Sensei Biotherapeutics Reports Full Year 2023 Financial Results and Recent Business Highlights
Sensei Biotherapeutics, Inc. (SNSE) reports positive clinical data on SNS-101, showing a potentially best-in-class safety profile and PK, with topline efficacy data expected in Q2 2024. The company plans an end-of-Phase 1 meeting with the FDA in Q4 2024. Sensei's strong balance sheet extends cash runway into Q4 2025.
The recent updates from Sensei Biotherapeutics regarding their anti-VISTA antibody, SNS-101, are indicative of significant advancements in the immuno-oncology field. The ability of SNS-101 to reach pharmacologically relevant dose levels without dose-limiting toxicities presents a promising therapeutic option for patients with advanced solid tumors. The conditionally active nature of this antibody, targeting the immune checkpoint VISTA, is particularly noteworthy as it harnesses the acidic tumor microenvironment, which is a novel approach to cancer treatment. Considering the implications for patient care, the favorable safety and pharmacokinetic profile of SNS-101, both as a monotherapy and in combination with PD-1 blockade, could translate into improved outcomes for patients with 'cold' tumors, such as microsatellite stable colorectal cancer, which are typically less responsive to immunotherapies.
From a financial perspective, Sensei Biotherapeutics' announcement is crucial as it directly impacts the company's valuation and investor sentiment. The expedited timeline for reporting topline efficacy and biomarker data in Q2 2024, ahead of previous guidance, may lead to positive market anticipation. Furthermore, the strong cash position with a runway into Q4 2025 provides the company with a buffer to continue its R&D efforts without the immediate need for additional capital raises, which could dilute existing shareholders. The decrease in R&D and G&A expenses reflects a strategic realignment and cost-saving measures that could enhance the company's financial sustainability. However, investors should consider the inherent risks of clinical trials and the binary nature of outcomes, which can significantly influence the company's stock performance.
The pharmacokinetic data indicating linear elimination kinetics and dose-proportional increases in exposure for SNS-101 are essential for determining the optimal dosing regimen. These pharmacokinetics suggest that a once every three-week dosing schedule could be feasible, potentially offering convenience and adherence advantages over more frequent dosing schedules. The decision to pause IND-enabling work on preclinical-stage programs to focus resources on SNS-101 reflects a strategic prioritization that could accelerate its path to market, assuming positive trial outcomes. However, this focus also represents a concentration of risk, as the company's prospects become more closely tied to the success of a single candidate. The selection of solid tumor types for the dose expansion cohorts is strategic, aiming to demonstrate efficacy in both immunologically 'hot' and 'cold' tumors, which could broaden the potential therapeutic reach of SNS-101.
02/28/2024 - 07:30 AM
- Updated dose escalation data from SNS-101 clinical study supports favorable and potentially best-in-class safety and PK profile both as monotherapy and in combination with PD-1 blockade -
- Topline efficacy and biomarker data for both monotherapy and combination arms of dose escalation study now expected in Q2 2024, ahead of previous guidance -
- Strong balance sheet with cash runway into fourth quarter of 2025 -
BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the full year 2023, and provided corporate updates.
“2023 saw the entry of our differentiated anti-VISTA antibody, SNS-101, into clinical development,” said John Celebi, President and Chief Executive Officer. “Initial data revealed in November, and updated today, support a favorable and potentially best-in-class clinical safety and PK profile, consistent with preclinical studies, thus overcoming major hurdles associated with prior efforts to drug VISTA. We believe SNS-101 is now the first anti-VISTA therapy to reach pharmacologically relevant dose levels in a clinical study, and we are looking forward to an exciting year for Sensei. Based on the rapid pace of enrollment, we now plan to share topline efficacy and biomarker data for both monotherapy and combination arms in the second quarter of 2024, which is ahead of previous guidance. Looking ahead, part of management’s attention in 2024 will be directed toward preparations for an end-of-Phase 1 meeting with FDA in the fourth quarter of 2024 and defining the paths we intend to follow over the next several years to maximize the value of SNS-101 and our additional novel product candidates.”
Highlights and Milestones
SNS-101
SNS-101 is a conditionally active antibody harnessing the acidic tumor microenvironment to target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation). 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. Recent updates include:
As of February 23, 2024: A total of 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase of this study. In the monotherapy dose escalation arm, 16 patients have been enrolled and cleared all planned dosing cohorts of 0.3, 1, 3, 10, and 15 mg/kg. In the combination dose escalation arm, 17 patients have been enrolled and cleared the first two planned dosing cohorts of 3 and 10 mg/kg + Libtayo. The third cohort at a dose level of 15.0 mg/kg of SNS-101 plus Libtayo is enrolling. Patient enrollment has started for the recently announced monotherapy dose expansion arm in patients with microsatellite stable (MSS) colorectal cancer (CRC) at a dose level of 15 mg/kg. The combination dose expansion arm will commence once the safety monitoring committee reviews the third combination dose escalation cohort. SNS-101 +/- Libtayo has been well tolerated in both the monotherapy and combination dose escalation cohorts with no dose-limiting toxicities observed. In the monotherapy dose escalation arm, 13/16 patients (81% ) experienced at least one treatment-emergent adverse event (TEAE), with the majority of adverse events (AEs) Grade 1 or 2. In the combination dose escalation arm, 10/17 patients (59% ) experienced at least one TEAE, with the majority of AEs Grade 1 or 2. SNS-101 has demonstrated potentially best-in-class pharmacokinetics, with linear elimination kinetics and dose-proportional increases in exposure across monotherapy and combination cohorts. There was no notable difference in pharmacokinetics between monotherapy and combination dosing. The pharmacokinetic data support once every 3-week dosing for SNS-101. As a result of rapid enrollment, Sensei now expects to report both topline monotherapy and combination dose escalation data in Q2 2024. Initial data for the SNS-101 dose expansion cohorts is expected by the end of 2024. In January 2024 , Sensei announced plans to enroll up to 40 additional patients in both monotherapy and in combination with Libtayo in specific tumor types to further optimize the design of the Phase 2 trial. In the monotherapy dose expansion arm, Sensei plans to enroll up to 10 patients with MSS CRC at a dose level of 15 mg/kg. In the combination dose expansion arm, Sensei plans to enroll up to 30 patients with MSS CRC, head and neck cancer (H&N), non-small cell lung cancer (NSCLC), and melanoma. The initially selected solid tumor types are focused on a basket of more commonly occurring histologies, including both “hot” (NSCLC, H&N, Melanoma) and “cold” (CRC) tumors. All patients with “hot” tumors enrolling into the expansion arm are expected to have been previously treated with a PD-1/L1 checkpoint inhibitor. Additional tumor types and doses may be considered for both the monotherapy and combination expansion arms. Sensei presented supporting SNS-101 data at numerous medical meetings throughout 2023: On November 3, 2023 , Sensei reported initial data from the monotherapy dose-escalation portion of the Phase 1/2 clinical trial for SNS-101 in a late-breaker poster presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, showing that SNS-101 has a potential best-in-class safety and pharmacokinetic profile.On October 23, 2023 , Sensei presented a trial-in-progress poster from the Phase 1/2 clinical trial for SNS-101 at the European Society for Medical Oncology Congress (ESMO) 2023.On September 21, 2023 , Sensei presented new preclinical data reinforcing SNS-101’s pharmacokinetic profile, safety characteristics, and mechanism of action at the Seventh Annual CRI-ENCI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival (CICON).In February 2023 , preclinical data presented at the Keystone Symposia on Next-Generation Antibody Therapeutics included crystal structure analysis further elucidating SNS-101’s mechanism of action, showing that the antibody directly blocks the pH-dependent interaction between VISTA and PSGL-1. In February 2024 , Sensei co-authored a publication discussing the development of a preclinical in vivo model to assess cytokine release syndrome (CRS).In August 2023 , Sensei published a review article describing its pH-sensitive antibody engineering efforts, entitled “Conditionally Active, pH-Sensitive Immunoregulatory Antibodies Targeting VISTA and CTLA-4 Lead an Emerging Class of Cancer Therapeutics,” in Antibodies, an international, peer-reviewed journal.In June 2023 , Sensei hosted a KOL event featuring James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology at the National Cancer Institute (NCI) entitled “A New Vista for Cancer Care: Exploring SNS-101’s Potential as a Transformative Treatment Option for Patients with Solid Tumors”.Sensei announced two collaborations key to the development of SNS-101 and the Phase 1/2 clinical trial: A Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), executed in February 2023, is designed to further demonstrate the role of VISTA in checkpoint resistance and will enable Sensei to explore SNS-101’s potential as a combination therapy beyond anti-PD-1. The NCI will also participate as a clinical site in the Phase 1/2 clinical trial.In January 2023 , the Company signed a clinical supply agreement with Regeneron that will enable Sensei to evaluate SNS-101 in combination with the anti-PD1 therapy Libtayo® (cemiplimab). Corporate Updates
On January 4, 2024, Sensei announced the appointment of Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer. On November 1, 2023, Sensei announced the appointment of Stephanie Krebs, MS, MBA, as Chief Business Officer. In January 2024, Sensei announced a realignment of its resources to fully support the Phase 1/2 clinical trial of SNS-101. As a result, Sensei has paused IND-enabling work on its preclinical-stage TMAb programs, including SNS-102 (VSIG4), SNS-103 (CD39) and SNS-201 (VISTAxCD28). Preclinical work to characterize selected lead antibodies, including their mechanisms of action, and target biology is expected to continue throughout 2024. As a result of this realignment of resources Sensei’s cash runway now extends into the fourth quarter of 2025. Year End 2023 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $65.8 million as of December 31, 2023, as compared to $107.1 million as of December 31, 2022. The decrease is due to cash used to fund operations and $9.8 million relating to shares repurchased during the year ended December 31, 2023. Sensei expects its current cash balance to fund operations into the fourth quarter of 2025.
Research and Development (R&D) Expenses: R&D expenses were $18.3 million for the year ended December 31, 2023, compared to $30.4 million for the year ended December 31, 2022. The decrease in R&D expenses was primarily attributable to lower manufacturing-related expenses, lower personnel costs due to the Company’s December 2022 restructuring and lower expense relating to lab supply purchases, partially offset by higher expense associated with clinical trials.
General and Administrative (G&A) Expenses: G&A expenses were $18.8 million for the year ended December 31, 2023, compared to $19.8 million for the year ended December 31, 2022. The decrease in G&A expense was primarily attributable to lower expense related to director and officer insurance and decreased personnel costs due to the Company’s December 2022 restructuring.
Net Loss: Net loss was $34.1 million for the year ended December 31, 2023, compared to $48.6 million for the year ended December 31, 2022.
About Sensei Biotherapeutics 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) Year Ended 2023 2022 Operating expenses: Research and development $ 18,299 $ 30,383 General and administrative 18,765 19,805 Total operating expenses 37,064 50,188 Loss from operations (37,064 ) (50,188 ) Total other income 2,963 1,600 Net loss (34,101 ) (48,588 ) Net loss per share, basic and diluted $ (1.22 ) $ (1.58 ) Weighted-average common shares outstanding, basic and diluted 27,952,857 30,703,295
Selected Condensed Balance Sheet Data (Unaudited, in thousands) December 31, December 31, Cash and cash equivalents $ 13,011 $ 17,795 Marketable securities 52,746 89,321 Total assets 74,374 118,375 Total liabilities 9,479 14,968 Total stockholders’ equity 64,895 103,407
Investor Contact: mbiega@senseibio.com
Media Contact: Jallaire@lifesciadvisors.com
What is the ticker symbol for Sensei Biotherapeutics, Inc.?
The ticker symbol for Sensei Biotherapeutics, Inc. is SNSE.
What is the status of SNS-101 clinical study?
Updated dose escalation data from SNS-101 clinical study supports favorable safety and PK profiles, with topline efficacy data expected in Q2 2024.
What are the recent updates on SNS-101 trial?
As of February 23, 2024, 33 patients have been treated with SNS-101 +/- Libtayo in the dose escalation phase, showing good tolerability and potentially best-in-class pharmacokinetics.
What are the financial results for Sensei Biotherapeutics, Inc. for the year 2023?
As of December 31, 2023, Sensei had $65.8 million in cash, with R&D expenses of $18.3 million and G&A expenses of $18.8 million.
What corporate updates were announced by Sensei Biotherapeutics, Inc. recently?
Recent corporate updates include the appointment of a new Chief Medical Officer, Chief Business Officer, and a realignment of resources to focus on the Phase 1/2 clinical trial of SNS-101.
