Financial Performance - The company reported a net loss of $26.7 million for the nine months ended September 30, 2023, compared to a net loss of $36.4 million for the same period in 2022, indicating a 26% improvement in losses year-over-year[90]. - Net loss for Q3 2023 was $7.1 million, an improvement of $6.3 million compared to a net loss of $13.4 million in Q3 2022[104]. - Total operating expenses for the nine months ended September 30, 2023, were $28.9 million, down from $37.1 million in the same period of 2022, a decrease of $8.2 million[108]. - Research and development expenses decreased to $3.8 million for Q3 2023 from $9.2 million in Q3 2022, a reduction of $5.4 million[105]. - General and administrative expenses were $3.9 million for Q3 2023, down from $4.8 million in Q3 2022, reflecting a decrease of $0.8 million[106]. - The accumulated deficit as of September 30, 2023, was $224.5 million[112]. - Net cash used in operating activities was $25.9 million for the nine months ended September 30, 2023, compared to $29.5 million in the same period of 2022[113]. - Net cash provided by investing activities was $30.2 million for the nine months ended September 30, 2023, down from $33.9 million in the same period of 2022[115]. - The company expects existing cash and cash equivalents to fund operating expenses and capital expenditures at least into the second half of 2025[124]. Clinical Trials and Product Development - The company currently has 17 patients enrolled in the Phase 1/2 clinical trial for SNS-101, with 11 adverse events reported but no dose-limiting toxicities observed[86][87]. - SNS-101 is being evaluated as a monotherapy and in combination with cemiplimab for patients with advanced solid tumors, with initial pharmacokinetic and safety data expected to be reported in Q1 2024[91]. - SNS-102 and SNS-103 are in development, with SNS-102 being 585-fold more selective for VSIG4 at low pH conditions, and a product candidate expected to be selected for SNS-103 in 2023[91]. - The company anticipates significant increases in research and development expenses as it continues clinical trials and prepares regulatory filings for its product candidates[93]. - The company plans to continue investing in its TMAb platform and seek regulatory approvals for product candidates that successfully complete clinical trials[92]. Funding and Revenue Expectations - The company has raised a total of $123.4 million from private placements and $138.5 million from its IPO in February 2021, totaling $261.9 million in gross proceeds[89]. - The company does not expect to generate any revenue from product sales for at least the next several years, relying on funding from equity and convertible debt[89]. Operational and Compliance Costs - General and administrative expenses are expected to rise due to increased payroll and compliance costs associated with being a public company[100]. - The company is obligated to manage costs associated with operational expansion, regulatory approvals, and establishing sales and marketing capabilities for product candidates[127]. - The company is focused on the costs, timing, and outcomes of regulatory reviews for its product candidates[127]. Company Classification and Reporting - The company qualifies as an Emerging Growth Company (EGC) and may take advantage of reduced disclosure requirements until it exceeds $1.235 billion in annual revenue or $700 million in market value held by non-affiliates[130]. - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million in the most recently completed fiscal year[132]. - The company intends to rely on exemptions from certain disclosure requirements available to smaller reporting companies, including presenting only the two most recent fiscal years of audited financial statements[133]. - The company has not opted out of the extended transition period for complying with new or revised accounting standards, allowing it to adopt standards at the same time as private companies[131]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[135].

PART I: FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) This section presents the unaudited financial statements for the period ended June 30, 2023, detailing a net loss of $19.6 million and $78.8 million in cash and equivalents [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to $89.6 million from $118.4 million, with total liabilities at $10.4 million and stockholders' equity at $79.2 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,226 | $17,795 | | Marketable securities | $68,614 | $89,321 | | Total current assets | $81,069 | $108,589 | | Total assets | $89,580 | $118,375 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $5,357 | $9,066 | | Total liabilities | $10,379 | $14,968 | | Total stockholders' equity | $79,201 | $103,407 | | Total liabilities and stockholders' equity | $89,580 | $118,375 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $9.4 million for Q2 2023 and $19.6 million for the six months ended June 30, 2023, primarily due to lower research and development expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,784 | $6,393 | $9,988 | $13,848 | | General and administrative | $5,393 | $4,319 | $11,197 | $9,351 | | Loss from operations | $(10,177) | $(10,712) | $(21,185) | $(23,199) | | Net loss | $(9,386) | $(10,535) | $(19,563) | $(22,940) | | Net loss per share, basic and diluted | $(0.31) | $(0.34) | $(0.64) | $(0.75) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operations was $21.2 million, offset by $21.8 million from investing activities, resulting in a $7.6 million net decrease in cash Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,199) | $(22,649) | | Net cash provided by investing activities | $21,838 | $25,389 | | Net cash used in financing activities | $(8,208) | $0 | | Net (decrease) increase in cash | $(7,569) | $2,740 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail accounting policies, liquidity, and commitments, highlighting $78.8 million in cash and equivalents, a $7.7 million share repurchase, and a subsequent $2.0 million repurchase agreement - The company expects its cash, cash equivalents, and marketable securities of **$78.8 million** as of June 30, 2023, will be sufficient to fund operations for at least the next twelve months[23](index=23&type=chunk) - On June 1, 2023, the company completed the repurchase of **4,454,248 shares** of its common stock from the Apeiron Parties for **$1.58 per share**, totaling approximately **$7.0 million**, plus **$0.75 million** for costs[33](index=33&type=chunk)[53](index=53&type=chunk)[72](index=72&type=chunk) - A restructuring plan initiated in December 2022 was completed, with all related accrued liabilities paid out by June 30, 2023[76](index=76&type=chunk)[78](index=78&type=chunk) - Subsequent to the quarter end, on July 31, 2023, the company agreed to repurchase **1,587,302 shares** from Cambrian BioPharma for approximately **$2 million**[79](index=79&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operations, and liquidity, focusing on the TMAb™ platform, SNS-101 clinical trial, and the sufficiency of $78.8 million in cash until H2 2025 [Overview](index=18&type=section&id=Overview) Sensei is an immuno-oncology company developing TMAb™ platform therapeutics, with lead candidate SNS-101 in Phase 1/2 clinical trials and preclinical candidates SNS-102 and SNS-103 advancing - Lead product candidate SNS-101, targeting VISTA, initiated a first-in-human Phase 1/2 clinical trial in May 2023[83](index=83&type=chunk) - The company expects to report initial pharmacokinetic and safety data for the SNS-101 trial by year-end 2023, with topline monotherapy and initial combination data in 2024[83](index=83&type=chunk) - Preclinical candidates SNS-102 (targeting VSIG4) and SNS-103 (targeting CD39) are in lead optimization, with product candidate selection expected in 2023[83](index=83&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Operating results for Q2 and H1 2023 show a decrease in R&D expenses and an increase in G&A expenses, primarily due to stockholder activism costs Comparison of Operating Expenses (in thousands) | Expense Category | Q2 2023 | Q2 2022 | Change | H1 2023 | H1 2022 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,784 | $6,393 | $(1,609) | $9,988 | $13,848 | $(3,860) | | General and administrative | $5,393 | $4,319 | $1,074 | $11,197 | $9,351 | $1,846 | - The **$1.1 million** increase in G&A expenses for Q2 2023 was primarily driven by a **$1.6 million** increase in external professional services related to stockholder activism for the 2023 annual meeting[101](index=101&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held **$78.8 million** in cash and equivalents, projected to fund operations into the second half of 2025, with R&D as the primary cash use - As of June 30, 2023, the company had cash, cash equivalents and marketable securities of **$78.8 million**[108](index=108&type=chunk) - The company expects its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements at least into the second half of 2025[119](index=119&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,199) | $(22,649) | | Net cash provided by investing activities | $21,838 | $25,389 | | Net cash used in financing activities | $(8,208) | $0 | [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Sensei is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Sensei is not required to provide the information otherwise required under this item[131](index=131&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2023[134](index=134&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended June 30, 2023[135](index=135&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, with an ongoing Ontario matter not expected to materially impact financial results - The Company is not currently a party to any material legal proceedings[138](index=138&type=chunk) - Regarding a lawsuit in Ontario, Canada, management believes the outcome is not likely to have any material impact on the Company's results, cash flows, or financial position[49](index=49&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section details key risks including the need for additional funding, a history of significant losses, dependence on early-stage product candidates, reliance on third parties, and potential shareholder activism - **Financial Risk:** The company has a history of significant losses (**$217.4 million** accumulated deficit as of June 30, 2023) and will need substantial additional funding, which may not be available on favorable terms[146](index=146&type=chunk)[156](index=156&type=chunk) - **Development Risk:** The business is highly dependent on the success of its early-stage product candidates; clinical development is long, expensive, and uncertain, and positive preclinical results may not translate to human trials[165](index=165&type=chunk)[180](index=180&type=chunk) - **Third-Party Reliance:** The company relies on third-party CROs for clinical trials and CMOs for manufacturing, which reduces control and introduces risks related to performance, compliance, and supply chain disruptions[203](index=203&type=chunk)[217](index=217&type=chunk) - **Shareholder Activism Risk:** The company's business could be negatively affected by shareholder activism, which could cause significant expense and hinder the execution of its business strategy[331](index=331&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=66&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities and details a share repurchase of **4,454,248 shares** at **$1.58 per share** completed on June 1, 2023 - There were no unregistered sales of equity securities during the quarter[366](index=366&type=chunk) Issuer Purchases of Equity Securities (Q2 2023) | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2023 | — | $— | | May 2023 | — | $— | | June 2023 | 4,454,248 | $1.58 | | **Total** | **4,454,248** | **$1.58** | [Defaults Upon Senior Securities](index=66&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[370](index=370&type=chunk) [Mine Safety Disclosures](index=66&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[371](index=371&type=chunk) [Other Information](index=66&type=section&id=Item%205.%20Other%20Information) On July 31, 2023, the company agreed to repurchase **1,587,302 shares** from Cambrian BioPharma for approximately **$2 million**, including standstill and voting provisions, in a related-party transaction - On July 31, 2023, the company agreed to repurchase **1,587,302 shares** of its common stock from Cambrian BioPharma at **$1.26 per share** for an aggregate price of approximately **$2 million**[372](index=372&type=chunk) - The agreement includes standstill restrictions and a voting agreement where Cambrian will vote its shares in line with the Board's recommendations until a specified time before the 2025 Annual Meeting[372](index=372&type=chunk) - This is a related-party transaction, as James Peyer, a director of Sensei Biotherapeutics, is the CEO of Cambrian[374](index=374&type=chunk) [Exhibits](index=67&type=section&id=Item%206.%20Exhibits) This section lists key corporate documents and agreements filed as exhibits, including a significant purchase agreement and officer certifications - Lists key corporate documents and agreements filed as exhibits, including the Purchase Agreement with Apeiron Investment Group and officer certifications (302 and 906)[375](index=375&type=chunk) Signatures - The report was signed on August 3, 2023, by John Celebi, President and Chief Executive Officer, and Erin Colgan, Chief Financial Officer[379](index=379&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39980 Sensei Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1863385 (State or other j ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39980 Sensei Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1863385 (State or other jurisdiction of incorporation or organization) For th ...

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------------------------------------------------------|-------|--------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Conditionally Active Antibodies for I ...

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------|-------|-------|-------|-------------------------------------------------------|-------|-------|--------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Conditionally Active Antibodies for I ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39980 Sensei Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1863385 (State or oth ...

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------|-------|-------|---------------------------------------------|-------|--------------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Next Generation Immuno-Oncology Medicines | | | | | | | | | | | | | | | | John K. Celebi, MBA | | | | | | | | | | | | | | | | President & Chief Executive Officer | | | | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39980 Sensei Biotherapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 83-1863385 (State or other ju ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (Exact name of Registrant as specified in its Charter) Delaware 83-1863385 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 451 D Street, Suite 710 Boston, MA 02210 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (240) 243-8000 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ...