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Sensei Biotherapeutics Inc

For the period ended Jun 30, 2024. Filed Aug 6, 2024.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 6, 2024

FTH$22.05+10.7%Stored close · as of Nov 6, 2026

What changed in Risk Factors?

Read the current filing

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 347 previous paragraphs and 346 current paragraphs.

335 unchanged; 4 reworded; 7 added; 8 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (7)

Current report

If we fail to meet all applicable Nasdaq listing requirements and Nasdaq determines to delist our common shares, the delisting could adversely affect the market liquidity of our common shares and the market price of our common shares could decrease.

Current report

On July 10, 2024, we received a letter from the Listing Qualifications Department of Nasdaq, notifying us that, for the previous 30 consecutive business days, the bid price for our common shares had closed below the minimum $1.00 per share requirement for continued listing on The Nasdaq Global Market under Nasdaq Listing Rule 5450(a)(1). Under Nasdaq Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days, or until January 6, 2025, to regain compliance with the rule referred to in this paragraph. To regain compliance, during this 180-day compliance period, our minimum bid price of listed securities must close at $1.00 per share or more for a minimum of 10 consecutive business days. If we do not regain compliance with the Nasdaq Listing Rules prior to the expiration of the 180-day compliance period, we may be eligible for additional time to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii) by transferring to the Nasdaq Capital Market.

Current report

There can be no assurance that we will maintain compliance with the requirements for listing our common shares on the Nasdaq Global Market, or if transferred, The Nasdaq Capital Market.

Current report

Delisting could adversely affect our ability to raise additional capital through the public or private sale of equity securities, would significantly affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our common shares. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities.

Current report

Rule 10b5-1 Trading Plans

Current report

From time to time, our officers (as defined in Rule 16a-1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading plans (as each such term is defined in Item 408 of Regulation S-K). The trading plans are intended to satisfy the affirmative defense in Rule 10b5-1(c). During the three months ended June 30, 2024 our officers and directors took the following actions with respect to 10b5-1 trading plans:

Current report

On June 6, 2024, Cambrian BioPharma, Inc., a beneficial owner of more than 5% of the Company’s outstanding shares of common stock (“Cambrian”) entered into a trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) (the “Cambrian 10b5-1 Plan”). James Peyer, a director of the Company, is the Chief Executive Officer of Cambrian and in such capacity may direct the voting and disposition of the shares held by Cambrian, subject in certain instances to the approval of Cambrian’s board of directors. The Cambrian 10b5-1 Plan commenced on June 6, 2024, and willrun through December 10, 2025. The aggregate maximum number of shares of common stock that may be sold pursuant to the Cambrian 10b5-1 Plan is up to 195,000 shares.
Removed paragraphs (8)

Previous report

During the three months ended March 31, 2024, none of our directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted or terminated any contracts, instructions or written plans for the purchase or sale of our securities.

Previous report

Appointment of John Celebi as Principal Financial Officer and Principal Accounting Officer

Previous report

On May 7, 2024, our board of directors appointed John Celebi, our Chief Executive Officer, as our principal financial officer and principal accounting officer, effective as of such date. The board of directors appointed Mr. Celebi to serve as our principal financial officer and principal accounting officer until the day after the filing of this Report. Biographical information for Mr. Celebi is available in our proxy statement filed with the Securities and Exchange Commission on April 29, 2024 in connection with our 2024 annual meeting of stockholders, such information being incorporated herein by reference.

Previous report

Appointment of David Gaiero as Principal Financial Officer and Principal Accounting Officer

Previous report

On May 7, 2024, our board of directors appointed David Gaiero as our principal financial officer and principal accounting officer, effective as of the day after the filing of this Report.

Previous report

Mr. Gaiero, age 46, currently serves as a partner with Monomoy Advisors, LLC ("Monomoy Advisors"), a financial advisory services firm. Mr. Gaiero served as Chief Financial Officer of Cyteir Therapeutics, Inc. from January 2023 to May 2024 and previously as their Vice President of Finance from December 2020 until January 2023. Prior to joining Cyteir, Mr. Gaiero served in various roles at Wave Life Sciences from 2017 to 2020, most recently serving as Interim Chief Financial Officer and prior to that, serving as Vice President and Corporate Controller. Prior to joining Wave, from 2015 to 2017, Mr. Gaiero served as Vice President and Corporate Controller of OvaScience, Inc. Prior to that, Mr. Gaiero held various positions of increasing responsibility and scope in finance and accounting at iRobot Corporation. Mr. Gaiero began his career in public accounting at PricewaterhouseCoopers LLP. Mr. Gaiero received a B.B.A. in Accounting from the University of Massachusetts, Amherst, and is a Certified Public Accountant in Massachusetts.

Previous report

In connection with Mr. Gaiero's appointment as our principal financial officer and principal accounting officer, we amended an existing services agreement with Monomoy Advisors, pursuant to which Mr. Gaiero will be made available to us on a part-time basis at the rate of $13,000 per month. Under the amended services agreement, Mr. Gaiero will fulfill duties and responsibilities typical of an interim Chief Financial Officer. The foregoing description of the amended services agreement is not complete and is qualified in its entirety by reference to the services agreement, as amended, which is filed herewith as Exhibit 10.4 and incorporated by reference herein.

Previous report

The selection of Mr. Gaiero to serve as principal financial officer and principal accounting officer was not pursuant to any arrangement or understanding between him and any other person. Mr. Gaiero has no family relationship with any director or executive officer of the Company, and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K of the Securities Exchange Act of 1934, as amended.
Reworded paragraphs (4)

Previous wording

To date, we have primarily financed our operations through the sale of equity securities. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. We cannot assure you that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. While the long-term economic impact of each of the conflicts in Ukraine and the Middle East and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures are difficult to assess or predict, each of these events has caused significant disruptions to the global financial markets and contributed to a general global economic slowdown. Furthermore, inflation rates, particularly in the United States and the U.K., have increased recently to levels not seen in decades. Increased inflation may result in increased operating costs (including labor costs) and may affect our operating budgets. In addition, the U.S. Federal Reserve has raised, and is expected to further raise, interest rates in response to concerns about inflation. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. If the disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our financial condition and our ability to pursue our business strategy.

Current wording

To date, we have primarily financed our operations through the sale of equity securities. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. We cannot assure you that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. While the long-term economic impact of each of the conflicts in Ukraine and the Middle East and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures are difficult to assess or predict, each of these events has caused significant disruptions to the global financial markets and contributed to a general global economic slowdown. Furthermore, inflation rates, particularly in the United States and the U.K., have increased recently to levels not seen in decades. Increased inflation may result in increased operating costs (including labor costs) and may affect our operating budgets. In addition, the U.S. Federal Reserve has raised, and may in the future further raise interest rates in response to concerns about inflation. Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks. If the disruptions and slowdown deepen or persist, we may not be able to access additional capital on favorable terms, or at all, which could in the future negatively affect our financial condition and our ability to pursue our business strategy.

Previous wording

We have incurred significant net losses since our inception. Our net loss was $8.0 million and $10.2 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $239.9 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities and borrowings of convertible debt.

Current wording

We have incurred significant net losses since our inception. Our net loss was $15.1 million and $19.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $247.0 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities and borrowings of convertible debt.

Previous wording

Many drug candidates that initially showed promise in early stage testing for treating cancer have later been found to be ineffective and/or cause side effects that prevented further development of the compound or resulted in their removal from the market. For example, in a third-party clinical trial of an anti-VISTA monoclonal antibody, dose limiting toxicities caused by cytokine release syndrome resulted in early termination of the clinical trial. Although initial clinical data from our Phase 1/2 clinical trial of SNS-101 demonstrate favorable safety, pharmacokinetics and cytokine release profiles, there is no assurance that data from additional patients will produce similar results. As a result of these and other risks described herein that are inherent in the development and commercialization of novel therapeutic agents, we may not successfully develop and commercialize our drug candidates, in which case we may not achieve profitability and the value of our stock may decline.

Current wording

Many drug candidates that initially showed promise in early stage testing for treating cancer have later been found to be ineffective and/or cause side effects that prevented further development of the compound or resulted in their removal from the market. For example, in a third-party clinical trial of an anti-VISTA monoclonal antibody, dose limiting toxicities caused by cytokine release syndrome resulted in early termination of the clinical trial. Although initial clinical data from our Phase 1/2 clinical trial of SNS-101 demonstrate favorable safety, pharmacokinetics and cytokine release profiles, as well as preliminary evidence of anti-tumor activity, there is no assurance that data from additional patients will produce similar results. As a result of these and other risks described herein that are inherent in the development and commercialization of novel therapeutic agents, we may not successfully develop and commercialize our drug candidates, in which case we may not achieve profitability and the value of our stock may decline.

Previous wording

As of May 1, 2024, we had 27 full-time employees. As our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need additional managerial, operational, financial and other personnel, including personnel to support our product development and planned future commercialization efforts. Future growth will impose significant added responsibilities on members of management, including:

Current wording

As of August 2, 2024, we had 28 full-time employees. As our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need additional managerial, operational, financial and other personnel, including personnel to support our product development and planned future commercialization efforts. Future growth will impose significant added responsibilities on members of management, including: