Vivesto Ab · OMXSTO:VIVE
Vivesto Ab — Oasmia Pharmaceutical — Naventus Life Sciences Summit 2021
18 slides from Vivesto Ab's conference presentation, Sep 29, 2021
Slide 1: Naventus Life Sciences Summit
NAVENTUS LIFE SCIENCES SUMMIT F.R. Martelet, M.D., CEO 29th September 2021 1
Slide 2: Forward-looking statement
Forward-looking statement IMPORTANT NOTICE The information in this presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would require p
Slide 3: Building a sustainable global oncology business
Building a sustainable global oncology business Approved product & growing pipeline Portfolio expansion strategy focused on hard-to-treat and late- targeting multiple oncology stage cancers with limited treatment MoAs through in-licensing & options M&A Strong in-house capabilities including New lead
Slide 4: Our areas of focus
Our areas of focus Oncology R&D: in-licensed & wholly-owned development-stage assets: • Cantrixil • Docetaxel Micellar • Strategic pipeline development Commercial: revenues from out-licensed products and technologies: • Apealea® • XR-17™/ XR-18 / XR-19 • Animal health assets (for partnering) 4
Slide 5: Oncology R&D: emerging portfolio ready for further expansion
Oncology R&D: emerging portfolio ready for further expansion Registration / Commercial Product Indication Pre-clinical Phase 1 Phase 2 Phase 3 approval Launch Geography Human Health Portfolio Cantrixil Ovarian cancer Global Docetaxel Prostate cancer EU/EAA micellar Animal Health Portfolio (Canines)
Slide 6: Oncology Commercial: targeting revenues from out-licensed products & technologies
Oncology Commercial: targeting revenues from out-licensed products & technologies Registration / Commercial Product Indication Pre-clinical Phase 1 Phase 2 Phase 3 approval Launch Geography Human Health Portfolio Apealea® / Ovarian cancer EU / EEA Paclical® (paclitaxel) Ovarian cancer USA Project Ob
Slide 7: Transformed leadership with broad industry experience
Transformed leadership with broad industry experience 7
Slide 8: A revamped strategy to drive expansion 2021 – 2023
A revamped strategy to drive expansion 2021 – 2023 Build broad portfolio with multiple shots on goal Apealea® royalties and Creating a Progress Cantrixil milestones to global & Docetaxel support cash oncology micellar flow partner Leverage drug delivery technology platforms 8
Slide 9: The 'string of pearls' approach to build critical mass
The ‘string of pearls’ approach to build critical mass • Leveraging our Development, Regulatory & Commerical Partnering skills • Evaluating a wide range of targets with multiple MoA (pre-clinical to late Phase 3) • Potential for high value exit opportunities from Phase 2 Registration / Pre-clinical
Slide 10: Mid-stage oncology assets are key industry value drivers
Mid-stage oncology assets are key industry value drivers “A dissection of five years' biopharma buyout spending reveals that most deals are struck over preclinical and mid-stage assets, while buyers remain most interested in cancer and neurological disorders.” Amy Brown, EvaluatePharma 10
Slide 11: Cantrixil – Phase 2 in ovarian cancer to start in H2-2022
Cantrixil – Phase 2 in ovarian cancer to start in H2-2022 • Global rights to first-in-class Cantrixil licensed from Kazia Therapeutics Limited (ASX:KZA) March 2021 • Targeting ovarian cancer – an area of unmet need with 314k new cases and 207k deaths worldwide in 2020* • Tubulin-binding small molecu
Slide 12: Docetaxel micellar – Phase 1b in prostate cancer underway
Docetaxel micellar – Phase 1b in prostate cancer underway • Phase 1b trial initiated by SAKK - Swiss Group for Clinical Cancer Research ‒ Open-label, multicenter, single-stage trial at major 1 hospitals in Switzerland ‒ Recruiting 18 chemotherapy-naïve patients with metastatic castration resistant p
Slide 13: Apealea – global licensing deal & European approval in ovarian cancer
Apealea® – global licensing deal & European approval in ovarian cancer Approved in EU for treatment of first relapse ovarian cancer1 Targeting patients unable to tolerate solvent-based paclitaxel Solvent-free IV formulation of paclitaxel • No polyoxyethylated castor oil or dehydrated alcohol • No gl
Slide 14: Apealea – out licensed to Elevar and its partners
Apealea® – out licensed to Elevar and its partners Russia and CIS Worldwide Peak sales estimates Commercialisation agreement ~$275m - $282m Europe signed between Oasmia and (ovarian cancer1) USA Commercialization agreement FarmaMondo signed between Elevar • Pathway to commercialization identified Th
Slide 15: Apealea - Elevar planning a US IND filing in Q1 2022
Apealea® - Elevar planning a US IND filing in Q1 2022 • Elevar has developed a comprehensive plan to support NDA • Partnership with Gynecologic Oncology Group (GOG) Foundation to develop clinical registrational study concept • Current intention to seek FDA feedback by Q1 2022 prior to initiating cli
Slide 16: Q2 Financial results
Q2 Financial results Significant reduction in Opex (MSEK) • Net sales of 4.6 MSEK ‒ Vials shipped to Elevar Canada for PK study • Operating costs totalled MSEK 32 ‒ Confirming annualized cost savings of approx. MSEK 100 • Operating cashflow of MSEK -41 ‒ Confirming ”cash burn” year to date at around
Slide 17: Looking ahead – multiple catalysts to drive value in 2022
Looking ahead – multiple catalysts to drive value in 2022 Potential near- and mid-term value drivers • Sustained M&A & in-licensing to build critical mass in oncology • Cantrixil – initiation of Phase 2 • Docetaxel micellar – Phase 1b completion • Apealea® – initiation of additional US pivotal studi
Slide 18: Building a sustainable global oncology business
Building a sustainable global oncology business • String of pearls strategy – creating an oncology pipeline with multiple shots on goal • Becoming a global oncology partner – broad capabilities to maximize M&A and in-licensing opportunities • Focus on mid-stage value drivers – Cantrixil progressing
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