innovation in allergy immunotherapy...3 visiongain, allergic rhinitis drug market forecast 2015-2025...
TRANSCRIPT
INNOVATION IN ALLERGYIMMUNOTHERAPY
INVESTORS PRESENTATION
APRIL 2019
Disclaimer
This presentation (“Presentation”) has been prepared by ASIT biotech (“ASIT”) to provide an overview of the Company, it does not constitute a prospectus, an audit or due diligence review and should not be construed as such. While the information contained in this Presentation is believed to be accurate, no representation or warranty, express or implied, is made as to the fairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any loss howsoever arising, directly or indirectly, from this Presentation of its contents.
The Presentation includes forward looking statements and includes assumptions about future developments, operations and results. Although such statements are believed to be reasonable, there can be no assurances that such assumptions and views of the future are accurate, or that estimates and projections will be realized. Forward looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. No representation, warranties or other assurances will be made by ASIT concerning the anticipated performance of the company.
This document and its contents may not be viewed by persons within the United States (within the meaning of Regulation S under the Securities Act) other than (i) by QIBs (qualified Institutional Buyers) or (ii) in “offshore transactions” within the meaning of Regulation S. This document and any materials distributed in connection with this document are not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The distribution of this document in certain jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe any such restrictions. This document does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of ASIT nor should it or any part of it from the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Company, nor shall it or any part of it from the basis of or be relied on in connection with any contract or commitment whatsoever.
2
ASIT biotech team3
Louis Champion, Chairman of the Board
• MD, graduated from Lyon (France) medical school, and MBA from INSEAD
• COO of Stallergènes from 2000 to 2011, where he built up the commercial operations, the R&D organization and the project management group
• He is Board member of several companies in private primary care, biotechnology and medical device sectors.
Michel Baijot, Director & Chief Executive Officer
• Bioengineer, PhD
• Over 25 years of experience in building biologicals businesses with significant contribution in strategy, licensing, M&A and technology transfer
• Previously Executive Director Europe at Serum Institute of India, Head of Cipla Global Vaccine, Chief Business Officer at Janssen/Crucell, Vice President Worldwide Strategic Alliances and Business Development at GlaxoSmithKline Biologicals and Vice President Business Development at Innogenetics.
Yves Désiront, Chief Financial Officer ad interim
• Master degree as Ingénieur Commercial in Business Administration and Technology Interface from I.C.H.E.C. Brussels
• Managing Partner of 3T Finance, a private equity fund based in Brussels
• Previously Group CFO under a consulting contract with BGP Investment, a Luxembourg real estate group, and Group CFO of Orco Property Group, listed in Paris and Prague.
ASIT biotech: a listed advanced-clinical stage immunotherapy company4
A BIOPHARMACEUTICAL COMPANY
OWNING A TECHNOLOGICAL PLATFORM
DEVELOPING PRODUCTS BASED ON A
UNIQUE MIXTURE OF NATURAL
ALLERGEN PEPTIDES TARGETING
RESPIRATORY AND FOOD ALLERGIES
A ROBUST SCIENTIFIC TRACK RECORD IN DEVELOPING INNOVATIVE ALLERGY
IMMUNOTHERAPY TREATMENTS:
gp-ASIT+™: LEAD CANDIDATE IN GRASS POLLEN ALLERGY WITH FIRST
PHASE III (554 PATIENTS) AND A CONFIRMATORY ONE WITH PRIMARY END
POINTS EXPECTED IN DECEMBER 2019
pnt-ASIT+™ & hdm-ASIT+™: CANDIDATES IN RESPECTIVELY PEANUT-
AND HOUSE-DUST MITES ALLERGIES, DEDICATED TO PARTNERING UPON
COMPLETION OF PRECLINICAL PACKAGES EXPECTED MID-2019
Invested more than €80 million since inception
€23.4m IPO (2016) on Euronext Brussels & Paris
€15.4m private placement (2018)
€12m equity line (2018, convertible bonds to be called until January 2020)
Cash position (31.12.18): €8.5 million, reinforced by a €8 million convertible bonds still to be called as of that
date (€5.9 million as of end of March 2019) and €4.2 million warrants at an exercise price of €3.83 per share
Spin-off of the Free University of Brussels (ULB)
5The allergy immunotherapy (AIT) market:<15% of the allergy drug market because of inefficient therapies
Sources: 1 World Allergy Organization, White Book on Allergy, Update 2013 2 Visiongain, Global Allergic Rhinitis Drugs Market 2018-2028, August 20183 Visiongain, Allergic Rhinitis Drug Market forecast 2015-2025
23
1
Competitive landscape in AIT market6
Use of adjuvant
Rapidity
of treatment
With adjuvant
Adjuvant free
Short-term Long-term
Long and cumbersome AIT treatments result in low acceptance and poor compliance7
* Source: Kiel MA et al. J Allergy Clin Immunol 2013; 132: 353-60
** (23% compliance for SCIT and 7% for SLIT after Y3)*acceptance rate (50%)
8
ASIT’s short course immunotherapy is much more efficient than current AIT
Only 4 visits for gp-ASIT+™ treatment are expected to provide protection for the entire pollen season
and protection mechanisms are already in place 1 week after the last visit
ASIT biotech developed a versatile platform for allergy immunotherapy9
ASIT BIOTECH TREATMENTS CONSIST OF A UNIQUE MIXTURE
OF HIGHLY PURIFIED PEPTIDES FROM DIFFERENT SELECTED SIZES,
PRODUCED FROM NATURAL SOURCES OF ALLERGENS, FREE OF
ADJUVANT, FOR ALLERGY IMMUNOTHERAPY
THE ASIT+™ PLATFORM OFFERS:
A validated production process
at commercial scale
Validated QC procedures
A scalable solution that is
applicable to various allergens
(e.g., House Dust Mites, Peanuts)
Already available Ex-vivo
screening, immunogenicity and
therapeutic models
HIGH GRADE
PURIFICATION
OF ALL ALLERGENS
FROM NATURAL
EXTRACTS
STANDARD
ENZYMATIC
HYDROLYSIS
SELECTION OF
ALLERGEN
FRAGMENTS
BASED ON SIZE
DISTRIBUTION*
HIGHLY
PURIFIED
ALLERGEN
FRAGMENTS
WITH OPTIMAL
SIZE
DISTRIBUTION
* 1-10 kDa
ASIT biotech‘s strategy: focus on the ongoing confirmatory Phase III study with gp-ASIT+™ and partnerships for the platform & other drug candidates
10
gp-ASIT+™
ASIT+™ platform
Business Development
• Focus of financial capacity & human resources on the finalization of the second
phase III study, conceived according to an improved protocol, with primary end points
delivered by end of the year 2019
• Option upon financing: initiate a follow-up study for 2020 with the same patients
developing long term data’s with a 2nd season treatment
• Finalize toxicity and ex-vivo studies on hdm-ASIT+™ (house dust mite) and pnt-
ASIT+™ (peanut) by mid-2019
• Demonstrate efficacy of the platform in selecting product candidates
• Establish partnership for the IND and clinical phases in the US
• Establish partnerships for the clinical phases of hdm-ASIT+™ and pnt-ASIT+™
• Establish partnerships for the selection of new product candidates
ASIT Biotech pipeline & expected milestones11
2019 2020
gp-ASIT+™ confirmatory phase III
H1 H2 H1
Candidate Selection
FDA MeetingResults
Filing (GER)
H2
The time to market for the gp-ASIT+™ is expected to be 12 to 18 months after the initiation of
the discussions with the German regulator end of the second quarter in 2020.
Grass pollen
gp-ASIT+™
Peanut
pnt-ASIT+™
House dust mite
hdm-ASIT+™
Other allergens + Partner
Egg white / cow’s milk
pnt-ASIT+™
(phase I)
Results*
hdm-ASIT+™
(phase I )
Results*
PA
RT
NE
RS
HI
P
Follow up
gp-ASIT+™ demonstrated safety and efficacy in a first Phase III study 12
PL: Placebo; LPP: Lolium Perenne Peptides (gp-ASIT+™)
* CSMS : Combined Symptom-Medication Score
** CPT: conjunctival provocation test (score from 1 to 4; most severe patients = CPT 3 & 4)
# ASIT received positive scientific advice from the German regulator, the Paul-Ehrlich Institute, and is now ongoing a redesigned confirmatory Phase III study (all patients randomized)
0
0,5
1
1,5
All patients Most severe**
CS
MS
Placebo
gp-ASIT+
CSMS OVER
ENTIRE
POLLEN
SEASON
P=0.03 P=0.05
0
0,5
1
1,5
2
All patients Most severe**
CS
MS
Placebo
gp-ASIT+
CSMS:
PEAK
POLLEN
PERIOD
P=0.04 P=0.05
17.9% 24.4%
15.5% 19.8%
In a Phase III study
• gp-ASIT+™ resulted in a statistically significant improvement
in CSMS* during the peak pollen period and the entire pollen
season in the whole Phase III patient population
• The predefined absolute average 20% difference in CSMS*
between placebo and the treatment group was nearly achieved
over the peak season despite a poor results in Germany, which
was heavily weighted in the study#
• In a patient subgroup with the highest CPT** reactivity at
baseline (more than ½ of patients), CSMS* improvement was
even higher
Secondary endpoint
• Reactivity to the conjunctival provocation test (CPT) decreased
significantly in 60.0% of patients treated with gp-ASIT+™
compared with 35.6% in the placebo group
CLINICAL DATA FROM PHASE II AND PHASE III HAS BEEN PUBLISHED BY WORLD-CLASS SCIENTIFIC PARTNERS IN HIGHLY RANKED JOURNALS
Reliable immunological data correlates with strong efficacy data*13
* Blood samples from a representative sub-group of Phase III patients in Belgium (n=32) were compared from V8 (after the grass pollen season) vs. V6 (after treatment before the pollen season)
** CSMS : Combined Symptom-Medication Score
The production of sIgE due to exposure
to natural allergens during the pollen
season was blunted in a sub-group of
Belgian patients* receiving gp-ASIT+™
compared to those receiving placebo
0
10
20
30
40
gp-ASIT+ Placebo
sIg
E(k
UA/L
) sp
ecif
ic
to g
rass
po
llen
P<.001
IgE PRODUCTION
DURING THE POLLEN SEASON
BELGIUM *
Data from 32 patients in Belgium
showed a 35% reduction in CSMS**
during the peak pollen period and
>50% reduction for the entire
pollen season (both highly
significant)
Ongoing gp-ASIT+™ phase III study: next milestones14
2019
Q1 Q2 Q3
LPLV
Q4
A reduced level of exposure to execution risks over time
Ris
ksc
ale
Achieved with
strict criteriaPatients’ recruitment
>85% achieved Patients’ treatment
Pollen season 70 sites selected
Compliant reporting Data collection on E-diaries
Results
December
2019LP Treated
Key success factors of the ongoing confirmatory gp-ASIT+™ phase III study15
• Strong efficacy for most severe patients
• sIgE (pro-allergic antibodies) are blunted and production of sIgG4 (blocking antibodies that prevent sIgE
antibodies from binding allergens) is boosted
• Identification of the biological process with the Imperial College of London allowing an ex-vivo study on the
selected product candidates
1
Learning’s
from the
1st phase III
• Early start of recruitment with 30 to 35 patients per site over 70 sites with an online follow-up of the recruitment
for each site. Enrollment target of a total of 624 patients reached
• Recruit only moderate to severe patients with moderate to severe RC during the 2017-2018 seasons based on
ARIA criteria AND significant sIgE level AND SPT wheal diameter
• High pollen count and high-quality data recording history has been used to select the clinical centres
2
Patients’
recruitment
• The study is subcontracted to one single Top Ten CRO experienced in allergy studies, ICON plc.
• Paper diaries are replaced by smart phone electronic diaries (including an alert system)
• Pollen count monitoring is centralized by the European Aeroallergen Network from the University of Vienna
3
Data
collection
Randomization successfully completed with the anticipated number of patients
gp-ASIT+™ will take over significant market share of an existing AIT market 16
• Long and cumbersome existing AIT treatments result in low acceptance and poor compliance
• ASIT offers a pre-season treatment consisting of 4 visits with two injections per visit
An opportunity in allergy immunotherapy (AIT) to migrate from old,
inefficient therapies to a new generation of preventive treatment
1
Short
treatment
• Only 1/3 of the 100 Million patients estimated to suffer from Allergic Rhinitis (AR) are offered AIT, out of which
50% accept the treatment with a low level of compliance :
Less than 10% of eligible patients complete the existing treatments
2
Underserved
market
• Pricing will potentially range from €500 (all Europe except Germany), to €750 (Germany) and $1,200 (USA) based
on the cost of existing treatments. The pricing should be correlated with the efficacy demonstrated. No Generics.
Pricing policy could be supported by long-term results from a follow up study in 2020
3
Potential
pricing
A clear market access strategy to commercialize gp-ASIT+™ directly or with a strategic partner
A clear partnering strategy for gp-ASIT+™, preclinical candidates & new products17
hdm-ASIT+™
Ready for Phase I (mid-2019)
New products
Develop/pay on demand
(e.g. Japanese Cedar,
Birch)
gp-ASIT+™
The proof of concept
pnt-ASIT+™
Ready for Phase I
(mid-2019)
ASIT+™ Patform
• Purified peptides from natural
allergens
• Immunological signature similar to
that of the gp-ASIT+™
• Direct / partner in the EU
• Develop for US with a partner
• Co-development and commercialization with a partner in
major developed (USA & Europe) and emerging markets
(China)
• Filing of a request for Phase I/II as soon as the Company
identifies a partner
• Launch partnerships
in birch allergy or
allergy to Japanese
cedar for example
Strategic achievements since the beginning of 201918
AchievementsObjectives
Reinforced cash positionSetting up of a €9-12m convertible
bond issueFinancing
Optimization of the development of new
product candidates
First interest for pnt and hdm as well
as for Japanese cedarPartnering
Optimization of the management structureDedicated team to gp-ASIT+™
Structured BD strategy & teamManagement
SAB organized by ASIT recommended to
develop long term data and pediatric
investigation plan
Improving market position of gp-
ASIT+™ with long term dataKOL support
gp-ASIT+™ study Phase III well on trackRandomization of all patients
completedClinical development
Full control of the manufacturingOngoing internalization for
commercial capacityManufacturing
ASIT biotech held SAB with highly recognized experts in allergy immunotherapy 19
Pr. KLIMEK
Pr. MOSGES
Pr. PANZNER
Pr. PFAAR
Pr. PRIEELS
Pr. SHAMJI Pr. CALDERON
Pr. DEMOLY
Pr. BACHERT
Follow up season
Confirm LT effects to prescribers and regulators
Optimal Target Product Profile (TPP)
Confirm the interest of targeting the most severe
patient population
Pediatric Investigational Plan (PIP)
Clarifying the optimal approach to address the
challenges of pediatric development
SAB Agenda
ASIT biotech: innovation in allergy immunotherapy20
A unique investment opportunity at the edge of the confirmatory phase III results
in grass pollen rhinitis
Potentially the first registered
SCIT short-course treatment
across EU and in the US
3Further upsides: - partnerships in house-dust
mite & peanut allergies- new products from the
ASIT+™ platform
5
ASIT+™ innovative
technology platform
applicable to other allergens
4
Seasoned management team
with solid know-how in the
field of allergy
6
Allergy: a global issue with
significant unmet medical
need
1
An expected short time to
market in grass pollen rhinitis
2
www.asitbiotech.com
Registered address
Avenue Ariane 5
1200 Brussels, Belgium
Operations
Rue des Chasseurs Ardennais 7,
4031 Liège, Belgium
Contact: [email protected]