Genprex, Inc. 8-K

What Happened
On January 7, 2026 Genprex, Inc. (GNPX) filed an 8‑K announcing progress on its diabetes gene therapy candidate GPX‑002. The company reported expansion of preclinical work into Type 2 diabetes (T2D) with in‑vivo proof‑of‑concept, transfer of GPX‑002 manufacturing from academic collaborators to an experienced CDMO network, and that it submitted a request to the FDA for a meeting about IND‑enabling studies (meeting scheduled for Q1 2026). Genprex also furnished an investor presentation (Exhibit 99.1) that will be posted on its website.

Key Details

• Filing date: January 7, 2026; FDA meeting request submitted by end of 2025, meeting planned for Q1 2026.
• Preclinical: GPX‑002 showed proof‑of‑concept in T2D animal studies (rejuvenated exhausted beta cells and normalized glucose) and prior T1D data in mice and non‑human primates (decreased insulin requirements, increased c‑peptide, improved glucose tolerance).
• Manufacturing: Process transferred to integrated CDMO/vendor network; plan to begin clinical‑scale production in a cGMP facility to support IND‑enabling work.
• Next steps: Company is optimizing constructs (including a second‑generation lipid nanoparticle non‑viral approach) and will finalize and initiate toxicology studies after FDA interaction, with toxicology data expected to support an IND filing.

Why It Matters
These are preparatory but material development steps: regulatory engagement with the FDA, manufacturing scale‑up in cGMP facilities, completion of tox studies and positive preclinical data are typical prerequisites to filing an IND and starting human trials. For investors, the update signals progress toward clinical development of GPX‑002 but remains preclinical and subject to regulatory, development, manufacturing and financial risks. The 8‑K includes standard forward‑looking statement cautions and refers investors to the company’s SEC filings (including risk factors) for more detail.