Turnstone Biologics (TSBX) Q2 2024 earnings summary

Executive summary

• Focused on developing next-generation tumor-infiltrating lymphocyte (TIL) therapies for solid tumors, with three ongoing Phase 1 trials for lead candidate TIDAL-01 and a preclinical pipeline including TIDAL-02 and a viral immunotherapy combination program.

• Reported positive initial data from the Phase 1 trial of TIDAL-01 in metastatic colorectal cancer, including a 25% overall response rate, 50% disease control rate, and a complete response in one of four patients for over a year.

• Prioritized development of TIDAL-01 in solid tumor indications with high unmet need, including colorectal cancer, head and neck cancer, and uveal melanoma, while deprioritizing cutaneous melanoma and breast cancer.

• Leadership changes included promotion of Ines Verdon to SVP of Clinical Development and expanded R&D oversight for David Stojdl.

• No products approved for sale; revenue is currently derived from collaboration agreements, notably with Takeda, which has now been terminated.

Financial highlights

• Cash, cash equivalents, and short-term investments totaled $62.4 million as of June 30, 2024, down from $94.8 million at December 31, 2023.

• Net loss was $40.9 million for the six months ended June 30, 2024, compared to $21.4 million for the same period in 2023.

• R&D expenses were $17.7 million for Q2 2024, up from $17.2 million in Q2 2023, mainly due to increased manufacturing costs for TIDAL-01 trials.

• G&A expenses were $4.3 million for Q2 2024, down from $4.7 million in Q2 2023, primarily due to lower personnel costs.

• No collaboration revenue recognized in 2024; $19.3 million was recognized in the first half of 2023, mainly from the now-terminated Takeda agreement.

Outlook and guidance

• Existing cash and investments are expected to fund operations into Q3 2025; substantial doubt exists about the ability to continue as a going concern beyond that without additional capital.

• Plans to raise additional capital through equity, debt, or strategic partnerships; failure to secure funding may require scaling back or discontinuing development programs.

• Next clinical update for TIDAL-01 expected in the first half of 2025.

• Continued enrollment in multiple Phase 1 trials of TIDAL-01, focusing on three high unmet need indications.