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 July 2019
 
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

On July 8, 2019, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing its positive top-line results from its Phase 3 program evaluating Epsolay® microencapsulated benzoyl peroxide cream, 5%, for the treatment of papulopustular rosacea, which includes preliminary financial results for the second quarter ended June 30, 2019.  The Company is also posting on its website a presentation titled “Epsolay® Phase 3 Results”.
 
Attached hereto and incorporated by reference in this Report on Form 6-K are the following exhibits:
 
Exhibit 99.1: Press Release titled “Sol-Gel Announces Positive Top-Line Results from Epsolay® Phase 3 Program in Papulopustular Rosacea”.
 
Exhibit 99.2: Corporate presentation titled “Epsolay® Phase 3 Results”.

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:  July 8, 2019
By:
/s/ Gilad Mamlok
 
 
Gilad Mamlok
 
 
Chief Financial Officer

 
3



Exhibit 99.1

Sol-Gel Announces Positive Top-Line Results from Epsolay®
Phase 3 Program in Papulopustular Rosacea


All primary and secondary endpoints achieved in both Phase 3 clinical trials

Rapid efficacy demonstrated, with statistical significance reached as early as Week 2 compared with vehicle

Favorable safety and tolerability profile, similar to vehicle

Conference call and webcast today at 8:30 AM ET

NESS ZIONA, Israel, July 08, 2019 – Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) (“Sol-Gel” or the “Company”), today announced positive results from its Phase 3 program evaluating Epsolay® microencapsulated benzoyl peroxide cream, 5%, made with the Company’s proprietary microencapsulation technology, for the treatment of papulopustular rosacea. In two 12-week clinical studies, SGT 54-01 and SGT 54-02, Epsolay demonstrated statistically significant improvement in both co-primary endpoints of (1) the number of patients achieving “clear” or “almost clear” in the Investigator Global Assessment (IGA) and (2) absolute mean reduction from baseline in inflammatory lesion count. In an additional analysis, Epsolay demonstrated rapid efficacy achieving statistically significant improvements on both co-primary endpoints compared with vehicle as early as Week 2. Epsolay demonstrated a favorable safety and tolerability profile similar to vehicle.
 
James J. Leyden, M.D., dermatologist and Emeritus Professor CE of Dermatology at the University of Pennsylvania commented on the results, “It’s exciting that Epsolay delivered outstanding and rapid efficacy with a microencapsulated benzoyl peroxide without irritating the sensitive skin of rosacea patients. These findings are extremely positive and, if Epsolay is approved, it has the potential to represent a significant advance in the treatment of papulopustular rosacea.”
 
Epsolay is the first in a pipeline of dermatologic product candidates in development using Sol-Gel’s proprietary microencapsulation technology. This platform was designed to enable drug substances to be entrapped in porous silica microcapsules in order to address the limitations of topical drug delivery by stabilizing active drug ingredients, extending drug delivery time and reducing potential irritation caused by direct application to the skin. In the fourth quarter of 2019, top-line Phase 3 results are expected for TWIN, the Company’s investigational fixed-dose combination of microencapsulated benzoyl peroxide and microencapsulated tretinoin being studied for acne vulgaris.
 
“While we expected to see strong efficacy and tolerability with Epsolay, the rapid efficacy was a standout in our Phase 3 studies,” said Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “It’s very difficult for patients of any dermatological disease, let alone rosacea, to wait months for a positive clinical result. That a quarter of Epsolay patients in both trials reached their treatment goals within a month, when the efficacy of existing topical products can be quite slow, is clinically meaningful and illustrates a clear unmet need within a rapidly growing marketplace.”
 
SGT 54-01 and SGT 54-02 Trial Design
 
To assess the efficacy and safety of Epsolay in moderate-to-severe papulopustular rosacea, 733 patients aged 18 and older were enrolled in two identical, double-blind, vehicle-controlled Phase 3 clinical trials at 54 sites across the U.S. Patients were randomized at a 2:1 ratio to be treated once-daily with either Epsolay (n=493) or vehicle cream (n=240) for 12 weeks. After the initiation of treatment, clinical and safety evaluations were performed at Weeks 2, 4, 6, 8 and 12. The primary efficacy endpoints for both trials were success in IGA score at Week 12, defined as “clear” (0) or almost clear” (1) on a scale of 0 to 4, and a reduction in absolute mean inflammatory lesion count at week 12.
 

Baseline Papulopustular Rosacea Severity
 
In study SGT 54-01, patients in the Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 25.7 and 26.3, respectively. The proportion of patients with “moderate” (3) or “severe” (4) IGA in the Epsolay treatment group was 86.4% and 13.6%, respectively, and 88.1% and 11.9%, respectively, in the vehicle treatment group.
 
In study SGT 54-02, patients in Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 29.8 and 27.5, respectively. The proportion of patients with “moderate” (3) or “severe” (4) IGA in the Epsolay treatment group was 90.8% and 9.2%, respectively, and 91.8% and 8.2%, respectively, in the vehicle treatment group.
 
Primary Endpoint Results (intention-to-treat population)
 
 
SGT 54-01
SGT 54-02
Epsolay
N=243
Vehicle
N=118
p-value
Epsolay
N=250
Vehicle
N=122
p-value
Proportion of patients achieving “clear” or “almost clear” at Week 12
43.5%
16.1%
<0.001
50.1%
25.9%
<0.001
Absolute mean change in inflammatory lesion count from baseline at week 12
-17.4
-9.5
<0.001
-20.3
-13.3
<0.001

Secondary Endpoint Results (intention-to-treat population)
 
 
SGT 54-01
SGT 54-02
Epsolay
Vehicle
p-value
Epsolay
Vehicle
p-value
Proportion of patients achieving “clear” or “almost clear” at Week 4
25.4%
6.5%
<0.001
26.1%
14.1%
0.009
Absolute mean change in inflammatory lesion count from baseline at Week 4
-14.6
-8.7
<0.001
-16.7
-10.5
<0.001
Proportion of patients achieving “clear” or “almost clear” at Week 8
39.6%
15.8%
<0.001
44.0%
26.0%
0.006
Absolute mean change in inflammatory lesion count from baseline at Week 8
-16.8
-10.6
<0.001
-20.0
-12.4
<0.001

2

 
Exploratory Endpoint Results (intention-to-treat population)
 
 
SGT 54-01
SGT 54-02
Epsolay
Vehicle
p-value
Epsolay
Vehicle
p-value
Proportion of patients achieving “clear” or “almost clear” at Week 2
9.5%
3.1%
0.009
13.2%
5.5%
0.017
Absolute mean change in inflammatory lesion count from baseline at Week 2
-10.5
-5.5
<0.001
-13.0
-8.0
<0.001

Safety and Tolerability
 
Epsolay appeared to be generally safe and well-tolerated with a low rate of cutaneous side effects (e.g., dryness, scaling, itching and burning/stinging) comparable to vehicle. Adverse events were primarily mild to moderate in severity with the most frequently reported adverse events across both studies being application site erythema and application site pain reported by less than 3.4% of subjects. There was no treatment-related serious adverse events, with a combined total of 2 unrelated serious adverse events (1 Epsolay, 1 vehicle) reported across both trials. A combined total of 11 subjects (9 Epsolay, 2 vehicle) discontinued treatment due to an adverse event across both trials.
 
Preliminary Financial Results for the Second Quarter Ended June 30, 2019
 
The Company estimates its revenue for the second quarter of 2019 attributable to sales of its partnered generic product, acyclovir cream, 5%, with Perrigo to be approximately $7.0 million.  To date, this is the only generic acyclovir cream available on the U.S. market.  As of June 30, 2019, the Company’s cash, cash equivalents, deposits and marketable securities is expected to be approximately $49.8 million, excluding the approximate $7.0 million in revenue from acyclovir cream, 5%, in the second quarter of 2019.  Based on current assumptions, the Company expects its existing cash resources will enable funding of operational and capital expenditure requirements through the third quarter of 2020.
 
The estimates above represent the most current information available to the Company’s management and do not present all necessary information for an understanding of the Company’s financial condition as of and the results of operations for the quarter ended June 30, 2019. The Company is currently preparing its financial results for the three months ended June 30, 2019.  The Company’s actual results may differ materially from these estimates. The company plans to release final second quarter financial results on August 8, 2019.
 
3

Conference Call and Live Webcast (with slides) @ 8:30 AM Eastern Time
 
U.S. toll free:          877-282-0504
 
International:          270-215-9895
 
Passcode:                2570059
 
Webcast:                 https://edge.media-server.com/mmc/p/3ukswwiw
 
The webcast can be accessed live on the Events & Presentations section of the Company’s website at http://ir.sol-gel.com.  It will be archived for 30 days following the call.
 
About Epsolay
 
Benzoyl peroxide has not been approved by the FDA for the treatment of rosacea and may cause significant skin irritation in rosacea patients. Epsolay is an innovative topical cream containing microencapsulated benzoyl peroxide, 5%, in development for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products. If approved, Epsolay has the potential to be the first FDA-approved single-active benzoyl peroxide prescription drug product.

About Papulopustular Rosacea
 
Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans.1 The 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 pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.

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’s current product candidate pipeline consists of late-stage branded product candidates that leverage our proprietary, silica-based microencapsulation technology platform, and several generic product candidates across multiple indications.

4

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. 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 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: (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 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 21, 2019 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 to changes in our expectations.

For further information:

Sol-Gel Contact:
U.S. Investor Contact:
Media Contact:
Gilad Mamlok
Chiara Russo
Stephanie Bukantz
Chief Financial Officer
Solebury Trout
Chamberlain Healthcare PR
+972-8-9313433
+1-617-221-9197
+973-477-1814
 
crusso@soleburytrout.com
Stephanie.bukantz@syneoshealth.com

Source: Sol-Gel Technologies Ltd.




1 Data on file, Sol-Gel

5



Exhibit 99.2

 EPSOLAY® PHASE 3 RESULTS 
 

 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. 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: 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 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 our product candidates; 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; our ability to establish adequate sales, marketing, and distribution channels; 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; 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; potential product liability claims; potential adverse federal, state, and local government regulation in the United States, Europe, or Israel; 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 21, 2019, 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 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. 
 

 EPSOLAY® PHASE 3 STUDY DESIGN  Multicenter, parallel, double-blind, randomized, vehicle-controlled, 2:1 ratio, QDInclusion criteria:Male & female ≥ 18 years of age IGA score “moderate” to “severe”≥ 15 ≤ 70 inflammatory lesions≤ 2 nodules  IGA Definition:“Clear”: Skin clear of inflammatory papules or pustules“Almost clear”: Very few small papules or pustules and very mild dull erythema is present“Mild”: Few small papules or pustules and mild dull or light pink erythema is present“Moderate”: Several to many small or larger papules or pustules and moderate light to bright red erythema is present“Severe”: Numerous small and/or larger papules or pustules and severe erythema that is bright red to deep red is present 
 

 STUDY POPULATION & DISCONTINUATION  Study 54-02  Study 54-01  # of Patients  Epsolay®  Vehicle  # of Patients 
 

 PATIENT SEVERITY AT BASELINE    Study 54-01    Characteristic  Epsolay®  Vehicle   IGA “Moderate”IGA “Severe”  210 (86.4%)33 (13.6%)  104 (88.1%)14 (11.9%)  Mean lesion count (SD)Median lesion count (range)  25.7 (11.07)22.0 (15-69)  26.3 (12.45)21.0 (15-70)  Study 54-02    Epsolay®  Vehicle   227 (90.8%)23 (9.2%)  112 (91.8%)10 (8.2%)  29.8 (14.00)25.0 (15-70)  27.5 (13.04)22.5 (15-70) 
 

 PRIMARY ENDPOINTS (ITT)  Study 54-02  Study 54-01  P-value < 0.001  P-value < 0.001  Success in IGA @ Week 12  Inflammatory Lesion Count Change from Baseline @ Week 12  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01 
 

 SECONDARY ENDPOINT (ITT)  Study 54-02  Study 54-01  Inflammatory Lesion Percent Change from Baseline @ Week 12  P-value < 0.001  P-value < 0.001 
 

 EXPLORATORY ENDPOINTS (ITT)  Study 54-02  Study 54-01  Success in IGA @ Week 2  Inflammatory Lesion Count Change from Baseline @ Week 2  P-value = 0.009  P-value = 0.017  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01 
 

 Success in IGA @ Week 4  Inflammatory Lesion Count Change from Baseline @ Week 4  P-value < 0.001  P-value = 0.009  P-value < 0.001  P-value < 0.001  SECONDARY ENDPOINTS (ITT)  Study 54-02  Study 54-01  Study 54-02  Study 54-01 
 

 SECONDARY ENDPOINTS (ITT)  Success in IGA @ Week 8  Inflammatory Lesion Count Change from Baseline @ Week 8  P-value < 0.001  P-value = 0.006  P-value < 0.001  P-value < 0.001  Study 54-02  Study 54-01  Study 54-02  Study 54-01 
 

 ABSOLUTE REDUCTION IN LESION COUNT OVER TIME  Statistical significant improvement in reducing inflammatory lesions as of Week 2  P-value < 0.001  P-value < 0.001 
 

 SUCCESS IN IGA OVER TIME (ITT)  Statistical significant improvement in in getting patients to the stage of “clear” or “almost clear”  P-value < 0.001  P-value < 0.001 
 

 Rapid efficacy of Epsolay®   (†) Sol-Gel did not conduct a head-to-head comparison trial or study. The results described above are for illustrative purposes only and should not be construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study  SIDE-BY-SIDE WITH HISTORICAL SOOLANTRA® RESULTS(†) 
 

 Baseline Characteristics of Active Arm  IGA  Severe  33  23  82  113  26  65  0  51  71      Moderate  210  227  369  346  172  418  557  444  443      Mild  0  0  0  0  0  0  0  0  0    Inflammatory Lesions    25.7  29.8  31.0  33.3  21.6  21.7  18.3  28.5  30.0  Inflammatory Lesions – Mean Percent Change from Baseline @ Week 12  SIDE-BY-SIDE WITH OTHER HISTORICAL TRIAL RESULTS(†)  Success in IGA @ Week 12  Difference from Vehicle  FMX103  Minocycline foam, 1.5%  10-week study  Epsolay®   (†) Sol-Gel did not conduct a head-to-head comparison trial or study. The results described above are for illustrative purposes only and should not be construed as conclusions to be drawn as if we conducted a head-to-head comparison trial or study 
 

 LESION COUNT IMPROVEMENT OVER TIME 
 

 SKIN TOLERABILITY (SAFETY POPULATION)  Study 54-01  Study 54-02      Itching Burning/Stinging Dryness Scaling  Percent of Patients                  Epsolay®      Vehicle              Percent of Patients  Itching Burning/Stinging Dryness Scaling     
 

 No. (%) of Subjects  Study 54-01      Epsolay®  Vehicle  Subjects reporting any TEAE  49 (20.5%)  17 (15.0%)  Serious TEAE  1 (0.4%)1    Severe TEAE  2 (0.8%)    Discontinuation  5 (2.1%)  1 (0.9%)  Treatment-related  14 (5.9%)  3 (2.7%)  Study 54-02    Epsolay®  Vehicle  50 (20.2%)  22 (18.2%)  1 (0.4%)2    2 (0.8%)3    4 (1.6%)  1 (0.8%)4  9 (3.6%)    1 Femur fracture2 Spinal compression fracture3 One subject with spinal compression fracture4 Subject with urinary tract infection – Discontinuation defined as “other” reason   (†)TEAE = Treatment-Emergent Adverse Events  TEAEs (†) (SAFETY POPULATION) 
 

 NASDAQ: SLGLwww.sol-gel.com