eradicating hpv infection before it causes cervical cancer€¦ · before it causes cervical cancer...
TRANSCRIPT
1
ERADICATING HPV INFECTION BEFORE IT CAUSES CERVICAL CANCER
MODIFIEZ LE STYLE DU TITRE2015 Annual Results & 2016 Strategy
March 14, 2016
INNOVATIVE IMMUNOTHERAPIES
TO FIGHT INFECTIOUS DISEASES AND CANCER
2
DISCLAIMER
This document has been prepared by Genticel (the "Company")and is for information purposes only.
The information and opinions contained in this document areprovided as of the date of this document only and may beupdated, supplemented, revised, verified or amended, and thussuch information may be subject to significant changes. TheCompany is not under any obligation to update the information oropinions contained herein which are subject to change withoutprior notice.
The information contained in this document has not been subject toindependent verification. No representation, warranty orundertaking, express or implied, is made as to the accuracy,completeness or appropriateness of the information and opinionscontained in this document. The Company, its subsidiaries, itsadvisors and representatives accept no responsibility for and shallnot be held liable for any loss or damage that may arise from theuse of this document or the information or opinions containedherein.
This document contains information on the Company’s markets andcompetitive position, and more specifically, on the size of itsmarkets. This information has been drawn from various sources orfrom the Company’s own estimates. Investors should not base theirinvestment decision on this information.
This document contains certain forward-looking statements. Thesestatements are not guarantees of the Company's futureperformance. These forward-looking statements relate to theCompany's future prospects, developments and marketing strategyand are based on analyses of earnings forecasts and estimates ofamounts not yet determinable. Forward-looking statements are
subject to a variety of risks and uncertainties as they relate to futureevents and are dependent on circumstances that may or may notmaterialize in the future. Forward-looking statements cannot, underany circumstance, be construed as a guarantee of the Company'sfuture performance and the Company’s actual financial position,results and cash flow, as well as the trends in the sector in which theCompany operates, may differ materially from those proposed orreflected in the forward-looking statements contained in thisdocument. Even if the Company’s financial position, results, cash-flows and developments in the sector in which the Companyoperates were to conform to the forward-looking statementscontained in this document, such results or developments cannotbe construed as a reliable indication of the Company's future resultsor developments. The Company does not undertake any obligationto update or to confirm projections or estimates made by analysts orto make public any correction to any prospective information inorder to reflect an event or circumstance that may occur after thedate of this document.
This document does not constitute an offer to sell or subscribe or asolicitation to purchase or subscribe for securities in France, theUnited States or any other jurisdiction. Securities may not be offeredor sold in the United States absent registration under the USSecurities Act of 1933, as amended, or an exemption fromregistration thereunder. No public offering of securities may beconducted in France or abroad prior to the delivery by the FrenchAutorité des marchés financiers (Financial Markets Authority) of avisa on a prospectus that complies with the provisions of Directive2003/71/CE as amended. No offering of securities is contemplatedin France or any jurisdiction outside France.
33
2015 OPERATING REVIEW
▌ REMINDER OF THE ACTIVITY
Technologies, therapeutic area,
candidates, market …
▌ 2015 CORPORATE HIGHLIGHTS
4
GENTICEL’S HIGHLIGHTS
Experienced management team with track record of
success
GTL001, 1st-in-class
therapeutic vaccine for HPV 16/18 positive
women
Specialist in HPV & HPV-induced cancer
immunotherapy: significant need for
therapeutic solutions
GTL002, multivalent HPV follow-on
therapeutic HPV vaccine
for a larger population
Unique antigen delivery platform,
Vaxiclase, the basis for multivalent
therapeutic vaccines in multiple
indications
Multiple licensing opportunities for the HPV franchise and
the Vaxiclase technology
Strong and unique intellectual property
Pipeline expansion and partnering opportunities
5
AN ANTIGEN DELIVERY VECTOR SUITED TO DEVELOP IMMUNOTHERAPIES IN MULTIPLE INDICATIONS
CyaA,
(adenylate cyclase),a breakthrough vaccine
carrier licensed from
Institut Pasteur
Unique mechanism of action that triggers both killer and helper T cells
X
CyaA platform
Chosen antigen
Recombinant CyaA protein incorporating
the antigen of choice
Binding domain targets an integrin receptor of antigen-presenting cells
6
A BREAKTHROUGH ANTIGEN DELIVERY VECTOR WITH DUAL MECHANISM OF ACTION
The chosen antigen is incorporated in the CyaA protein
The recombinant CyaA protein delivers the antigen TO and INTO
human immune sentinel cells
Sentinel cells activate antigen-specific immune killer * T cells and
helper T cells
Killer cells eliminate cells
that contain the antigen
Antigen Presenting Cell (APC)
* cytotoxic
CyaA +
adjuvant
Chosen
antigen
Helper T cells
Killer T cells
Eradication
of infected
cells
7
VAXICLASE, A NEXT-GENERATION, PROPRIETARY ANTIGEN DELIVERY PLATFORM
License agreement signed with Serum Institute of India Limited (SIIL) in Feb. 2015 to evaluate Vaxiclase for use in multivalent vaccines containing pertussis antigens
Largest worldwide producer of vaccine doses
Up to $57 million in upfront & milestones payments plus single digit royalties on net sales
High-value markets not part of the license
First income recorded in 2015, next milestone in H2 2016
MULTIPLE
OR LARGE
ANTIGENSVAXICLASE ASSETS
X Y Z
A
Technological improvements of the native adenylate
cyclase structure
Particularly well suited to large or multiple antigens in multivalent applications
Can be used with many antigens
in multiple indications
Driver for market expansion
Same proven mechanism of action as CyaA PARTNERSHIP WITH SIIL
Potential to be used in numerous infectious diseases and immuno-oncology applications
8
X ? Y ? Z ?
A ?
Large spectrum of potential targets: viral and bacterial diseases caused by
HBV, HBC, EBV, CMV, HSV, VZV, HIV, C. trachomatis, M. tuberculosis, …
HPV (Human papillomavirus),
a widespread
carcinogenic virus
causing
cervical cancer
X ?
The most common sexually-
transmitted viral disease
The cause of cervical cancer
(Nobel Prize discovery 2008)
58% of women with invasive
cervical cancer die
300M women worldwide HPV positive
500,000 new cases each year
275,000 deaths per year
HPV AS FIRST TARGET
9
GTL001, A “FIRST-IN-CLASS” THERAPEUTIC VACCINE TARGETING THE 2 MOST ONCOGENIC HPV TYPES
HPV 16 and 18 together cause 70% of cervical cancer cases
GTL001consists of 2 CyaA proteins
one carrying the E7 antigen of HPV 16
the other carrying the E7 antigen of HPV 18
16-
E7
18-
E7
CyaA-HPV16-E7
+CyaA-HPV18-E7
+Adjuvant (imiquimod cream 5%)
GTL001
first-in-classfirst-in-indicationtherapeutic
vaccine
2 inter-dermal injections 6 weeks apart
2 applications of imiquimod cream 5%, 15 minutes
and 24 hours after each injection
10
DISEASE PROGRESSION IS MARKEDLY QUICKER IN HPV16/18 ATHENA STUDY1: 3-YEAR CUMULATIVE INCIDENCE RATE OF CIN2+
0
5
10
15
20
25
30
35
0 1 2 3
Cu
mu
lativ
e in
cid
en
ce
ra
te (
95
% C
I)
Years of Follow-up
n
(% of 40,901)
Screening
test
3-yr CIR
(95% CI)
36,626 (89,5) HPV negative0.9
(0.5-1.5)
1,167 (2.9) HPV 16/1828.1
(24.9-30.8)
3,108 (7.6)HPV
12 other HR
10.8 (9.6-12.1)
HPV16
HPV18
Other HPV
HPV -Wright et al. Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening testGynecol Oncol 2015: 136; 189-197
11
GTL002 (MULTIVALENT HPV)FOLLOW-ON THERAPEUTIC VACCINE CANDIDATE
IN VIVO PRECLINICAL PROOF OF CONCEPT
Immune response for each of the 6 HPV-
derived proteins in the vaccine
In vivo therapeutic efficacy shown by
tumor eradication
Robust manufacturing data
93 millionHPV 16/18
% cervical cancer 70% 100%
300 millionAll HPV types
85%
#
HP
V i
nfe
cte
d w
om
en
158 million4 additional HPV
GTL
00
2
GTL
00
1
Boosts the attractiveness of the HPV franchise to a potential partner
Based on proprietary Vaxiclase platform Includes 6 oncoproteins from 6 most oncogenic HPV types,
including HPV 16 and 18.
12
from
cytology
…
… to HPV
testing
increasingly
being used
as a first-line
diagnostic (2)
HPV testing is more reliable and allows for earlier detection BEFORE cytological anomalies occur
(1) Wright at al. Gynecologic Oncology 136 (2015) 189–197(2) Saslow et al. CA Cancer J Clin. 2012 ; 62(3): 147–172 , Simultaneous HPV testing and cytology is
recommended in the USA & in many European countries
Traditional PAP screening (cytology) is insufficiently reliable
30% of CIN 1 - 3 are not detected(1)
EARLY HPV DETECTION WITH HPV MOLECULAR TESTINGUNVEILS A LARGE UNMET MEDICAL NEED
13
SCREENING
CONFIRMATION
Normal cytology = NILM ASCUS/LSIL HSIL
Normal histology CIN1 CIN2 CIN3Cervical
cancer
ASCUS = Atypical
Squamous Cells of
Undetermined
Significance
NILM = Negative
for Intraepithelial
Lesion or
Malignancy
LSIL = Low-grade
Squamous
Intraepithelial
Lesion
HSIL = High-grade
Squamous
Intraepithelial
Lesion
CIN = Cervical
Intraepithelial
Neoplasia
HPV - FROM INFECTION TO CERVICAL CANCERCYTOLOGICAL AND HISTOLOGICAL CLASSIFICATION REMINDER
Adapted from Woodman et al. The natural history of cervical HPV infection: unresolved issues. Nature Reviews
Cancer 7, 11-22 (January 2007)
14
Normal
CIN1* CIN2 CIN3Cervical
cancer
93 million women(1)
infected with HPV 16 and/or 18
No treatment available – Only watchful waiting
GTL001designed to clear the virus and
prevent disease progression
ASCUS/LSIL HSIL
Prophylactic vaccines
Non-infected young people
(1) de Sanjosé, Lancet Infect. Dis., 2007: 453-9 - Worldwide population aged 15 to 75 with HPV16 and/or 18.(2) CDC: Vaccination Coverage Among Adolescents Aged 13–17 Years* CIN: Cervical Intraepithelial Neoplasia – see appendices for glossary
HPV 16/18 THERAPEUTIC GAP
Gardasil Cervarix
US: 38% vaccination rate (2)
Advaxis - Phase 2
Inovio - Phase 2
ISA - Phase 2
Photocure - Phase 2
Genexine
Phase 2
Traditional treatments (surgery, chemo…)
GTL001, NO COMPETITION ON TARGET POPULATION
Normal histology
Normal cytology (NILM)
15
Annual sales (at peak) > €1.0 billion
Mature markets (1) Emerging markets (2)
Expected patients(at peak)
HPV 16/18 + women with access to diagnostics
Impact of prophylactics
Impact of screening frequency & coverage
Patient acceptance
Market access studies : Bridgehead UK (2010) – Patient acceptance survey : Creativ-Ceuticals SA (2012) (1): US + EU 27 + Japan + Switzerland + Canada + South Korea + Australia + New Zealand(2): Brazil + India + Mexico + Russia + China + South Africa + Turkey(3): 10% of top and middle class of selected emerging markets
12,000,000
8,000,000
2,000,000
1,500,000
35,000,000
-
700,000 (3)
500,000
1.0
million
0.3
million
BLOCKBUSTER POTENTIAL AS IMMUNOTHERAPEUTIC SOLUTION FOR 1.3 MILLION WOMEN
16
Annual sales (at peak**) > €1.0 billion
Conservative estimate* of expected patients
(at peak)
1.3
million
93 millionof HPV 16/18
infected women
* See slide 16 – market assumptions ** expected commercialization GTL001 2021 - GTL002 2026
Annual sales (at peak**) > €2.0 billion
158 millionof women infected w/ HPV 16/18
+ 4 most oncogenic types
GTL001
Doubles market potential
Secures franchise against new comers
GTL002
APPEALING HPV PORTFOLIO TO MANY PHARMA COMPANIES
IN VACCINES, IMMUNO-ONCOLOGY OR WOMEN’S HEALTH
HPV FRANCHISE WITH BLOCKBUSTER POTENTIAL
17
2015 CORPORATE HIGHLIGHTS
License agreement
on Vaxiclase
signed with SIIL*
In vivo results for GTL001
presentedat AACR :
potential to treat and protect
In vivo preclinical
proof of concept of
GTL002
FDA clearance
for U.S. Phase 1
trial of GTL001
US patent protecting
use of Genticel’splatforms to treat
cancer in combination therapy
1st US patient
vaccinated with
GTL001
02/15 04/15 05/15 06/15 09/15 10/15
All key milestones announced at IPO reached on time
* Serum Institute of India Ltd
1818
POST YEAR CLOSE NEWS
▌ RECENT CSO APPOINTMENT
▌ AGREEMENT WITH ROCHE
▌ RESULTS AT 12 MONTHS FROM PHASE 2 TRIAL OF GTL001
AND STATUS OF ITS CLINICAL DEVELOPMENT
19
RECENT CSO APPOINTMENT
Head Chronic Disorder Immunotherapeutic Program , GlaxoSmithKline, Vaccines division (2009- 2015)
Head Cancer Preclinical Immunotherapeutics and Director, R & D, North America, GSK Biologics, Canada (2006-2009)
Commercial Manager of Oncology Portfolio, World Wide Commercial Strategy group, GSK Biological, Belgium (2004-05)
Sr. Scientist Positions in the Therapeutic Cancer Vaccine Program and Chronic Disorders Immunotherapy, GSK Biological, Belgium (1997-2004)
Appointment of
Rémi Palmantier, PhD, as Chief Scientific
Officer
Support strategy to expand pipeline of innovative immunotherapies
20
ISO15189 certified qPCR test
Most sensitive and quantitative commercialized test
Available in Belgium only
AGREEMENT WITH ROCHE MOLECULAR SYSTEMSTO EVALUATE cobas® HPV TEST FOR USE IN PHASE 3 PROGRAM
cobas® HPV test, only test both EU-labeled and FDA-approved
Extensively tested in the Athena trial1
HPV 16/ 18 genotyping (+ 12 other high-risk HPV)
Only test approved in the US as first-line primary screening in women 25
years of age and older instead of cytology
PHASE 2 (EUROPEAN PROGRAM): AML TEST
PHASE 3 (GLOBAL PROGRAM): NEED OF A WIDELY AVAILABLE HPV GENOTYPING TEST
Wright et al. Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening test , Gynecol Oncol 2015: 136; 189-197
Agreement to evaluate cobas® HPV TEST for use in
GTL001 phase 3 program
21
PC10VAC02
Phase 2 (EU), ongoing
PC10VAC01
Phase 1 (BE)
Core study completed
Extension ongoing
PC10VAC03 &
PC10VAC04
Phase 3 (EU, USA),
planned
• 47 women (25-50 yrs), HPV16 +/- 18 positive, NILM
• Dose escalation (100, 600, 1200 µg)
• Safety, tolerability & immunogenicity study
• 222 women (25-50 yrs), HPV16 +/- 18 positive, NILM or ASCUS/LSIL
• Proof of concept study
• Randomized, double-blind, placebo-controlled, 1 dose-level
• Primary endpoint: Virology
• 2 x 1200 women (25-65 yrs), HPV16 +/- 18 positive, NILM or ASCUS/LSIL
• Pivotal study
• RDB placebo-controlled
• Clinical primary endpoint : progression to CIN2/3 at Month 24
PC10VAC05
Phase 1b (USA), bridging
• 20 women (25-65 yrs), HPV16 +/- 18 positive, NILM or ASCUS/LSIL
• Safety and immunogenicity
21
REMINDER OF GTL001 CLINICAL DEVELOPMENT PLAN
22
No dose-limiting toxicity
No treatment-related Serious Adverse Effects (SAE)
No patients stopped trial participation (no drop-outs)
Reactions are mostly local, generally mild or
moderate, as expected
All reactions are transient (<7 d.), as expected
Demonstrated safety profile
Induced an E7- specific T cell
immune responseMore patients treated with GTL001 and
followed for > 12 months remained virus free
17%
62%
0 20 40 60 80 100
Placebo
GTL001
43% (2)
0 20 40 60 80 100
Placebo
GTL001
33%
78% (3)
0 20 40 60 80 100
Placebo
GTL001
74%
More patients treated with GTL001
eradicated their HPV
(1) Warning: this phase 1 study was not designed to provide statistically significant efficacy data. Data
provided above are strictly for indicative purposes (data as at 31/12/2012 ; average of 16.6 months post 1st
vaccination ; pooled small groups; no statistical analysis)
(2) Natural clearance of HPV 16/18 is 40 to 50% after 1 year
(3) 8/9 without reinfection for the HPV type present at enrolment ; 7/9 without any reinfection
n = 19
n = 7
n = 18
n = 6 n = 3
n = 9
GTL001 PHASE 1 STUDY COMPELLING RESULTSON 47 HPV 16 AND/OR 18 POSITIVE WOMEN (1) –NILM ONLY
23
PHASE 2 PROOF OF
CONCEPT STUDY
222 HPV16 +/- 18 positive women (25-50)
W Europe - 7 countries GER, UK, FIN, SP, FR, BE, NL
39 centers
600 µg + imiquimod
Viral clearance
at M6 & 12
Maintenance of
viral clearance
n =111
Placebo + imiquimod
n =111
Last patient in Nov 14 H1 16 H1 17
STUDY
POPULATION
EFFICACY
ENDPOINTS
< 6 weeks >
< 6 weeks >
Women 25-50 yrs infected by HPV 16 and/or 18 with NILM, LSIL or ASCUS cytology, exclusion of CIN2+ by colposcopy/histology
Primary endpoint at M12 Efficacy of GTL001 + imiquimod to clear HPV 16 and 18 cervical infection
as compared to placeboMain secondary endpoints Sustained clearance at M24 Progression to CIN2+
M12 M24
GTL001 PHASE 2 TRIAL (RHEIA-VAC)HALFWAY THROUGH 24-MONTH PROTOCOL CONDUCT
Viral clearance
at M15 & 18
M18
24
NEXT VIRAL CLEARANCE DATA AT 15 &18 MONTHS IN Q3 2016
INITIAL RESULTS AT 12 MONTHS
No statistical difference*
in the overall population
(NILM, ASCUS, LSIL)
No safety issues. DSMB**
recommends trial continuationas planned
* Primary endpoint: statistically significant difference in viral clearance rate at 12 months vs. placebo** DSMB : Data Safety and Monitoring Board
STATUS OF GTL001 EUROPEAN PHASE 2 STUDY
Statistical difference in 2 key, predefined
subgroups, NILM and < 30 y. old
THERAPEUTIC EFFICACY COULD BE DELAYED IN THE HIGH NUMBER (73%)
OF ASCUS / LSIL PATIENTS IN THE STUDY POPULATION
Consistent with phase 1 results,
NILM only -16.6 mo.
25
12-MONTH ANALYSIS MAIN RESULTS
Clearance rate at M12 GTL001
(n=117)
Placebo
(n=116)
p-value
Overall population (PEP) 57 (48.7%) 46 (39.7%) p=0.110*
Normal cytology at baseline 20/32 (62.5%) 12/30 (40%) p=0.018**
Age < 30 at baseline 17/29 (58.6%) 9/28 (32.1%) p=0.049**
Intent-To-Treat (ITT) population (randomized dosed patients with at least one post-baseline evaluation * Fisher exact test ** Cochran-Mantel-Haenszel test, adjusted with age and clinical status
Population enrolled: Majority ASCUS/LSIL (73%), 27% Normal Cytology (NILM)
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
Baseline 12 months
GTL001 Placebo
Normal cytology (NILM)
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
Baseline 12 months
GTL001 Placebo
Age < 30 yr
SUBGROUP OF HPV 16/18 POSITIVE WOMEN WITH NORMAL CYTOLOGY
(NILM)
> 70% OF TARGET
POPULATION 1
(1) Wright et al. Dépistage du cancer cervical primaire avec le virus du papillome humain : Fin de résultats de l'étude
ATHENA utilisant HPV comme test de dépistage en première ligne
Gynecol Oncol 2015: 136; 189-197
26
PHASE 1 TOLERABILITY
STUDY
Single arm, open label
20 HPV16 +/- 18 positive women (25-65)
US - 4 centers
Diane Harper, MD, lead investigator
600 µg + imiquimod
Primary endpoint:
tolerability
Last patient in
Q1 16H1 16
STUDY
POPULATION
ENDPOINTS
< 6 weeks >
Women 25-65 yrs. infected by HPV 16 and/or 18 with Normal, LSIL or ASCUS cytology, exclusion of CIN2+ by colposcopy/histology
Primary endpoint at M3 Tolerability of GTL001, notably in the age group 50-65 (not studied
previously)
Secondary endpoint Immune response at M3
Warning: as with any phase 1 study, the study is not designed to provide statistically significant efficacy data.
n =20
2 cohorts: 25-50 and 50-65 years of age
M3
GTL001 US PHASE 1 STUDYIND GRANTED IN JUNE 2015 - STUDY ON-GOING
1ST patient in
10/2015
27
PHASE 3 PIVOTAL TRIALS
1,200 (x 2) HPV16 +/- 18 positive women (25-65)
• 400 in placebo arm • 800 in vaccine arm *
Same design EU / US**
600 µg + imiquimod
Primary endpoint:
60% decrease in
progression to CIN2+
n =400
Placebo +/- imiquimod
n =800
STUDY
POPULATION
EFFICACY
ENDPOINTS
< 6 weeks >
< 6 weeks >
Women 18-65 yrs. infected by HPV 16 and/or 18, cytology status to be determined post Phase 2
Primary objective at M24 CIN2+ prevention (HPV16 and/or18) at 24 months post first vaccination
Main secondary objectives Safety and Immunogenicity at 6, 12, 18, 24 months Virology, cytology and histology at 6, 12, 18, 24 months
TWO STUDIES IN PARALLEL IN EUROPE AND IN THE UNITED STATES
* 400/800 provide 90% power to demonstrate efficacy – 1,600 immunized patients satisfying FDA safety database requirements** To be confirmed following submission of final protocol, updated chemistry, manufacturing, controls information, and review by appropriate regulatory agencies after end of phase 2
M24
POTENTIEL DESIGN OF A PHASE 3 PROGRAM
2828
2015 FINANCIAL REVIEW
▌ INCOME STATEMENT
▌ BALANCE SHEET
▌ CASH FLOW STATEMENT
▌ STOCK PERFORMANCE
▌ CASH & SHARHOLDER STRUCTURE
29
INCOME STATEMENT (IFRS)
Figures in line with company’s expectationAudited data in K€ 20141 2015
Revenues - 178
R&D expenses (11,190) (10,935)
Subsidies (CIR2) 2,904 2,940
G&A expenses (2,763) (3,599)
Operating result (11,049) (11,417)
Financial result 105 223
Net income (10,944) (11,193)
Net income per share (0.79) (0.72)
1 2014 financial statements have been amended in application of IAS 8 (please refer to half-year 2015 financial statements for detailed information)2 Research tax credit (crédit d’impôt recherche) in France3 Onetime recruitment costs, ad-hoc market access studies, Intellectual Property management expenses
Advance on GLT001 phase 2 in EU
Initiation of a phase 1 in the U.S.
Non-recurring expenses (€0.7 million)3
Interest earned
from investing funds
30
BALANCE SHEET (IFRS)
Audited data in K€ 20141 2015
Non current assets 10,303 5,501
Current receivables 3,172 3,706
Current financial assets 12,557 5,022
Cash & equivalents 10,170 11,660
TOTAL ASSETS 36,202 25,889
Shareholders equity 30,217 20,335
Employee LT Obligation 380 322
Financial debts 2,158 2,522
Other liabilities 3,447 2,710
TOTAL LIABILITIES 36,202 25,889
1 2014 financial statements have been amended in application of IAS 8 (please refer to half-year 2015 financial statements for detailed information)
2 Total cash position results from €11,7 M in cash & equivalents, €5,1 M in non current assets (capitalization contract) and €5 M in current financial assets (term deposits) in accordance with IFRS standards.
€5.2 million of capitalization contract
€5.0 million in short time deposits
Trade payables for €1.9 million
Total cash position of €21,8 million2
in line with pipeline development
advances
incl. €2.9 million of Research Tax Credit 2015
Repayable advances for €2.6 million
31
CASH FLOW STATEMENT (IFRS)
Audited data in K€ 20141 2015
Cash flow from operating
activities(9,847) (11,744)
Cash flow from investing
activities (22,573) 12 585
Cash flow from financing
activities 38,752 649
Opening cash & equivalents 3,839 10,170
Variation 6,331 1,490
Closing cash & equivalents 10,170 11,660
Breakdown of change in WCR
Audited data in K€20141 2015
Other non-current financial assets 17 (7)
Inventories (net inventory
impairment)(13) 21
Other receivables 588 514
Trade payables and related
accounts(740) 776
Tax & social security liabilities (192) (37)
Other creditors & miscellaneous
liabilities18 (1)
Total change (322) 1,266
1 2014 financial statements have been amended in application of IAS 8 (please refer to half-year 2015 financial statements for detailed information
Growth in WCR (€1.2 million in 2015 versus -€0.3 million in 2014) mainly due to decrease in trade
payables between 2014 and 2015 (versus increase between 2013 et 2014)
32
STOCK PERFORMANCE 2015 – 2016 YTD
31/12/14 5,61 €
31/12/15 6,68 €
10/03/16 4,50 €
CONSENSUS 8,08 €
UPSIDE 78%
GTCL
Next Biotech
0
50%
50%
33
Cash balance: € 21.8 million*
No additional funding required
to execute IPO program
€70.1 million raised since inception,
incl. €34.7 million at IPO (04/2014)
15,541,086 shares outstanding*
SOLID CASH BALANCE & SHAREHOLDER BASE
* As at December 31, 2015
3434
2016 STRATEGIC UPDATE
35
VALUE DRIVERS AND MILESTONES
2015 License agreement on
Vaxiclase signed
with SIIL*
02/15
In vivo results for GTL001
show ability to treat &
protect
04/15
In vivo preclinical proof of
concept of GTL00205/15
FDA Clearance
for U.S. Phase 1 trial
of GTL001
06/15
US patent protecting use
of platforms to treat
cancer
09/15
1st US patient vaccinated
with GTL00110/15
2016 GTL001
Phase 2 efficacy data
at M12
GTL001
US phase 1 recruitment
completed
H1 16
GTL002
in-vivo immunology dataH1 16
GTL001
Phase 2
immunology dataH1 16
GTL001
Phase 2 interim efficacy
data at M18
Q3 16
GTL001
US phase 1 resultsH2 16
Vaxiclase
1st milestone with SIIL*H2 16
2017 GTL001
End of phase 2 at M24Q1 17
GTL002
Preclinical milestonesH2 17
Ongoing business
development activities
* Serum Institute of India Ltd
36
Strategic focus
on GTL001
clinical activities
Phase 2 in Europe
Phase 1 in the U.S.
Focus on
business
development
activities
Select an appropriate partner for the HPV pipeline Expand pipeline by accessing innovative development-stage molecules
with unique market potential Study identified opportunities for new strategic alliances
STRATEGIC UPDATE FOR 2016
1 Good Manufacturing Practice
Treasury preservation in 2016 and 2017
Extension of Company’s funding well into 2018
Defer by 12 months : the industrial GMP1 production planned for GTL001 Phase 3 the semi-industrial production planned for GTL002 Phase 1 trial
Proposed workforce reduction by approximately 30%
37
CONTACTS
Copyright Genticel 2016
GENTICEL EU INVESTORS US INVESTORS MEDIAValerie Leroy
[email protected] Puissant
[email protected] Ritchie
[email protected] Carmagnol
+33 (0)1 82 82 00 20 +33 (0)1 53 67 36 77 +1 (212) 915 2578 +33 6 64 18 99 59