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SLGL Sol Gel Technologies Ltd

0.429
-0.0112 (-2.54%)
20 Dec 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Sol Gel Technologies Ltd NASDAQ:SLGL NASDAQ Common Stock
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -0.0112 -2.54% 0.429 0.405 0.51 0.479899 0.411 0.4409 48,614 21:30:00

Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

16/08/2024 12:15pm

Edgar (US Regulatory)


0001684693--12-31false6-K2024-06-30Q2


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 August 2024
 
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 August 16, 2024, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing the Company's financial results for the quarter ended June 30, 2024. In addition, the Company is submitting with this Form 6-K its unaudited condensed consolidated financial statements as of June 30, 2024 and for the three and six months then ended.
 
Attached hereto are the following exhibits:
 
 
 
Exhibit 99.1 (other than the two paragraphs immediately preceding the heading “Q2 2024 and Recent Corporate Developments”) and 99.2 are hereby incorporated by reference into the Company's Registration Statements on Form S-8 (Registration Nos. 333-223915 and 333-270477) and its Registration Statement on Form F-3 (Registration No 333-264190).
 
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: August 16, 2024
By:
/s/ Eyal Ben-Or
 
 
Eyal Ben-Or
 
 
Chief Financial Officer

 

3



Exhibit 99.1

          

Sol-Gel Reports Second Quarter 2024 Financial
Results and Provides Corporate Updates
 

Following recent transactions and cost-cutting efforts, Sol-Gel’s cash runway is expected to extend into the first quarter of 2026
 

Ongoing Phase 3 clinical trial of SGT-610 for Gorlin Syndrome with over 30 clinical sites activated; Top-line results are expected by the second quarter of 2026


SGT-210 proof-of-concept study in patients suffering from Darier disease, a significant unmet medical need in dermatology, is ongoing
 

Sol-Gel sells its rights in the Abbreviated New Drug Application (ANDA) drug product generic to Zoryve® Cream (roflumilast cream 0.3%)
 

Following management realignment, Mr. Mori Arkin, the Company’s executive chairman and controlling shareholder to be appointed as Company’s interim CEO as of January 1, 2025, subject to shareholders approval
 

Sol-Gel recently signed license agreements with respect to TWYNEO and EPSOLAY in Europe and South Africa and is negotiating additional license deals in Latin America and other territories
 
NESS ZIONA, Israel, August 16 2024 (GLOBE NEWSWIRE) - Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with severe skin conditions, conducting a Phase-3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced financial results for the second quarter ended June 30, 2024, and provided a corporate update.
 
Q2 2024 and Recent Corporate Developments
 
On August 15, 2024, Sol-Gel signed a new agreement with Padagis, which replaces the parties’ prior collaborative agreement for the development and commercialization of a drug product generic to Zoryve® Cream (roflumilast cream 0.3%). Under this new agreement, Sol-Gel is to unconditionally receive quarterly payments which will be paid over 24 months and low single digit royalties from gross profits from sales of roflumilast cream for a period of five years, in lieu of its 50% share in future gross profits from such sales. In addition, Sol-Gel will cease paying any outstanding and future costs related to this prior collaborative agreement. The amount to be received by Padagis together with the elimination of future expected expenses related to this asset is expected to enhance our cash position by approximately $6 million. Recognizing that TWYNEO and EPSOLAY have a significant commercial potential also outside the U.S., during July 2024, Sol-Gel has successfully signed six initial license agreements with key partners covering most European countries and South Africa. Sol-Gel expects to sign additional agreements covering the majority of Latin American countries, Australia, New Zealand, South Korea, Spain, Italy and Portugal. These already signed agreements together with agreements we anticipate to sign in the future, are expected to provide upfront and regulatory milestone payments of up to $3.7 million, which we expect to utilize on adapting TWYNEO and EPSOLAY to the regulatory requirements of these new territories. Based on the forecasts received from Sol-Gel’s current and potential partners, Sol-Gel expects that TWYNEO and EPSOLAY will launch in the majority of these new territories in 2027 and 2026 respectively, and following launch these transactions are anticipated to provide Sol-Gel with an annual royalty revenue stream starting with approximately $1 million to $2 million in 2026 and growing gradually to approximately up to $10 million for the year 2030 and further.
 

The Phase 3 study in Sol-Gel’s key asset SGT-610 in approximately 140 subjects (with 100 subjects required to complete the Study), at about 42 experienced clinical centers is ongoing. To date, Sol-Gel has signed agreements with 39 centers in multiple countries, including the U.S., Germany, Italy, France, and the UK, and approximately 29 of these enters have been activated. Top line results are anticipated in Q2 2026. SGT-610 is a topically applied patidegib, a hedgehog signaling pathway blocker 2% gel If approved, SGT-610 is expected to be the first approved product for the prevention of new BCC lesions in Gorlin syndrome patients and is targeting a market exceeding $300 million annually.
 
Sol-Gel’s proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease is ongoing. Darier disease is a significant unmet medical need, with a market potential estimated between $200 to $300 million. If we successfully complete this proof-of-concept study and  the required pre-clinical studies, we anticipate filing for a Phase 2 IND in Q2 2025. SGT-210 is currently being used in a compassionate use treatment of a pediatric patient suffering from a rare disease, and given the preliminary highly encouraging response, we are cautiously optimistic about the potential for success in other viable keratoderma indications, recognizing that further research and clinical studies are necessary to validate any broader applications of our therapy.
 
Subject to shareholders approval, Mr. Arkin, the Company’s executive chairman and controlling shareholder, who has several decades of experience in leading positions in the pharmaceutical industry and in the dermatological space in particular, will assume the role of interim CEO as of January 1, 2025. During his tenure as interim CEO, Mr. Arkin plans to transition away from the majority of his other business activities in order to dedicate himself to his new full time position as interim CEO of the Company. Mr. Arkin will not be entitled to any compensation for assuming this position. On July 15, 2024, Sol-Gel announced management realignment whereby pending shareholder approval our CEO Dr. Alon Seri-Levy will step down as CEO and Board member, effective December 31, 2024, and will then continue to serve the Company as a consultant to our new CEO and management team for at least one year.
 
Effective July 12, 2024, Mr. Eyal Ben-Or, the Company's previous Director of Finance, assumed the role of Chief Financial Officer (CFO). Prior to his employment in Sol-Gel Mr. Ben-Or worked at Mobileye and KPMG Israel. Mr. Ben-Or, is a certified public accountant, holds an MBA and a BA in accounting from the College of Management in Israel. Mr. Ben-Or replaces the Company’s previous CFO, Mr. Gilad Mamlok, who will facilitate the transition through December 31, 2024.
 
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Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "We are encouraged by Sol-Gel’s financial results for the second quarter of 2024 and our ability to extend our cash runway into the first quarter of 2026. We will continue to explore opportunities for non-dilutive funding to potentially further extend our runway through topline results. In our pipeline, we continue to conduct the pivotal Phase 3 clinical trial of SGT-610 for preventing new basal cell carcinomas in Gorlin Syndrome patients, targeting a market exceeding $300 million, with top line results anticipated in the second quarter of 2026 along with our proof-of-concept study for SGT-210 (topical erlotinib) in Darier disease patients targeting a market of between $200 to $300 million. These two rare disease projects reflect the huge growth potential of a company of our size. The Sol-Gel management team and I are committed to spare no effort to realize this potential"
 
Financial Results for the Second Quarter 2024
 
Total revenue in the second quarter was $5.4 million, which primarily consisted of a one-time licensing revenue from Beimei, Galderma and Searchlight, compared to $0.6 million revenues for the same period in 2023.
 
Research and development expenses were $2.4 million compared to $5.3 million for the same period in 2023. The decrease of $2.9 million was primarily attributed to a decrease of $0.7 million in manufacturing expenses related to TWYNEO, a decrease of $0.7 million in clinical development expenses related to a generic product candidate, a decrease of $0.5 million in payroll expenses due to the adoption of cost saving measures initiated during the third quarter of 2023, a decrease of $0.5 related to R&D expenses, a decrease of $0.3 million in clinical trial expenses related to SGT-610 and a decrease of $0.2 in clinical expenses related to SGT-210.
 
General and administrative expenses were $1.4 million compared to $1.8 million for the same period in 2023. The decrease of $0.4 million was mainly attributed to a decrease in professional expenses.
 
Sol-Gel reported a net income of $1.9 million for the second quarter of 2024 and earnings of $0.07 per basic and diluted share, compared to a net loss of $6.0 million and a loss of $0.22 per basic and diluted share for the same period in 2023.
 
As of June 30, 2024, Sol-Gel had $15.6 million in cash, cash equivalents, and deposits and $14.9 million in marketable securities for a total balance of $30.5 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2026.
 
About TWYNEO and EPSOLAY
 
TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; 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. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream.
 
3

EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment.

About Gorlin Syndrome and SGT-610
 
SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors.
 
About Darier Disease and SGT-210
 
SGT-210 is a topical erlotinib drug candidate that is formulated for the treatment of Darier Disease and other hyperkeratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor that acts on the epidermal growth factor receptor, a protein present on cell surfaces that plays a key role in promoting cell growth and division. Darier Disease is a rare, genetic keratinization disorder which is classically characterized scaly crusted  papules in a seborrheic  distribution and in skin folds.
 
About Sol-Gel Technologies
 
Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults.
 
The Company’s pipeline also includes Phase 3 clinical trial of Orphan and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyper keratinization disorders.
 
For additional information, please visit our new website:  www.sol-gel.com
 
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, including, but not limited to the amounts to be received under our current and future licensing agreements and our agreement with Padagis with respect to the generic drug product to Zoryve® Cream (roflumilast cream, 0.3%), the out-licensing Twyneo and Epsolay in additional territories, our expected cash runway, the expected royalties amounts to be received from Galderma, the potential of Sol-Gel’s assets including Twyneo, Epsolay, SGT-610, and SGT-210, the timeline for advancing SGT-610 and SGT-210, and the size of SGT-610’s market.  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 expectations 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, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations, a delay in the timing of our clinical trials, the success of our clinical trials, and an increase in our anticipated costs and expenses, 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 collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ 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, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and,  (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors 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 13, 2024, 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. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release.
 
Sol-Gel Contact:
Eyal Ben-Or
Chief Financial Officer
info@sol-gel.com
+972-8-9313429
 
 
Source: Sol-Gel Technologies Ltd.
 
5

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
December 31,
   
June 30,
 
   
2023
   
2024
 
A s s e t s
           
CURRENT ASSETS:
           
Cash and cash equivalents
 
$
7,513
   
$
11,549
 
Bank deposits
   
10,012
     
4,012
 
Marketable securities
   
20,471
     
14,912
 
Accounts receivables
   
377
     
6,059
 
Prepaid expenses and other current assets
   
2,794
     
1,750
 
TOTAL  CURRENT ASSETS
   
41,167
     
38,282
 
                 
NON-CURRENT ASSETS:
               
Restricted long-term deposits and cash equivalents
   
1,284
     
1,273
 
Property and equipment, net
   
434
     
305
 
Operating lease right-of-use assets
   
1,721
     
1,507
 
Other long-term assets
   
55
     
34
 
Funds in respect of employee rights upon retirement
   
626
     
604
 
TOTAL  NON-CURRENT ASSETS
   
4,120
     
3,723
 
TOTAL  ASSETS
 
$
45,287
   
$
42,005
 
Liabilities and shareholders' equity
               
CURRENT LIABILITIES:
               
Accounts payable
 
$
154
   
$
679
 
Other accounts payable
   
3,921
     
4,147
 
Current maturities of operating leases
   
447
     
376
 
TOTAL  CURRENT LIABILITIES
   
4,522
     
5,202
 
                 
LONG-TERM LIABILITIES
               
Operating leases liabilities
   
1,206
     
1,018
 
Liability for employee rights upon retirement
   
915
     
883
 
TOTAL  LONG-TERM LIABILITIES
   
2,121
     
1,901
 
TOTAL  LIABILITIES
   
6,643
     
7,103
 
                 
SHAREHOLDERS' EQUITY:
               
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2023 and June 30, 2024; issued and outstanding: 27,857,620 as of December 31, 2023 and June 30, 2024.
   
774
     
774
 
Additional paid-in capital
   
258,173
     
258,799
 
Accumulated deficit
   
(220,303
)
   
(224,671
)
TOTAL SHAREHOLDERS' EQUITY
   
38,644
     
34,902
 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
 
$
45,287
   
$
42,005
 

6

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
Six months ended
June 30
   
Three months ended
June 30
 
   
2023
   
2024
   
2023
   
2024
 
REVENUE
 
$
894
   
$
5,899
   
$
594
   
$
5,433
 
RESEARCH AND DEVELOPMENT EXPENSES
   
14,698
     
7,783
     
5,312
     
2,438
 
GENERAL AND ADMINISTRATIVE EXPENSES
   
3,786
     
3,203
     
1,809
     
1,371
 
OPERATING INCOME (LOSS)
 
$
(17,590
)
 
$
(5,087
)
 
$
(6,527
)
 
$
1,624
 
FINANCIAL INCOME, net
   
899
     
719
     
557
     
352
 
NET INCOME (LOSS) FOR THE PERIOD
 
$
(16,691
)
 
$
(4,368
)
 
$
(5,970
)
 
$
1,976
 
BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE
 
$
(0.63
)
 
$
(0.16
)
 
$
(0.22
)
 
$
0.07
 
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
   
26,306,484
     
27,857,620
     
27,660,326
     
27,857,620
 

7

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Exhibit 99.2
 
SOL-GEL TECHNOLOGIES LTD.
 
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2024
 

SOL-GEL TECHNOLOGIES LTD.
 
UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2024
 
TABLE OF CONTENTS
 
 
Page
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
 
F - 2
F - 3
F - 4 - F - 5
F - 6
F - 7 - F - 13
 
_______________________________
_____________________________________________
_______________________________
 
The amounts are stated in U.S. dollars in thousands, except share and per share data
 

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
December 31,
   
June 30,
 
   
2023
   
2024
 
A s s e t s
           
CURRENT ASSETS:
           
Cash and cash equivalents
 
$
7,513
   
$
11,549
 
Bank deposits
   
10,012
     
4,012
 
Marketable securities
   
20,471
     
14,912
 
Accounts receivables
   
377
     
6,059
 
Prepaid expenses and other current assets
   
2,794
     
1,750
 
TOTAL CURRENT ASSETS
   
41,167
     
38,282
 
                 
NON-CURRENT ASSETS:
               
Restricted long-term deposits and cash equivalents
   
1,284
     
1,273
 
Property and equipment, net
   
434
     
305
 
Operating lease right-of-use assets
   
1,721
     
1,507
 
Other long-term assets
   
55
     
34
 
Funds in respect of employee rights upon retirement
   
626
     
604
 
TOTAL NON-CURRENT ASSETS
   
4,120
     
3,723
 
TOTAL ASSETS
 
$
45,287
   
$
42,005
 
Liabilities and shareholders' equity
               
CURRENT LIABILITIES:
               
Accounts payable
 
$
154
   
$
679
 
Other accounts payable
   
3,921
     
4,147
 
Current maturities of operating leases
   
447
     
376
 
TOTAL CURRENT LIABILITIES
   
4,522
     
5,202
 
                 
LONG-TERM LIABILITIES
               
Operating leases liabilities
   
1,206
     
1,018
 
Liability for employee rights upon retirement
   
915
     
883
 
TOTAL LONG-TERM LIABILITIES
   
2,121
     
1,901
 
TOTAL LIABILITIES
   
6,643
     
7,103
 
                 
SHAREHOLDERS' EQUITY:
               
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2023 and June 30, 2024; issued and outstanding: 27,857,620 as of December 31, 2023 and June 30, 2024.
   
774
     
774
 
Additional paid-in capital
   
258,173
     
258,799
 
Accumulated deficit
   
(220,303
)
   
(224,671
)
TOTAL SHAREHOLDERS' EQUITY
   
38,644
     
34,902
 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
 
$
45,287
   
$
42,005
 
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
 
F - 2

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
Six months ended
June 30
   
Three months ended
June 30
 
   
2023
   
2024
   
2023
   
2024
 
REVENUE
 
$
894
   
$
5,899
   
$
594
   
$
5,433
 
RESEARCH AND DEVELOPMENT EXPENSES
   
14,698
     
7,783
     
5,312
     
2,438
 
GENERAL AND ADMINISTRATIVE EXPENSES
   
3,786
     
3,203
     
1,809
     
1,371
 
OPERATING INCOME (LOSS)
 
$
(17,590
)
 
$
(5,087
)
 
$
(6,527
)
 
$
1,624
 
FINANCIAL INCOME, net
   
899
     
719
     
557
     
352
 
NET INCOME (LOSS) FOR THE PERIOD
 
$
(16,691
)
 
$
(4,368
)
 
$
(5,970
)
 
$
1,976
 
BASIC AND DILUTED EARNINGS (LOSS) PER ORDINARY SHARE
 
$
(0.63
)
 
$
(0.16
)
 
$
(0.22
)
 
$
0.07
 
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
   
26,306,484
     
27,857,620
     
27,660,326
     
27,857,620
 
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F - 3

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
Ordinary shares
   
Additional
paid-in capital
   
Accumulated
deficit
   
Total
 
   
Number of shares
   
Amounts
   
Amounts
 
BALANCE AS OF JANUARY 1, 2023
   
23,129,469
     
638
     
234,640
     
(193,065
)
   
42,213
 
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2023:
                                       
Loss for the period
                           
(16,691
)
   
(16,691
)
Issuance of shares and warrants through public offering, net of issuance costs
   
2,560,000
     
74
     
11,468
             
11,542
 
Issuance of shares and warrants through private placement from the controlling shareholder
   
2,000,000
     
56
     
9,944
             
10,000
 
Exercise of options
   
116,485
     
3
     
177
             
180
 
Share-based compensation
                   
1,052
             
1,052
 
BALANCE AT JUNE 30, 2023
   
27,805,954
     
771
     
257,281
     
(209,756
)
   
48,296
 
                                         
BALANCE AS OF JANUARY 1, 2024
   
27,857,620
     
774
     
258,173
     
(220,303
)
   
38,644
 
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2024:
                                       
Loss for the period
   
-
     
-
             
(4,368
)
   
(4,368
)
Share-based compensation
   
-
     
-
     
626
             
626
 
BALANCE AT JUNE 30, 2024
   
27,857,620
     
774
     
258,799
     
(224,671
)
   
34,902
 
 
F - 4

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
Ordinary shares
   
Additional
paid-in capital
   
Accumulated
deficit
   
Total
 
   
Number of shares
   
Amounts
   
Amounts
 
BALANCE AS OF APRIL 1, 2023
   
25,702,237
     
712
     
246,678
     
(203,786
)
   
43,604
 
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2023:
                                       
Loss for the period
                           
(5,970
)
   
(5,970
)
Issuance of shares and warrants through private placement from the controlling shareholder
   
2,000,000
     
56
     
9,944
             
10,000
 
Exercise of options
   
103,717
     
3
     
161
             
164
 
Share-based compensation
                   
498
             
498
 
BALANCE AT JUNE 30, 2023
   
27,805,954
     
771
     
257,281
     
(209,756
)
   
48,296
 
                                         
BALANCE AS OF APRIL 1, 2024
   
27,857,620
     
774
     
258,524
     
(226,647
)
   
32,651
 
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2024:
                                       
Income for the period
   
-
     
-
             
1,976
     
1,976
 
Share-based compensation
   
-
     
-
     
275
             
275
 
BALANCE AT JUNE 30, 2024
   
27,857,620
     
774
     
258,799
     
(224,671
)
   
34,902
 
 
* less than $1 thousand.
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
 
F - 5

SOL-GEL TECHNOLOGIES LTD.
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
   
Six months ended
June 30
 
   
2023
   
2024
 
CASH FLOWS FROM OPERATING ACTIVITIES:
           
Loss for the period
 
$
(16,691
)
 
$
(4,368
)
Adjustments required to reconcile loss to net cash used in operating activities:
               
Depreciation
   
185
     
125
 
Changes in accrued liability for employee rights upon retirement, net
   
9
     
(10
)
Share-based compensation expenses
   
1,052
     
626
 
Financial expenses (income), net
   
(1
)
   
(2
)
Net changes in operating leases
   
(36
)
   
(45
)
Changes in fair value of marketable securities
   
(66
)
   
(87
)
Changes in operating asset and liabilities:
               
Receivables from collaborative and licensing arrangements
   
5,653
     
-
 
Accounts receivables
   
-
     
(5,682
)
Prepaid expenses and other current assets
   
(1,063
)
   
1,065
 
Accounts payable, accrued expenses and other
   
2,623
     
751
 
Net cash used in operating activities
   
(8,335
)
   
(7,627
)
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Purchase of property and equipment
   
(94
)
   
-
 
Proceeds from sale of property and equipment
   
-
     
4
 
Investment in marketable securities
   
(17,114
)
   
-
 
Proceeds from sales and maturity of marketable securities
   
7,995
     
5,646
 
Short-term deposits
   
(1,000
)
   
6,000
 
Long-term deposits
   
12
     
821
 
Net cash provided by (used in) investing activities
   
(10,201
)
   
12,471
 
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Proceeds from exercise of options
   
180
     
-
 
Proceeds from issuance of shares and warrants through placement from the controlling shareholder
   
10,000
     
-
 
Proceeds from issuance of shares and warrants through public offering,
     net of issuance costs
   
11,542
     
-
 
Net cash provided by financing activities
   
21,722
     
-
 
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS
   
1
     
2
 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS
   
3,187
     
4,846
 
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD
   
13,598
     
7,863
 
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
 
$
16,785
   
$
12,709
 
Cash and Cash equivalents
   
15,618
     
11,549
 
Restricted cash
   
1,167
     
1,160
 
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS
   
16,785
     
12,709
 
SUPPLEMENTARY DISCLOSURE OF NON-CASH ACTIVITIES:
 
 
           
Recognition of new operating lease ROU and liabilities   $ 190      
-
 
SUPPLEMENTARY INFORMATION:
               
Interest received
 
$
590
   
$
1,121
 
 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
 
F - 6

SOL-GEL TECHNOLOGIES LTD.
 
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
 
(Unaudited)
 
NOTE 1 - NATURE OF OPERATIONS
 
Sol-Gel Technologies Ltd. (collectively with its U.S. subsidiary, the Company) is an Israeli Company incorporated in 1997.
 
The Company is an innovative dermatology company with a successful track record of two NDA approvals and advanced orphan drugs pipeline. The Company has two approved drugs: (i) Twyneo®, which was developed for the treatment of acne vulgaris and received marketing authorization by the U.S. Food and Durg Administration (the "FDA") on July 27, 2021 and (ii) Epsolay®, a treatment for subtype II rosacea that received marketing authorization by the FDA on April 25, 2022. In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of Twyneo® and Epsolay® in the United States, see Note 6a. On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician. In addition to the novel products, the Company’s products included the approved generic products Acyclovir, Ivermectin and other generic product candidates. In November 2021, the Company entered into an agreement with Padagis, to sell its rights in relation to ten generic collaborative agreements between the parties, including the agreements for the two aforementioned approved generic drug products. Under the new agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates, see note 5c.
 
On January 27, 2023 the Company entered into an asset purchase agreement ("APA") with PellePharm, Inc. (hereafter-“PellePharm”), pursuant to which the Company agreed to purchase all of the assets related to the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome (such compound designated as investigational compound SGT-610). On January 30, 2023, upon closing of the transaction, the Company paid an upfront payment (hereafter- "upfront payment") of $4 million to PellePharm. The Company is required to pay an additional amount of $0.7 million, subject to the terms as defined in the APA, 15 months from the closing date. In addition, the Company will be required to pay total development and NDA acceptance milestones of up to $6 million, and up to $64 million in commercial milestones which amount increases to $89 million when sales exceed $500 million as well as single digit royalties which increase to double digit royalties when sales exceed $500 million. During March 2024 the first developement milestone event has completed and the Company recorded an amount of $500 as clinical expenses.
 
The upfront payment and the additional development milestone payments under the APA represent payments for research and development in-process ("IPR&D") acquired as part of an asset purchase, which has not reached technological feasibility and has no alternative future use. Accordingly, such payments were expensed as incurred and recognized as research and development expenses.
 
On May 15, 2024, the Company and Shenzhen Beimei Pharmaceutical Co. Ltd. ("Beimei"), entered into an asset purchase agreement, For further details, see Note 6c.
 
The Company has a wholly owned U.S. subsidiary - Sol-Gel Technologies Inc. (the "Subsidiary"). The Subsidiary supports the Company with regards to marketing, regulatory affairs and business development relating to its products and technology in the U.S.
 
In October 2023, Hamas terrorists infiltrated Israel’s southern border and launched a series of attacks against Israel. Following these attacks, Israel’s security cabinet declared war against Hamas and initiated a military campaign. As of the issuance date of this report, there was no material impact on the Company's ongoing operations in Israel. The Company continues to monitor its ongoing activities and will make any needed adjustments to ensure continuity of its business, while supporting the safety and well-being of its employee
 
F - 7

SOL-GEL TECHNOLOGIES LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)
NOTE 1 - NATURE OF OPERATIONS (continued):
 
Risk and Uncertainties
 
Since incorporation through June 30, 2024, the Company has an accumulated deficit of $224,671 and its activities have been funded mainly by its shareholders, collaboration revenues and license agreements, see also Notes 5 and 6. The Company expects to continue to incur significant research and development and other costs related to its ongoing operations.
 
Management expects that the Company's cash and cash equivalents, deposits and marketable securities as of June 30, 2024 will allow the Company to fund its operating plan through at least the next 12 months from the financial statement issuance date.

 

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES:
 
  a.
Basis of Presentation
 
The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2024, the consolidated results of operations and the statements of changes in shareholders' equity for the six month periods ended June 30, 2024 and 2023 and the statements of cash flows for the six month period ended June 30, 2024 and 2023.
 
The consolidated results for the six month period ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024.
 
These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2023. The comparative balance sheet at December 31, 2023 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP.
 
Earnings (Loss) per share
 
Basic earnings (loss) per share is computed on the basis of the net earnings (loss) for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted earnings (loss) per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
 
The calculation of diluted earnings per share, does not include 6,501,769 options and warrants for the three months ended June 30, 2024 as they are out of the money and therefore, their effect would be anti-dilutive.
 
The calculation of diluted loss per share does not include 6,993,858 options and warrants for the six months ended June 30, 2024 and 5,961,999 and 7,120,463 options and warrants for the six and the three months ended June 30, 2023, respectively, because the effect would be anti-dilutive.

 

F - 8

SOL-GEL TECHNOLOGIES LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
  b.
Recently issued accounting pronouncements, not yet adopted
 
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements and related disclosures.

 

NOTE 3 - MARKETABLE SECURITIES:
 
The following table sets forth the Company’s marketable securities for the indicated periods:
 
   
December 31,
   
June 30,
 
   
2023
   
2024
 
Level 2 securities:
           
U.S government and agency bonds
   
2,583
     
1,612
 
Other foreign government bonds
   
1,946
     
1,974
 
Corporate bonds*
   
15,942
     
11,326
 
Total
   
20,471
     
14,912
 
 
* Investments in Corporate bonds rated A or higher.
 
The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis.
 
The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value.
 
The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the indicated periods:
 
   
Marketable securities
 
   
For the year ended
   
For the six months
 
   
December 31, 2023
   
ended June 30, 2024
 
             
Balance at beginning of the period
 
$
8,678
   
$
20,471
 
Additions
   
23,164
     
-
 
Sale or maturity
   
(11,807
)
   
(5,646
)
Changes in fair value during the period
   
436
     
87
 
Balance at end of the period
 
$
20,471
   
$
14,912
 

 

F - 9

SOL-GEL TECHNOLOGIES LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)
NOTE 3 - MARKETABLE SECURITIES (continued):
 
As of June 30, 2024, the Company’s debt securities had the following maturity dates:
 
   
Market value
 
   
June 30,
 
   
2024
 
Due within one year
 
$
14,912
 
 
The fair value of bank deposits approximates their carrying value, since they bear interest at rates close to the prevailing market rates. In addition, due to the short-term nature and/or low-risk nature of the Company's cash and cash equivalents, restricted cash equivalents, accounts receivable, accounts payable and other payables , their carrying amounts approximates their fair value

 

NOTE 4 -  REVENUE:
 
The following table sets forth the Company’s revenues for the indicated periods:
 
   
Six months ended
June 30
   
Three months ended
June 30
 
   
2023
   
2024
   
2023
   
2024
 
Royalties revenue
 
$
514
   
$
1,056
   
$
214
   
$
612
 
Sale of IP and license revenue
   
380
     
4,800
     
380
     
4,800
 
Support services
   
-
     
43
     
-
     
21
 
Total revenue
 
$
894
   
$
5,899
   
$
594
   
$
5,433
 

 

NOTE 5 - COLLABORATION AGREEMENTS:
 

  a.
In 2007, the Company granted rights to a third party for use and commercialization of a product for skin protection. Under this agreement, the Company is entitled to royalties during the years 2016 to 2024. Based on current sales, royalties are not material.
 
  b.
In 2016 through 2020, the Company entered into several collaboration agreements mainly with one third party (the "Partner") for the development, manufacturing and commercialization of several product candidates (including an agreement assumed by the Company in August 2018, following the transfer of an in-process research and development product candidate from a related party).
 
  c.
Under the agreements, the Partner is obligated to conduct regulatory, scientific, clinical and technical activities necessary to develop the products and prepare and file an abbreviated new drug application ("ANDA"), with the FDA and gain regulatory approval. The Company participates in the development of the product candidates, including participation in joint steering committees and is obligated for sourcing the active pharmaceutical ingredient (API) during the development phase.
 
Upon FDA approval, the Partner has exclusive rights and is required to use diligent efforts to commercialize these products in territories defined under the agreements, including all required sales, marketing and distributing activities associated with the agreements. The Company is entitled to a share of the Partner's gross profits related to the sale of the products, as such term is defined in each of the agreements.
 
F - 10

SOL-GEL TECHNOLOGIES LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)
NOTE 5 - COLLABORATION AGREEMENTS (continued):
 
These Agreements are considered to be within the scope of ASC 808, as the parties are active participants and exposed to the risks and rewards of the collaborative activity. The Company recognizes collaboration revenues when the related sales occur.
 
In November 2021, the Company entered into a new agreement ("New Agreement") with the Partner, to sell its rights to the Partner in relation to ten generic collaborative agreements between the parties in consideration of $21,500 which was paid over 24 months. Under the New Agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates, and is no longer entitled to receive its share in profit as detailed above.
 
In addition, the Company ceased paying any outstanding and future operational costs related to these collaborative agreements.
 
In August 15, 2024 the Company entered into a Termination Agreement with the Partner, For further details, see note 9.
 
NOTE 6 - AGREEMENTS:
 
  a.
In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of two of the Company's most advanced investigational drug products (Twyneo® and Epsolay®) in the United States. The Company was entitled to amounts of up to $7.5 million per product in upfront payments and regulatory approval milestone payments assuming 2021 approval of each respective product. The Company 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.
 
According to the agreement, the Company has an option to regain commercialization rights five years following first commercialization.
 
On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician, See note 1. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician, See also note 1. The Company recognized $723 and $466 during the six-month periods ended June 30, 2024 and 2023, respectively, as royalty revenue in respect of the license agreement for both products.
 
  b.
On June 6, 2023, the Company and Searchlight Pharma Inc. (“Searchlight”), a private Canadian specialty pharmaceutical company, signed on an exclusive license agreements for Twyneo® and Epsolay® for the Canadian market, over a fifteen-year term that is renewable for subsequent five-year periods. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell the drugs in Canada, with support from the Company.
 
Under the agreement, the Company will receive up to $11 million in upfront payments and regulatory and sales milestones for both drugs, combined. In addition, the Company will be entitled to royalty percentages of all Canadian net sales ranging from low-double-digits to high teens.
 
F - 11

SOL-GEL TECHNOLOGIES LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)
NOTE 6 - AGREEMENTS (continued):
 
In June 2023, the Company received $500 as an upfront payment in connection with the license agreement and related support provided to Searchlight for obtaining the regulatory approval in the Canadian market. The Company is also required to support Searchlight during such period if needed based on agreed upon rates. The Company has identified two performance obligations in the license agreement as follows: (i) the license to market the products in Canada; and (ii) continuing support during the regulatory approval process.
 
For the six-month period ended June 30, 2024, the Company recognized a total amount of $42 for continuing support. The remaining outstanding contract liability in respect of the support services, is, as of June 30, 2024 $78 .
 
  c.
On May 15, 2024, the Company and Beimei, a private Chinese company, signed an agreement for the purchase and license by Beimei of certain rights in the intellectual property ("IP") related to Twyneo, for the treatment of acne vulgaris, in the mainland of China, Hong Kong, Macau, Taiwan and Israel.
 
Under the terms of the agreement, Beimei will purchase and license from the Company the IP in these territories. The Company is also required to support Beimei to a certain extent during the period until obtaining regulatory approval. The Company may provide further support services to Beimei, if needed, based on agreed upon rates. In return, Sol-Gel is to receive payments of up to $10 million (including amounts contingent on achieving certain milestones) and up to $5 million as royalty payments on net sales.
 
The Company has identified multiple performance obligations in the agreement. Revenue from sale and license of IP is recognized at a point in time, upon transfer of control over the license and the IP to Beimei. Support services are recognized over time as the services are performed.
 
For the six-month period ended June 30, 2024, the Company recognized revenue for a total amount of $4.8 million. This amount does not include variable consideration that was determined to be constrained (not probable that would not result in a significant reversal). In addition, the Company recorded $200 as a contract liability in respect of the support services.
 
In July 2024, the Company received $2 million as the first payment in connection with the agreement.

 

F - 12

SOL-GEL TECHNOLOGIES LTD.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)

 

(Unaudited)

NOTE 7 - SHARE BASED COMPENSATION:

 
During the six months ended June 30, 2024, the Company granted 300,000 options to Directors as follows:
 
In January 2024, the board of directors approved and recommended the Company's shareholders to approve a grant of 300,000 options to the Company's Directors to purchase ordinary shares at an exercise price of $1.2 per share. The Company's shareholders approved the grant in February 28, 2024.
 
The options vest over a period of 3 years; one third of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following two years. The options expire on the tenth anniversary of their grant date.
 
The fair value of options granted in 2024 was $207. The underlying data used for computing the fair value of the options are as follows:
 
   
2024
 
Value of one ordinary share
 
$
1.2
 
Dividend yield
   
0
%
Expected volatility
   
72
%
Risk-free interest rate
   
4.8
%
Expected term
 
4 years
 

 

NOTE 8 - RELATED PARTIES:
 
  a.
Related parties include the controlling shareholder and companies under his control, the board of directors and the executive officers of the Company.
 
  b.
As to options granted to directors and executive officers, see note 7.

 

NOTE 9 SUBSEQUENT EVENT
 
In August 15, 2024, the Company entered into a Termination Agreement ("the Agreement") with the Partner. The purpose of the Agreement is to terminate the Development, Manufacturing and Commercialization Agreement dated June 28, 2020, and to sell its rights to the Partner in relation to Roflumilast cream and Roflumilast foam. As consideration for the Agreement between the parties, the Partner will pay to the Company $4,250, which will paid in quarterly installments during 24 months. In addition, in the end of each quarter for five years as of the Launch Date (the date of first commercial sale of the Product in the Territory by the Partner or its Affiliates pursuant to the ANDA), the Partner shall pay Sol-Gel 2% royalties of the Partner’s Gross Profits for that Product.
 
F - 13

v3.24.2.u1
Document and Entity Information
6 Months Ended
Jun. 30, 2024
Cover [Abstract]  
Entity Central Index Key 0001684693
Current Fiscal Year End Date --12-31
Document Fiscal Year Focus 2024
Document Fiscal Period Focus Q2
Amendment Flag false
Document Type 6-K
Document Period End Date Jun. 30, 2024
Entity Registrant Name SOL-GEL TECHNOLOGIES LTD.
Entity Address, Address Line One 7 Golda Meir Street
Entity Address, City or Town Ness Ziona
Entity Address, Postal Zip Code 7403650
Entity Address, Country IL
v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
CURRENT ASSETS:    
Cash and cash equivalents $ 11,549 $ 7,513
Bank deposits 4,012 10,012
Marketable securities 14,912 20,471
Accounts receivables 6,059 377
Prepaid expenses and other current assets 1,750 2,794
TOTAL CURRENT ASSETS 38,282 41,167
NON-CURRENT ASSETS:    
Restricted long-term deposits and cash equivalents 1,273 1,284
Property and equipment, net 305 434
Operating lease right-of-use assets 1,507 1,721
Other long-term assets 34 55
Funds in respect of employee rights upon retirement 604 626
TOTAL NON-CURRENT ASSETS 3,723 4,120
TOTAL ASSETS 42,005 45,287
CURRENT LIABILITIES:    
Accounts payable 679 154
Other accounts payable 4,147 3,921
Current maturities of operating leases 376 447
TOTAL CURRENT LIABILITIES 5,202 4,522
LONG-TERM LIABILITIES    
Operating leases liabilities 1,018 1,206
Liability for employee rights upon retirement 883 915
TOTAL LONG-TERM LIABILITIES 1,901 2,121
TOTAL LIABILITIES 7,103 6,643
SHAREHOLDERS' EQUITY:    
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2023 and June 30, 2024; issued and outstanding: 27,857,620 as of December 31, 2023 and June 30, 2024. 774 774
Additional paid-in capital 258,799 258,173
Accumulated deficit (224,671) (220,303)
TOTAL SHAREHOLDERS' EQUITY 34,902 38,644
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 42,005 $ 45,287
v3.24.2.u1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - ₪ / shares
Jun. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Ordinary shares, par value ₪ 0.1 ₪ 0.1
Ordinary shares, shares authorized 50,000,000 50,000,000
Ordinary shares, shares issued 27,857,620 27,857,620
Ordinary shares, shares outstanding 27,857,620 27,857,620
v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
REVENUE $ 5,433 $ 594 $ 5,899 $ 894
RESEARCH AND DEVELOPMENT EXPENSES 2,438 5,312 7,783 14,698
GENERAL AND ADMINISTRATIVE EXPENSES 1,371 1,809 3,203 3,786
OPERATING INCOME (LOSS) 1,624 (6,527) (5,087) (17,590)
FINANCIAL INCOME, net 352 557 719 899
NET INCOME (LOSS) FOR THE PERIOD $ 1,976 $ (5,970) $ (4,368) $ (16,691)
BASIC EARNINGS (LOSS) PER ORDINARY SHARE $ 0.07 $ (0.22) $ (0.16) $ (0.63)
DILUTED EARNINGS (LOSS) PER ORDINARY SHARE $ 0.07 $ (0.22) $ (0.16) $ (0.63)
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC LOSS PER SHARE 27,857,620 27,660,326 27,857,620 26,306,484
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF DILUTED LOSS PER SHARE 27,857,620 27,660,326 27,857,620 26,306,484
v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) - USD ($)
$ in Thousands
Ordinary shares [Member]
Additional Paid-In Capital [Member]
Accumulated deficit [Member]
Total
Balance at Dec. 31, 2022 $ 638 $ 234,640 $ (193,065) $ 42,213
Balance, shares at Dec. 31, 2022 23,129,469      
Loss for the period     (16,691) (16,691)
Issuance of shares and warrants through public offering, net of issuance costs $ 74 11,468   11,542
Issuance of shares and warrants through public offering, net of issuance costs Shares 2,560,000      
Issuance of shares and warrants through private placement from the controlling shareholder $ 56 9,944   10,000
Issuance of shares and warrants through private placement from the controlling shareholder Shares 2,000,000      
Exercise of options $ 3 177   180
Exercise of options, shares 116,485      
Share-based compensation   1,052   1,052
Balance at Jun. 30, 2023 $ 771 257,281 (209,756) 48,296
Balance, shares at Jun. 30, 2023 27,805,954      
Balance at Mar. 31, 2023 $ 712 246,678 (203,786) 43,604
Balance, shares at Mar. 31, 2023 25,702,237      
Loss for the period     (5,970) (5,970)
Issuance of shares and warrants through private placement from the controlling shareholder $ 56 9,944   10,000
Issuance of shares and warrants through private placement from the controlling shareholder Shares 2,000,000      
Exercise of options $ 3 161   164
Exercise of options, shares 103,717      
Share-based compensation   498   498
Balance at Jun. 30, 2023 $ 771 257,281 (209,756) 48,296
Balance, shares at Jun. 30, 2023 27,805,954      
Balance at Dec. 31, 2023 $ 774 258,173 (220,303) $ 38,644
Balance, shares at Dec. 31, 2023 27,857,620     27,857,620
Loss for the period $ 0   (4,368) $ (4,368)
Share-based compensation 0 626   626
Balance at Jun. 30, 2024 $ 774 258,799 (224,671) $ 34,902
Balance, shares at Jun. 30, 2024 27,857,620     27,857,620
Balance at Mar. 31, 2024 $ 774 258,524 (226,647) $ 32,651
Balance, shares at Mar. 31, 2024 27,857,620      
Loss for the period $ 0   1,976 1,976
Share-based compensation 0 275   275
Balance at Jun. 30, 2024 $ 774 $ 258,799 $ (224,671) $ 34,902
Balance, shares at Jun. 30, 2024 27,857,620     27,857,620
v3.24.2.u1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:          
Loss for the period $ 1,976 $ (5,970) $ (4,368) $ (16,691)  
Adjustments required to reconcile loss to net cash used in operating activities:          
Depreciation     125 185  
Changes in accrued liability for employee rights upon retirement, net     (10) 9  
Share-based compensation expenses 275 498 626 1,052  
Financial expenses (income), net     (2) (1)  
Net changes in operating leases     (45) (36)  
Changes in fair value of marketable securities     (87) (66)  
Changes in operating asset and liabilities:          
Receivables from collaborative and licensing arrangements     0 5,653  
Accounts receivables     (5,682) 0  
Prepaid expenses and other current assets     1,065 (1,063)  
Accounts payable, accrued expenses and other     751 2,623  
Net cash used in operating activities     (7,627) (8,335)  
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of property and equipment     0 (94)  
Proceeds from sale of property and equipment     4 0  
Investment in marketable securities     0 (17,114) $ (23,164)
Proceeds from sales and maturity of marketable securities     5,646 7,995 11,807
Short-term deposits     6,000 (1,000)  
Long-term deposits     821 12  
Net cash provided by (used in) investing activities     12,471 (10,201)  
CASH FLOWS FROM FINANCING ACTIVITIES:          
Proceeds from exercise of options     0 180  
Proceeds from issuance of shares and warrants through placement from the controlling shareholder     0 10,000  
Proceeds from issuance of shares and warrants through public offering, net of issuance costs     0 11,542  
Net cash provided by financing activities     0 21,722  
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS     2 1  
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS     4,846 3,187  
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD     7,863 13,598 13,598
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AND CASH EQUIVALENTS AT END OF THE PERIOD 12,709 16,785 12,709 16,785 7,863
Cash and Cash equivalents 11,549 15,618 11,549 15,618 7,513
Restricted cash 1,160 1,167 1,160 1,167  
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS $ 12,709 $ 16,785 12,709 16,785 $ 7,863
SUPPLEMENTARY DISCLOSURE OF NON-CASH ACTIVITIES:          
Recognition of new operating lease ROU and liabilities     0 190  
SUPPLEMENTARY INFORMATION:          
Interest received     $ 1,121 $ 590  
v3.24.2.u1
NATURE OF OPERATIONS
6 Months Ended
Jun. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
NATURE OF OPERATIONS
NOTE 1 - NATURE OF OPERATIONS
 
Sol-Gel Technologies Ltd. (collectively with its U.S. subsidiary, the Company) is an Israeli Company incorporated in 1997.
 
The Company is an innovative dermatology company with a successful track record of two NDA approvals and advanced orphan drugs pipeline. The Company has two approved drugs: (i) Twyneo®, which was developed for the treatment of acne vulgaris and received marketing authorization by the U.S. Food and Durg Administration (the "FDA") on July 27, 2021 and (ii) Epsolay®, a treatment for subtype II rosacea that received marketing authorization by the FDA on April 25, 2022. In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of Twyneo® and Epsolay® in the United States, see Note 6a. On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician. In addition to the novel products, the Company’s products included the approved generic products Acyclovir, Ivermectin and other generic product candidates. In November 2021, the Company entered into an agreement with Padagis, to sell its rights in relation to ten generic collaborative agreements between the parties, including the agreements for the two aforementioned approved generic drug products. Under the new agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates, see note 5c.
 
On January 27, 2023 the Company entered into an asset purchase agreement ("APA") with PellePharm, Inc. (hereafter-“PellePharm”), pursuant to which the Company agreed to purchase all of the assets related to the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome (such compound designated as investigational compound SGT-610). On January 30, 2023, upon closing of the transaction, the Company paid an upfront payment (hereafter- "upfront payment") of $4 million to PellePharm. The Company is required to pay an additional amount of $0.7 million, subject to the terms as defined in the APA, 15 months from the closing date. In addition, the Company will be required to pay total development and NDA acceptance milestones of up to $6 million, and up to $64 million in commercial milestones which amount increases to $89 million when sales exceed $500 million as well as single digit royalties which increase to double digit royalties when sales exceed $500 million. During March 2024 the first developement milestone event has completed and the Company recorded an amount of $500 as clinical expenses.
 
The upfront payment and the additional development milestone payments under the APA represent payments for research and development in-process ("IPR&D") acquired as part of an asset purchase, which has not reached technological feasibility and has no alternative future use. Accordingly, such payments were expensed as incurred and recognized as research and development expenses.
 
On May 15, 2024, the Company and Shenzhen Beimei Pharmaceutical Co. Ltd. ("Beimei"), entered into an asset purchase agreement, For further details, see Note 6c.
 
The Company has a wholly owned U.S. subsidiary - Sol-Gel Technologies Inc. (the "Subsidiary"). The Subsidiary supports the Company with regards to marketing, regulatory affairs and business development relating to its products and technology in the U.S.
 
In October 2023, Hamas terrorists infiltrated Israel’s southern border and launched a series of attacks against Israel. Following these attacks, Israel’s security cabinet declared war against Hamas and initiated a military campaign. As of the issuance date of this report, there was no material impact on the Company's ongoing operations in Israel. The Company continues to monitor its ongoing activities and will make any needed adjustments to ensure continuity of its business, while supporting the safety and well-being of its employee
 
Risk and Uncertainties
 
Since incorporation through June 30, 2024, the Company has an accumulated deficit of $224,671 and its activities have been funded mainly by its shareholders, collaboration revenues and license agreements, see also Notes 5 and 6. The Company expects to continue to incur significant research and development and other costs related to its ongoing operations.
 
Management expects that the Company's cash and cash equivalents, deposits and marketable securities as of June 30, 2024 will allow the Company to fund its operating plan through at least the next 12 months from the financial statement issuance date.
v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
SIGNIFICANT ACCOUNTING POLICIES
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES:
 
  a.
Basis of Presentation
 
The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2024, the consolidated results of operations and the statements of changes in shareholders' equity for the six month periods ended June 30, 2024 and 2023 and the statements of cash flows for the six month period ended June 30, 2024 and 2023.
 
The consolidated results for the six month period ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024.
 
These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2023. The comparative balance sheet at December 31, 2023 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP.
 
Earnings (Loss) per share
 
Basic earnings (loss) per share is computed on the basis of the net earnings (loss) for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted earnings (loss) per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
 
The calculation of diluted earnings per share, does not include 6,501,769 options and warrants for the three months ended June 30, 2024 as they are out of the money and therefore, their effect would be anti-dilutive.
 
The calculation of diluted loss per share does not include 6,993,858 options and warrants for the six months ended June 30, 2024 and 5,961,999 and 7,120,463 options and warrants for the six and the three months ended June 30, 2023, respectively, because the effect would be anti-dilutive.

 

  b.
Recently issued accounting pronouncements, not yet adopted
 
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements and related disclosures.
v3.24.2.u1
MARKETABLE SECURITIES
6 Months Ended
Jun. 30, 2024
Investments, Debt and Equity Securities [Abstract]  
MARKETABLE SECURITIES
NOTE 3 - MARKETABLE SECURITIES:
 
The following table sets forth the Company’s marketable securities for the indicated periods:
 
   
December 31,
   
June 30,
 
   
2023
   
2024
 
Level 2 securities:
           
U.S government and agency bonds
   
2,583
     
1,612
 
Other foreign government bonds
   
1,946
     
1,974
 
Corporate bonds*
   
15,942
     
11,326
 
Total
   
20,471
     
14,912
 
 
* Investments in Corporate bonds rated A or higher.
 
The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis.
 
The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value.
 
The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the indicated periods:
 
   
Marketable securities
 
   
For the year ended
   
For the six months
 
   
December 31, 2023
   
ended June 30, 2024
 
             
Balance at beginning of the period
 
$
8,678
   
$
20,471
 
Additions
   
23,164
     
-
 
Sale or maturity
   
(11,807
)
   
(5,646
)
Changes in fair value during the period
   
436
     
87
 
Balance at end of the period
 
$
20,471
   
$
14,912
 

 

As of June 30, 2024, the Company’s debt securities had the following maturity dates:
 
   
Market value
 
   
June 30,
 
   
2024
 
Due within one year
 
$
14,912
 
 
The fair value of bank deposits approximates their carrying value, since they bear interest at rates close to the prevailing market rates. In addition, due to the short-term nature and/or low-risk nature of the Company's cash and cash equivalents, restricted cash equivalents, accounts receivable, accounts payable and other payables , their carrying amounts approximates their fair value
v3.24.2.u1
REVENUE
6 Months Ended
Jun. 30, 2024
Revenue from Contract with Customer [Abstract]  
REVENUE
NOTE 4 -  REVENUE:
 
The following table sets forth the Company’s revenues for the indicated periods:
 
   
Six months ended
June 30
   
Three months ended
June 30
 
   
2023
   
2024
   
2023
   
2024
 
Royalties revenue
 
$
514
   
$
1,056
   
$
214
   
$
612
 
Sale of IP and license revenue
   
380
     
4,800
     
380
     
4,800
 
Support services
   
-
     
43
     
-
     
21
 
Total revenue
 
$
894
   
$
5,899
   
$
594
   
$
5,433
 
v3.24.2.u1
COLLABORATION AGREEMENTS
6 Months Ended
Jun. 30, 2024
Collaboration Agreements [Abstract]  
COLLABORATION AGREEMENTS

NOTE 5 - COLLABORATION AGREEMENTS:
 

  a.
In 2007, the Company granted rights to a third party for use and commercialization of a product for skin protection. Under this agreement, the Company is entitled to royalties during the years 2016 to 2024. Based on current sales, royalties are not material.
 
  b.
In 2016 through 2020, the Company entered into several collaboration agreements mainly with one third party (the "Partner") for the development, manufacturing and commercialization of several product candidates (including an agreement assumed by the Company in August 2018, following the transfer of an in-process research and development product candidate from a related party).
 
  c.
Under the agreements, the Partner is obligated to conduct regulatory, scientific, clinical and technical activities necessary to develop the products and prepare and file an abbreviated new drug application ("ANDA"), with the FDA and gain regulatory approval. The Company participates in the development of the product candidates, including participation in joint steering committees and is obligated for sourcing the active pharmaceutical ingredient (API) during the development phase.
 
Upon FDA approval, the Partner has exclusive rights and is required to use diligent efforts to commercialize these products in territories defined under the agreements, including all required sales, marketing and distributing activities associated with the agreements. The Company is entitled to a share of the Partner's gross profits related to the sale of the products, as such term is defined in each of the agreements.
 
These Agreements are considered to be within the scope of ASC 808, as the parties are active participants and exposed to the risks and rewards of the collaborative activity. The Company recognizes collaboration revenues when the related sales occur.
 
In November 2021, the Company entered into a new agreement ("New Agreement") with the Partner, to sell its rights to the Partner in relation to ten generic collaborative agreements between the parties in consideration of $21,500 which was paid over 24 months. Under the New Agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates, and is no longer entitled to receive its share in profit as detailed above.
 
In addition, the Company ceased paying any outstanding and future operational costs related to these collaborative agreements.
 
In August 15, 2024 the Company entered into a Termination Agreement with the Partner, For further details, see note 9.
v3.24.2.u1
AGREEMENTS
6 Months Ended
Jun. 30, 2024
License Agreements [Abstract]  
AGREEMENTS
NOTE 6 - AGREEMENTS:
 
  a.
In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of two of the Company's most advanced investigational drug products (Twyneo® and Epsolay®) in the United States. The Company was entitled to amounts of up to $7.5 million per product in upfront payments and regulatory approval milestone payments assuming 2021 approval of each respective product. The Company 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.
 
According to the agreement, the Company has an option to regain commercialization rights five years following first commercialization.
 
On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician, See note 1. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician, See also note 1. The Company recognized $723 and $466 during the six-month periods ended June 30, 2024 and 2023, respectively, as royalty revenue in respect of the license agreement for both products.
 
  b.
On June 6, 2023, the Company and Searchlight Pharma Inc. (“Searchlight”), a private Canadian specialty pharmaceutical company, signed on an exclusive license agreements for Twyneo® and Epsolay® for the Canadian market, over a fifteen-year term that is renewable for subsequent five-year periods. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell the drugs in Canada, with support from the Company.
 
Under the agreement, the Company will receive up to $11 million in upfront payments and regulatory and sales milestones for both drugs, combined. In addition, the Company will be entitled to royalty percentages of all Canadian net sales ranging from low-double-digits to high teens.
 
In June 2023, the Company received $500 as an upfront payment in connection with the license agreement and related support provided to Searchlight for obtaining the regulatory approval in the Canadian market. The Company is also required to support Searchlight during such period if needed based on agreed upon rates. The Company has identified two performance obligations in the license agreement as follows: (i) the license to market the products in Canada; and (ii) continuing support during the regulatory approval process.
 
For the six-month period ended June 30, 2024, the Company recognized a total amount of $42 for continuing support. The remaining outstanding contract liability in respect of the support services, is, as of June 30, 2024 $78 .
 
  c.
On May 15, 2024, the Company and Beimei, a private Chinese company, signed an agreement for the purchase and license by Beimei of certain rights in the intellectual property ("IP") related to Twyneo, for the treatment of acne vulgaris, in the mainland of China, Hong Kong, Macau, Taiwan and Israel.
 
Under the terms of the agreement, Beimei will purchase and license from the Company the IP in these territories. The Company is also required to support Beimei to a certain extent during the period until obtaining regulatory approval. The Company may provide further support services to Beimei, if needed, based on agreed upon rates. In return, Sol-Gel is to receive payments of up to $10 million (including amounts contingent on achieving certain milestones) and up to $5 million as royalty payments on net sales.
 
The Company has identified multiple performance obligations in the agreement. Revenue from sale and license of IP is recognized at a point in time, upon transfer of control over the license and the IP to Beimei. Support services are recognized over time as the services are performed.
 
For the six-month period ended June 30, 2024, the Company recognized revenue for a total amount of $4.8 million. This amount does not include variable consideration that was determined to be constrained (not probable that would not result in a significant reversal). In addition, the Company recorded $200 as a contract liability in respect of the support services.
 
In July 2024, the Company received $2 million as the first payment in connection with the agreement.
v3.24.2.u1
SHARE BASED COMPENSATION
6 Months Ended
Jun. 30, 2024
Stockholders' Equity Note [Abstract]  
SHARE BASED COMPENSATION

NOTE 7 - SHARE BASED COMPENSATION:

 
During the six months ended June 30, 2024, the Company granted 300,000 options to Directors as follows:
 
In January 2024, the board of directors approved and recommended the Company's shareholders to approve a grant of 300,000 options to the Company's Directors to purchase ordinary shares at an exercise price of $1.2 per share. The Company's shareholders approved the grant in February 28, 2024.
 
The options vest over a period of 3 years; one third of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following two years. The options expire on the tenth anniversary of their grant date.
 
The fair value of options granted in 2024 was $207. The underlying data used for computing the fair value of the options are as follows:
 
   
2024
 
Value of one ordinary share
 
$
1.2
 
Dividend yield
   
0
%
Expected volatility
   
72
%
Risk-free interest rate
   
4.8
%
Expected term
 
4 years
 
v3.24.2.u1
RELATED PARTIES
6 Months Ended
Jun. 30, 2024
Related Party Transactions [Abstract]  
RELATED PARTIES
NOTE 8 - RELATED PARTIES:
 
  a.
Related parties include the controlling shareholder and companies under his control, the board of directors and the executive officers of the Company.
 
  b.
As to options granted to directors and executive officers, see note 7.
v3.24.2.u1
SUBSEQUENT EVENT
6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
SUBSEQUENT EVENT
NOTE 9 SUBSEQUENT EVENT
 
In August 15, 2024, the Company entered into a Termination Agreement ("the Agreement") with the Partner. The purpose of the Agreement is to terminate the Development, Manufacturing and Commercialization Agreement dated June 28, 2020, and to sell its rights to the Partner in relation to Roflumilast cream and Roflumilast foam. As consideration for the Agreement between the parties, the Partner will pay to the Company $4,250, which will paid in quarterly installments during 24 months. In addition, in the end of each quarter for five years as of the Launch Date (the date of first commercial sale of the Product in the Territory by the Partner or its Affiliates pursuant to the ANDA), the Partner shall pay Sol-Gel 2% royalties of the Partner’s Gross Profits for that Product.
v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Basis of Presentation
  a.
Basis of Presentation
 
The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2024, the consolidated results of operations and the statements of changes in shareholders' equity for the six month periods ended June 30, 2024 and 2023 and the statements of cash flows for the six month period ended June 30, 2024 and 2023.
 
The consolidated results for the six month period ended June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024.
 
These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2023. The comparative balance sheet at December 31, 2023 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP.
Earnings (Loss) per share
Earnings (Loss) per share
 
Basic earnings (loss) per share is computed on the basis of the net earnings (loss) for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted earnings (loss) per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
 
The calculation of diluted earnings per share, does not include 6,501,769 options and warrants for the three months ended June 30, 2024 as they are out of the money and therefore, their effect would be anti-dilutive.
 
The calculation of diluted loss per share does not include 6,993,858 options and warrants for the six months ended June 30, 2024 and 5,961,999 and 7,120,463 options and warrants for the six and the three months ended June 30, 2023, respectively, because the effect would be anti-dilutive.
Recently issued accounting pronouncements, not yet adopted
  b.
Recently issued accounting pronouncements, not yet adopted
 
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements and related disclosures.
v3.24.2.u1
MARKETABLE SECURITIES (Tables)
6 Months Ended
Jun. 30, 2024
Investments, Debt and Equity Securities [Abstract]  
Schedule of Marketable Securities
   
December 31,
   
June 30,
 
   
2023
   
2024
 
Level 2 securities:
           
U.S government and agency bonds
   
2,583
     
1,612
 
Other foreign government bonds
   
1,946
     
1,974
 
Corporate bonds*
   
15,942
     
11,326
 
Total
   
20,471
     
14,912
 
 
* Investments in Corporate bonds rated A or higher.
Schedule of Summary of Changes in Fair Value of Marketable Securities
   
Marketable securities
 
   
For the year ended
   
For the six months
 
   
December 31, 2023
   
ended June 30, 2024
 
             
Balance at beginning of the period
 
$
8,678
   
$
20,471
 
Additions
   
23,164
     
-
 
Sale or maturity
   
(11,807
)
   
(5,646
)
Changes in fair value during the period
   
436
     
87
 
Balance at end of the period
 
$
20,471
   
$
14,912
 

 

Schedule of Debt Securities
   
Market value
 
   
June 30,
 
   
2024
 
Due within one year
 
$
14,912
 
v3.24.2.u1
REVENUE (Tables)
6 Months Ended
Jun. 30, 2024
Revenue from Contract with Customer [Abstract]  
Schedule of Components of Revenues
   
Six months ended
June 30
   
Three months ended
June 30
 
   
2023
   
2024
   
2023
   
2024
 
Royalties revenue
 
$
514
   
$
1,056
   
$
214
   
$
612
 
Sale of IP and license revenue
   
380
     
4,800
     
380
     
4,800
 
Support services
   
-
     
43
     
-
     
21
 
Total revenue
 
$
894
   
$
5,899
   
$
594
   
$
5,433
 
v3.24.2.u1
SHARE BASED COMPENSATION (Tables)
6 Months Ended
Jun. 30, 2024
Stockholders' Equity Note [Abstract]  
Schedule of Assumptions Used to Estimate Fair Value
   
2024
 
Value of one ordinary share
 
$
1.2
 
Dividend yield
   
0
%
Expected volatility
   
72
%
Risk-free interest rate
   
4.8
%
Expected term
 
4 years
 
v3.24.2.u1
NATURE OF OPERATIONS (Narrative) (Details) - USD ($)
$ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Jan. 30, 2023
Mar. 31, 2024
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Accumulated deficit     $ (224,671)   $ (224,671)   $ (220,303)
Sales amount     $ 5,433 $ 594 $ 5,899 $ 894  
PellePharm, Inc. [Member] | Asset Purchase Agreement [Member] | Development And Nda Acceptance Milestones [Member]              
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Sales milestone payments $ 6,000            
PellePharm, Inc. [Member] | Asset Purchase Agreement [Member] | Commercial Milestones [Member]              
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]              
Sales milestone payments $ 64,000            
Description of upfront payment $4 million to PellePharm. The Company is required to pay an additional amount of $0.7 million, subject to the terms as defined in the APA, 15 months from the closing date.            
Increase in sales milestone amount due to sales exceed dollar 500 million $ 89,000            
Sales amount $ 500,000            
Clinical expenses   $ 500          
v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Options and Warrants [Member]        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Anti-dilutive securities excluded from computation 6,501,769 7,120,463 6,993,858 5,961,999
v3.24.2.u1
MARKETABLE SECURITIES (Schedule of Company's Marketable Securities) (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Dec. 31, 2022
Level 2 securities:      
Marketable securities $ 14,912 $ 20,471 $ 8,678
U.S government and agency bonds [Member]      
Level 2 securities:      
Marketable securities 1,612 2,583  
Other foreign government bonds [Member]      
Level 2 securities:      
Marketable securities 1,974 1,946  
Corporate bonds [Member]      
Level 2 securities:      
Marketable securities [1] $ 11,326 $ 15,942  
[1] Investments in Corporate bonds rated A or higher.
v3.24.2.u1
MARKETABLE SECURITIES (Schedule of Changes in Fair Value of Company's Marketable Securities) (Details) - USD ($)
$ in Thousands
6 Months Ended 12 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]      
Balance at beginning of the period $ 20,471 $ 8,678 $ 8,678
Additions 0 17,114 23,164
Sale or maturity (5,646) $ (7,995) (11,807)
Changes in fair value during the period 87   (436)
Balance at end of the period $ 14,912   $ 20,471
v3.24.2.u1
MARKETABLE SECURITIES (Schedule of Company's debt marketable securities) (Details)
$ in Thousands
Jun. 30, 2024
USD ($)
Investments, Debt and Equity Securities [Abstract]  
Due within one year $ 14,912
v3.24.2.u1
REVENUE (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Total revenue $ 5,433 $ 594 $ 5,899 $ 894
Royalties revenue [Member]        
Total revenue 612 214 1,056 514
Sale of IP and license revenue [Member]        
Total revenue 4,800 380 4,800 380
Support services [Member]        
Total revenue $ 21 $ 0 $ 43 $ 0
v3.24.2.u1
COLLABORATION AGREEMENTS (Narrative) (Details)
$ in Thousands
12 Months Ended
Dec. 31, 2007
Nov. 01, 2021
USD ($)
Agreement
Candidate
Program
Number of generic collaborative agreements to sell rights | Agreement   10
Number of generic programs retained for collaboration rights | Program   2
Number of generic drug candidates | Candidate   4
Expected revenue receivable over twenty four months | $   $ 21,500
Minimum [Member]    
Royalties maturity 2016  
Maximum [Member]    
Royalties maturity 2024  
v3.24.2.u1
AGREEMENTS (Narrative) (Details) - USD ($)
$ in Thousands
1 Months Ended 6 Months Ended
Jun. 06, 2023
Jun. 30, 2021
Jun. 30, 2024
Jun. 30, 2023
Twyneo [Member] | License Agreements With Galderma [Member]        
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]        
Regulatory approval milestone payments received   $ 7,500    
Twyneo [Member] | License Agreements With Beimei [Member]        
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]        
Sales milestone payments     $ 2,000  
Upfront payments received     10,000  
Royalties revenues     5,000  
Contract liability     200  
Estimated variable consideration     4,800  
Twyneo And Epsolay [Member] | License Agreements With Galderma [Member]        
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]        
Sales milestone payments   $ 9,000    
Royalties revenues     723 $ 466
Twyneo And Epsolay [Member] | License Agreements With Searchlight [Member]        
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]        
Upfront payments received $ 11,000     $ 500
Royalties revenues     42  
Contract liability     $ 78  
v3.24.2.u1
SHARE BASED COMPENSATION (Narrative) (Details) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 6 Months Ended
Jan. 31, 2024
Jun. 30, 2024
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Fair value of options granted   $ 207
Director [Member]    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Option grants 300,000 300,000
Exercise price $ 1.2  
Option vesting period 3 years  
v3.24.2.u1
SHARE BASED COMPENSATION (Schedule of Assumptions Used to Estimate Fair Value) (Details)
6 Months Ended
Jun. 30, 2024
$ / shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Value of one ordinary share $ 1.2
Dividend yield 0.00%
Expected volatility 72.00%
Risk-free interest rate 4.80%
Expected term 4 years
v3.24.2.u1
SUBSEQUENT EVENT (Narrative) (Details) - Subsequent Event [Member] - Partner [Member]
$ in Thousands
Aug. 15, 2024
USD ($)
Subsequent Event [Line Items]  
Consideration for agreement $ 4,250
Royalties percentage 2.00%

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