Sol-Gel Technologies Ltd 6-K, filed Jun 28, 2021
Sol-Gel Technologies Ltd. (SLGL)
6-K
2021-06-28
For: 2021-06-28
View Original
Added on
April 08, 2026
About this 6-K
Sol-Gel Technologies Ltd filed this 6-K on June 28, 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 June 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”) is posting on its website a corporate presentation, including updates on its balance of
$42.1 million in cash and investments as of May 31, 2021 and its estimate that cash resources will enable funding of the Company’s operational and capital expenditure requirements into the first quarter of 2023 (assuming FDA approval of both
EPSOLAY® and TWYNEO® in 2021, and based on Galderma’s upfront and milestone payments).
Attached hereto and incorporated by reference in this Report on Form 6-K is the following exhibit:
This Form 6-K (without Exhibit 99.1) is hereby incorporated by reference into the Company's Registration Statement on Form S-8 (Registration No. 333-223915) and its Registration Statement on Form
F-3 (Registration No. 333-230564).
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: June 28, 2021
|
By:
|
/s/ Gilad Mamlok
|
|
|
|
|
Gilad Mamlok
|
|
|
|
|
Chief Financial Officer
|
|
3
Exhibit 99.1
NASDAQ: SLGL June 2021
FORWARD-LOOKING STATEMENTS 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 PDUFA goal date for TWYNEO, approval and commercial launch of EPSOLAY
and TWYNEO, the strategic partnership with Galderma, anticipated timing of the initiation of clinical trials for SGT-510, the intellectual property protection that would be provided by patents for SGT-210 and our tapinarof drug product, the
timing of the launch of our tapinarof drug product, the future markets for various skin diseases, the timing of a test and a second POC study of erlotinib, projected profit margins, 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 and TWYNEO; the risk that we not receive any or all of the anticipated benefits of the strategic partnership with Galderma, the risk of a delay in the clinical trials for SGT-510;
the risk that patents for SGT-210 and our tapinarof drug product will not provide the anticipated intellectual property protection; the risk of a delay in the launch of our tapinarof drug product; the risk that our estimate of the markets for
psoriasis, atopic dermatitis and for hyperkeratotic skin diseases are inaccurate; the risk that our tapinarof drug product will not be the only other player besides the brand for a number of years; the risk of a delay in the timing of a test of
erlotinib with a much higher concentrations in an animal model and the risk of a delay of a second POC study on PPK patients; 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.
ROFLUMILAST (SGT-510)Our innovative investigational topical formulation of
roflumilast (SGT-510) was found to be more effective than roflumilast cream, 0.3%, that was formulated by Sol-Gel according to conventional methods of cream formulation, in a human xenograft psoriasis animal model IPO$86.3M raised in
February 2018 PERRIGO PARTNERSHIPTwelve 50/50 gross profit-sharing collaborations TAPINAROF (SGT-310)We are currently developing an innovative investigational formulation of tapinarof (SGT-310) aiming to offer product formulation
innovations and increased affordability for patients compared to the brand expected to be launched ERLOTINIB (SGT-210)Our proof-of-concept study for erlotinib gel (SGT-210) in palmoplantar keratoderma patients was completed and indicated a
possible modest improvement. We plan to investigate higher concentrations of erlotinib GALDERMA PARTNERSHIP5-year license, with option to regain brands. EPSOLAY PDUFA goal date was set for April 26, 2021 (awaiting FDA’s
pre-approval inspection). TWYNEO PDUFA goal date set for August 1, 2021 Our Pipeline OUR DERMATOLOGY COMPANY OVERVIEW
STRATEGIC PARTNERSHIP WITH GALDERMA RECENT UPDATES Option to regain commercialization rights 5
years following first saleWe expect that by then markets will be well-established EPSOLAY and TWYNEO are patent protected until 2040 and 2038, respectively Deal is immediately cash flow positive, with capital to be redeployed towards our
pipeline Exclusive commercialization agreements in the US for TWYNEO and EPSOLAYUp to $15 million in upfront and product approval payments (assuming 2021 approvals of both products)Tiered double-digit royalties (mid- to high-teen
percentage) of net salesUp to an additional $9 million in sales milestone payments
Aiming to provide effective and tolerable topical therapies to achieve local action THE SCIENCE
BEHIND OUR PROPRIETARY TECHNOLOGY
Silica-based shell wraps the BPO crystal and is intended to serve as a barrier between the BPO crystals
and the skin CRYO-SEM PICTURE After application onto skin, BPO slowly migrates through the shell resulting in a continuous flow of BPO for up to 24 hours ENERGY-DISPERSIVE X-RAY SPECTROSCOPY MAPPING ENCAPSULATED BENZOYL PEROXIDE
(E-BPO) ENCAPSULATION IS DESIGNED TO ALLOW FOR CONTINUOUS FLOW
Complete encapsulation allows stabilization of tretinoin in the presence of BPO SEM
PICTURE Silica-based shell allows for slow delivery of tretinoin to the skin over time SEM PICTURE ENCAPSULATED TRETINOIN (E-TRETINOIN) ENCAPSULATION IS DESIGNED TO ENHANCE STABILITY
Papulopustular RosaceaChronic, inflammatory condition that primarily affects the face and is
often characterized by flushing, redness, inflamed bumps, and pustules How is it Treated?Topical antimicrobials (metronidazole, clindamycin)Topical anti-mite (ivermectin)Systemic antibiotics (minocycline, doxycycline) Current Treatment
ShortfallsInsufficient efficacy resulting in poor adherenceSystemic side effectsContributing to antibiotic resistance UNMET NEED IN PAPULOPUSTULAR ROSACEA CHRONIC CONDITION WITH POOR ADHERENCE TO CURRENT TREATMENTS THE CHALLENGE
Encapsulation was designed to allow the BPO to slowly migrate from the microcapsules to help reduce
irritationPDUFA goal date was set for April 26, 2021. Awaiting FDA’s pre-approval inspectionPotential to be the first single-active BPO approved by the FDA as a prescription drug product Benzoyl Peroxide Cream, 5% SOL-GEL
SOLUTION*EPSOLAY® * EPSOLAY is investigational. Safety and efficacy have not been established
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio,
QD EPSOLAY® PHASE III STUDIES
P<0.001 P<0.001 Change from Baseline in Inflammatory Lesion Count Success in IGA Week 12Success
in IGA (ITT) Week 12Inflammatory Lesion Count Change from Baseline (ITT) Study 54-01 Study 54-02 SUCCESS IN PRIMARY ENDPOINTS PHASE III RESULTS P<0.001 P<0.001 Study 54-01 Study 54-02
Success in IGA Week 2Exploratory Endpoint (ITT) Week 8Secondary Endpoint
(ITT) P<0.009 P<0.017 Study 54-01 Study 54-02 P<0.001 P<0.009 Study 54-01 Study 54-02 P<0.001 P<0.006 Study 54-01 Study 54-02 Week 4Secondary Endpoint (ITT) IMPROVEMENT AS OF WEEK 2 SUCCESS IN IGA
Week 2Exploratory Endpoint (ITT) Week 4Secondary Endpoint (ITT) Week 8Secondary Endpoint (ITT) Change
from Baseline in Inflammatory Lesion Count P<0.001 P<0.001 Study 54-01 Study 54-02 P<0.001 P<0.001 Study 54-01 Study 54-02 P<0.001 P<0.001 Study 54-01 Study 54-02 IMPROVEMENT AS OF WEEK 2 REDUCTION OF LESIONS
* Individual results vary BASELINE “Severe”; 31 inflamed lesions WEEK 2 “Clear”; No inflamed
lesions WEEK 4 “Clear”; No inflamed lesions WEEK 12 “Almost Clear”; 1 inflamed lesion WEEK 8 “Clear”; No inflamed lesions ONSET OF ACTION AS OF WEEK 2 SUBJECT 116-009 || 41 YEARS OLD | FEMALE | WHITE | NOT HISPANIC OR LATINO*
Phase III Studies Followed by 40 Weeks Long-Term Safety Study Extension Percentage of
Subjects IMPROVEMENT IN IGA* LONG-TERM SAFETY STUDY * This study was not designed for efficacy; however, efficacy was evaluated. Interpret results with caution
MULTIFACTORIAL DISEASE REQUIRING POWERFUL COMBINATION TREATMENTS Acne VulgarisA multifactorial
disease of the pilosebaceous unit, involving abnormalities in sebum production, follicular epithelial desquamation, bacterial proliferation, and inflammation How is it Treated?Topical BPO, retinoids (such as tretinoin, adapalene), antibiotics,
and their combinationsOral Isotretinoin and antibiotics Current Treatment ShortfallsInsufficient efficacy negatively affects self-esteemSystemic side effectsContributes to antibiotic resistance UNMET NEED IN ACNE VULGARIS LONG-TERM SAFETY
STUDY
Benzoyl Peroxide 3% & Tretinoin 0.1%, Cream SOL-GEL SOLUTION*TWYNEO® * TWYNEO is
investigational. Safety and efficacy have not been established Encapsulation was designed to stabilize tretinoin and to enable both tretinoin and BPO to slowly migrate from their microcapsules to help reduce irritationPDUFA goal date set for
August 1, 2021Potential to be first FDA-approved acne treatment that contains fixed-dose combination of BPO and tretinoin
Two Parallel, Multicenter, Double-Blinded, Randomized, Vehicle-Controlled Studies, 2:1 Ratio,
QD TWYNEO® PHASE III STUDIES
Success in IGA Week 12Success in IGA (ITT) P<0.001 Study 65-04 P<0.017 Study 65-05 SUCCESS IN
IGA PHASE III RESULTS
Week 12Inflammatory Lesion Count Change From Baseline Change from Baseline in Inflammatory Lesion
Count P<0.001 Study 65-04 P=0.018 Study 65-05 P<0.001 Study 65-04 P<0.001 Study 65-05 Week 12Non-Inflammatory Lesion Count Change From Baseline SUCCESS IN REDUCING LESIONS PHASE III RESULTS
* Individual results vary BASELINE “Severe”; 29 inflamed lesions31 non-inflamed lesions; 1
nodule WEEK 12 “Moderate”; 9 inflamed lesions5 non-inflamed lesions; No nodules IMPROVEMENT IN SEVERE PATIENT SUBJECT 507-003 || 18 YEARS OLD | FEMALE | WHITE | NOT HISPANIC OR LATINO*
BROAD LONG-TERM INTELLECUAL PROPERTYESTATE TWYNEO is protected until 2038 by granted patents and
until 2041 by a pending patent application EPSOLAY is protected until 2040 by granted patents and until 2041 by a pendingpatent application 25 patent applications for erlotinib, tapinarof and roflumilast in various skin conditions
(as of February 26, 2021)
LUCRATIVE GENERIC PRODUCTS AND PIPELINE Source: 1 IQVIA sale data 12 collaborations with
Perrigo with 50/50 gross profit sharing 2015 In March 2017, Perrigo filed a Paragraph IV Certification for SOOLANTRA® March 2017 In February 2019, Perrigo launched acyclovir cream, 5%, developed in collaboration with Sol-Gel. This
product generated $22.8 million in net revenues in 2019, $8.7 million in net revenues in 2020 and $0.7 million in net revenues in 1Q/21 February 2019 13:00 - 14:00 In January 2020, Perrigo filed a Paragraph IV Certification
for BRYHALI® January 2020 In June 2020, Perrigo was first-to-file a Paragraph IV Certification for DUOBRII® June 2020 In June 2021, Perrigo began selling a generic ivermectin cream, 1% product. In 2019, sales of the brand name product
amounted to $1921 million in the U.S. June 2021 13:00 - 14:00
Our innovative investigational topical formulation of roflumilast (SGT-510) was found to be more
effective than roflumilast cream, 0.3%, that was formulated by Sol-Gel according to conventional methods of cream formulation, in a human xenograft psoriasis animal model We are currently developing an innovative investigational
formulation of tapinarof (SGT-310) aiming to offer product formulation innovations and increased affordability for patients compared to the brand expected to be launched Our proof-of-concept study for erlotinib gel (SGT-210) in
palmoplantar keratoderma patients was completed and indicated a possible modest improvement. We plan to investigate higher concentrations of erlotinib PIPELINE PROGRESS RECENT UPDATES
REVENUE STREAM FROM PARTNERSHIPS WILL SUPPORT DEVELOPMENT OF OUR INNOVATIVE
PIPELINE EPSOLAY®(benzoyl peroxide) Cream, 5%Papulopustular Rosacea TWYNEO® (benzoyl peroxide and tretinoin) Cream, 3%/0.1%Acne Vulgaris SGT-210 (erlotinib)Palmoplantar Keratoderma SGT-310 (tapinarof)Psoriasis & Other Dermatologic
Indications SGT-510 (roflumilast)Psoriasis & Other Dermatologic Indications Galderma Partnership – U.S. Galderma Partnership – U.S. research pre-clinical phase II phase III filed research pre-clinical phase II phase
III filed research non-clinical phase II phase III filed research non-clinical phase II phase III filed research non-clinical phase II phase III filed EPSOLAYPDUFA GOAL date was set for April 26. Awaiting
FDA's pre-approval inspection.TWYNEOPDUFA goal date set for August 1, 2021 A DIVERSE PIPELINE OF TOPICAL SKIN MEDICATIONS
01 Gross proceeds of $86.3 million raised in IPO on February 5, 2018 02 Gross proceeds
of $11.5 and $23 million raised in public follow-on offerings on August 12, 2019 and February 13, 2020, respectively 03 Additional $5 million investment by controlling shareholder in April 2020 04 23,028,264 Ordinary Shares as of March 31,
2021 05 $8.7 million net revenues from generic products in 2020 and $0.7 million net revenues from generic products in 1Q/21 06 $42.1 million in cash and investments as of May 31, 2021 07 Based on Galderma’s upfront and milestone
payments, we expect that our cash resources will enable funding of operational and capital expenditure requirements into the first quarter of 2023 (assuming timely approval of both products in 2021) FINANCIAL PROFILE RECENT UPDATES
NASDAQ: SLGL