Hyloris Pharmaceuticals Sa · EURONEXT:HYL
Hyloris Pharmaceuticals Sa — Corporate Update (February 2021)
21 slides from Hyloris Pharmaceuticals Sa's corporate update, Feb 5, 2021
Slide 1: Hyloris and Purna Female Healthcare: A New Partnership in Women's Health
Hyloris and Purna Female Healthcare A New Partnership in Women’s Health 5 February 2021
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by, and is the sole responsibility of, Hyloris Pharmaceuticals SA (the "Company") for discussions with investors in relation to the Company and its group. For the purposes of this notice, “presentation” means this document, oral presentation, any questi
Slide 3: Today's Presenters
Today’s Presenters Prof. dr. Gilbert Donders Bart Peeters Stijn Van Rompay Gynaecologist, Professor CEO Purna Female CEO Hyloris Antwerp University Hospital Healthcare Pharmaceuticals 2
Slide 4: A Unique Partnership
A Unique Partnership To add value to women’s health by developing an innovative therapy to treat severe and recurrent vulvovaginal candidiasis (rVVC) with a patented, proprietary topical combination product of Miconazole (MCZ) and Domiphen Bromide (DB) • Belgian based spin-off (Purna Pharmaceuticals
Slide 5: Vulvovaginal Candidiasis
Vulvovaginal Candidiasis 4
Slide 6: Vulvovaginal Candidiasis – Pathogenesis
Vulvovaginal Candidiasis – Pathogenesis • Infection caused by Candida sp. yeast • Causes irritation, vaginal discharge and intense itchiness of the vagina and the vulva • Affecting 1 in every 2 women during their life Uncomplicated VVC (80%) Complicated VVC (20%) Sporadic or infrequent VVC Recurrent
Slide 7: Vulvovaginal Candidiasis – SoC & Unmet Needs
Vulvovaginal Candidiasis – SoC & Unmet Needs Standard of Care (SoC) LOCAL SYSTEMIC Challenges • Azole resistance • Liver toxicity • Drug-Drug interactions • Pregnancy and miscarriage warnings • Lack-of-efficiency in complicated VVC There is a high unmet medical need for improved treatment options So
Slide 8: Severe and rVVC – Debilitating, Chronic Conditions
Severe and rVVC – Debilitating, Chronic Conditions • Approximately 20% of all VVC patients • No effective treatments available due to drug-resistant biofilm formation in yeast • Patients associate severe and rVVC with oppression, isolation, embarrassment, frustration, powerlessness, sadness, and hop
Slide 9: Potential Solution
Potential Solution 8
Slide 10: Potential Solution – Novel MCZ-DB Combination
Potential Solution – Novel MCZ-DB Combination REPURPOSED MOLECULE ANTIMYCOTIC DOMIPHEN BROMIDE (DB) MICONAZOLE (MCZ) potentiator for fungicidal Prevents growth of fungus activity FUNGICIDAL ACTIVITY REPURPOSED MOLECULE ANTIMYCOTIC DOMIPHEN BROMIDE (DB) MICONAZOLE (MCZ) potentiator for fungicidal Pre
Slide 11: Novel MCZ-DB Mode of Action – In Vitro Validation
Novel MCZ-DB Mode of Action – In Vitro Validation Domiphen Bromide: • Enables increased FKD (azole) uptake in Candida cells at low doses • Alters cytoplasmatic distribution of high FKD doses • Negatively affects vacuolar integrity, thereby releasing vacuole-sequestered MCZ Increased intracellular MC
Slide 12: Novel MCZ-DB Combination – In Vitro Mode of Action
Novel MCZ-DB Combination – In Vitro Mode of Action (A) (B) Effect of domiphen bromide (DB) on cytoplasmic distribution of fluorescently labeled ketoconazole derivative (FKD) in C. glabrata BG2 planktonic stationary phase cultures High Fluorescence panel B shows high-uptake of the combo drug Sources:
Slide 13: Novel MCZ-DB Combination – Highly Effective In Vivo
Novel MCZ-DB Combination – Highly Effective In Vivo Fungal Growth NO treatment (VIC) Current SoC (1% MCZ) 1% MCZ + 1/6 DB Intravaginal fungal burden in log colony forming units (cfu) per swab during Degree of infection expressed in area under the curve (AUC) after 4 days different therapies expresse
Slide 14: Novel MCZ-DB Combination – In Vivo Tolerance
Novel MCZ-DB Combination – In Vivo Tolerance Vaginal tissue after hematoxyline-eosine staining of untreated control, 1% miconazole and 1% miconazole + 1/6 domiphen bromide. Different groups showed adequate cornification (dark grey zone), meaning they are all-in oestrus (due to effective hormone trea
Slide 15: MCZ-DB – IP position
MCZ-DB – IP position International Publication Number (IPN): WO 2019/015975 A1 Patent Number: GB1711512 Main Claim: A composition for topical use comprising miconazole or a salt thereof and domiphen bromide as active ingredients for use in treating or preventing infection with Candida spp. July 2018
Slide 16: Large Opportunity
Large Opportunity 4 s sf i Po
Slide 17: Global VVC – Market Dynamics
Global VVC – Market Dynamics Recurrent VVC 6% Severe VVC 14% Total number of drug products sold ± 175.000.000 Average annual growth rate 5.5% Classification Creams: 47% Pessaries: 34% Other: 19% Uncomplicated VVC 80% No innovation over the past few decades Opportunity to disrupt the market with nove
Slide 18: Recurrent Vulvovaginal Candidiasis (rVVC)
Recurrent Vulvovaginal Candidiasis (rVVC) • Characterized by ≥3 episodes of acute vulvovaginal candidiasis per year • Affects 6-9% of women during child-bearing years, 138 million women annually globally, 372 million women over their lifetime - estimated to increase to almost 158 million women annua
Slide 19: PFH Partnership – Perfectly Fits within Hyloris' Strategy
PFH Partnership – Perfectly Fits within Hyloris’ Strategy Continuously growing portfolio of product Acquisition and in-licensing product candidates based on: candidates characterized by: Clear rationale Fast market adoption Approved molecules Maximized ROI Technical feasibility Clear regulatory path
Slide 20: Novel MCZ-DB Topical Treatment – Key Takeaways
Novel MCZ-DB Topical Treatment – Key Takeaways • Opportunity to address unmet medical need in severe and recurrent vulvovaginal candidiasis • Potential first innovation since decades • Novel MOA, potential first-in-class to address biofilm formation and drug-resistant Candida infections • Developed
Slide 21: Q&A
Q&A \ 20
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