extraordinary safety

extraordinary safety Stockholm, 12 June 2017 Promore Pharma at a - PowerPoint PPT Presentation

Late stage clinical development projects with extraordinary safety Stockholm, 12 June 2017 Promore Pharma at a Glance 1 PXL01 for prevention of post-surgical adhesions to enter Phase III in EU, US and India Late-stage programs

  1. Late stage clinical development projects with extraordinary safety Stockholm, 12 June 2017

  2. Promore Pharma at a Glance 1 ▪ PXL01 for prevention of post-surgical adhesions to enter Phase III in EU, US and India Late-stage programs ▪ LL-37 for treatment of VLU to enter Phase IIb in EU with high safety Multi-functional human peptides with extraordinary safety -- low risk for adverse effects ▪ 2 Bioactive wound care represents the segment within wound care with the highest ▪ projected CAGR (double-digit) Strong commercial potential ▪ Aiming at segments without any existing prescription products ▪ Post-surgical adhesions and VLU represent indications with limited R&D competition 3 ▪ Aggregated blockbuster potential with sales exceeding 1 billion USD Future add-on ▪ Both key programs represent significant opportunities for indication broadening opportunities Opportunities for co-development partnerships that can provide partial future funding ▪ CONFIDENTIAL 2

  3. Peptides: A Unique Class of Therapeutics Chemistry Biology Molecular Weight (Da) 10 2 10 3 10 4 10 5 10 6 CONFIDENTIAL 3

  4. Two Main Candidates First-in-category treatments for tendon injuries and leg ulcers PXL01 a therapeutic peptide for prevention of post LL-37 a therapeutic peptide for treatment of hard-to-heal surgical adhesions after tendon repair surgery venous leg ulcers READY FOR PHASE IIb READY FOR PHASE III CONFIDENTIAL 4

  5. Bioactive Wound Care Fastest Growing Market Segment ▪ The global wound care market is expected to reach USD 20.4 billion by 2021 Bioactive wound care is forecasted to be the fastest growing segment in the wound care market ▪ ▪ Promore is going into Phase III with an extraordinary safety profile in a high growth segment Drivers Global bioactive wound care market 2015-2020 (USD bn) ▪ Increased recognition of health economics from reimbursing agents 8 (payers) 7 6 ▪ Increase in aging population 5 ▪ Escalating prevalence of underlying 4 chronic disease (CVD and T2D) 3 2 1 0 2015 2020 CONFIDENTIAL 5 Source: Technavio ”Global bioactive wound care market 2016- 2020”


  7. Tendon Injuries: The Medical Need Tendon injuries occur both ▪ Annual incidence of accidental tendon professionally and recreationally injuries corresponds to 0.1% in the general population Tendon injuries are often accompanied by ▪ In 2015, U2’s singer had a injuries on adjacent nerves bicycle accident with a hand injury resulting in impaired ▪ It is estimated that 20-50% of subjects ability to play guitar. undergoing surgery of tendons of the hand never recover full mobility and finger strength post-surgery There are currently no pharmaceutically ▪ active products (Rx) on the market for adhesion prevention Methods for clinical assessment of tendon injuries are (i) validated , (ii) quantitative ▪ Addressable market for first indication estimated at 600 MUSD (EU + NA) per and (iii) standardized year at peak CONFIDENTIAL 7

  8. PXL01: Product Concept Single-injection of lubricating hyaluronate-based gel containing PXL01 which is a multi-functional anti-inflammatory human peptide PRE-FILLED SYRINGE: ANTI-INFLAMMATORY: Sterile solution, 0.5 ml Inhibition of TNF- a and with stability of >12 mo IL-1 DOSING: Single administration at the surgery BIOAVAILABILITY: Drug available at site of action SAFETY: Rapid degradation of peptides PRO-FIBRINOLYTIC: in the bloodstream: very Down-regulation of PAI-1 low systemic exposure CONFIDENTIAL 8

  9. Large Medical Benefit of PXL01 Endpoint PXL01 Placebo P-Value DIPAM (the most distal finger joint) 6 M post-surgery ✔ 60 degrees 41 degrees P<0.05 ✔ Patients with optimal nerve recovery (normal or 76% 35% P<0.05 diminished light touch) 12 weeks post-surgery Secondary endpoint in Per-Protocol Set: Recommendation for re-surgery PXL01 Placebo 12% 30% P< 0.10 in PPAS CONFIDENTIAL 9

  10. Opportunities to Expand PXL01 Market Potential for expansion of geographies and indications is strong In 2015, >300 million surgical procedures conducted world-wide >3 million procedures Tendon- and nerve injury repair >4 million TKAs Orthopedic surgery, e.g. TKA >40 million relevant procedures Dermal scarring PXL01 in hyaluronic acid CONFIDENTIAL


  12. Chronic Wounds: The Medical Need Auxiliary VLU:s Pressure ulcers DFU:s • There are an estimated 15 million patients with challenging wounds on the major pharmaceutical markets There are no prescription products for • Addressable market for VLU alone is VLU:s estimated at 3 bnUSD (EU and US) per year The medical value of existing pharmaceutical • products for DFU:s is considered very limited ”…Less than 30% of all challenging wounds are being treated properly …” • There is a major need for curative BioMedGPS, 2014 therapies in all categories of wounds SmartTRACK Business Intelligence Report CONFIDENTIAL 12

  13. LL-37: Product Concept A viscous hydrogel containing the peptide is applied 2-3 times weekly in conjunction with regular dressing changes DOSING: Flexible ▪ Does not require change of medical dosing by choice of practice injection volume Application frequency matches ▪ current medical standards COMPATIBLE: Can readily be combined with Can be applied by patient or a nurse ▪ the most common compression bandages ▪ Excipients are well characterized and can be procured at a very low cost FILM: The hydrogel forms a thin local ”film” over the wound area CONFIDENTIAL 13

  14. LL-37 Efficacy: Wound Area Reduction (%) Optimal dose range for Phase IIb identified Randomization Placebo 120 Optimal dose 0.5 mg/ml interval identified 1.6 mg/ml Percentage of baseline wound area (RP2D) 100 3.2 mg/ml 80 60 40 * ** ** 20 ** * p<0.05 Treatment Period Follow-up Period ** p<0.001 0 0 3 6 9 12 15 18 21 24 16 Visit No. CONFIDENTIAL 14

  15. Clinical Development Program A portfolio of novel therapeutic peptides Product 2017 2018 2019 2020 Financing Indication candidate Tendon Repair Project started Fully funded PXL01 Phase III EU Surgery Tendon Repair Financing with Planning Phase III North America PXL01 IPO proceeds Surgery Financing with Venous Leg Project started Phase IIb Phase III (with partner) LL-37 IPO proceeds Ulcers Financing with Diabetic Foot Planning LL-37 Phase lIa IPO proceeds Ulcers 1 st patient Clinical data ▪ Expected market approval of PXL01 in EU and North America in 2021 ▪ Expected market launch of PXL01 in 2022 Significant proportion of prospective costs are already secured through alliances and partnerships ▪ CONFIDENTIAL 15

  16. Management Team Jonas Ekblom, CEO Jenni Björnulfson, CFO ▪ Dr. Jonas Ekblom has over 25 years of experience from ▪ Mrs. Jenni Björnulfson has close to 15 years of experience the life science sector, with a focus in pharmacology and from the financial markets with a strong focus on the drug development. Dr. Ekblom has served as CEO of Bows health care sector. Mrs. Björnulfson spent the majority of Pharmaceuticals AG. Prior to that, he has held her financial market career within investment banking at senior/executive management positions in Pharmacia, Handelsbanken Markets and Alfred Berg/ABN AMRO. Biovitrum, Sequenom and Invitrogen. Most recently Mrs. Björnulfson held various management positions within GHP, a specialised health care services ▪ Ekblom has published over 60 peer-reviewed articles company. Ulrika Wennberg, COO Margit Mahlapuu, CSO ▪ Ms. Ulrika Wennberg has over 20 years of business ▪ Dr. Margit Mahlapuu is an executive with close to 15 experience as an entrepreneur, project manager, years of experience in discovery and development of management consultant and business leader. Ms. novel pharmaceuticals from the biotech and pharma Wennberg has broad experience from several different industry. Dr. Mahlapuu joined the company in 2007 and industries, e.g. consulting, IT, media and biotech. has since then been responsible for R&D function and clinical strategy of the programs. ▪ Dr. Mahlapuu has authored 40 articles in peer-reviewed scientific journals and is inventor on 5 pending patent applications CONFIDENTIAL 16

  17. Investment Case Late stage clinical development projects with extraordinary safety 1 Late stage clinical development phase 2 Unmet medical need – no pharmaceutical products 3 Validated technology with strong IP protection 4 Strong safety profile and low development costs 5 High growth potential 6 Low fixed costs and significant financing secured 7 Experienced management and Board of Directors CONFIDENTIAL 17

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