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SOUTH SAN FRANCISCO - CERo Therapeutics Holdings, Inc. (NASDAQ:CERO), a micro-cap biotech company valued at $7.1 million that has seen its shares decline over 95% year-to-date according to InvestingPro data, has administered a second dose to the second patient in the first cohort of its Phase 1 CER-1236 clinical trial for acute myeloid leukemia (AML), the company announced Monday.
The multi-dose intensification, authorized by the study’s Institutional Review Board following review of initial pharmacokinetic data showing cell expansion, will double the amount of cell product infused compared to the previous protocol. Despite recent clinical progress, analysts maintain a bullish stance with price targets ranging from $30 to $60, significantly above current trading levels.
"The recent modification to our study will allow us to evaluate the feasibility and safety of administering multiple infusions of CER-1236 in patients with AML and to assess the implications of increased dosing in this Phase 1 study," said Robert Sikorski, Chief Medical Officer at CERo.
The company also reported that study investigator Abhishek Maiti from The University of Texas MD Anderson Cancer Center presented the original study protocol at the Society of Hematologic Oncology’s 13th annual meeting on September 3.
The first-in-human, multi-center Phase 1/1b study is evaluating CER-1236 in patients with AML that is either relapsed/refractory, in remission with measurable residual disease, or newly diagnosed with specific mutations. The study includes dose escalation followed by an expansion phase.
CER-1236 utilizes the company’s Chimeric Engulfment Receptor T cell (CER-T) technology, which integrates phagocytic mechanisms into T cells to target cancer cells.
CERo is preparing to enroll the third patient in the cohort while monitoring the second patient following their second dose, according to the press release statement. While the company maintains a strong cash position relative to debt, InvestingPro analysis indicates weak overall financial health, with additional insights available to subscribers including 12 more ProTips and comprehensive financial metrics.
In other recent news, CERo Therapeutics Holdings, Inc. has made significant strides in its clinical and financial activities. The company announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational compound, CER-1236, for the treatment of Acute Myeloid Leukemia. This designation aims to expedite the development and review process of therapies addressing serious conditions. Additionally, CERo has dosed the second patient in its Phase 1 clinical trial for CER-1236, with ongoing monitoring for safety and efficacy. On the financial front, CERo completed an additional sale of Series D convertible preferred stock, raising approximately $397,600. The company also entered a $17.5 million equity purchase agreement with an institutional investor, further strengthening its financial position. Furthermore, CERo has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. These developments reflect CERo’s ongoing efforts to advance its therapeutic programs and maintain financial stability.
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