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

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

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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

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

Stockholm, Feb 2019

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SLIDE 2

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

2

Vision

To solve the global problems of scarring, adhesions and chronic wounds

Phase IIb – LL-37

  • Preventing adhesions after tendon

repair surgery

  • No prescription drugs
  • 1 million patients in EU, NA & JP
  • Addressable EU market 300 MUSD
  • Indication broadening opportunities

Phase III – PXL01

  • Treating chronic wounds, mainly

VLUs

  • No prescription drugs
  • 6 million patients in EU, NA & JP
  • Addressable global market 3 BUSD
  • Indication broadening opportunities
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SLIDE 3

2018 in the Rear Mirror

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Expiration of Cellastra’s

  • ption for PXL01

in NA Regained manufacturing rights in PXL01 Out-licensing

  • f PXL01 in

spinal surgery to PRP CTA approval in HEAL LL-37 in SE and PL Meeting with FDA regarding PXL01 program First-patient-in HEAL LL-37 trial National CTA approval for PHSU03 in India

2018

An eventful year with operational delivery according to plan

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SLIDE 4

Global Needs and Healthcare Costs

CNS > 600 BUSD Cardiovascular 600 BUSD Trauma 400 BUSD Oncology 300 BUSD

Wounds, trauma and amputations account for the third largest area

  • f healthcare spending in the

world patients in the world, will contract a hard-to-heal wound, a dermal scar or a complication due to a post-surgical adhesion every year

60

million

4

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SLIDE 5

Bioactive Wound Care

Fastest Growing Market Segment

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1 2 3 4 5 6 7 8

2015 2020

Source: Technavio ”Global bioactive wound care market 2016-2020”

bUSD/year

▪ 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

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Su Surgical products 20 BEUR Ti Tissue Repair 3 BEUR De Derma matology >16 BEUR Portfolio potential of >1 billion EUR in converging business area Promore Pharma’s Market Opportunity

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PXL01: Prevention of Adhesions and Scars

Tendon repair surgery Spinal surgery, including DDD Total Knee Arthroplasty Numerous abdominal surgical procedures, eg colorectal cancer Thyriod surgery Dermal scarring, following plastic surgery

  • r burn wounds/trauma

Adhesions form after almost any type of surgery and are a significant cause of post-surgical complications

  • Prolong subsequent surgery
  • Constitute considerable burden on healthcare systems

Promore Pharma Indications

  • Tendon Repair Surgery
  • Phase III being prepared in EU and India
  • Medical need – high incidence of scar

formation and no pharmaceutical products

  • Straightforward clinical development
  • Over 1 million procedures globally
  • Est addressable market in EU; 300 MEUR
  • Dermal Scarring
  • Phase I/II being prepared in Sweden
  • High willingness to pay for scar prevention

among plastic surgery patients

  • Large market with few/no effective products
  • Spinal surgery/DDD
  • Out-licensed to PharmaResearch Products
  • 1-2 million procedures globally
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Large Medical Benefits of PXL01

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Endpoint PXL01 Placebo P-Value

Mobility in injured finger DIPAM (the most distal finger joint) 6 months post- surgery 60 degrees 41 degrees P<0.05 Nerve function Patients with optimal nerve recovery (normal or diminished light touch) 12 weeks post-surgery 76% 35% P<0.05 Need for secondary surgery Frequency of recommendation for tenolysis during first 12 months post-surgery 12% 30% P<0.10

Primary end-point in Phase III Important secondary value of product Large health economic value

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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

8 Visit 3 2 w Visit 1 Day 0 (Screen, Surgery) Visit 2 1-5 days post surgery Visit 4 4 w Visit 5 6 w Visit 6 8 w Visit 7 12 w Follow up visit 1 6 months Follow up visit 2 12 months

Administration Trial Product Randomization (Active or Placebo) Post-Operative Assessment Visits End of Trial

420 Patients Completing Protocol

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LL-37: Treatment of Chronic Wounds

  • >15 million patients with challenging

wounds on the major pharmaceutical markets

  • Very few prescription products

– Some available for DFUs, but all with limited medical value

  • Low R&D competition
  • Costs for treating chronic wounds exceed

10,000 USD per episode

Medical Need and Costs for Society

VLUs DFUs Pus Other

Promore Pharma and LL-37 ▪ Naturally occurring peptide (cathelicidin)

–

Antimicrobial

–

Angiogenic

–

Stimulates keratinocyte migration

  • LL-37 involved in wound biology

– Present in acute wounds but not in chronic wounds

  • First indication VLUs

– Largest patient population in major pharmaceutical markets – No pharmaceuticals available – Not as complicated from a development perspective

  • All chronic wounds could potentially be

addressed with LL-37

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LL-37 Efficacy: Wound Area Reduction (%)

Optimal dose range for Phase IIb identified

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20 40 60 80 100 120 1 2 3 4 5 6 7 8 9 Series2 Series3 Series4 Series5 3 6 8 10 12 14 15 16

Treatment Period Follow-up

Randomization

Placebo LL-37 (0.5 mg/ml) LL-37 (1.6 mg/ml) LL-37 (3.2 mg/ml) Optimal dose interval identified (RP2D) Percentage of baseline wound area Visit no

* p<0.05 ** p<0.001

* ** ** **

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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

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Criteria for evaluation:

  • % completely healed wounds
  • Multiple secondary endpoints

Day -30 Day -21 Day 0 7M Screening Run-In Randomisation 3M Last Dose Time points for digital wound area assessment

The subjects are randomised to three groups:

  • Placebo (N=40)
  • LL-37 0.5 mg/mL (N=40)
  • LL-37 1.6 mg/mL (N=40)

End of Study

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Business Strategy

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▪ Phase III program (PHSU03) being prepared in EU and India ▪ Market Authorization and Commercialization ▪ Develop PXL01 all the way to market in EU; target timeline is 2022 ▪ Either commercialize first indication independently in EU or through partnerships ▪ Seeking partnerships for both other territories (ex-EU) and indications ▪ Phase IIb (LL-37 HEAL) ongoing in EU ▪ Target timeline for completion of the Phase IIb clinical trial is 2020 ▪ After completion, Promore Pharma will seek

  • ne or several partnerships with multi-

national companies for confirmatory trials and MA ▪ Potential for indication broadening to other common types of hard-to-heal wounds

Take PXL01 to market in EU Partnering LL-37

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Phase III Costs & Risks

13 10 20 30 40 50 60 10 20 30 40 50 60 70 80

Phase III Success Rate Phase III Costs

Ref: Martinez, 2016 Driving Drug Innovation and Market Access: Part 1-Clinical Trial Cost Breakdown Ref: BIO 2016, Clinical Development Success Rates 2006-2015

Cost MUSD Phase Success Rate (%)

High cost-effectiveness in late stage development

Musculoskeletal

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5 000 000 10 000 000 15 000 000 20 000 000 25 000 000 30 000 000 35 000 000 40 000 000 Q4 2017 Q4 2018 2017 2018

Operating expenses

Commodities and supplies Other external expenses Personnel costs Depreciation and impairments on fixed assets Other operating expenses

2018 Financial Data

  • Operating loss was 32.7 MSEK in 2018 compared

to an operating loss of 9.6 MSEK in 2017

– Increase in R&D expenses explained by increased development activities in both projects – External costs decreased in 2018 due to higher costs in 2017 because of the Nasdaq First North listing – Personnel costs increased in absolute terms in 2018 following the employment of the CEO in May 2017 – In 2017 the company also received milestone payments from PRP of 1.5 MEUR, which improved EBIT

  • Cash at end of 2018 was 31.0 MSEK

– Listed warrants matured 22 February 2019 did not generate any funds

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64% 56% 21% 58% 25% 43% 54% 38% 68% 16% 12%

EBIT (MSEK)

  • 10.4
  • 6.5
  • 9.6
  • 32.7

14%

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Executive Summary

Late stage clinical development project with extraordinary safety

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Late stage clinical development phase 1 Unmet medical need – no pharmaceutical products 2 Validated technology with strong IP protection 3 Strong safety profile and low development costs 4 High growth potential – high growth market segment and additional indications 5