SNS-101(Sensei Biotherapeutics)

- SNS-101 Phase 1/2 dose expansion clinical data expected in the first half of 2025 - - Organizational restructuring to focus resources on advancing the clinical development of SNS-101 - - Cash runway extended into the second quarter of 2026 - BOSTON, Nov. 14, 2024 (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 ended September 30, 2024, and provided corporate updates. “The third quarter of 2024 saw significant progress in advancing patient enrollment in the dose expansion portion of the Phase 1 study for SNS-101 across dose levels and patients with primary and acquired resistance to PD-1 inhibitors. Looking ahead, management has focused its attention on preparing for Phase 2 studies,” said John Celebi, President and Chief Executive Officer. “We believe SNS-101 has disruptive potential for the treatment of a multitude of cancer indications and for this reason we are making the difficult decision to reduce our headcount to focus our resources on advancing the clinical development of SNS-101. We anticipate that these changes will extend our cash runway into the second quarter of 2026. We look forward to sharing a clinical update focused primarily on the activity profile of SNS-101 and additional details about the design of Phase 2 studies. I want to express my gratitude to all our affected employees for the contributions they have made to the Company.” Clinical Highlights and Milestones SNS-101 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 SNS-101 as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) in patients with advanced solid tumors. Patient enrollment is advancing in the dose expansion portion of the Phase 1/2 study, with approximately half of the dose expansion study enrolled. To further the Company’s objective of generating clinical data that informs both the optimal dose and patient population for Phase 2 studies, including comprehensive data from patients with both primary and acquired resistance to PD-1 inhibitors, the Company expects to report clinical data across two dose levels in multiple tumor types in the first half of 2025.Sensei received preliminary guidance from the FDA on the dose optimization strategy for SNS-101. The Company plans to re-engage with the agency following additional data from the dose expansion portion of the Phase 1/2 clinical trial.SNS-101 continues to be well tolerated with a best-in-class pharmacological profile among anti-VISTA antibodies.In November, Sensei presented an overview of SNS-101 at PEGS Europe: Protein and Antibody Engineering Summit.In November, the Company presented data on spatial proteomic profiling of VISTA and PSGL-1 interactions across cancer indications in a poster presentation at the Society of Immunotherapy Cancer (SITC) 39th Annual Meeting. Corporate Updates Sensei is announcing an organizational restructuring to streamline operations and focus resources on advancing the clinical development of SNS-101. The Company will close its research site in Rockville, Maryland and reduce its workforce by approximately 46 percent, with most of the headcount reductions in the Company’s preclinical research and development group. These changes are anticipated to extend cash runway into the second quarter of 2026.In July, the Company announced the appointment of Josiah Craver as Senior Vice President, Finance. In September, Josiah was appointed as the Company’s principal financial officer and principal accounting officer. Third Quarter 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $47.0 million as of September 30, 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 $4.6 million for the quarter ended September 30, 2024, compared to $3.8 million for the quarter ended September 30, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials, personnel costs and manufacturing related expense partially offset by lower costs for preclinical research and lower consulting fees. General and Administrative (G&A) Expenses: G&A expenses were $3.2 million for the quarter ended September 30, 2024, compared to $3.9 million for the quarter ended September 30, 2023. The decrease in G&A expense was primarily attributable to decreased costs associated with insurance premiums as well as lower outside services expense, personnel costs and license fees. Net Loss: Net loss was $7.3 million for the quarter ended September 30, 2024, compared to $7.1 million for the quarter ended September 30, 2023. About Sensei BiotherapeuticsSensei 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 SNS-101, 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 September 30, 2024 2023 Operating expenses: Research and development $4,637 $3,818 General and administrative 3,186 3,919 Total operating expenses 7,823 7,737 Loss from operations (7,823) (7,737)Total other income 570 613 Net loss (7,253) (7,124)Net loss attributable to common stockholders (7,253) (7,124)Net loss per share, basic and diluted $(0.29) $(0.28)Weighted-average common shares outstanding, basic and diluted 25,147,999 25,514,115 Selected Condensed Balance Sheet Data (Unaudited, in thousands) September 30, 2024 December 31, 2023 Cash and cash equivalents $19,131 $13,011 Marketable securities 27,870 52,746 Total assets 53,254 74,374 Total liabilities 7,475 9,479 Total stockholders’ equity 45,779 64,895 Cautionary Note Regarding Forward-Looking StatementsAny 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 SNS-101, 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 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 November 14, 2024 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 BiegaSenior Director, Investor RelationsSensei Biotherapeuticsmbiega@senseibio.com Media Contact: Joyce Allaire LifeSci Advisors Jallaire@lifesciadvisors.com

Plus, news about Allogene, Telix, Cullgen, Pulmatrix, Gilead, Innocoll, Durect and Sensei: Zai Lab’s $200M offering: The Shanghai-based drugmaker is selling shares the same week as announcing revenue growth of 47% year-over-year. It also said it plans to submit the schizophrenia drug KarXT for approval in China “early” next year. The FDA in September approved the medicine, owned by Bristol Myers Squibb. — Kyle LaHucik Kronos Bio to seek “strategic alternatives”: The company made the decision after looking at the data for a CDK9 inhibitor called istisociclib and deeming “the benefit-risk profile” as not warranting additional development. Istisociclib was designed to treat platinum-resistant high-grade serous ovarian cancer. Kronos had $124.9 million in cash, cash equivalents and investments as of the end of September. — Max Gelman Allogene halts enrollment in Phase 1 leukemia trial: The company was investigating cemacabtagene in patients with relapsed or refractory chronic lymphocytic leukemia. In its latest securities filing, Allogene blamed slow enrollment and “the emergence of new alternative treatment options” for its decision to halt enrollment altogether. The company added that it would be reallocating resources from the trial to other programs. Its shares $ALLO were down about 6% on Thursday morning. — Katherine Lewin Telix’s Nasdaq debut : The Australian radiopharma started trading on the Nasdaq as $TLX on Thursday. The company didn’t sell any new shares as part of the listing, though. It had pulled its Nasdaq IPO plans in the 11th hour in June. — Kyle LaHucik Cullgen to take Pulmatrix’s spot: Cullgen and the Nasdaq-listed Pulmatrix will reverse merge in a deal expected to close by the end of March. Cullgen makes protein degraders and degrader-antibody conjugates, or DACs, that are in Phase 1. Another DAC maker, Orum Therapeutics, is looking to go public , but in South Korea. Pre-merger Cullgen stockholders will get about 96.4% of the combined company. — Kyle LaHucik Gilead lays off 72 workers in Seattle: The cuts were attributed to a site closure and are set to begin in January, according to a WARN notice in Washington state. A spokesperson for Gilead did not immediately respond to a request for comment. The pharma gained a foothold in the Seattle area after acquiring Corus Pharma for $365 million in 2006. — Max Bayer Innocoll Pharmaceuticals ends licensing pact with Durect: Durect said the termination is effective in May. Innocoll had snagged US commercial rights to Durect’s non-opioid analgesic in December 2021. — Max Bayer Sensei to lay off 46% of staff, close research site in Rockville, MD: The cuts will extend Sensei’s runway into 2026, the company said. They will also help Sensei “focus resources on advancing the clinical development of SNS-101,” which the company is developing both as a monotherapy and a combination in advanced solid tumors. It had 27 employees as of Feb. 23. Its stock $SNSE fell about 11% on Thursday morning. — Max Gelman