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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 2023
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 May 12, 2023, Sol-Gel Technologies Ltd. (the "Company") issued a press
release reporting first quarter 2023 financial results and corporate update.
Attached hereto is the following exhibit:
Exhibit 99.1: Registrant's press release entitled: "Sol-Gel Technologies
Reports First Quarter 2023 Financial Results and Corporate Update"
.
Exhibit 99.1 (other than the two paragraphs immediately preceding the heading
"Q1 2023 and Recent Corporate Developments") 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 12, 2023 By: /s/ Gilad Mamlok
Gilad Mamlok
Chief Financial Officer
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Exhibit 99.1
Sol-Gel Technologies Reports First Quarter 2023 Financial Results and Provides
Corporate Update
. Positive trends continue for TWYNEO
(R)
and EPSOLAY
(R)
with recurrent prescriber bases at 98% for TWYNEO and 92% for EPSOLAY during Q1 2023
. Sol-Gel on track to advance Orphan Drug candidate, SGT-610 (patidegib) for Gorlin syndrome into Phase 3 testing in late 2023
. Phase 1 trial for SGT-210 (erlotinib) demonstrated no systemic absorption-related
adverse events; Sol-Gel intends to advance this drug candidate
. Sol-Gel has cash runway into the second half of 2025
NESS ZIONA, Israel, May 12, 2023 -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL),
a dermatology company with two innovative dermatology products, EPSOLAY and
TWYNEO, that were launched in the U.S., SGT-610, which is Phase 3-ready, and
an earlier-stage SGT-210, today announced financial results for the first
quarter ended March 31, 2023 and provided a corporate update.
"This year we turned our focus towards a high-value segment of dermatology and
helping those patients with significant unmet needs. We remain on track with
our plans to initiate the pivotal Phase 3 trial for SGT-610, or patidegib, our
recently acquired, Breakthrough-designated, Orphan Drug candidate with a
market potential of over $300 million for the treatment of Gorlin syndrome, in
late 2023," stated Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel.
"In parallel, we continue to be pleased by the pace of uptake by prescribers,
patients and payors for our Galderma-partnered products, TWYNEO and EPSOLAY.
Galderma had an impressive presence to support both brands at the American
Academy of Dermatology in March of this year, hosting several educational
events and thought-leader presentations for physicians, and then held a
targeted sales force training on EPSOLAY ahead of peak rosacea season. We
remain confident about prospects to improve TWYNEO and EPSOLAY reimbursement
and profitability over time and continue to seek out-licensing opportunities
for our non-U.S. rights to both drugs."
Q1 2023 and Recent Corporate Developments
. On January 27, 2023, Sol-Gel announced the acquisition of topically applied patidegib, a hedgehog signaling pathway
blocker, for the treatment of Gorlin syndrome from PellePharm, Inc. for an upfront payment of $4.7 million; in addition,
Sol-Gel agreed to pay PellePharm total development and NDA acceptance milestones of up to $6.0 million, and, based
on the expected market potential, up to $64.0 million in commercial milestones as well as single-digit royalties.
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. Related to the acquisition, Sol-Gel announced the pricing of $22.8 million in parallel registered direct and
private placement offerings, the proceeds from which will support the Phase 3 trial of patidegib expected
to begin in the fourth quarter of 2023 and for general corporate purposes. The $10 million private placement
portion of the offering was approved by shareholders on March 30, 2023 and received in April 2023.
. Prescribers continue to report positive experiences with TWYNEO (launched in April
2022), with the recurring base of prescribers increasing to a high of 98% in the
first quarter of 2023, from 82% in the fourth quarter of 2022, with consistent
prescribing quantities per healthcare provider and increasing patient refill rates.
The recurring base of prescribers, defined as the percentage of all TWYNEO prescribers
who have written since launch and continue to prescribe, continues to be a
positive indicator of the drug's acceptance. According to IQVIA data, there have
been over 28,000 prescriptions written for TWYNEO in the first quarter of 2023.
. As of Q1 2023, nine months post its June 2022 launch, EPSOLAY remains at the #2 position among branded topical rosacea
treatments. EPSOLAY's recurring base of prescribers increased to 92% of its total prescribers in Q1 2023, from 64% in
the fourth quarter of 2022, and prescriptions written per provider continue to increase along with patient refill rates.
According to IQVIA data, there have been over 12,000 prescriptions of EPSOLAY written in the first quarter of 2023.
. Since launching, TWYNEO and EPSOLAY have improved their commercial managed care accessibility, reaching over 60%
and 40% of commercial covered lives respectively. Beyond broad managed care adoption of TWYNEO across the three
major Pharmacy Benefit Managers (PBMs), the drug was moved by CVS Corporation to preferred status on its formulary
as of January 1, 2023; while EPSOLAY is now also covered by Express Scripts Holding Company and OptumRx, Inc.
. Galderma hosted several medical education events to support brand visibility of both
TWYNEO and EPSOLAY at the American Academy of Dermatology in March and also held targeted
sales force education and training activities for EPSOLAY ahead of Rosacea Awareness
Month in April, during peak rosacea season, to drive increased prescription volumes.
. Sol-Gel has completed a Phase 1 study of SGT-210, or erlotinib, an EGFR inhibitor. The trial was designed
as a single-center, single-blind, parallel-group, maximal use systemic exposure (MUSE) study evaluating
the pharmacokinetics, safety and tolerability of erlotinib topical treatment in healthy volunteers. A
total of 12 healthy adult subjects were assigned to two doses of erlotinib treatment in a 1:1 ratio. The
subjects were treated once daily for 28 days. Study results showed the topical therapy had no systemic
absorption-related adverse events affecting patient treatment adherence and minimal systemic absorption was
detected. Study drug-related adverse events were mainly designated as mild, and all were resolved during
study duration. Results from this Phase 1 study support further development of this product candidate
.
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Financial Results for the Quarter Ended March 31, 2023
Total revenue in the first quarter was $0.8 million, which primarily consisted
of licensing revenue compared to nominal revenues for the same period in 2022.
Research and development expenses were $9.4 million compared to $4.0 million
for the same period in 2022. The increase of $5.4 million was primarily
attributed to the $4.7 million upfront payment associated with the acquisition
of topically applied patidegib.
General and administrative expenses were $2.0 million in 2023 compared to $1.9
million for the same period in 2022. The increase of $0.1 million was mainly
attributed to an increase in professional expenses.
Sol-Gel reported net loss of $10.3 million for the first quarter of 2023 and a
loss of $0.41 per basic and diluted share, compared to a net loss of $5.6
million and a loss of $0.24 per basic and diluted share for the same period in
2022.
As of March 31, 2023, Sol-Gel had $20.3 million in cash, cash equivalents and
deposits, and $18.4 million in marketable securities for a total balance of
$38.7 million. The balance as of March 31, 2023, does not include $10 million
received in April 2023 as part of the $22.8 million raised in the recent
financing. The Company expects that its cash resources will enable funding of
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 Gorlin syndrome, 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 basal cell
carcinoma (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 is a dermatology company focused on identifying, developing and
commercializing or partnering drug products for the treatment of 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 U.S.
The Company's pipeline includes Orphan Drug candidate, SGT-610 for the
prevention of new basal cell carcinomas in Gorlin syndrome patients, and also
includes topical drug candidate SGT-210 under investigation for the treatment
of rare skin keratodermas.
For additional information, please visit
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
benefits of and projections of our future financial performance as a result of
our acquisition of SGT-610; the timing and success of any clinical studies and
obtaining of regulatory approval for our product candidates, including
SGT-610; our expected cash runway, the commercial acceptance, profitability
and reimbursement of TWYNEO and EPSOLAY, our ability to
out-license non-U.S. rights for TWYNEO and EPSOLAY
, and the potential of SGT-210. These forward-looking statements include
information about possible or assumed future results of our business,
financial condition, results of operations, liquidity, plans and objectives.
In some cases, you can identify forward-looking statements by terminology such
as "believe," "may," "estimate," "continue," "anticipate," "intend," "should,"
"plan," "expect," "predict," "potential," or the negative of these terms or
other similar expressions. Forward-looking statements are based on information
we have when those statements are made or our management's current
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, the risk that the
initiation or results of the Phase 3 study for
SGT-610 will be delayed or not occur, the risk that our annual net sales from
SGT-610, if approved,
will be lower than expected, risks that our cash runway will be shorter than
expected, risks relating to the current global macroeconomic climate as well
as the following factors: (i) the adequacy of our financial and other
resources, particularly in light of our history of recurring losses and the
uncertainty regarding the adequacy of our liquidity to pursue our complete
business objectives; (ii) our ability to complete the development of our
product candidates; (iii) our ability to find suitable co-development
partners; (iv) our ability to obtain and maintain regulatory approvals for our
product candidates in our target markets, the potential delay in receiving
such regulatory approvals and the possibility of adverse regulatory or legal
actions relating to our product candidates even if regulatory approval is
obtained; (v) our ability to commercialize our pharmaceutical product
candidates; (vi) our ability to obtain and maintain adequate protection of our
intellectual property; (vii) our ability to manufacture our product candidates
in commercial quantities, at an adequate quality or at an acceptable cost;
(viii) our ability to establish adequate sales, marketing and distribution
channels; (ix) acceptance of our product candidates by healthcare
professionals and patients; (x) the possibility that we may face third-party
claims of intellectual property infringement; (xi) the timing and results of
clinical trials that we may conduct or that our competitors and others may
conduct relating to our or their products; (xii) intense competition in our
industry, with competitors having substantially greater financial,
technological, research and development, regulatory and clinical,
manufacturing, marketing and sales, distribution and personnel resources than
we do; (xiii) potential product liability claims; (xiv) potential adverse
federal, state and local government regulation in the United States, Europe or
Israel; and (xv) loss or retirement of key executives and research scientists.
These and other important factors discussed in the Company's Annual Report on
Form 20-F filed with the Securities and Exchange Commission ("SEC") on March
10, 2023, as amended, 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.
For further information, please contact:
Investors:
Irina Koffler
Investor relations, LifeSci Advisors
ikoffler@lifesciadvisors.com
+1 917 734 7387
Sol-Gel Technologies
Gilad Mamlok
Chief Financial Officer
gilad.mamlok@sol-gel.com
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SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
December 31, March 31,
2022 2023
Assets
CURRENT ASSETS:
Cash and cash $ 12,448 $ 6,806
equivalents
Bank deposits 12,500 8,500
Marketable 8,678 18,439
securities
Receivables from 7,858 5,806
collaborative
and licensing
arrangements
Prepaid 1,571 1,128
expenses and
other current
assets
TOTAL CURRENT 43,055 40,679
ASSETS
NON-CURRENT
ASSETS:
Restricted 1,288 1,296
long-term
deposits
and cash
Long-term - 5,000
bank deposits
Property and 660 632
equipment, net
Operating 876 707
lease
right-of-use
assets
Funds in respect 749 729
of employee
rights upon
retirement
TOTAL 3,573 8,364
NON-CURRENT
ASSETS
TOTAL ASSETS $ 46,628 $ 49,043
Liabilities
and
shareholders'
equity
CURRENT
LIABILITIES:
Accounts $ 251 $ 339
payable
Other accounts 2,360 3,040
payable
Current 718 544
maturities
of operating
leases
TOTAL CURRENT 3,329 3,923
LIABILITIES
LONG-TERM
LIABILITIES:
Operating 54 30
leases
liabilities
Liability for 1,032 1,028
employee
rights upon
retirement
TOTAL 1,086 1,058
LONG-TERM
LIABILITIES
TOTAL 4,415 4,981
LIABILITIES
SHAREHOLDERS'
EQUITY:
Ordinary shares, NIS 0.1 par value - authorized: 50,000,000 638 712
as of December 31, 2022 and March 31, 2023, respectively;
issued and outstanding: 23,129,469 and 25,702,237 as
of December 31, 2022 and March 31, 2023, respectively
Additional 234,640 246,678
paid-in
capital
Accumulated (193,065 ) (203,328 )
deficit
TOTAL 42,213 44,062
SHAREHOLDERS'
EQUITY
TOTAL $ 46,628 $ 49,043
LIABILITIES AND
SHAREHOLDERS'
EQUITY
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SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Three months ended
March 31
2022 2023
LICENSE $ 3 $ 758
REVENUES
RESEARCH AND 4,042 9,386
DEVELOPMENT EXPENSES
GENERAL AND 1,911 1,977
ADMINISTRATIVE EXPENSES
OPERATING LOSS $ 5,950 $ $ 10,605
FINANCIAL (353 ) (342 )
INCOME,
net
LOSS FOR $ 5,597 $ 10,263
THE PERIOD
BASIC AND DILUTED LOSS 0.24 0.41
PER ORDINARY SHARE
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED 23,127,484 24,944,220
IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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