Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in
the discovery and development of cell therapies, today announced
its consolidated financial results for the six-month period ending
30 June 2016 prepared in accordance with IFRS as endorsed by the
European Union. The full interim financial report (regulated
information) is available on our website in the Investors section.
The Half Year 2016 consolidated financial statements were subject
to a limited review by the company's statutory auditors.
Operational highlights
Immuno-Oncology Platform
The NKR-2 autologous program (Phase I single
administration, dose escalation trial investigating the safety and
feasibility of NKR-2 in AML and MM patients):
- Successful completion of the second and third dose level
cohorts.
- The last patient in the fourth, and final, dose level cohort
has been infused and will be evaluated upon completion of the
21-day safety follow-up period.
- No dose limiting toxicities have been reported to date.
- Results from the trial are expected to be available in the
fourth quarter of 2016.
- Initiation of multiple-dose trials in AML, MM and solid tumors
(bladder, triple-negative breast, colorectal, ovarian and
pancreatic cancers) to commence upon successful completion and
analysis of the fourth dose level cohort. Interim data from the
multiple dose trials is expected in the second half of 2017.
- Scientific Partnerships and Collaborations
- Following the end of the first half, on July 11, we announced
an exclusive licensing agreement with ONO Pharmaceutical for the
development and commercialization of our allogeneic NKR-2 T-cell
therapy in Japan, Korea and Taiwan. Total deal value of up to
31.325 JPY B (€282 million or $311.5 million) plus double digit
royalties on net sales in ONO territories.
- Academic research collaboration with Institut Curie's Immunity
and Cancer Unit to benefit from their translational, pre-clinical
and clinical expertise in cancer biology and immunology.
- Creation of a Scientific Advisory Board, comprised of ten of
the leading international immuno-oncology experts.
- Management Team and Leadership
- Dr. David Gilham, one of Scientific Advisory Board members,
joined Celyad full-time as Vice President of Research and
Development.
- Intellectual Property
Our allogeneic platform
- Issuance of US Patent 9,273,283 that provides broad protection
for our proprietary method of producing allogeneic human T-cells
that are engineered to be T-Cell Receptor (TCR)-deficient and
express a Chimeric Antigen Receptor (CAR).
- In combination with US Patent 9,181,527, issued in November
2015 and covering all TCR-deficient T-cells, regardless of
production method, we possess a robust IP portfolio in the field of
TCR-deficient T-cells for the treatment of cancer and other
diseases.
- We plan to enter allogeneic NKR-2, which incorporates TCR
Inhibitory Molecules (TIMs), into the clinic in 2H17.
Cardiovascular Platform
- Clinical Trials
- At the end of June, we announced the top-line results of the
Phase III CHART-1 trial, evaluating C-CURE® for the treatment of
ischemic heart failure. The primary endpoint of the trial was not
met.
- We are analyzing the data and evaluating potential options for
the C-CURE® program. We are encouraged by initial indications from
investigators that a significant subgroup of patients, within
well-defined baseline end-diastolic volume parameters, receive a
clinically meaningful benefit from C-CURE® therapy.
- CHART-1 results will be outlined in a Late Breaking Session at
the European Society of Cardiology Congress on Sunday, August 28,
2016.
- Partnerships and Collaborations
- We will seek guidance from the European Medicines Agency (EMA)
regarding future steps and will pursue a partner to continue the
development and commercialization of C-CURE®.
Corporate and financial Highlights
- During the first half of the year, we enhanced our executive
management team with the hire of several experienced professionals:
David Gilham - VP Research & Development; Jean-Pierre Latere -
VP Business Operations & Commercialization; Richard Mountfield
- VP Global Clinical Operations & Regulatory Affairs; and
Graham Morrell - VP Investor Relations & Communication.
- Celyad ended the first half of 2016 with EUR 86 million in cash
and short-term deposits. This amount in treasury should enable to
fund the Group operating expenses and capital expenditure
requirements, based on the current scope of our activities, until
the end of 2018.
Dr. Christian Homsy, CEO of Celyad, said:
"The first half of 2016 was an important period for Celyad. We
continued to deliver on our development objectives for NKR-2 and
reached important clinical milestones with the successful
completion of our Phase I trial first three cohorts. With the
last patient of the trial being treated, we now look forward to
reporting the outcome and starting the next phase of our clinical
development plan, the start of our multiple dosing umbrella trials
testing NKR-2 in five solid and two blood malignancies. The
signature of key international academic and industrial partnerships
and the strong reinforcement of our intellectual property portfolio
have confirmed the potential and attractiveness of our
platform.
Celyad has also announced the results of the
CHART-1 Phase III trial evaluating C-Cure® cell therapy. Though the
primary endpoint was unfortunately not met, a clinically and
statistically significant outcome, consistent across all parameters
tested, was observed for a substantial, clearly definable, group of
heart failure patients. Those results and the feedback from our
cardiology program advisors encourage us to seek guidance from the
regulatory authorities in Europe and the USA on the path forward
for this promising technology. Consistent with our strategic
repositioning in immune-oncology, we are actively looking for a
partner to further develop C-Cure and fund the CHART-2 trial in the
USA.
Looking forward, Celyad is focusing its efforts
and accelerating the development of its immuno-oncology platform,
with the objective to become a global leader in engineered
cell-based immunotherapies for cancer treatment. The funds raised
last year as well as the payment resulting from our license
agreement with ONO provide a solid financial foundation for us to
continue to advance our vision of developing pioneering
breakthrough therapies for life-threatening diseases."
Patrick Jeanmart, Chief Financial Officer of
Celyad, said: "We terminated the first semester of 2016 with a
solid cash position. The EUR 86 million in hands does not include
yet the EUR 11 million payment of ONO Pharmaceuticals, resulting
from the license deal announced earlier in July. This cash position
offers us a lot of perspectives in our future Immuno-oncology
development activities."
Selected First Half 2015 Financial
Results
In million euros |
H1 2016 |
H1 2015 |
Research & Development expenses |
14.8 |
11.5 |
General & Administration expenses |
4.7 |
3.6 |
Operating loss |
17.2 |
15.1 |
Loss of the period |
16.9 |
15.3 |
Loss per share (in €) |
1.8 |
2.1 |
Change in net cash and cash equivalent |
46.5 |
88.5 |
Cash and short term investment |
86.0 |
107.5 |
Management to Host Conference Call at 2pm
(CEST)/8am (EDT) today
Conference Call Details
A conference call will be held on Thursday 25
2016 at 2:00pm (CEST) / 8:00am (EDT) to review the financial
results. Christian Homsy, Chief Executive Officer, and Patrick
Jeanmart, Chief Financial Officer, will deliver a brief
presentation followed by a Q&A session.
Participants are asked to call the assigned
numbers approximately five minutes before the conference call
begins.
The call can be accessed by dialling the numbers
below and using the passcode: 70807261.
International:
+44 (0) 1452 584233
Belgium:
024003425 France:
0800947325
UK:
08002795994 US:
1
866 629 0057
***END***
For more information, please contact:
For Europe: Consilium Strategic Communications Chris
Gardner, Chris Welsh, and Laura Thornton -
T: +44 (0)20 3709 5700
-celyad@consilium-comms.com |
For France: NewCap Pierre Laurent and Nicolas
Mérigeau - T: + 33(0)1 44 71 94 94 -
celyad@newcap.eu |
For Belgium: Comfi Gunther De Backer - T.: +32 (0)2 290
90 90 - gunther@comfi.be |
Celyad Belgium: Christian Homsy, CEO, Patrick
Jeanmart, CFO: T: +32 (0)10 39 41 00 -
investors@celyad.com USA: Graham Morrell, VP Investor
Relations and Communication: T: +1 (0) 857 990 6909
gmorrell@celyad.com |
To subscribe to Celyad's newsletter,
visitwww.celyad.com Follow us on Twitter @CelyadSA
and on LinkedIn
About Celyad
Celyad is a clinical-stage biopharmaceutical
company focused on the development of specialized cell-based
therapies. The Company utilizes its expertise in cell engineering
to target severe diseases with significant unmet need, including
cancer. Celyad's Natural Killer Receptor (NKR) based T-Cell
platform has the potential to treat a broad range of solid and
liquid tumors. Its lead oncology candidate, NKR-2, is currently
being evaluated in a Phase I clinical trial. In addition, Celyad
has completed a Phase III trial in the EU for its C-Cure®
cardiovascular disease candidate in ischemic heart failure.
Celyad was founded in 2007 and is based in
Mont-Saint-Guibert, Belgium, and Boston, Massachusetts. Celyad's
ordinary shares are listed on the Euronext Brussels and Euronext
Paris exchanges, and its American Depository Shares are listed on
NASDAQ Global Market, all under the ticker symbol CYAD.
Forward looking statements
In addition to historical facts or statements of
current condition, this press release contains forward-looking
statements, including statements about the potential safety and
feasibility of NKR-2 T-cell therapy and C-Cure and the clinical
potential of the Company's technology platform generally and the
timing of future clinical trials, which reflect our current
expectations and projections about future events, and involve
certain known and unknown risks, uncertainties and assumptions that
could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements.
In particular, it should be noted that the
safety data described in the release are preliminary in nature and
the Phase I trial is not completed. There is limited data
concerning safety and feasibility of NKR-2. These data may not
continue for these subjects or be repeated or observed in ongoing
or future studies involving our NKR-2 therapy, C-Cure or other
product candidates. It is possible that safety issues or adverse
events may arise in the future.
These forward-looking statements are further
qualified by important factors, which could cause actual results to
differ materially from those in the forward-looking statements,
including risks associated with conducting clinical trials; the
risk that safety, bioactivity, feasibility and/or efficacy
demonstrated in earlier clinical or pre-clinical studies may not be
replicated in subsequent studies; risk associated with the timely
submission and approval of anticipated regulatory filings; the
successful initiation and completion of clinical trials, including
Phase III clinical trials for C-Cure® and Phase I clinical trial
for NKR-2; risks associated with the satisfaction of regulatory and
other requirements; risks associated with the actions of regulatory
bodies and other governmental authorities; risks associated with
obtaining, maintaining and protecting intellectual property, our
ability to enforce our patents against infringers and defend our
patent portfolio against challenges from third parties; risks
associated with competition from others developing products for
similar uses; risks associated with our ability to manage operating
expenses;, and risks associated with our ability to obtain
additional funding to support our business activities and establish
and maintain strategic business alliances and business initiatives.
A further list and description of these risks, uncertainties and
other risks can be found in the Company's Securities and Exchange
Commission filings and reports, including in the Company's
prospectus filed with the SEC on June 19, 2015 and future filings
and reports by the Company. Given these uncertainties, the reader
is advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the
date of publication of this document. The Company expressly
disclaims any obligation to update any such forward-looking
statements in this document to reflect any change in its
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based,
unless required by law or regulation.
C3BS-CQR-1, C-Cure, NKG2D CAR T-cell, NKR-2,
C-CathezTM, Celyad, CHART-1, CHART-2 and OnCyte logos are signs
internationally protected under applicable Intellectual Property
Laws. Mayo Clinic holds equity in Celyad as a result of
intellectual property licensed to the Company.
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