On May 6, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the first quarter 2025, and provided corporate updates (Press release, Sensei Biotherapeutics, MAY 6, 2025, View Source [SID1234652595]).

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"This was a breakthrough quarter for Sensei," said John Celebi, President and CEO. "We observed favorable signs of clinical activity in patients with PD-(L)1-resistant cancers from our dose expansion cohort—patients who face poor odds and few options. Beyond the responses we have observed, what’s striking is the emerging potential for prolonged benefit, with some PD-(L)1-resistant patients approaching a year on study. In a population with historically low response rates and fleeting benefit from PD-(L)1 rechallenge, we observed response rates nearly three times higher than what would typically be expected in this setting. With dose expansion enrollment now complete, we’re laser-focused on finalizing a Phase 2 strategy for solnerstotug, guided by the full dataset we plan to present later this year."

Highlights and Milestones

Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

Recent updates include:

In March, Sensei announced preliminary data from the dose expansion stage of its ongoing Phase 1/2 trial, showing favorable activity in patients with PD-(L)1 resistant "hot" tumors.
Enrollment is now complete with a total of 63 patients:
10 MSS CRC patients in the monotherapy arm
53 patients in the cemiplimab combination arm consisting of 10 MSS CRC patients and 43 PD-(L)1 resistant "hot" tumor patients.
Full dose expansion data from the Phase 1/2 study expected by year-end 2025.
A replay of the March 2025 webcast related to these preliminary results, featuring study investigator Dr. Shiraj Sen, is available on the Sensei website.

Other corporate highlights included:

Canaccord Genuity Horizons in Oncology Virtual Conference: On April 7, 2025, John Celebi, President and CEO of Sensei Biotherapeutics, participated in a panel discussion titled "New Radiotherapy and Targeted Therapy Approaches." The panel focused on emerging innovations in cancer treatment and Sensei’s approach to selectively modulating the tumor microenvironment. A replay of the discussion is available on the conference website.
Oppenheimer’s 35th Annual Healthcare Life Sciences Conference: On February 11, 2025, Mr. Celebi delivered a presentation at Oppenheimer’s 35th Annual Healthcare Life Sciences Conference. The presentation provided insights into the company’s clinical progress and strategic direction. A webcast of the presentation is available in the Investors section of the Sensei website.
First Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $34.3 million as of March 31, 2025, as compared to $41.3 million as of December 31, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $3.7 million for the quarter ended March 31, 2025, compared to $4.9 million for the year ended March 31, 2024. The decrease in R&D expenses was primarily attributable to lower personnel costs, and lower facilities and lab supply costs, partially offset by increased expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024. The decrease in G&A expense was due to lower personnel costs partially offset by higher consulting fees.

Net Loss: Net loss was $6.9 million for the quarter ended March 31, 2025, compared to $8.0 million for the quarter ended March 31, 2024.