Turnstone Biologics (US:TSBX)2024-08-14 20:23Financial Performance - The net loss for the six months ended June 30, 2024, was $40.933 million, compared to a net loss of $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 $217.691 million, up from $176.758 million at the end of 2023, reflecting ongoing financial challenges[8]. - Total stockholders' equity decreased to $59.736 million as of June 30, 2024, from $98.667 million at the end of 2023, a decline of approximately 39.4%[8]. - The company experienced a comprehensive loss of $41.040 million for the six months ended June 30, 2024, compared to 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 $0.92 for the three months ended June 30, 2024, compared to a loss of $7.56 per share for the same period in 2023[10]. - The net loss for the six months ended June 30, 2024, was $40.933 million, compared to a net loss of $21.431 million for the same period in 2023, representing an increase of approximately 91%[10]. - The accumulated deficit increased to $217.691 million as of June 30, 2024, from $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 $42.748 million, compared to $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 $17.730 million, compared to $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 $22.1 million, compared to $21.9 million for the same period in 2023, an increase of $205,000[154]. - General and administrative expenses for the six months ended June 30, 2024, were $9.2 million, an increase of $0.5 million, or 6.2%, compared to $8.7 million for the same period in 2023[163]. - Research and development expenses increased significantly from $5,675,000 on December 31, 2023, to $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 $17.5 million, down from $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 $20 million, with a requirement to secure at least $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 $17.5 million over five years for research and development services, starting from June 1, 2023[79]. - The Company is entitled to receive up to $200 million in aggregate upon achieving certain clinical and regulatory milestones for the first Takeda Licensed Product[62]. - The Company recognized a $19.4 million charge to research and development expense related to the asset acquisition of Myst during the year ended December 31, 2020[89]. - The Company ceased all work under the Takeda Agreement as of March 31, 2023, following the termination notice[65]. - Collaboration revenue was $0.0 million for the six months ended June 30, 2024, compared to $19.3 million for the same period in 2023, a decrease of $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 $76.877 million, down from $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 $52.238 million, including $7.125 million in money market funds and $44.997 million in U.S. government securities[48]. - The Company’s total financial liabilities included $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].