PledPharma. Redeye Life Science Seminar November 24, Nicklas Westerholm, CEO
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1 PledPharma Redeye Life Science Seminar November 24, 2017 Nicklas Westerholm, CEO
2 CEO & President Nicklas Westerholm PledPharma CMO Stefan Carlsson VP Product Strategy and Development Christian Sonesson Founded: 2006 Permanent Employees: 7 CSO Jaques Näsström CFO** Yilmaz Mahshid Listed: Market cap*: Nasdaq First North Cash position (Q3): ~900 mkr Location: CMC Sven Jacobsson Project Director & Reg Affairs Malin Nittve 354 mkr Stockholm Project Director Aladote Dennis Henriksen Clinical Project Director Marie Bengtsson 2 * ** Change of CFO in December. Yilmaz to join, Michaela to depart CFO** Michaela Gertz
3 PledPharma s drug candidates in clinical development PledOx (calmangafodipir) (Phase 3) Prevents nerve damage caused by chemotherapy treatment in colorectal cancer patients Aladote (calmangafodipir) (Phase 1b/2a) Prevents acute liver failure caused by paracetamol (acetaminophen) poisoning 3
4 4 No approved drug for prevention or treatment of Chemotherapy Induced Peripheral Neuropathy
5 PledOx PledOx aims to become new standard of care Chemotherapy Prevention of chemotherapy induced peripheral neuropathy + without negative impact on the efficacy of chemotherapy Easy to administrate as pre-treatment to chemotherapy 5
6 6 Recent PledPharma and PledOx newsflow
7 PledOx Phase 3 program Two double-blind, randomised, placebo controlled studies: POLAR-M (Metastatic CRC): 300 patients in US and EU undergoing chemotherapy (FOLFOX). PledOx with the doses 2 μmol/kg respective 5 μmol/kg vs placebo. POLAR-A (Adjuvant CRC): 200 patients in EU undergoing chemotherapy (FOLFOX). PledOx with the dose 5 μmol/kg vs placebo. Two complementary studies: POLAR-A provides CIPN evaluation in a homogenous population. POLAR-M is central to confirm that PledOx has no detrimental effect on chemotherapy. Primary endpoint Based on patient reported symptoms using the validated FACT/GOG-Ntx* instrument Assessed 9 months after first dose of chemotherapy Survival data Impact on progression free survival (PFS; POLAR-M), overall survival (OS; POLAR M) and disease free survival (DFS; POLAR A) assessed after 1 and 2 years (and 3 years for OS) Timelines Initiation of studies in 2017 PledPharma expects existing funds to cover delivery of top-line results, anticipated during * FACT/GOG-Ntx is a validated, relevant & sensitive patient reported outcome instrument for scoring, analysis and interpretation of neuropathy in a disease specific target patient population used in ~6,700 patients in 34 studies
8 Design of POLAR-studies POLAR-M (US+EU) N=100 PledOx 5 umol/kg + FOLFOX Top line results R N=100 N=100 PledOx 2 umol/kg + FOLFOX Placebo Primary Endpoint (CIPN) PFS OS PFS OS OS + FOLFOX t=0 EoT* 9 months 1 years 2 years 3 years POLAR-A (EU) R N=100 N=100 PledOx 5 umol/kg + FOLFOX Placebo Primary Endpoint (CIPN) DFS DFS + FOLFOX 8 t=0 EoT* 9 months 1 years 2 years *EoT= End of Treatment
9 9 Recent PledPharma and PledOx newsflow
10 Solasia as a partner for PledOx in Asia Development and commercialization of drug for cancer treatment and supportive care in Asia Founded: 2006 Listed: Tokyo Stock Exchange Pipeline 3 products Business model: In licensing of late stage programs Market cap*: ~300 MUSD Location: Japan, China Pipeline Product Indication Status JPN Status China In licensed from SP-01 Sancuso SP-02 darinaparsin SP-03 episil Chemotherapy induced nausea and vomiting Peripheral T- cell lymphoma Chemotherapy induced Pain associated with Oral mucositis No rights NDA Strakan International Ltd PII/Pivotal study ongoing Approved Launch in 2018 Initiation of PII/Pivotal study NDA ZIOPHARM Camurus AB 10
11 PledOx Asia deal structure PledOx for Chemotherapy Induced Perepheral Neuropathy (CIPN) Colorectal cancer License to develop and commercialize PledOx in Japan, China, Hong Kong, Macau, South Korea, and Taiwan. Solasia will pay upfront, development, regulatory and sales milestones of up to USD 83 million (approximately SEK 700 million)*. Solasia will pay industry standard royalty rates on sales applicable for an in licensed asset in Phase III development. Solasia will also fully finance an expansion of the Phase III program (POLAR-A and POLAR-M) to include Asian patients subject to regulatory consultations. A Phase I study in Japanese and Caucasian Healthy Volunteers with focus on safety, pharmacokinetics and tolerability under initiation. Fully financed by Solasia. 11 * JPY 9,3 billion
12 Key value drivers of Asia licensing agreement Partnership with Solasia and its capabilities 3-4 years of accelerated development in Asia Milestones & Royalties Expansion of Phase 3 program will further enhance robustness 12
13 PledOx development timelines Calmangafodipir composition of matter patent expires 2017 Initiation of Phase 3 program Initiation of Phase 1 study JPN 2019 All patients treated 2021 Regulatory submissions start First patient randomized and recruitment of Patients P3 Phase 1 study JPN completed 2020 Top line results of primary endpoint (CIPN) and key safety endpoints (1 year PFS/OS/DFS) 13
14 PledPharma Pipeline Summary and Opportunities Prevents nerve damage caused by chemotherapy treatment in colorectal cancer patients Prevents acute liver failure PledOx caused by paracetamol Aladote (acetaminophen) poisoning Business opportunity: CRC 3rd most diagnosed cancer 500K per year US/EU5 and Japan. High incidence of CIPN (40-60%) in CRC patients. CIPN can lead to discontinuation of cancer treatment % of patients with symptoms >7 years later No available prevention or treatment/ very limited competition Asia development will further realise PledOx Global commercial potential Development status: Phase 2 data provide reason to believe in Phase 3. Initiation of Phase 3 before year end Asian expansion of Phase 3, subject to regulatory consultations Top-line results in POLAR-studies expected 2020 with regulatory submissions starting in Business opportunity: Paracetamol poisoning is a life-threatening condition. ~ 80K cases per year in US and UK respectively. Limited effect of standard of care for late-arrivals, ~ 25% of patients. Development status: Published Pre-clinical data supports ongoing study. Ongoing Ph1b/2a study with results expected during H Development strategy TBD based on Ph1b/2a data, regulatory interactions and Scientific Advisory Board. 14 with opportunities for life-cycle management in to other indications based on its mechanism of action
15 Significant shareholder value driving milestones and news flow* PledOx FPI (POLAR-M and POLAR-A) Results PI Study JPN Patient inclusion status DSMB decisions All patients included (POLAR-M and POLAR-A) DSMB decisions Top line results (POLAR- M and POLAR-A) 1Y PFS, OS and DFS data in both studies Regulatory submissions start Results Phase 1b/2a Development strategy TBD Aladote 15 *All timelines are current best estimates and may be subject to changes
16 16 PledPharma
17 Scientific Advisory Board established for PledOx Prof. Guido Cavaletti, MD Head of the Neuroimmunology Center, S. Gerardo Hospital, Monza and Senior consultant neurologist, Ita Rolf Karlsten, MD, PhD Head of Rehabilitation Medicine and the Multidisciplinary Pain Centre at Uppsala University hospital, Swe Prof. em. Bengt Glimelius, MD Professor Emeritus in oncology at University of Uppsala and Consultant at the University hospital, Swe Prof. David Cella Ralph Seal Paffenbarger Professor and Chair of the Department of Medical Social Sciences at the Northwestern University Feinberg School of Medicine, US A fifth member of the Scientific Advisory Board is a non-disclosed American, who is a leading international expert in chemotherapy induced peripheral neuropathy 17
18 Board of Directors Håkan Åström Chairman of the board Board member since: 2011 Other assignments: Chairman of the boards of directors of Affibody Holding AB, Tubulus RP Förvaltning AB and MedCore AB. Board member of Ferrosan Medical Devices A/S and Rhenman & Partner Asset Management Gunilla Osswald Board member Board member since: 2017 PhD in biopharmacy and pharmacokinetics Other assignments: CEO BioArctic AB Marie Ekström Trägårdh Board member Board member since: 2017 Other assignments: CEO Sectra Imaging IT Solutions and Executive Vice President of the Group Sectra AB Elisabeth Svanberg Board member Board member since: 2017 MD, PhD, Assoc Professor in surgery Other assignments: Chief Development Officer Ixaltis SA Sten Nilsson Board member Board member since: 2013 Professor in oncology with affiliation to the Karolinska Institute (KI), MD, PhD. Other assignments: Board member of the Swedish Cancer Society Research Council and Rhenman & Partner Asset Management 18
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