Smith-Kingsmore Syndrome

- Series B led by Double Point Ventures with major support from Viking Global Investors as well as other new and existing investors - - A combined $27.1 million Series B first close and $8.1 million in converting outstanding notes funds the company’s two assets in development, SM-020 for the treatment of seborrheic keratoses and SM-030 for the treatment of melasma, through end of Phase 2 meetings with FDA and commencement of Phase 3 trials - BOSTON--(BUSINESS WIRE)-- DermBiont, Inc., a clinical-stage biotechnology company that is advancing targeted topical therapeutics for the treatment of dermatological indications, today announced a $35.2 million Series B financing, including a $27.1 million Series B first close and $8.1 million in converting outstanding notes. Proceeds will be used to advance two drugs in development, SM-020, a topical novel AKT kinase inhibitor for the treatment of seborrheic keratoses (SKs), and SM-030, a topical novel PKC-beta inhibitor for the treatment of melasma and other hyperpigmentation disorders of the skin. The Series B was led by new institutional investor, Double Point Ventures, and includes continued support from Viking Global Investors, Civilization Ventures, Olive Tree Capital, and others. Concurrent with the financing, Daniel Yadegar, M.D., Managing Partner at Double Point Ventures, joined DermBiont’s board of directors, adding, “I am excited to be working closely with DermBiont’s team to advance two products, one for the treatment of seborrheic keratoses and the other for the treatment of melasma, two of the most frequently diagnosed skin diseases by dermatologists. These products prioritize the patient experience by addressing the root cause of both diseases with excellent efficacy, safety, and tolerability. Physicians understand that patients with SKs and hyperpigmentation disorders of the skin are seeking effective, safe, and well-tolerated topical treatment options compared with existing ablative surgical procedures for treating SKs or ineffective lasers with frequent recurrence or unsafe toxic chemicals with very low efficacy like hydroquinone for treating melasma.” The proceeds from the Series B financing will be used to advance the clinical development of SM-020 and SM-030. They are expected to fund the company through end of its Phase 2 meetings with the U.S. Food and Drug Administration (FDA), which are expected in the second half of 2024 for both programs. In the next twelve months, DermBiont will commence enrollment for three planned seborrheic keratoses clinical trials and one melasma trial as follows: Phase 2b randomized, double-blind, vehicle-controlled clinical trial in 60 subjects with seborrheic keratoses treated with SM-020 gel 1% or vehicle twice daily for 28 days. Phase 2b open label clinical trial in 10 subjects with DPN (Dermatosis Papulosa Nigra) treated with SM-020 gel 1% twice daily for 28 days. Phase 2 open label clinical trial extension in 25 additional subjects with seborrheic keratoses treated with SM-020 gel 0.1% or SM-020 gel 1% daily or twice daily for 28 to 56 days. Phase 2b randomized, observer-blinded, placebo-controlled clinical trial in 138 subjects with melasma treated with SM-030 gel 0.64%, SM-030 gel 0.08%, or placebo gel twice daily for 12 weeks “The addition of Double Point Ventures as a major backer alongside continued financial and strategic support from Viking Global Investors and other investors allows us to accelerate the development of our pipeline of novel topical therapeutics for the treatment of the number one and number three most frequently diagnosed disorders of the skin by dermatologists in the US, seborrheic keratoses and hyperpigmentation, respectively,” stated Karl Beutner, M.D., Ph.D., Chief Executive Officer and Co-Founder of DermBiont. “This funding comes on the heels of our successful Phase 2 proof of concept trials, where SM-030 gel 0.64% achieved greater efficacy than 4% hydroquinone, and where over 80% of SKs responded to treatment with SM-020 gel 1.0% twice daily for 14 to 28 days and over 50% of SK lesions completely cleared in the most effective dosing regimen.” About DermBiont DermBiont’s mission is to become the world’s leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent skin diseases. The company aims to impact the root causes of skin diseases through the development of first-in-class targeted therapeutics with well-defined mechanisms of action. The company’s targeted topical therapeutics pipeline includes two lead assets: SM-020 for the treatment of seborrheic keratoses and SM-030 for the treatment of melasma and other hyperpigmentation disorders of the skin. For more information, please visit . About Double Point Ventures At Double Point Ventures, we see beyond today's treatments to envision tomorrow's cures. Our fund invests in revolutionary companies developing cutting-edge therapeutics, from gene therapies to precision medicines. While novel drugs are our focus, we also target innovative early revenue-stage diagnostic companies, medical device startups, digital health startups, and healthcare services providers catalyzing the future of healthcare. Backed by visionary investors, our mission is clear - fund the science superstars solving the medical mysteries of our time. By powering pioneering companies, we strive to bring groundbreaking treatments from bench to bedside. Double Point Ventures is led by Managing Partner, Daniel Yadegar, M.D. For more information, please visit .

- Phase 2 proof of concept trial met primary endpoint of a one-point improvement in PLA score at last visit and safety via local tolerability in 35 patients with seborrheic keratoses (SKs) target lesions with baseline PLA scores of 2 or 3 - - Over 80% of SKs treated for 14 to 28 days with SM-020 gel 1.0% had at least a one-point improvement in PLA score at last visit - - SM-020 Investigational New Drug application filing expected in Q2 2023 - BOSTON--(BUSINESS WIRE)-- DermBiont, Inc., a clinical-stage biotechnology company that is advancing targeted topical therapeutics for the treatment of a variety of dermatological indications, today announced that its Phase 2 adaptive design trial with of investigational drug SM-020 gel 1.0% met its primary endpoint of a one point improvement in Physician’s lesion assessment (PLA) score at last visit and safety via local tolerability, as well as key multiple secondary endpoints including complete clearance of treated lesions. SM-020 is a selective and potent AKT inhibitor applied by patients at home to their seborrheic keratoses (SK) lesions. Dr. Karl Beutner, Co-Founder and Chief Executive Officer of DermBiont, presented the trial results at the Late Breakers session of the American Academy of Dermatology (AAD) Annual Meeting, taking place in New Orleans, LA from March 17-21, 2023. SKs are the most common benign tumors of the skin, with estimates of at least 80 million Americans and a quarter of the global population impacted by them. SKs are initiated by clonal mutations and sustained by activation of AKT which blocks normal timed cell death (apoptosis). SKs are currently treated with ablative surgical procedures and there is currently no available topical therapy for these tumors. Prior to the Phase 2 trial of SM-020, the topical therapy was demonstrated to induce apoptosis of SK cells in vitro in cell-based assays as well as ex vivo in SK explant studies. DermBiont’s Phase 2 proof-of-concept, adaptive open-label trial tested SM-020 gel 0.1% and 1.0%, enrolling 35 subjects with 4 SK target lesions across seven treatment cohorts. SKs were classified based on Physician’s Lesion Assessment (PLA) scores as follows: PLA 3 (thick: a visible, elevated SK lesion (thickness >1mm), PLA 2 (thin: a visible, elevated SK lesion (thickness ≤1mm), PLA 1 (near clear: a visible, not elevated SK lesion with a surface appearance different from the surrounding skin), and PLA 0 (no visible SK lesion with a surface appearance no different from the surrounding skin). In the clinical trial only PLA 2 and 3 SKs were treated. All seven cohorts saw improvement and clearance of SKs, with the effect being most pronounced in the second of seven cohorts of subjects treated with SM-020 gel 1% applied BID for 28 days, with 100% (n=14) of SKs achieving a one-point or greater drop in PLA score and 57% (n=8) of SKs with a PLA score of 0 (complete clearance) as of last follow-up visit on Day 98. SM-020 was also very well tolerated with no drug-related adverse events and only rare local tolerability reactions, most commonly erythema and pruritis that were nearly exclusively mild in severity and transient in duration. “The results of this trial have defined a highly effective, and very well tolerated treatment regimen that we will now advance to a larger, vehicle-controlled trial,” stated Karl Beutner, M.D., Ph.D., and CEO of DermBiont. “The current standard of care for treatment of patients’ SKs involves painful and destructive surgical procedures, including cryosurgery that carries a risk of both scarring and post-inflammatory hyperpigmentation and hypopigmentation. We believe that SM-020 has the potential to provide patients with a safe, well-tolerated, and easy to apply product to treat their SK lesions at home, and we look forward to continuing development of this product.” SM-020 Gel 1% 14- and 28-day BID Results (Cohorts 1, 2, 3 and 5) 36% (n=20/55) of SK lesions treated for 28 days cleared completely, reaching a PLA score of PLA 0. 64% (n=35/55) of SK lesions treated for 28 days were clear or nearly clear, reaching a PLA score of PLA 1 or PLA 0. 80% (n=44/55) of SK lesions treated for 28 days experienced at least a one-point drop in their PLA score. All treatment arms were well tolerated with no drug-related adverse events or serious adverse events. There were rare and almost exclusively mild (only one moderate) transient application site reactions across patient-reported and investigator-measured reactions, including: pain, pruritus, erythema, edema, and scabbing. No subjects ended treatment due to tolerability issues. "We are pleased to have presented positive results from our Phase 2 adaptive, open-label trial with SM-020 at the prominent AAD annual meeting. SM-020’s demonstration of 36% total target lesion clearance, and at least a partial response in 100% of lesions when treating SKs for 28 days with SM-020 1% is an important breakthrough for patients seeking an alternative to the current standard of care ablative treatments,” said Dr. Emma Taylor, M.D., Chief Medical Officer at DermBiont. “Most importantly, our Phase 2 study delivered the intended information that we hoped for to help define an appropriate and effective dosing regimen moving forward, as well as striking efficacy results. We are excited about our development achievements as well as the asset’s potential to provide patients with a new treatment for seborrheic keratoses. As a board-certified, practicing medical dermatologist, I am excited about the prospect of offering patients a safe and effective topical alternative to ablative procedures that patients may currently avoid due to pain and risks of hyperpigmentation and hypopigmentation, particularly for people of color.” Based on the trial results DermBiont expects to Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in Q2 2023, and subsequently initiate a Phase 2b trial in 2023. About SM-020 SM-020 is an AKT kinase inhibitor. AKT kinase, also known as Protein Kinase B (PKB), is a central node in the tyrosine kinase/PI3K/AKT/mTOR and Ras/mitogen-activated protein kinase pathways, which are tumorigenesis/tumor suppression pathways. AKT inhibits apoptotic mechanisms and is involved in cellular survival pathways, can promote protein synthesis, and is important in cellular pathways promoting tissue growth. Apoptosis is the normal timed death of a cell and an increase in AKT activity can prevent apoptosis or normal cell death and promote tumor growth. SKs are proliferations of benign tumor cells, which can be explained by increased AKT phosphorylation and activity, as well as a decrease in cell death. AKT inhibitors can therefore block AKT activity, enabling apoptosis and cell death of SK cells. About DermBiont DermBiont’s mission is to become the world’s leading precision dermatology company developing and commercializing targeted topical therapeutics that treat, cure, and prevent diseases. The company aims to impact the root causes of skin diseases through the development of targeted small molecule therapeutics with well-defined mechanisms of action and biotherapeutics that repair an imbalance of the microbiome. The company’s targeted topical therapeutics pipeline includes two lead assets: SM-020 for the treatment of seborrheic keratosis and SM-030 for the treatment of hyperpigmentation disorders of the skin. For more information, please visit .