TiGenix reports 2016 full year results
(Thomson Reuters ONE) -
PRESS RELEASE
Regulated information
insider information
TiGenix reports 2016 full year results
(Conference call and webcast today at 13:00 CEST)
Leuven (BELGIUM) - April 6, 2017, 07:00h CEST - TiGenix NV (Euronext Brussels
and NASDAQ: TIG), an advanced biopharmaceutical company developing and
commercializing novel therapeutics which exploit the anti-inflammatory
properties of allogeneic, or donor-derived, stem cells, today reported its
business and financial highlights for 2016 and post year-end events.
Key 2016 and post year-end highlights:
* Cx601 reached significant value inflection points in Europe and the U.S.
* Day 120 List of Questions responses submitted to the European Medicines
Agency (EMA) to support the Marketing Authorization Approval (MAA) for
Cx601 following submission of the application in March 2016
* Day 180 List of Outstanding Issues (LoOI) received from the Committee
for Medicinal Products for Human Use (CHMP) of the EMA
* European Commission decision anticipated in 2017, triggering a payment
of EUR 15.0 million from Takeda Pharmaceuticals upon approval of the
market authorization
* The global pivotal Phase III trial for the U.S. registration of Cx601 is
expected to begin in the first half of 2017. TiGenix is also exploring
further expedited pathways to accelerate the submission and review
process for its future Biologics License Application (BLA)
* Cx601 delivered positive follow-up results at 52 and 104 weeks,
confirming the long-term safety and efficacy profile
* Strong relationship with Takeda Pharmaceuticals
* Licensing agreement for the ex-U.S. rights of Cx601 signed in July 2016
for up to EUR 355.0 million in regulatory and sales milestones and EUR
25.0 million on signing
* EUR 10.0 million in equity investment realized in December 2016
* Exercised option to develop and commercialize Cx601 in both Japan and
Canada
* Continued progress with pipeline
* First patient enrolled in Phase I/II clinical trial of Cx611 for the
treatment of severe sepsis
* Promising Phase I/II trial results of AlloCSC-01 in Acute Myocardial
Infarction (AMI)
* Strong cash position at December 31, 2016 of EUR 78.0 million, due to:
* Equity raise of EUR 23.8 million in March 2016 with marquee investors
* Upfront cash payment of EUR 25.0 million from Takeda deal in July 2016
and EUR 10.0 million of equity investment in December
* EUR 34.1 million (USD 35.7 million) raised with Nasdaq IPO
* Strategic appointments
* Dr. June Almenoff appointed as an Independent Director to the Board
"The past year has been truly transformational for TiGenix. We have reached the
final phase before our first allogeneic product potentially enters the market in
Europe, published our positive Phase III data in The Lancet[i], signed a major
licensing deal with a world-class partner, raised substantial funds and advanced
our pipeline," said Eduardo Bravo, CEO of TiGenix. "I am proud of what has been
achieved and enormously excited about the rest of the year, including taking the
next steps in developing Cx601 for the U.S. market and in further indications."
Business highlights
Cx601 reached major value inflection points
2016 has been an extraordinary year for TiGenix as we continue the
transformation of the company to focus on products from our allogeneic stem cell
platforms. Our most advanced product, Cx601, reached significant major value
inflection points and the vision of bringing this innovative medicine to
patients suffering a severe, debilitating complication of Crohn's disease has
become tangible with the signing of an exclusive licensing agreement for the
development and commercialization of Cx601 outside the U.S. with Takeda, a world
leader in gastroenterology.
In July, TiGenix received a payment of EUR 25.0 million upon signing the
licensing agreement with Takeda. TiGenix is eligible to receive additional
regulatory and sales milestone payments for up to a potential total of EUR
355.0 million and double digit royalties on net sales. In addition to these
financial benefits, we believe the partnership with Takeda has increased the
probability of commercial success by drawing on the reimbursement and commercial
expertise of one of the leaders in the gastroenterology field.
Since signing of the licensing agreement, Takeda has made an additional equity
investment of EUR 10.0 million in the share capital of TiGenix, has exercised
the option to develop and commercialize Cx601 in both Japan and Canada, and has
launched a series of key activities to ensure the timely launch of Cx601 as soon
as the marketing approval is obtained.
Cx601 has continued to produce impressive results following the meeting of the
primary endpoint at week 24. The positive 24-week results were presented at the
two major congresses for gastrointestinal specialists on both sides of the
Atlantic and published in The Lancet(i), one of the most reputable peer reviewed
publications in the scientific community. In March 2016, TiGenix announced
positive follow-up results at 52 weeks for Cx601, confirming its sustained
efficacy and safety profile. A single administration of Cx601 was statistically
superior to control (placebo) in achieving combined remission at week 52, in
line with the primary endpoint results at week 24. In March 2017, Cx601
delivered positive follow-up results at 104 weeks, confirming its long-term
safety and efficacy profile.
In March 2016, TiGenix filed a centralized European MAA for Cx601. In March
2017, we received the Day 180 List of Outstanding Issues from the CHMP. Having
reviewed the LoOI, we remain confident that Cx601 is on track to receive
Marketing Authorization. A CHMP opinion and decision by the European Commission
is expected in 2017 and upon obtaining the Marketing Authorization, TiGenix is
eligible to receive from Takeda a EUR 15.0 million milestone payment. The path
to European commercialization was also further advanced in October 2016 when
Cx601 was granted Orphan Drug Designation (ODD) in Switzerland.
In parallel to the progress in Europe, we have been advancing our program to
bring Cx601 to U.S. patients. In January 2017, the FDA agreed to an improved
protocol for the global Phase III trial of Cx601, which has now been formally
endorsed by a new SPA. With these amendments, the FDA has agreed that a
Biologics License Application (BLA) could be filed based on the efficacy and
safety follow-up of patients assessed at week 24, instead of week 52.
Furthermore, the FDA has agreed to accept fewer patients than originally planned
in the study, and has endorsed a broader target population that will ultimately
facilitate the recruitment process. With these adjustments, the study will
benefit from an expedited recruitment process that should lead to shorter
timelines, an earlier filing, and the possibility of an earlier approval in the
U.S. As a result of these modifications, the trial design is even more similar
to the European ADMIRE-CD than before.
The global pivotal Phase III trial for the U.S. registration of Cx601 is
expected to begin in the first half of 2017. In parallel, TiGenix is exploring
further expedited pathways to accelerate the submission and review process for
its future BLA.
Progress with pipeline
In June 2016, TiGenix announced preliminary interim six-month results for the
Phase I/II (CAREMI) study of AlloCSC-01 in Acute Myocardial Infarction (AMI) and
in March 2017 announced the top-line results of the study. CAREMI is the first-
in-human clinical trial with the primary objective being safety and evaluating
the feasibility of an intracoronary infusion of AlloCSCs in patients with AMI
and left ventricular dysfunction treated within the first week post-AMI.
Importantly, the trial is the first cardiac stem cell study to integrate a
highly discriminatory magnetic resonance imaging (MRI) strategy to select
patients at increased risk of heart failure and late adverse outcomes. CAREMI
was not powered to establish efficacy therefore no conclusion can be drawn on
the secondary efficacy end-points.
All safety objectives of the study have been met. No mortality or major cardiac
adverse events (MACE) have been found at 30 days meeting the primary end-point
of the study. Moreover neither mortality nor MACE have been found at 6 months or
12 months follow-up. Of particular relevance to this allogeneic approach, no
immune-related adverse events have been recorded at one-year follow-up. A larger
reduction in infarct size was found in one pre-specified subgroup associated
with poor long-term prognosis which represents more than half of the patient
population of the randomization phase of the study. This finding has revealed
valuable insight, and provides a specific direction for potential studies in a
targeted subset of high-risk patients and we expect to announce next steps in
the development of AlloCSC-01 later in 2017.
Cx611, our second eASC-based product candidate, is a potential first-in-class
intravenous injectable allogeneic (or donor derived) stem cell therapy intended
for the treatment of severe sepsis, a major cause of mortality in the developed
world. We believe that Cx611 represents a highly innovative potential treatment
for this indication. The Phase I/II SEPCELL study was launched in the second
half of 2016 and the first patient was dosed in January 2017. Data is expected
to be available in 2019.
In July, 2016, TiGenix announced the initiation of the withdrawal of the
marketing authorization for ChondroCelect. TiGenix decided to initiate the
withdrawal process for commercial reasons. After the effective day, November
30, 2016, TiGenix no longer expects to generate any revenues from this product.
Ultimately, this decision is in line with TiGenix's strategy to concentrate its
resources and capabilities on its allogeneic stem cell platforms.
Corporate development
In September 2016 TiGenix announced the appointment of Dr. June Almenoff as an
independent director. June Almenoff MD, PhD has more than 20 years'
pharmaceutical industry experience including leading the process towards FDA
approval for a GI product, broad experience in clinical development, scientific
licensing and business development, an expertise in infectious diseases, and a
clear focus on the U.S. market.
Financial highlights for 2016
Key figures for the full year 2016 (consolidated)
Revenues for 2016 amounted to EUR 26.8 million, compared to EUR 2.2 million in
2015. The increase is mainly driven by License revenues obtained from the
licensing agreement signed in July 2016 with Takeda. The decrease in Royalties
and Grants and other operating income during the year is due to the withdrawal
of the marketing authorization of ChondroCelect for commercial reasons.
Total operating charges for 2016 amounted to EUR 29.8 million, compared to EUR
26.3 million in 2015. The increase is mainly due to the increase in Research and
Development expenses, driven by Cx601 clinical development progress (including
U.S. Cx601 clinical start-up activities), the clinical activities related to the
Cx611 Phase I/II clinical trial in severe sepsis (SEPCELL) and those related to
the AlloCSC-01 Phase I/II in AMI (CAREMI). General and Administrative expenses
increased to EUR 8.4 million from EUR 6.7 million in 2015 mainly driven by the
expenses related to the Nasdaq IPO.
As a result of the above, the operating loss decreased in 2016 to EUR 3.0
million, from EUR 24.1 million in 2015.
The Interest on borrowings and other finance costs for 2016 amounted to EUR 7.3
million. These costs include both cash financial expenditures (for EUR 3.5
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 bonds and the governmental loans). The fair value
gains for 2016 amounted to EUR 11.6 million. These gains include non-cash income
resulting from the change in the fair value of the warrant component of the
convertible bonds (mainly as a result of the lower share price at year-end 2016
compared to the share price at year-end 2015) and the warrants issued for the
Kreos loan. Income tax benefits amounted to EUR 2.1 million and refer to the tax
deductions under Spanish tax law obtained from R&D activities.
As a result of the above, the profit for the year 2016 amounted to EUR 3.8
million compared to a loss of EUR 35.1 million in 2015.
Cash and cash equivalents amounted to EUR 78.0 million on December 31, 2016. We
end the year in a strong financial position following the equity raise of EUR
23.8 million in March 2016 with marquee investors, upfront cash payment of EUR
25.0 million from the Takeda deal in July 2016, EUR 10.0 million of equity
investment from Takeda in December and EUR 34.1 million (USD 35.7 million)
raised with the Nasdaq IPO. Net cash provided by operating activities in 2016
amounted to EUR 3.5 million.
Outlook for the rest of 2017
* 1H 2017 - Opening of U.S. operations
* 1H 2017 - Start of global phase III for Cx601 BLA
* 2H 2017 - Cx601 EU approval decision
* 2H 2017 - EUR 15,0 million milestone potential payment by Takeda
* 2H 2017 - Plan on new indications for Cx601
* 1H 2018 - Takeda to launch Cx601 in EU markets
* 1H 2018 - Cx601 IND and start of recruitment in U.S. centers
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 2016 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, on or around 6 April 2017.
Financial statements
The financial statements for the year ended 31 December 2016 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 2016 via the Company's
website on or around 6 April 2017.
Webcast
TiGenix will conduct a conference call on 6 April 2017, at 13:00pm CEST /
7:00am EDT, which will also be webcast. To participate in the conference call,
please call on the following numbers to participate:
Confirmation Code: 1332273
London, United Kingdom: +44 (0)20 3427 1908
New York, United States of America: +1 212 444 0896
Paris, France: +33 (0)1 76 77 22 28
Brussels, Belgium: +32 (0)2 402 3092
Madrid, Spain: +34 91 453 34 34
Amsterdam, Netherlands: +31 (0)20 716 8295
The webcast can be followed live online via the link: http://edge.media-
server.com/m/p/hmntjv4f
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 TiGenix
TiGenix NV (Euronext Brussels [and NASDAQ]: TIG) is a biopharmaceutical company
developing and commercializing novel therapeutics which exploit the anti-
inflammatory properties of allogeneic, or donor-derived, stem cells generated by
its proprietary platform technologies.
TiGenix's lead product, Cx601, has successfully completed a European Phase III
for the treatment of complex perianal fistulas - a severe, debilitating
complication of Crohn's disease. Cx601 has been filed for regulatory approval in
Europe and a global Phase III trial intended to support a future U.S. Biologic
License Application (BLA) is expected to start in 2017. TiGenix has entered into
a licensing agreement with Takeda, a large pharmaceutical company active in
gastroenterology, under which Takeda acquired the exclusive right to
commercialize Cx601 for complex perianal fistulas outside the U.S. Our second
adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe
sepsis - a major cause of mortality in Western world hospitals. Finally,
AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive
results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is
headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more
information, please visit http://www.tigenix.com
About Cx601
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC)
locally injected. Cx601 is an investigational agent being developed for the
treatment of complex perianal fistulas in Crohn's disease patients that failed
conventional therapy including antibiotics, immunosuppressant, or anti-TNF
therapy. 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, recognizing 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) and launched in Europe and Israel a Phase III study (ADMIRE-CD) a
randomized, double-blind, placebo-controlled Phase III trial designed to comply
with the requirements laid down by the EMA. 'Madrid Network', an organization
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 program was funded by The Secretary of State for Research,
Development and Innovation (Ministry of Economy and Competitiveness) within the
framework of the INNTEGRA plan. The ADMIRE-CD 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. The ADMIRE-CD study reported
positive results 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 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 24-week results of the Phase III ADMIRE-CD trial investigating Cx601
have been published in The Lancet(i).The ADMIRE-CD study has completed a follow-
up analysis at 52 weeks and at 104 weeks post-treatment. Based on the positive
24 weeks Phase III study results, TiGenix has submitted a Marketing
Authorization Application to the EMA and a decision is expected in 2017. TiGenix
is preparing to develop Cx601 in the U.S. after having reached an agreement with
the FDA through a special protocol assessment procedure (SPA). In July 2016
TiGenix entered into a licensing agreement with Takeda, a pharmaceutical company
leader in gastroenterology, whereby Takeda acquired exclusive rights to develop
and commercialize Cx601 for complex perianal fistulas in Crohn's patients
outside of the U.S.
About Cx611
Cx611 is an intravenously-administered product of allogeneic (or donor derived)
expanded adipose-derived stem cells (eASCs). In May 2015, TiGenix completed a
Phase I sepsis challenge trial showing a favorable safety and tolerability
profile for Cx611. Based on the results of this study, TiGenix is now sponsoring
a Phase I/II clinical trial (the SEPCELL study) in severe sepsis secondary to
community-acquired pneumonia (CAP). SEPCELL is a randomized, double-blind,
placebo-controlled, Phase I/II study in patients with CAP requiring mechanical
ventilation and/or vasopressors. The trial is expected to enroll 180 patients,
and will be conducted in multiple European centers. Subjects will be randomized
1:1 to receive either active investigational product (Cx611) or placebo.
Additionally all patients will be treated with the standard of care, which
generally includes antibiotics and anti-inflammatory drugs. The primary endpoint
is the number, frequency and type of adverse events during a 90 day period with
an exploratory follow-up reaching up to two years. Secondary endpoints include
the reduction in the duration of mechanical ventilation and/or vasopressors,
improved survival, clinical cure of sCAP, and other infection-related endpoints.
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 has recently concluded a Phase I/II clinical trial (CAREMI). The
CAREMI trial comprised two consecutive phases: an open-label dose-escalation
phase (n=6) and a 2:1 randomized, double-blind, placebo-controlled phase (n=49).
The objective of this clinical trial was 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. MACE is a broader safety
endpoint that covers all-cause mortality as well as new AMI, hospitalization due
to heart failure, sustained ventricular tachycardia, ventricular fibrillation
and stroke. The study met all safety objectives, demonstrating that allogeneic
cardiac stem cells can be transplanted safely through the coronary tree.
Furthermore, study results indicated a larger reduction in infarct size in one
pre-specified subgroup associated with poor long-term prognosis (patients with a
large myocardial infarction). The CAREMI trial has benefitted from the support
of the CARE-MI consortium (Grant Number 242038, http://www.caremiproject.eu/)
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.
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.
--------------------------------------------------------------------------------
[i] Panés P, et al. Expanded allogeneic adipose-derived mesenchymal stem cells
(Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised,
double-blind controlled trial. The Lancet [online]. Published online July
28, 2016, available at http://dx.doi.org/10.1016/S0140-6736(16)31203-X.
Key figures for the full year 2016 (consolidated):
http://hugin.info/137616/R/2094170/791768.JPG
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TiGenix via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.04.2017 - 07:01 Uhr
Sprache: Deutsch
News-ID 534813
Anzahl Zeichen: 29473
contact information:
Town:
Leuven
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 235 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TiGenix reports 2016 full year results"
steht unter der journalistisch-redaktionellen Verantwortung von
TiGenix (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
