Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing gene-based treatments for cancer and diabetes. Its oncology programs use the ONCOPREX delivery system to deliver tumor suppressor genes, while its diabetes work centers on adeno-associated virus-based gene therapy licensed from the University of Pittsburgh.

3.84

— Genprex, Inc.
	%
Oncology gene therapy platform	0% Systemic, non-viral gene therapy candidates and delivery technology for cancer.
Diabetes gene therapy platform	0% Licensed gene therapy programs targeting Type 1 and Type 2 diabetes.
Clinical development programs	0% Human trials and related regulatory work for lead oncology candidates.
Preclinical research	0% Animal-model and IND-enabling studies supporting future product candidates.
Licensed technology and know-how	0% Exclusive and non-exclusive rights from the University of Pittsburgh.

Genprex does not currently sell commercial products; its near-term counterparties are research institutions, clinical...

Research collaboratorsprimary
Universities and scientific partners that perform animal-model and translational studies to advance the pipeline.
Clinical trial participants and sitesprimary
Patients and trial centers enrolled in Acclaim-1 and Acclaim-3 to generate efficacy and safety data.
Regulatory authoritiesprimary
FDA and other agencies that must clear IND-enabling work and approve clinical advancement.
Manufacturing and development vendorssecondary
Specialized third parties that support process scale-up, formulation, and clinical supply.
Future commercial patientsemerging
Cancer and diabetes patients who would be treated if the company reaches approval and launch.

Genprex is headquartered in the United States and its development work is centered there, including clinical...

•United States is the core operating base and clinical-development center
•FDA interactions are central because U.S. approval is the main near-term gate
•Europe is a stated regulatory target for future product approval
•Worldwide license rights expand the potential commercial footprint
•No country revenue disclosed because the company has not generated product sales

Genprex is prioritizing advancement of its lead oncology trials while continuing preclinical and IND-enabling work for...

Complete enrollment and advance lead oncology trialsshort-term

Clinical data are the main value driver and are needed for regulatory and partnering optionality.

Advance diabetes program toward IND-enabling workmedium-term

The diabetes platform broadens the pipeline and could create a second development path.

Preserve liquidity through cost reduction and financingshort-term

The company has no product revenue and depends on external capital to fund R&D.

Optimize manufacturing and development executionmedium-term

Gene therapy programs require reliable, scalable manufacturing to support trials and future launch.

Genprex is a pre-revenue biotech company with substantial clinical, regulatory, and financing risk...

critical

Going-concern and financing risk

The company has recurring losses and no product sales, so it must raise capital to continue operations.

Scope: Equity offerings, ATM, ELOC, debt, and collaborations
Materiality: high

high

Clinical trial failure

Lead programs are still in development and may not demonstrate sufficient efficacy or safety.

Scope: Acclaim-1, Acclaim-3, diabetes preclinical work
Materiality: high

high

Regulatory approval risk

FDA and other regulators may require additional studies or reject applications.

Scope: IND-enabling studies, U.S. and Europe approvals
Materiality: high

high

Nasdaq delisting risk

Failure to meet continued listing standards could impair liquidity and financing access.

Scope: Minimum bid price and stockholders' equity requirements
Materiality: medium

medium

Manufacturing and scale-up risk

Gene therapy production is complex and vendor transitions can affect quality and timing.

Scope: New manufacturing vendors and process adaptation
Materiality: medium

Research and development costs

Clinical, preclinical, and manufacturing costs flow through earnings immediately

Going-concern assessment

Material disclosure affecting investor assessment of solvency

Equity financing and dilution

Common stock outstanding and capital structure

Accruals and vendor-related estimates

Expense timing and liabilities

Genprex, Inc.

Going-concern and financing risk

Clinical trial failure

Regulatory approval risk

Nasdaq delisting risk

Manufacturing and scale-up risk

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