Vivesto Ab · OMXSTO:VIVE
Vivesto Ab — Oasmia Pharmaceutical — IPO Roadshow (October 2015)
36 slides from Vivesto Ab's IPO roadshow presentation, Oct 20, 2015
Slide 1: Oasmia Pharmaceutical AB Corporate Presentation – October 2015
1 Oasmia Pharmaceutical AB Corporate Presentation – October 2015
Slide 2: Important Notice
Important Notice REGISTERED OFFERING: The Company has filed a registration statement (File No. 333 - 205515) (including a prospectus) with the Securities and Exchange C ommission (the “SEC”) for the offering to which this communication relates. The registration statement has not been declared effect
Slide 3: Disclaimer
Disclaimer IMPORTANT NOTICE: This document (or any part of it) is not to be reproduced, distributed, passed on, or the contents otherwise divulged, direct ly or indirectly, in or into the United States of America, Canada, Republic of Ireland, Switzerland, South Africa, Japan, Hong Kong, Singapore, A
Slide 4: Company Specific Risks
Company Specific Risks Our business is subject to numerous risks that could prevent us from successfully implementing our business strategy, includi ng: ▪ We are substantially dependent on the success of our product and product candidates, of which none may receive full regulator y a pproval or be s
Slide 5: Transaction Summary
Transaction Summary Corporate Name: • Oasmia Pharmaceutical AB Industry: • Pharmaceuticals - Oncology Corporate Headquarters: • Uppsala, Sweden Exchange / Symbol: • Listing on NASDAQCM as OASM concurrent with capital raise • Stockholm – OASM • Frankfurt – OMAX Capital Raise: • $13,000,000 USD Struct
Slide 6: Investment Highlights
Investment Highlights XR - 17, a Novel, Broadly Applicable Technology • Nanotechnology platform used to improve drug (API) solubility; patent protection filed to 2028 • Applicable across wide variety of APIs; can be combined with novel compounds and generic drugs • Nanoparticle drug delivery within
Slide 7: Corporate Overview
Corporate Overview ▪ Oasmia Pharmaceutical AB (NASDAQ OMX: OASM) is a Swedish pharmaceutical company focused on innovative treatments within human and animal oncology. ▪ The product and product candidates utilize a proprietary, nanoparticle formulation technology that is designed to facilitate the a
Slide 8: The XR-molecule Technology Platform
The XR - 17 molecule Hydrophilic, polar head Hydrophobic, non - polar chain API Micelle consisting of XR - 17 and paclitaxel Paclitaxel A water - insoluble cytostatic Needs to be water - soluble to be injected Technology Platform Water - soluble Active Pharmaceutical Ingredient (API) ▪ Based on nove
Slide 9: Carrier to API ratio vs existing therapies
CARRIER PRODUCT (API) RATIO (CARRIER vs API) HYPERSENSITIVITY XR - 17 Paclical ® (paclitaxel) 1.3 : 1.0 No Doxophos (doxorubicin) 2.1 : 1.0 No Docecal (docetaxel) 2.25 : 1.0 No HSA Abraxane® (paclitaxel) 9.0 : 1.0 Yes Cremophor El Taxol® (paclitaxel) 88.0 : 1.0 Yes (severe), premedication is standar
Slide 10: Potential API Candidates
Potential API Candidates Water insoluble compounds Water soluble compounds Dual encapsulation compounds ▪ Taxanes • Cabazitaxel • Docetaxel • Ixabepilone ▪ Etoposide ▪ Retinoids • Fenretinide • Etretinate • Tazarotene – Bexarotene / Adapalene ▪ Immunosuppressants • Cyclosporine • Sirolimus • Tacroli
Slide 11: Robust Product Pipeline
Robust Product Pipeline 11 HUMAN HEALTH Candidate Indication Pre - clinical Phase I Phase II Phase III Reg/Approval Geography Rights Paclical ® (paclitaxel) Ovarian cancer Global (ex - RUS/CIS) Ovarian cancer Approved RUS/CIS Metastatic breast cancer On - going Global Metastatic breast cancer Pharma
Slide 12: Paclical
Paclical ® ▪ Despite being one of the most widely used chemotherapeutics, paclitaxel has a poor safety and tolerability profile, as pre - medication is required prior to administration. ▪ In an open, randomized, cross over, multi - center pharmacokinetics study (n=18): • Plasma concentrations of tot
Slide 13: Paclical - Competitors
Paclical ® - Competitors Product Paclical ® Taxol Abraxane Cynviloq Company Oasmia NASDAQ:OASM) Generic Celgene Corporation (NASDAQ:CELG) Sorrento Therapeutics (NASDAQ:SRNE) Infusion solution Micellar solution Emulsion Colloidal suspension Micellar solution Particle size 25 nm 10 - 22 nm 130 nm ~25
Slide 14: Paclical: Phase III Study
Paclical ® : Phase III Study Indication: Epithelial ovarian cancer ( orphan designation granted in US and EU) Phase: Phase III ongoing ( enrollment completed ) Type of study: Open , randomized , comparative ( Taxol ) Dose: 250mg/m 2 (Paclical ® ); 175mg/m 2 (Taxol) Cycles: 6 (3 - week cycles ); 1hr
Slide 15: Non-Inferiority Established
Non - Inferiority Established ▪ Of interest, patients treated with Paclical® tended to have longer progression free survival as compared to those patients receiving TAXOL® ▪ Patient with more frequent CT ( every 3rd month during follow - up ) also showed an advantage for Paclical® Median PFS = Pacli
Slide 16: Comparable Safety & Tolerability
▪ Neutropenia, vomiting, and diarrhea were more common in the Paclical® group; however, all of the reported adverse events are well - known side effects of chemotherapy ▪ The majority of neutropenia cases was seen in the analysis of the blood sample; the patients were without symptoms. ▪ Apart from
Slide 17: Risk Benefit Profile of Paclical
▪ The infusion time is 1 hour ▪ Number of patients with hyperensitivity reactions is the same with Paclical without pre - medication as with Taxol with pre - medication with corticosteroids and antihistamines ▪ There are more cases of myelosuppression, especially grade 4 neutropenia, but these event
Slide 18: Paclical vs. Abraxane – Pharmacokinetic Study
Paclical vs. Abraxane – Pharmacokinetic Study ▪ Cross - over, 2 cycles, 3 weeks between treatments • Patients randomized to a sequence o Paclical + Abraxane or Abraxane + Paclical • Infusion period: 1 h • Dose 260 mg/m2 • 28 patients received both treatments • Primary objective: to compare plasma co
Slide 19: Plasma concentrations of paclitaxel: Paclical vs Abraxane
Plasma concentrations of paclitaxel following 1h - infusion of Paclical or Abraxane (260 mg/m2), cross - over study Time, h 0 2 4 6 8 10 12 Mean (±SD) Total Plasma Paclitaxel Concentration, ng/mL 0 2000 4000 6000 8000 10000 12000 14000 Paclical, n= 28 Abraxane, n= 28 Time, h 0 2 4 6 8 10 12 Mean (±S
Slide 20: Plasma concentrations of paclitaxel: Paclical vs Taxol
Plasma concentrations of paclitaxel following 3h - infusion of Paclical or Taxol (175 mg/m2), cross - over study 0 20 40 60 80 100 120 0 10 20 30 Time (h) Paclical (ng/mL) Paclical Mean Taxol Mean Mean curves of unbound plasma concentration of paclitaxel after identical doses of Paclical and Taxol,
Slide 21: Paclical Regulatory Timelines
H2 - 2014 H1 - 2015 H2 - 2015 H1 - 2016 H2 - 2016 H1 - 2017 Phase 3 Study Complete Russian Approval Complete European Filing European Approval US NDA Filing US Approval Paclical ® Regulatory Timelines ▪ In April 2015, Paclical® received market authorization in the Russian Federation and will be mark
Slide 22: Phase 1/2 dose escalating study
Phase 1/2 dose escalating study ▪ Oasmia conducted an open, one - armed, dose escalating Phase 1/2 study (n=34) in patients with recurrent malignant solid tumors • Study conducted at two (2) Swedish sites from 2004 - 2007 • Primary endpoints included determining the maximum tolerated dose (MTD) and
Slide 23: The Global Oncology Market
The Global Oncology Market Source: IMS Institute for Healthcare Informatics 2013, Company estimates Total Oncology Therapeutics Market ▪ Four major products dominate the generic cytostatic market: • Paclitaxel (Taxol) • Docetaxel (Taxotere) • Abraxane • Doxorubicin (Doxil/Caelyx) • Carboplatin ▪ Bef
Slide 24: Docecal - Competitors
Docecal - Competitors Product Docecal Taxotere Company Oasmia Sanofi - Aventis (now generic) Particle size 20 nm No particles Excipient XR - 17 Polysorbate 80, ethanol Dose 80 - 110 mg/m 2 75 - 100 mg/m 2 Ratio 2.25 : 1.0 26.0 : 1.0 Infusion time 1 hour 1 hour Pre - treatment No Yes Hypersensitivity
Slide 25: Growing investments from animal health industry
25 Growing investments from animal health industry Increased numbers of aging animals presented to vet clinics Veterinarians become gradually accustomed to treating an aging pet population • Increasing access to specialist oncologists and willingness to refer • Improving levels of diagnosis by first
Slide 26: Paccal Vet-CA1 and Doxophos Vet
Paccal Vet - CA1 and Doxophos Vet PACCAL VET - CA1 DOXOPHOS VET API: Paclitaxel Doxorubicin Phase: Launched ( mammary / squamous cell); Clinical Phase III (mast cell tumours ) Clinical Phase 2 study on - going MUMS: Yes Yes Indications: Mammary carcinoma , squamous cell carcinoma , mast cell tumours
Slide 27: Launch of US Brand and Sales Platform
Launch of US Brand and Sales Platform ▪ New proprietary platform and sales network to introduce veterinarians to Oasmia’s leading companion animal therapeutic. • Paccal Vet - CA1 was previously distributed by Zoetis, a veterinary drug company that was spun off from Pfizer in 2013. • Due in part to Z
Slide 28: Upcoming Milestones – 2015/2016
Upcoming Milestones – 2015/2016 August 2015 Release of top line clinical data of Paclical ® vs Abraxane October 2015 Listing on the NASDAQ October 2015 Initiating Docecal Phase I clinical studies Q3 - 2015 Launch of Paclical ® in Russia and CIS with Pharmasyntez Q4 - 2015 Filing for final sales appr
Slide 29: Extensive IP Portfolio
Extensive IP Portfolio Patent/Application Number Title Territory Status US 6,642,271 Potentiating Compounds United States Europe Japan Issued (11/4/2003) US 7,030,158 Therapeutic Compounds United States Europe Issued (4/18/2006) US 12/809,252 Drug Delivery System for Administration of Poorly Water S
Slide 30: Paclical: Commercial
Paclical ® : Commercial ▪ Paclical ® can be launched with a targeted sales force in North America. • Focus on key specialty distributors and gaining formulary acceptance at major cancer centers. • Initially target ovarian cancer with an intent to expand the label into additional indications. • Taxol
Slide 31: Management Team & Board Members
Management Team & Board Members ▪ Julian Aleksov – Executive Chairman • Co - founder of Oasmia, serves as a Board Member, and was previously the Chief Executive Officer. • He is an economist with extensive experience in coordinating research projects and strategic development of global intellectual
Slide 32: Management Team & Board Members
Management Team & Board Members ▪ Anders Blom – Executive Vice President • Partner at Nexttobe AB, a VC firm focused on growth equity investments in healthcare, medical devices and specialty pharmaceutical companies. • Former Senior Director of Corporate and Business Development at Q - Med AB, a med
Slide 33: Management Team & Board Members
Management Team & Board Members ▪ Margareta Eriksson – Vice President Clinical Development • 30+ years of experience within the international pharmaceutical industry as a manager and project leader in clinical research. • Former Project Manager for Quintiles Transnational Holdings Inc. (NYSE:Q), and
Slide 34: Management Team & Board Members
Management Team & Board Members ▪ Horst Domdey – Member of the Board • Managing Director of BioM, the cluster development and management organization of the Munich Biotech Cluster. Since 2006 he also manages the Bavarian Biotechnology Cluster. • Cofounder of BIO Deutschland, of the Association of th
Slide 35: Ownership & Capitalization Structure
Ownership & Capitalization Structure Ownership Structure The 10 major shareholders as of June 30th, 2015 Shares of votes and capital (%) Alceco International S.A. (1) 36.0% Nexttobe AB (2) 20.0% Försäkringsaktiebolaget Avanza Pension 4.2% J P Morgan Clearing Corp 3.0% DDS Sverige 2.5% Goldman Sachs
Slide 36: Oasmia Pharmaceutical AB
36 Oasmia Pharmaceutical AB Corporate Presentation – October 2015 Corporate Address: Vallongatan 1, Uppsala 752 28 Sweden Corporate Website: www.oasmia.com