BOSTON, June 13, 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 that it will implement a 1-for-20 reverse stock split of its issued and outstanding shares of common stock ("Reverse Stock Split"), effective at 5:00 p.m. Eastern Time on June 16, 2025. The Reverse Stock Split was approved by the Company's stockholders at the Company's Annual ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39980 Sensei Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1863385 (State or other j ...

Exhibit 99.1 Sensei Biotherapeutics Reports First Quarter 2025 Financial Results and Updates on Clinical Progress - 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, MA – 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, today re ...

- 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 br ...

BOSTON, April 02, 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 that John Celebi, President and Chief Executive Officer, will participate in the New Radiotherapy and Targeted Therapy Approaches panel at the Canaccord Genuity Horizons in Oncology Virtual Conference on Monday, April 7 at 2:00 p.m. ET. About Sensei Biotherapeutics Sensei Bi ...

Therapeutic Development - The company is focused on developing next-generation therapeutics for cancer patients through its TMAb™ platform, which targets immunosuppressive signals in the tumor microenvironment[14]. - Solnerstotug, a conditionally active monoclonal antibody targeting VISTA, is currently in a Phase 1/2 trial with 60 patients dosed as of March 17, 2025[16]. - The company plans to initiate a Phase 2 trial of solnerstotug in Q1 2026, pending sufficient capital[21]. - The TMAb platform is designed to unlock previously undruggable immune targets for oncology applications[18]. - The company has paused development of preclinical product candidates SNS-102, SNS-103, and SNS-201 to focus resources on solnerstotug[17]. - The combination of solnerstotug with cemiplimab showed a 14% objective response rate and a 62% disease control rate among 21 evaluable PD-(L)1 resistant "hot" tumor patients[63]. - Solnerstotug has a greater than 600-fold selective binding affinity for active VISTA at low pH compared to physiological pH[34]. - The company aims to leverage unique tumor features, such as acidity, to design therapeutics that selectively activate within the tumor[19]. - No dose-limiting toxicities were reported for solnerstotug, with the majority of adverse events being Grade 1 or 2[21]. - The pharmacokinetic profile of solnerstotug supports once every three week dosing, demonstrating linear elimination kinetics and dose-proportional increases in exposure[63]. Clinical Trial Results - Clinical data from the trial showed a 14% objective response rate and a 62% disease control rate among 21 evaluable PD-(L)1 resistant "hot" tumor patients[21]. - In the Phase 1/2 clinical trial, 94 patients have been enrolled as of March 17, 2025, with 60 patients dosed in the Phase 1 dose expansion portion[59][62]. - SNS-101 demonstrated significant tumor growth inhibition of 77% when combined with anti-mPD-1 compared to the isotype control group, with a p-value of <0.0001[50]. - SNS-101 was observed to enhance anti-PD-1 response and increase tumor-infiltrating CD8 T cells in VISTA-KI mice[44]. - The combination of SNS-101 with anti-mPD-1 resulted in a 50% survival benefit compared to 12.5% in the anti-mPD-1 alone group[50]. - Solnerstotug was well tolerated, with no dose-limiting toxicities observed, and the majority of adverse events were Grade 1 or 2 in severity[63]. Financial Performance and Funding - The company has incurred significant losses every year since its inception and expects to continue incurring losses over the next several years, with no assurance of achieving profitability[195]. - The company will require substantial additional funding to meet its financial needs and pursue business objectives, with potential delays or reductions in product development if capital is not raised[197]. - The company has primarily financed operations through the sale of equity securities and may seek additional capital through various means, including public or private equity offerings and debt financings[199]. - The company incurred a net loss of $34.1 million for the year ended December 31, 2023, and an accumulated deficit of $262.1 million as of December 31, 2024[207]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[209]. - Plans to initiate a Phase 2 clinical trial of solnerstotug in the first quarter of 2026 are contingent upon the ability to raise sufficient additional capital[201]. - The company may need to significantly delay, scale back, or discontinue the development or commercialization of its product candidates if unable to raise additional capital[200]. Regulatory Environment - Regulatory approval processes require significant time and financial resources, with the FDA reviewing biologics through a Biologics License Application (BLA) that must demonstrate safety, purity, and potency[99][112]. - The FDA has a 60-day period to accept a BLA for filing, followed by a ten-month review period for standard applications and six months for priority reviews[115]. - The FDA requires compliance with cGMP regulations for manufacturing facilities before approving a BLA, ensuring consistent production within required specifications[116]. - Orphan drug designation can provide financial incentives such as grant funding opportunities, tax advantages, and user fee waivers, and grants exclusivity for seven years post-approval[118]. - Fast track designation is available for new biological product candidates intended to treat serious conditions, expediting the review process[119]. - Priority review is granted to products that significantly improve safety and effectiveness compared to existing therapies, directing additional resources to their evaluation[121]. - Accelerated approval may be granted if a product shows meaningful advantages over existing therapies and meets specific endpoint criteria[122]. - Breakthrough therapy designation offers intensive guidance from the FDA for products showing substantial improvement over current therapies[123]. - Post-marketing requirements include monitoring adverse experiences and compliance with promotion regulations, with potential penalties for non-compliance[127]. Market Competition - The company operates in a highly competitive market for immunotherapies, with substantial investments made in recent years[89]. - The company faces substantial competition from large pharmaceutical and biotechnology firms, as well as smaller companies forming collaborations to enhance their research and development capabilities[90]. - Competitors include major players like AstraZeneca, Bristol Myers Squibb, and Merck, which have greater financial resources and expertise in research and development[93][94]. - The company’s commercial opportunity may be diminished if competitors develop safer, more effective, or economically beneficial products[96]. - Mergers and acquisitions in the pharmaceutical sector may lead to increased resource concentration among competitors, intensifying competition[94]. Compliance and Legal Risks - Compliance with healthcare laws and regulations is resource-intensive and may divert management's attention from core business operations[138]. - Non-compliance with healthcare laws can result in significant penalties, including civil, criminal, and administrative actions, which could adversely affect business operations[139]. - The company may face challenges from ongoing legislative initiatives aimed at reducing healthcare costs, which could create uncertainty in the market[149]. - Changes in regulations could necessitate modifications to manufacturing arrangements, product labeling, or even lead to product recalls, impacting business operations[137]. - Non-compliance with foreign regulatory requirements may result in fines, product recalls, and other severe consequences[175]. Workforce and Restructuring - The company plans to reduce its workforce by approximately 46% as part of a restructuring plan, incurring costs of $0.7 million primarily for employee termination and severance payments[185]. - As of March 24, 2025, the company had 14 full-time employees and one part-time employee, maintaining a good relationship with its workforce[184]. Economic Factors - Economic downturns, inflation, and geopolitical events may adversely affect the company's business and financial performance[217]. - The Federal Reserve has raised interest rates multiple times in response to inflation concerns, which may increase economic uncertainty and affect financing conditions[219].

- Cash runway into the second quarter of 2026 - Exhibit 99.1 Sensei Biotherapeutics Reports Full Year 2024 Financial Results and Update on Clinical Progress - Preliminary ef icacy 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 - BOSTON, ...

Core Insights - Sensei Biotherapeutics reported promising preliminary efficacy data for solnerstotug in patients resistant to PD-(L)1 therapy, showing durable responses and tumor shrinkage [1][2] - The company achieved target enrollment in the dose expansion cohort and expects full data by the end of 2025 [1][9] - Sensei's cash position is projected to fund operations into the second quarter of 2026 [11] Clinical Development - Solnerstotug is designed to target the immune checkpoint VISTA, which is associated with poor survival rates in various cancers [3] - The ongoing Phase 1/2 clinical trial is evaluating solnerstotug as a monotherapy and in combination with Regeneron's PD-1 inhibitor Libtayo® [4] - Preliminary data indicated a 14% overall response rate (ORR) and a 62% disease control rate (DCR) in evaluable PD-(L)1 resistant "hot" tumor patients [8] Safety Profile - Solnerstotug has shown a favorable safety profile, with no dose-limiting toxicities reported and most adverse events being Grade 1 or 2 [6] - Among 60 patients, only four (7%) experienced mild Grade 1 cytokine release syndrome [6] Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $41.3 million, down from $65.8 million in 2023 [11] - Research and development expenses increased slightly to $18.6 million in 2024 from $18.3 million in 2023, primarily due to clinical trial costs [12] - General and administrative expenses decreased to $13.0 million in 2024 from $18.8 million in 2023, attributed to lower external service costs [13] Corporate Updates - The company has made organizational changes to streamline operations and focus on advancing solnerstotug [16] - Key appointments include Josiah Craver as Senior Vice President of Finance and Ron Weitzman, M.D., as part-time Chief Medical Officer [16]

Core Insights - Sensei Biotherapeutics has reported initial clinical activity of solnerstotug in a PD-(L)1 resistant population, showing an overall response rate (ORR) of 14%, which is nearly three times higher than historical response rates for PD-(L)1 rechallenge [1][3][4] - The study included patients with various "hot" tumors and demonstrated durable responses, including a complete response in a Merkel Cell Carcinoma (MCC) patient and partial responses in other patients [1][6][13] - The company plans to initiate a Phase 2 study in Q1 2026, pending sufficient capital, with ongoing analyses to optimize patient selection and trial design [10] Company Overview - Sensei Biotherapeutics is a clinical-stage biotechnology company focused on developing next-generation immunotherapies for cancer, utilizing its TMAb™ platform to create conditionally active therapeutics [14] - The lead product candidate, solnerstotug, targets VISTA to restore T cell activity in tumors resistant to checkpoint inhibitors [14] Clinical Trial Details - The Phase 1 dose expansion trial is evaluating solnerstotug as a monotherapy and in combination with Libtayo (cemiplimab) across various tumor types, including both "hot" and "cold" tumors [4][6] - As of March 17, 2025, the trial has enrolled 60 patients, with 21 evaluable PD-(L)1 resistant "hot" tumor patients showing a 14% ORR and a 62% disease control rate (DCR) [5][6] Safety and Tolerability - Solnerstotug has been well tolerated, with no dose-limiting toxicities reported; the majority of adverse events (AEs) were Grade 1 or 2 in severity [7] - There were four cases (7%) of Grade 1 cytokine release syndrome, all mild and manageable [7] Treatment Landscape - Patients with PD-(L)1 resistant tumors face a poor prognosis, with a ≤5% likelihood of response to PD-(L)1 rechallenge, highlighting a significant unmet medical need [3][8] - Current treatment options for these patients are limited, often involving chemotherapy or experimental therapies [8] Future Directions - The company is preparing for the Phase 2 study, with plans to incorporate biomarker-based patient selection strategies based on ongoing trial results [10]

Core Viewpoint - Sensei Biotherapeutics, Inc. (SNSE) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years [2]. - The recent upgrade for Sensei Biotherapeutics is driven by a 42.9% increase in the Zacks Consensus Estimate over the past three months, with expected earnings of -$1.17 per share for the fiscal year ending December 2024, representing a 4.1% change from the previous year [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors adjusting their valuations based on these estimates [5][6]. Zacks Rating System - The Zacks Rank stock-rating system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. - The upgrade of Sensei Biotherapeutics to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].