Azelaic Acid

VYN201 Phase 2b vitiligo trial exceeds enrollment target; Expected to be fully enrolled in December 2024 with top-line results on track for mid-2025Reported positive first-in-human Phase 1a SAD data for VYN202, with MAD data expected in Q4 2024 BRIDGEWATER, N.J., Nov. 07, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced financial results as of and for the three and nine months ended September 30, 2024 and provided a business update. “We continue to make excellent progress in advancing our two InhiBET™ clinical programs VYN201 and VYN202, and believe each product candidate has the potential to be a differentiated, class-leading therapy for immune-mediated diseases,” said David Domzalski, President and Chief Executive Officer of VYNE. “We recently reported positive SAD data from our Phase 1a SAD/MAD trial of oral, BD2-selective BET inhibitor, VYN202, and we anticipate reporting data from the MAD portion of the trial later this quarter. We are encouraged by the strong enrollment in our ongoing Phase 2b trial for VYN201 which we believe underscores the significant unmet need in the treatment of vitiligo. We expect to complete enrollment next month and report topline data mid- next year.” Recent Pipeline Updates VYN201, a locally-administered small molecule pan-BD BET inhibitor: Phase 2b trial of VYN201 in nonsegmental vitiligo exceeds initial enrollment target and expected to complete enrollment next month. The Phase 2b trial is expected to be fully enrolled in December 2024, with approximately 40 to 50 subjects per arm. The trial was initiated in June 2024 and VYNE expects to report top-line results from the 24-week double-blind portion of the trial in mid-2025.The Phase 2b trial (NCT06493578) is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily VYN201 gel in three dose cohorts (1%, 2% and 3% concentrations) compared to vehicle for 24 weeks. Subjects are being randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle. Following the 24-week treatment period, subjects who have been randomized in the three dose cohorts will have the option to continue treatment with their respective dose concentrations for an additional 28-week extension. Subjects who have been randomized in the vehicle group during the initial 24-week treatment period will be equally re-randomized into one of the three active dose cohorts for an additional 28 weeks. VYN202, an oral small molecule BD2-selective inhibitor: VYNE expects to report top-line results from the multiple ascending dose (“MAD”) portion of the Phase 1a trial in the fourth quarter of 2024. Data from the single ascending dose (“SAD”) portion of the trial, announced in September 2024, showed that VYN202 was generally well tolerated with no drug related adverse events. Assessment of key pharmacokinetic and pharmacodynamic parameters demonstrated dose dependent drug concentrations of VYN202 in the blood and showed pharmacodynamic impact of VYN202 on key target-engagement and inflammatory biomarkers in whole blood assays, including an inhibitory effect on select inflammatory biomarkers relevant to psoriasis and rheumatoid arthritis.Pending successful completion of the Phase 1a trial, VYNE plans to initiate Phase 1b trials in adult subjects with moderate-to-severe plaque psoriasis and moderate-to-severely active rheumatoid arthritis, with top-line results anticipated in the second half of 2025. Financial Results as of and for the Third Quarter Ended September 30, 2024 Cash position. As of September 30, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of $70.2 million. VYNE believes its cash, cash equivalents, restricted cash and marketable securities as of September 30, 2024 will be sufficient to fund its operations through the end of 2025. Share count. As of September 30, 2024, VYNE had 14,751,433 shares issued and outstanding, and outstanding pre-funded warrants to purchase 27,842,740 shares of common stock at an exercise price of $0.0001 per share. Revenues. Revenues totaled $0.1 million for both the quarters ended September 30, 2024 and 2023, respectively, consisting of royalty revenue from the Company's royalty agreement with LEO Pharma, to whom VYNE previously licensed the rights to Finacea® foam. Research and development expenses. VYNE’s research and development expenses for the quarter ended September 30, 2024 were $10.2 million, representing an increase of $6.9 million, or 208.9%, compared to $3.3 million for the quarter ended September 30, 2023. The increase was primarily driven by increased expenses associated with VYNE's ongoing Phase 2b trial of VYN201 in subjects with nonsegmental vitiligo and its ongoing Phase 1a SAD/MAD trial of VYN202 of $5.0 million and $1.7 million, respectively. Both trials were initiated in June 2024. In addition, employee-related expenses increased by $0.3 million following the hiring of additional research and development personnel. General and administrative expenses. VYNE’s general and administrative expenses for both the quarters ended September 30, 2024 and 2023 were approximately $3.0 million, representing an immaterial change year-over-year. Net loss. Net loss and net loss per share for the quarter ended September 30, 2024 were $12.2 million and $0.29, respectively, compared to a net loss and net loss per share of $6.6 million and $2.01, respectively, for the comparable period in 2023. About VYNE Therapeutics Inc. VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE's unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity. For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts. Investor Relations:John FrauncesLifeSci Advisors, LLC917-355-2395jfraunces@lifesciadvisors.com Tyler ZerondaVYNE Therapeutics Inc.908-458-9106Tyler.Zeronda@VYNEtx.com Media Relations: Mike BeyerSam Brown Inc.312-961-2502mikebeyer@sambrown.com Cautionary Statement Regarding Forward-Looking Statements This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding VYNE's ability to successfully complete its Phase 1a trial of VYN202, future clinical trials of VYN202, the expected enrollment and timing for reporting top-line results from trials of VYN201 and VYN202, VYNE’s projected cash runway, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2023, and VYNE’s other filings from time to time with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events. Third-party products and company names mentioned herein may be the trademarks of their respective owners. VYNE THERAPEUTICS INC.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands, except share and per share data)(Unaudited) September 30, December 31, 2024 2023 Assets Current Assets: Cash and cash equivalents$16,272 $30,620 Restricted cash 47 54 Investment in marketable securities 53,913 62,633 Prepaid and other current assets 3,303 2,656 Total Current Assets 73,535 95,963 Non-current Assets: Operating lease right-of-use assets 122 207 Non-current prepaid expenses and other assets 2,541 1,515 Total Non-current Assets 2,663 1,722 Total Assets$76,198 $97,685 Liabilities and Stockholders’ Equity Current Liabilities: Trade payables$3,986 $1,659 Accrued expenses 6,168 4,119 Employee related obligations 1,071 1,645 Operating lease liabilities 123 115 Other current liabilities 1,313 — Total Current Liabilities 12,661 7,538 Long-term Liabilities: Non-current operating lease liabilities — 99 Other liabilities — 1,313 Total Long-term Liabilities — 1,412 Total Liabilities 12,661 8,950 Commitments and Contingencies Stockholders' Equity: Preferred stock: $0.0001 par value; 20,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023 — — Common stock: $0.0001 par value; 150,000,000 shares authorized at September 30, 2024 and December 31, 2023; 14,751,433 and 14,098,888 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 1 1 Additional paid-in capital 782,650 780,044 Accumulated other comprehensive income 34 26 Accumulated deficit (719,148) (691,336)Total Stockholders' Equity 63,537 88,735 Total Liabilities and Stockholders’ Equity$76,198 $97,685 VYNE THERAPEUTICS INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands, except per share data)(Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenues Royalty revenues$121 $114 $417 $348 Total Revenues 121 114 417 348 Operating Expenses: Research and development 10,248 3,318 21,262 13,284 General and administrative 2,964 3,030 10,022 9,490 Total Operating Expenses 13,212 6,348 31,284 22,774 Operating Loss (13,091) (6,234) (30,867) (22,426)Other income, net 934 163 3,074 706 Loss from continuing operations before income taxes (12,157) (6,071) (27,793) (21,720)Income tax expense — — — — Loss from continuing operations (12,157) (6,071) (27,793) (21,720)Loss from discontinued operations, net of income taxes — (513) (19) (544)Net Loss$(12,157) $(6,584) $(27,812) $(22,264) Loss per share from continuing operations, basic and diluted$(0.29) $(1.85) $(0.65) $(6.66)Income (loss) per share from discontinued operations, basic and diluted$0.00 $(0.16) $0.00 $(0.17)Loss per share, basic and diluted$(0.29) $(2.01) $(0.65) $(6.82) Weighted average shares outstanding - basic and diluted 42,587 3,282 42,592 3,271

WINLEVI poster presentations at 2024 Fall Clinical Dermatology Conference also include data affirming reduced acne severity and tolerability in patients with skin of color. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries or associate companies), today presented data strengthening the clinical rationale for the use of WINLEVI ® (clascoterone) cream 1% to treat acne. In poster presentations at the 44th Annual Fall Clinical Dermatology Conference, data show WINLEVI significantly reduces sebum (oil) production and demonstrates excellent stability in the presence of other commonly prescribed topical acne treatments, supporting the use of WINLEVI in combination with those medications. Data also showed patients with skin of color, an under-represented population in studies of acne medications, experienced reduced acne severity and tolerability while taking WINLEVI. Collectively, the data continue to show that WINLEVI improves acne severity and is well tolerated. "As we learn more about the importance of sebum as a main cause of acne, it is gratifying to see new data supporting the use of WINLEVI to reduce sebum production as well as its suitability for combination treatment with other commonly prescribed topical agents," said Abhay Gandhi, chief executive officer, North America at Sun Pharma. "We are also encouraged by the reported reductions in acne severity and tolerability in people with skin of color, for whom the impact of acne can be profound. Together, these latest studies further establish WINLEVI as a safe and effective acne medication that dermatology professionals can confidently prescribe to their patients." WINLEVI is the first and only androgen receptor inhibitor indicated for the topical treatment of acne vulgaris (acne) in patients 12 years of age and older, and the first and only FDA-approved topical treatment available in the U.S. that targets sebum production in the skin. Sebum is an oily wax that protects and moisturizes skin, but too much of it feeds bacteria inside the skin, causing inflammation and acne lesions. Acne is the most prevalent skin condition in the U.S., affecting up to 50 million Americans and 80% of people at some point during their lives.1,2 It is the most common dermatological disorder in Black/African American and Hispanic/Latino populations.3 WINLEVI cream is a topical prescription medicine to treat acne in people 12 and older. The most common side effects include reddening, scaling or dryness, and itching. Local irritation may occur. Sebum reduction data Researchers presented 12-week interim results from a yearlong study of the effect of WINLEVI on facial sebum production in patients with acne. The study's primary objective and efficacy endpoint was reduction in casual facial sebum levels, as measured by a sebumeter, a device that directly measures the amount of lipids on the skin's surface. The study was also designed to assess the ability of WINLEVI to reduce the Investigator's Global Assessment (IGA) score, a scale designed for investigators to assess the level of facial acne (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe). Other study objectives and efficacy endpoints included inflammatory and noninflammatory acne lesion counts, and investigator-assessed oily appearance, pore size, and facial shine; the latter three endpoints were assessed on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Among the 40 participating patients, the mean age was 20.9 years; most patients were female (60%) and White (63%). All patients entered the study with mild (57.5%) or moderate (42.5%) acne, as well as a mean sebumeter reading of 115.9 ± 50.5. The researchers reported significant reductions in sebumeter measurements following use of WINLEVI at six (-22%, P = 0.002), 10 (-19%, P = 0.005), and 12 weeks (-27%, P <0.001). They also observed significant improvements in facial oily appearance after four weeks of WINLEVI treatment (-8%, P = 0.008), with continued improvement through 12 weeks (-40%, P <0.001). Similarly, patients' pore size improved significantly after six weeks (-13%, P = 0.002), and continued to improve through 12 weeks (-23%, P <0.001). Additionally, facial shine levels significantly improved after four weeks (-9%, P = 0.004) with continued improvement through 12 weeks (-39%, P <0.001). By Week 12, patients using WINLEVI experienced a statistically significant 29% reduction in IGA score (P <0.001). Use of WINLEVI also resulted in significant reductions in the numbers of inflammatory and noninflammatory lesions (-48% and -40%, respectively; P <0.001 for both measurements) after four weeks, with continued improvement through 12 weeks (-54% and -34%, respectively; P <0.001 for both). WINLEVI was well tolerated through Week 12, with no reports of adverse reactions. "This is exciting news for people living with acne because this is the first study to demonstrate a reduction in measured facial sebum production following the use of clascoterone cream 1%," said lead investigator Zoe D. Draelos, MD, of Dermatology Consulting Services, PLLC, in High Point, N.C. "In addition to confirming the sebum-reducing effect of WINLEVI, our findings support data from previous clinical trials which showed reductions in the number of inflammatory and noninflammatory lesions, further demonstrating the clinical utility of this topical acne medication." Stability in combination therapy data Dr. Draelos and colleagues also reported results from a study assessing the stability of WINLEVI when layered with other topical acne medications such as tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid 15%, benzoyl peroxide 5%/clindamycin 1%, benzoyl peroxide 2.5%/adapalene 0.1%, and benzoyl peroxide encapsulated 5%. Each of these medications were placed separately on individual microscope slides with WINLEVI and incubated for eight hours at 37° Celsius. Material from the slides was extracted for analysis via high-performance liquid chromatography-mass spectrometry (HPLC-MS). WINLEVI concentrations remained stable after layering with other acne medications. The percentage of WINLEVI recovered after layering ranged from 98% to 119%, indicating that none of the acne medications evaluated induced degradation of WINLEVI when used in combination. "Multimodal topical therapy, incorporating products with multiple mechanisms of action to target multiple mechanisms of disease, has become standard practice in the treatment of acne," commented Dr. Draelos. "In this in vitro study, WINLEVI demonstrated consistent and reproducible stability in the presence of other acne medications. Our findings support the combination of WINLEVI with topical retinoids, topical antibiotics, and/or benzoyl peroxide as a viable acne treatment strategy and complement the encouraging results observed in the sebum reduction and skin of color trials." Skin of Color Data A separate team of researchers presented 16-week interim results from a 56-week, single-center, open-label pilot study evaluating the efficacy and safety of WINLEVI in 10 patients (mean age 24 years) with skin of color (Fitzpatrick skin types IV, V, and VI) and moderate-to-severe facial acne. The study met its primary endpoint, with seven (78%) patients achieving an IGA score of 0 (clear) or 1 (almost clear) at Week 16 (P = 0.008 vs. baseline). The study also met its secondary endpoints at Week 16, including significant reductions in inflammatory (91.8%, P = 0.008), noninflammatory (90.9%, P = 0.009), and total lesions (90.9%, P = 0.009). Investigator- and participant-assessed tolerability parameters were absent or minimal at most time points through Week 16. There were no reports of adverse events during the 16-week interim analysis period. For complete prescribing information please click here. INDICATION WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, discontinue or reduce the frequency of application of WINLEVI cream. Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment with WINLEVI. In the pharmacokinetics (PK) trial, HPA axis suppression was observed in 1/20 (5%) of adult subjects and 2/22 (9%) of adolescent subjects at Day 14. All subjects returned to normal HPA axis function at follow-up 4 weeks after stopping treatment. Conditions which augment systemic absorption include use over large surface areas, prolonged use, and the use of occlusive dressings. Attempt to withdraw use if HPA axis suppression develops. Pediatric patients may be more susceptible to systemic toxicity. Hyperkalemia: Elevated potassium levels were observed in some subjects during the clinical trials. Shifts from normal to elevated potassium levels were observed in 5% of WINLEVI-treated subjects and 4% of vehicle-treated subjects. ADVERSE REACTIONS Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in >3% of patients and were reported in a similar percentage of subjects treated with vehicle. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References 1 Skin conditions by the numbers. American Academy of Dermatology Association, 2021. Available at Skin conditions by the numbers (aad.org). Accessed January 11, 2023. 2 Collier CN, Harper JC, Cafardi JA, et al. The prevalence of acne in adults 20 years and older. J Am Acad Dermatol. 2008;58(1):56-59. 3 Taylor SC. Epidemiology of skin diseases in people of color. Cutis. 2003;71(4):271-275. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED