late stage clinical development projects with ... · the global wound care market is expected to...
TRANSCRIPT
Late stage clinical
development projects with
extraordinary safety
Stockholm, May 2017
CONFIDENTIAL
Promore Pharma at a Glance
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Strong commercial
potential
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▪ 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
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▪ 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
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▪ 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
CONFIDENTIAL
Two Main CandidatesFirst-in-category treatments for tendon injuries and leg ulcers
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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
CONFIDENTIAL
Peptides: A Unique Class of Therapeutics
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Molecular Weight (Da)
102 103 104 105 106
BiologyChemistry
• Standardized mfg process• Low(er) COGs• Low generic erosion
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
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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)
CONFIDENTIAL
SURGICAL ADHESIONS
PXL01
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CONFIDENTIAL
Tendon Injuries: The Medical Need
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▪ 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.
CONFIDENTIAL
PXL01: Product Concept
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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
CONFIDENTIAL
Phase II Outcome SummaryPatients in Per Protocol Analysis Set (PPAS)
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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 ✔
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
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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
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
CONFIDENTIAL
CHRONIC LEG ULCERS
LL-37
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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
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”…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
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
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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
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
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***
* p<0.05
** p<0.001****
LL-37 Efficacy: Wound Area Reduction (%) Optimal dose range for Phase IIb identified
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Optimal dose
interval identified
(RP2D)
CONFIDENTIAL
Clinical Development ProgramA portfolio of novel therapeutic peptides
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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
CONFIDENTIAL
Management Team
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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.
CONFIDENTIAL
Board of Directors
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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.
CONFIDENTIAL
Investment CaseLate stage clinical development projects with extraordinary safety
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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
CONFIDENTIAL
Important Notice and Disclaimer
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