CERo Therapeutics Reports $8.3 Million Net Loss for 2024 Amid Increased R&D Expenses

CERo Therapeutics Holdings, Inc. (CERO), formerly Phoenix Biotech Acquisition Corp., reported a net loss of $8.3 million for the year ended December 31, 2024, compared to a net loss of $7.3 million in 2023. This increase is primarily attributable to higher research and development (R&D) and general and administrative expenses. R&D expenses rose to $7.1 million in 2024 from $5.3 million in 2023, driven by increased activity related to the Investigational New Drug Application (IND) filing for CER-1236 and preparations for clinical trials. General and administrative expenses increased to $9.1 million in 2024 from $2.4 million in 2023, partially due to remaining underwriting fees from the initial public offering and increased personnel costs. Offsetting these increases was a $7.9 million increase in other income, primarily due to gains on the revaluation of earnout liabilities and a gain from the settlement of vendor liabilities.

Significant changes occurred during the reporting period. The company completed a merger with CERo Therapeutics, Inc. on February 14, 2024, resulting in a change of name and the conversion of outstanding shares and warrants. A reverse stock split, effective January 8, 2025, converted each 100 shares of common stock into one share. The company also completed a public offering on February 7, 2025, raising approximately $4.5 million in net proceeds. Furthermore, the FDA cleared the IND for CER-1236 in November 2024, following a brief clinical hold, and accepted a second IND application for NSCLC and ovarian cancer in March 2025. The company also experienced several Nasdaq notices of non-compliance related to bid price and market value requirements, ultimately resulting in a transfer to the Nasdaq Capital Market in February 2025.

As of April 8, 2025, CERo had eight full-time employees, including two executive officers and six in R&D. The company's strategy focuses on advancing the clinical development of CER-1236 for AML, leveraging existing CAR-T approvals to shorten regulatory pathways, and expanding CER-1236 development to target solid tumors. Preclinical studies on CER-1236 demonstrated target-dependent activation, cytotoxicity, phagocytosis of tumor cells, and no observed off-target toxicities. The company anticipates beginning Phase 1 clinical trials for CER-1236 in the first half of 2025, initially targeting relapsed/refractory AML patients.

The company's financial statements reflect a significant accumulated deficit of $70.9 million as of December 31, 2024, and the company acknowledges substantial doubt about its ability to continue as a going concern. The company's future funding requirements will depend on the success of its clinical trials, regulatory approvals, and ability to secure additional financing. The company's outlook is contingent upon successful clinical development, regulatory approvals, and commercialization of its product candidates, all of which remain uncertain. The company does not anticipate paying dividends in the foreseeable future.