Turnstone Biologics (TSBX)2024-08-14 20:23Financial Performance - The net loss for the six months ended June 30, 2024, was 21.431 million for the same period in 2023, indicating a significant increase in losses[10]. - The accumulated deficit as of June 30, 2024, was 176.758 million at the end of 2023, reflecting ongoing financial challenges[8]. - Total stockholders' equity decreased to 98.667 million at the end of 2023, a decline of approximately 39.4%[8]. - The company experienced a comprehensive loss of 21.251 million for the same period in 2023[10]. - The company reported a net loss per share attributable to common stockholders of 7.56 per share for the same period in 2023[10]. - The net loss for the six months ended June 30, 2024, was 21.431 million for the same period in 2023, representing an increase of approximately 91%[10]. - The accumulated deficit increased to 176.758 million at the end of 2023, marking an increase of approximately 23%[8]. Operating Expenses - Total operating expenses for the six months ended June 30, 2024, were 41.552 million for the same period in 2023, representing an increase of 2.9%[10]. - Research and development expenses for the three months ended June 30, 2024, were 17.193 million for the same period in 2023, showing a year-over-year increase of 3.1%[10]. - Total operating expenses for the three months ended June 30, 2024, were 21.9 million for the same period in 2023, an increase of 9.2 million, an increase of 8.7 million for the same period in 2023[163]. - Research and development expenses increased significantly from 9,187,000 on June 30, 2024, representing an increase of approximately 62.5%[57]. Cash and Funding - Cash, cash equivalents, and restricted cash at the end of the period were 21.6 million at the beginning of the period[18]. - The company anticipates future financing needs to support ongoing research and development efforts, although specific amounts and timelines were not disclosed[4]. - The company entered into a Loan and Security Agreement for a revolving credit facility of up to 40 million in new funding by March 31, 2025[25]. - The company is dependent on its ability to raise additional funding to continue as a going concern, facing substantial doubt about its ability to do so within the next 12 months[24]. - The company expects to require substantial additional funding to support ongoing operations and product development, particularly for clinical trials and commercialization efforts[172]. Clinical Trials and Research - The company is currently conducting three ongoing Phase 1 clinical trials for its TIL therapies, targeting colorectal cancer, head and neck cancer, and uveal melanoma[19]. - The company is advancing three ongoing Phase 1 clinical trials for TIDAL-01, targeting colorectal cancer, head and neck cancer, and uveal melanoma[119]. - TIDAL-01 has shown a 25% overall response rate (ORR) and a 50% disease control rate (DCR) in a multi-site trial for advanced colorectal cancer, significantly outperforming the current standard of care which has an ORR of 1-6%[123]. - The company plans to substantially increase research and development expenses in the foreseeable future to advance product candidates and improve manufacturing processes[157]. - TIDAL-02 is in preclinical development and aims to enhance TIL quality and function, addressing distinct solid tumor indications compared to TIDAL-01[124]. Collaboration and Agreements - The Company agreed to pay Moffitt a total of at least 200 million in aggregate upon achieving certain clinical and regulatory milestones for the first Takeda Licensed Product[62]. - The Company recognized a 0.0 million for the six months ended June 30, 2024, compared to 19.3 million[161]. Stock and Equity - The company executed a 1-for-7.9872 reverse stock split on July 14, 2023, adjusting all share and per share amounts retroactively[20]. - The Company’s authorized capital stock is now 500 million shares, consisting of 490 million shares of common stock and 10 million shares of undesignated preferred stock[22]. - The Company had 23,128,454 shares of common stock outstanding as of June 30, 2024, compared to 23,099,335 shares at the end of 2023[8]. - The fair value of stock options granted was estimated using the Black-Scholes model, with a risk-free interest rate of 4.30% for the six months ended June 30, 2024[102]. - The Company adopted the 2023 Equity Incentive Plan, reserving 1,889,435 new shares for future issuance[100]. Financial Position - The total liabilities and stockholders' equity as of June 30, 2024, was 112.815 million at the end of 2023, indicating a reduction in overall financial position[8]. - The Company’s total financial assets were valued at 7.125 million in money market funds and 1.024 million in contingent consideration as of June 30, 2024[48]. - The Company has not generated any revenue from product sales and has financed its operations primarily through equity offerings and collaboration revenue[25]. - The company has incurred significant operating losses and expects to continue doing so for the foreseeable future, heavily relying on successful product development for profitability[170].