Alaunos Therapeutics(US:TCRT)2021-08-13 20:58Financial Performance - For the six months ended June 30, 2021, the company reported a net loss of $44.2 million, with an accumulated deficit of approximately $808.3 million since its inception in 2003[138]. - The company has incurred net losses and negative cash flows from operations since inception, with no revenue generated from product sales[167]. - As of June 30, 2021, the accumulated deficit was approximately $808.3 million, indicating ongoing financial challenges[181]. - The company anticipates continued losses for the foreseeable future, impacting cash requirements significantly[181]. Research and Development - Research and development expenses for the three months ended June 30, 2021, increased by 13% to $13.57 million compared to $12.05 million in the same period of 2020[154]. - The increase in research and development expenses for the six months ended June 30, 2021, was primarily due to a $6.4 million increase in headcount and related costs, offset by a $7.3 million decrease in Controlled IL-12 program costs[155]. - The company is developing T cell receptor (TCR) therapies targeting neoantigens in solid tumors, with a Phase 1/2 clinical trial evaluating TCRs from its library[134]. - The FDA cleared the IND application for the Phase 1/2 clinical trial, with patient dosing anticipated in the second half of 2021[141]. - The Controlled IL-12 platform is designed to conditionally produce IL-12 to treat patients with solid tumors, utilizing a gene delivery system[137]. - The company is winding down its existing Controlled IL-12 clinical program for recurrent glioblastoma multiforme while seeking a partner for this program[152]. - The joint venture with Eden BioCell is focused on advancing CAR T cell therapies in Greater China, with two patients treated in a clinical trial[146]. - The estimated timelines for clinical trials are 1-2 years for Phase 1, 2-3 years for Phase 2, and 2-4 years for Phase 3[162]. Financial Resources and Capital - The company continues to seek additional financial resources to fund product development, with potential delays if sufficient capital is not obtained[139]. - A term loan of $25.0 million was secured on August 6, 2021, with an additional $25.0 million available upon meeting certain milestones[173]. - The company expects existing cash and the $25.0 million gross debt proceeds will fund operations into Q4 2022, with no committed sources of additional capital at this time[176]. - The company may need to curtail development efforts if adequate additional funds are not available when required[177]. Cash Flow and Expenses - Net cash used in operating activities for the six months ended June 30, 2021 was $36.8 million, an increase from $23.9 million for the same period in 2020, primarily due to a net loss of $44.2 million[178]. - Net cash used in investing activities was $2.6 million for the six months ended June 30, 2021, compared to $4.0 million for the same period in 2020[179]. - Net cash provided by financing activities was $1.0 million for the six months ended June 30, 2021, a significant decrease from $101.7 million in the same period of 2020[180]. - General and administrative expenses for the three months ended June 30, 2021 increased by 38% to $9.1 million compared to $6.6 million for the same period in 2020[164]. - General and administrative expenses for the six months ended June 30, 2021 increased by 38% to $17.3 million compared to $12.5 million for the same period in 2020[165]. - Working capital decreased to $75.8 million as of June 30, 2021, down from $112.2 million as of December 31, 2020[181]. - Total contractual obligations amounted to $11.5 million as of June 30, 2021, with $2.9 million due within one year[182]. - The company has commitments for operating leases totaling $7.1 million, with $1.2 million due within one year[182]. Operational Challenges - The ongoing COVID-19 pandemic has impacted business operations, potentially delaying clinical programs and timelines[140]. - Other income (expense), net for the three months ended June 30, 2021 was $(31,000), a decrease of 410% compared to $10,000 for the same period in 2020[166]. - The company is realigning resources towards the Sleeping Beauty program, which is expected to reduce cash expenditures on the Controlled IL-12 program[181]. - The company has no off-balance sheet arrangements as defined by SEC regulations[189].