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Inhibitor Therapeutics (INTI) advances Gorlin PK study and plans global patent

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(Moderate)
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Form Type
8-K

Rhea-AI Filing Summary

Inhibitor Therapeutics, Inc. furnished an update on its itraconazole program for Gorlin Syndrome, covering clinical progress, formulation strategy and intellectual property plans. The company is running a three-way crossover pharmacokinetic study in healthy adults in Malaysia under fasting conditions, in collaboration with Avior Bio.

Period 2 dosing is scheduled for April 10, 2026 and Period 3 for April 24, 2026, with plasma samples expected to be shipped for bioanalysis on or about May 1, 2026. Inhibitor believes this PK study is expected to be the final clinical study before a planned New Drug Application for surgically eligible basal cell carcinomas in BCCNS.

The program uses a proprietary amorphous itraconazole formulation intended to improve solubility and absorption versus conventional crystalline drug. Inhibitor is also preparing a new global patent application on this formulation, which it expects would be owned by the company without ongoing royalty obligations and would complement its existing oncology-focused IP portfolio.

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Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
PK study Period 2 date April 10, 2026 Scheduled dosing period in three-way crossover PK study
PK study Period 3 date April 24, 2026 Final dosing period in ongoing PK clinical study
Plasma shipment timing On or about May 1, 2026 Expected shipment of plasma samples for bioanalysis
Bioanalysis duration Approximately two weeks Estimated time required for PK sample bioanalysis
Statistical analysis duration Approximately two weeks Estimated time following bioanalysis for data statistics
pharmacokinetic (PK) clinical program medical
"today provided an update on its ongoing pharmacokinetic (PK) clinical program supporting the treatment"
three-way crossover study medical
"is designed as a three-way crossover study against a reference listed drug"
505(b)(2) pathway regulatory
"intended to support the Company’s regulatory strategy under the FDA’s 505(b)(2) pathway"
A 505(b)(2) pathway is a U.S. regulatory route that lets a drug developer get approval by relying in part on existing clinical data or published studies instead of repeating every test. Think of it as building on someone else’s homework to shorten development time and cost. For investors, it signals potentially faster, lower‑risk market entry and a chance for competitive protection compared with starting brand‑new drug approvals.
New Drug Application (NDA) regulatory
"expected to represent the final clinical study required prior to submission of a New Drug Application (NDA)"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
amorphous morphology technical
"by incorporating itraconazole in an amorphous morphology, which is intended to enhance solubility"
Investigational Medicinal Product Dossier (IMPD) regulatory
"The Company’s Investigational Medicinal Product Dossier (IMPD) characterizes the underlying challenges"
A registrational packet that describes an experimental drug’s composition, how it is made and tested, and the safety and animal or early human data regulators need to approve clinical trials. Think of it as the drug’s technical dossier and safety report that lets regulators decide whether a candidate is safe enough for people to try. Investors watch it because a complete, well-organized dossier speeds regulatory clearance and reduces trial delays or costly hold-ups.
Understanding 8-K Material Events →
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or Section 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 1, 2026 (March 31, 2026)

 

 

 

Inhibitor Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-13467   30-0793665
(State or other jurisdiction
of incorporation)		   (Commission
File Number)		  

(IRS Employer

Identification No.)

 

3014 West Palmira Ave., Suite 302

Tampa, FL 33629 (813) 864-2562

(Address, including Zip Code and Telephone Number, including Area Code, of Principal Executive Offices)

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
None   N/A   N/A

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

Item 8.01. Other Events

 

On March 31, 2026, Inhibitor Therapeutics, Inc. (the “Company”) issued a press release titled: Inhibitor Therapeutics Provides Clinical, Formulation and IP Update on Itraconazole Program for Gorlin Syndrome.

 

A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “8-K”), and is incorporated herein by reference.

 

The information furnished under this Item 8.01 and in the accompanying Exhibits 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing.

 

Cautionary Note on Forward-Looking Statements

 

This 8-K contains projections and other forward-looking statements regarding future events and our future financial performance. All statements other than present and historical facts and conditions contained in this 8-K, including any statements regarding future results of operations and financial positions, business strategy and plans, expectations for future product sales, our ability to convert our pipeline to revenue and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. We undertake no obligation to update the information made in this 8-K in the event facts or circumstances subsequently change after the date of this 8-K. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, you should not rely on or place undue reliance on these forward-looking statements. Actual events or results may differ materially from those contained in the projections or forward-looking statements.

 

For a detailed discussion of these risks, uncertainties and other factors that could cause the Company’s actual results to differ materially from those anticipated or expressed in any forward-looking statements, see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission (“SEC”). Additional risks and uncertainties are discussed from time to time in current, quarterly and annual reports filed by the Company with the SEC, which are available on the SEC’s website at https://www.sec.gov/.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) The following exhibit is filed with this report.

 

Exhibit No.   Description of Exhibit
     
99.1   Inhibitor Therapeutics, Inc. Press Release, dated March 31, 2026.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: April 1, 2026 INHIBITOR THERAPEUTICS, INC.
     
  By:

/s/ Francis E. O’Donnell

  Name:  Francis E. O’Donnell
  Title: Executive Chairman and CEO

 

 

 

 

Exhibit 99.1

 

Inhibitor Therapeutics Provides Clinical, Formulation and IP Update on Itraconazole Program for Gorlin Syndrome

 

Company outlines near-term pharmacokinetic milestones, highlights amorphous formulation strategy, and announces planned global patent filing

 

TAMPA, Fla., March 31, 2026 — Inhibitor Therapeutics, Inc. (OTCQB: INTI) (“Inhibitor” or the “Company”), today provided an update on its ongoing pharmacokinetic (PK) clinical program supporting the treatment of surgically eligible basal cell carcinomas (BCCs) in Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome, and announced plans to file a new global patent application covering its proprietary itraconazole formulation.

 

Inhibitor’s comparative PK, safety and tolerability study is being conducted in healthy adult subjects under fasting conditions in Malaysia and is designed as a three-way crossover study against a reference listed drug. The study is being executed in collaboration with Avior Bio, Inc. The Company’s collaboration with Avior Bio, spanning formulation development through clinical execution, has proceeded in line with planned timelines and budget and is intended to support the Company’s regulatory strategy under the FDA’s 505(b)(2) pathway.

 

The study is currently progressing through its crossover dosing periods, with Period 2 scheduled for April 10, 2026, and Period 3 scheduled for April 24, 2026. Following the final PK sampling in Period 3, plasma samples are expected to be shipped for bioanalysis on or about May 1, 2026. Bioanalytical work is expected to require approximately two weeks, followed by approximately two additional weeks of statistical analysis. The Company expects to receive top-line comparative PK and relative bioavailability results in advance of the full Clinical Study Report, which will follow completion of the final study documentation. Based on the Company’s current development plan, Inhibitor believes this PK study is expected to represent the final clinical study required prior to submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for its BCCNS program.

 

A key differentiating feature of the Company’s program is its proprietary amorphous formulation approach. In its conventional crystalline form, itraconazole is known to present significant solubility limitations, which can contribute to variability in absorption and systemic exposure. Inhibitor’s formulation strategy is designed to address those limitations by incorporating itraconazole in an amorphous morphology, which is intended to enhance solubility and dissolution behavior by reducing particle agglomeration and improving dispersion. This approach may support improved intestinal absorption and more consistent, predictable pharmacokinetic performance.

 

The Company’s Investigational Medicinal Product Dossier (IMPD) characterizes the underlying challenges associated with itraconazole and supports the scientific rationale for the formulation strategy. While the bulk drug substance is described as crystalline and practically insoluble in water, the formulated product candidate evaluated in the dossier was shown by X-ray diffraction to be amorphous, without detectable crystalline peaks, and was developed with the intent of suppressing crystallization and improving intestinal solubility and absorption.

 

 

 

 

In parallel with clinical advancement, Inhibitor is preparing a new patent application directed to the composition of its proprietary formulation. The Company expects to seek global patent protection for the formulation and, if granted, the patent would be owned by Inhibitor Therapeutics without any ongoing royalty obligations. The Company believes this planned filing has the potential to materially strengthen its intellectual property estate by expanding protection around the formulation itself, complementing its existing portfolio related to the use of itraconazole in oncology indications. If granted, the Company believes such patent protection could enhance the strategic value of the BCCNS program as it advances toward potential NDA submission, commercialization and broader partnering discussions.

 

Gorlin Syndrome is a rare hereditary disorder characterized by the development of multiple basal cell carcinomas over a patient’s lifetime. Inhibitor is developing itraconazole for surgically eligible BCCs in BCCNS as a differentiated therapeutic approach intended to address a significant unmet need for patients who often face repeated surgical procedures and associated morbidity.

 

About Inhibitor Therapeutics

 

Inhibitor Therapeutics, Inc. is a publicly traded, clinical-stage pharmaceutical development company (OTCQB: INTI) focused on developing and commercializing innovative therapies using repurposed, already approved active pharmaceutical ingredients that have clinical value and are patent protected. The Company’s lead program is itraconazole for the treatment of surgically eligible basal cell carcinomas (BCCs) in Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. For more information, visit the Company’s website at www.inhibitortx.com.

 

Forward-Looking Statements

 

This press release contains projections and other forward-looking statements regarding future events and our future financial performance. All statements other than present and historical facts and conditions contained in this release, including any statements regarding future results of operations and financial positions, business strategy and plans, expectations for future product sales, our ability to convert our pipeline to revenue and our objectives for future operations, are forward-looking statements (within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). These statements are only predictions and reflect our current beliefs and expectations with respect to future events and are based on assumptions and subject to risk and uncertainties and subject to change at any time. We undertake no obligation to update the information made in this release in the event facts or circumstances subsequently change after the date of this press release. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, you should not rely on or place undue reliance on these forward-looking statements. Actual events or results may differ materially from those contained in the projections or forward-looking statements.

 

Investor Relations Contact

 

Simon Bettink

VP of Operations

Inhibitor Therapeutics, Inc.

sbettink@inhibitortx.com

 

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What clinical update did Inhibitor Therapeutics (INTI) provide on its itraconazole program?

Inhibitor Therapeutics reported progress on a comparative pharmacokinetic study of itraconazole in healthy adults in Malaysia. The three-way crossover trial supports treatment of surgically eligible basal cell carcinomas in Gorlin Syndrome and is intended to underpin a future New Drug Application submission.

What are the key upcoming study milestones for Inhibitor Therapeutics (INTI)?

The pharmacokinetic study dosing Period 2 is scheduled for April 10, 2026 and Period 3 for April 24, 2026. Plasma samples are expected to be shipped for bioanalysis around May 1, 2026, followed by bioanalysis and statistical work before top-line PK and bioavailability results.

How is Inhibitor Therapeutics (INTI) trying to improve itraconazole performance?

The company uses a proprietary amorphous itraconazole formulation designed to overcome solubility limits of crystalline drug. By reducing particle agglomeration and improving dispersion, the approach aims to enhance intestinal absorption and deliver more consistent, predictable pharmacokinetic behavior in patients.

What regulatory pathway is Inhibitor Therapeutics (INTI) pursuing for its BCCNS program?

Inhibitor Therapeutics is advancing its itraconazole program under the FDA’s 505(b)(2) regulatory pathway. The company believes the current pharmacokinetic study is expected to be the final clinical trial before submitting a New Drug Application for surgically eligible basal cell carcinomas in Gorlin Syndrome.

What intellectual property steps is Inhibitor Therapeutics (INTI) planning?

The company is preparing a new global patent application covering the composition of its proprietary itraconazole formulation. If granted, the patent would be owned by Inhibitor without ongoing royalty obligations and is intended to strengthen and expand its oncology-focused intellectual property estate.

What condition is Inhibitor Therapeutics (INTI) targeting with itraconazole?

The program targets Basal Cell Carcinoma Nevus Syndrome, also called Gorlin Syndrome, a rare hereditary disorder with multiple basal cell carcinomas over a lifetime. Inhibitor is developing itraconazole for surgically eligible basal cell carcinomas as a differentiated option for patients facing repeated surgical procedures.

Filing Exhibits & Attachments

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