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SOUTH SAN FRANCISCO - The U.S. Food and Drug Administration has granted Orphan Drug Designation to Senti Biosciences, Inc.’s (NASDAQ:SNTI) SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including Acute Myeloid Leukemia (AML), the company announced Wednesday. The clinical-stage biotech company, currently valued at $72.5 million, has shown promising developments despite challenging market conditions. According to InvestingPro analysis, while the company maintains strong liquidity with a current ratio of 4.22, it faces significant cash burn challenges in its development phase.
SENTI-202 is a first-in-class off-the-shelf CAR NK cell therapy currently being evaluated in a Phase 1 clinical trial. The therapy is designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy bone marrow cells.
"SENTI-202 continues to demonstrate encouraging promise as a potential treatment option for relapsed/refractory AML, an indication with significant unmet need and a median survival rate of 5.3 months," said Timothy Lu, Co-Founder and CEO of Senti Biosciences, in the press release. Analysts share this optimism, with InvestingPro data showing price targets ranging from $12 to $15, significantly above current trading levels. Get access to 7 more exclusive InvestingPro Tips about SNTI’s financial outlook and market position.
The Orphan Drug Designation provides several benefits to drug developers, including tax credits, exemptions from certain FDA fees for clinical trials, and the potential for seven years of market exclusivity following drug approval. The designation is granted to products showing potential to treat rare diseases affecting fewer than 200,000 people in the United States.
According to the company, approximately 20,800 new AML cases are diagnosed in the U.S. annually, with 60% of patients experiencing relapse or death within 12 months.
Senti Biosciences is developing cell and gene therapies using its proprietary Gene Circuit platform, which aims to engineer treatments with enhanced precision and control. The company’s technology is designed to precisely target cancer cells while sparing healthy cells. While the company operates with a moderate debt level and maintains healthy short-term liquidity, InvestingPro analysis indicates the stock currently trades below its Fair Value, potentially presenting an opportunity for investors interested in the biotechnology sector.
In other recent news, Senti Biosciences has reported promising interim results from its Phase 1 trial of SENTI-202, a novel treatment for relapsed or refractory acute myeloid leukemia (AML). The trial data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, showed no dose-limiting toxicities and identified a preliminary recommended Phase 2 dose. Notably, five out of seven evaluable patients achieved an overall response, with some achieving complete remission. Laidlaw analysts have initiated coverage on Senti Biosciences with a Buy rating, citing optimism about SENTI-202’s potential. The company has also joined Webull’s Corporate Connect Service to enhance shareholder communication and transparency. Additionally, Senti Bio appointed Dr. James B. Trager to its Scientific Advisory Board, bringing extensive experience in cellular therapy development. The company continues to advance its Gene Circuit platform, aiming to create precise cell and gene therapies for incurable diseases. As part of its financial updates, Senti Biosciences reported a net loss of $14.1 million for the first quarter of 2025, with cash and cash equivalents at approximately $33.8 million.
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