Inhibitor Therapeutics' Cash Dwindles Amid Rising R&D Costs

TL;DR

**INTI is burning cash with no revenue, and while they're pushing for FDA approval without new trials, it's a long shot with high dilution risk.**

AI Summary

Inhibitor Therapeutics, Inc. (INTI) reported a net loss of $2,004,972 for the nine months ended September 30, 2025, an increase from the $1,917,358 net loss in the same period of 2024. The company generated no revenue in either period. Cash and cash equivalents significantly decreased to $2,976,658 as of September 30, 2025, from $5,606,863 at December 31, 2024, primarily due to $2,630,205 in cash used for operating activities. Research and development expenses rose to $939,470 for the nine months ended September 30, 2025, up from $869,756 in 2024, while general and administrative expenses decreased to $1,172,069 from $1,303,404. The company is focused on developing itraconazole for basal cell carcinoma (BCC), prostate, and lung cancers, and has an exclusive license agreement with Johns Hopkins University for a patent related to these treatments. INTI is pursuing a pre-IND meeting with the FDA for BCCNS and has engaged Avior Bio, Inc. to develop a novel itraconazole formulation, with the goal of submitting a New Drug Application (NDA) without further clinical trials. The company believes its $3.0 million cash on hand is sufficient for the foreseeable future to pursue the FDA process for the BCCNS product.

Why It Matters

Inhibitor Therapeutics' continued net losses and significant cash burn raise serious questions about its long-term viability and ability to bring its itraconazole-based therapies to market. For investors, the reliance on existing cash and the potential need for future capital raises, especially without a clear path to revenue, presents substantial dilution risk. Employees and customers face uncertainty given the company's pre-revenue status and the inherent risks of drug development. In the competitive pharmaceutical landscape, INTI's strategy of repurposing an approved drug for new indications is common, but its financial position could hinder its ability to compete effectively against larger, better-funded biotechs.

Risk Assessment

Risk Level: high — The company reported a net loss of $2,004,972 for the nine months ended September 30, 2025, and has no ongoing source of revenue. Cash and cash equivalents decreased by over 47% from $5,606,863 at December 31, 2024, to $2,976,658 at September 30, 2025, indicating a rapid depletion of liquidity without offsetting income. The company explicitly states, "there can be no assurances that the Company will be successful in the execution of its operational plan nor, if determined to be required, that the Company will be successful in raising additional capital on economically reasonable terms, if at all."

Analyst Insight

Investors should exercise extreme caution and consider this a highly speculative investment. Given the significant cash burn and lack of revenue, potential investors should wait for clear evidence of FDA approval for their BCCNS product and a concrete plan for commercialization and revenue generation before considering a position.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

N/A

total Debt

N/A

net Income

-$2,004,972

eps

N/A

gross Margin

N/A

cash Position

$2,976,658

revenue Growth

N/A

Key Numbers

• $2,004,972 — Net Loss (for the nine months ended September 30, 2025, an increase from $1,917,358 in 2024)
• $2,976,658 — Cash and Cash Equivalents (as of September 30, 2025, down from $5,606,863 at December 31, 2024)
• $2,630,205 — Net Cash Used in Operating Activities (for the nine months ended September 30, 2025)
• $939,470 — Research and Development Expenses (for the nine months ended September 30, 2025, up from $869,756 in 2024)
• $1,172,069 — General and Administrative Expenses (for the nine months ended September 30, 2025, down from $1,303,404 in 2024)
• $3,000,000 — Deferred Revenue (from royalties advanced by Mayne Pharma, classified as non-current)
• 172,573,545 — Common Stock Shares Outstanding (as of September 30, 2025)
• $3,453 — Total Stockholders' Equity (as of September 30, 2025, a significant decrease from $1,985,040 at December 31, 2024)
• $40,000 — Upfront License Fee (paid to Johns Hopkins University on December 12, 2023)
• $3.0 million — Aggregate Development-Related Milestone Payments (owed to Johns Hopkins University upon achieving milestones)

Key Players & Entities

• Inhibitor Therapeutics, Inc. (company) — registrant
• Johns Hopkins University (company) — licensor of patent rights
• Niraj Vasisht (person) — President and Chairman of the Board of Avior Bio, Inc. and member of INTI's Board of Directors
• Avior Bio, Inc. (company) — drug development company engaged by INTI
• Mayne Pharma Ventures Pty Ltd. (company) — advanced $3 million in royalties to INTI
• U.S Food and Drug Administration (regulator) — regulatory body for drug approval
• Division of Dermatology (regulator) — FDA division INTI initially met with
• Division of Oncology (regulator) — FDA division INTI believes is required for consultation
• Center for Drug Evaluation and Research (regulator) — FDA center leading RDEA pilot program
• Center for Biologics Evaluation and Research (regulator) — FDA center leading RDEA pilot program

FAQ

Risk Factors

• Significant Net Losses and Cash Burn [high — financial]: INTI reported a net loss of $2,004,972 for the nine months ended September 30, 2025, an increase from the prior year's $1,917,358 loss. The company generated no revenue in either period. Cash and cash equivalents decreased to $2,976,658 from $5,606,863, primarily due to $2,630,205 in cash used for operating activities.
• Dependence on FDA Approval Process [high — regulatory]: The company's strategy hinges on obtaining FDA approval for itraconazole for various cancers, including pursuing a pre-IND meeting for BCCNS. The success of this strategy is entirely dependent on the FDA's review and approval process, which is inherently uncertain and can be lengthy.
• Reliance on Third-Party Development [medium — operational]: INTI has engaged Avior Bio, Inc. to develop a novel itraconazole formulation. This reliance on external partners introduces execution risk and potential delays if the partner fails to meet development milestones or quality standards.
• Limited Cash Runway [high — financial]: While the company states its $3.0 million cash on hand is sufficient for the foreseeable future to pursue the FDA process for the BCCNS product, the increasing net losses and significant cash burn rate of $2,630,205 for nine months indicate a limited runway if development or regulatory processes are extended or encounter unforeseen costs.
• Intellectual Property and Licensing [medium — legal]: The company's core asset is based on an exclusive license agreement with Johns Hopkins University for a patent. Any disputes or challenges to this intellectual property or licensing agreement could severely impact the company's development plans and future prospects.
• Negative Stockholders' Equity [high — financial]: Total stockholders' equity has significantly decreased to $3,453 as of September 30, 2025, from $1,985,040 at December 31, 2024. This substantial decline, coupled with ongoing net losses, indicates a precarious financial position.

Industry Context

The oncology drug development landscape is highly competitive and capital-intensive, with significant R&D investment required for clinical trials and regulatory approvals. Companies like INTI are often focused on niche indications or novel formulations of existing compounds to carve out market share. The success of such ventures is heavily dependent on demonstrating clear clinical benefit and navigating complex regulatory pathways.

Regulatory Implications

INTI's strategy to pursue an NDA without further clinical trials for itraconazole is an aggressive approach that carries substantial regulatory risk. The FDA may require additional data or studies, potentially delaying or preventing market approval. Successful navigation of the pre-IND process and subsequent NDA submission will be critical.

What Investors Should Do

1. Monitor FDA interactions and guidance closely.
2. Evaluate the cash runway and future financing needs.
3. Assess the scientific and clinical validity of the 'no further clinical trials' strategy.
4. Track progress with Avior Bio, Inc.

Key Dates

• 2025-09-30: Nine months ended September 30, 2025 — Reported net loss of $2,004,972 and cash and cash equivalents of $2,976,658, with $2,630,205 used in operating activities.
• 2024-09-30: Nine months ended September 30, 2024 — Reported net loss of $1,917,358, indicating an increase in losses for the comparable period.
• 2024-12-31: As of December 31, 2024 — Cash and cash equivalents stood at $5,606,863, and total stockholders' equity was $1,985,040.
• 2023-12-12: Upfront License Fee Paid — Paid $40,000 to Johns Hopkins University for exclusive license agreement.

Glossary

Pre-IND Meeting

A meeting between a drug sponsor and the U.S. Food and Drug Administration (FDA) before submitting an Investigational New Drug (IND) application. It allows sponsors to discuss their development plan and seek guidance from the FDA. (INTI is pursuing this to align its development strategy for itraconazole with FDA requirements for BCCNS.)

New Drug Application (NDA)

A formal request to the FDA for approval to market a new drug in the United States. It contains comprehensive data from preclinical and clinical studies, manufacturing information, and proposed labeling. (INTI aims to submit an NDA for itraconazole without further clinical trials, a strategy that carries significant regulatory risk.)

Cash Burn Rate

The rate at which a company is spending its cash reserves, typically used for companies that are not yet profitable. It indicates how long the company can continue operating before running out of money. (INTI's net cash used in operating activities of $2,630,205 for nine months highlights a substantial cash burn rate.)

Stockholders' Equity

The residual interest in the assets of an entity after deducting all its liabilities. It represents the net worth of the company from an accounting perspective. (INTI's significantly declining stockholders' equity to $3,453 indicates a deteriorating financial position.)

Deferred Revenue

Revenue that has been received by a company for goods or services that have not yet been delivered or rendered. In this case, it's an advance from Mayne Pharma. (The $3,000,000 in deferred revenue from Mayne Pharma provides a non-current financial resource, but its ultimate realization depends on future events.)

Year-Over-Year Comparison

For the nine months ended September 30, 2025, Inhibitor Therapeutics, Inc. (INTI) reported a higher net loss of $2,004,972 compared to $1,917,358 in the same period of 2024, despite a reduction in General and Administrative expenses. Research and Development expenses increased, contributing to the overall higher loss. The company's cash position has significantly depleted, falling from $5,606,863 at year-end 2024 to $2,976,658, driven by substantial operating cash outflows of $2,630,205. Stockholders' equity has also drastically reduced, signaling a worsening financial condition.

Filing Documents

• form10-q.htm (10-Q) — 573KB
• ex31-1.htm (EX-31.1) — 12KB
• ex31-2.htm (EX-31.2) — 8KB
• ex32-1.htm (EX-32.1) — 4KB
• ex32-2.htm (EX-32.2) — 4KB
• 0001493152-25-022178.txt ( ) — 2967KB
• inti-20250930.xsd (EX-101.SCH) — 21KB
• inti-20250930_cal.xml (EX-101.CAL) — 31KB
• inti-20250930_def.xml (EX-101.DEF) — 73KB
• inti-20250930_lab.xml (EX-101.LAB) — 204KB
• inti-20250930_pre.xml (EX-101.PRE) — 164KB
• form10-q_htm.xml (XML) — 385KB

Financial Statements (unaudited)

Financial Statements (unaudited) Condensed Balance Sheets as of September 30, 2025 and December 31, 2024 1 Condensed Statements of Operations for the three and nine months ended September 30, 2025 and 2024 2 Condensed Statements of Stockholders' Equity for the three and nine months ended September 30, 2025 and 2024 3 Condensed Statements of Cash Flows for the nine months ended September 30, 2025 and 2024 4 Notes to Condensed Financial Statements 5 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 12 Item 3.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 15 Item 4.

Controls and Procedures

Controls and Procedures 15 Cautionary Note Regarding Forward Looking Statements 16

Other Information

Part II. Other Information Item 1

Legal Proceedings

Legal Proceedings 17 Item 1A.

Risk Factors

Risk Factors 17 Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 17 Item 3 Defaults upon Senior Securities 17 Item 4 Mine Safety Disclosures 17 Item 5 Other Information 17 Item 6. Exhibits 18

Signatures

Signatures 19 INHIBITOR THERAPEUTICS, INC. CONDENSED BALANCE SHEETS AS OF SEPTEMBER 30, 2025 AND DECEMBER 31, 2024 (Unaudited) September 30, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 2,976,658 $ 5,606,863 Prepaid expenses and other assets 87,428 87,795 Total current assets 3,064,086 5,694,658 Operating lease right-of-use assets 71,081 — Total assets $ 3,135,167 $ 5,694,658 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 19,646 $ 15,896 Accrued expenses and other liabilities 40,432 693,722 Current portion of operating lease obligations 27,455 — Total current liabilities 87,533 709,618 Deferred revenue 3,000,000 3,000,000 Operating lease obligations, less current portion 44,181 — Total liabilities 3,131,714 3,709,618 Commitments and contingencies (Note 6) — — Stockholders' equity: Series A preferred stock, $ 0.0001 par value; 500,000 shares authorized; no shares issued and outstanding at September 30, 2025 and December 31, 2024 — — Series B convertible, redeemable, preferred stock, $ 0.0001 par value; 7,246,377 shares authorized; no shares issued and outstanding at September 30, 2025 and December 31, 2024 — — Undesignated preferred stock, $ 0.0001 par value; 2,253,623 shares authorized; no shares issued and outstanding at September 30, 2025 and December 31, 2024 — — Preferred stock, value — — Common stock, $ 0.0001 par value; 500,000,000 shares authorized; 172,573,545 and 172,323,545 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively 17,257 17,232 Additional paid-in capital 54,110,425 54,087,065 Accumulated deficit ( 54,124,229 ) ( 52,119,257 ) Total stockholders' equity 3,453 1,985,040 Total liabilities and stockholders' equity $ 3,135,167 $ 5,694,658 See notes to condensed financial statements 1 INHIBITOR THERAPEUTICS, INC. CONDENSED

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