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 November 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
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.
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: November 16, 2021
|
By:
|
/s/ Gilad Mamlok
|
|
|
|
Gilad Mamlok
|
|
|
|
Chief Financial Officer
|
3
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, 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
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
ACHIEVING FDA APPROVAL and BUILDING our FUTURE Investor Highlights Completed development of
EPSOLAY and TWYNEO on time Gained FDA approval for TWYNEOEPSOLAY pre-approval inspection is pending Built a strong balance sheet that currently allows us to finance our activities 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 $46 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
TWYNEO® EPSOLAY® MAXIMIZING COMMERCIALIZATION SUCCESS of EPSOLAY and TWYNEO Strategic Partnership
with Market Leader Galderma
MAXIMIZING COMMERCIALIZATION SUCCESS of EPSOLAY and TWYNEO Galderma Leads the US Acne and Rosacea
Markets
MAXIMIZING COMMERCIALIZATION SUCCESS of EPSOLAY and TWYNEO Galderma is Committed to Innovation
TWYNEO® EPSOLAY® MAXIMIZING COMMERCIALIZATION SUCCESS of EPSOLAY and TWYNEO Strategic
Partnership with Market Leader Galderma Up to $15 million in upfront and product approval payments Mid- to high-teen percentage of net sales royaltiesUp to an additional $9 million in sales milestone paymentsOption to regain commercialization
rights 5 years following 1st sale at no cost to Sol-Gel Cash-flow positive deal as of launchFocusing on innovative pipeline
2 generic drugs: acyclovir cream and ivermectin cream8 unapproved generic programs FOCUSING on
INNOVATIVE PIPELINE while SECURING NON-DILUTIVE FUNDING Sale of Generic Assets to Padagis
FOCUSING on INNOVATIVE PIPELINE while SECURING NON-DILUTIVE FUNDING Sale of Generic Assets to
Padagis Focusing on innovative pipeline Reducing the need to raise dilutive capital $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
Acne vulgaris is a multifactorial disease. Even though benzoyl peroxide and tretinoin are widely
prescribed separately and have a complimentary 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, using
Sol‑Gel’s patented technology to prevent tretinoin from being degraded by benzoyl peroxide and slowly releasing 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 TWYNEO® OFFERING COMPREHENSIVE TREATMENT for ACNE PATIENTS First and only FDA Approved Fixed‑Dose Combination of Tretinoin and Benzoyl Peroxide
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. Awaiting FDA’s pre-approval inspection; delayed due to COVID-19 travel restrictionsPatent 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
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 favourable 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 this year); 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 BUILDING a STRONG BALANCE SHEET Financial Profile
NASDAQ: SLGL