Health Canada clears Sol-Gel (SLGL) therapy EPSOLAY®, tied into SEC registrations

Rhea-AI Filing Summary

Sol-Gel Technologies Ltd. filed a report noting that it has received Health Canada approval for EPSOLAY®. This approval, announced in a company press release, represents official clearance for the product in the Canadian market. The filing also states that portions of the press release are incorporated by reference into Sol-Gel’s existing registration statements on Form S-8 and Form F-3, linking the product approval to the company’s broader capital markets documentation.

Positive

• Health Canada approval of EPSOLAY® provides formal regulatory clearance for the product in Canada, potentially opening a new geographic market and enhancing the company’s dermatology portfolio and long-term revenue opportunities.

Negative

• None.

Insights

Biopharma regulatory analyst

Sol-Gel gains Health Canada approval for EPSOLAY®, expanding its regulatory footprint.

Sol-Gel Technologies reports that EPSOLAY® has received Health Canada approval. Regulatory approval is a key gate for selling prescription therapies, so this clears a formal path to market the product in Canada, subject to commercial execution and any reimbursement dynamics described elsewhere.

The company also incorporates the first two paragraphs of the approval press release into multiple registration statements on Form S-8 and Form F-3. This ties the Canadian approval disclosure directly into its securities offerings framework, ensuring investors reviewing those registrations see the updated product status.

The actual commercial impact will depend on factors not detailed here, such as launch timing, market uptake and pricing in Canada. Future company filings or disclosures may provide more detail on sales performance or partnerships related to EPSOLAY® following this regulatory milestone.

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 2025

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 4, 2025, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing Health Canada Approval of EPSOLAY®.

Attached hereto is the following exhibit:

Exhibit 99.1 Press release dated September 4, 2025

The first and second paragraphs of Exhibit 99.1 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 Statement on Form F-3 (Registration No 333-286822).

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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 4, 2025	By:	/s/ Eyal Ben-Or
		Eyal Ben-Or
		Chief Financial Officer

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FAQ

What did Sol-Gel Technologies Ltd. (SLGL) announce in this 6-K filing?

Sol-Gel Technologies reported that EPSOLAY® received Health Canada approval. The company disclosed that this approval was announced via a press release and then linked that disclosure into several existing registration statements, integrating the new regulatory milestone into its broader capital markets documentation.

What is the significance of Health Canada approving EPSOLAY® for Sol-Gel (SLGL)?

Health Canada’s approval of EPSOLAY® allows Sol-Gel to market the product in Canada, subject to commercial arrangements. Regulatory clearance is essential for prescription therapies, so this milestone may support future revenue from the Canadian market as commercialization progresses over time.

How did Sol-Gel (SLGL) update its SEC registration statements in connection with EPSOLAY®?

Sol-Gel incorporated the first and second paragraphs of the EPSOLAY® approval press release into its Form S-8 registration statements and its Form F-3 registration statement. This ensures those filings now include the latest information on Health Canada’s approval of EPSOLAY® for investors and regulators.

Which specific SEC registration statements reference the EPSOLAY® Health Canada approval?

The company incorporated the press release paragraphs into its Form S-8 registration statements with Registration Nos. 333-223915, 333-270477 and 333-286820, and its Form F-3 registration statement with Registration No. 333-286822, aligning those documents with the new Health Canada approval.

Does the Sol-Gel (SLGL) 6-K include financial results or earnings data?

The 6-K focuses on the regulatory approval of EPSOLAY® by Health Canada and related incorporation into registration statements. It does not present earnings figures, revenue data, or detailed financial tables within this excerpt, concentrating instead on the product’s regulatory status update.

What role did Sol-Gel’s Chief Financial Officer play in this 6-K filing?

The 6-K report was signed on behalf of Sol-Gel Technologies by Chief Financial Officer Eyal Ben-Or. His signature confirms that the company has duly authorized submission of the report, which formally documents the Health Canada approval of EPSOLAY® for regulatory and investor audiences.