On March 21, 2024 Turnstone Biologics Corp. ("Turnstone" or the "Company") (Nasdaq: TSBX), a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent business highlights (Press release, Turnstone Biologics, MAR 21, 2024, View Source [SID1234641352]).

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"2023 marked a transformative year for Turnstone Biologics in which we transitioned into a publicly traded company and continued to advance our pipeline through clinical development. We are encouraged by the increasing momentum in the TIL landscape that paves the way for next-generation approaches like our Selected TIL therapy, which is designed to create a TIL product with a significantly greater population of potent tumor-reactive T cells, which we believe is the key to extending their therapeutic potential to high unmet medical needs in solid tumors beyond melanoma," said Sammy Farah, M.B.A., Ph.D., Turnstone’s President and Chief Executive Officer. "In 2024, we look forward to generating clinical data that potentially highlights the differentiation of our platform and supports further development of our lead asset, TIDAL-01, which is currently being evaluated in Phase 1 studies in patients with colorectal cancer, head and neck squamous cell carcinoma, breast cancer, uveal melanoma, and cutaneous melanoma. We remain on-track to share initial clinical data for TIDAL-01 in mid-2024 and we believe we are well-positioned for another year of meaningful progress for our organization."

Fourth Quarter and Recent Business Highlights

Advancing TIDAL-01 in Multiple Phase 1 Clinical Trials and Expanding of Targeted Solid Tumor Indications. TIDAL-01 employs an unbiased identification and functional screening process to isolate and selectively expand the greatest breadth of tumor-reactive TILs from the patient’s tumor. Turnstone believes TIDAL-01 can expand the utility of TIL therapy to solid tumor types where first-generation TILs have not to date shown objective responses in clinical trials and is pursuing several indications with critical unmet need, potentially enabling meaningful therapeutic differentiation. Recently, Turnstone expanded their trials to evaluate additional solid tumor types in addition to the existing indications of breast cancer and uveal melanoma. The multi-site STARLING trial protocol has been amended to cover head and neck squamous cell carcinoma (HNSCC), and the H. Lee Moffitt Cancer Center and Research Institute sponsored trial has been expanded to include colorectal cancer (CRC) and HNSCC. Turnstone expects to provide an initial clinical update across these trials in mid-2024.

Preclinical Data Presentations at the 2023 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting Support Ongoing Clinical and Preclinical Efforts. In November 2023, Turnstone presented preclinical data on its Selected TIL therapies, including the demonstration of the feasibility of selecting and expanding tumor-reactive TIL as further evidence for the potential of TIDAL-01 as a treatment option for patients with colorectal and gastric cancers. Turnstone also presented on its next Selected TIL program from its development pipeline, TIDAL-02, which seeks to utilize a novel direct selection method, genetically engineered to rapidly select for the greatest breadth of tumor-reactive T cells.

Strengthened Company’s Scientific Advisory Board. In October 2023, Turnstone appointed Jeffrey S. Weber, M.D., Ph.D., to its Scientific Advisory Board. Dr. Weber, a world-renowned thought leader with extensive experience in innovative immunotherapies for solid tumors, currently serves as Deputy Director of the Perlmutter Cancer Center and Co-Director of the Melanoma Research Program at the New York University-Langone Cancer Center.

Fourth Quarter 2023 Financial Results

Cash, Cash Equivalents and Short-Term Investments: As of December 31, 2023, cash, cash equivalents and short-term investments were $94.8 million. The Company expects that the combined cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses for the three months ended December 31, 2023, were $13.6 million, compared to $20.2 million for the same period in 2022. The decrease was due primarily to decreases in pre-clinical and regulatory costs, personnel-related costs, and manufacturing expenses due to the termination of the discovery, collaboration and license agreement entered into on November 7, 2019, with Takeda Oncology for certain viral immunotherapy candidates offset by an increase due to ramp up of TIDAL-01 activities.

General and Administrative (G&A) Expenses: G&A expenses for the three months ended December 31, 2023, were $4.4 million, compared to $4.4 million for the same period in 2022.

Net Loss: Net loss for the three months ended December 31, 2023, was $16.5 million, compared to net loss of $13.7 million for the same period in 2022.

Full Year 2023 Financial Results

Cash, Cash Equivalents and Short-Term Investments: For the full year ended December 31, 2023, cash, cash equivalents and short-term investments were $94.8 million.

Research and Development (R&D) Expenses: R&D expenses for the full year ended December 31, 2023, were $60.5 million, compared to $86.7 million for the prior year period. The decrease was due primarily to decreases in pre-clinical and regulatory and manufacturing expenses due to the termination of the discovery, collaboration and license agreement entered into on November 7, 2019, with Takeda Oncology for certain viral immunotherapy candidates offset by an increase in personnel-related costs and costs due to ramp up of TIDAL-01 activities.

General and Administrative (G&A) Expenses: G&A expenses for the full year ended December 31, 2023, were $17.8 million, compared to $18.2 million for the prior year period. We anticipate that G&A expenses will remain stable as we support public company operations.

Net Loss: Net loss for the full year ended December 31, 2023, was $55.2 million, compared to net loss of $30.8 million for the prior year period.