MD Boston false 0001829802 0001829802 2025-03-28 2025-03-28

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 28, 2025

 

 

Sensei Biotherapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-39980   83-1863385

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1405 Research Blvd, Suite 125

Rockville, MD

  20850
(Address of Principal Executive Offices)   (Zip Code)

 

451 D Street, Suite 710  
Boston, MA   02210
(Former Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (240) 243-8000

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:

 

Title of each class

 

Trading

symbol

 

Name of each exchange

on which registered

Common Stock   SNSE   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 

 


Item 2.02

Results of Operations and Financial Condition.

On March 28, 2025, Sensei Biotherapeutics, Inc. issued a press release announcing its financial results for the full year ended December 31, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

The information in Item 2.02 and the exhibit attached hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, whether filed before or after the date hereof and regardless of any general incorporation language in such filing.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
Number

  

Exhibit Description

99.1    Press Release of Sensei Biotherapeutics, Inc., dated March 28, 2025
104    The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

 

2


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

      Sensei Biotherapeutics, Inc.
Date: March 28, 2025      

/s/ Christopher W. Gerry

      Christopher W. Gerry
      General Counsel

 

3

Exhibit 99.1

Sensei Biotherapeutics Reports Full Year 2024 Financial Results and Update on Clinical Progress

- 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, MA – March 28, 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 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 patients, the combination of solnerstotug + cemiplimab demonstrated a 14% ORR (overall response rate), which is almost 3x higher than historical PD-(L)1 rechallenge response rates (≤5%), and a 62% DCR (disease control rate), suggesting meaningful disease control in resistant tumors.

 

   

One durable complete response in a patient with Merkel Cell Carcinoma (MCC).

 

   

Two partial responses (PRs): one in a second MCC patient and one in a microsatellite instability-high (MSI-H) Colorectal Cancer (CRC) patient.

 

   

All patients with tumor shrinkage remain on treatment, suggesting potential for prolonged clinical benefit.


   

An additional 11 patients have not yet reached the first baseline scan, and an additional eight patients discontinued the study prior to any post-baseline scan.

 

   

All patients in this cohort had progressed on prior PD-(L)1.

Yesterday, Sensei hosted an investor webcast to discuss the dose expansion data, featuring Company leadership and Dr. Shiraj Sen, M.D., Medical Oncologist and Director of Clinical Research at NEXT-Oncology, Dallas, an investigator on the Phase 1/2 study. The replay of the webcast is available here.

 

   

Favorable Safety Profile:

 

   

Solnerstotug continues to be well tolerated, with no dose-limiting toxicities and the majority of AEs Grade 1 or 2 in severity to date. Out of 60 patients, there have been four (7%) cases of Grade 1 cytokine release syndrome (CRS), all mild and manageable. Two patients in the combination cohort experienced immune-mediated events.

 

   

Clinical Progress and Outlook:

 

   

Target enrollment (n=60) in the dose expansion cohort has been achieved.

 

   

Full expansion data expected by year-end 2025.

 

   

Scientific and Clinical Visibility:

Sensei presented new data and mechanistic insights across multiple forums in 2024:

 

   

SITC 2024: Spatial proteomic profiling of VISTA and PSGL-1 in diverse tumor types.

 

   

Nature Communications: Sensei published a peer-reviewed research paper in Nature Communications in April 2024 describing the mechanism of action of solnerstotug selectively targeting the active form of VISTA within the tumor microenvironment.

 

   

PEGS Europe, IO360, Keystone Symposia, and others: Continued showcasing of solnerstotug and the TMAb platform.

Corporate Updates

 

   

In Q4, Sensei implemented an organizational restructuring to streamline operations and focus resources on clinically advancing solnerstotug.

 

   

Appointed Josiah Craver as Senior Vice President of Finance and later as Principal Financial and Accounting Officer.

 

   

Named Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer.

Year End 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $41.3 million as of December 31, 2024, as compared to $65.8 million as of December 31, 2023. 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 $18.6 million for the year ended December 31, 2024, compared to $18.3 million for the year ended December 31, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials and one-time employee termination benefits primarily offset by lower preclinical research expense and consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $13.0 million for the year ended December 31, 2024, compared to $18.8 million for the year ended December 31, 2023. The decrease in G&A expense was primarily attributable to lower costs for external professional services, lower personnel costs, and lower insurance costs.


Net Loss: Net loss was $30.2 million for the year ended December 31, 2024, compared to $34.1 million for the year ended December 31, 2023.

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)

 

     Year Ended December 31,  
     2024      2023  

Operating expenses:

     

Research and development

   $ 18,627      $ 18,299  

General and administrative

     13,036        18,765  

Long-lived asset impairment

     951        —   
  

 

 

    

 

 

 

Total operating expenses

     32,614        37,064  
  

 

 

    

 

 

 

Loss from operations

     (32,614      (37,064

Total other income

     2,457        2,963  

Net loss

     (30,157      (34,101
  

 

 

    

 

 

 

Net loss attributable to common stockholders

     (30,157      (34,101

Net loss per share, basic and diluted

   $ (1.20    $ (1.22
  

 

 

    

 

 

 

Weighted-average common shares outstanding, basic and diluted

     25,117,238        27,952,857  
  

 

 

    

 

 

 


Selected Condensed Balance Sheet Data

(Unaudited, in thousands)

 

     December 31,
2024
     December 31,
2023
 

Cash and cash equivalents

   $ 9,994      $ 13,011  

Marketable securities

     31,341        52,746  

Total assets

     45,361        74,374  

Total liabilities

     6,975        9,479  

Total stockholders’ equity

     38,386        64,895  

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 Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 28, 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

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