Sol-Gel Technologies Announces U.S. Commercial Partner Galderma to Promote TWYNEO® at the American Academy of Dermatology Annual Meeting to be Held March 25-29 in Boston, MA

Rhea-AI Summary

Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) announces the commercial launch of TWYNEO in Spring 2022, a groundbreaking 2-in-1 topical cream combining tretinoin and benzoyl peroxide, specifically designed to treat moderate-to-severe acne.

Galderma, Sol-Gel’s U.S. commercialization partner, will promote TWYNEO at the AAD Annual Meeting from March 25-29, 2022, in Boston. TWYNEO utilizes patented microencapsulation technology for effective and timely delivery. CEO Alon Seri-Levy highlights the significance of this product for both patients and investors.

Positive

• TWYNEO is the first tretinoin and benzoyl peroxide combination approved for moderate-to-severe acne treatment.
• Galderma's marketing efforts at AAD Annual Meeting enhance visibility and commercial opportunities for TWYNEO.
• The product leverages innovative microencapsulation technology for improved efficacy.

Negative

• Forward-looking statements include risks regarding commercial launch delays and uncertainty about patient uptake.
• Potential impacts from COVID-19 may affect commercialization efforts.

TWYNEO will be officially launched for commercial availability in Spring 2022.

NESS ZIONA, Israel, March 25, 2022 (GLOBE NEWSWIRE) -- 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, today announced that its U.S. commercialization partner, Galderma, will be promoting TWYNEO (tretinoin and benzoyl peroxide) Cream, 0.1%/3% at the American Academy of Dermatology (AAD) Annual Meeting, March 25-29, 2022, in Boston, Massachusetts. TWYNEO Cream is the first and only tretinoin and benzoyl peroxide 2-in-1 combination proven to treat moderate-to-severe acne.^1,2 Patented microencapsulation technology unites two ingredients that previously could never be combined and enables their slow release to deliver visible results in as little as two weeks.^2-4

Sol-Gel’s partner Galderma will make a presentation on TWYNEO during its series of speaker forum talks. Information on this presentation is below:

Groundbreaking Acne Treatment: TWYNEO Cream: Dermatology’s Only Combination .1% Tretinoin and 3% BPO for Moderate to Severe Acne Vulgaris

Omar Noor, MD, FAAD

Saturday, March 26 12:30-12:55 pm ET

Galderma booth #1117

In addition, TWYNEO will be featured in one of Galderma’s four product theatres set up with the purpose discuss to new research findings as part of their product portfolio:

Acne: TWYNEO & AKLIEF®

Hilary Baldwin, MD, FAAD

Friday, March 25 10:30 – 11:15 am ET

Theater 2

Alon Seri-Levy, PhD, Chief Executive Officer of Sol-Gel Technologies, commented, “We are very pleased that our first approved product that is based on our proprietary microencapsulation technology, TWYNEO, will be showcased at a key medical dermatology meeting by our U.S. commercialization partner, Galderma. The high degree of visibility afforded to TWYNEO by the Galderma team is a testament to their commitment to optimize the commercial opportunities for this drug as well as to communicate its benefits as the first-ever tretinoin and benzoyl peroxide combination that can be used to treat even moderate-to-severe cases of acne.”

About Acne Vulgaris

Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects up to 50 million people in the U.S. The disease occurs most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne vulgaris patients suffer from the appearance of lesions on areas of the body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules, nodules) or non-inflamed (comedones). Acne vulgaris can have a profound effect on the quality of life of those suffering from the disease. In addition to carrying a substantial risk of permanent facial scarring, the appearance of lesions may cause psychological strain, social withdrawal and lowered self-esteem.

About TWYNEO

TWYNEO is a topical cream containing a fixed‑dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older. TWYNEO is the first acne treatment that contains a fixed‑dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the same cream.

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 to Galderma for U.S. commercialization.

The Company’s pipeline also includes early-stage topical drug candidates SGT-210, SGT-310 and SGT-510 under investigation for the treatment of plaque psoriasis and other dermatologic indications.

For additional information, please visit www.sol-gel.com.

About Galderma

Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story.

For additional information, please visit www.galderma.com/us.

For additional information on TWYNEO, please visit www.twyneo.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 commercial launch of TWYNEO and statements regarding the benefits we expect to receive under our agreement with Galderma. 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 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 that we will not receive all of the anticipated benefits under our agreement with Galderma, the risk of a delay in the commercial availability of TWYNEO, the risk that TWYNEO 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. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.

For further information, please contact:

Investors:

Irina Koffler
Investor relations, LifeSci Advisors
ikoffler@lifesciadvisors.com
+1 917 734 7387

Sol-Gel Technologies

Gilad Mamlok
Chief Financial Officer
gilad.mamlok@sol-gel.com

References

1. TWYNEO (tretinoin and benzoyl peroxide) cream. Prescribing Information.
2. Sol-Gel Technologies Ltd. Sol-Gel Technologies announces FDA approval of TWYNEO. Sol-Gel Advanced Topical Therapy. https://ir.sol-gel.com/news-releases/news-release-details/sol-gel-technologies-announces-fda-approval-twyneor
3. Galderma Laboratories, L.P. Clinical Study Report SGT-65-04. 2020, May 28.
4. Galderma Laboratories LP. Clinical Study Report SGT-65-05. 2020, June 5.

FAQ

What is TWYNEO and how does it work?

TWYNEO is a topical cream combining tretinoin (0.1%) and benzoyl peroxide (3%) for treating moderate-to-severe acne through patented microencapsulation technology.

When will TWYNEO be commercially available?

TWYNEO is set for commercial availability in Spring 2022.

What events is Sol-Gel Technologies participating in for TWYNEO?

Sol-Gel Technologies will showcase TWYNEO at the AAD Annual Meeting from March 25-29, 2022, in Boston.

What are the expected benefits of TWYNEO?

TWYNEO aims to deliver visible results in as little as two weeks due to its unique formulation.

What risks does Sol-Gel face regarding TWYNEO?

Risks include potential delays in commercial launch and challenges in achieving expected patient treatment levels.