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SOUTH SAN FRANCISCO - CERo Therapeutics Holdings, Inc. (NASDAQ:CERO), a clinical-stage biotech company with a market capitalization of $2.7 million currently trading near its 52-week low of $6.71, has dosed the second patient in the first cohort of its Phase 1 clinical trial evaluating CER-1236 for acute myeloid leukemia (AML), the company announced Thursday. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics.
The patient was dosed at the Sarah Cannon Research Institute at Colorado Blood Cancer Institute in Denver, with Dr. Yazan Migdady serving as principal investigator. The company reported that more than seven days have passed since the infusion, with monitoring continuing for safety, tolerability, and efficacy endpoints. With an EBITDA of -$16.35 million in the last twelve months, CERo continues to invest heavily in its clinical development programs.
CERo also provided an update on the first patient treated in the trial, reporting that CER-1236 cells expanded 20.8-fold, reaching peak levels 14 days after infusion. The company previously reported no dose-limiting toxicities were observed during the 28-day observation period for this patient.
The Phase 1/1b study is evaluating CER-1236 in patients with relapsed/refractory AML, AML in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The trial consists of a dose escalation phase followed by an expansion phase.
CER-1236 is an autologous CAR-T therapeutic candidate targeting TIM-4L. The therapy uses what the company calls Chimeric Engulfment Receptor T cells (CER-T), designed to redirect patient-derived T cells to eliminate tumors through phagocytic mechanisms.
"We are encouraged that in our very first patient treated we saw rapid and significant expansion in CER-1236 cells after infusion," said Chris Ehrlich, CEO of CERo, in the press release.
The information in this article is based on a company press release statement.
In other recent news, Cero Therapeutics Holdings, Inc. announced the completion of an additional sale of its Series D preferred stock, raising approximately $397,600 from institutional investors. This transaction is part of a broader private placement offering under a Securities Purchase Agreement. The company also entered into a new equity purchase agreement with an institutional investor, which allows it to issue and sell up to $17.5 million worth of common stock, continuing its equity line program. Additionally, Cero Therapeutics has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market.
The company further amended its securities purchase agreement to include new institutional investors in its Series D preferred stock sale, which can be converted into common stock. In another development, D. Boral Capital upgraded Cero Therapeutics’ stock rating from Hold to Buy, citing confidence in the company’s innovative T cell engineering approach for solid tumors. This upgrade comes after discussions with Cero’s CEO and reflects optimism about the company’s strategic direction. These recent activities highlight Cero Therapeutics’ efforts to strengthen its financial position and strategic initiatives.
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