NESS ZIONA, Israel, May 12, 2023 (GLOBE NEWSWIRE) — 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
Financial Results for the Quarter Ended March 31, 2023
Total revenue in the first quarter was $0.8 million, which primarilyconsisted 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.
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
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 equivalents | $ | 12,448 | $ | 6,806 | |||||||
Bank deposits | 12,500 | 8,500 | |||||||||
Marketable securities | 8,678 | 18,439 | |||||||||
Receivables from collaborative and licensing arrangements | 7,858 | 5,806 | |||||||||
Prepaid expenses and other current assets | 1,571 | 1,128 | |||||||||
TOTAL CURRENT ASSETS | 43,055 | 40,679 | |||||||||
NON-CURRENT ASSETS: | |||||||||||
Restricted long-term deposits and cash | 1,288 | 1,296 | |||||||||
Long-term bank deposits | – | 5,000 | |||||||||
Property and equipment, net | 660 | 632 | |||||||||
Operating lease right-of-use assets | 876 | 707 | |||||||||
Funds in respect of employee rights upon retirement | 749 | 729 | |||||||||
TOTAL NON-CURRENT ASSETS | 3,573 | 8,364 | |||||||||
TOTAL ASSETS | $ | 46,628 | $ | 49,043 | |||||||
Liabilities and shareholders’ equity | |||||||||||
CURRENT LIABILITIES: | |||||||||||
Accounts payable | $ | 251 | $ | 339 | |||||||
Other accounts payable | 2,360 | 3,040 | |||||||||
Current maturities of operating leases | 718 | 544 | |||||||||
TOTAL CURRENT LIABILITIES | 3,329 | 3,923 | |||||||||
LONG-TERM LIABILITIES: | |||||||||||
Operating leases liabilities | 54 | 30 | |||||||||
Liability for employee rights upon retirement | 1,032 | 1,028 | |||||||||
TOTAL LONG-TERM LIABILITIES | 1,086 | 1,058 | |||||||||
TOTAL LIABILITIES | 4,415 | 4,981 | |||||||||
SHAREHOLDERS’ EQUITY: | |||||||||||
Ordinary shares, NIS 0.1 par value – authorized: 50,000,000 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 | 638 | 712 | |||||||||
Additional paid-in capital | 234,640 | 246,678 | |||||||||
Accumulated deficit | (193,065) | (203,328) | |||||||||
TOTAL SHAREHOLDERS’ EQUITY | 42,213 | 44,062 | |||||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 46,628 | $ | 49,043 |
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 REVENUES | $ | 3 | $ | 758 | |||
RESEARCH AND DEVELOPMENT EXPENSES | 4,042 | 9,386 | |||||
GENERAL AND ADMINISTRATIVE EXPENSES | 1,911 | 1,977 | |||||
OPERATING LOSS | $ | 5,950 | $ | 10,605 | |||
FINANCIAL INCOME, net | (353 | ) | (342 | ) | |||
LOSS FOR THE PERIOD | $ | 5,597 | $ | 10,263 | |||
BASIC AND DILUTED LOSS PER ORDINARY SHARE | 0.24 | 0.41 | |||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 23,127,484 | 24,944,220 |
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