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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): May 6, 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)

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 May 6, 2025, Sensei Biotherapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item 2.02 and the exhibit attached hereto are 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 May 6, 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: May 6, 2025      

/s/ Christopher W. Gerry

      Christopher W. Gerry
      General Counsel and Secretary

 

3

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 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 $34.3 million as of March 31, 2025, as compared to $41.3 million as of December 31, 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 $3.7 million for the quarter ended March 31, 2025, compared to $4.9 million for the year ended March 31, 2024. The decrease in R&D expenses was primarily attributable to lower personnel costs, and lower facilities and lab supply costs, partially offset by increased expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024. The decrease in G&A expense was due to lower personnel costs partially offset by higher consulting fees.

Net Loss: Net loss was $6.9 million for the quarter ended March 31, 2025, compared to $8.0 million for the quarter ended March 31, 2024.

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

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