TiGenix: TiGenix reports 2015 full year results
(Thomson Reuters ONE) -
PRESS RELEASE
Regulated information
TiGenix reports 2015 full year results
Leuven (BELGIUM) - April 12, 2016, 07:00h CET - TiGenix NV (Euronext Brussels:
TIG), an advanced biopharmaceutical company focused on developing and
commercialising novel therapeutics from its proprietary platforms of allogeneic
expanded stem cells, reported today its business and financial highlights for
2015 and post year-end events.
Key 2015 and post year-end highlights
* Cx601 reached major value inflection points:
* Cx601 met the primary endpoint of ADMIRE-CD, a pivotal Phase III trial
in complex perianal fistulas in Crohn's disease patients with inadequate
response to previous therapies, including anti-TNFs. Results were
presented at the plenary session of the 11(th) Annual Congress of the
European Crohn's and Colitis Organization (ECCO) in March 2016
* Cx601 delivered positive follow-up results at 52 weeks, confirming its
sustained efficacy and safety profile in March 2016
* Solid progress was made on the regulatory front. In Europe, the Cx601
Marketing Authorization Application was submitted to the European
Medicines Agency (EMA) in March 2016. In the United States, the Food and
Drug Administration (FDA) agreed with the design of the US pivotal Phase
III trial through a Special Protocol Assessment (SPA) procedure
* The Cx601 patent portfolio was strengthened with the grant of two key
patents in Europe and in the United States
* The safety and tolerability of Cx611 was confirmed by Phase I sepsis
challenge trial results. The upcoming Phase II study in severe sepsis was
awarded EUR 5.4 million by the European Commission
* Acquisition of allogeneic cardiac stem cells platform. The Phase I/II trial
of AlloCSC-01 for the treatment of acute myocardial infarction (AMI) is
ongoing (CAREMI study). Enrolment has been completed and 6 month interim
data are expected during the second half of 2016
* The cash position at 31 December 2015 was of EUR 18.0 million. EUR 23.8
million raised in March 2016
"In 2015 we have laid the ground for our future growth. Cx601, our fully owned
lead product, has successfully delivered positive Phase III results and is one
step closer to market authorization in Europe, while in the US the FDA's
agreement on our clinical design and analysis plan has clarified the regulatory
pathway for approval in the US" said Eduardo Bravo, CEO of TiGenix.
"Simultaneously, we have further developed our platform in severe sepsis,
expanded our pipeline in the cardiology space with a Phase II asset in a very
large indication, strengthened our financial resources with specialized
investors and prepared the company to list on NASDAQ as soon as conditions are
right. We are a stronger company with an exciting pipeline and well-defined
value creation milestones for 2016".
Business Highlights
Cx601 reached major value inflection points
In August 2015, Cx601 - our fully owned lead product - met the primary endpoint
in the pivotal ADMIRE-CD Phase III study (ITT, n=212). A single treatment of
Cx601 was statistically superior to placebo in achieving combined remission at
week 24 in patients with inadequate response to previous therapies, including
anti-TNFs. More than 50% of patients treated with Cx601 achieved combined
remission at week 24 and a higher number of Cx601-treated patients had their
fistulas closed by week 6. Efficacy results were robust and consistent across
all statistical populations. The abstract describing the 24-week results of
Cx601 ADMIRE-CD Phase III study was selected as one of the thirty best abstracts
deserving an oral presentation at the plenary session of the 11th Annual
Congress of the European Crohn's and Colitis Organization (ECCO) held in March
2016.
In March 2016, the top line follow-up data of the ADMIRE-CD study showed that a
single injection of Cx601 was statistically superior to placebo in achieving
combined remission at week 52 in line with the primary endpoint results at week
24. In particular, 54.2% of patients treated with Cx601 achieved combined
remission at week 52 compared to 37.1% in the placebo arm. Moreover, 75.0% of
Cx601 treated patients who achieved combined remission at week 24 remained in
combined remission at week 52 compared to only 55.9% in the placebo arm. The
results also confirmed the favorable safety and tolerability profile of Cx601
already reported at week 24. The sustained benefit of Cx601 at one year was
highlighted by Prof. Panés, Global Study Coordinator, as a remarkable
breakthrough in the treatment of complex perianal fistulas in Crohn's disease
patients.
Following the positive results at week 24 of the pivotal ADMIRE-CD Phase III
study, TiGenix filed a centralized European MAA for Cx601 in March 2016. Such
application is eligible for parallel evaluation under the centralized procedure
for the approval of medicinal products in the European Union (EU). Cx601 falls
within the mandatory scope of the procedure because it is an Advanced Therapy
Medicinal Product and an orphan-designated product. For eligible drugs, the
centralized procedure offers the substantial benefit of having to submit only a
single marketing application to the EMA. If approved, a drug can then be
marketed in all EU member countries, as well as in Iceland, Liechtenstein and
Norway, instead of having to seek approval in each individual country, thus
reducing the time to market significantly. In parallel, in February 2016,
TiGenix obtained the license for commercial production of Cx601 from the Spanish
Medicines Agency (AEMPS). Meeting these goals on schedule is in line with the
expectation of making Cx601 available to European patients in the second half of
2017.
In August 2015, TiGenix reached an agreement with the US Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase III
registration trial of Cx601 in the US. The design submitted to the SPA defines
the primary endpoint as combined remission, which combines clinical assessment
of closure of all treated external openings draining at baseline, despite gentle
finger compression, with absence of collections > 2cm confirmed by MRI by week
24. This primary endpoint is equivalent to the one used in the ADMIRE-CD Phase
III study. The Phase III trial in the United States will be initiated in the
first half of 2017. An agreement has been made with Lonza to manufacture the
material for the trial in its cell therapy production facility in Walkersville,
Maryland (US).
Finally, the Cx601 patent portfolio was strengthened with the granting of two
patents by the European and United States patent offices.
Cx611 progressing in Sepsis
Safety and tolerability of Cx611 confirmed in the Phase I Sepsis Challenge trial
In May 2015, TiGenix announced that Cx611 Phase I proof-of-principle study for
Cx611 had demonstrated a favourable safety and tolerability profile, consistent
with a previous Phase IIa study of the product in patients with rheumatoid
arthritis. No serious adverse events were reported with any of the three doses
tested.
On the basis of such results TiGenix designed its SEPCELL Phase Ib/IIa study in
severe sepsis secondary to severe community-acquired pneumonia (sCAP) expected
to start in the second half of 2016. In October 2015, the SEPCELL consortium led
by TiGenix, was awarded a EUR 5.4 million fund from the European Commission.
Current treatments for sepsis are insufficient and mainly symptomatic. The
incidence has dramatically increased over the last decade reaching over 15
million cases worldwide in 2012 according to The Lancet. In the United States
only, sepsis generates $20 billion in hospital related costs and is the most
expensive condition billed to Medicare. Thus, severe sepsis represents an
important unmet medical need and a relevant market opportunity.
Expansion of the pipeline into cardiology
In July 2015, TiGenix expanded its pipeline in the cardiology space with the
acquisition of an allogeneic cardiac stem cell platform. Its lead product,
AlloCSC-01, is currently in a Phase I/II clinical trial (the CAREMI trial) for
acute myocardial infarction (AMI). The CAREMI study has already completed
recruitment and a six-month interim analysis is expected in the second half of
2016 with final results due in the first half of 2017.
Cardiovascular disease remains a very large and costly indication. Up to 1.9
million people annually are diagnosed with acute myocardial infarction in the
United States, Europe and Japan. In 2015, the American Heart Association
estimated that the direct and indirect cost of coronary heart disease, the main
cause of myocardial infarction, was $182 billion and is expected to reach $322
billion in 2030.
Financial Highlights
Key figures for the full year 2015 (consolidated)
Revenues for 2015 amounted to EUR 2.2 million, compared to EUR 6.3 million in
2014. The decrease is mainly driven by the fact that revenues in 2014 were
positively impacted by grants related to government loans received at below
market rate in previous years and fully recognized in 2014 (Euro 4.5 million).
In addition to grants recognized in 2015 amounting to EUR 0.8 million, revenues
for the year include EUR 0.5 million of royalties from net sales of
ChondroCelect and EUR 0.9 million of other operating income.
Total operating charges for 2015 amounted to EUR 26.3 million, compared to EUR
18.9 million in 2014. The augment is mainly due to the increase in Research and
Development (R&D) expenses, driven by Cx601 clinical development progress, the
clinical activities related to Cx611 in sepsis and AlloCSC-01 in AMI after the
acquisition of Coretherapix in late July 2015. General and Administrative (G&A)
expenses were reduced to EUR 6.7 million from EUR 7.4 million in 2014 despite
the Coretherapix acquisition.
As a result of the foregoing the operating loss increased in 2015 to EUR 24.1
million, from EUR 12.6 million in 2014.
The interest on borrowings and other finance costs for 2015 amounted to EUR 6.7
million. These costs include both cash financial expenditures (for EUR 2.2
million) and non-cash financial expenditures resulting mainly from the recording
of the financial liabilities at amortized cost (Kreos loan, the ordinary note
component of the convertible bond and the governmental loans). The fair value
gains/(losses) for 2015 amounted to EUR 6.7 million. These costs include non-
cash expenses resulting from the change in fair value of the warrant component
of the convertible bonds (mainly as a result of the higher share price at year-
end compared to the share price at the time of the convertible bond issuance),
the warrants issued for the Kreos loan and the contingent consideration for the
acquistion of Coretherapix. Income tax benefits amounted to EUR 1.3 million and
refer to the tax deductions under Spanish tax law obtained from R&D activities.
As a result of the above, the loss for the year 2015 amounted to EUR 35.1
million, compared to EUR 13.0 milion in 2014.
Cash and cash equivalents amounted to EUR 18.0 million on 31 December 2015. On
March 14, 2016, TiGenix raised 23.8 million euros in gross proceeds through a
private placement to specialist investors in Europe and the United States. Net
cash used in operating activities in 2015 amounted to EUR 19.6 million.
Outlook
TiGenix expectations for the next 18 months include:
* 2H 2016 interim analysis of Phase I/II trial of AlloCSC-01 (CAREMI) in
acute myocardial infarct
* 2H 2016 start of Cx611 Phase Ib/IIa trial in severe sepsis
* 1H 2017 final results of the Phase II trial of AlloSCS-01 (CAREMI) in
acute myocardial infarction
* 1H 2017 start of Cx601 US pivotal Phase III trial
* 2H 2017 grant of European Market Authorisation to Cx601 for the
treatment of complex perianal fistulas in Crohn's disease patients
Auditor's report
The statutory auditor of the Company, BDO Bedrijfsrevisoren Burg. Ven. CBVA, has
completed its audit of the financial statements of the Company for the year
ended on 31 December 2015 and issued an unqualified audit opinion. The auditor's
report on the consolidated financial statements can be found in the Newsroom
section of the TiGenix website, www.tigenix.com.
Financial statements
The financial statements for the year ended 31 December 2015 can be found in the
Newsroom section of the TiGenix website, www.tigenix.com. TiGenix will publish
its audited Annual Report for the year ended 31 December 2015 via the Company's
website on or around 29 April 2016.
Webcast
On Tuesday, 12 April, at 15:00h CET/9.00am ET, TiGenix will conduct a conference
call and webcast. The following speakers will present the full year results for
2015 and an update on the business, and will take questions:
Eduardo Bravo, Chief Executive Officer, TiGenix
Claudia D'Augusta, Chief Financial Officer, TiGenix
Please dial one of the following numbers to participate:
London, United Kingdom: +44(0)20 3427 1904
New York, USA: +1646 254 3366
Paris, France: +33(0)1 70 48 01 66
Brussels, Belgium: +32(0)2 404 0660
Madrid, Spain: +3491 114 6582
Montreal, Canada: +1514 841 2153
Amsterdam, Netherlands: +31(0)20 716 8256
Stockholm, Sweden: +46(0)8 5065 3938
Confirmation Code: 3587419
The webcast can be followed live online via the link: http://edge.media-
server.com/m/p/zmiz5jiz
The press release and the webcast slide presentation will be made available in
the Newsroom section of the TiGenix website. A replay of the webcast will be
available on the website shortly after the live webcast has finished.
For more information
Claudia D'Augusta
Chief Financial Officer
T: +34 91 804 92 64
claudia.daugusta(at)tigenix.com
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
injected intra-lesionally. Cx601 is being developed for the treatment of complex
perianal fistulas in Crohn's disease patients. Crohn's disease is a chronic
inflammatory disease of the intestine and patients can suffer from complex
perianal fistulas for which there is currently no effective treatment. In 2009,
the European Commission granted Cx601 orphan designation for the treatment of
anal fistulas, recognising the debilitating nature of the disease and the lack
of treatment options. Based on positive Phase II results, TiGenix sought
scientific advice from the European Medicines Agency (EMA) on the future
development path of Cx601. TiGenix then initiated a randomised, double-blind,
placebo-controlled Phase III trial in Europe and Israel designed to comply with
the requirements laid down by the EMA (the ADMIRE-CD trial). 'Madrid Network',
an organisation within the Autonomous Region of Madrid which helps companies to
grow through high-technology innovation, issued a soft loan to help finance this
Phase III study. The programme is funded by The Secretary of State for Research,
Development and Innovation (Ministry of Economy and Competitiveness) within the
framework of the INTEGRA plan. The study's primary endpoint was combined
remission, defined as clinical assessment at week 24 of closure of all treated
external openings draining at baseline despite gentle finger compression, and
absence of collections >2cm confirmed by MRI. In the ADMIRE-CD trial, the
results of which were reported in August 2015, Cx601 achieved statistically
significant superiority (p<0.025) on the primary endpoint with 49.5% combined
remission at week 24 compared to 34.3% in the placebo arm in the ITT[1]
population. These results translate into a relative risk of 1.44, meaning that
patients receiving Cx601 had a 44% greater probability of achieving combined
remission than placebo patients. Efficacy results were robust and consistent
across all statistical populations. Treatment-emergent adverse events (non-
serious and serious) and discontinuations due to adverse events were comparable
between Cx601 and placebo arms. The ADMIRE-CD trial has also completed a follow-
up analysis at 52 weeks post-treatment. Based on the positive 24 week Phase III
results, TiGenix has submitted a Marketing Authorisation Application to the EMA
in early 2016. TiGenix is preparing to develop Cx601 for the US market after
having reached an agreement with the FDA through a special protocol assessment,
or SPA, procedure on its proposed protocol on August 7, 2015.
About Cx611 in Severe Sepsis
Cx611 is an intravenously-administered product of allogeneic expanded adipose-
derived stem cells (eASCs). In May 2015, TiGenix completed a Phase I sepsis
challenge trial demonstrating the favourable safety and tolerability profile of
Cx611. Based on the results of this study, TiGenix has designed a Phase Ib/IIa
trial in severe sepsis secondary to severe community-acquired pneumonia (sCAP)
which is expected to enroll 180 patients across Europe (the SEPCELL project).
SEPCELL has been awarded a ?5.4M grant by the European Union under the Horizon
2020 Research and Innovation Programme under Grant Agreement 681031.
About AlloCSC-01
AlloCSC-01 is a cellular product consisting of adult allogeneic cardiac stem
cells isolated from the right atrial appendages of donors, and expanded in
vitro. Pre-clinical data has shown evidence of the strong cardio-protective and
immune-regulatory activity of AlloCSC-01. In vivo studies suggest that AlloCSC-
01 has cardio-reparative potential by activating endogenous regenerative
pathways and by promoting the formation of new cardiac tissue. In addition,
AlloCSC-01 has displayed a strong tropism for the heart enabling a high
retention of cells in the myocardium after intracoronary administration.
AlloCSC-01 is currently in clinical development in a Phase I/II clinical trial
(CAREMI). The CAREMI trial comprises two consecutive phases: an open-label dose-
escalation phase (n=6) and a 2:1 randomised, double-blind, placebo-controlled
phase (n=49). The objective of this clinical trial is to evaluate the safety and
the efficacy of the cardiac stem cells product AlloCSC-01 in the acute phase of
ischemic heart disease. The primary endpoint of the CAREMI Phase I study is all-
cause mortality within 30 days and all adverse events of any cause from the
patient's inclusion until 7 days after treatment administration. Secondary
safety endpoints throughout the study include all AEs within 30 days, then
monthly up to 6 months, then quarterly post-AlloCSC-01, all-cause mortality and
death from cardiovascular cause at 12 months, and MACE measured at 6 and 12
months. Secondary efficacy endpoints for the randomised phase include MRI
parameters (evolution of infarct size and evolution of biomechanical parameters)
and clinical parameters (including the 6 minute walking test and the New York
Heart Association class). Eight centers are participating in Spain and Belgium
and patient recruitment is now finished. The CAREMI trial has benefitted from
the support of the CARE-MI consortium (Grant Number 242038) funded by the
Seventh Framework Programme of the European Commission under the coordination of
the Centro Nacional the Investigaciones Cardiovasculares (CNIC) and the
participation of research institutions and companies from nine EU countries.
Final results will be released in the first half of 2017 with a six-month
interim analysis of blinded and exploratory efficacy data in the second half of
2016.
About TiGenix
TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company
focused on developing and commercialising novel therapeutics from its
proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two
products from the adipose-derived stem cell technology platform are currently in
clinical development. Cx601 is in Phase III for the treatment of complex
perianal fistulas in Crohn's disease patients. Cx611 has completed a Phase I
sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective
July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product,
AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial
infarction (AMI). In addition, the second product candidate from the cardiac
stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being
developed in a chronic indication. TiGenix also developed ChondroCelect, an
autologous cell therapy product for cartilage repair of the knee, which was the
first Advanced Therapy Medicinal Product (ATMP) to be approved by the European
Medicines Agency (EMA). From June 2014, the marketing and distribution rights of
ChondroCelect were exclusively licensed to Sobi for the European Union (except
for Finland, where it is distributed by the Finnish Red Cross Blood Service),
Norway, Russia, Switzerland and Turkey, and the countries of the Middle East and
North Africa. TiGenix is headquartered in Leuven (Belgium) and has operations in
Madrid (Spain). For more information, please visit www.tigenix.com.
Forward-looking information
This press release may contain forward-looking statements and estimates with
respect to the anticipated future performance of TiGenix and the market in which
it operates. Certain of these statements, forecasts and estimates can be
recognised by the use of words such as, without limitation, "believes",
"anticipates", "expects", "intends", "plans", "seeks", "estimates", "may",
"will" and "continue" and similar expressions. They include all matters that are
not historical facts. Such statements, forecasts and estimates are based on
various assumptions and assessments of known and unknown risks, uncertainties
and other factors, which were deemed reasonable when made but may or may not
prove to be correct. Actual events are difficult to predict and may depend upon
factors that are beyond the Company's control. Therefore, actual results, the
financial condition, performance or achievements of TiGenix, or industry
results, may turn out to be materially different from any future results,
performance or achievements expressed or implied by such statements, forecasts
and estimates. Given these uncertainties, no representations are made as to the
accuracy or fairness of such forward-looking statements, forecasts and
estimates. Furthermore, forward-looking statements, forecasts and estimates only
speak as of the date of the publication of this press release. TiGenix disclaims
any obligation to update any such forward-looking statement, forecast or
estimates to reflect any change in the Company's expectations with regard
thereto, or any change in events, conditions or circumstances on which any such
statement, forecast or estimate is based, except to the extent required by
Belgian law.
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[1] ITT: Intention to Treat i.e. all patients randomized.
Key figures for the full year 2015 (consolidated):
http://hugin.info/137616/R/2002631/739094.JPG
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Datum: 12.04.2016 - 07:00 Uhr
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