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].
sensei(SNSE) - 2023 Q3 - Quarterly Report