Genprex delays 2024 annual report to finish financial statements and audit

The late annual report

Genprex, Inc. told the Securities and Exchange Commission on April 1, 2025 that it could not file its 2024 annual report on Form 10-K by the due date without unreasonable effort or expense. The Form 12b-25 notice is signed by Ryan Confer, who is president, chief executive officer and chief financial officer. The company is based in Austin, Texas.

The company says it worked diligently on the 2024 Form 10-K, including the financial statements and the audit procedures needed to issue them, but that more time was required. It expects to file on or before the fifteenth calendar day after the due date. The notice says all other periodic reports for the preceding 12 months have been filed, and that no significant change in results from the prior year is expected.

The notice gives no figures for revenue, loss or cash.

The lead program

Genprex describes itself as a clinical-stage gene therapy company. Its lead oncology candidate is REQORSA, also called quaratusugene ozeplasmid and previously known as GPX-001. It is given intravenously in lipid nanoparticles and delivers the TUSC2 tumor suppressor gene, licensed from The University of Texas MD Anderson Cancer Center. The company is developing it alongside approved cancer drugs for non-small cell and small cell lung cancer. The company also has a diabetes program aimed at turning pancreatic alpha cells into beta-like cells.

The Acclaim-1 trial combines REQORSA with AstraZeneca's Tagrisso (osimertinib) in late-stage non-small cell lung cancer with EGFR mutations that progressed on Tagrisso or Tagrisso-containing regimens.

The trial record

The Phase 1 dose-escalation portion finished in May 2023. The safety review committee found no dose-limiting toxicities and set a recommended Phase 2 dose of 0.12 mg/kg. The company says that is twice the highest dose used in an earlier trial combining REQORSA with Tarceva.

The company's clinical signal rests on three patients from that Phase 1 portion who had prolonged progression-free survival. One reached a partial remission and has stayed on treatment through 47 courses, about 35 months. A second had stable disease through 32 courses, about 24 months, then progressed and stopped treatment.

The Phase 2a expansion enrolled its first patient in January 2024. In August 2024, Genprex said it would limit enrollment to patients who had received only prior Tagrisso, and stop enrolling the cohort that had received Tagrisso and chemotherapy, to focus resources. In February 2025 it amended the protocol to admit patients progressing on Tagrisso or Tagrisso-containing regimens, noting that both patients with prolonged progression-free survival had received chemotherapy and Tagrisso.

The Phase 2a expansion is now expected to enroll about 33 patients, all of whom have progressed on Tagrisso. A Phase 2b randomized portion, in which patients are assigned 1:1 to REQORSA with Tagrisso or to platinum-based chemotherapy, is unchanged. An interim analysis follows 19 patients in Phase 2a. The company expects to enroll those 19 by the end of 2025 and to report the interim analysis in the first half of 2026.

The FDA has granted Fast Track designation for the Acclaim-1 combination in non-small cell lung cancer.

Critical read

The enrollment rules changed in August 2024 and again in February 2025, and the company's clinical signal comes from three patients. The notice does not say what the additional audit work involves. The interim analysis will rest on 19 patients, a small group.

What comes next

Genprex expects to file the 2024 Form 10-K within the Rule 12b-25 grace period. It expects to finish enrolling the first 19 Phase 2a patients by the end of 2025, with the interim analysis in the first half of 2026, and it plans about 33 patients in the expansion overall.

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