Genprex(US:GNPX)2024-11-13 14:16Clinical Trials - The company is currently enrolling and treating patients in the Phase 1 dose escalation portion of the Acclaim-3 clinical trial, which combines REQORSA and Tecentriq for extensive stage small cell lung cancer (ES-SCLC) patients [111]. - In the Acclaim-3 trial, the first patient treated experienced a partial remission, defined as at least a 30% decrease in tumor size after two cycles of maintenance therapy [111]. - The FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq in June 2023, and Orphan Drug Designation for REQORSA for SCLC in August 2023 [111]. - The Acclaim-1 trial is currently in the Phase 2a expansion portion, using REQORSA and Tagrisso in late-stage NSCLC patients, with the recommended Phase 2 dose set at 0.12 mg/kg [114]. - The Acclaim-1 trial has shown prolonged progression-free survival in two patients, with one maintaining a partial remission for approximately 30 months [114]. - The Phase 2a expansion portion of the Acclaim-1 study is expected to enroll approximately 33 patients, focusing on those who received only prior Tagrisso treatment [114]. - The company decided to cease enrollment in the Acclaim-2 trial to prioritize resources for the Acclaim-1 and Acclaim-3 trials due to enrollment challenges [112]. - The company plans to conduct clinical trials for its Acclaim-1 and Acclaim-3 programs, with enrollment for the first 19 patients in Acclaim-1 expected in the first half of 2025 [148]. Financial Performance - The company reported a net loss of $4,315,987 for the three months ended September 30, 2024, a decrease of 44% compared to a net loss of $7,748,243 for the same period in 2023 [139]. - For the nine months ended September 30, 2024, the net loss was $16,780,701, representing a decrease of 33% from $24,931,209 in 2023 [140]. - As of September 30, 2024, the company had an accumulated deficit of $150,468,981 and has never generated revenue from product sales [141]. - Net cash used in operating activities decreased to $13,279,658 for the nine months ended September 30, 2024, down 33% from $19,774,740 in 2023 [151]. - The company provided $1,167 in net cash from investing activities for the nine months ended September 30, 2024, compared to a net cash outflow of $61,383 in 2023 [152]. - Net cash provided by financing activities was $8,029,143 for the nine months ended September 30, 2024, a decrease of $2,564,230 from $10,593,373 in 2023 [153]. - The company expects to fund its operations and clinical trials into December 2024 based on current cash levels [149]. Research and Development - The company has entered into a three-year sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes [110]. - The oncology platform utilizes the Oncoprex® Delivery System to deliver tumor suppressor gene-expressing plasmids to cancer cells, administered intravenously [108]. - The company is in early stages of discovery programs to identify other cancer candidates that can be delivered using the ONCOPREX Delivery System [110]. - Research and Development (R&D) expense for Q3 2024 was $2,756,081, a decrease of 40% from $4,616,546 in Q3 2023 [131]. - R&D expense for the nine months ended September 30, 2024 was $7,696,982, down 45% from $13,903,611 in the same period of 2023 [132]. General and Administrative Expenses - General and Administrative (G&A) expense for Q3 2024 was $1,566,085, a decrease of 51% from $3,166,057 in Q3 2023 [133]. - G&A expense for the nine months ended September 30, 2024 was $9,135,225, down 18% from $11,173,643 in the same period of 2023 [134]. Interest and Depreciation - Interest income for Q3 2024 was $8,080, a decrease of $43,311 from $51,391 in Q3 2023 [135]. - Interest income for the nine months ended September 30, 2024 was $58,851, down $116,562 from $175,413 in the same period of 2023 [136]. - Depreciation expense for Q3 2024 was $1,272, a decrease of 66% from $3,724 in Q3 2023 [137]. - Depreciation expense for the nine months ended September 30, 2024 was $6,230, down 46% from $11,578 in the same period of 2023 [138]. Workforce Reduction - The company has reduced its workforce from 31 employees at September 30, 2023, to 19 employees at September 30, 2024, as part of its expense reduction strategies [139]. Future Plans - The company plans to request further regulatory guidance from the FDA in the first half of 2025 regarding nonclinical studies for its diabetes gene therapy product candidates [116]. - The company is considering transferring its diabetes clinical development program and gene therapy assets into a new wholly-owned subsidiary by the end of 2024, subject to financing and approvals [116]. - The company sold 2,318,450 shares of common stock for net proceeds of $2,117,752 during the nine months ended September 30, 2024 [143].