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 million 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 shareholder 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 replacesthe Company’s previous
CFO, Mr. Gilad Mamlok, who will facilitate the transition through
December 31, 2024.
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 million 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 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
million 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
million 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.
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
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-OrChief Financial
Officerinfo@sol-gel.com+972-8-9313429
Source: Sol-Gel Technologies Ltd.
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 |
|
|
|
|
Assets |
|
|
|
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 |
|
|
|
SOL-GEL TECHNOLOGIES LTD. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
(U.S. dollars in thousands, except share and per share data) |
(Unaudited) |
|
|
|
Six months ended |
Three months ended |
|
June 30 |
|
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 |
Sol Gel Technologies (NASDAQ:SLGL)
過去 株価チャート
から 11 2024 まで 12 2024
Sol Gel Technologies (NASDAQ:SLGL)
過去 株価チャート
から 12 2023 まで 12 2024