Sensei Biotherapeutics Q1 2024 Financial Results and Business Highlights

Sensei Biotherapeutics, Inc., a clinical-stage immuno-oncology company, has announced its financial results for the first quarter ending March 31, 2024. The company is focused on developing next-generation therapeutics for cancer patients. Their lead product candidate, SNS-101, is a conditionally active antibody designed to selectively target the VISTA immune checkpoint in the acidic tumor microenvironment. VISTA is associated with several cancer types and its expression is linked to lower survival rates.

The company has completed the dose escalation portion of its Phase 1/2 clinical trial for SNS-101, both as a monotherapy and in combination with Regeneron’s PD-1 inhibitor, Libtayo® (cemiplimab), in patients with advanced solid tumors. A total of 16 patients were enrolled in the monotherapy arm and 18 in the combination arm. The dosing cohorts for monotherapy included 0.3, 1, 3, 10, and 15 mg/kg, while the combination arm included 3, 10, and 15 mg/kg of SNS-101 plus Libtayo. Importantly, no dose-limiting toxicities were observed in either arm.

Sensei plans to present topline data from these dose escalation studies at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The presentation will feature initial results from the first-in-human Phase 1 study of SNS-101, either alone or in combination with cemiplimab, in patients with advanced solid tumors.

The company is now advancing patient enrollment in the dose expansion portion of the clinical trial. During this phase, patients with microsatellite stable (MSS) colorectal cancer are being enrolled in the monotherapy arm at a dose level of 15 mg/kg. For the combination arm, patients with MSS CRC, head and neck cancer, non-small cell lung cancer (NSCLC), and melanoma are being enrolled at 15 mg/kg of SNS-101 plus Libtayo. The selection of these tumor types is based on their common occurrence and varying response to immunotherapy, aiming to further evaluate SNS-101's clinical benefit.

Sensei expects to report initial data from these dose expansion cohorts and hold an end-of-Phase 1 meeting with the FDA by the end of 2024. The company also published a peer-reviewed paper in Nature Communications in April 2024, detailing the mechanism of action of SNS-101 in selectively targeting VISTA within the tumor microenvironment. Earlier in the year, data on SNS-101 was presented at various scientific conferences, including the Keystone Symposia’s Cancer Immunotherapy event and the 10th Annual Immuno-Oncology 360 Conference.

On the corporate front, Sensei has made significant updates, including the appointment of Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer in January 2024. The company also realigned its resources to fully support the Phase 1/2 clinical trial of SNS-101, pausing IND-enabling work on other preclinical-stage programs. This realignment has extended their cash runway into the fourth quarter of 2025.

Financially, Sensei reported a cash position of $58.1 million as of March 31, 2024, down from $65.8 million as of December 31, 2023, primarily due to operational expenses. Research and development expenses for the quarter were $4.9 million, a slight decrease from the previous year, while general and administrative expenses were $3.8 million, down from $5.8 million in the same period last year. The net loss for the first quarter was $8.0 million, compared to $10.2 million in the first quarter of 2023.

Sensei Biotherapeutics continues to focus on advancing its clinical programs and aims to leverage its cash runway to build on its clinical and scientific progress, benefiting the patients it serves.