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Sol-Gel Reports First Quarter 2025 Results
Globenewswire· 2025-05-23 11:15
Core Viewpoint - Sol-Gel Technologies, Ltd. reported financial results for the first quarter of 2025, showing an increase in total revenue but a higher net loss compared to the same period in 2024 [2][4]. Financial Performance - Total revenue for the first quarter of 2025 was $1 million, a 100% increase from $0.5 million in the same period in 2024 [2]. - Research and development expenses rose to $8.8 million from $5.3 million in the first quarter of 2024, primarily due to supplier-led manufacturing development for SGT-610 [3]. - General and administrative expenses decreased to $1.3 million from $1.8 million in the same period in 2024, attributed to cost measures taken in 2024 [4]. - The net loss for the first quarter of 2025 was $8.8 million, compared to a net loss of $6.3 million in the first quarter of 2024, with a basic and diluted loss per share of $3.2 compared to $2.3 in 2024 [4]. Cash Position - As of March 31, 2025, Sol-Gel had $16.9 million in cash and cash equivalents, with no marketable securities, expected to fund operations into the first quarter of 2027 [5]. Company Overview - Sol-Gel Technologies focuses on developing and commercializing drug products for skin diseases, with FDA-approved products TWYNEO and EPSOLAY for acne and rosacea, respectively [6]. - The company's pipeline includes SGT-610, an Orphan Drug candidate for basal cell carcinoma prevention, and SGT-210 for rare skin keratodermas [7].
Sol-Gel Announces Reverse Share Split
GlobeNewswire News Room· 2025-05-01 11:00
Core Points - Sol-Gel Technologies Ltd. announced a 10-for-1 reverse share split to increase the per share market price and regain compliance with Nasdaq's minimum bid price requirement [4][5][6] Group 1: Reverse Share Split Details - The reverse share split will consolidate every ten ordinary shares into one ordinary share, effective at 11:59 p.m. Eastern Time on May 2, 2025 [3][5] - The first trading day on Nasdaq under the new share structure is expected to be May 5, 2025, with the symbol "SLGL" remaining unchanged [3][4] - The par value of the ordinary shares will increase from NIS 0.1 to NIS 1.0, and the total share capital will adjust from 50 million to 5 million ordinary shares [6] Group 2: Shareholder Approval and Process - Shareholders approved the reverse split ratio at a special meeting on April 1, 2025, with the board of directors confirming the 10-for-1 ratio on April 9, 2025 [2] - Equiniti Trust Company, LLC will act as the exchange and transfer agent for the reverse split, and shareholders holding shares electronically will not need to take action to receive post-split shares [7] Group 3: Company Overview - Sol-Gel Technologies is focused on developing and commercializing drug products for skin diseases, with FDA-approved products including TWYNEO for acne and EPSOLAY for rosacea [8] - The company's pipeline includes SGT-610, an orphan drug candidate for Gorlin syndrome, and SGT-210, a topical drug candidate for rare skin keratodermas [9]
Sol-Gel(SLGL) - 2024 Q4 - Annual Report
2025-04-29 12:50
[Introduction](index=4&type=section&id=INTRODUCTION) This section defines key product terms, distinguishing approved products Twyneo and Epsolay from investigational candidates SGT-610 and SGT-210 - Key product terms defined include **Twyneo** and **Epsolay** as approved products, and **SGT-610** and **SGT-210** as investigational candidates[18](index=18&type=chunk) [Key Information](index=8&type=section&id=ITEM%203.%20KEY%20INFORMATION) [Risk Factors](index=9&type=section&id=D.%20Risk%20Factors) The company faces substantial risks, including financial losses, funding dependency, reliance on partner commercialization, clinical development uncertainties, and operational risks in Israel and Nasdaq compliance - The company reported a net loss of **$27.2 million** in 2023 and **$10.6 million** in 2024, with an accumulated deficit of **$230.9 million** as of December 31, 2024[37](index=37&type=chunk) - Future product development, particularly for SGT-610, critically depends on a **$6 million** payment from Mayne Pharma[29](index=29&type=chunk)[44](index=44&type=chunk) - Commercial success of Twyneo and Epsolay is highly dependent on partners like Beimei (China) and Searchlight (Canada)[29](index=29&type=chunk)[53](index=53&type=chunk) - Operations in Israel expose the company to political, economic, and military instability, including the ongoing conflict since October 2023[197](index=197&type=chunk)[198](index=198&type=chunk) - The company's likely status as a Passive Foreign Investment Company (PFIC) for 2024 could lead to adverse U.S. federal income tax consequences for shareholders[237](index=237&type=chunk) - Nasdaq non-compliance regarding minimum bid price, despite an extension and reverse stock split, poses a delisting risk[221](index=221&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) [Information on the Company](index=49&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) [History and Development of the Company](index=49&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Sol-Gel Technologies Ltd., incorporated in Israel in 1997, completed its IPO in 2018 and now trades on Nasdaq, with minimal capital expenditures in 2024 - The company was incorporated in Israel on **October 28, 1997**[259](index=259&type=chunk) Capital Expenditures (in thousands) | Year | 2022 | 2023 | 2024 | | :--- | :--- | :--- | :--- | | Capital Expenditures | $171 | $134 | $2 | [Business Overview](index=49&type=section&id=B.%20Business%20Overview) Sol-Gel is an innovative dermatology company with two FDA-approved products, Twyneo and Epsolay, a pipeline for orphan indications, and proprietary silica-based microencapsulation technology - The company has two FDA-approved products: **Twyneo** for acne vulgaris and **Epsolay** for inflammatory lesions of rosacea[262](index=262&type=chunk)[265](index=265&type=chunk) - Key pipeline candidates include **SGT-610** for Gorlin syndrome (Phase 3, results expected Q4 2026) and **SGT-210** for Darier Disease (Phase 1 completed)[263](index=263&type=chunk)[264](index=264&type=chunk)[269](index=269&type=chunk) - U.S. rights for Twyneo and Epsolay were sold to Mayne Pharma in April 2025, with commercialization agreements also in place with Beimei (China) and Searchlight (Canada)[262](index=262&type=chunk)[266](index=266&type=chunk) - The core technology is a proprietary **silica-based microencapsulation platform** for stable formulation and reduced skin irritation[303](index=303&type=chunk)[304](index=304&type=chunk) - The patent portfolio includes **70 patents and patent applications** covering manufacturing, formulations, and methods of use[307](index=307&type=chunk) [Organizational Structure](index=78&type=section&id=C.%20Organizational%20Structure) This section is not applicable as the company does not have a complex organizational structure to report [Property, Plant and Equipment](index=78&type=section&id=D.%20Property,%20Plant%20and%20Equipment) The company's principal executive offices, laboratories, and production are in a **1,534 square meter leased facility** in Ness Ziona, Israel, with the lease expiring December 31, 2025 - The main facility is a leased **1,534 square meter** space in Ness Ziona, Israel, with the lease expiring at the end of 2025[444](index=444&type=chunk) [Operating and Financial Review and Prospects](index=79&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) [Operating Results](index=81&type=section&id=A.%20Operating%20Results) In FY2024, revenues significantly increased to **$11.6 million**, while reduced R&D and G&A expenses led to a substantially lower net loss of **$10.6 million** compared to 2023 Financial Performance (in thousands) | Metric | 2023 | 2024 | Change | | :--- | :--- | :--- | :--- | | **Revenues** | $1,554 | $11,538 | +$9,984 | | **R&D Expenses** | $23,541 | $17,803 | -$5,738 | | **G&A Expenses** | $7,373 | $5,749 | -$1,624 | | **Total Operating Loss** | ($29,305) | ($12,014) | +$17,291 | | **Net Loss** | ($27,238) | ($10,580) | +$16,658 | - The **$5.7 million decrease** in 2024 R&D expenses was primarily due to a **$2.8 million reduction** in clinical expenses and a **$2.1 million decrease** in payroll[480](index=480&type=chunk) - The **$1.6 million decrease** in 2024 G&A expenses was mainly due to a **$1.0 million reduction** in payroll and a **$0.6 million decrease** in professional services[481](index=481&type=chunk) [Liquidity and Capital Resources](index=84&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) As of December 31, 2024, Sol-Gel held **$23.9 million** in cash and equivalents, with management confident existing resources are sufficient for at least the next 12 months - As of December 31, 2024, cash, cash equivalents, bank deposits, and marketable securities totaled **$23.9 million**[486](index=486&type=chunk) - In January 2023, the company raised approximately **$22.8 million** in gross proceeds through a registered direct offering and private placement[487](index=487&type=chunk) Cash Flow Summary (in thousands) | Activity | 2023 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,730) | ($13,889) | | Net cash (used in) provided by investing activities | ($9,742) | $26,692 | | Net cash provided by financing activities | $21,810 | $0 | - Management confirms existing cash resources are sufficient to fund operations for at least **12 months** from the report filing date[493](index=493&type=chunk) [Critical Accounting Estimates](index=87&type=section&id=E.%20Critical%20Accounting%20Estimates) The most significant accounting estimates involve determining the fair value of share-based compensation using the Black-Scholes model, requiring subjective assumptions - The most critical accounting estimate is the valuation of **share-based compensation** using the **Black-Scholes model**[499](index=499&type=chunk)[500](index=500&type=chunk) - Key Black-Scholes assumptions include expected share price volatility and the expected option term[501](index=501&type=chunk) [Directors, Senior Management and Employees](index=88&type=section&id=ITEM%206.%20DIRECTORS,%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) [Directors and Senior Management](index=88&type=section&id=A.%20Directors%20and%20Senior%20Management) The company is led by Moshe Arkin, Executive Chairman and interim CEO, with detailed biographies of the senior management team and board of directors provided - **Moshe Arkin** serves as Executive Chairman of the Board and interim CEO effective January 1, 2025[502](index=502&type=chunk) - The senior management team includes Eyal Ben-Or (CFO), Dr. Ofer Toledano (VP R&D), Dr. Ofra Levy-Hacham (VP Clinical, Regulatory & Quality), Michael Glezin (CBO), Dr. Itzik Yosef (COO), and Tamar Fishman Jutkowitz (VP & General Counsel)[502](index=502&type=chunk) [Compensation](index=90&type=section&id=B.%20Compensation) Aggregate compensation for executive officers and directors was approximately **$2.6 million** in 2024, guided by a new policy aligning interests with long-term performance - Aggregate compensation for executive officers and directors totaled approximately **$2.6 million** for the year ended December 31, 2024[515](index=515&type=chunk) 2024 Compensation for Top 5 Highest Compensated Officers (in thousands) | Name and Position | Base Salary | Social Benefits | Equity Based Comp. | Other Comp. | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Alon Seri-Levy / Former CEO | 324 | 64 | 392 | 321 | 1,101 | | Gilad Mamlok / Former CFO | 263 | 52 | - | 206 | 521 | | Ofer Toledano / VP R&D | 204 | 58 | 107 | 89 | 458 | | Ofra Levy-Hacham / VP Clinical, RA & QA | 172 | 50 | 86 | 67 | 375 | | Tamar Fishman Jutkowitz / VP & GC | 162 | 48 | 35 | 61 | 306 | - A new compensation policy was adopted on **April 1, 2024**, and a clawback policy became effective **October 2, 2023**[526](index=526&type=chunk)[534](index=534&type=chunk) [Board Practices](index=92&type=section&id=C.%20Board%20Practices) The nine-member Board of Directors, including three external directors, operates under Israeli law as a "controlled company," with detailed policies on committees, related-party transactions, and indemnification - The board comprises **nine directors**, including three external directors like Ran Gottfried and Yuval Yanai, meeting Israeli legal requirements[535](index=535&type=chunk)[537](index=537&type=chunk) - The Audit Committee is chaired by **Yuval Yanai**, and the Compensation Committee by **Ran Gottfried**, with both including Sharon Kochan[563](index=563&type=chunk)[570](index=570&type=chunk) - As a **"controlled company"** and foreign private issuer, Sol-Gel follows home country practices, exempting it from certain Nasdaq governance requirements like independent board majority[227](index=227&type=chunk)[805](index=805&type=chunk) - Indemnification agreements with directors and officers have a maximum aggregate amount of the greater of **25% of shareholders' equity** or **$40 million**[634](index=634&type=chunk) [Employees](index=105&type=section&id=D.%20Employees) As of December 31, 2024, Sol-Gel had **34 employees** in Israel, primarily in management and R&D, with no collective bargaining agreements and a good employee relationship Employee Headcount by Function | Function | 2023 | 2024 | | :--- | :--- | :--- | | Management | 8 | 8 | | Research and development and other | 28 | 26 | | **Total Employees** | **36** | **34** | [Share Ownership](index=106&type=section&id=E.%20Share%20Ownership) This section details the company's 2014 and 2024 equity incentive plans, with **778,026 ordinary shares** available for issuance and **2,176,079 options** outstanding as of year-end 2024 - The company operates under a **2014 Share Incentive Plan** and a **2024 Share Incentive Plan** for equity awards[614](index=614&type=chunk) - As of December 31, 2024, **2,176,079 options** were outstanding with a weighted average exercise price of **$3.78 per share**[624](index=624&type=chunk) - As of April 1, 2025, **778,026 ordinary shares** were available for future issuance under the 2024 Plan[615](index=615&type=chunk) [Major Shareholders and Related Party Transactions](index=107&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) [Major Shareholders](index=107&type=section&id=A.%20Major%20Shareholders) As of April 1, 2025, **M. Arkin Dermatology Ltd.** is the controlling shareholder with **61.04%** ownership, with Mr. Moshe Arkin as its sole beneficial owner Beneficial Ownership (as of April 1, 2025) | Shareholder | Shares Beneficially Owned | Percentage | | :--- | :--- | :--- | | M. Arkin Dermatology Ltd. (1) | 18,227,792 | 61.04% | | Phoenix Holdings Ltd. (2) | 2,470,192 | 8.87% | | All directors and executive officers as a group (12 persons) | 19,789,335 | 63.24% | - **Mr. Moshe Arkin** beneficially owns **61.34%** of the company through direct ownership and control of Arkin Dermatology[630](index=630&type=chunk) [Related Party Transactions](index=109&type=section&id=B.%20Related%20Party%20Transactions) Key related party transactions include a **January 2023 private placement** with Arkin Dermatology Ltd., indemnification agreements with directors, and a renewed registration rights agreement - In January 2023, Arkin Dermatology Ltd. purchased **2 million unregistered ordinary shares** and warrants for up to **2 million ordinary shares** in a private placement[632](index=632&type=chunk) - The company has entered into **indemnification agreements** with all current directors and officers[634](index=634&type=chunk) - A registration rights agreement with Arkin Dermatology was renewed in **March 2023**, granting demand, short-form, and piggyback registration rights[635](index=635&type=chunk) [Financial Information](index=110&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) [Financial Statements and Other Financial Information](index=110&type=section&id=A.%20Financial%20Statements%20and%20Other%20Financial%20Information) This section presents the company's audited financial statements, noting no historical or anticipated cash dividends due to retained earnings strategy and Israeli Companies Law restrictions - The company has never paid cash dividends and does not plan to in the foreseeable future[640](index=640&type=chunk) - Dividend payments are restricted by Israeli Companies Law, requiring sufficient retained earnings or recent profits and assurance of meeting obligations[641](index=641&type=chunk) [The Offer and Listing](index=110&type=section&id=ITEM%209.%20THE%20OFFER%20AND%20LISTING) [Offer and Listing Details](index=110&type=section&id=A.%20Offer%20and%20Listing%20Details) The company's ordinary shares began trading on Nasdaq in **February 2018** at **$12.00 per share** and were transferred to The Nasdaq Capital Market in **November 2024** under "SLGL" - The company's ordinary shares trade on The Nasdaq Capital Market under the symbol **"SLGL"**[643](index=643&type=chunk) - The initial public offering occurred on **January 31, 2018**, at a price of **$12.00 per share**[643](index=643&type=chunk) [Additional Information](index=111&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) [Memorandum and Articles of Association](index=111&type=section&id=B.%20Memorandum%20and%20Articles%20of%20Association) This section outlines key provisions of the company's governing documents and Israeli law, covering voting rights, board composition, shareholder meeting quorums, and acquisition frameworks - All ordinary shares have **one vote per share** and the company's purpose is to engage in any lawful activity[651](index=651&type=chunk)[653](index=653&type=chunk) - The board of directors must consist of **not less than five and no more than ten directors**[536](index=536&type=chunk) - Shareholder meeting quorum requires at least two shareholders holding **33 1/3% of voting rights**, with adjourned meetings requiring any number of shareholders[664](index=664&type=chunk) - Israeli law governs acquisitions, with specific rules for **full tender offers** (over 90% of shares) and **special tender offers** (25% or more, or over 45% of voting rights)[669](index=669&type=chunk)[672](index=672&type=chunk) [Taxation](index=117&type=section&id=E.%20Taxation) This section details Israeli and U.S. federal income tax considerations, including Israel's **23% corporate tax rate** and the company's potential **Passive Foreign Investment Company (PFIC)** status for U.S. shareholders - The general corporate tax rate in Israel is **23% for 2024**[688](index=688&type=chunk) - The company may be eligible for tax benefits under Israel's Law for the Encouragement of Capital Investments, potentially providing tax exemptions or reduced rates[695](index=695&type=chunk)[703](index=703&type=chunk)[707](index=707&type=chunk) - The company believes it was a **Passive Foreign Investment Company (PFIC)** for its 2024 taxable year, potentially leading to adverse U.S. federal income tax consequences for U.S. Holders[737](index=737&type=chunk)[738](index=738&type=chunk) - If a PFIC, U.S. Holders face special tax rules on excess distributions and gains, taxed at highest ordinary income rates plus interest, unless mark-to-market or QEF elections are made[740](index=740&type=chunk)[742](index=742&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=129&type=section&id=ITEM%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) [Foreign Currency Exchange Risk](index=130&type=section&id=Foreign%20Currency%20Exchange%20Risk) The company's primary market risk is foreign currency exchange risk, with over **50% of 2024 expenses** in NIS, and a **5% USD/NIS fluctuation** impacting operating expenses by **2.02%** - The company's functional currency is the U.S. dollar, but over **50% of 2024 expenses** are denominated in New Israeli Shekels (NIS)[776](index=776&type=chunk) - A **5% fluctuation** in the USD/NIS exchange rate would have impacted operating expenses by approximately **2.02%** in fiscal year 2024[776](index=776&type=chunk) - The company uses foreign currency exchange derivative instruments to hedge its exposure to non-U.S. dollar currencies[778](index=778&type=chunk) [Controls and Procedures](index=131&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) [Disclosure Controls and Procedures](index=131&type=section&id=(a)%20Disclosure%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of the end of the reporting period - Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period[786](index=786&type=chunk) [Management's Annual Report on Internal Control over Financial Reporting](index=131&type=section&id=(b)%20Management's%20Annual%20Report%20on%20Internal%20Control%20over%20Financial%20Reporting) Management assessed and concluded that the company's internal control over financial reporting was effective as of December 31, 2024, based on the COSO 2013 framework - Based on the **COSO framework**, management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[789](index=789&type=chunk)[790](index=790&type=chunk) [Corporate Governance](index=132&type=section&id=ITEM%2016.%20CORPORATE%20GOVERNANCE) [Audit Committee Financial Expert](index=132&type=section&id=16A.%20AUDIT%20COMMITTEE%20FINANCIAL%20EXPERT) The board has determined that **Mr. Ran Gottfried** and **Mr. Yuval Yanai** qualify as independent audit committee financial experts under Nasdaq Listing Rules - The board has identified **Mr. Ran Gottfried** and **Mr. Yuval Yanai** as audit committee financial experts[794](index=794&type=chunk) [Code of Ethics](index=132&type=section&id=16B.%20CODE%20OF%20ETHICS) The company has adopted a code of ethics applicable to its principal executive, financial, and other senior financial personnel, available on its investor relations website - A code of ethics has been adopted for senior executive and financial officers[795](index=795&type=chunk) [Principal Accountant Fees and Services](index=132&type=section&id=16C.%20PRINCIPAL%20ACCOUNTANT%20FEES%20AND%20SERVICES) Total fees paid to the independent accounting firm were **$251 thousand** in FY2024, up from **$229 thousand** in 2023, with all services pre-approved by the audit committee Accountant Fees (in thousands) | Service | 2023 | 2024 | | :--- | :--- | :--- | | Audit Fees | $220 | $187 | | Tax Fees | $7 | $62 | | Other Fees | $2 | $2 | | **Total** | **$229** | **$251** | [Corporate Governance](index=133&type=section&id=16G.%20CORPORATE%20GOVERNANCE) As a foreign private issuer and "controlled company," Sol-Gel follows Israeli corporate governance practices, exempting it from certain Nasdaq rules regarding board independence and shareholder approvals - The company is a **"controlled company"** due to Arkin Dermatology's over **50% voting power**, exempting it from certain Nasdaq requirements like a majority-independent board[807](index=807&type=chunk) - As a foreign private issuer, the company follows Israeli practices for governance matters, including shareholder approval for equity plans and quorum for adjourned meetings[805](index=805&type=chunk) [Cybersecurity](index=134&type=section&id=16K.%20CYBERSECURITY) The company has implemented a cybersecurity risk management program, overseen by the Board and managed by operations, with no material incidents reported to date - The company has a cybersecurity risk management program based on **ISO 27001** and **SOX frameworks**[811](index=811&type=chunk)[812](index=812&type=chunk) - The Board of Directors provides oversight, with daily operations managed by the COO and a third-party IT provider[816](index=816&type=chunk)[818](index=818&type=chunk) - No cybersecurity threats or incidents have had a material effect on the company's business or financial condition to date[815](index=815&type=chunk) [Financial Statements](index=135&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) [Consolidated Financial Statements](index=140&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements for FY2024 show **$11.5 million** in revenues, a **$10.6 million** net loss, **$35.8 million** in total assets, and an unqualified audit opinion from Kesselman & Kesselman (PwC) Consolidated Balance Sheet (in thousands) | | Dec 31, 2023 | Dec 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $41,167 | $31,295 | | **Total Assets** | $45,287 | $35,846 | | **Total Current Liabilities** | $4,522 | $5,285 | | **Total Liabilities** | $6,643 | $6,996 | | **Total Shareholders' Equity** | $38,644 | $28,850 | Consolidated Statement of Operations (in thousands) | | 2022 | 2023 | 2024 | | :--- | :--- | :--- | :--- | | **Revenues** | $3,883 | $1,554 | $11,538 | | **Total Operating Loss** | ($16,244) | ($29,305) | ($12,014) | | **Net Loss** | ($14,923) | ($27,238) | ($10,580) | | **Basic and Diluted EPS** | ($0.65) | ($1.01) | ($0.38) | - The independent auditor, **Kesselman & Kesselman (PwC Israel)**, issued an unqualified opinion on the consolidated financial statements[836](index=836&type=chunk)
Sol-Gel and Mayne Pharma Announce the Purchase of EPSOLAY® and TWYNEO® in the U.S.
Globenewswire· 2025-04-17 12:40
Core Viewpoint - Sol-Gel Technologies has entered into a product purchase agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to EPSOLAY and TWYNEO, which will enhance the company's cash position and support the development of its product SGT-610 [1][6][7] Financial Summary - Sol-Gel will receive a total of $16 million from Mayne Pharma, with $10 million in Q2 2025 and $6 million in Q4 2025, extending the company's cash runway into Q1 2027 [1][9] - As of March 31, 2025, Sol-Gel had $16.9 million in cash and cash equivalents, with no marketable securities [5] Product Overview - EPSOLAY is a topical cream with 5% encapsulated benzoyl peroxide for treating inflammatory lesions of rosacea in adults [2][14] - TWYNEO is a fixed-dose combination cream containing 3% encapsulated benzoyl peroxide and 0.1% encapsulated tretinoin for treating acne vulgaris [2][13] Development Focus - The company will concentrate on the clinical and commercial development of SGT-610, a hedgehog signaling pathway blocker aimed at preventing basal cell carcinomas in Gorlin syndrome patients [3][15] - The U.S. market potential for SGT-610 is estimated to be between $400 million and $500 million annually [4][9] Clinical Trial Progress - The Phase-III clinical trial for SGT-610 is progressing well, with 80% of the planned patient enrollment completed, and top-line results expected in Q4 2026 [8][9] - The ongoing Phase 1b trial for SGT-210 in Darier disease patients has seen 50% of participants complete the trial [9][12] Market Potential - The global business potential for EPSOLAY and TWYNEO is expected to exceed that of the U.S. market, with many partnership agreements already signed [6][7] - SGT-210 has an estimated market potential of $200 million to $300 million if clinical efficacy is demonstrated [12]
SLGL Gears Up to Report Q4 Earnings: Here's What You Should Know
ZACKS· 2025-02-25 16:05
Core Viewpoint - Investors are expected to focus on Sol-Gel Technologies, Ltd.'s compliance with Nasdaq requirements and pipeline developments during the upcoming fourth-quarter and full-year 2024 results announcement [1]. Financial Performance - The Zacks Consensus Estimate for the upcoming quarter's revenues is $2 million, with an expected loss of 11 cents per share [1][12]. - Over the past year, Sol-Gel's shares have decreased by 46.2%, contrasting with a 1.9% increase in the industry [2]. Product Development - Sol-Gel has developed Twyneo and Epsolay, both FDA-approved treatments for acne vulgaris and rosacea, respectively [4]. - The company has licensing agreements for Twyneo and Epsolay, which generate royalties and milestone payments [4]. - Sol-Gel is also collaborating with Padagis for the development of a generic version of Zoryve Cream [5]. Revenue Sources - The company's revenue is primarily derived from licensing agreements with partners such as Padagis, Galderma, and Searchlight Pharma, with expectations of increased licensing revenues in the upcoming quarter [5]. Pipeline Candidates - The key pipeline candidate, SGT-610, is in phase III development for Gorlin Syndrome, with top-line data expected in the second half of 2026 [6]. - A proof-of-concept study for SGT-210, aimed at treating Darier disease, is also underway [6]. Compliance and Regulatory Updates - In November 2024, Sol-Gel received a notification from Nasdaq regarding the transfer of its shares to The Nasdaq Capital Market due to non-compliance with the Minimum Bid Price Requirement, with an additional 180 days granted to regain compliance [9]. Earnings Surprise History - Sol-Gel has a mixed earnings surprise history, beating estimates in two of the last four quarters, with an average surprise of 41.93% [10].
Is SolGel Technologies (SLGL) a Great Value Stock Right Now?
ZACKS· 2024-12-25 15:41
Core Viewpoint - The article emphasizes the importance of value investing and highlights SolGel Technologies (SLGL) as a strong value stock based on its financial metrics and Zacks Rank [2][3][6] Company Summary - SolGel Technologies (SLGL) currently holds a Zacks Rank of 2 (Buy) and has received an "A" grade in the Value category, indicating it is among the strongest value stocks available [3] - The stock's price-to-book (P/B) ratio is 1.32, which is significantly lower than the industry average of 3.77, suggesting that SLGL may be undervalued [4] - Over the past 52 weeks, SLGL's P/B ratio has fluctuated between a high of 1.32 and a low of 0.29, with a median of 0.63 [4] - The price-to-sales (P/S) ratio for SLGL is 2.33, which is also lower than the industry's average P/S of 2.78, reinforcing the notion of potential undervaluation [5] - The combination of these valuation metrics and a strong earnings outlook positions SLGL as an impressive value stock at present [6]
SolGel Technologies (SLGL) Upgraded to Buy: Here's What You Should Know
ZACKS· 2024-11-20 18:00
Core Viewpoint - Sol-Gel Technologies Ltd. (SLGL) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that rising earnings estimates can lead to higher stock prices [4][6]. - For the fiscal year ending December 2024, Sol-Gel Technologies is expected to earn -$0.56 per share, reflecting a 44.6% change from the previous year's reported number [8]. Analyst Sentiment and Market Position - Analysts have been increasing their earnings estimates for Sol-Gel Technologies, with a 2.6% rise in the Zacks Consensus Estimate over the past three months [8]. - The upgrade to Zacks Rank 2 places Sol-Gel Technologies in the top 20% of Zacks-covered stocks, indicating strong potential for near-term price appreciation [11]. Zacks Rank System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of generating significant returns for top-ranked stocks [7][9]. - Only the top 5% of Zacks-covered stocks receive a 'Strong Buy' rating, while the next 15% are rated as 'Buy', highlighting the selectivity and effectiveness of the rating system [9][10].
Sol-Gel Technologies Ltd. (SLGL) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2024-11-15 14:11
Core Insights - Sol-Gel Technologies Ltd. reported a quarterly loss of $0.01 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.13, and an improvement from a loss of $0.21 per share a year ago, indicating a 92.31% earnings surprise [1] - The company achieved revenues of $5.36 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 99.29%, compared to revenues of $0.21 million in the same quarter last year [2] - Sol-Gel Technologies shares have declined approximately 54.8% year-to-date, contrasting with the S&P 500's gain of 24.7% [3] Financial Performance - Over the last four quarters, Sol-Gel Technologies has exceeded consensus EPS estimates two times and topped consensus revenue estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $1.83 million, and for the current fiscal year, it is -$0.57 on revenues of $8.5 million [7] Industry Outlook - The Medical - Generic Drugs industry, to which Sol-Gel Technologies belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - The performance of Sol-Gel Technologies' stock may be influenced by the overall industry outlook and trends in earnings estimate revisions [5][8]
Sol-Gel Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
GlobeNewswire News Room· 2024-11-15 12:00
Core Insights - Sol-Gel Technologies, Ltd. has appointed Mori Arkin as interim CEO effective January 1, 2025, replacing founder Dr. Alon Seri-Levy, who will continue as a consultant for at least one year [2] - The company is conducting a Phase 3 clinical trial of SGT-610 for Gorlin Syndrome, with over 40 clinical sites activated and top-line results expected in the second half of 2026 [2][4] - Financial results for Q3 2024 show total revenue of $5.4 million, a significant increase from $0.2 million in Q3 2023, primarily driven by licensing revenue [5] Corporate Developments - The transfer of Sol-Gel's Ordinary Shares from The Nasdaq Global Market to The Nasdaq Capital Market was approved, effective November 15, 2024, to provide a second 180-day compliance period for the minimum bid price rule [2] - A new agreement with Padagis will enhance Sol-Gel's cash position by approximately $6 million through eight quarterly payments and low single-digit royalties from sales of a generic drug product [2] - Sol-Gel signed a license agreement for the commercialization of TWYNEO and EPSOLAY in South Korea, with expected upfront and regulatory milestone payments of up to $3.7 million [2] Clinical Trials and Product Pipeline - The Phase 3 study of SGT-610 is ongoing with approximately 140 subjects enrolled across 40 clinical centers, targeting a market exceeding $300 million annually if approved [2][4] - The proof-of-concept study for SGT-210 in patients with Darier disease is also ongoing, with a market potential estimated between $200 million to $300 million [2][4] - SGT-210 is currently being used in a compassionate use treatment for a pediatric patient, showing promising preliminary results [3] Financial Performance - Research and development expenses for Q3 2024 were $4.8 million, slightly up from $4.7 million in Q3 2023, primarily due to increased clinical trial expenses [6] - General and administrative expenses decreased to $1.4 million from $1.9 million in the same period last year, attributed to cost-saving measures [7] - The net loss for Q3 2024 was $0.4 million, a significant improvement compared to a net loss of $5.7 million in Q3 2023 [8] Cash Position - As of September 30, 2024, Sol-Gel had $14.6 million in cash and cash equivalents, and $14.6 million in marketable securities, totaling $29.2 million [8] - The company expects its cash resources to fund operations into the first quarter of 2026 [8]
SolGel Technologies (SLGL) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
ZACKS· 2024-09-17 14:55
Core Viewpoint - Sol-Gel Technologies Ltd. (SLGL) has experienced a recent downtrend, losing 8.4% over the past two weeks, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest and positive earnings outlook from analysts [1]. Group 1: Technical Analysis - A hammer chart pattern was formed in the last trading session, indicating that bulls may have countered the bears, suggesting potential support for the stock [1]. - The hammer pattern signals a possible bottom in a downtrend, indicating that selling pressure may be exhausting [2]. - Hammer candles can appear on various timeframes and are used by both short-term and long-term investors, but should be combined with other bullish indicators for confirmation [2]. Group 2: Fundamental Analysis - There has been a positive trend in earnings estimate revisions for SLGL, with a 31.3% increase in the consensus EPS estimate for the current year over the last 30 days, indicating expected better earnings [3]. - SLGL holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks, which typically outperform the market [3]. - The Zacks Rank serves as a timing indicator, suggesting that the company's prospects are beginning to improve, further supporting the potential for a trend reversal [3].