Genprex(US:GNPX)2025-05-12 20:31Clinical Trials - The company is currently enrolling patients in the Phase 2a expansion portion of the Acclaim-1 clinical trial, which combines REQORSA and AstraZeneca's Tagrisso for late-stage NSCLC patients [120]. - The recommended Phase 2 dose (RP2D) of REQORSA in the Acclaim-1 trial is determined to be 0.12 mg/kg, which is twice the highest dose level delivered in previous trials [120]. - The Phase 2a expansion portion of the Acclaim-1 trial is expected to enroll approximately 33 patients who have progressed on Tagrisso or Tagrisso-containing regimens [120]. - The FDA has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients [121]. - The Acclaim-3 clinical trial is currently enrolling patients using a combination of REQORSA and Genentech's Tecentriq for extensive stage small cell lung cancer (ES-SCLC) [124]. - The RP2D of REQORSA in the Acclaim-3 trial is also set at 0.12 mg/kg, based on safety data showing no dose limiting toxicities [124]. - The Acclaim-3 trial aims to enroll approximately 50 patients across 10 to 15 U.S. sites, with a primary endpoint of determining the 18-week progression-free survival rate [124]. - The Acclaim-3 clinical trial has received FDA Fast Track Designation and Orphan Drug Designation for the patient population [125]. - The company expects interim enrollment of the Phase 2a expansion portion of the Acclaim-1 trial to be completed by the end of 2025 [153]. Financial Performance - Research and development (R&D) expense for Q1 2025 was $2,539,993, a decrease of 22% from $3,274,380 in Q1 2024, primarily due to the closure of the Acclaim-2 clinical trial and a reduction in R&D staff from 15 to 9 employees [143]. - General and administrative (G&A) expense for Q1 2025 was $1,429,299, down 47% from $2,719,667 in Q1 2024, attributed to expense reduction strategies and a decrease in G&A staff from 11 to 6 employees [144]. - Net loss for Q1 2025 was $3,964,601, a reduction of 34% compared to $5,968,869 in Q1 2024, mainly due to decreased clinical and manufacturing expenses and overall staff reduction from 26 to 15 employees [147]. - As of March 31, 2025, the company had an accumulated deficit of $158,764,044, having never generated revenue from product sales since inception [148]. - In 2024, the company sold 5,366,503 shares of common stock for net proceeds of $6.3 million and completed a registered direct offering for approximately $5.8 million [149]. - During the three months ended March 31, 2025, the company sold 13,278,666 shares of common stock for gross proceeds of approximately $6.2 million, resulting in net proceeds of $6,028,103 after offering expenses [150]. - Net cash used in operating activities decreased by $1,136,466, or 21%, from $5,297,891 in Q1 2024 to $4,161,425 in Q1 2025, primarily due to the closure of the Acclaim-2 clinical trial and expense reduction strategies [156]. - Net cash provided by financing activities was $6,028,103 for the three months ended March 31, 2025, a decrease of $765,096 compared to $6,793,199 in Q1 2024 [158]. - The company had no net cash provided by or used in investing activities for the three months ended March 31, 2025, compared to a net cash outflow of $15,822 in Q1 2024 [157]. Strategic Focus - The company has entered into a sponsored research agreement with MD Anderson to support further preclinical studies of TUSC2 and other tumor suppressor genes [119]. - The company is focusing on optimizing and re-focusing its diabetes and oncology clinical development programs to enhance the likelihood of success [116]. - The company is currently developing GPX-002 for both Type 1 and Type 2 diabetes, with preclinical studies ongoing at the University of Pittsburgh [126]. - The company plans to seek further regulatory guidance from the FDA on IND-enabling studies in the second half of 2025 [126]. - A new sponsored research agreement with the University of Pittsburgh was established in May 2025 to study Type 1 and Type 2 diabetes in animal models [126]. - The company is exploring a non-viral lipid nanoparticle delivery system for multiple treatments [126]. - The company has implemented strategies to optimize clinical and research programs and is considering various strategic alternatives to enhance stockholder value [138]. - The company anticipates needing to raise additional capital to fund future operations, including ongoing clinical trials, as it does not expect to generate revenue from product sales in the near term [153]. - The company estimates it can fund its current operations and planned clinical trial activities through the end of the second quarter of 2025 [154]. - The company may seek additional capital through strategic collaborations or transactions, but there is uncertainty regarding its ability to maintain liquidity over the next 12 months [153]. - The company has utilized all available capacity under the current prospectus supplement for the 2023 ATM Facility as of the filing date of the Quarterly Report [153].