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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 May 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):
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INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On April 1, 2024, Sol-Gel Technologies Ltd. (the "Company") issued a press
release entitled "Sol-Gel Reports First Quarter 2024 Financial Results and
Provides Corporate Updates".
Attached hereto is the following exhibit:
Exhibit 99.1
Press release dated May 20, 2024
Exhibit 99.1 (other than the two paragraphs immediately preceding the heading
"Financial Results for the Financial Results for the First Quarter Year Ended
March 31
st
, 2024") is 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).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SOL-GEL TECHNOLOGIES LTD.
Date: May 20, 2024 By: /s/ Gilad Mamlok
Gilad Mamlok
Chief Financial Officer
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Exhibit 99.1
Sol-Gel Reports First Quarter 2024 Financial Results and Provides
Corporate Updates
. Phase 3 clinical trial of SGT-610 for Gorlin Syndrome with the first patient screened, is ongoing.
. Sol-Gel and Beimei Pharma announced an Asset Purchase Agreement to commercialize TWYNEO(R)
in China, Hong Kong, Macau, Taiwan and Israel, for a total consideration of up to $
1
15 million.
. Sol-Gel
recently initiated a proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease.
. Highly encouraging clinical response for SGT-210 from a Compassionate use
treatment for a pediatric patient suffering from an ultra-rare disease.
. Sol-Gel's collaboration partner, Padagis, submitted First-to-File ANDA Drug Product Generic to Zoryve(R) Cream.
. Sol-Gel maintains its cash runway into the second half of 2025.
NESS ZIONA, Israel, May 20, 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
(R)
and EPSOLAY
(R)
, today announced financial results for the first quarter ended March 31, 2024
and provided a corporate update.
Q1 2024 and Recent Corporate Developments
. On May 16, Sol-Gel and Beimei Pharma announced an Asset Purchase Agreement, pursuant to which Beimei purchases and licenses
the rights to commercialize and manufacture TWYNEO(R) in China, Hong Kong, Macau, Taiwan and Israel. Sol-Gel is expected
to receive, subject to applicable government approvals, a total consideration of up to $15 million, out of which $10 million
will be paid as upfront and regulatory milestones, and the remaining $5 million will be paid as royalties on net sales.
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1
All $ amounts are in U.S. dollars
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. We initiated a proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease, and have been
using SGT-210 in a compassionate use treatment for to a pediatric patient suffering from an ultra-rare disease.
. On April 1, 2024, Sol-Gel announced that Padagis Israeli
Pharmaceuticals, Sol-Gel's collaboration partner, submitted a
first-to-file Abbreviated New Drug Application (ANDA) to the
for Roflumilast Cream 0.3%, a drug product generic to Zoryve
(R)
Cream (roflumilast cream 0.3%) indicated for the treatment of plaque
psoriasis in patients six years of age and older. On March 26, 2024,
Arcutis Biotherapeutics Inc (Nasdaq: ARQT) initiated a patent
infringement action in the US District Court in New Jersey regarding
the Padagis Roflumilast 0.3% ANDA. Should the ANDA is approved by
the FDA, Padagis believes that its product may be entitled to 180
days of generic market exclusively. According to IQVIA, the annual
market sales in the 12 months ended in January 2024 for Zoryve
(R)
Cream were approximately $ 95 million
.
. SGT-610 Phase 3 clinical trial is ongoing. On November 30,
2023, Sol-Gel announced that it had begun for Gorlin syndrome,
with the first patient screened. Sol-Gel acquired topically applied patidegib, a
hedgehog signaling pathway blocker 2% from PellePharm Inc. and is currently the only
therapy in development to prevent the development of new BCC lesions in Gorlin syndrome
patients. SGT-610 is a new topical hedgehog inhibitor to prevent the new basal cell
carcinoma (BCC) lesions in patients with Gorlin syndrome that is expected to have an
improved safety profile compared to oral hedgehog inhibitors. Sol-Gel is conducting
a Phase 3 clinical trial to investigate SGT-610 in approximately 140 subjects at about
40 experienced clinical centers in North America, the United Kingdom, and Europe.
. Total prescriptions for TWYNEO in Q1 2024 totaled approximately 21,000,
declining 23% from Q4 2023. Patient refills in Q1 declined by 18% for the
same time period. This is in part due to a targeted patient adherence
campaign facilitated in Q4 2023 and to the adjustments in the promotional
model. TWYNEO new prescribers continue to grow with a 5% quarterly increase.
Average weekly TWYNEO prescriptions/prescriber remained relatively
constant at 1.6/week for Q1 with commercial managed care coverage for TWYNEO
increasing by 1.5M lives since Q4 2023 to 102.2M commercial lives covered.
. Total prescriptions for EPSOLAY in Q1 2024 totaled approximately 12,500, declining 14%
from Q4 2023. Patient refills declined by 8% for Q1 2024 vs. Q4 2023. Consistent with
TWYNEO, the quarterly decrease for EPSOLAY was negatively impacted by strong prescriptions
in Q4 2023 influenced by a targeted patient adherence campaign and to the adjustments
in the promotional model. EPSOLAY new prescribers continue to grow with a 6% increase
vs. Q4 2023. Average weekly EPSOLAY prescriptions/prescriber remained consistent at
1.3/week for Q1. Managed care coverage for EPSOLAY has grown since Q4 2023 with total
commercial lives covered increasing by over 1M lives to 67.1M commercial lives covered.
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Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel, stated:
"We continue to focus on rare indications affecting the skin which have no
approved treatments. In this regard, we are continuing to enroll patients for
our pivotal Phase 3 clinical trial of SGT-610 for the prevention of new basal
cell carcinomas in patients with Gorlin Syndrome, with a potential market
estimated at more than $300 million. We also initiated a proof-of-concept
study for SGT-210 (topical erlotinib) in patients with Darier disease, with
results expected in H1/2025. In addition, SGT-210 is currently being used in
a Compassionate use treatment of a pediatric patient suffering from an
ultra-rare disease, and given the preliminary highly encouraging
response, the treatment with SGT-210 continues, and the company will explore
other commercially viable keratoderma indications" said Alon Seri-Levy, Ph.D.,
Chief Executive Officer of Sol-Gel.
"We recently signed an agreement with Beimei Pharma for the commercialization
of TWYNEO in China, Hong Kong, Macau, Taiwan and Israel. This agreement
demonstrates the potential of TWYNEO, and we expect to announce other
agreements regarding the commercialization of both our FDA-approved assets,
TWYNEO and EPSOLAY, in other territories," further added Dr. Seri-Levy.
Financial Results for the First Quarter Year Ended March 31
st
, 2024
Total revenue in the first quarter was $0.5 million, which primarily consisted
of licensing revenue from Galderma and Searchlight, compared to $0.3 million
revenues for the same period in 2023. As disclosed in connection with the
filing of the June 30, 2023, financial statements, in the first quarter of
2023, wholesaler ordering patterns were disrupted ahead of Galderma's
implementation of a new enterprise resource planning system, which impacted
its standard forecasting procedures and its quarterly assessment of rebate
accruals. As a result, previously reported revenue for the first quarter of
2023 was revised as reflected in the below income statement.
Research and development expenses were $5.3 million compared to $9.4 million
for the same period in 2023. The decrease of $4.1 million was primarily
attributed to a decrease of $1.8 million in R&D expenses related to SGT-610
and SGT-210, a decrease of $1.4 million in expenses related to clinical
development of a generic product candidate, a decrease of $0.3 million in
payroll expenses, and a decrease of $0.3 in general R&D expenses.
General and administrative expenses were $1.8 million compared to $2.0 million
for the same period in 2023. The decrease of $0.2 million was mainly
attributed to a decrease in professional expenses.
Sol-Gel reported a net loss of $6.3 million for the first quarter of 2024 and
a loss of $0.23 per basic and diluted share, compared to a net loss of $10.7
million and a loss of $0.43 per basic and diluted share for the same period in
2023.
As of March 31, 2024, Sol-Gel had $16.2 million in cash, cash equivalents, and
deposits and US$16.8 million in marketable securities for a total balance of
$33.0 million. The Company expects its cash resources to fund operational and
capital expenditure requirements into the second half of 2025.
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.
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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. both drugs are exclusively licensed
to and commercialized by Galderma in the US; and are exclusively licensed to
Searchlight in Canada. TWYNEO was purchased and licensed by Beimei Pharma to
be exclusively commercialized by them in China, Hong Kong, Macau, Taiwan and
Israel.
The Company's pipeline also includes a 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
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 the agreement with Beimei, out-licensing Epsolay
and Twyneo in additional territories, the potential of Sol-Gel's assets
including Twyneo, Epsolay SGT-610, and SGT-210, and SGT-610's market value.
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, 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 :
Gilad Mamlok
Chief Financial Officer
info@sol-gel.com
+972-8-9313433
Source: Sol-Gel Technologies Ltd.
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SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Three months ended
March 31
2023 2024
LICENSE REVENUES $ 300 $ 466
RESEARCH AND DEVELOPMENT EXPENSES 9,386 5,345
GENERAL AND ADMINISTRATIVE EXPENSES 1,977 1,833
OPERATING LOSS $ 11,063 $ 6,712
FINANCIAL INCOME, (342 ) (368 )
net
LOSS FOR THE PERIOD $ 10,721 $ 6,344
BASIC AND DILUTED LOSS PER ORDINARY SHARE 0.43 0.23
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN 24,944,220 27,857,620
COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
December 31, March 31,
2023 2024
Assets
CURRENT ASSETS:
Cash and cash $ 7,513 $ 11,210
equivalents
Bank deposits 10,012 5,012
Marketable 20,471 16,795
securities
Accounts 377 869
receivables
Prepaid expenses and 2,794 2,121
other current assets
TOTAL CURRENT 41,167 36,007
ASSETS
NON-CURRENT
ASSETS:
Restricted long-term deposits 1,284 1,264
and cash equivalents
Property and 434 366
equipment, net
Operating lease 1,721 1,612
right-of-use assets
Other long-term 55 45
assets
Funds in respect of employee 626 617
rights upon retirement
TOTAL NON-CURRENT 4,120 3,904
ASSETS
TOTAL ASSETS $ 45,287 $ 39,911
Liabilities and
shareholders' equity
CURRENT
LIABILITIES:
Accounts $ 154 $ 582
payable
Other accounts 3,921 4,257
payable
Current maturities 447 386
of operating leases
TOTAL CURRENT 4,522 5,225
LIABILITIES
LONG-TERM
LIABILITIES:
Operating leases 1,206 1,133
liabilities
Liability for employee 915 902
rights upon retirement
TOTAL LONG-TERM 2,121 2,035
LIABILITIES
TOTAL 6,643 7,260
LIABILITIES
SHAREHOLDERS'
EQUITY:
Ordinary shares, NIS 0.1 par value - authorized: 774 774
50,000,000 as of December 31, 2023 and March 31, 2024,
respectively; issued and outstanding: 27,857,620 and
27,857,620 as of December 31, 2023 and March 31,
2024,
respectively
Additional 258,173 258,524
paid-in capital
Accumulated (220,303 ) (226,647 )
deficit
TOTAL SHAREHOLDERS' 38,644 32,651
EQUITY
TOTAL LIABILITIES AND $ 45,287 $ 39,911
SHAREHOLDERS' EQUITY
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{graphic omitted}