Alaunos Therapeutics(US:TCRT)2020-11-05 21:02Financial Performance - For the nine months ended September 30, 2020, the company reported a net loss of $57.2 million, with an accumulated deficit of approximately $741.3 million since inception in 2003[149]. - Net cash used in operating activities for the nine months ended September 30, 2020 was $40.0 million, compared to $29.2 million for the same period in 2019[183]. - The company anticipates that losses will continue for the foreseeable future, impacting cash requirements significantly[180]. - As of September 30, 2020, the accumulated deficit as of September 30, 2020 was approximately $741.3 million[186]. - Working capital as of September 30, 2020 was $135.8 million, an increase from $93.0 million as of December 31, 2019[186]. Research and Development - Research and development expenses for the three months ended September 30, 2020, increased by 62% to $13.968 million compared to $8.641 million in the same period of 2019[162]. - For the nine months ended September 30, 2020, research and development expenses rose by 38% to $38.725 million from $28.115 million in the prior year[163]. - The increase in research and development expenses for the three months ended September 30, 2020, was primarily due to $3.9 million in increased gene therapy manufacturing costs and $2.0 million related to increased headcount and facilities costs[162]. - The Controlled IL-12 platform is currently being evaluated in a Phase 1/2 clinical trial for the treatment of diffuse intrinsic pontine glioma (DIPG), with plans to dose up to 12 patients[147]. - The company is collaborating with the National Cancer Institute (NCI) on a Phase 2 clinical trial for autologous TCR-T therapies targeting neoantigens in solid tumors[155]. - Eden BioCell is preparing for a clinical trial of Sleeping Beauty-generated CD19-specific CAR+ T therapies in Taiwan, with preliminary observations supporting the benefit of the RPM technology[156]. - The company expects to initiate a clinical trial with MD Anderson for its Library TCR-T approach in mid-2021, targeting several cancer types[154]. Administrative Expenses - General and administrative expenses for the three months ended September 30, 2020 increased by 32% to $6.4 million compared to $4.8 million in the same period of 2019[172]. - General and administrative expenses for the nine months ended September 30, 2020 increased by 38% to $18.9 million compared to $13.7 million in the same period of 2019[173]. Financing Activities - The company completed a public offering of 29,110,111 shares at a price of $3.25, resulting in net proceeds of $88.7 million after expenses[178]. - Net cash provided by financing activities for the nine months ended September 30, 2020 was $101.7 million, compared to $56.1 million for the same period in 2019[185]. - The company continues to seek additional financial resources to fund product development, with potential delays in programs if sufficient capital is not obtained[152]. Operational Challenges - The company has implemented work-from-home policies due to the COVID-19 pandemic, which may negatively impact productivity and clinical program timelines[153]. - Management identified a material weakness in internal control over financial reporting as of September 30, 2020, affecting the accuracy of third-party clinical trial costs[203]. - The company has implemented measures to remediate the identified control deficiency, including training for accounting personnel[205]. Contractual Obligations - As of September 30, 2020, total contractual obligations amount to $9,743,000, with $4,062,000 due in less than one year[187]. - Operating leases total $3,157,000, with $1,128,000 due in less than one year[187]. - CRADA obligations total $3,125,000, with $2,500,000 due in less than one year[187]. - Royalty and license fees total $3,461,000, with $434,000 due in less than one year[187]. - The company is obligated to pay an annual licensing fee of $0.1 million under the License Agreement with PGEN[191]. - Minimum annual royalties of $0.3 million are required under the Patent License with the NCI, reducing to $0.1 million after cumulative payments of $1.5 million[192]. Currency and Risk Management - There were no off-balance sheet arrangements during the periods presented[194]. - The company has no clinical studies outside of the United States, minimizing currency exchange rate risk[197].