Sol-Gel Technologies Ltd 6-K, filed Jun 28, 2021
Sol-Gel Technologies Ltd. (SLGL)
6-K
2021-06-28
For: 2021-06-28
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Added on
July 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
SOL-GEL TECHNOLOGIES LTD.
(Translation of registrant’s name into English)
For the month of May 2021
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
On May 13, 2021, Sol-Gel Technologies Ltd. (the “Company”) issued two press releases: (i) a press release announcing exclusive licenses with Galderma for the commercialization of EPSOLAY® and
TWYNEO® in the United States and (ii) a press release announcing the Company’s pipeline update and future development plans.
Attached hereto are the following exhibits:
This 6-K and Exhibits 99.1 and 99.2 are 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).
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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: June 28, 2021
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By:
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/s/ Gilad Mamok
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Gilad Mamlok
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Chief Financial Officer
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Exhibit 99.1
Sol-Gel Technologies and Galderma announce exclusive licenses for the
commercialization of EPSOLAY® and TWYNEO® in the United States
- Upfront and approval payments of up to $15 million
- Tiered royalties ranging from mid- to high-teen percentage of net sales
- Sol-Gel option to regain commercialization rights 5 years following first commercialization
NESS ZIONA, Israel / LAUSANNE, Switzerland, June 28, 2021 – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, and Galderma, the world’s largest independent
dermatology company, today announced they have signed two exclusive 5-year license agreements for the commercialization of EPSOLAY® and TWYNEO® in the United States.
Under these agreements, Galderma has an exclusive license to commercialize Sol-Gel’s most advanced investigational drug products using Sol-Gel’s proprietary micro-encapsulation technology, in each
case provided the product is approved by the FDA:
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EPSOLAY (benzoyl peroxide, 5%, cream) is under investigation for the treatment of inflammatory lesions of rosacea in adults, with a Prescription Drug User Fee Act (PDUFA) goal date originally set for April 26, 2021. Action on the NDA
for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre-approval inspection of the production site of EPSOLAY due to COVID-19 travel restrictions.
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TWYNEO (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream) is under investigation for the treatment of acne vulgaris with a PDUFA goal date set for August 1, 2021.
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Sol-Gel is entitled to up to $15 million in upfront payments and regulatory approval milestone payments assuming 2021 approval of both products. Sol-Gel is also eligible to receive tiered double-digit royalties ranging
from mid-teen to high-teen percentage of net sales as well as up to $9 million in sales milestone payments.
“Galderma already owns the current market leading brands for rosacea and acne, and I am therefore delighted that Galderma views EPSOLAY and TWYNEO as innovative and with the potential to become key market brands,”
stated Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Our partnerships with Galderma represent an important development for rosacea and acne patients while also strengthening our balance sheet by providing non-dilutive capital without
compromising our desire to establish Sol-Gel as a leading dermatology company. We intend to remain focused on developing our promising pipeline and we are appreciative of the flexibility that these agreements provide through Sol-Gel retaining
commercial rights after the initial five-year term,” commented Dr. Seri-Levy.
“Innovation is at the heart of our commitment to advancing dermatology,” said Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma. “The potential to deliver two
innovative products featuring Sol-Gel’s proprietary micro-encapsulation technology represents an important milestone for acne and rosacea patients and underscores Galderma’s position as the partner of choice in dermatology.”
About EPSOLAY
EPSOLAY is an investigational topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea, also known as papulopustular rosacea, in adults.
EPSOLAY utilizes a patented technology process to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to release benzoyl peroxide slowly over
time to provide a favorable efficacy and safety profile. If approved, EPSOLAY has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product. EPSOLAY is not approved by the FDA and the safety and efficacy
have not been established.
About Papulopustular Rosacea
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans. Rosacea condition is common, especially in fair-skinned people of Celtic and
northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin, or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness
becomes more persistent, blood vessels become visible and inflammatory lesions (papules and pustules) often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
About TWYNEO
TWYNEO is an investigational, fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. If approved, TWYNEO will be
the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin, which are separately encapsulated in silica using Sol-Gel’s proprietary micro-encapsulation technology. Tretinoin and benzoyl peroxide are widely
prescribed separately as a combination treatment for acne; 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. The
silica-based microcapsule is designed to protect tretinoin from oxidative decomposition by benzoyl peroxide, thereby enhancing the stability of the active drug ingredients. The silica-based shell is also designed to release the ingredients slowly
over time to provide a favorable efficacy and safety profile. TWYNEO is not approved by the FDA and the safety and efficacy have not been established.
About Acne Vulgaris
Acne vulgaris is a common multifactorial skin disease that according to the American Academy of Dermatology affects approximately 40 to 50 million people in the United States. The disease occurs
most frequently during childhood and adolescence (affecting 80% to 85% of all adolescents) but it may also appear in adults. Acne 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 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 Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin
diseases. Sol-Gel leverages its proprietary micro-encapsulation technology platform for the development of TWYNEO, under investigation for the treatment of acne vulgaris, and EPSOLAY, under investigation for the treatment of papulopustular rosacea.
The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. 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 more information: www.galderma.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 FDA approval of EPSOLAY AND TWYNEO and statements regarding the timing and
potential commercialization of EPSOLAY and TWYNEO. 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, including statements regarding the financial benefits of the agreements with Galderma, the benefits of EPSOLAY and TWYNEO to patients, and the timing of the commercial availability of EPSOLAY
and TWYNEO. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation 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 of a delay in receipt of approval, if any, of the NDA for TWNYEO, the
risk of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk that Sol-Gel will not receive all the financial benefits under the agreements with Galderma, the risk of a delay in the commercial availability of ESPSOLAY
and/or TWYNEO, the risk that EPSOLAY and 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. Any such forward-looking statements
represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements.
For further information, please contact:
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Sol-Gel Technologies
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Galderma
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Gilad Mamlok
Chief Financial Officer
gilad.mamlok@sol-gel.com
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Shannon Iwaniuk
Global Communications, US
shannon.iwaniuk@galderma.com
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Irina Koffler
Investor relations, LifeSci Advisors
ikoffler@lifesciadvisors.com
+1 917 734 7387
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Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 21 642 71 99
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Exhibit 99.2
Sol-Gel Announces Pipeline Update and Future Development Plans
● Sol-Gel investigational
SGT-510 was found to be more effective than roflumilast cream, 0.3%, in a human
xenograft psoriasis animal model
● Sol-Gel is developing
tapinarof cream, 1%, 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 SGT-210 (erlotinib gel) in palmoplantar keratoderma patients has been
completed and indicated a possible modest improvement
● Sol-Gel to host
Conference Call today at 8:00 am U.S. EDT to discuss the data and provide a corporate update
NESS ZIONA, Israel, June 28, 2021 – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on
identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced positive pre-clinical data for SGT-510, its investigational topical roflumilast drug candidate and provided a
corporate update.
The study was conducted at the Skin Research Laboratory, Rappaport Faculty of Medicine, Technion Institute of Technology, Haifa, Israel,
under the supervision of Professor Amos Gilhar, M.D. Professor Gilhar has pioneered a human psoriasis xenograft mouse model, consisting of immunodeficient mice
transplanted with healthy human skin, and used it to validate a number of approved topical and systemic dermatology products, including those sold by large pharmaceutical companies. For the study, the human xenograft animal model was induced with
psoriasis by injection of activated allogeneic IL2-enriched peripheral blood mononuclear cells isolated from psoriatic patients. The mice were then treated with several topical agents and assessed for recovery after each intervention.
"Our model has been proven to predict efficacy for novel approaches in the treatment of psoriasis, providing very valuable information to
the companies leveraging this assay,” commented Professor Gilhar.
All tested articles were applied for 14 days either once or twice daily:
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Nine (9) out of 10 animals fully recovered following a twice-daily application of dexamethasone (the positive control);
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None (0) out of 10 recovered following a once-daily application of vehicle cream (the negative control);
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Three (3) out of 10 animals recovered following a once-daily application of roflumilast cream, 0.3% that was formulated by Sol-Gel according to conventional methods of cream formulation;
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Six (6) out of 10 animals fully recovered following once-daily application of SGT-510.
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Based on these results, Sol-Gel filed a provisional patent application for its novel and non-obvious formulation of SGT-510. By the end
of 2022, the Company expects to have head-to-head data against a formulation of roflumilast cream, 0.3% and expects to initiate Phase 2 work thereafter.
Mr. Mori Arkin, Executive Chairman of the Board of Sol-Gel, commented, “While this small study does not represent a formal statistical
analysis, we are very pleased that these early-stage results, demonstrating 60% recovery after a once-daily application of SGT-510 in the human psoriasis xenograft mouse model, supported our predefined hypothesis and confirmed our expectations
about formulation superiority using our approach. Given our expertise in formulation science and topical drug delivery, we believe that we have an advantage due to the patentability of SGT-510. It is our belief that if these results are
corroborated by clinical studies, a patent, if granted, will provide us not only freedom to operate, but more importantly, intellectual property protection against generic entrants until expiry of our patent in 2040.
Mr. Arkin continued, “Due to the safety-limiting features of steroids, the prospect of an effective alternative to steroid medicine for
the treatment of psoriasis, such as SGT-510, is significant and would fill a critical unmet need for these patients. Sol-Gel intends to develop SGT-510 in accordance with the 505(b)(2) regulatory pathway by only referencing the oral roflumilast
brand DALIRESP®. The rationale for this carefully planned regulatory strategy is to create a clear path to market, with no litigation requirement. We expect that all Orange Book-listed DALIRESP® patents will have expired by the time of its New
Drug Application (NDA) submission, and that no Paragraph IV certification with a consequent 30-month stay would be required. As we plan to develop more than one roflumilast product, including potential combination products, we may also utilize
alternative regulatory strategies. Our deep involvement in topical generics along with the supportive view of independent intellectual property experts guides us to believe that there is a significant risk that present patents and patent
applications for roflumilast 0.3% cream may be unable to prevent early genericization of the roflumilast products currently under development. Should this be the case, our innovative formulations of roflumilast, if approved by the FDA, would give
us the opportunity to become a leading player in the multi-billion-dollar psoriasis and atopic dermatitis markets in the second half of the decade.”
Mr. Arkin added, “Separately, we have made progress towards the development of our proprietary formulation of tapinarof cream, 1%,
SGT-310. We plan to pursue a de-novo NDA via the 505(b)(1) regulatory pathway, with the goal of creating a second alternative to an investigational tapinarof cream, 1%, for which an NDA was already submitted to the FDA. According to this strategy,
we plan to launch our tapinarof drug product worldwide no later than five years following the U.S. approval of the first tapinarof cream, aiming to increase affordability for patients compared to the brand expected to be launched. In addition, we
intend to differentiate ourselves by offering tapinarof product formulation innovations for new indications. We have already been refining our strategy in line with best regulatory practices, and our drug product will be developed via our active
pharmaceutical ingredient (API) manufacturing collaboration with Wavelength Pharmaceuticals, previously known as Perrigo API, a company with an impressive track record of FDA GMP compliance.”
Mr. Arkin further added: “Our proof-of-concept (POC) study for SGT-210 (erlotinib gel) in six (6) palmoplantar keratoderma (PPK) patients
has been completed and indicated modest improvement and a favorable safety profile. In this study, we used a very low concentration of erlotinib. We are now planning to test erlotinib at much higher concentrations in an animal model in the second
half of 2021 and if successful, will conduct a second POC study on PPK patients in 2022. We remain optimistic about this program.”
Management to Host Conference Call Today
Sol-Gel will host an investor conference call today at 8 AM U.S. EDT to discuss today’s announcement, herein, and the strategy of the
company following today’s partnership news, announced separately.
To participate in the call, dial either the domestic or international number fifteen minutes before the conference call begins:
Domestic: 1-877-407-0784
International: 1-201-689-8560
Passcode: 13720829
The live conference call and replay can also be accessed by audio webcast here and also on the Investor Relations section of the Company’s website, located at https://ir.sol-gel.com/investor-relations.
About Roflumilast
Roflumilast is a selective, long-acting inhibitor of Phosphodiesterase-4 (PDE4). It is the active ingredient in the Food and Drug
Administration (FDA) approved medication, DALIRESP®, which is as an oral treatment indicated in the U.S. as a therapy to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of
exacerbations.
A roflumilast cream 0.3% formulation is under investigation as a once-daily treatment of plaque psoriasis and positive Phase 3 results
were recently reported.
About Tapinarof
Tapinarof is a novel, first-in-class, small-molecule topical therapeutic aryl hydrocarbon receptor (AhR)–modulating agent. It is
in clinical development for the treatment of psoriasis and atopic dermatitis. The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a ligand-dependent transcription factor, leading to the
downregulation of proinflammatory cytokines, including interleukin 17, and regulation of skin barrier protein expression to promote skin barrier normalization.
About Erlotinib
Erlotinib is a tyrosine kinase receptor inhibitor which acts on the Epidermal Growth Factor Receptor (EGFR). It is the active
pharmaceutical ingredient (API) in Tarceva® which is used to orally treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. Currently, there are no topical products of erlotinib, and erlotinib is not approved for
plaque psoriasis.
About Wavelength Pharmaceuticals
Wavelength is a customer-focused backward-integrated world-class developer and manufacturer of Active Pharmaceutical Ingredients
(APIs). It is the independent company of choice for pharmaceutical industry leaders that require advanced API solutions and reliable supply to gain sustainable competitive advantage. The company is on the same wavelength as its customers – a
partner in tune with the results required to best support their needs. Founded in Israel in 1987, with more than 280 customers in 50 countries, Wavelength produces more than 630 metric tons of commercial products every year, across a wide range
of technologies including injectables, inhalables, highly potent, cytotoxic and controlled substances. Its cGMP-compliant facility is a first-class operation recognized for excellence in safety and environmental stewardship. Wavelength has
achieved an exceptional track record for more than 30 years with all leading global regulatory authorities, including USFDA, EU-EMA, PMDA, TGA, KFDA, ANVISA and COFEPRIS. The company includes experts in complex chemistry, process development and
scale-up, enzymatic reactions, crystalline forms and particle design, spray drying and other bioavailability-enhancing solutions. Wavelength offers end-to-end customized solutions to meet individual customer requirements, including full-spectrum
API CDMO services from pre-clinical grams to multi-ton commercial scale – always with uncompromising consistent quality, regulatory compliance and exceptional customer service.
About Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug
products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for the development of TWYNEO® under investigation for the treatment of acne vulgaris with an NDA filed with the FDA and a PDUFA goal date set for August 1, 2021; and EPSOLAY®, under investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA goal date set for April 26, 2021. Both product candidates are exclusively licensed for U.S. commercialization with Galderma Holding SA. Action on the NDA for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre-approval inspection of the production site of EPSOLAY as a result of
COVID-19 travel restrictions. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, under investigation for the treatment of palmoplantar keratoderma, and preclinical
assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.
Forward-Looking Statements
This press release contains
“forward-looking statements” within the meaning Securities of the Private 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. 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, including
statements regarding the timing for the initiation of a Phase I study for SGT-510, the intellectual property protection that would be provided by a patent for SGT-210, the anticipated status of patents at the time of an NDA submission for
SGT-210, the timing of the launch of our tapinarof drug product and the timing of a test of erlotinib with a much higher concentrations in an animal model and a second POC study on PPK patients. Forward-looking statements are based on information we have when those statements are made or our management’s current expectation 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 of a delay in receipt
of approval, if any, of the NDA for TWNYEO, the risk of a further delay in receipt of approval, if any, of the NDA for EPSOLAY, the risk of a delay in the initiation of a Phase I study for SGT-510, the risk that a patent for SGT-210 will not
provide the anticipated intellectual property protection, the risk that all Orange Book-listed DALIRESP® patents will not have expired by the time of our NDA application for SGT-21 and that a consequent 30-month stay will required, the risk of a
delay in the launch of our tapinarof drug product, the risk of a delay the timing of a test of erlotinib with a much higher concentrations in an animal model and the risk of a delay in a second POC study on PPK patients, 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. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any
forward-looking statements after the date of this press release to conform these statements.
For further information, please contact:
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Sol-Gel Technologies
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Gilad Mamlok
Chief Financial Officer
+972-8-9313433
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Investor relations
Irina Koffler
LifeSci Advisors
+1-917-734-7387
ikoffler@lifesciadvisors.com
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