On March 5, 2025 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the three months and full year ended December 31, 2024, and provided a business update (Press release, TScan Therapeutics, MAR 5, 2025, View Source [SID1234650906]).
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"The progress we achieved across our pipeline in 2024 has paved the way for a transformative year ahead. We are encouraged by the ALLOHA heme data presented at ASH (Free ASH Whitepaper) with only 2 of 26 patients having relapsed compared to 4 of 12 control-arm subjects. We look forward to presenting additional data from the Phase 1 trial by the end of the year, including two-year relapse data on the initial patients," said Gavin MacBeath, Ph.D., Chief Executive Officer. "For the PLEXI-T solid tumor program, we continue to enroll patients investigating seven different TCR-Ts, including the recently added MAGE-A4 TCR-T (TSC-202-A0201). We look forward to treating our first patient with multiplex therapy in the first half of 2025 and sharing safety and response data for multiplex therapy in the second half of the year."
Recent Corporate Highlights
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The Company recently presented updated results from the ongoing ALLOHA trial of TSC-100 and TSC-101 at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
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Infusions with TSC-100 and TSC-101 were well-tolerated with no dose limiting toxicities and adverse events were consistent with hematopoietic cell transplantation (HCT).
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TSC-100 and TSC-101 TCR-T cells have been detected >1 year post infusion and have a clear dose-persistence relationship.
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2 of 26 (8%) treatment-arm subjects relapsed as compared to 4 of 12 (33%) control-arm subjects.
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Median time to relapse was not evaluable in TCR-T-treated subjects vs 160 days in the control arm.
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Event-free survival strongly favors the treatment arm (HR=0.30).
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In December 2024, the Company refinanced its previous convertible debt facility maturing in 2026 with a non-dilutive term loan for up to $52.5 million from Silicon Valley Bank (SVB), a division of First Citizens Bank, of which $32.5 million was drawn at closing. The SVB term loan allows for monthly interest-only payments through September 30, 2027, and matures on September 1, 2029.
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In December 2024, the Company completed a $30 million registered direct offering with Lynx1 Capital Management LP (Lynx1), a large existing shareholder of the Company, and an investment fund advised by Lynx1, for pre-funded warrants to purchase up to 7,500,000 shares of the Company’s voting common stock at a price of $4.00 per pre-funded warrant, representing a premium of 37% to the previous closing price of TScan Therapeutics’ common stock. Net proceeds from the offering extended the Company’s cash runway into the first quarter of 2027.
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The Company announced that it has been named one of the Top Places to Work in Massachusetts for the third consecutive year in the 17th annual, employee-based survey from The Boston Globe. The 2024 Top Places to Work issue can be found online at Globe.com/TopPlaces.
Upcoming Anticipated Milestones
Heme Malignancies Program: TScan’s two lead TCR-T therapy candidates, TSC-100 and TSC-101, are designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) undergoing allogeneic HCT (the ALLOHA trial, NCT05473910).
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Opened expansion cohorts at dose level 3 to further characterize safety and evaluate translational and efficacy endpoints.
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Plans to continue development of TSC-101 only, as TSC-101 enables treatment of ~98% of patients with HLA type A*02:01.
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Initiate a registration trial for TSC-101, pending further feedback from regulatory authorities, in the second half of 2025.
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Plans to present additional data from the Phase 1 trial by the end of the year, including two-year relapse data on the initial patients.
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Plans to file an investigational new drug (IND) application for TSC-102-A0301, a TCR-T targeting CD45 on HLA-A*03:01, in the second half of 2025.
Solid Tumor Program: TScan continues to expand the ImmunoBank, a collection of TCR-T therapy candidates that target different cancer-associated antigens presented on diverse HLA types. TScan’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial, NCT05973487).
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IND filing for TCR targeting MAGE-A4 on HLA-A*02:01 (TSC-202-A0201) recently cleared by U.S. Food and Drug Administration (FDA).
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The Company now has seven TCR-Ts cleared for clinical development in its PLEXI-T Phase 1 trial.
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Progressing through initial dose levels across the TCR-T therapy candidates.
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Plans to dose first patient with multiplex TCR-T therapy in the first half of 2025.
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Safety and response data for multiplex TCR-T therapy anticipated in the second half of 2025.
Financial Results
Revenue: Revenue for the fourth quarter of 2024 was $0.7 million, compared to $7.2 million for the fourth quarter of 2023, and $2.8 million for the full-year 2024, compared to $21.0 million for the full-year 2023. The decrease in both periods was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen which commenced in May 2023 compared to the collaboration and license agreement with Novartis which ended in March 2023.
R&D Expenses: Research and development (R&D) expenses for the fourth quarter of 2024 were $29.4 million, compared to $22.4 million for the fourth quarter of 2023, and $107.4 million for the full-year 2024, compared to $88.2 million for the full-year 2023. The period over period increases were primarily driven by an increase in clinical studies expense associated with the ongoing enrollment of our ALLOHA Phase 1 heme trial and start-up activities and initial enrollment in our PLEXI-T Phase 1 solid tumor clinical trial, as well as an increase in personnel expenses due to additional headcount in support of our expanded research and development activities. R&D expenses included non-cash stock compensation expense of $1.3 million and $0.9 million for the fourth quarter of 2024 and 2023, respectively, and $4.8 million and $2.9 million for the full-year 2024 and 2023, respectively.
G&A Expenses: General and administrative (G&A) expenses for the fourth quarter of 2024 were $8.0 million, compared to $6.2 million for the fourth quarter of 2023, and $30.3 million for the full-year 2024, compared to $26.4 million for the full-year 2023. The period over period increases were primarily driven by an increase in personnel expenses due to increased headcount to support business activities. G&A expenses included non-cash stock compensation expense of $1.4 million and $0.6 million for the fourth quarter of 2024 and 2023, respectively, and $4.7 million and $2.3 million for the full-year 2024 and 2023, respectively.
Net Loss: Net loss was $35.8 million for the fourth quarter of 2024, compared to $19.6 million for the fourth quarter of 2023, and included net interest income of $2.0 million and $1.7 million, respectively. Net loss for the full-year 2024 was $127.5 million, compared to $89.2 million for the full-year 2023, and included net interest income of $8.4 million and $4.2 million, respectively. Net loss for the fourth quarter of 2024 and full-year 2024 included a $1.1 million loss on extinguishment of debt.
Cash Position: Cash, cash equivalents, and marketable securities as of December 31, 2024 were $290.1 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the first quarter of 2027.
Share Count: As of December 31, 2024, the Company had issued and outstanding shares of 56,590,627, which consists of 52,314,039 shares of voting common stock and 4,276,588 shares of non-voting common stock, and outstanding pre-funded warrants to purchase 73,087,945 shares of voting common stock at an exercise price of $0.0001 per share.