PITTSBURGH, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the 8th Annual Evercore Healthcare Conference on December 3, 2025, in Miami. Krish S. Krishnan, Chairman and Chief Executive Officer, will take part in a fireside chat scheduled at 10:00 am ET and host investor meetings throughout the day. A webcast of the presentation will be available here beginning at 10:00 am ET on Wednesday, December 3, 2025 and will be ...

Company Participation - Krystal Biotech, Inc. will participate in the Cantor Global Healthcare Conference 2025 on September 4, 2025, in New York [1] - Krish S. Krishnan, Chairman and CEO, will engage in a fireside chat at 10:20 am ET and host investor meetings throughout the day [1] Webcast Information - A webcast of the presentation will be available starting at 10:20 am ET on September 4, 2025, and will be posted on the Company's website [2] Company Overview - Krystal Biotech, Inc. is a fully integrated, commercial-stage global biotechnology company focused on genetic medicines for diseases with high unmet medical needs [3] - The Company's first commercial product, VYJUVEK®, is the first-ever redosable gene therapy and the first genetic medicine approved in the US, Europe, and Japan for dystrophic epidermolysis bullosa [3] - The Company is advancing a robust pipeline of investigational genetic medicines in various fields including respiratory, oncology, dermatology, ophthalmology, and aesthetics [3]

Core Insights - Jeune Aesthetics, Inc. announced positive safety and efficacy results for KB304, a treatment aimed at restoring skin by delivering collagen and elastin, with significant improvements in skin attributes such as wrinkles and elasticity [1][7][9] Study Results - The PEARL-2 study was a randomized, double-blind, placebo-controlled Phase 1 trial involving 19 subjects, with 12 receiving KB304 and 7 receiving placebo [4][13] - At three months post-treatment, 100% of KB304 subjects reported at least a one-point improvement in wrinkles, compared to 28.6% in the placebo group [5] - Subject Satisfaction Questionnaire (SSQ) indicated that 81.8% of KB304 subjects reported improved satisfaction with their wrinkles' appearance, versus 14.3% for placebo [5] Additional Findings - Improvements were also noted in other skin attributes such as elasticity, crepiness, hydration, and radiance, with 100% of KB304 subjects showing at least a one-point improvement across these metrics at all assessment points [6] - The safety profile of KB304 was consistent with previous studies, with mild-to-moderate adverse events reported, primarily after the first dose, and no severe drug-related adverse events [8] Future Development - Based on the positive results, KB304 will progress to Phase 2 development for treating wrinkles in the décolleté, a site with no FDA-approved injectable products [9] - Jeune plans to meet with the FDA to discuss the Phase 2 study protocol, aiming to initiate the study in the first half of 2026 [9]

Core Viewpoint - Krystal Biotech, Inc. has initiated its Phase 3 clinical trial named "IOLITE" to evaluate KB803 for treating and preventing corneal abrasions in patients with dystrophic epidermolysis bullosa (DEB) [1][2] Group 1: Clinical Trial Details - IOLITE is a double-blind, multicenter, placebo-controlled study with a crossover design, focusing on KB803 administered as eye drops [4] - The trial will enroll approximately 16 subjects, with a primary endpoint measuring the change in average days per month with corneal abrasion symptoms while receiving KB803 versus placebo [5][6] - Patients must complete a 12-week run-in period in an ongoing natural history study before participating in IOLITE [4][5] Group 2: Patient Population and Disease Impact - Over 25% of DEB patients are believed to experience ocular complications, with more than 50% of patients suffering from the recessive form of DEB (RDEB) [2] - The estimated number of DEB patients in the U.S. exceeds 750, with over 2,000 affected globally [2] - Current management of DEB-related ocular complications is limited to supportive care and surgical interventions, with no corrective therapies available [2] Group 3: Previous Findings and Compassionate Use - A previous compassionate use case of KB803 demonstrated full corneal healing at three months and significant visual acuity improvement from hand motion to 20/25 by eight months [1][12] - The compassionate use case involved a patient with severe cicatrizing conjunctivitis secondary to DEB, treated with regular B-VEC administration [11][12] Group 4: Company Overview - Krystal Biotech, Inc. is a global biotechnology company focused on developing genetic medicines for diseases with high unmet medical needs [13] - The company’s first commercial product, VYJUVEK®, is the first-ever redosable gene therapy approved by the FDA and EMA for treating dystrophic epidermolysis bullosa [13]

VYJUVEK Commercial Performance and Expansion - VYJUVEK has generated over $429 million in revenue since its launch[15] - Q1 2025 net revenue reached $88.2 million, a 95% increase compared to Q1 2024[16, 18] - The gross margin for Q1 2025 was 94%, with a gross to net of 17%[18] - Over 540 reimbursement approvals have been secured as of April 2025, with 45% from commercial payers and 39% from Medicaid[24, 25] - 97% of covered lives under commercial and Medicaid plans have positive access[25] Clinical Development Programs - Four clinical readouts are expected in 2025 for KB407 (cystic fibrosis), KB408 (AATD lung disease), KB304 (aesthetic skin conditions), and KB803 (ocular DEB)[19] - A Phase 1/2 study evaluating KB801 for neurotrophic keratitis is underway, with the first patient expected to be dosed this month[43] - Initial KB408 molecular data showed 35% AAT positive cells at baseline increasing to 39% after KB408 in patient 07[37] Financial Stability - The company's cash and investments totaled $7653 million as of March 31, 2025[54] - Non-GAAP R&D and SG&A expense guidance for the full year 2025 is $150 million to $175 million[55]