Rosacea

SCOTTSDALE, Ariz., March 18, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, announced today that the FDA has accepted the Company’s New Drug Application (“NDA”) for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date of November 4, 2024. “We are pleased that the FDA has set a PDUFA date of November 4, 2024 for DFD-29 and we look forward to collaborating with the agency throughout the review process in order to bring this unique treatment option to patients suffering from rosacea,” said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical. “If approved, we believe that DFD-29 will be the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea, and will be a preferred treatment option by physicians and their patients to address the condition.” Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, added, “The NDA submission is supported by positive data from Journey Medical’s two DFD-29 Phase 3 clinical trials for the treatment of rosacea. The Phase 3 clinical trials achieved all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment (IGA) treatment success as well as the reduction in the total inflammatory lesion count in both studies. For the secondary endpoint evaluating erythema (redness) associated with rosacea, DFD-29 showed a statistically significant reduction in Clinician’s Erythema Assessment (CEA) compared to placebo in both clinical trials.” About Rosacea Rosacea is a long-term, inflammatory skin condition that causes small, red, pus-filled bumps, redness and visible blood vessels in the face. The disorder affects approximately 16 million people in the United States according to the National Rosacea Society. About Journey Medical Corporation Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA -approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit . Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third- party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful development and regulatory approval of the DFD-29 product candidate and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward- looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact: Jaclyn Jaffe (781) 652-4500 ir@jmcderm.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com

An ongoing phase 3 clinical trial of SGT-610 for Gorlin Syndrome with the first patient screened; Results are expected by the end of 2025 Sol-Gel maintains a cash runway into the second half of 2025 NESS ZIONA, Israel, March 13, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company with an innovative pipeline and approaches to develop a pioneering treatment for patients with severe skin conditions, is conducting a phase 3 clinical trial of SGT-610 (Patidegib gel, 2%), an Orphan Drug candidate with the potential to be the first therapy for preventing new basal cell carcinomas in Gorlin syndrome and partnered with Galderma to commercialize two approved large-category dermatology products, TWYNEO® and EPSOLAY®, in the U.S, today announced financial results for the full year ended December 31st, 2023 and provided a corporate update. 2023 - Corporate Highlights and Recent Developments On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened. Sol-Gel acquired Patidegib from PellePharm Inc. and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients. SGT-610 is a new topical hedgehog inhibitor to prevent the new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors. Sol-Gel is conducting a Phase-3 clinical trial to investigate SGT-610 in approximately 140 subjects at about 40 experienced clinical centers in North America, the United Kingdom, and Europe.On June 6, 2023, Sol-Gel and Searchlight Pharma Inc. announced licensing agreements to commercialize TWYNEO and EPSOLAY in Canada, according to which Sol-Gel is to receive up to $11 million in upfront payments and regulatory and sales milestones for both drugs, combined plus additional royalties ranging from low double digits to high- teen.On January 27, 2023, Sol-Gel announced the acquisition of topically applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome for PellePharm Inc., for an upfront payment of $4.7 million, total development and NDA acceptance milestones of up to $6 million and based on the expected market potential up to $64 million in commercial milestones, as well as single digit royalties. Gorlin syndrome is a rare disease with no currently approved therapies by the U.S. Food and Drug Administration (FDA) or European Medical Association (EMA). Investigational compound SGT-610 has the potential to be the first-ever drug for the chronic prevention of BCCs in Gorlin syndrome patients if approved.Over the full year of 2023, TWYNEO grew its total prescriptions, with cumulative annual total prescriptions exceeding 106,000 and total prescriptions in the fourth quarter exceeding 27,000, as reported by IQVIA. The number of prescribers also grew quarterly, with a 6% growth of new prescribers for the fourth quarter. The majority of scripts were written by TWYNEO’s high base of recurring prescribers, with fourth-quarter patient refills increasing by 12%, driven by a targeted adherence campaign. In addition, TWYNEO increased its broad commercial formulary coverage, with over 6 million additional lives covered between December 2022 and December 2023 per MMIT Analytics. (*)Over the full year of 2023, EPSOLAY also grew its total prescriptions every quarter, leading to cumulative annual total prescriptions of approximately 53,000 and total prescriptions in the fourth quarter exceeding 14,000, as reported by IQVIA. EPSOLAY also experienced quarterly growth in terms of the number of prescribers, with unique prescribers growing by 8% in the fourth quarter. Resulting from a targeted patient adherence campaign also for EPSOLAY, there was a significant increase in patient refills of 34% in the quarter. Overall, EPSOLAY grew commercial formulary coverage annually by over 12 million covered or better lives, according to MMIT Analytics.(*) MMIT - Managed Markets Insight & Technology Based on Sol-Gel's financing and adoption of cost-saving measures during 2023, the company continues to maintain its cash runway into the second half of 2025. Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel, stated: "Sol-Gel is advancing the pivotal Phase 3 clinical trial with SGT-610 in accordance with the planned timelines and expects to have the results by the end of 2025. We estimate that the current trial protocol and its defined targets may facilitate the essential outcome, allowing Sol-Gel to provide Gorlin syndrome patients with the first drug that could prevent new BCCs, with a potential market estimated at more than $300 million. Concurrently, we are pursuing additional out-license agreements similar to the agreements signed this year with Searchlight Pharma for Canada. Sol-Gel’s current product portfolio, led by SGT-610 and SGT-210, positions us with substantial assets for the future." Financial Results for the Year Ended December 31st, 2023 We generated $1.6 million in revenue in 2023, mainly related to the license agreements with Galderma and Searchlight, comprised of milestone and royalty payments, compared with $3.9 million in total revenues in 2022. The decrease in revenues in 2023 resulted mainly from the milestone payment from Galderma related to the FDA approval of Epsolay in 2022. Our research and development expenses were $23.5 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022. The increase of $10.9 million was primarily attributed to the $4.7 million upfront payment associated with the acquisition of topically applied patidegib, or SGT-610, $4.2 million related to the pivotal Phase 3 clinical trial for SGT-610, and $2.8 million related to clinical expenses for a generic product. Our general and administrative expenses were $7.4 million for the year ended December 31, 2023, compared to $7.4 million for the year ended December 31, 2022. Sol-Gel reported a net loss of $27.2 million and $1.01 or $1.01 per basic share and diluted share, compared to a net loss of $14.9 million in 2022 and a loss of $0.65 per basic and diluted share. As of December 31, 2023, Sol-Gel had $17.6 million in cash, cash equivalent, and bank deposits and $20.4 million in marketable securities for a total balance of $38.0 in comparison to December 31, 2022, of $24.9 million in cash, cash equivalent, and bank deposit and $8.7 million in marketable securities for a total balance of $33.6 million. 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 is a clinical-stage 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 inadults 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 US, and Searchlight in Canada. 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 hyperkeratinization 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 potential market of SGT-610, SGT-610 potential as the first therapy for preventing new basal cell carcinomas in Gorlin syndrome, SGT-610 improved safety profile compared to oral hedgehog inhibitors, timing of completing the Phase 3 clinical trial of SGT-610, number of subjects and clinical centers in the Phase 3 clinical trial of SGT-610, success of any clinical studies, and obtaining regulatory approval for our product candidates including SGT-610; our expected cash runway; our ability to out-license additional international rights for TWYNEO and EPSOLAY; and the commercial acceptance and profitability of TWYNEO and EPSOLAY. 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, a delay in the timing of our clinical trials, including the timing of completing the Phase 3 clinical trial of SGT-610, 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, 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 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. Sol-Gel Contact:Gilad MamlokChief Financial Officer+972-8-9313433 Source: Sol-Gel Technologies Ltd. SOL-GEL TECHNOLOGIES LTD.CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands, except share and per share data) December 31 2022 2023 Assets CURRENT ASSETS: Cash and cash equivalents$12,448 $7,513Bank deposits 12,500 10,012Marketable securities 8,678 20,471Accounts receivables 62 377Receivables from collaborative arrangements 7,858 -Prepaid expenses and other current assets 1,509 2,794TOTAL CURRENT ASSETS 43,055 41,167 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,288 1,284Property and equipment, net 660 434Operating lease right-of-use assets 876 1,721Other long-term assets - 55Funds in respect of employee rights upon retirement 749 626TOTAL NON-CURRENT ASSETS 3,573 4,120TOTAL ASSETS $46,628 $45,287 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable$251 $154Other accounts payable 2,360 3,921Current maturities of operating leases 718 447TOTAL CURRENT LIABILITIES 3,329 4,522 LONG-TERM LIABILITIES: Operating leases liabilities 54 1,206Liability for employee rights upon retirement 1,032 915TOTAL LONG-TERM LIABILITIES 1,086 2,121 TOTAL LIABILITIES 4,415 6,643 COMMITMENTS (Note 7) SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2022 and 2023, respectively; issued and outstanding: 23,129,469 and 27,857,620 as of December 31, 2022 and December 31, 2023, respectively 638 774Additional paid-in capital 234,640 258,173Accumulated deficit (193,065) (220,303) TOTAL SHAREHOLDERS' EQUITY 42,213 38,644 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$46,628 $45,287 SOL-GEL TECHNOLOGIES LTD.CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except share and per share Data) Year ended December 31, 2021 2022 2023 COLLABORATION REVENUES23,772 - -LICENSE REVENUES7,500 3,883 1,554TOTAL REVENUES31,272 3,883 1,554 RESEARCH AND DEVELOPMENT EXPENSES20,381 12,682 23,541GENERAL AND ADMINISTRATIVE EXPENSES8,451 7,445 7,373OTHER INCOME, net524 - 55TOTAL OPERATING INCOME (LOSS)2,964 (16,244) (29,305)FINANCIAL INCOME, net 257 1,321 2,067NET INCOME (LOSS) FOR THE YEAR 3,221 (14,923) (27,238)BASIC EARNINGS (LOSS) PER ORDINARY SHARE 0.14 (0.65) (1.01)DILUTED EARNINGS (LOSS) PER ORDINARY SHARE0.14 (0.65) (1.01)WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE: BASIC23,063,493 23,128,722 27,087,081DILUTED23,566,182 23,128,722 27,087,081

Clinical trial achieved all three primary objectives and subjects completed 16-week treatment with no significant safety issues Results indicate that DFD-29 can be safely used for up to 16 weeks with no detectable effects on microbiota in the skin, GI tract, or vagina New Drug Application for DFD-29 currently under review by U.S. FDA March 11, 2024 -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, announces that data from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting that took place March 8-12, 2024, in San Diego, CA. The clinical trial also assessed the safety and tolerability of the treatment. The data were presented by Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. DFD-29 is being developed for the treatment of rosacea in collaboration with Dr. Reddy’s Laboratories Ltd. Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, stated, “We are encouraged by the data presented at the AAD meeting as they demonstrate that DFD-29 can be safely used for up to 16 weeks with no significant risk of microbiota suppression or development of resistance. Based on the robust safety and efficacy data seen throughout all of our clinical trials, we believe that DFD-29 has the potential to change the treatment landscape for the millions of patients suffering from rosacea. If approved, DFD-29 has potential to be best-in-class and the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea.” DFD-29-CD-006 is a multicenter, randomized, double-blind, placebo-controlled, parallel group study that enrolled 60 healthy, adult subjects (30 males and 30 females) in a 2:1 randomization between DFD-29 and placebo. Treatment was administered once daily orally over 16 weeks. Microbiological samples were collected from the skin (forehead), stool and vagina at multiple timepoints through the study. The study achieved all primary objectives and no significant safety issues were noted during the study. Additional information on the DFD-29 Phase 1 clinical trial can be found on ClinicalTrials.gov using the identifier NCT05597462. Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects well over 16 million Americans and as many as 415 million worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent reported that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition. Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. The content above comes from the network. if any infringement, please contact us to modify.