Genprex(GNPX)
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Congressman Who Bought Small-Cap Stocks In 2025 Is Back With New 2026 Pick: Here's What He's Buying
Benzinga· 2026-02-25 23:20
The trading activity of members of Congress is closely monitored and investors are looking to see which Magnificent Seven stocks are most loved and which large-cap names are being bought and sold. When it comes to a member of Congress buying up shares of small-cap stocks, investors may pay even closer attention. • Genprex stock is among today’s weakest performers. What’s behind GNPX decline?Congressman Buys Small-Cap Stocks AgainCongressman Tim Moore (R-N.C.) made multiple trades in 2025, including buying s ...
Genprex Strengthens Intellectual Property Portfolio with Japanese and EU Patents for Reqorsa® Gene Therapy in Combination with Immunotherapies to Treat Cancer
Prnewswire· 2026-02-23 13:00
Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should re ...
Genprex Announces IP Australia's Intent to Grant Patent for Reqorsa® Gene Therapy in Combination with PD-L1 Antibodies to Treat Cancers
Prnewswire· 2026-02-10 13:00
Core Viewpoint - Genprex has received a Notice of Acceptance from IP Australia for a patent application related to Reqorsa® Gene Therapy in combination with PD-L1 antibodies for cancer treatment, which will enhance its intellectual property portfolio and protect its therapeutic combination currently in the Acclaim-3 clinical trial [1]. Patent Development - The patent application claims the use of Reqorsa® Gene Therapy with PD-L1 antibodies, which has already been granted in other countries [1]. - A granted patent will provide exclusivity in Australia, preventing competitors from manufacturing, using, or selling the drug combination [1]. - Genprex is pursuing additional patent applications in key international markets, including Europe, Canada, Brazil, China, and Israel, to safeguard its innovations [1]. Clinical Trial Updates - Genprex has opened an additional clinical trial site for the Acclaim-3 trial at the University of Kentucky to expand patient reach and expedite enrollment [1]. - The Acclaim-3 trial is a Phase 1/2 study evaluating the combination of REQORSA and Genentech's Tecentriq® in patients with extensive stage small cell lung cancer (ES-SCLC) [1]. - The Phase 2 expansion study aims to enroll approximately 50 patients, with the primary endpoint being the 18-week progression-free survival rate [1]. Company Overview - Genprex is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes, utilizing innovative technologies to deliver disease-fighting genes [1]. - The company's lead product candidate, Reqorsa® Gene Therapy, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [1]. - Genprex's diabetes gene therapy approach aims to rejuvenate and replenish exhausted beta cells, with ongoing developments in both Type 1 and Type 2 diabetes treatments [2].
Genprex(GNPX) - Prospectus(update)
2025-11-26 21:31
Table of Contents As filed with the Securities and Exchange Commission on November 26, 2025 Registration No. 333-291722 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GENPREX, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 90-0772347 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identifi ...
Data from Genprex's Acclaim-1 Phase 1 Gene Therapy Clinical Trial Published in Clinical Lung Cancer
Prnewswire· 2025-11-24 12:00
Core Viewpoint - Genprex, Inc. announced the publication of data from its Acclaim-1 Phase 1 clinical trial of Reqorsa Gene Therapy in combination with Tagrisso for advanced non-small cell lung cancer, highlighting promising safety and early efficacy results [1][2][3]. Group 1: Clinical Trial Details - The Acclaim-1 trial is an open-label, multi-center Phase 1/2 study evaluating Reqorsa in combination with osimertinib in patients with late-stage NSCLC who have progressed after osimertinib treatment [2][3]. - The trial's dose escalation portion primarily assessed safety, establishing a Recommended Phase 2 Dose (RP2D) of 0.12 mg/kg with no Dose Limiting Toxicities (DLTs) reported [3][8]. Group 2: Patient Outcomes - Among the 12 patients treated, three experienced prolonged time to progression, including one with a continuing partial response after 47 cycles over 32 months [4][5]. - Specific patient outcomes included one patient achieving partial remission after extensive prior treatments and continuing treatment for over three years [5][6]. Group 3: Safety Profile - Reqorsa administration was generally well tolerated, with no DLTs and manageable infusion-related reactions similar to those seen with antibody treatments [8][10]. - Symptoms from infusion-related reactions were effectively managed with prophylactic medications [8]. Group 4: Company Overview - Genprex, Inc. focuses on developing gene therapies for cancer and diabetes, utilizing a non-viral Oncoprex Delivery System to administer disease-fighting genes [9][10]. - The company's lead product, Reqorsa, is under evaluation for NSCLC and small cell lung cancer (SCLC), with both programs receiving Fast Track Designation from the FDA [10].
Genprex(GNPX) - Prospectus
2025-11-21 21:56
Table of Contents As filed with the Securities and Exchange Commission on November 21, 2025 Registration No. 333- (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 90-0772347 (I.R.S. Employer Identification Number) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GENPREX, INC. (Exact name of registrant as specified in its charter) Copies ...
Genprex Adds Clinical Trial Site for Acclaim-1 and Acclaim-3 Lung Cancer Clinical Trials
Prnewswire· 2025-11-19 12:00
Core Insights - Genprex, Inc. has added Gabrail Cancer Center in Canton, Ohio, as a new clinical trial site for its Acclaim-1 and Acclaim-3 clinical trials studying Reqorsa® Gene Therapy for lung cancer [1][2] - The company aims to expand its reach and expedite patient enrollment in these trials, which have received FDA Fast Track Designation [1][4] Acclaim-1 Clinical Trial - Acclaim-1 is a Phase 1/2 clinical trial evaluating the combination of Reqorsa and AstraZeneca's Tagrisso® for late-stage non-small cell lung cancer (NSCLC) patients with activating EGFR mutations [2][4] - The Phase 1 portion showed that Reqorsa was well tolerated with no dose-limiting toxicities, and early signs of efficacy were observed [3][4] - The trial plans to enroll approximately 33 patients, with an interim analysis expected after treating 19 patients, anticipated to be completed in the first half of 2026 [4] Acclaim-3 Clinical Trial - Acclaim-3 is a Phase 1/2 clinical trial evaluating the combination of Reqorsa and Genentech's Tecentriq® as maintenance therapy for extensive stage small cell lung cancer (ES-SCLC) [5][7] - The Phase 2 expansion is expected to enroll around 50 patients, with the primary endpoint being the 18-week progression-free survival rate [7] - An interim analysis will be conducted after the 25th patient reaches 18 weeks of follow-up, with completion of enrollment for this analysis also expected in the first half of 2026 [7] Company Overview - Genprex, Inc. is focused on developing gene therapies for cancer and diabetes, utilizing its Oncoprex® Delivery System to administer disease-fighting genes [8][9] - The company's lead product candidate, Reqorsa, is being evaluated in two clinical trials for NSCLC and SCLC, both of which have received FDA Fast Track Designation [9]
Morning Market Movers: OLMA, LFMD, ATGL, INLX See Big Swings
RTTNews· 2025-11-18 13:20
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Olema Pharmaceuticals, Inc. (OLMA) has seen a substantial increase of 213%, trading at $26.68 - Diginex Limited (DGNX) is up 12%, currently priced at $15.25 - Gorilla Technology Group Inc. (GRRR) has risen by 11%, trading at $14.05 - Amer Sports, Inc. (AS) is up 9%, priced at $33.47 - Click Holdings Limited (CLIK) has increased by 9%, trading at $7.38 - Beamr Imaging Ltd. (BMR) is up 9%, currently at $2.14 - James Hardie Industries plc (JHX) has risen by 8%, trading at $18.22 - Arvinas, Inc. (ARVN) is up 8%, priced at $12.00 - Axalta Coating Systems Ltd. (AXTA) has increased by 7%, trading at $30.28 - Genprex, Inc. (GNPX) is up 6%, currently at $4.31 [3] Premarket Losers - LifeMD, Inc. (LFMD) has decreased by 22%, trading at $3.65 - Alpha Technology Group Limited (ATGL) is down 21%, currently priced at $17.00 - Intellinetics, Inc. (INLX) has fallen by 19%, trading at $7.25 - Energizer Holdings, Inc. (ENR) is down 16%, priced at $20.00 - Invivyd, Inc. (IVVD) has decreased by 14%, currently at $2.42 - BellRing Brands, Inc. (BRBR) is down 12%, trading at $22.30 - Sadot Group Inc. (SDOT) has fallen by 9%, currently priced at $3.99 - CEVA, Inc. (CEVA) is down 8%, trading at $21.60 - Helmerich & Payne, Inc. (HP) has decreased by 7%, currently at $25.44 - Opendoor Technologies Inc. (OPEN) is down 5%, trading at $7.39 [4]
Genprex(GNPX) - 2025 Q3 - Quarterly Report
2025-11-14 21:11
Clinical 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]
Genprex Announces Registered Direct Offering of up to $10.0 Million Priced At-The-Market Under Nasdaq Rules
Prnewswire· 2025-10-28 15:19
Core Points - Genprex, Inc. has announced a registered direct offering of 377,780 shares of common stock at a price of $9.00 per share, with potential additional gross proceeds of up to $6.6 million from short-term warrants [1][2] - The offering is expected to close around October 29, 2025, subject to customary closing conditions [1] - H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering [2] Financial Details - The gross proceeds from the offering are anticipated to be approximately $3.4 million before deducting fees and expenses [2] - The short-term warrants will allow the purchase of up to 755,560 shares at an exercise price of $8.75 per share, which will be immediately exercisable [1][2] Regulatory Information - The shares are being offered under a "shelf" registration statement that was declared effective by the SEC on June 9, 2023 [3] - The unregistered warrants and underlying shares are being offered in a private placement and have not been registered under the Securities Act [4] Company Overview - Genprex, Inc. is a clinical-stage gene therapy company focused on developing therapies for cancer and diabetes [6] - The company's lead product candidate, Reqorsa® Gene Therapy, is being evaluated in clinical trials for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [7] - Genprex's diabetes gene therapy approach aims to transform pancreatic alpha cells into functional beta-like cells to produce insulin [7]