安克赛斯生物科学公司 2025年季度报告

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______Commission file number001-37492 (Exact name of registrant as specified in its charter) Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reporting company☒Emerging growth company☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ Condensed Consolidated Balance Sheets (Unaudited) as of April 30, 2025 and October 31, 2024 Condensed Consolidated Statements of Operations (Unaudited) for the three and six months ended April 30, 2025 and 2024Condensed Consolidated Statements of Equity (Unaudited) for the three months ended April 30, 2025 and 2024 Condensed Consolidated Statements of Cash Flows (Unaudited) for the six months ended April 30, 2025 and 2024Notes to Condensed Consolidated Financial Statements (Unaudited) Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Item 4. Controls and Procedures. Item 1. Legal Proceedings. Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. noshares issued or outstandingCommon stock, par value $.01per share;100,000,000shares authorized;32,211,092and32,196,862shares issued and outstanding as of April 30, 2025 and October 31, the patients. As of May 28, 2025, we are preparing to enroll patients in the fourth dose cohort, where we will be administering a 30-times higherdose than the original dose cohort. tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells. Thestudy is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy. The study We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing this technology, we areworking in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer, focused initially on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This proteindisappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that In October 2021, following the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients ina Phase 1 clinical trial of our breast cancer vaccine. This study, which is being fully funded by a U.S. Department of Defense grant to ClevelandClinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage,triple-negative breast cancer as well as monitor immune response. The study is being conducted at Cleveland Clinic. During the course of the Phase1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. Thefirst segment of the study, Phase 1a, will consist of approximately 24 patients who have completed treatment for early-stage, triple-negative breast presented show that in the vaccinated women who had been tested to date, various levels of antigen-specific T cell responses were observed at alldose levels. Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the different key components of thevaccine. Further, in November 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that includesparticipants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk ofdeveloping TNBC in the future, and have elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination ofparticipants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following treatmentand are currently undergoing treatment with pembrolizumab (Keytruda®). In November 2024, we presented the most recent data from each of thethree arms of the trial at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Key findings presented include i) patients exhibitedantigen-specific immune responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in tissue, this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED naturally andmarkedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.Researchers at Clevelan