Genprex(US:GNPX)2025-11-14 21:11Clinical 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[145] - 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[145] - Three patients in the Phase 1 portion of the Acclaim-1 trial experienced prolonged progression-free survival (PFS), with one patient maintaining a partial remission for approximately 39 months[145] - The Acclaim-2 trial, which involved REQORSA and Merck's Keytruda, has been closed due to slow enrollment and competition for eligible patients[148] - The Phase 2 expansion portion of the Acclaim-3 trial is expected to enroll approximately 50 patients, with a primary endpoint of determining the 18-week progression-free survival rate[149] - The FDA has granted Fast Track Designation for the Acclaim-1 treatment combination of REQORSA and Tagrisso in NSCLC patients who have progressed on Tagrisso treatment[146] - The Acclaim-3 trial has also received FDA Fast Track Designation and Orphan Drug Designation for the patient population with extensive stage small cell lung cancer[150] - The company is collaborating with MD Anderson to discover and develop biomarkers to select the patient population most likely to respond to REQORSA[144] - The company has experienced delays in clinical trial enrollment due to competition for patients and disruptions caused by the COVID-19 pandemic[194] - The company expects interim enrollment for the Phase 2a expansion of the Acclaim-1 trial and the Phase 2 dose expansion of the Acclaim-3 trial to be completed in the first half of 2026[193] Research and Development - The ONCOPREX Delivery System is designed to deliver tumor suppressor genes to cancer cells, with the potential to combat multiple types of cancer[142] - The company is in early stages of discovery programs to identify other cancer candidates using the ONCOPREX Delivery System[144] - The company has licensed multiple gene therapy technologies for Type 1 and Type 2 diabetes from the University of Pittsburgh, utilizing an adeno-associated virus vector containing the Pdx1 and MafA genes[151] - GPX-002 is being developed for both Type 1 and Type 2 diabetes, with preclinical studies showing decreased insulin requirements and improved glucose tolerance in treated non-human primate models[152] - The company submitted a request to the FDA in December 2023 for guidance on nonclinical studies needed for an Investigational New Drug application, with plans to initiate research in Type 2 diabetes animal models by the end of 2025[151] - The new sponsored research agreement with the University of Pittsburgh includes a revised research plan for Type 1 and Type 2 diabetes, incorporating the latest technologies acquired in 2023[151] - The company is working on regulatory and clinical strategic planning for its diabetes gene therapy products, aiming for IND-enabling studies by the end of 2025[151] Financial Performance - An equity line of credit agreement was established with Lincoln Park Capital Fund, allowing the company to sell up to $12.5 million in common stock over 24 months, with net proceeds of approximately $2.9 million from sales in Q3 2025[153] - A reverse stock split was approved at a ratio of one-for-fifty, effective October 21, 2025, to adjust share prices[155] - The company completed two registered direct offerings in October 2025, raising approximately $2.5 million and $3.1 million in net proceeds, respectively, from the sales of common stock[156][157] - The company has filed a prospectus supplement for up to $11.495 million of common stock under the 2023 ATM Facility, selling 242,537 shares for aggregate net proceeds of $1,006,740 since October 1, 2025[158] - The company has a full valuation allowance on deferred tax assets due to a history of operating losses since inception, with cumulative net operating losses recorded from April 1, 2009, to September 30, 2025[165] - Research and development (R&D) expense for Q3 2025 was $2,192,881, a decrease of $563,200 or 20% compared to Q3 2024[176] - R&D expense for the nine months ended September 30, 2025 was $7,232,370, a decrease of $464,613 or 6% compared to the same period in 2024[177] - General and administrative (G&A) expense for Q3 2025 was $1,153,032, a decrease of $413,053 or 26% compared to Q3 2024[178] - G&A expense for the nine months ended September 30, 2025 was $4,764,617, a decrease of $4,370,608 or 48% compared to the same period in 2024[179] - Net loss for Q3 2025 was $3,799,240, a decrease of $516,747 or 12% compared to Q3 2024[184] - Net loss for the nine months ended September 30, 2025 was $12,438,742, a decrease of $4,341,960 or 26% compared to the same period in 2024[185] - As of September 30, 2025, the accumulated deficit was $167,238,185[187] - The company sold 338,811 shares of common stock for gross proceeds of approximately $7.2 million during the nine months ended September 30, 2025[189] - The company entered into an equity line of credit purchase agreement with Lincoln Park for up to $12.5 million[190] - As of September 30, 2025, the company had $1,103,315 in cash and cash equivalents[192] - The company does not expect to generate revenue from product sales until successful development and regulatory approval of its product candidates, which may take several years[193] - The company anticipates needing to raise additional capital to fund operations, including ongoing clinical trials, with uncertainty regarding its ability to maintain liquidity over the next 12 months[193] - Net cash used in operating activities decreased by $2,840,198, or 20%, from $14,053,136 in 2024 to $11,212,938 in 2025, primarily due to the closure of the Acclaim-2 trial and expense reduction strategies[196] - The company had no net cash provided by investing activities in 2025, compared to $774,645 in 2024, due to timing associated with patent prosecution costs[197] - Net cash provided by financing activities increased by $2,685,450, from $8,029,143 in 2024 to $10,714,593 in 2025, due to higher amounts raised from capital raising activities[198] - The overall headcount of the company reduced from nineteen employees in 2024 to thirteen employees in 2025, contributing to decreased operating expenses[196] - There is substantial doubt regarding the company's ability to continue as a going concern due to recurring losses and the need for additional financing[193]