Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
Late stage development of
two first-in-category wound
care products
Stockholm, May 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
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
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
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
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
PXL01
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
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
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
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
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
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
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
LL-37
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
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
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
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
Corporate
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
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
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
▪ 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
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.
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.
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