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Genprex Inc. (GNPX-0.75%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's focus on developing gene-based therapies for cancer and diabetes. Genprex's lead oncology drug candidate, REQORSA, is being developed for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The company is also advancing its diabetes gene therapy, GPX-002, for Type 1 and Type 2 diabetes.
The company reported a net loss of approximately $21.1 million for the year ended December 31, 2024, compared to a net loss of approximately $31.0 million in the previous year. Genprex highlighted that its cash and cash equivalents as of December 31, 2024, were approximately $1.6 million.
Genprex continues to rely on third-party contract development and manufacturing organizations (CDMOs) for the production of its product candidates. The company has transferred its manufacturing processes from MD Anderson to CDMOs and scaled up clinical production for its Acclaim-1 and Acclaim-3 clinical trials.
The filing outlines Genprex's ongoing clinical trials, including the Acclaim-1 trial for NSCLC patients progressing on Tagrisso treatment and the Acclaim-3 trial for SCLC patients receiving Tecentriq as maintenance therapy. The Acclaim-2 trial, which involved a combination of REQORSA and Keytruda, has been closed due to slow enrollment.
Genprex has received three Fast Track Designations from the FDA for its REQORSA drug candidate, which is intended to expedite the development and review of products that address unmet medical needs.
The company has entered into a new exclusive license agreement with the University of Pittsburgh for its diabetes gene therapy technology and formed a wholly-owned subsidiary, Convergen Biotech, Inc., to focus on developing and commercializing GPX-002.
Genprex acknowledges the need for substantial additional funding to complete the development and commercialization of its product candidates. The company has raised capital through various offerings and an at-the-market (ATM) offering program.
The filing also addresses the company's intellectual property strategy, including its exclusive licenses from MD Anderson and the University of Pittsburgh, and ongoing efforts to protect its proprietary technologies.
Genprex highlights the competitive landscape in the biotechnology and pharmaceutical industries, noting the presence of larger companies with greater resources. The company emphasizes its reliance on collaborations and partnerships to advance its product candidates.
The report concludes with a discussion of the risks associated with the company's operations, including regulatory challenges, competition, and the need for additional capital to sustain its development programs.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Genprex Inc. annual 10-K report dated April 1, 2025. To report an error, please email earnings@qz.com.