Senti Bio reports Q2 results, SENTI-202 clinical development advances.

• Senti Biosciences reports Q2 financial results • Completed dose finding for SENTI-202 clinical study • Confirmed recommended Phase 2 dose (RP2D) • Enrolling patients in dose expansion phase • Received Orphan Drug Designation for SENTI-202 • Strengthened leadership with new Scientific Advisory Board and Board of Directors members • Senti Bio is a clinical-stage biotech company developing next-gen cell and gene therapies using its proprietary Gene Circuit platform.

Senti Biosciences (NASDAQ: SNTI), a clinical-stage biotech company, has reported its Q2 2025 financial results and provided key updates on its SENTI-202 program for Acute Myeloid Leukemia (AML). The company has completed the dose-finding phase and confirmed the recommended Phase 2 dose (RP2D) in its ongoing Phase 1 clinical trial. SENTI-202 received FDA Orphan Drug Designation for AML treatment. Financial highlights include a cash position of $21.6M as of June 30, 2025 (down from $48.3M in December 2024), R&D expenses of $10.0M (up $0.8M YoY), and G&A expenses of $6.8M (up $2.6M YoY). The company reported a net loss of $14.7M ($0.56 per share) for Q2 2025. Additionally, Senti Bio secured a $1.0M grant from CIRM for SENTI-202's clinical development.

The company's Q2 results reveal significant clinical progress with their lead candidate SENTI-202 for acute myeloid leukemia (AML), now advancing from dose finding to dose expansion phase with a confirmed recommended Phase 2 dose (RP2D). This milestone, coupled with the FDA's Orphan Drug Designation, represents meaningful development progress toward their Q4 2025 data readout. The financial picture, however, presents concerns. Cash reserves have dropped sharply from $48.3 million at year-end 2024 to $21.6 million as of June 30, 2025 – a 55% reduction in just six months. With quarterly operating expenses of approximately $16.8 million ( $10.0 million R&D + $6.8 million G&A), the current burn rate suggests a cash runway that could be insufficient to reach key milestones beyond Q4 2025 without additional financing. Of particular note is the 62% jump in G&A expenses year-over-year ( $6.8 million vs $4.2 million ), primarily from personnel costs. While R&D expenses increased modestly by 8.7%, the disproportionate G&A growth raises efficiency questions. The $1.0 million CIRM grant provides minimal relief against the $14.7 million quarterly net loss.

Senti Bio's announcement that SENTI-202 has completed the dose-finding phase and established a recommended Phase 2 dose (RP2D) represents a significant developmental milestone in their AML program. This progression to the dose expansion phase, where additional relapsed/refractory AML patients will be enrolled at the established RP2D, follows the standard clinical development pathway and indicates the therapy has demonstrated a manageable safety profile sufficient to advance. The FDA's grant of Orphan Drug Designation for SENTI-202 in AML provides important regulatory advantages including tax credits for clinical trials, exemption from user fees, and the potential for seven years of market exclusivity upon approval. This designation acknowledges both the rarity and severity of AML, particularly in relapsed/refractory settings where treatment options remain limited.

The press release strategically positions the upcoming Q4 2025 data readout as including "additional efficacy and durability data," suggesting that some preliminary efficacy signals may have been observed. However, this expanded dataset will be the true test of SENTI-202's potential. In relapsed/refractory AML, meaningful complete remission rates with durability beyond 3-6 months would represent clinically significant outcomes. Senti's Gene Circuit platform approach differentiates it technologically, potentially enabling more precise targeting of cancer cells while sparing healthy tissues. However, the field of cell therapies for AML remains challenging, with multiple competitive approaches in development. The Q4 2025 data will be crucial in determining whether SENTI-202 can deliver the efficacy, durability and safety profile needed to advance toward registration trials in this difficult-to-treat malignancy.

References:
[1] https://www.stocktitan.net/news/SNTI/senti-bio-reports-second-quarter-2025-financial-results-and-confirms-pqahty096hev.html