Sol-Gel Technologies Ltd 6-K, filed Jan 5, 2022
Sol-Gel Technologies Ltd. (SLGL)
6-K
2022-01-05
For: 2022-01-05
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April 08, 2026
About this 6-K
Sol-Gel Technologies Ltd filed this 6-K on January 5, 2022.
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 January 2022
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. (the “Company”) has made available an updated presentation about its business, a copy of which is furnished herewith as Exhibit 99.1 and incorporated by reference.
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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.
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SOL-GEL TECHNOLOGIES LTD.
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Date: January 5, 2022
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By:
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/s/ Gilad Mamlok
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Gilad Mamlok
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Chief Financial Officer
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Exhibit 99.1
NASDAQ: SLGL
This presentation contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,”
“anticipate,” “could,” “future,” “outlook,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions, although not all
forward-looking statements contain these words. The forward-looking statements in this presentation relate to, among other things, statements regarding the Food and Drug Administration (FDA) approval of EPSOLAY, the strategic partnership
with Galderma, the sale of generic assets to Padagis, progress on our innovative earlier stage programs, including the anticipated timing of the clinical development of SGT-510, SGT-310 and SGT-210, the future markets for various skin
diseases, and, our expectations regarding our liquidity and ability to fund operational and capital expenditure requirements. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties, and
other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statement, including but
not limited to the following: risks relating to the timing of the PDUFA action date for EPSOLAY, the timing of FDA approval, if any, of EPSOLAY; the risk that we will not be successful in marketing additional products and the timing of such
marketing; the risk that we will not receive the anticipated benefits of the strategic partnership with Galderma or the agreement with Padagis; the risk that we don’t progress on our innovative earlier stage programs, the risk of a delay in
the clinical development of SGT-510, SGT-310 and SGT-210, if any; the risk that our estimate of the markets for psoriasis and plaque psoriasis are inaccurate; the fact that we have and expect to continue to incur significant losses; our
need for additional funding, which may not be available; our ability to complete the development of, and obtain marketing approval for, our product candidates; our ability to obtain and maintain regulatory approvals for our product
candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; our ability to commercialize and launch our product candidates at all or
on a timely basis; our ability to obtain and maintain adequate protection of our intellectual property; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; acceptance
of our product candidates by healthcare professionals and patients; the possibility that we may face third-party claims of intellectual property infringement; 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; delays in the launch of product candidates and generic drugs; intense competition in our industry; potential product liability claims; potential adverse federal, state,
and local government regulation in the United States, Europe, or Israel; the impact of pandemics, such as COVID-19 (coronavirus); and 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 in 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 presentation. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in
the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as
expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this presentation. This presentation contains
trademarks, trade names, and service marks of other companies, which are the property of their respective owners. We do not intend our use or display of other parties' trademarks, trade names, or service marks to imply, and such use or
display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties. Forward-Looking Statements
EPSOLAY®Benzoyl Peroxide Cream, 5%forInflammatory Lesions of Rosacea PIONEERING TOPICAL DRUGS IN
ACNE AND ROSACEA Potential to Change Treatment Landscape* * EPSOLAY is investigational drug product. Safety and efficacy have not been established TWYNEO® Tretinoin and Benzoyl Peroxide Cream, 0.1%/3%forAcne
Vulgaris >>Pre-approval inspection during the week of February 14th <<
PARTNERING WITH MARKET LEADER GALDERMA Galderma has Heritage of Successful Drugs in Acne and
Rosacea
REACHING FAVORABLE COMMERCIALIZATION AGREEMENT Option to Regain Commercialization Rights after 5
Years at No Cost $11 million in upfront and product approval payments Mid- to high-teen percentage of royalties on net salesUp to an additional $9 million in sales milestone payments Option to regain commercialization rights 5
years following 1st sale at no cost to Sol-Gel Cash-flow positive deal as of launchAllows for focus on innovative pipeline
TWYNEO® OFFERING COMPREHENSIVE TREATMENT FOR ACNE PATIENTS First and only FDA Approved Fixed‑Dose
Combination of Tretinoin and Benzoyl Peroxide 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 tretinoinTWYNEO 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 profilePatent protected until 2038 by granted patents and until 2041 by a pending patent application
BASELINE “Severe”; 29 inflamed lesions31 non-inflamed lesions; 1 nodule WEEK 12 “Moderate”; 9
inflamed lesions5 non-inflamed lesions; No nodules TREATING SEVERE ACNE PATIENT Subject 507-003 || 18 Years Old | Female | White | Not Hispanic or Latino* * Individual results vary
Inflammatory lesions of rosacea resemble acne vulgaris, except that comedones (whiteheads and
blackheads) are absent and only inflammatory lesions existEPSOLAY 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 vehiclePDUFA goal date was set for April 26, 2021. FDA’s pre-approval inspection which was delayed due to COVID-19 travel restrictions is now scheduled for the week of February 14th,
2022Patent protected until 2040 by granted patents and until 2041 by a pending patent application EPSOLAY® OFFERING A NEW EFFECTIVE TOPICAL TREATMENT FOR ROSACEA PATIENTS First and only Benzoyl Peroxide in Inflammatory Lesions of
Rosacea* * EPSOLAY is investigational drug product. Safety and efficacy have not been established
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 Subject 116-009 || 41 Years Old | Female | White | Not Hispanic or Latino* WEEK 4 * Individual results vary
FOCUSING ON INNOVATIVE PIPELINE WHILE SECURING NON-DILUTIVE FUNDING Sale of Generic Assets to
Padagis $21 million in quarterly installments over 24 monthsProceed with 50/50 gross profit-sharing collaboration on 2 programs encompassing 4 high-value generic drug candidates Allows for focus on innovative pipeline Reducing the need to
raise dilutive capital
pre-clinical phase II phase III filed research phase I pre-clinical phase
II phase III filed research phase I FDA approval07/26/21 EPSOLAY®Benzoyl Peroxide Cream, 5%Inflammatory Lesions of Rosacea TWYNEO® Tretinoin and Benzoyl Peroxide Cream, 0.1%/3%Acne Vulgaris SGT-510Topical
RoflumilastPsoriasis & Other Dermatologic Indications PURSUING LEADERSHIP IN DERMATOLOGY Innovative Pipeline of Topical Skin Medications SGT-210Topical erlotinibPalmoplantar Keratoderma & Other Dermatologic
Indications non-clinical phase II phase III filed research phase I SGT-310Tapinarof CreamPsoriasis & Other Dermatologic Indications non-clinical phase II phase III filed research phase
I POC Pending pre-approval Inspection non-clinical phase II phase III filed research phase I
Initiate clinical development with a higher concentration of erlotinib in H2 22 DEVELOPING FIRST
ERLOTINIB TOPICAL DRUG SGT-210 for Palmoplantar Keratoderma and other Skin Conditions NEXTSTEPSSGT-210 12 patent applications for erlotinib in various skin conditions (as of August 16, 2021)Potential IP protection until 2041 A
proof-of-concept clinical study in palmoplantar keratoderma patients indicated a potential modest improvement with a favorable safety profile
Initiate clinical development in H2 22 DEVELOPING NOVEL TAPINAROF CREAM SGT-310 for Psoriasis and
other Skin Conditions NEXTSTEPSSGT-310 31 patent applications for tapinarof in various skin conditions (as of August 16, 2021)Potential IP protection until 2042 SGT-310 is intended to be an alternative to an investigational
tapinarof cream, 1%, for which an NDA was already submitted to the FDA
SGT-510 is designed to be potentially more effective than roflumilast cream, 0.3%, for which an NDA
was already submitted to the FDA DEVELOPING NOVEL ROFLUMILAST TOPICAL DRUG SGT-510 for Psoriasis and other Skin Conditions NEXTSTEPSSGT-510 A patent application was filedPotential IP protection until 2039 Initiate clinical
development in H2 22
Financials September 30, 2021 Cash and Investments $45.6 million Shares Outstanding 23,119,068
ordinary shares Expected Partnership Payments EPSOLAY approval milestone payment (if approved); Quarterly payments by Padagis; Royalties from Galderma Cash Runway Based on expected payments from Galderma and Padagis, we anticipate that
our cash resources will enable funding of operational and capital expenditure requirements until the end of 2023 Gross proceeds of $86.3 million raised in IPO on February 5, 2018 Gross proceeds of
$11.5 and $23 million raised in public follow-on offerings on August 12, 2019, and February 13, 2020, respectively Additional $5 million investment by controlling shareholder in April 2020 $2.9 million net revenues from generic products
in the first 9 months of 2021 SECURING A STRONG BALANCE SHEET Financial Profile
BUILDING OUR FUTURE Investor Highlights Completed development of EPSOLAY and TWYNEO
Gained FDA approval for TWYNEOEPSOLAY pre-approval inspection has been scheduled Built a strong balance sheet that currently allows for financing of operations until the end of 2023 Secured additional $21 million by transferring rights in
2 generic drugs and 8 unapproved programs to PadagisRetained rights to 4 high-value generic drug candidates Generated non-dilutive income totaling $42 million from agreements with Galderma and royalties from two generic drugs Maximized
probability of launch success for EPSOLAY and TWYNEO through commercialization agreements with US market leader, GaldermaRetained the option to regain commercialization rights 5 years following 1st commercial sale Defined innovative
product pipeline which targets multiple US markets exceeding $2 billion
NASDAQ: SLGL