TiGenix Business and Financial Update for the First Half of 2015
(Thomson Reuters ONE) -
Leuven (BELGIUM) - 15 September 2015 - 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, today announced its Business and Financial Update for the first half of
2015 and recent significant events.
* Cx601 reached major value inflection points
* Cx601 met the primary endpoint of its European Phase III trial in
complex perianal fistulas in Crohn's disease patients. The positive
results confirm the efficacy and safety of Cx601 and allow for filing
for marketing authorisation in Europe in the first quarter of 2016
* Clear approval path for Cx601 in the United States with the Food and
Drug Administration's (FDA) endorsement of the Company's pivotal Phase
III trial through a Special Protocol Assessment (SPA). Manufacturing for
the clinical trial, scheduled to start towards the end of 2016, secured
with Lonza
* Significant strengthening of intellectual property with two key patents
granted, one in Europe and the other in the United States
* Expansion of TiGenix pipeline into cardiology with a new platform of
allogeneic cardiac stem cells through the acquisition of Coretherapix and
its lead product, AlloCSC-01, which is in a Phase II clinical trial for
acute myocardial infarction
* Safety and tolerability of Cx611 confirmed in a Phase I sepsis challenge
trial. Phase II efficacy study in severe sepsis expected to be initiated in
the fourth quarter of 2015
* Cash position at 30 June 2015 of EUR 22.7 million
"The major achievements recently announced are highly significant steps towards
fully realising our potential and will have a tremendous impact on the company
and its future", said Eduardo Bravo, CEO of TiGenix. "We have full commercial
rights to Cx601 with positive Phase III data, ready for filing in Europe, with a
clear, FDA endorsed pathway for filing in the United States, in a potential two
billion Euro market. We have recently acquired Coretherapix, a company with a
platform of cardiac stem cells, whose lead compound AlloCSC-01 for acute
myocardial infarction is in a very advanced Phase II clinical trial. And, with
Cx611, we expect to start a Phase II trial in severe sepsis, the leading cause
of death in hospitals in the western world. We are extremely proud of being one
of the few companies that can offer such a promising near-term future."
Business Update
Cx601 reached major value inflection points
Cx601 met the primary efficacy endpoint of its European Phase III trial in
complex perianal fistulas in Crohn's disease patients
In August, the Company communicated that its lead compound, Cx601, met the
primary endpoint in the Phase III ADMIRE-CD trial in Crohn's disease patients
with complex perianal fistulas. Cx601 is a suspension of allogeneic expanded
adipose-derived stem cells (eASC) injected intra-lesionally. A single injection
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.
In the ITT[1] population (n=212), Cx601 achieved statistically significant
superiority (p<0.025) with 49.5% combined remission at week 24 compared to
34.3% in the placebo arm. In the mITT[2] population (n=204), the combined
remission rates at week 24 were 51.5% and 35.6% for Cx601 and placebo
respectively (p<0.025). These clinically significant results translate into an
observed relative risk of 1.44, meaning that patients receiving Cx601 had a 44%
greater chance of achieving combined remission than placebo patients. Efficacy
results were robust and consistent across all statistical populations. The study
results confirm the favourable safety and tolerability profile of Cx601. Full
efficacy and safety results will be presented at the 11th Congress of ECCO
(European Crohn's and Colitis Organisation).
TiGenix now intends to file for marketing authorisation in Europe in the first
quarter of 2016, which should allow for a product launch in Europe in 2017.
FDA endorsed Special Protocol Assessment for the Cx601 Phase III registration
trial in the United States
In August, 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 for the treatment of complex perianal fistulas in
Crohn's disease patients. The SPA describes the primary endpoint as combined
remission, defined as clinical assessment by week 24 of closure of all treated
external openings draining at baseline despite gentle finger compression, and
absence of collections > 2cm confirmed by MRI. This primary endpoint is exactly
the same as the one for the European Phase III trial for which positive results
were announced in August. The company expects to begin Phase III trial enrolment
in the United States towards the end of 2016.
TiGenix started the marketing authorisation application process for Cx601 in
Europe
In June, TiGenix submitted to the European Medicines Agency (EMA) a letter of
intent to file, and a request for the assignment of Rapporteur and Co-
Rapporteur, for the Marketing Authorisation Application (MAA) for Cx601 in the
treatment of complex perianal fistulas in patients with Crohn's disease. The
letter of intent, which must be filed at least seven months prior to the
submission of a MAA, initiates a process to address a number of pre-submission
requirements, including the assignment of a Rapporteur and Co-Rapporteur, who
are members of the Committee for Advanced Therapies (CAT), and two Co-ordinators
from the Committee for Human Medicinal Products (CHMP). For advanced-therapy
medicines, CAT prepares a draft opinion on the product's quality, safety and
efficacy, based on which the CHMP adopts a final opinion.
In addition, TiGenix has submitted this request to be eligible for parallel
evaluation under the centralised 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, however, the centralised 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.
Patent and Trademark Office issued a key US patent to TiGenix for the use of
adipose-derived stromal cells in the treatment of fistulas
In April, the United States Patent and Trademark Office issued US Patent
8,999,709 relating to the use of an adipose-derived stromal cell population in
the treatment of fistula. The patent entitled, "Use of adipose tissue-derived
stromal stem cells in treating fistula", expires in 2030 and provides coverage
for the company's lead development product, Cx601, in the key US market. This is
an important milestone in the Company's strategy for the development and
commercialisation or licensing of Cx601 in the United States market.
TiGenix and Lonza signed an agreement for the manufacture of Cx601 in the US
In February, Lonza, a global leader in biological and cell therapy
manufacturing, and TiGenix announced an agreement for the supply of Cx601 in the
United States. Under the agreement, Lonza will manufacture material for the
Phase III trial of Cx601 in the United States at Lonza's cell therapy production
facility in Walkersville, Maryland (US). Technology transfer is underway and is
expected to be completed in the second half of 2016.
Patent Office issued a key patent to TiGenix for expanded adipose-derived stem
cell compositions
In January, the European Patent Office (EPO) issued European Patent EP2292736
relating to an adipose-derived stem cell composition. The patent is entitled
"Identification and isolation of multipotent cells from non-osteochondral
mesenchymal tissue". The claims of the granted patent cover both a specified
population of expanded adipose-derived multipotent cells and their therapeutic
uses, as well as pharmaceutical compositions of such cells.
Expansion of the pipeline and entry into cardiology
Acquisition of Coretherapix and its allogeneic cardiac stem cell product,
AlloCSC-01, for acute myocardial infarction
In July, TiGenix announced its acquisition of the cardiology-focused cell
therapy company Coretherapix S.L., which was owned by Genetrix S.L. Its lead
programme, AlloCSC-01, is an allogeneic cardiac stem cell product currently in a
Phase II clinical trial for acute myocardial infarction, and in preclinical
development for ventricular tachycardia. This acquisition expands the TiGenix
development pipeline into cardiology indications. TiGenix paid ?1.2M in cash and
?5.5M in equity. Genetrix may receive up to ?15M in new TiGenix shares depending
on the results of the ongoing clinical trial of AlloCSC-01. Based on, and
subject to, future sales milestones, Genetrix may receive up to an additional
?245M in milestone payments plus certain percentages of the direct net sales of
the first product, or certain percentages of any third party royalties and sales
milestones for the first product. Sales milestones start when annual net sales
reach ?150M and the final milestone payment will be due once annual net sales
are above ?750M. Also, Genetrix will receive a ?25M milestone payment for each
additional product reaching the market.
The ongoing randomised, placebo-controlled, multicentre Phase II study of
AlloCSC-01 is being conducted in 8 hospitals in Belgium and Spain. After a
successful open-label dose escalation Phase I of 6 patients, the Phase II
clinical trial is aiming at recruiting 49 additional patients who will be
randomised 2:1 to receive either AlloCSC-01 or placebo by intracoronary
injection 5 to 7 days after the myocardial infarction. The primary endpoint is
all-cause mortality and MACE (Major Adverse Cardiac Events) at 30 days and at 1
year. Secondary endpoints include efficacy MRI parameters (evolution of infarct
size, evolution of biomechanical parameters, and evolution of edema, all
measured at 6 and 12 months), and clinical parameters (including the 6-minute
walking test and the New York Heart Association (NYHA) scale). More than 70% of
patients have already been recruited and the final results are expected in the
first half of 2017. A six-month interim analysis is expected to provide data in
the second half of 2016. Existing efficacy and safety data, gathered in relevant
pre-clinical studies in pigs and rodents, have demonstrated the efficacy of
AlloCSC-01 in reducing scar size, thus limiting cardiac remodeling.
Cx611 progressing in Sepsis
Safety and tolerability of Cx611 confirmed in the Phase I Sepsis Challenge trial
In May, TiGenix announced that a Phase I proof-of-principle study for Cx611, an
intravenously-administered product of eASCs, 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. TiGenix is finalising
preparations for a Phase II trial for Cx611 in severe sepsis which is expected
to start towards the end of this year.
Financial Update
Financial results for the first half-year of 2015
During the first six-month period of 2015, total revenues increased by 14% to
EUR 0.9 million compared to EUR 0.8 million in the same period of 2014, mainly
driven by royalties and other operating income received from Sobi.
Research and development expenses for the first six-month period of 2015
amounted to EUR 7.7 million, compared to EUR 5.1 million for the same period in
2014, representing a 51% increase which is mainly attributable to clinical trial
activities such as the conclusion of the ADMIRE pivotal Phase III trial for
Cx601 and the Phase I Sepsis Challenge trial of Cx611, as well as other key
activities necessary in filing for marketing authorisation for Cx601 in Europe.
General and administrative expenses remain at the same level as the previous
period and amounted to EUR 2.8 million.
As a result of the above, the operating loss amounted to EUR 9.6 million
compared to EUR 7.1 million during the same period of 2014. This increase is
attributable to a higher spend on research and development activities.
The net financial loss of the first six months of 2015 amounted to EUR 1.1
million compared to EUR 0.2 million during the same period of 2014. Net
financial loss comprises financial income, financial expenses and foreign
exchange differences.
During the first six months of 2015, the loss from discontinued operations
amounted to EUR 0.0 million compared to EUR 1.8 million in the same period in
2014.
As a result of the above, the loss for the first six-month period amounted to
EUR 10.6 million, compared to EUR 9.2 million for the same period in 2014,
representing an increase of 15%.
Cash position at 30 June 2015 of EUR 22.7 million
At the end of June 2015, the Company had cash and cash equivalents of EUR 22.7
million, compared to EUR 13.5 million at the beginning of the year. The net
increase is mainly due to the net proceeds from the convertible bonds issued in
March 2015. The cash used in operating activities during the first six months of
2015 amounted to EUR 9.0 million.
Outlook
TiGenix expects to take the following steps within the next 18 months:
* Q4 2015: start Phase IIa study of Cx611 in severe sepsis
* Q4 2015: complete patient enrolment for Phase II trial for AlloCSC-01 in
acute myocardial infarction
* Q1 2016: file for marketing authorisation for Cx601 in Europe
* H2 2016 begin patient enrolment for Phase III trial of Cx601 in complex
perianal fistulas in Crohn's disease patients in the United States
* H2 2016: interim analysis of Phase II trial of AlloCSC-01 in acute
ischaemic cardiac disease
Auditor's limited review
The review of the statutory auditor of the Company, BDO Bedrijfsrevisoren Burg.
Ven. CBVA, can be found in the Condensed Consolidated Financial Statements for
the first half of 2015 in the investor section of the TiGenix website,
www.tigenix.com
Interim financial statements
The interim financial statements for the first half of 2015 can be found in the
investor section of the TiGenix website, www.tigenix.com
Webcast
Today, 15 September, at 18:45h CET/12:45h EDT, TiGenix will conduct a conference
call and webcast. The following speakers will present the half-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 1905
New York, USA: +1646 254 3361
Paris, France: +33(0)1 76 77 22 27
Brussels, Belgium: +32(0)2 620 0138
Madrid, Spain: +3491 114 6583
Montreal, Canada: +1514 841 2154
Amsterdam, Netherlands: +31(0)20 716 8256
Stockholm, Sweden: +46(0)8 5033 6538
Confirmation Code: 9894390
The webcast can be followed live online via the link: http://edge.media-
server.com/m/p/g4kvinkh
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
Ana Pombo
Strategic Planning and IR Manager
T: + 34 91 804 92 64
ana.pombo(at)tigenix.com
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
intra-lesionally injected. 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. '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
INNTEGRA plan. The study primary endpoint is 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. The trial has a first complete analysis of
results at 24 weeks, with a follow-up analysis to be performed at 52 weeks post-
treatment. Recruitment of the whole sample of patients was completed in the
fourth quarter of 2014. Based on the positive Phase III results, TiGenix will
submit a Marketing Authorisation Application to EMA early 2016. TiGenix is
preparing to develop Cx601 for the US market after having obtained FDA's
endorsement of its pivotal Phase III trial through SPA on the 7th of August
2015.
About AlloCSC-01
AlloCSC-01 consists 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.
About Cx611
Cx611 is an intravenously-administered product of allogeneic expanded adipose-
derived stem cells (eASC's). TiGenix is currently developing Cx611 for patients
with early rheumatoid arthritis and for patients with severe sepsis. For the
first of these two indications, in 2013 TiGenix reported positive 6-month safety
data from its Phase IIa study of Cx611 in refractory rheumatoid arthritis, as
well as a first indication of therapeutic activity using standard outcome
measures and biologic markers of inflammation for at least three months after
dosing. A Phase I sepsis challenge trial was completed in May 2015 demonstrating
the favourable safety and tolerability profile of Cx611.
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 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/II trial in
rheumatoid arthritis, as well as a Phase I sepsis challenge trial. Effective as
of 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). Coretherapix is planning to initiate the clinical evaluation
of AlloCSC-01 in the chronic setting as well and is also involved in the pre-
clinical development of a pharmaceutical formulation of growth factors to treat
AMI. Finally, 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 document 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 document. 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.
--------------------------------------------------------------------------------
[1] ITT: Intention To Treat, i.e. patients randomised
[2] mITT: modified ITT, i.e. patients randomised and treated, and with at least
one post-baseline efficacy value
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: TiGenix via GlobeNewswire
[HUG#1952270]
Unternehmensinformation / Kurzprofil:
Datum: 15.09.2015 - 18:27 Uhr
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News-ID 420269
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contact information:
Town:
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