Sol-Gel Technologies Ltd 6-K, filed Dec 21, 2021
Sol-Gel Technologies Ltd. (SLGL)
6-K
2021-12-21
For: 2021-12-21
View Original
Added on
April 08, 2026
About this 6-K
Sol-Gel Technologies Ltd filed this 6-K on December 21, 2021.
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 December 2021
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 ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On December 21, 2021, Sol-Gel Technologies Ltd. issued a press release announcing a positive update related to the FDA’s review of EPSOLAY®.
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: December 21, 2021
|
By:
|
/s/ Gilad Mamlok
|
|
|
|
Gilad Mamlok
|
|
|
|
Chief Financial Officer
|
3
Exhibit 99.1
Sol-Gel Technologies Announces
Positive Update Related to FDA Review Status of EPSOLAY®
- FDA informs Sol-Gel that it intends
to conduct a pre-approval inspection of the
production site for EPSOLAY during the
week of February 14th, 2022
NESS ZIONA, Israel, December 21, 2021
-- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today that the Food and Drug
Administration (FDA) has informed the Company that it intends to conduct a pre-approval inspection of the production site for the Company’s drug product, EPSOLAY®, a proprietary topical formulation of benzoyl peroxide, 5%, during the week
of February 14th, 2022. EPSOLAY is under review by the FDA for the treatment of the inflammatory lesions of rosacea in adults.
“We are pleased that the FDA has informed us of the timing of its pre-approval inspection of the production site for EPSOLAY, which, since
April 26, 2021, has been delayed due to COVID-19 related travel restrictions", said Alon Seri Levy, Ph.D., Chief Executive Officer of Sol-Gel. “We believe that EPSOLAY has the potential to change the treatment landscape for adult patients suffering
from inflammatory lesions of rosacea, a skin disorder that affects millions of people in the U.S. and expect that this development will bring us closer to the anticipated EPSOLAY approval and launch in the U.S. by our partner Galderma.”
About EPSOLAY
EPSOLAY is a topical cream containing benzoyl peroxide, 5%, under FDA review for the treatment of inflammatory lesions of rosacea in
adults. EPSOLAY utilizes a proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over
time to provide a favorable efficacy and safety profile. EPSOLAY is protected by granted patents until 2040.
About Inflammatory Lesions of Rosacea
Inflammatory lesions of rosacea is a chronic and recurrent skin disorder that affects millions of Americans. The condition is especially
common in fair-skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time.
As the condition progresses, the redness becomes more persistent, blood vessels become visible, and inflammatory lesions often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
About Sol-Gel Technologies
Sol-Gel is a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the
treatment of skin diseases. Sol‑Gel leveraged its proprietary microencapsulation technology platform for TWYNEO, which is approved for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, under
investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA goal date that was set for April 26, 2021. Both drugs are exclusively licensed for U.S. commercialization to Galderma.
The Company’s pipeline also includes early-stage topical drug candidates SGT-210 (topical erlotinib) under investigation for the treatment
of palmoplantar keratoderma, SGT-310 (tapinarof cream) and SGT-510 (topical roflumilast) under investigation for the treatment of plaque psoriasis and other dermatologic indications.
For additional information, please visit www.sol-gel.com.
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 pre-approval
inspection of the production site for EPSOLAY and the FDA approval of EPSOLAY. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans
and objectives. 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 expectation 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 further delay in the timing of the pre-approval inspection of
the production site for EPSOLAY, whether due to COVID-19 travel restrictions or otherwise, a delay in the receipt of approval, if any, of the NDA for EPSOLAY, the risk of a delay in the commercial availability of ESPSOLAY, the risk that EPSOLAY will
not provide treatment to the number of patients anticipated, risks relating to the effects of COVID‑19 (coronavirus) as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of
recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (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 ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to
manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our 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, Europe or Israel; and (xv) loss or retirement of key executives and research
scientists. These 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 4, 2021 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. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no
obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.
For further information, please contact:
Investors:
Irina Koffler
Investor relations, LifeSci Advisors
ikoffler@lifesciadvisors.com
+1 917 734 7387
Investor relations, LifeSci Advisors
ikoffler@lifesciadvisors.com
+1 917 734 7387
Sol-Gel Technologies
Gilad Mamlok
Chief Financial Officer
gilad.mamlok@sol-gel.com
Chief Financial Officer
gilad.mamlok@sol-gel.com