Sol-Gel Provides Update Following Unblinding of Phase 1b Study of SGT-210 in Darier Disease

Rhea-AI Summary

Sol-Gel (NASDAQ: SLGL) announced results after unblinding a vehicle-controlled Phase 1b proof-of-concept study of SGT-210 in Darier disease on Dec 17, 2025. The company reported that the study did not show differentiation between SGT-210 and vehicle on efficacy assessments, and will not advance SGT-210 to the next development stage in Darier disease. The company said it plans to pursue very small, low-cost feasibility studies of SGT-210 in other indications with stronger mechanistic rationale. Sol-Gel also reiterated its ongoing focus on completing the Phase 3 program for SGT-610 in Gorlin syndrome and preparatory activities for a potential Phase 3 program in high-frequency BCC, contingent on Gorlin Phase 3 success.

Positive

• Decision to stop SGT-210 Darier development limits further R&D spend
• Company will pursue low-cost feasibility studies for SGT-210 in other indications
• Phase 3 focus retained for SGT-610 in Gorlin syndrome

Negative

• Phase 1b of SGT-210 in Darier disease showed no superiority vs vehicle
• SGT-210 will not advance in Darier disease, reducing that pipeline opportunity

Key Figures

Trial phase Phase 1b Proof-of-concept study of SGT-210 in Darier disease

Program stage Phase 3 Ongoing SGT-610 program in Gorlin syndrome

Market Reality Check

$42.75 Last Close

Volume Volume 9,480 vs 20-day average 15,360 (relative volume 0.62x), indicating subdued trading before this update. low

Technical Shares at 42.125, trading above 200-day MA of 18.55 and 19.39% below the 52-week high.

Peers on Argus

Before this trial setback, SLGL was down 1.51% with relatively light volume, while close biotech peers showed mixed moves (e.g., ABVC +1.48%, NRXP +5%, INKT -1.4%). No evidence of a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 20	Q3 2025 earnings	Neutral	-0.8%	Lower revenue and net loss but reaffirmed pipeline timelines and cash runway.
Sep 04	Drug approval news	Positive	+19.7%	Health Canada approval of EPSOLAY with future milestones and royalty potential.
Aug 15	Q2 2025 earnings	Positive	+1.3%	Strong revenue from product sale, net income, and SGT-610 trial progress.

Pattern Detected

Positive regulatory or earnings-related milestones have previously aligned with upward price moves, while a mixed earnings update saw a mild decline, suggesting the stock has generally reacted directionally with news tone.

Recent Company History

Over the last few months, Sol-Gel highlighted a shift toward rare dermatologic diseases alongside partnered revenues and ex-U.S. expansion plans. Q2 2025 showed $17.2M revenue and net income, while Q3 2025 reverted to a small revenue base and net loss but reaffirmed cash runway into Q1 2027 and advanced SGT-610 and SGT-210 programs. Health Canada’s approval of EPSOLAY on Sep 4, 2025 drove a strong positive reaction. Today’s failed SGT-210 Phase 1b signal contrasts with earlier optimism around that asset.

Market Pulse Summary

This announcement reports that SGT-210’s vehicle-controlled Phase 1b proof-of-concept study in Darier disease failed to show superiority over vehicle, and Sol-Gel will not advance this indication. The company plans only small feasibility studies for SGT-210 in other unmet needs while prioritizing the Phase 3 SGT-610 program in Gorlin syndrome and preparatory work for high-frequency BCC. Investors may track progress and data timing for SGT-610 as the key late-stage driver alongside partnered products like EPSOLAY and TWYNEO.

Key Terms

vehicle-controlled medical

"vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

proof-of-concept medical

"vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease"

A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.

phase 1b medical

"vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

phase 3 medical

"successful completion of our Phase 3 program of SGT-610 in Gorlin syndrome"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

darier disease medical

"Phase 1b study of SGT-210 on Darier disease."

A rare inherited skin disorder caused by a genetic defect that disrupts how skin cells stick together and mature, leading to oily, wart-like bumps, cracked skin and sensitivity to heat or friction. For investors, it matters because the small, well-defined patient group and clear biological cause make it a target for specialty drug development, clinical trials and niche therapies — similar to fixing a specific broken part on a production line rather than redesigning the whole factory.

gorlin syndrome medical

"Phase 3 program of SGT-610 in Gorlin syndrome and preparatory activities"

A rare inherited genetic condition that increases a person’s lifetime risk of developing multiple skin cancers and other growths, often beginning in childhood or early adulthood. For investors it matters because the small, defined patient group and predictable medical needs make the condition a target for specialized drugs, diagnostics and long‑term care markets; think of it like a known design flaw that creates steady demand for fixes and monitoring.

bcc medical

"potential Phase 3 program in high-frequency BCC, subject to successful completion"

bcc is the "blind carbon copy" field in an email that sends a copy to one or more recipients without showing their addresses to others on the message. For investors and corporate communications it matters because it controls who is quietly informed versus publicly notified, which can affect confidentiality, regulatory disclosure duties and the perception of selective information sharing — similar to slipping a copy of a memo to someone without others knowing.

mechanistic rationale medical

"areas of unmet medical need where the mechanistic rationale for SGT-210 is strong."

A mechanistic rationale is the scientific explanation of how a treatment or intervention is expected to produce its effects, based on known biology or chemistry. For investors, it matters because a clear, plausible rationale acts like a blueprint or recipe that increases confidence the approach could work, helps design smarter clinical tests, and reduces uncertainty when assessing the likelihood of regulatory approval, commercial potential, or partnership value.

AI-generated analysis. Not financial advice.

NESS ZIONA, Israel, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease.

Following unblinding, the data from the vehicle-controlled Phase 1b proof-of-concept study did not show differentiation between SGT-210 and vehicle on the study’s efficacy assessments.

Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "After unblinding the clinical data from our trial, the study did not demonstrate a signal of superiority of active treatment versus vehicle, and we have therefore decided not to advance to the next stage of development in this indication. We intend to pursue very small, low-cost feasibility studies in other areas of unmet medical need where the mechanistic rationale for SGT-210 is strong. We continue to prioritize the successful completion of our Phase 3 program of SGT-610 in Gorlin syndrome and preparatory activities supporting a potential Phase 3 program in high-frequency BCC, subject to successful completion of the Gorlin Phase 3 trial."

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 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 statements regarding the successful completion of Phase 3 program of SGT-610 in Gorlin syndrome and a potential Phase 3 program in high-frequency BCC. 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 we will not successfully complete the Gorlin Phase 3 trial or that it will be delayed, that we will not commence a potential Phase 3 program in high-frequency BCC, and if we do that it will not be successful, the risk that the market for SGT-610 and SGT-210 will not be as anticipated, including with respect to High-Frequency BCC for SGT-610, our ability to enter into further collaborations, a delay in the timing of our clinical trials, top-line results and regulatory filings, 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-Or
Chief Financial Officer
info@sol-gel.com
+972-8-9313429

Source: Sol-Gel Technologies Ltd.

FAQ

What did Sol-Gel (SLGL) announce about SGT-210 on December 17, 2025?

Sol-Gel said the vehicle-controlled Phase 1b study of SGT-210 in Darier disease did not show differentiation versus vehicle and the company will not advance the program in that indication.

Does the Dec 17, 2025 update mean Sol-Gel is abandoning SGT-210 entirely (SLGL)?

No; the company said it will pursue very small, low-cost feasibility studies of SGT-210 in other indications with stronger mechanistic rationale.

How does the SGT-210 Phase 1b result affect Sol-Gel's (SLGL) pipeline priorities?

Sol-Gel will deprioritize SGT-210 for Darier disease and continue to prioritize completion of the Phase 3 program for SGT-610 in Gorlin syndrome.

Will Sol-Gel (SLGL) start a new Phase 3 for SGT-210 after the Dec 17, 2025 update?

No; the company said it will not advance SGT-210 to the next development stage in Darier disease following the Phase 1b unblinding.

What are Sol-Gel's (SLGL) next steps after the SGT-210 Phase 1b unblinding?

The company plans targeted, low-cost feasibility studies for SGT-210 in other indications and to continue work on SGT-610 Phase 3 in Gorlin syndrome.