Celyad’s management will host a conference
call at 2pm CEST / 8am EDT today
Celyad (Euronext Brussels:CYAD) (Euronext Paris:CYAD)
(NASDAQ:CYAD), a pioneer in the discovery and development of CAR-T
cell therapies, today announced its consolidated financial results
for the six-month period ending 30 June 2017, prepared in
accordance with IFRS as endorsed by the European Union. The full
interim financial report is available on Celyad’s website in the
Investors section. The half year 2017 consolidated financial
statements were subject to a limited review by the company’s
statutory auditors.
Operational Highlights of the first half
of 2017
Immuno-oncology Platform
Steady progress has been made in advancing the
THINK trial (THerapeutic
Immunotherapy with CAR-T NKG2D),
Celyad’s second clinical trial with its lead product candidate,
CYAD-01 (CAR-T NKG2D).
The THINK trial was initiated in late 2016 and
is being conducted in the United States and Europe. THINK includes
two stages: a dose escalation and an extension stage. The dose
escalation stage is being conducted in parallel in five solid
cancers (colorectal, pancreatic, ovarian, triple negative breast
and bladder) and in two hematologic cancer groups (Acute Myeloid
Leukemia (AML) and Multiple Myeloma (MM), while the extension phase
will evaluate in parallel each tumor type independently. The dose
escalation design includes three dose levels adjusted to body
weight: up to 3x108, 1x109 and 3x109 CYAD-01 cells. At each dose,
the patients receive three successive administrations, two weeks
apart, of CYAD-01 at the specified dose.
All patients enrolled in the second cohort of
the solid arm have been dosed successfully, as well as the first
patient enrolled in the second cohort of the liquid arm. No adverse
events have been reported.
Major clinical milestones achieved in the first
half of 2017 include:
- No adverse events reported in patients treated to date in both
the solid and liquid arms, in-line with the positive safety profile
seen in the CM-CS1 Phase I clinical trial conducted in 2015 and
2016 in the US. To date there have been no reports of safety
concerns including unexpected serious adverse reactions, dose
limiting toxicities or cytokine release syndrome toxicity;
- Promising early clinical results were reported at the 3-month
follow-up from the first dose-level in solid tumors. At the first 3
x 108 cell dose-level administered to a total of three patients
with metastatic cancer, the two colorectal cancer (mCRC)
patients progressing after at least two prior chemotherapy
regimens, achieved a confirmed Stable Disease according to
RECIST criteria at three months.
In July, Celyad initiated the SHRINK trial
(Standard CHemotherapy
Regimen and Immunotherapy with
CAR-T NKG2D), the third clinical trial with
CYAD-01. SHRINK is an open-label Phase I trial evaluating the
safety and clinical activity of multiple doses of CYAD-01,
administered concurrently with the neoadjuvant FOLFOX treatment in
patients with potentially resectable liver metastases from
colorectal cancer.
Dr. Christian Homsy, CEO of Celyad,
said: “We are very pleased with these encouraging
preliminary results from the THINK trial, with signs of clinical
activity reported in colorectal cancer patients at the first dose
administered. With these early data, we feel even more encouraged
about the clinical development plan of our lead program, CYAD-01,
and look forward to quickly advancing the SHRINK trial. We
hope to gather additional evidence of clinical activity in both
hematological and solid tumor indications over the second half of
2017.”
Cardiovascular Platform
In May, Celyad announced that the U.S. Food and
Drug Administration (FDA) had granted Fast Track designation for
its C-Cure® therapy. The FDA granted Fast Track Development Program
designation based on CHART-1 data related to reduction in
mortality, hospitalization and improvement of quality of life in
patients with chronic heart failure secondary to ischemic
cardiomyopathy with baseline Left Ventricular End-Diastolic Volumes
(LVEDV) between 200 and 370ml.
Intellectual Property
In January, the U.S. Patent and Trade Office
(USPTO) upheld, for a third time, Celyad’s U.S. Patent No.
9,181,527 relating to allogeneic human primary T-cells that are
engineered to be TCR-deficient and express a chimeric antigen
receptor (CAR). In March, the USPTO rejected another request for a
re-examination of the same patent. Celyad’s critical patent remains
valid and enforceable.
In May, Celyad obtained a new patent related to
its method of treating cancer by administering allogeneic primary
human T cells that are engineered to be T-Cell Receptor
(TCR)-deficient and to express a CAR. US Patent No. 9,663,763 is
the third patent in Celyad’s allogeneic intellectual property
portfolio awarded by the USPTO. This new patent claims specifically
methods of treating cancer patients with allogeneic TCR-deficient
CAR-T immunotherapies. Earlier patents were related to the
allogeneic TCR-deficient CAR-T cells per se, and to methods of
producing them. The combination of this patent with earlier granted
US patents consolidates Celyad’s strong intellectual property (IP)
position in the allogeneic CAR-T field and strengthens the Celyad’s
IP portfolio covering key elements in the allogeneic TCR-deficient
CAR-T cells production value chain.
Corporate Highlights of
the first half of 2017
In May, Celyad announced a non-exclusive license
agreement with Novartis regarding US patents related to allogeneic
CAR-T cells. The agreement includes Celyad’s intellectual property
rights under U.S. Patent No. 9,181,527 related to allogeneic human
primary T-Cells engineered to be TCR deficient and express a CAR.
This agreement is related to two undisclosed targets currently
under development by Novartis.
Under the terms of the agreement, Celyad
received an upfront payment and is eligible to receive
success-based clinical, regulatory and commercial milestone
payments in aggregate amounts of up to $96 million. In addition,
Celyad is eligible to receive royalties based on net sales of the
licensed target associated products at percentages in the single
digits. Celyad retains all rights to grant further licenses to
third parties for the use of allogeneic CAR-T cells.
In August 2017, Celyad amended its agreements
with Celdara Medical LLC and Dartmouth College related to the CAR-T
NK cell drug product candidates and related technology licensed in
January 2015 following the acquisition of OnCyte LLC. Under the
amended agreements Celyad is to receive an increased share of
future revenues generated by these assets, including revenues from
its sub-licensees.
In return, Celyad paid Celdara Medical LLC and
Dartmouth College an upfront payment of $12.5 million (€10.6
million) and issued to Celdara Medical LLC $12.5 million worth of
Celyad’s ordinary shares at a share price of €32.35. The financial
effects of the above transactions have not been brought to account
in the interim consolidated financial statements of Celyad as of 30
June 2017 and may materially impact Celyad’s income statement in
the consolidated financial statements at year end 2017.
Dr. Christian Homsy, CEO of Celyad,
continued: “The non-exclusive license agreement contracted
with Novartis serves as a key validation of our central
intellectual property position in the allogeneic CAR-T field.
Finally, the new terms negotiated with Celdara Medical and
Dartmouth College should help provide long-term value to Celyad’s
shareholders, while the increased ownership of Celdara Medical in
Celyad signals a commitment to our development of promising CAR-T
cell therapies.”
Patrick Jeanmart, Chief Financial
Officer of Celyad, commented: “Cash and resource
management of our group remains a key focus for Celyad, and this
effort has allowed us to meaningfully advance the preclinical and
clinical development of our promising CAR-T platform across
multiple important indications. We ended the first half of 2017
with €69 million in cash and short-term deposits which we believe
is sufficient to support operating expenses and capital expenditure
requirements, based on the current scope of our activities, through
the first half of 2019.”
Selected First Half 2017 Financial Results
In million euros |
H1 2017 |
H1 2016 |
Revenues |
3.0 |
|
- |
|
Research & Development expenses |
(11.1 |
) |
(15.4 |
) |
General & Administration expenses |
(4.2 |
) |
(4.7 |
) |
Other income/(expenses) |
(1.3 |
) |
2.9 |
|
Operating loss |
(13.7 |
) |
(17.2 |
) |
Loss of the period |
(14.4 |
) |
(16.9 |
) |
Loss per share (in €) |
(1.52 |
) |
(1.82 |
) |
Net cash burned over the period |
(13.8 |
) |
(21.5 |
) |
Cash and short-term investment |
68.8 |
|
86.0 |
|
Celyad’s management will host a conference
call at 2pm CEST/8am EDT todayConference Call
Details
A conference call will be held on Tuesday 29
August 2017 at 2:00pm (CEST) / 8:00am (EDT) to comment on the
mid-year operational and 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: 76183347
International:
+44 (0) 1452
584233Belgium:
02 400
3425France:
0800 947325UK:
0800 2795994US:
1 866 629 0057
About
Celyad
Celyad is a clinical-stage biopharmaceutical
company focused on the development of specialized CAR-T cell based
therapies. Celyad utilizes its expertise in cell engineering to
target cancer. Celyad’s Natural Killer Receptor based T-Cell
(NKR-T) platform has the potential to treat a broad range of solid
and hematologic tumors. Its lead oncology candidate, CYAD-01 (CAR-T
NKG2D), has been evaluated in a single dose escalation Phase I
clinical trial to assess the safety and clinical activity of
multiple administrations of autologous CYAD-01 cells in seven
refractory cancers including five solid tumors (colorectal,
ovarian, bladder, triple-negative breast and pancreatic cancers)
and two hematological tumors (acute myeloid leukemia and multiple
myeloma). 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
the NASDAQ Global Market, all under the ticker symbol CYAD.
For more information about Celyad, please visit:
www.celyad.com
For more information, please
contact:
For Europe: Consilium Strategic Communications
Chris Gardner and Chris Welsh
- T: +44 (0)20 3709 5700 –
celyad@consilium-comms.com |
For France: NewCapPierre
Laurent and Nicolas Mérigeau - T: +
33(0)1 44 71 94 94 - celyad@newcap.eu |
For Belgium: ComfiGunther De
Backer and Sabine Leclercq - T.: +32 (0)2
290 90 90 – celyad@comfi.be |
For the U.S.: Stern Investor RelationsWill
O’Connor and Michael Schaffzin – T.: +1
212.362.1200 – celyad@sternir.com |
To subscribe to Celyad’s newsletter,
visit www.celyad.comFollow us on LinkedIn &
Twitter @CelyadSA
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 CYAD-01 cell therapy, including current and planned
preclinical and clinical trials for Celyad’s product candidates;
the clinical and commercial potential of these product candidates
and the adequacy of Celyad’s financial resources; Celyad’s
intellectual property portfolio, including plans related thereto;
Celyad’s expectations regarding its strategic collaborations and
license agreements with third parties, including Novartis, Celdara
Medical, and Dartmouth College, and the potential impact of such
collaborations on Celyad’s future financial condition; and Celyad’s
expected cash burn, which reflect Celyad’s 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. These forward-looking
statements are further qualified by important factors and risks,
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 trials
or preclinical studies may not be replicated in subsequent trials
or studies; risks associated with the timely submission and
approval of anticipated regulatory filings; the successful
initiation and completion of clinical trials, including its
clinical trials for CYAD-01; 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, Celyad’s ability to enforce its patents
against infringers and defend its patent portfolio against
challenges from third parties; risks associated with competition
from others developing products for similar uses; risks associated
with Celyad’s ability to manage operating expenses; and risks
associated with Celyad’s ability to obtain additional funding to
support its 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 Celyad’s U.S. Securities and Exchange Commission
(SEC) filings and reports, including in its Annual Report on Form
20-F filed with the SEC on April 4, 2017 and subsequent filings and
reports by Celyad. 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. Celyad 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.
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