed CT-P72/ABP-102 at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting from November 6-10, 2025.
- The poster for CT-P72/ABP-102, a tetravalent bispecific antibody targeting HER2 and CD3, was selected as one of the Top 150 abstracts out of more than 1,300 submissions.
- Preclinical data demonstrates potent and selective anti-tumor activity in HER2-high models, including Enhertu-resistant tumors, and a favorable safety profile in non-human primates.
- These findings support the advancement of CT-P72/ABP-102 toward first-in-human clinical studies for HER2-positive cancers, with plans to initiate trials next year.
Nov 4, 2025, 12:00 PM
Abpro Announces 1-for-30 Reverse Stock Split
ABP
Delisting/Listing Issues
- Abpro Holdings, Inc. announced a 1-for-30 reverse stock split that became effective at 5:01 p.m. Eastern Time on October 31, 2025, with split-adjusted trading commencing on November 3, 2025.
- This action will reduce the number of outstanding common shares from approximately 81.2 million to 2.7 million and is a necessary step to maintain Nasdaq listing compliance.
- The company also reported achieving an estimated ~60% reduction in operating costs compared to the same period in 2024.
Nov 3, 2025, 12:00 PM
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