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

Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

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Page 1: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Late stage development of

two first-in-category wound

care products

Stockholm, May 2019

Page 2: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

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

Page 3: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Trauma Has the Third Largest Spend

3

CNS Cardiovascular Trauma Oncology

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

60million

>600USD billion1)

600USD billion1)

400USD billion1)

300USD billion1)

27%of clinical studies2)

10%of clinical studies2)

15%of clinical studies2)

18%of clinical studies2)

Wounds, trauma and amputations

account for the third largest area of

healthcare spending in the world

1) World Health Organization (WHO) 2018

2) Clinicaltrials.gov; an estimate of number of planned and ongoing clinical studies

Page 4: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Peptides: A Unique Class of Therapeutics

4

Molecular weight (Da)

Biology

Chemistry

Peptides present a combination

of advantages compared to the

most common drug classes

102 103 104 105 106

Page 5: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

5

Local Delivery of Peptides: The Way to Go

SAFETY

Rapid degradation of peptides in the

bloodstream: very low systemic exposure

DOSING

Flexible dosing by choice of injection volume

DURATION

Temporal exposure can readily be controlled

through choice of formulation

BIOAVAILABILITY

Drug available at site of action in a medically

relevant amount

Page 6: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

PXL01

Page 7: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

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

or 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 and PXL01

7

▪ Derivative of naturally occurring peptide

(lactoferricin)

– Unique anti-inflammatory action: prevents

fibroblastic adhesions without interfering

with wound healing

– Pro-fibrinolytic properties

• First indication: Prevention of

adhesions after tendon repair surgery

(hand, arm and foot)

• Other indications

– Prevention of fibrosis in conjunction with

spinal surgery (corporate partnership)

– Clinical feasibility testing of PXL01 in dermal

scar prevention

Page 8: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

In 2015, U2’s singer had a

bicycle accident with a

hand injury resulting in

impaired ability to play

guitar

▪ Annual incidence of accidental tendon injuries

corresponds to 0.1% in the general population

– procedures in the hand account for one third

▪ 20–50% of subjects undergoing surgery of tendons

of the hand never recover full mobility and finger

strength post-surgery

▪ There are currently no pharmaceutically active

products on the market for anti-adhesion

▪ Tendon transections are often accompanied by nerve

damage resulting in pain or sensory loss

▪ High incidence of scar formation

▪ Methods for clinical assessment are:

– Validated

– Quantitative

– Standardized

▪ Mainly young and healthy patients

▪ Surgery in a limited number of specialized centers

The medical need Criteria for effective clinical documentation

Tendon Injuries: The Medical Need

8

Nerve damage

Page 9: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

PXL01: Product Concept

9

DOSING: Single administration at the

surgery

BIOAVAILABILITY: Drug available at

site of action

SAFETY: Rapid degradation of

peptides in the bloodstream: very low

systemic exposure

Single-injection of lubricating hyaluronate-based gel containing PXL01

PRE-FILLED SYRINGE: Sterile

solution, 0.5 ml with stability of >12 mo

Page 10: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Large Medical Benefits of PXL01

10

Endpoint PXL01 Placebo P-Value

Mobility in injured fingerDIPAM (the most distal finger joint) 6 months post-surgery

60 degrees 41 degrees P<0.05

Nerve functionPatients with optimal nerve recovery (normal or diminished

light touch) 12 weeks post-surgery

76% 35% P<0.05

Need for secondary surgeryFrequency 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

Page 11: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

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

11

Visit 3

2 w

Visit 1

Day 0

(Screen,

Surgery)

Visit 2

1-5 days

post surgery

Visit 4

4 wVisit 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 Trial420 Patients Completing Protocol

Page 12: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Comparing Phase III Costs and Success Rates

12

Lower Phase III costs for PXL01 program Musculoskeletal show with higher success rates

11

17

24 25

52

Promore Endocrine Oncology CVD CNS

Phase III cost, USDm1)

1) Martinez, 2016 Driving Drug Innovation and Market Access: Part 1-Clinical Trial Cost Breakdown

2) BIO 2016, Clinical Development Success Rates 2006-2015

7065

57 55

40

Promore Endocrine CNS CVD Oncology

Success rate in Phase III, %2)

High cost-effectiveness in late stage development

Musculo

skele

tal

Page 13: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Tendon- and

nerve injury

repair

Degenerative disc

disease

Opportunities to Expand PXL01 Market

Dermal scarring

>1 million

procedures globally

Preparing for Phase III

1-2 million

Procedures globally

Partnership with PRP

PXL01 in hyaluronic acid

>40 million

relevant procedures globally

Planned feasibility study in 2020

13

Potential for expansion of geographies and indications is strong

Page 14: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

LL-37

Page 15: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

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

15

Page 16: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

LL-37: Product Concept

▪ Does not require change of medical practice

▪ Application frequency matches current medical

standards

▪ Can be applied by patient or a nurse

▪ Excipients are well characterized and can be procured

at a very low cost

DosingFlexible dosing by choice of injection volume

CompatibilityCan readily be combined with the most common

compression bandages

FilmThe hydrogel forms a thin local ”film” over the wound area

A viscous hydrogel containing the peptide is applied 2-3 times weekly in conjunction with regular dressing changes

16

Page 17: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

LL-37 Efficacy: Wound Area Reduction (%) Optimal dose range for Phase IIb identified

17

0

20

40

60

80

100

120

1 2 3 4 5 6 7 8 9

Series2 Series3 Series4 Series5

Treatment Period Follow-up

Randomization

*

****

**

Per

cen

tag

e o

f b

asel

ine

wo

un

d a

rea

120

100

80

60

40

20

0

1 3 6 8 10 12 14 15 16

Wound Area Reduction (%)

* p<0.05

** p<0.001

Placebo

LL-37 (0.5 mg/ml)

LL-37 (1.6 mg/ml)

LL-37 (3.2 mg/ml)

Optimal dose

interval identified

(RP2D)

▪ Two doses of LL-37 demonstrated

unambiguous efficacy, including healing rate

and wound area reduction

▪ LL-37 was considered safe and well tolerated in

the two lower doses

▪ The highest dose caused local reactions: MTD

was established

▪ Two doses defined for Phase IIb (RP2D)

Visit no

Page 18: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

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

18

Criteria for evaluation:

• % completely healed wounds

• Multiple secondary endpoints

Day -30 Day -21 Day 0 7M

Screening Run-In Randomization

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

Page 19: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Corporate

Page 20: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Company Milestones

20

▪ Finalize PXL01

manufacturing logistics

▪ 50% of patients enrolled

in HEAL LL-37

▪ Financing event

20192018

Regained

manufacturing

rights in PXL01

Out-licensing of

PXL01 in spinal

surgery to PRP

First-patient-in

HEAL LL-37 trial

Meeting with

FDA regarding

PXL01 program

CTA approval for

PHSU03 in India

✓ ✓ ✓

✓✓

An eventful 2018 with operational delivery according to plan

Page 21: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Business Strategy

21

▪ 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

one 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

Page 22: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Financial Snapshot

• 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 costs

in 2017 related to 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

22

0

5 000 000

10 000 000

15 000 000

20 000 000

25 000 000

30 000 000

35 000 000

40 000 000

2017 2018

Operating expenses

Other operating expenses

Depreciation and impairments

on fixed assets

Personnel costs

Other external expenses

Commodities and supplies

EBIT -9.6 -32.7

Page 23: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

▪ Approximately 600 shareholders

▪ Additional warrant programs entitles to subscription

of 1,910,310 shares

– Exercise price quota value (0.04 SEK per share)

– Warrant holders Technomark, Kentron,

PharmaResearch Products

– Warrant maturity 31 December 2022

Overview of shareholder base 28 March 2019

Shareholder Shares, # Ownership, %

Midroc Group 6,813,219 33.7%

Rosetta Capital IV Sarl 6,291,592 31.1%

PharmaResearch Products Ltd 4,772,715 23.6%

Avanza Pension 236,031 1.2%

Mikael Lönn 228,195 1.1%

Philip Diklev 158,049 0.8%

Chalmers Tekniska Högskola 128,355 0.6%

Nordnet Pensionsförsäkring 125,255 0.6%

Hans-Peter Ostler 111,343 0.6%

Others 1,370,336 6.7%

Total 20,235,090 100.0%

Shareholders

231) Including known changes

Page 24: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Management Team

24

Jonas Ekblom, CEO▪ Dr. Jonas Ekblom has over 25 years of experience from

the life science sector, with a focus in pharmacology and drug development. Dr. Ekblom has served as CEO of Bows Pharmaceuticals AG. Prior to that, he has held senior/executive management positions in Pharmacia, Biovitrum, Sequenom and Invitrogen.

▪ Ekblom has published over 60 peer-reviewed articles

Margit Mahlapuu, CSO▪ Dr. Margit Mahlapuu is an executive with close to 20

years of experience in discovery and development of novel pharmaceuticals from the biotech and pharma industry. Dr. Mahlapuu joined the company in 2007 and has since then been responsible for R&D function and clinical strategy of the programs.

▪ Dr. Mahlapuu has authored 50 articles in peer-reviewed scientific journals and is inventor on 7 pending patent applications

Ulrika Wennberg, COO▪ Ms. Ulrika Wennberg has over 20 years of business

experience as an entrepreneur, project manager, management consultant and business leader. Ms. Wennberg has broad experience from several different industries, e.g. consulting, IT, media and biotech.

Jenni Björnulfson, CFO▪ Mrs. Jenni Björnulfson has >20 years of experience from

the financial markets with a strong focus on the health care sector. Mrs. Björnulfson spent the majority of her financial market career within investment banking at Handelsbanken Markets and Alfred Berg/ABN AMRO. Most recently Mrs. Björnulfson held various management positions within GHP, a specialized health care services company.

Page 25: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Board of Directors

25

Göran Pettersson, Chairman▪ Mr. Göran Pettersson has served as chairman at Axelar,

Medivir and OxyPharma. Previous positions include board member at Recipharm and CEO and board member at Meda Sverige AB and Pharmacia AB.

Torsten Goesch▪ Dr. Torsten Goesch has been Partner of Rosetta Capital

Limited since 2002. Dr. Goesch is responsible for the management of several Rosetta Capital investments and serves as board member of Forward Pharma, Vistagen Pte Ltd, Dilafor AB and Modus Therapeutics AB

Göran Linder▪ Mr. Göran Linder serves as board member and CEO at

Midroc New Technology AB. Mr. Linder is also board member at Powercell Sweden AB (publ), Nilsson Special Vehicles AB (publ), Minesto AB, Crunchfish AB and Heliospectra AB (publ).

Satyendra Kumar▪ Dr. Satyendra Kumar represent Pharmaresearch

Products LTD

▪ Dr. Kumar combines a medical background with years of operational and deal-making experience in the life science sector

Marianne Dicander Alexandersson▪ Mrs. Marianne Dicander Alexandersson is the founder

and chairwoman of MDA Management AB. MrsDicander Alexandersson is also board member at Enzymatica AB (publ), Camurus AB (publ), RecipharmAB (publ), Addera Care AB (publ) and Praktikertjänst AB.

Kerstin Valinder Strinnholm▪ Mrs. Kerstin Vainder Strinnholm is also board member

at Camurus AB (publ), Immunicum AB (publ), Klifo A/S,Corline Biomedical AB, Gedea Biotech AB and CavastorAB.

Page 26: Late stage development of two first-in-category …...Promore Pharma in Brief Listed on Nasdaq First North since July 2017 (PROMO) Two late stage, first-in-category products Human

Executive SummaryLate stage clinical development project with extraordinary safety

26

Late stage clinical development phase1

Unmet medical need – no pharmaceutical products2

Validated technology with strong IP protection3

Strong safety profile and low development costs4

High growth potential – high growth market segment and additional indications 5