Sol-Gel completes Phase 3 visits in Gorlin trial

Rhea-AI Filing Summary

Sol-Gel Technologies Ltd. (SLGL) reported that the last patient has completed the final scheduled visit in its pivotal Phase 3 clinical trial (SGT-610-01) of SGT-610 (patidegib gel, 2%) for prevention of basal cell carcinoma lesions in adults with Gorlin syndrome. This last patient last visit milestone completes the treatment and follow-up phase, after which the company will conduct database lock and statistical analysis, with top-line results expected in late November 2026. The randomized, double-blind, vehicle-controlled study enrolled 113 patients, of whom 102 completed 12 months of twice-daily treatment with either SGT-610 or vehicle, with a primary endpoint of the number of new facial BCCs at month 12 and secondary endpoints including new surgically eligible BCCs.

The company highlights SGT-610 as its lead investigational candidate, described as an orphan- and breakthrough-designated topical hedgehog inhibitor being developed for Gorlin syndrome and potentially high-frequency BCC, alongside its pipeline candidate SGT-210 and its two FDA-approved dermatology products TWYNEO and EPSOLAY.

Filing Explained

Beyond the trial update, the September 17 Form 6-K incorporates the attached press release—except its fourth paragraph—by reference into the listed S-8 and F-3 registration statements; this records the disclosure in those registration statements, not an issuance of securities.

Key Figures

Patients enrolled in Phase 3 SGT-610-01: 113 patients Patients completing Phase 3 SGT-610-01: 102 patients Treatment duration: 12 months +3 more

6 metrics

Patients enrolled in Phase 3 SGT-610-01 113 patients Randomized, double-blind, vehicle-controlled Phase 3 trial in Gorlin syndrome

Patients completing Phase 3 SGT-610-01 102 patients Completed 12 months of treatment and follow-up in the SGT-610 Gorlin syndrome study

Treatment duration 12 months Patients received SGT-610 or vehicle for 12 months of twice-daily treatment

Dosing frequency twice daily SGT-610 or vehicle applied twice daily during the 12-month treatment period

Primary endpoint timing month 12 Number of new facial BCCs at month 12 is the primary endpoint

Top-line results timing late November 2026 Company expectation for reporting top-line results from the SGT-610 Phase 3 trial

Key Terms

last patient last visit, database lock, top-line results, topical hedgehog inhibitor, +2 more

6 terms

last patient last visit medical

"the last patient has completed the last scheduled study visit in the Company's pivotal Phase 3"

The point when the final study participant completes their final scheduled clinical visit, marking the end of active data collection for that trial. It matters to investors because it signals that the sponsor can lock and analyze trial data, move toward regulatory filings or public results, and set clearer timelines for potential approvals or commercial milestones—like the last puzzle piece being placed before you can see the full picture.

database lock medical

"The Company is now proceeding with database lock, followed by statistical analysis"

A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.

top-line results financial

"Sol-Gel expects to report top-line results in late November 2026"

Top-line results are the headline, high-level numbers released first that summarize a company’s most important outcome — for businesses this usually means total revenue or sales, and for clinical or regulatory programs it means the primary, initial outcome of a study. Investors watch them like a score in a game: they give an immediate read on performance and can move share prices quickly, even before the deeper details are examined.

topical hedgehog inhibitor medical

"an orphan- and breakthrough-designated topical hedgehog inhibitor being developed"

Gorlin syndrome medical

"evaluating SGT-610 ... for the prevention of BCC lesions in adult patients with Gorlin syndrome"

A rare inherited genetic condition that increases a person’s lifetime risk of developing multiple skin cancers and other growths, often beginning in childhood or early adulthood. For investors it matters because the small, defined patient group and predictable medical needs make the condition a target for specialized drugs, diagnostics and long‑term care markets; think of it like a known design flaw that creates steady demand for fixes and monitoring.

surgically eligible BCCs (SEBCCs) medical

"Secondary endpoints include the number of new surgically eligible BCCs (SEBCCs)"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What milestone did Sol-Gel Technologies (SLGL) announce for its SGT-610 Phase 3 trial?

Sol-Gel announced that the last patient last visit has occurred in its pivotal Phase 3 clinical trial SGT-610-01 for Gorlin syndrome, meaning patient treatment and follow-up are complete and the study is moving to database lock and statistical analysis.

When does Sol-Gel Technologies (SLGL) expect top-line results from the SGT-610 Phase 3 trial?

Sol-Gel expects to report top-line results in late November 2026 after completing database lock and statistical analysis for the pivotal Phase 3 trial of SGT-610 in Gorlin syndrome.

How many patients were enrolled and completed Sol-Gel’s SGT-610 Phase 3 Gorlin syndrome study?

The randomized, double-blind, vehicle-controlled Phase 3 study enrolled 113 patients with Gorlin syndrome, of whom 102 completed the study following 12 months of treatment with either SGT-610 or vehicle.

What is the primary endpoint of Sol-Gel’s SGT-610 Phase 3 trial in Gorlin syndrome?

The primary endpoint is the number of new basal cell carcinomas (BCCs) on the face at month 12 after twice-daily treatment with SGT-610 or vehicle over 12 months.

What type of drug is SGT-610 in Sol-Gel Technologies’ pipeline?

SGT-610 (patidegib gel, 2%) is described as a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed to prevent new basal cell carcinoma lesions in patients with Gorlin syndrome, with potential future opportunity in high-frequency BCC subject to regulatory approval.

What other products and candidates does Sol-Gel Technologies (SLGL) have besides SGT-610?

Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor, and has developed two FDA-approved dermatology products, TWYNEO and EPSOLAY, for skin conditions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/17/2026 - 08:30 AM Accepted by SEC EDGAR 09/17/2026 - 08:30 AM Learn about SEC filing dates

UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer   

Pursuant to Rule 13a-16 or 15d-16 

Under the Securities Exchange Act of 1934

For the month of September 2026

Commission File Number 001-38367

SOL-GEL TECHNOLOGIES LTD. 

(Translation of registrant’s name into English)

7 Golda Meir Street 

Ness Ziona 7403650, Israel 

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒           Form 40-F ☐

Explanatory Note

On September 17, 2026, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing last patient last visit in pivotal Phase 3 clinical trial of SGT-610 in Gorlin Syndrome.

Attached hereto is the following exhibit:

Exhibit 99.1 Press release dated September 17, 2026

Exhibit 99.1 (other than the fourth paragraph thereof) is hereby incorporated by reference into the Company's Registration Statements on Form S-8 (Registration Nos. 333-223915, 333-270477 and 333-286820) and its Registration Statements on Form F-3 (Registrations No. 333-286822 and 333-270478).

2 

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, thereunto duly authorized.

	SOL-GEL TECHNOLOGIES LTD.
Date:  September 17, 2026	By:	/s/ Eyal Ben-Or
		Eyal Ben-Or
		Chief Financial Officer

3

Exhibit 99.1

Sol-Gel Technologies Announces Last Patient Last

Visit in Pivotal Phase 3 Clinical Trial of SGT-610 in

Gorlin Syndrome
 

• Last patient has completed the last scheduled study visit in the pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome

• Top-line results remain on track for late November 2026

NESS ZIONA, Israel, September 17, 2026 (GLOBE NEWSWIRE) - Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today announced that the last patient has completed the last scheduled study visit in the Company's pivotal Phase 3 clinical trial (SGT-610-01) evaluating SGT-610 (patidegib gel, 2%) for the prevention of BCC (basal cell carcinoma) lesions in adult patients with Gorlin syndrome.

The achievement of last patient last visit (LPLV) marks the completion of the patient treatment and follow-up phase of the study. The Company is now proceeding with database lock, followed by statistical analysis of the study results. Sol-Gel expects to report top-line results in late November 2026. The Company, investigators and patients remain blinded to treatment assignment.

The randomized, double-blind, vehicle-controlled Phase 3 study enrolled 113 patients with Gorlin syndrome, of whom 102 completed the study. Patients were randomized to receive SGT-610 or vehicle for 12 months of treatment. The primary endpoint of the study is the number of new BCCs on the face at month 12 after twice daily treatment. Secondary endpoints include the number of new surgically eligible BCCs (SEBCCs).

Mr. Mori Arkin, Executive Chairman and CEO of Sol-Gel, stated: "Reaching last patient last visit represents an important milestone for the SGT-610 program and brings us closer to understanding its potential to address the significant unmet need in patients with Gorlin syndrome. We are grateful to the patients, investigators and clinical site teams whose participation and commitment made this study possible. We look forward to completing the analysis and reporting the results."

About Sol-Gel Technologies

Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety profile relative to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. including, but not limited to statements regarding the timing of the release of top-line results for the Phase 3 program of SGT-610 in Gorlin syndrome. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, the risk of a delay in reporting the top-line results of Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, that we will not successfully complete the Gorlin Phase 3 clinical trial or that such clinical trial will fail to meet its primary endpoint or one or more of its secondary endpoints as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the security situation in Israel. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 19, 2026, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.

Sol-Gel Investor Relations:

Eyal Ben-Or

Chief Financial Officer

ir@sol-gel.com

2

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 EXHIBIT 99.1 12.7 KB