6-K
Sol-Gel Technologies Ltd. (SLGL)
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 February 2023
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
Sol-Gel Technologies Ltd. is posting on its website a corporate presentation.
Attached hereto and incorporated by reference in this Report on Form 6-K is the following exhibit:
Exhibit 99.1: Corporate Presentation.
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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: February 2, 2023 | By: | /s/ Gilad Mamlok |
| Gilad Mamlok | ||
| Chief Financial Officer |
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Exhibit 99.1
NASDAQ: SLGL
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 benefits we expect to receive under our agreement with Galderma; expected net sales and royalty income in line with volume growth of EPSOLAY and/or TWYNEO; and our expected cash runway. 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 the initiation or results of the Phase 3 study for patidegib will be delayed or not occur, the risk that our annual net sales from patidegib will be lower than expected, the risk that the investment by Mr. Mori Arkin will not be approved by shareholders, , risks that our cash runway will be shorter than expected, 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 April 4, 2022, as amended, 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 FORWARD-LOOKING STATEMENTS
PIONEERING TOPICAL DERMATOLOGICAL DRUGS Two FDA Approvals Within One Year Not a real patient Not a real patient
Say hello to thisnever-before-seen combo TWYNEO® FOR ACNE WAS LAUNCHED First and only FDA Approved Fixed‑Dose Combination of Tretinoin and Benzoyl Peroxide
TWYNEO® OFFERS COMPREHENSIVE TREATMENT FOR ACNE PATIENTS Potential to Become 1st Line Treatment Acne vulgaris is a multifactorial disease. Even though benzoyl peroxide and tretinoin are widely prescribed separately and have a complementary mechanism of action, so far, they could not be applied concomitantly because benzoyl peroxide decomposes tretinoin TWYNEO contains a fixed‑dose combination of tretinoin and benzoyl peroxide. TWYNEO uses Sol‑Gel’s patented technology to prevent tretinoin from being degraded by benzoyl peroxide and slowly releases each of the active drug ingredients over time to provide a favorable efficacy and safety profile TWYNEO is protected by granted patents until 2038 and by a pending patent application until 2041 Not a real patient
* Individual results vary BASELINE “Severe”; 29 inflamed lesions 31 non-inflamed lesions; 1 nodule WEEK 12 “Moderate”; 9 inflamed lesions 5 non-inflamed lesions; No nodules TREATING SEVERE ACNE PATIENT WITH TWYNEO® Subject 507-003 || 18 Years Old | Female | White | Not Hispanic or Latino*
EPSOLAY® FOR INFLAMMATORY LESIONS OF ROSACEA WAS LAUNCHED First and only Benzoyl Peroxide in Rosacea Rosacea care with the brilliant touch of technology
EPSOLAY® OFFERS EFFECTIVE TOPICAL TREATMENT FOR ROSACEA PATIENTS Potential to Change Treatment Landscape Inflammatory lesions of rosacea resemble acne vulgaris, except that comedones (whiteheads and blackheads) are absent and only inflammatory lesions exist EPSOLAY contains encapsulated benzoyl peroxide, using Sol‑Gel’s patented technology. Benzoyl peroxide is an effective antibacterial drug that is not associated with bacterial resistance and is used to treat acne but not rosacea as it is assumed that rosacea patients cannot tolerate benzoyl peroxide. In Phase III clinical studies, EPSOLAY demonstrated statistically significant higher efficacy than the vehicle and favorable safety and tolerability profile, similar to vehicle EPSOLAY is protected by granted patents until 2040 and by a pending patent application until 2041 Not a real patient
BASELINE “Severe”; 31 inflamed lesions WEEK 2 “Clear”; No inflamed lesions “Clear”; No inflamed lesions WEEK 12 “Almost Clear”; 1 inflamed lesion WEEK 8 “Clear”; No inflamed lesions TREATING SEVERE ROSACEA PATIENT WITH EPSOLAY® Subject 116-009 || 41 Years Old | Female | White | Not Hispanic or Latino* WEEK 4 * Individual results vary
PARTNERING WITH MARKET LEADER GALDERMA Galderma has Heritage of Successful Drugs in Acne and Rosacea
REACHING FAVORABLE AGREEMENT WITH GALDERMA Option to Regain Commercialization Rights at No Cost 5 Years following 1st Sale $11 million in upfront and product approval payments Mid- to high-teen percentage of royalties on net sales Up to additional $9 million in sales milestone payments Option to regain commercialization rights 5 years following first sale at no cost Cash-flow positive deal as of launch Allows for focus on innovative pipeline
IMPLEMENTING INNOVATION Enabling Microencapsulation Technology Proprietary silica-based microencapsulation technology allows development of drugs that have the potential to be more effective and tolerable than existing drugs Core/shell structure designed to boost tolerability High encapsulation efficiency aimed to improve stability Particle size and release rate tuned to allow efficient delivery of the entrapped API Patented platform strengthens our IP and creates barrier to entry for generic drugs
Indication: TWYNEO® (tretinoin and benzoyl peroxide) Cream, 0.1%/3% is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with TWYNEO Cream were pain (stinging, burning, or pain), dryness, exfoliation, erythema (redness), dermatitis, pruritus (itching) and irritation - all at the application site. Warnings/Precautions: Patients using TWYNEO Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of TWYNEO Cream immediately and seek medical attention. Skin irritation may be experienced, including application site dryness, pain (stinging, burning or pain), exfoliation, erythema (redness), dermatitis, pruritus (itching) and irritation. Depending upon the severity, use a moisturizer, reduce the frequency of the application, or discontinue use. Avoid application to cuts, abrasions, eczematous, or sunburned skin. TWYNEO Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of TWYNEO Cream at the first evidence of sunburn. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 IMPORTANT SAFETY INFORMATION Indication: EPSOLAY® (benzoyl peroxide) Cream, 5% is indicated for the treatment of inflammatory lesions of rosacea in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with EPSOLAY Cream were pain, erythema (redness), pruritus (itching) and edema (swelling), all at the application site. Warnings/Precautions: Patients using EPSOLAY Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of EPSOLAY Cream immediately and seek medical attention/initiate appropriate therapy. Skin Irritation/contact dermatitis may be experienced, including erythema (redness), scaling, dryness, and stinging/burning. Irritation and contact dermatitis may occur. Use a moisturizer and discontinue EPSOLAY Cream if symptoms do not improve. Avoid application to cuts, abrasions, eczematous, or sunburned skin. EPSOLAY Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of EPSOLAY Cream at the first evidence of sunburn. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088
PURSUING LEADERSHIP IN DERMATOLOGY Innovative Pipeline of Topical Skin Medications FDA Approved SGT-210 (topical erlotinib)Pachyonychia Congenita & other Rare Skin Indications SGT-610 (patidegib gel, 2%)Gorlin Syndrome Start H2/2023 FDA Approved Pre-clinical Phase 2 Phase 3 Filed Research Phase 1 U.S. commercialization by Ongoing
SGT-210 Aims to Reduce Hyperkeratosis Without Systemic Adverse Events Potentially first and only topical erlotinib Pachyonychia congenita is an example of a rare hyperkeratosis skin disorder inherited in an autosomal dominant fashion In this recent case report, orally-administered erlotinib improved the quality of life of pachyonychia congenita patients but was associated with significant adverse events, while topically applied erlotinib, 0.2%, failed to display significant improvement Sol-Gel’s scientists have managed to overcome erlotinib formulation limitations and SGT-210 contains 15 to 25 times higher concentration of erlotinib than the concentration reported to be inefficient Phase 1 is ongoing
Sale of Generic Assets and Securing Non-Dilutive Funding Focusing on innovative pipeline Sale of Generic Assets to Padagis in November 2021 in return for $21.5M in quarterly installments over 24 months Proceed with 50/50 gross profit-sharing collaboration on 2 programs encompassing 4 generic drug candidates Allows for focus on innovative pipeline and reduces the need to raise dilutive capital Sale of Generic Assets to Padagis in November 2021 in return for $21.5M in quarterly installments over 24 months Proceed with 50/50 gross profit-sharing collaboration on 2 programs encompassing 4 generic drug candidates Allows for focus on innovative pipeline and reduces the need to raise dilutive capital
SECURING A STRONG BALANCE SHEET Financial Profile $7.6M proceeds related to revenues from Padagis to be received in 2023 Financials December 31, 2022 Cash and Investments $33.6M Shares Outstanding 23,129,469 ordinary shares Expected Partnership Income Quarterly payments by Padagis; Royalties from Galderma Cash Runway Based on additional proceeds raised from this proposed offering, we anticipate that our cash resources will enable funding until mid-2025 Gross proceeds of $86.3M raised in IPO on February 5, 2018 Gross proceeds of $11.5, $23 and $5M raised in follow-on offerings on August, 2019, February 2020, and April 2020, respectively Generated non-dilutive income totaling $67.1M from agreements with Galderma, Padagis and royalties from two generic drugs
BUILDING OUR FUTURE Investor Highlights Completed development of EPSOLAY and TWYNEO and gained FDA approvals Maximized likelihood of market success for EPSOLAY and TWYNEO through commercialization agreements with US market leader, while retaining the option to regain commercialization rights 5 years following 1st commercial sale Defined innovative product pipeline which targets multiple significant US markets and paves the way, together with the market success of EPSOLAY and TWYNEO, to transform Sol-Gel into a leading dermatology company
NASDAQ: SLGL