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Late stage clinical development projects with extraordinary safety Stockholm, May 2017

Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

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Page 1: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

Late stage clinical

development projects with

extraordinary safety

Stockholm, May 2017

Page 2: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

CONFIDENTIAL

Promore Pharma at a Glance

2

Strong commercial

potential

2

▪ Bioactive wound care represents the segment within wound care with the highest

projected CAGR (double-digit)

▪ Aiming at segments without any existing prescription products

▪ Post-surgical adhesions and VLU represent indications with limited R&D competition

Future add-on

opportunities

3

▪ Aggregated blockbuster potential with sales exceeding 1 billion USD

▪ Both key programs represent significant opportunities for indication broadening

▪ Opportunities for co-development partnerships that can provide partial future funding

Late-stage programs

with high safety

1

▪ PXL01 for prevention of post-surgical adhesions to enter Phase III in EU, US and India

▪ LL-37 for treatment of VLU to enter Phase IIb in EU

▪ Multi-functional human peptides with extraordinary safety -- low risk for adverse effects

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CONFIDENTIAL

Two Main CandidatesFirst-in-category treatments for tendon injuries and leg ulcers

3

PXL01 a therapeutic peptide for prevention of post

surgical adhesions after tendon repair surgery

READY FOR PHASE III READY FOR PHASE IIb

LL-37 a therapeutic peptide for treatment of hard-to-heal

venous leg ulcers

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CONFIDENTIAL

Peptides: A Unique Class of Therapeutics

4

Molecular Weight (Da)

102 103 104 105 106

BiologyChemistry

• Standardized mfg process• Low(er) COGs• Low generic erosion

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CONFIDENTIAL

Bioactive Wound Care Fastest Growing Market Segment

▪ The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016

▪ Bioactive wound care is forecasted to be the fastest growing segment in the wound care market

o Expected to reach USD 7.3 billion in 2020, growing from USD 3.8 billion in 2015

▪ Promore is going into Phase III with an extraordinary safety profile in a high growth segment

5

0

1

2

3

4

5

6

7

8

2015 2020

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

Drivers

▪ Increase in aging population

▪ Escalating prevalence of underlying

chronic disease (CVD and T2D)

▪ Advancement in technology; new non-

pharmaceutical products capturing

premium pricing

▪ Increased recognition of health economics

from reimbursing agents (payers)

Global bioactive wound care market 2015-2020 (USD bn)

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CONFIDENTIAL

SURGICAL ADHESIONS

PXL01

6

Page 7: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

CONFIDENTIAL

Tendon Injuries: The Medical Need

7

▪ 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

The need

▪ Tendon transections are often

accompanied by nerve damage resulting

in pain or sensory loss

Nerve damage

Criteria for effective clinical documentation

▪ 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

In 2015, U2’s singer had a

bicycle accident with a hand

injury resulting in impaired

ability to play guitar.

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CONFIDENTIAL

PXL01: Product Concept

8

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

ANTI-INFLAMMATORY:

Inhibition of TNF-a and

IL-1

FIBRINOMODULATORY:

Down-regulation of PAI-1

Single-injection of lubricating hyaluronate-based gel containing PXL01 which is a multi-functional anti-inflammatory human peptide

PRE-FILLED SYRINGE:

Sterile solution, 0.5 ml

with stability of >12 mo

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CONFIDENTIAL

Phase II Outcome SummaryPatients in Per Protocol Analysis Set (PPAS)

9

Endpoint PXL01 Placebo P-Value

DIPAM (the most distal finger joint) 6 M post-surgery60 degrees 41 degrees P<0.05 ✔

Tip-to-crease distance 6 mo post-surgery5.0 mm 15.5 mm P<0.05

Patients with optimal nerve recovery (normal or

diminished light touch) 12 weeks post-surgery76% 35% P<0.05

Fraction of patients with ”Good” or ”Excellent”

functional score 6 M post-surgery61% 38% P<0.05 ✔

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CONFIDENTIAL

Large Health-Economic Benefit of PXL01Reduction of re-surgery

• Secondary endpoint in Per-Protocol Set

• The Investigator or delegated study personnel judged whether it was likely that the patient

would benefit from tenolysis to improve mobility in the treated finger

10

P< 0.10 in PPAS

PXL01 Placebo

12%

30%

At the time of the final follow-up visit, at 12 months post-surgery, there were more patients in

placebo group who were considered to likely benefit from tenolysis, compared to PXL01 group

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CONFIDENTIAL

Tendon- and nerve

injury repair

Orthopedic surgery,

e.g. TKA

Opportunities to Expand PXL01 MarketPotential for expansion of geographies and indications is strong

Dermal scarring

>3 million procedures

>4 million TKAs

PXL01 in hyaluronic acid

>40 million relevant

procedures

In 2015, >300 million surgical

procedures conducted world-wide

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CONFIDENTIAL

CHRONIC LEG ULCERS

LL-37

12

Page 13: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

CONFIDENTIAL

Chronic Wounds: The Medical Need

• There are an estimated 40 million patients

world-wide with challenging wounds

– 15 million on the major pharmaceutical

markets

• There are no prescription products for VLU:s

• The medical value of existing pharmaceutical

products for DFU:s is considered very limited

• There is a major need for effective multi-

functional products that can be used for

curative therapy in all categories of wounds

13

”…Less than 30% of all challenging wounds are

being treated properly…”

BioMedGPS, 2014SmartTRACK Business Intelligence Report

VLU:s

DFU:s

Auxiliary

Pressureulcers

Addressable market for VLU alone is

estimated at 3 bnUSD (EU and US) per year

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CONFIDENTIAL

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

14

A viscous hydrogel containing the peptide is applied 2-3 times weekly in

conjunction with regular dressing changes

DOSING: Flexible

dosing by choice of

injection volume

COMPATIBLE: Can

readily be combined with

the most common

compression bandages

FILM: The hydrogel

forms a thin local ”film”

over the wound area

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CONFIDENTIAL

0

20

40

60

80

100

120

0 3 6 9 12 15 18 21 24

Per

cen

tag

e o

f b

asel

ine

wo

un

d a

rea

Visit No.

Placebo

0.5 mg/ml

1.6 mg/ml

3.2 mg/ml

Randomization

Follow-up PeriodTreatment Period

16

***

* p<0.05

** p<0.001****

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

15

Optimal dose

interval identified

(RP2D)

Page 16: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

CONFIDENTIAL

Clinical Development ProgramA portfolio of novel therapeutic peptides

16

1st patient

Clinical data

PXL01Tendon Repair

Surgery

LL-37Venous Leg

Ulcers

Diabetic Foot

UlcersLL-37

Phase III EU

Tendon Repair

SurgeryPXL01

Phase IIb

Phase III North America

Phase lIa

Product

candidateIndication 2017

Planning

Project started

2018

Project started

2019 2020

Phase III (with partner)

Planning

▪ 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

Fully funded

Financing with

IPO proceeds

Financing with

IPO proceeds

Financing with

IPO proceeds

Financing

Page 17: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

CONFIDENTIAL

Management Team

17

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 15

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 40 articles in peer-reviewed scientific journals and is inventor on 5 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 close to 15 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 specialised health care services company.

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CONFIDENTIAL

Board of Directors

18

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 boardmember of Forward Pharma, Vistagen Pte Ltd, Dilafor AB and Dilaforette 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 boardmember at Enzymatica AB (publ), Camurus AB (publ), RecipharmAB (publ), Addera Care AB (publ) and Praktiertjänst AB.

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CONFIDENTIAL

Investment CaseLate stage clinical development projects with extraordinary safety

19

Late stage clinical development phase

1

Unmet medical need – no pharmaceutical products2

Validated technology with strong IP protection

3

Strong safety profile and low development costs4

Low fixed costs and significant financing secured6

High growth potential 5

Experienced management and Board of Directors7

Page 20: Late stage clinical development projects with ... · The global wound care market is expected to reach USD 20.4 billion by 2021 from USD 17.0 billion in 2016 ... • Excipients are

CONFIDENTIAL

Important Notice and Disclaimer

20

THIS PRESENTATION AND ANY OTHER INFORMATION DISCUSSED AT THE PRESENTATION (THE “PRESENTATION”) IS BEING PROVIDED TO YOU SOLELY FOR YOUR INFORMATION. THIS PRESENTATION, WHICH HAS BEEN

PREPARED AND IS ISSUED BY PROMORE PHARMA AB (THE “ISSUER”) IS PRELIMINARY IN NATURE, BASED ON MANAGEMENT BELIEFS AND IS SUBJECT TO UPDATING, REVISION AND AMENDMENT. THIS PRESENTATION MAY

NOT BE REPRODUCED IN ANY FORM, FURTHER DISTRIBUTED OR PASSED ON, DIRECTLY OR INDIRECTLY, TO ANY OTHER PERSON, OR PUBLISHED, IN WHOLE OR IN PART, FOR ANY PURPOSE. ANY FAILURE TO COMPLY

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