Sensei Biotherapeutics Reports First Quarter 2025 Financial Results and Updates on Clinical Progress
- Favorable clinical data showing response rates nearly 3x higher than expected in PD-(L)1 resistant patients
- Successfully completed enrollment of 63 patients in Phase 1/2 trial
- Reduced net loss to $6.9M from $8.0M year-over-year
- Cash runway extended into Q2 2026
- Decreased R&D and G&A expenses showing improved cost management
- Cash position decreased to $34.3M from $41.3M in previous quarter
- Full trial data not available until year-end 2025
Insights
Sensei's drug solnerstotug shows promising early results in hard-to-treat cancers with extended patient benefit and completed enrollment milestone.
Sensei Biotherapeutics has reported encouraging preliminary clinical activity for solnerstotug (formerly SNS-101) in patients with PD-(L)1 resistant cancers. This is particularly significant given the limited treatment options and poor prognosis typically associated with these resistant tumor types. The company reports response rates "nearly three times higher than typically expected" in this challenging patient population.
The durability signal is especially noteworthy - some patients approaching a year on study, which is unusual for PD-(L)1 resistant cases where response to rechallenge is typically fleeting. This suggests solnerstotug's mechanism targeting VISTA may offer unique benefits in the immunotherapy-resistant setting.
The dose expansion cohort has now completed enrollment with 63 total patients - 10 in the monotherapy arm (MSS CRC) and 53 in the combination arm with cemiplimab (including 43 PD-(L)1 resistant "hot" tumor patients). "Hot" tumors refer to those with significant immune cell infiltration, making them potentially more responsive to immunomodulatory approaches despite developing resistance to standard checkpoint inhibitors.
VISTA (V-domain Ig suppressor of T cell activation) represents a differentiated checkpoint target compared to PD-1/PD-L1, and its expression correlates with poor survival. Solnerstotug's conditional activation design aims to selectively target VISTA within the tumor microenvironment, potentially improving efficacy while reducing systemic side effects.
With full data expected by year-end 2025, the company appears positioned to advance into a focused Phase 2 strategy for solnerstotug. These early signals provide foundation for further development in a cancer treatment landscape that desperately needs new approaches for immunotherapy-resistant patients.
Sensei reports promising clinical results, completed enrollment milestone, and improved financial metrics with runway into Q2 2026.
Sensei Biotherapeutics' Q1 2025 financial results reveal a calculated approach to advancing their lead asset while maintaining fiscal discipline. The company closed the quarter with $34.3 million in cash, down from $41.3 million at year-end 2024, representing a quarterly burn rate of approximately $7 million. This burn rate appears manageable considering their projected cash runway into Q2 2026, which importantly covers the period through their full data readout expected by year-end 2025.
R&D expenses decreased to $3.7 million from $4.9 million year-over-year, primarily from reduced personnel, facilities, and lab supply costs, partially offset by increased clinical trial expenses. This suggests efficient resource allocation toward their most valuable clinical programs. Similarly, G&A expenses declined to $3.5 million from $3.8 million in the comparable quarter, reflecting continued operational discipline.
The net loss improved to $6.9 million compared to $8.0 million in Q1 2024, demonstrating progress toward more efficient operations while advancing their clinical pipeline. With dose expansion enrollment now complete at 63 patients, the company has achieved an important operational milestone.
The favorable clinical signals in PD-(L)1 resistant cancers represent potential value creation, addressing a significant unmet need. These early positive indications could strengthen Sensei's position for potential partnerships or financing options as they prepare for the next development phase.
The cash runway projection suggests Sensei is adequately funded through their next major catalyst (year-end 2025 data), though additional capital would likely be required for any Phase 2 program. Overall, the company appears to be executing well on both clinical and financial fronts.
- 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 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
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Net Loss: Net loss was
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™ (Tumor Microenvironment Activated biologics) platform, Sensei develops conditionally active therapeutics designed to disable immunosuppressive signals or activate immunostimulatory signals selectively in the tumor microenvironment to unleash T cells against tumors. Sensei’s lead product candidate is solnerstotug, a conditionally active antibody designed to block the V-domain Ig suppressor of T cell activation (VISTA) checkpoint selectively within the low pH tumor microenvironment, where VISTA acts as a suppressor of T cells by binding the receptor PSGL-1. For more information, please visit www.senseibio.com, and follow the company on X @SenseiBio and LinkedIn.
| Condensed Statements of Operations | |||||||||
| (Unaudited, in thousands except share and per share data) | |||||||||
| Three Months Ended March 31, | |||||||||
| 2025 | 2024 | ||||||||
| Operating expenses: | |||||||||
| Research and development | $ | 3,725 | $ | 4,917 | |||||
| General and administrative | 3,549 | 3,813 | |||||||
| Total operating expenses | 7,274 | 8,730 | |||||||
| Loss from operations | (7,274 | ) | (8,730 | ) | |||||
| Total other income | 410 | 738 | |||||||
| Net loss | (6,864 | ) | (7,992 | ) | |||||
| Net loss attributable to common stockholders | (6,864 | ) | (7,992 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.27 | ) | $ | (0.32 | ) | |||
| Weighted-average common shares outstanding, basic and diluted | 25,192,363 | 25,049,111 | |||||||
| Selected Condensed Balance Sheet Data | |||||||
| (Unaudited, in thousands) | |||||||
| March 31, 2025 | December 31, 2024 | ||||||
| Cash and cash equivalents | $ | 9,877 | $ | 9,994 | |||
| Marketable securities | 24,454 | 31,341 | |||||
| Total assets | 38,273 | 45,361 | |||||
| Total liabilities | 6,286 | 6,975 | |||||
| Total stockholders’ equity | 31,987 | 38,386 | |||||
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe”, “designed to,” “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Sensei’s product candidates, the timing of Sensei’s Phase 1/2 clinical trial of solnerstotug, including reporting of data therefrom, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the second quarter of 2026. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Sensei’s product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Sensei’s product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies and clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Sensei’s product candidates; the risk that Sensei’s product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Sensei anticipates; risks associated with Sensei’s dependence on third-party suppliers and manufacturers, including sole source suppliers, over which Sensei may not always have full control; risks regarding the accuracy of Sensei’s estimates of expenses, capital requirements and needs for additional financing; and other risks and uncertainties that are described in Sensei’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 6, 2025 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contact:
Michael Biega
Senior Director, Investor Relations
Sensei Biotherapeutics
mbiega@senseibio.com
Media Contact:
Joyce Allaire
LifeSci Advisors
Jallaire@lifesciadvisors.com
FAQ
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