Financial Performance - Total revenue for the three months ended September 30, 2025, was $0, a decrease of $0.2 million compared to $183,000 in the same period of 2024, representing a 100% decline [193]. - For the nine months ended September 30, 2025, total revenue was $0, a decrease of $0.2 million compared to $183,000 in 2024, also a 100% decline [200]. - Net loss for the three months ended September 30, 2025, was $1.657 million, a 21% improvement from a net loss of $2.093 million in 2024 [193]. - Net loss for the nine months ended September 30, 2025, was $8.528 million, a 119% increase from a net loss of $3.897 million in 2024 [200]. - The company had an accumulated deficit of $124.6 million as of September 30, 2025, and expects to incur operating losses in the foreseeable future [205]. Expenses - Research and development expenses for the three months ended September 30, 2025, were $243,000, down 62% from $642,000 in 2024, primarily due to personnel being on furlough since October 2024 [197]. - Research and development expenses for the nine months ended September 30, 2025, were $881,000, a decrease of 64% from $2.469 million in 2024 [202]. - General and administrative expenses decreased by $379,000 for the three months ended September 30, 2025, to $1,093,000, a 26% reduction compared to $1,472,000 in 2024 [198]. - General and administrative expenses increased by $810,000 for the nine months ended September 30, 2025, to $5.674 million, a 17% increase compared to $4.864 million in 2024 [203]. Cash Flow and Financing - As of September 30, 2025, the Company had cash of $328,000, which is insufficient to operate for at least 12 months, raising substantial doubt about its ability to continue as a going concern [212]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $5,386,000, a 3% increase compared to $5,215,000 for the same period in 2024 [217]. - Net cash provided by financing activities decreased by $1.8 million for the nine months ended September 30, 2025, totaling $2,711,000 compared to $4,495,000 in 2024 [218]. - The Company received net proceeds of $1.9 million from debt issuance and $688,000 from the sale of common stock during the nine months ended September 30, 2025 [218]. - The Company plans to seek additional funding through equity and debt financings, collaboration agreements, and research grants to finance its operations [212]. Compliance and Regulatory Issues - The merger with Atlantic Coastal Acquisition Corp. II was completed on November 13, 2024, resulting in the company being publicly traded on the Nasdaq Global Market [190]. - The Company received a notice from Nasdaq on April 2, 2025, indicating it no longer meets the minimum bid price requirement of $1.00 per share, with a compliance period until September 29, 2025 [206]. - On April 10, 2025, the Company was notified that it failed to meet the Market Value of Publicly Held Shares (MVPHS) requirement of $15 million and the Market Value of Listed Securities (MVLS) requirement of $50 million, with a compliance deadline of October 7, 2025 [207]. - The Company was granted continued listing on Nasdaq on November 10, 2025, subject to compliance with interim deadlines and conditions until March 30, 2026 [210]. Future Plans and Risks - The Company plans to advance preclinical activities and clinical trials for product candidates, including a Phase 1/2 trial for ABP-102 targeting HER2+ breast and gastric cancers [214]. - The Company faces risks related to obtaining marketing approvals, costs of patent enforcement, and the need for additional management personnel as it operates as a public company [216].
Atlantic Coastal Acquisition Corp. II(ACABU) - 2025 Q3 - Quarterly Report