SNSE

First patient dosed in Phase 1b/2 trial of PIKTOR in HR+/HER2- advanced breast cancer Topline Phase 2 data in patients with advanced endometrial cancer expected in second half 2026 BOSTON, May 15, 2026--(BUSINESS WIRE)--Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. "The first quarter of 2026 was transformational for the Company, with the acquisition of Faeth Therapeutics and the concurrent $200 million private placement in February, supported by a group of leading life sciences investors," said Christopher Gerry, President & General Counsel of Sensei Biotherapeutics. "This acquisition and injection of new capital will allow us to advance PIKTOR, a differentiated multi-node pathway inhibitor, through key clinical milestones." "New data across the industry continues to support the significant potential of multi-node inhibition of the PI3K/AKT/mTOR pathway," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "We believe PIKTOR is differentiated as an orally administered multi-node therapy specifically targeting PI3K-alpha, mTORC1 and mTORC2, with the potential to treat a variety of solid tumors. With our Phase 2 trial in advanced endometrial cancer expected to read out by the end of the year and the recent initiation of our Phase 1b/2 trial in advanced breast cancer, we are making great strides towards delivering the next generation of solid tumor therapies." Clinical Program Highlights Acquired through the Faeth transaction, PIKTOR is now Sensei’s lead program. The investigational, proprietary, all-oral combination of serabelisib and sapanisertib is designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting. In April 2026, the first patient was dosed in the Phase 1b/2 trial evaluating PIKTOR for the treatment of HR+/HER2- advanced breast cancer (Study FTH-PIK-101). Interim data from the trial is expected in 2027. The Phase 2 trial evaluating PIKTOR in advanced endometrial cancer (Study FTH-PIK-201) is on track to report topline data in the second half of 2026. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $202.8 million as of March 31, 2026, as compared to $21.2 million as of December 31, 2025. Research and Development (R&D)...

Faeth acquisition adds PIKTOR, an all-oral combination product candidate targeting multiple nodes of the PI3K/AKT/mTOR pathway $200 million private placement supports key clinical milestones in endometrial and breast cancer BOSTON, March 30, 2026--(BUSINESS WIRE)--Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) today reported financial results for the full year ended December 31, 2025, following its previously announced acquisition of Faeth Therapeutics and concurrent $200 million private placement. The financing, together with the Company's cash on hand, is expected to support advancement of PIKTOR through key clinical milestones, including topline data readouts from both the ongoing Phase 2 trial in advanced endometrial cancer (Study FTH-PIK-201) and the planned Phase 1b trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101). Acquired through the Faeth transaction, PIKTOR is now Sensei’s lead program. The investigational, proprietary, all-oral combination of serabelisib and sapanisertib is designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting. "2025 was a year of focus and discipline for Sensei, and with the addition of Faeth and injection of new capital, we are entering 2026 with a clear path forward," said Christopher Gerry, President & General Counsel of Sensei Biotherapeutics. "We are now focused on advancing PIKTOR through key clinical milestones, including topline data from the ongoing Phase 2 trial in advanced endometrial cancer and initiation of the planned Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year-end 2026." "The data to date suggest PIKTOR may achieve more comprehensive pathway suppression than single-node approaches, with an emerging tolerability profile that compares favorably to existing therapies, highlighting its potential to address significant unmet need in multiple solid tumor indications," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "We are focused on disciplined execution as we advance PIKTOR through clinical trials in endometrial and breast cancer, with additional opportunities in ovarian and lung cancer." Full Year 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $21.2 million as of December 31, 2025 as compared to $41.3 million as of December 31, 2024. Research and Developmen...

BOSTON, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the third quarter 2025. On October 30, 2025, the Company announced that its Board of Directors determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue development of solnerstotug and initiate a comprehensive review of strategic alternatives aimed at maximizing shareholder value. The Company is exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations. In connection with this strategic review, the Company has implemented a workforce reduction to preserve cash, reducing its workforce by approximately 65 percent. The Company is retaining a small team of employees to assist in exploring strategic alternatives, maintaining compliance with regulatory and financial reporting requirements, and managing the orderly cessation of development activities. Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $25.0 million as of September 30, 2025, as compared to $41.3 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses were $2.5 million for the quarter ended September 30, 2025, compared to $4.6 million for the quarter ended September 30, 2024. The decrease in R&D expenses was primarily attributable to lower personnel and facilities costs, and reduced lab supply costs. General and Administrative (G&A) Expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2025, compared to $3.2 million for the quarter ended September 30, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs. Net Loss: Net loss was $4.6 million for the quarter ended September 30, 2025, compared to $7.3 million for the quarter ended September 30, 2024. About Sensei Biotherapeutics Sensei Biotherapeutics (Nasdaq: SNSE) is a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients. Through its TMAb™ (Tum...

6-month progression-free survival (PFS) of 50% in the higher 15 mg/kg dose cohort compares favorably to historical PD-(L)1 refractory settings – All clinical responses, including a complete response, observed in the higher 15 mg/kg dose cohort – Favorable safety profile with six cases of mild, manageable grade 1 cytokine release syndrome (CRS) across all patients treated to date, all of which occurred in the 15 mg/kg dose cohort – Data support advancement to Phase 2 studies, currently being planned in Non-Small Cell Lung Cancer and Merkel Cell Carcinoma – Sensei to host investor webcast Monday, October 20th at 8:00 AM ET – BOSTON, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced results from the dose expansion portion of its Phase 1/2 trial evaluating solnerstotug (formerly SNS-101), a conditionally active monoclonal antibody targeting VISTA (V-domain Ig suppressor of T cell activation). The data will be shared today during a mini oral session at the ESMO Congress 2025. The Phase 1 dose expansion is a multi-center, open-label study evaluating solnerstotug as monotherapy and in combination with Libtayo® (cemiplimab), Regeneron’s PD-1 inhibitor. The study enrolled patients with a basket of “hot” tumor types (that typically respond to immunotherapy) (n=44), of whom 41 had previously received and progressed on PD-(L)1 therapy, as well as patients with “cold” tumor types (that typically exhibit primary resistance to immunotherapy) (n=20). Patients who progress following treatment with PD-(L)1 inhibitors (“secondary resistance”) face a particularly poor prognosis, as resistance to immune checkpoint blockade is a significant challenge in oncology. For patients who develop secondary resistance, the likelihood of benefiting from a rechallenge with the same therapy is estimated to be 5% or less.1 Currently, treatment options for PD-(L)1 resistant tumors are limited, with many patients receiving chemotherapy, experimental therapies in clinical trials, or palliative care in the absence of effective alternatives. While historical benchmarks in this setting are limited, docetaxel, which is widely used in the 2nd line post-PD-(L)1 setting for Non-Small Cell Lung Cancer (NSCLC), typically has a 6-m...

- Full data for Phase 1/2 dose expansion cohort expected by year-end 2025 - - Cash runway into the second quarter of 2026 - BOSTON, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the second quarter 2025, and provided a corporate update. “The second quarter was a key inflection point for Sensei, as we now transition from early response-focused readouts to longer-term and commercially relevant efficacy signals with the maturity of the data from our Phase 1/2 study of solnerstotug,” said John Celebi, President and CEO of Sensei. “Solnerstotug has demonstrated a favorable safety profile and in combination with cemiplimab has not demonstrated significant additional toxicity relative to what is typically observed with PD-(L)1 monotherapy, which we believe could translate into better patient adherence and more meaningful long-term outcomes with continued treatment, as well as physician preference and payor interest.” “As we look to next steps in the clinical advancement of solnerstotug, we envision multiple Phase 2 studies across PD-(L)1 resistant tumor types, aligned with unmet need and commercial potential. We view these differentiated opportunities as potentially derisking overall, while positioning solnerstotug for multiple indications in high-value immunotherapy segments of the ~$50 billion PD-(L)1 market,” added Mr. Celebi. “We continue to work on finalizing the Phase 2 strategy for solnerstotug, which will be strongly influenced by the full dose expansion dataset we plan to present later this year.” 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’s ongoing multi-center Phase 1/2 clinical trial is evaluating 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. Clinical Program Highlights: Full dose expansion data, including...

- Favorable clinical data in PD-(L)1 resistant patients - - Dose expansion enrollment complete with full data expected by year-end 2025 - - Cash runway into the second quarter of 2026 - BOSTON, May 06, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the first quarter 2025, and provided corporate updates. “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 da...

- Preliminary efficacy data from Phase 1/2 dose expansion cohort show durable responses and tumor shrinkage in a PD-(L)1 resistant “hot” tumor patient population - - Solnerstotug continues to demonstrate a well-tolerated safety and tolerability profile - - Achieved target enrollment in dose expansion cohort; full data expected by year-end 2025 - - Cash runway into the second quarter of 2026 - BOSTON, March 28, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2024, and provided corporate updates. “2024 was a pivotal year for Sensei, as we advanced solnerstotug through dose expansion and began to demonstrate its clinical potential in patients who have progressed on and are resistant to PD-(L)1 therapy” said John Celebi, President and CEO of Sensei Bio. “The responses we’ve observed in PD-(L)1 resistant tumors are highly encouraging and we believe support solnerstotug’s differentiated approach to targeting VISTA. In the context of available data across checkpoint inhibitor regimens, solnerstotug stands out for its encouraging response rates and favorable tolerability profile in PD-(L)1 resistant tumors, a setting with limited treatment options and no approved therapies targeting VISTA. We are now focused on completing dose expansion for patients on study and finalizing a robust Phase 2 strategy.” 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: Preliminary Activity in PD-(L)1 Resistant “Hot” Tumors In March 2025, Sensei presented preliminary dose expansion data showing, as of the data cutoff of March 17, 2025: Among 21 evaluable PD-(L)1 resistant “hot” tumor...