TScan Therapeutics(TCRX) - 2023 Q4 - Annual Results

TScan Therapeutics Fourth Quarter and Full Year 2023 Business Update and Financial Results Business and Clinical Highlights TScan Therapeutics advanced clinical programs, with all eight heme malignancy patients relapse-free and two new INDs cleared for solid tumors - In the ongoing Phase 1 study for heme malignancies, all 8 patients in the TSC-100 and TSC-101 treatment arms are relapse-free and show complete donor chimerism[1] - The FDA cleared two additional Investigational New Drug (IND) applications for the Solid Tumor Program: TSC-201-B0702 (targeting MAGE-C2) and TSC-204-A0101 (targeting MAGE-A1)[1][5] - The company is on track to treat the first patient in its Phase 1 solid tumor program in March 2024, with initial data from singleplex and multiplex cohorts expected in 2024[2] - A high-risk TP53-mutated MDS patient reached the one-year relapse-free milestone, a significant indicator of long-term positive outcomes[2][5] Clinical Program Updates and Outlook The company provided updates on its heme malignancies program, showing promising efficacy, and its advancing solid tumor program Hematologic Malignancies Program (TSC-100 & TSC-101) The Phase 1 trial for TSC-100 and TSC-101 shows strong results, with all eight treatment-arm patients relapse-free - All eight (100%) treatment-arm patients were free from relapse, with four patients having follow-up beyond ten months, indicating complete elimination of target cells[5] - Two of six patients in the control arm relapsed, and a third required clinical intervention due to concerns of impending relapse[5] - Upcoming Milestones: Complete Phase 1 enrollment and report one-year data in 2024; initiate registration trial and report two-year relapse data in 2025[13] Solid Tumor Program (ImmunoBank) The solid tumor program is rapidly advancing with six TCR-Ts cleared for clinical development, with first patient dosing in Q1 2024 - TScan now has six enhanced TCR-Ts cleared for clinical development, expanding its ImmunoBank of therapeutic TCRs[4][5] - The first patient in the Phase 1 solid tumor study is expected to be dosed in Q1 2024[4][13] - Upcoming Milestones: Share initial data from singleplex and multiplex cohorts in 2024; continue filing additional INDs throughout 2024; anticipate long-term duration of response data in 2025[13] Management and Corporate Developments TScan strengthened its leadership team with key appointments and promotions, and received 'Top Place to Work' recognition - Appointed Jason A. Amello as Chief Financial Officer and Justin McCue, Ph.D., as Chief Technology Officer[6] - Promoted Zoran Zdraveski, J.D., Ph.D., to Chief Legal and Strategy Officer, Cagan Gurer, Ph.D., to SVP, Discovery, and Jim Murray to SVP, Head of Development Operations[6][13] - For the second year in a row, the company was named a Top Place to Work by The Boston Globe in November 2023[13] Financial Performance TScan reported full-year 2023 revenue of $21.0 million, a net loss of $89.2 million, and a $192.0 million cash position Financial Results Summary (Q4 and Full Year 2023) Revenue increased in Q4 and full-year 2023 due to the Amgen collaboration, but higher expenses led to a wider net loss Financial Results Summary (Q4 and Full Year 2023) (Millions USD) | Financial Metric | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $7.2M | $3.1M | $21.0M | $13.5M | | R&D Expenses | $22.4M | $15.6M | $88.2M | $59.8M | | G&A Expenses | $6.2M | $6.1M | $26.4M | $20.4M | | Net Loss | ($19.6M) | ($18.7M) | ($89.2M) | ($66.2M) | - The increase in revenue is primarily due to the timing of research activities related to the Amgen collaboration, which commenced in May 2023[9] - As of December 31, 2023, cash, cash equivalents, and marketable securities were $192.0 million, which is expected to fund the current operating plan into 2026[14] Condensed Consolidated Balance Sheet As of December 31, 2023, TScan's total assets grew to $272.1 million, with cash increasing to $192.0 million Condensed Consolidated Balance Sheet (Thousands USD) | (in thousands) | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and marketable securities | $192,044 | $120,027 | | Total assets | $272,149 | $199,091 | | Total liabilities | $121,282 | $99,657 | | Total stockholders' equity | $150,867 | $99,434 | Condensed Consolidated Statements of Operations For 2023, TScan reported collaboration revenue of $21.0 million, total operating expenses of $114.5 million, and a net loss of $89.2 million Condensed Consolidated Statements of Operations (Thousands USD, except per share amounts) | (in thousands, except per share amounts) | Twelve Months Ended Dec 31, 2023 | Twelve Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Collaboration and license revenue | $21,049 | $13,535 | | Total operating expenses | $114,507 | $80,171 | | Loss from operations | ($93,458) | ($66,636) | | Net loss | ($89,218) | ($66,221) | | Net loss per share, basic and diluted | ($1.36) | ($2.75) |