Late stage development of two first-in-category wound care products - PowerPoint PPT Presentation

Late stage development of two first-in-category wound care products Stockholm, Feb 2019

Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) • Two late stage, first-in-category products • Human peptides for local administration with extraordinary safety • Phase III – PXL01 Phase IIb – LL-37 Treating chronic wounds, mainly • Preventing adhesions after tendon • VLUs repair surgery • No prescription drugs • No prescription drugs 6 million patients in EU, NA & JP • 1 million patients in EU, NA & JP • Addressable global market 3 BUSD • Addressable EU market 300 MUSD • • Indication broadening opportunities Indication broadening opportunities • Vision To solve the global problems of scarring, adhesions and chronic wounds 2

2018 in the Rear Mirror 2018 Expiration of Meeting with Out-licensing National CTA Cellastra’s FDA regarding approval for of PXL01 in option for PXL01 spinal surgery PXL01 PHSU03 in in NA to PRP program India Regained CTA approval First-patient-in manufacturing in HEAL LL-37 HEAL LL-37 rights in PXL01 in SE and PL trial An eventful year with operational delivery according to plan 3

Global Needs and Healthcare Costs 60 patients in the world, will contract Wounds, trauma and amputations a hard-to-heal wound, a dermal account for the third largest area scar or a complication due to a of healthcare spending in the million post-surgical adhesion every year world Cardiovascular CNS Trauma Oncology > 600 BUSD 400 BUSD 300 BUSD 600 BUSD 4

Bioactive Wound Care Fastest Growing Market Segment ▪ The global wound care market is expected to reach USD 20.4 billion by 2021, growing at 2-3% annually ▪ Bioactive wound care is forecasted to be the fastest growing segment in the wound care market, with an estimated 14% CAGR Global bioactive wound care market 2015-2020 Promore Pharma’s Market Opportunity Portfolio potential of >1 billion EUR bUSD/year 8 in converging business area 7 6 5 Su Surgical products 4 Tissue Repair Ti 20 BEUR 3 3 BEUR 2 1 0 2015 2020 De Derma matology Source: Technavio ”Global bioactive wound care market 2016- 2020” >16 BEUR 5 5

PXL01: Prevention of Adhesions and Scars Promore Pharma Indications Adhesions form after almost any type of surgery and are a significant cause of post-surgical complications • Tendon Repair Surgery • Prolong subsequent surgery Phase III being prepared in EU and India • • Constitute considerable burden on healthcare systems Medical need – high incidence of scar • formation and no pharmaceutical products Dermal scarring, following plastic surgery or burn wounds/trauma • Straightforward clinical development • Over 1 million procedures globally Est addressable market in EU; 300 MEUR • Thyriod surgery Tendon repair • Dermal Scarring surgery • Phase I/II being prepared in Sweden Numerous abdominal surgical • High willingness to pay for scar prevention procedures, eg colorectal cancer among plastic surgery patients Spinal surgery, Large market with few/no effective products • including DDD • Spinal surgery/DDD • Out-licensed to PharmaResearch Products Total Knee Arthroplasty 1-2 million procedures globally •

Large Medical Benefits of PXL01 Endpoint PXL01 Placebo P-Value Mobility in injured finger DIPAM (the most distal finger joint) 6 months post- 60 degrees 41 degrees P<0.05 surgery Nerve function Patients with optimal nerve recovery (normal or 76% 35% P<0.05 diminished light touch) 12 weeks post-surgery Need for secondary surgery Frequency of recommendation for tenolysis during 12% 30% P<0.10 first 12 months post-surgery Important Primary end-point in Large health secondary value of Phase III economic value product 7

PHSU03: Phase III in EU & India Study Basics PHSU-03: • ~600 patients with accidental transection of flexor tendon in zone II of the hand • Single administration in conjunction with surgery of PXL01 (two doses) vs. placebo (saline) (1:1:1) • Efficacy and safety followed until 12 months post-surgery Study centers in Sweden, Germany, Poland, India and at least one more EU country • End of Trial 420 Patients Completing Protocol Randomization (Active or Placebo) Administration Trial Product Post-Operative Assessment Visits Visit 1 Visit 4 Visit 6 Visit 7 Follow up Follow up Visit 2 Visit 3 Visit 5 Day 0 4 w visit 1 visit 2 1-5 days 6 w 8 w 12 w 2 w (Screen, 6 months 12 months post surgery Surgery) 8

LL-37: Treatment of Chronic Wounds Medical Need and Costs for Society Promore Pharma and LL-37 • >15 million patients with challenging ▪ Naturally occurring peptide (cathelicidin) wounds on the major pharmaceutical Antimicrobial – markets Angiogenic – Stimulates keratinocyte migration – VLUs LL-37 involved in wound biology • DFUs – Present in acute wounds but not in chronic Pus wounds Other • First indication VLUs – Largest patient population in major • Very few prescription products pharmaceutical markets – Some available for DFUs, but all with – No pharmaceuticals available limited medical value – Not as complicated from a development • Low R&D competition perspective Costs for treating chronic wounds exceed • All chronic wounds could potentially be • 10,000 USD per episode addressed with LL-37 9

LL-37 Efficacy: Wound Area Reduction (%) Optimal dose range for Phase IIb identified Randomization Placebo 120 LL-37 (0.5 mg/ml) Optimal dose interval identified 100 LL-37 (1.6 mg/ml) Percentage of baseline wound area (RP2D) LL-37 (3.2 mg/ml) 80 60 40 * ** ** 20 * p<0.05 ** ** p<0.001 Treatment Period Follow-up 0 1 3 2 3 6 4 8 5 10 6 12 7 14 8 15 9 16 Visit no Series2 Series3 Series4 Series5 10

HEAL LL-37: Phase IIb Trial in VLUs Study basics: Recruiting 120 patients (completing protocol) in 2 countries (Sweden, Poland) • 3 week run-in on placebo; followed by treatment with active or placebo for 3 months • (application 2 times per week); 4 months follow-up • 3 arms with 40 subjects in each: 2 doses of LL-37 vs. placebo Day -30 Day -21 Day 0 3M 7M Last Dose End of Study Screening Run-In Randomisation Time points for digital wound area assessment The subjects are randomised to three groups: Criteria for evaluation: Placebo (N=40) • • % completely healed wounds • LL-37 0.5 mg/mL (N=40) • Multiple secondary endpoints • LL-37 1.6 mg/mL (N=40) 11

Business Strategy Take PXL01 to market in EU Partnering LL-37 ▪ Phase III program (PHSU03) being prepared Phase IIb (LL-37 HEAL) ongoing in EU ▪ in EU and India Target timeline for completion of the ▪ Market Authorization and Commercialization Phase IIb clinical trial is 2020 ▪ ▪ Develop PXL01 all the way to market in ▪ After completion, Promore Pharma will seek EU; target timeline is 2022 one or several partnerships with multi- national companies for confirmatory trials and Either commercialize first indication ▪ MA independently in EU or through partnerships Potential for indication broadening to other ▪ common types of hard-to-heal wounds ▪ Seeking partnerships for both other territories (ex-EU) and indications 12

Phase III Costs & Risks Phase III Costs Phase III Success Rate 60 80 Phase Success Rate (%) 70 50 Cost MUSD 60 40 50 Musculoskeletal 30 40 30 20 20 10 10 0 0 Ref: Martinez, 2016 Driving Drug Innovation and Ref: BIO 2016, Clinical Development Success Rates Market Access: Part 1-Clinical Trial Cost Breakdown 2006-2015 High cost-effectiveness in late stage development 13

2018 Financial Data Operating expenses Operating loss was 32.7 MSEK in 2018 compared • 40 000 000 to an operating loss of 9.6 MSEK in 2017 35 000 000 – Increase in R&D expenses explained by increased 12% development activities in both projects 30 000 000 16% – External costs decreased in 2018 due to higher 25 000 000 14% costs in 2017 because of the Nasdaq First North 20 000 000 listing 38% 15 000 000 – Personnel costs increased in absolute terms in 10 000 000 54% 2018 following the employment of the CEO in May 21% 56% 25% 5 000 000 2017 64% 58% 43% 68% 0 In 2017 the company also received milestone – Q4 2017 Q4 2018 2017 2018 payments from PRP of 1.5 MEUR, which improved EBIT (MSEK) -10.4 -6.5 -9.6 -32.7 EBIT Commodities and supplies Other external expenses Personnel costs Depreciation and impairments on fixed assets • Cash at end of 2018 was 31.0 MSEK Other operating expenses – Listed warrants matured 22 February 2019 did not generate any funds 14

Executive Summary Late stage clinical development project 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 – high growth market segment and additional indications 15