Genprex Narrows Q3 Loss, Boosts Cash from Offerings Amid Clinical Progress

TL;DR

**Genprex is burning cash but making clinical progress, so watch for those interim trial results in 2026 before betting big.**

AI Summary

Genprex, Inc. (GNPX) reported a net loss of $3,799,240 for the three months ended September 30, 2025, a 11.97% improvement from the $4,315,987 net loss in the same period of 2024. For the nine months ended September 30, 2025, the net loss was $12,438,742, a significant 25.89% reduction from $16,780,702 in 2024. Total operating expenses decreased to $3,345,913 for the three months, down from $4,323,438, and to $11,996,987 for the nine months, down from $16,838,438, primarily due to reduced general and administrative expenses. Cash and cash equivalents declined to $1,103,315 as of September 30, 2025, from $1,601,660 at December 31, 2024. The company raised $10,714,593 in net proceeds from equity issuances during the nine months ended September 30, 2025, compared to $8,029,143 in the prior year. Genprex is advancing its REQORSA gene therapy in Phase 2a of the Acclaim-1 trial for NSCLC and Phase 2 of the Acclaim-3 trial for ES-SCLC, with interim analyses expected in the second half of 2026 for both. The Acclaim-2 trial for NSCLC was ceased due to enrollment challenges. The company also has a diabetes gene therapy candidate, GPX-002, in preclinical studies.

Why It Matters

Genprex's ability to reduce its net loss and secure additional financing through equity issuances is critical for its continued operations, especially as it progresses two key oncology clinical trials, Acclaim-1 and Acclaim-3, into Phase 2 expansion. The cessation of the Acclaim-2 trial highlights the intense competitive landscape and patient recruitment challenges in oncology, which could impact future development timelines and investor confidence. For investors, the ongoing cash burn and reliance on equity financing signal dilution risk, while the potential for REQORSA in NSCLC and ES-SCLC, particularly with Fast Track and Orphan Drug Designations, offers long-term upside if clinical milestones are met. Employees and customers are directly impacted by the strategic prioritization of clinical programs, focusing resources on the most promising candidates.

Risk Assessment

Risk Level: high — Genprex reported an accumulated deficit of $167,238,185 as of September 30, 2025, and a net loss of $12,438,742 for the nine months ended September 30, 2025. The company's cash and cash equivalents decreased to $1,103,315, indicating a significant cash burn rate relative to its current holdings, despite raising $10,714,593 from equity issuances. This financial position, coupled with the inherent risks of clinical-stage drug development, including the cessation of the Acclaim-2 trial due to enrollment challenges, points to a high-risk profile.

Analyst Insight

Investors should closely monitor the interim analysis results for the Acclaim-1 and Acclaim-3 trials, expected in the second half of 2026, as these will be critical catalysts. Given the high cash burn and reliance on equity financing, new investors should exercise extreme caution and consider the potential for further dilution. Existing investors should evaluate their risk tolerance and the company's ability to secure additional funding without excessive dilution.

Financial Highlights

debt To Equity

3.64

revenue

$0

operating Margin

N/A

total Assets

$3,562,513

total Debt

$2,794,706

net Income

-$12,438,742

eps

-$23.00

gross Margin

N/A

cash Position

$1,103,315

revenue Growth

N/A

Key Numbers

• $12,438,742 — Net Loss (for the nine months ended September 30, 2025, a 25.89% reduction from the prior year)
• $1,103,315 — Cash and Cash Equivalents (as of September 30, 2025, a decrease from $1,601,660 at December 31, 2024)
• $10,714,593 — Net Proceeds from Equity Issuances (for the nine months ended September 30, 2025, an increase from $8,029,143 in 2024)
• $167,238,185 — Accumulated Deficit (as of September 30, 2025, indicating significant historical losses)
• 2,270,346 — Common Stock Shares Outstanding (as of November 13, 2025, reflecting recent equity issuances)
• 0.12 mg/kg — Recommended Phase 2 Dose (RP2D) of REQORSA (determined for both Acclaim-1 and Acclaim-3 trials)
• 39 months — Prolonged Progression-Free Survival (achieved by one patient in Acclaim-1 Phase 1 trial)

Key Players & Entities

• Genprex, Inc. (company) — clinical stage gene therapy company
• REQORSA gene therapy (product) — lead oncology drug candidate
• The University of Texas MD Anderson Cancer Center (company) — exclusive worldwide licenses for TUSC2 gene
• AstraZeneca (company) — developer of Tagrisso (osimertinib)
• Tagrisso (osimertinib) (product) — approved cancer drug combined with REQORSA in Acclaim-1
• FDA (regulator) — granted Fast Track Designation for Acclaim-1 and Acclaim-3, and Orphan Drug Designation for Acclaim-3
• Merck & Co. (company) — developer of Keytruda (pembrolizumab)
• Keytruda (pembrolizumab) (product) — cancer drug combined with REQORSA in Acclaim-2 (trial ceased)
• Genentech, Inc. (company) — developer of Tecentriq (atezolizumab)
• Tecentriq (atezolizumab) (product) — maintenance therapy combined with REQORSA in Acclaim-3

FAQ

Risk Factors

• Substantial Accumulated Deficit and Need for Future Financing [high — financial]: As of September 30, 2025, Genprex has an accumulated deficit of $167,238,185. The company has consistently incurred net losses, reporting a net loss of $12,438,742 for the nine months ended September 30, 2025. This significant deficit indicates a history of unprofitability and highlights the company's ongoing reliance on external financing to fund its operations and development activities.
• Declining Cash Position [high — financial]: Cash and cash equivalents decreased to $1,103,315 as of September 30, 2025, from $1,601,660 at December 31, 2024. While the company raised $10,714,593 in net proceeds from equity issuances in the first nine months of 2025, the continued burn rate suggests that cash reserves may be insufficient to sustain operations for an extended period without further capital infusions.
• Clinical Trial Risks and Uncertainties [high — regulatory]: Genprex's gene therapy candidates, REQORSA and GPX-002, are in various stages of clinical development. The Acclaim-2 trial for NSCLC was ceased due to enrollment challenges, demonstrating the inherent difficulties in advancing drug candidates through clinical trials. Future success depends on positive outcomes from ongoing Phase 2a and Phase 2 trials, with interim analyses not expected until the second half of 2026.
• Dependence on Key Personnel and Third-Party Manufacturers [medium — operational]: The success of Genprex's gene therapy programs is heavily dependent on its scientific team and its ability to manage complex manufacturing processes, often involving third-party contract manufacturing organizations (CMOs). Any disruption in these relationships or loss of key personnel could significantly impede development and commercialization efforts.
• Competition in Oncology and Diabetes Markets [medium — market]: Genprex operates in highly competitive therapeutic areas, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and diabetes. The company faces competition from established pharmaceutical companies and emerging biotechs with potentially more advanced pipelines or greater financial resources, which could impact market penetration and pricing power.
• Derivative Liabilities [low — financial]: The company reported derivative liabilities of $243,000 as of September 30, 2025, which were not present at December 31, 2024. These liabilities can arise from financial instruments and may introduce volatility in earnings due to fluctuations in their fair value.

Industry Context

Genprex operates in the highly competitive and rapidly evolving biotechnology sector, focusing on gene therapies for oncology and diabetes. The oncology market, particularly for lung cancer treatments, is crowded with both established pharmaceutical giants and numerous smaller biotechs vying for market share. Advancements in personalized medicine and immunotherapy are key trends, requiring continuous innovation and significant R&D investment.

Regulatory Implications

The development and approval of gene therapies are subject to stringent regulatory oversight by bodies like the FDA. Genprex faces significant regulatory hurdles, including the need to demonstrate safety and efficacy through rigorous clinical trials. The cessation of the Acclaim-2 trial due to enrollment challenges underscores the inherent risks and complexities of navigating the regulatory pathway for novel therapeutics.

What Investors Should Do

1. Monitor clinical trial progress and interim analysis results.
2. Assess cash runway and future financing needs.
3. Evaluate competitive landscape and market positioning.

Key Dates

• 2025-09-30: End of Q3 2025 — Reported net loss of $3,799,240 for the quarter and $12,438,742 for the nine months. Cash and cash equivalents stood at $1,103,315.
• 2025-12-31: End of Fiscal Year 2024 — Cash and cash equivalents were $1,601,660. Accumulated deficit was $154,799,443.
• 2026-H2: Expected Interim Analyses — Interim analyses for the Acclaim-1 (NSCLC) and Acclaim-3 (ES-SCLC) trials are anticipated, which could provide crucial data on REQORSA's efficacy.

Glossary

Accumulated deficit

The total net losses of a company since its inception that have not been offset by net income. (Indicates Genprex's historical unprofitability, with a deficit of $167,238,185 as of September 30, 2025.)

Net loss per share

The portion of a company's profit or loss allocated to each outstanding share of common stock. (For the nine months ended September 30, 2025, Genprex reported a net loss per share of $23.00, a significant improvement from $344.92 in the prior year.)

Derivative liabilities

Obligations arising from financial contracts whose value is derived from an underlying asset, index, or rate. (Genprex reported $243,000 in derivative liabilities as of September 30, 2025, indicating potential financial instruments impacting its balance sheet.)

Gene therapy

A medical approach that uses genes to treat or prevent disease. (Genprex's core business revolves around developing gene therapies like REQORSA for cancer and GPX-002 for diabetes.)

NSCLC

Non-small cell lung cancer, the most common type of lung cancer. (Genprex is pursuing REQORSA for NSCLC in its Acclaim-1 trial.)

ES-SCLC

Extensive-stage small cell lung cancer, a more advanced form of SCLC. (Genprex is pursuing REQORSA for ES-SCLC in its Acclaim-3 trial.)

Year-Over-Year Comparison

Compared to the prior year's nine-month period, Genprex has significantly reduced its net loss by 25.89% to $12,438,742, driven by a substantial decrease in operating expenses, particularly general and administrative costs. While cash reserves have decreased from $1,601,660 to $1,103,315, the company has successfully raised more capital through equity issuances, increasing net proceeds to $10,714,593 from $8,029,143. The accumulated deficit has grown, reflecting ongoing investment in R&D, and new derivative liabilities have appeared on the balance sheet.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share GNPX The Nasdaq Capital M

Filing Documents

• gnpx20250930_10q.htm (10-Q) — 1125KB
• ex_857061.htm (EX-31.1) — 16KB
• ex_857062.htm (EX-31.2) — 14KB
• ex_857063.htm (EX-32.1) — 8KB
• 0001437749-25-035191.txt ( ) — 5780KB
• gnpx-20250930.xsd (EX-101.SCH) — 46KB
• gnpx-20250930_cal.xml (EX-101.CAL) — 19KB
• gnpx-20250930_def.xml (EX-101.DEF) — 334KB
• gnpx-20250930_lab.xml (EX-101.LAB) — 312KB
• gnpx-20250930_pre.xml (EX-101.PRE) — 354KB
• gnpx20250930_10q_htm.xml (XML) — 891KB

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 3 Condensed Consolidated Balance Sheets as of September 30, 2025 (unaudited) and December 31, 2024 3 Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2025, and 2024 (unaudited) 4 Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2025, and 2024 (unaudited) 5 Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025, and 2024 (unaudited) 6 Notes to Unaudited Condensed Consolidated Financial Statements 7 ITEM 2.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 21 ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 29 ITEM 4.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 29 PART II OTHER INFORMATION 30 ITEM 1.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 30 ITEM 1A.

RISK FACTORS

RISK FACTORS 30 ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 31 ITEM 3. DEFAULTS UPON SENIOR SECURITIES 31 ITEM 4. MINE SAFETY DISCLOSURES 31 ITEM 5. OTHER INFORMATION 31 ITEM 6. EXHIBITS 31

SIGNATURES

SIGNATURES 33 2 Table of Contents

- FINANCIAL INFORMATION

PART I - FINANCIAL INFORMATION

Financial Statements

Item 1. Financial Statements Genprex, Inc. Condensed Consolidated Balance Sheets September 30, December 31, 2025 2024 Assets (unaudited) (see Note 2) Current assets: Cash and cash equivalents $ 1,103,315 $ 1,601,660 Prepaid expenses and other 611,786 475,807 Total current assets 1,715,101 2,077,467 Other non-current assets: Research and development supplies 1,847,412 2,046,858 Total other assets 1,847,412 2,046,858 Total assets $ 3,562,513 $ 4,124,325 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 1,619,446 $ 1,074,295 Other current liabilities 932,260 1,429,875 Total current liabilities 2,551,706 2,504,170 Non-current liabilities: Derivative liabilities 243,000 — Total liabilities 2,794,706 2,504,170 Commitments and contingencies (Note 7) Stockholders' equity: Preferred stock $ 0.001 par value: 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively — — Common stock $ 0.001 par value: 200,000,000 shares authorized; 1,004,247 and 217,234 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 1,004 217 Additional paid-in capital 168,004,988 156,419,381 Accumulated deficit ( 167,238,185 ) ( 154,799,443 ) Total stockholders' equity 767,807 1,620,155 Total liabilities and stockholders' equity $ 3,562,513 $ 4,124,325 See accompanying notes to the unaudited condensed consolidated financial statements. 3 Table of Contents Genprex, Inc. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2025 2024 2025 2024 Operating expenses: Depreciation $ — $ 1,272 $ — $ 6,230 Research and development 2,192,881 2,756,081 7,232,370 7,696,983 General and administrative 1,153,032 1,566,085 4,764,617 9,135,225 Total operating expenses 3,345,913 4,323,

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