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, August 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

Summary H1 2019 • Continuous improvements in supply chain have ✓ • Phase III trial with PXL01 modified and the been made number of clinics expanded • Convinced that IMP can be produced for trial, with the aim to start recruitment in H1 2020 ✓ Kerstin Valinder Strinnholm elected • • Strong business development experience from member of the Board of Directors pharma industry added Half of the patients have been recruited in • • Delivery according to plan ✓ HEAL LL-37 • All patients included and randomized early 2020 • Patent granted for LL-37 in Japan ✓ • Improving our strong IP position 3

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 MUSD ▪ Thyroid 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 5

PHSU03: Phase III in EU & India Study Basics PHSU03: ▪ ~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, Italy and India ▪ 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) 6

Phase III Costs & Risks Phase III Costs Phase III Success Rate 60 80 70 50 Phase Success Rate (%) 60 40 Cost MUSD 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 7

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 8

LL-37 Efficacy: Wound Area Reduction (%) Optimal dose range for Phase IIb identified Wound Area Reduction (%) Randomization Percentage of baseline wound area 120 Placebo 120 Optimal dose LL-37 (0.5 mg/ml) interval identified LL-37 (1.6 mg/ml) 100 100 (RP2D) LL-37 (3.2 mg/ml) 80 80 ▪ Two doses of LL-37 demonstrated 60 60 unambiguous efficacy, including healing rate and wound area reduction 40 40 ▪ LL-37 was considered safe and well tolerated in * p<0.05 * ** p<0.001 the two lower doses ** 20 ** 20 ▪ The highest dose caused local reactions: MTD ** was established Treatment Period Follow-up 0 ▪ Two doses defined for Phase IIb (RP2D) 0 1 3 6 8 10 12 14 15 16 1 2 3 4 5 6 7 8 9 Visit no Series2 Series3 Series4 Series5 9

HEAL LL-37: Phase IIb Trial in VLUs Study basics HEAL LL-37: ▪ Recruiting 120 patients (completing protocol) in two countries (Sweden, Poland) Three week run-in on placebo; followed by treatment with active or placebo for three months ▪ (application two times per week); four months follow-up Three arms with 40 subjects in each: two doses of LL-37 vs. placebo ▪ 3M Day -30 Day -21 Day 0 7M Last Dose End of Study Screening Run-In Randomization 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) 10

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 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 11

Q2 2019 Financial Data Operating expenses 20 000 000 Operating loss was 7.3 MSEK in the second • 18 000 000 11% quarter 2019 (-9.8) and -12.8 MSEK in the first 16 000 000 16% half 2019 (-17.7) 14 000 000 15% Decrease in R&D expenses explained by high 12 000 000 – 10% activity in project preparations in 2018 10 000 000 17% 28% 8 000 000 External costs increased due to higher costs for – 14% 6 000 000 consultancy fees 28% 4 000 000 2 000 000 69% 52% 70% 53% • Cash at 30 June 2019 was 19.7 MSEK 0 Q2 2018 Q2 2019 H1 2018 H2 2019 64% 43% 68% EBIT (MSEK) -9.8 -7.3 -17.7 -12.8 Commodities and supplies Other external expenses Personnel costs Depreciation and impairments on fixed assets Other operating expenses 12

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 13