Celyad (Euronext Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a
clinical-stage biopharmaceutical company focused on the development
of specialized CAR-T cell based therapies, today provided an update
on key clinical and operational developments for the third quarter
ended Sept. 30, 2017.
THIRD QUARTER 2017 AND RECENT
HIGHLIGHTS
- Reported first complete response by a CAR-T therapy in a
patient with relapsed refractory AML (Acute Myeloid Leukemia) in
the Phase 1b THINK1 trial
- Reported promising safety and clinical activity of CYAD-01
(CAR-T NKG2D) in all AML patients treated so far in THINK
trial
- Announced amended agreements with Celdara Medical and Dartmouth
College following encouraging results from the THINK trial
- Initiated the Phase 1 SHRINK2 study in Belgium to evaluate the
synergetic effect of the concurrent administration of CYAD-01 with
standard chemotherapy in patients suffering from metastatic
colorectal cancer
Christian Homsy, CEO of Celyad
commented: “We are pleased with our progress
during the third quarter, particularly with the complete response
in a relapse refractory AML patient to the CYAD-01 therapy in our
THINK trial. This, together with the clinical activity detected in
all AML patients treated so far encourages us to rapidly progress
in our development. Having seen this activity, we want to build
upon it and explore how to strengthen it and make it more
robust. The research steps are behind us now, and the
development strategy we are engaged in will investigate approaches
that will both strengthen the responses and make them more durable,
when needed.”
The clinical responses obtained by Celyad are
perceived as a key milestone not only for the company, but also for
the CAR-T field as a whole, as this is the first time that a
patient has shown a complete response to a CAR-T therapy without
pre-conditioning. Christian Homsy added: “The
results validate CYAD-01 and NKG2D as a target in AML, a severe
disease that affects approximately 20,000 people in the US and
almost as many people in Europe. Celyad will further investigate
CYAD-01 in this indication as well as in colorectal cancers, an
indication for which CYAD-01 has also demonstrated interesting
results.”
THIRD QUARTER 2017 OPERATIONAL AND
FINANCIAL REVIEW
In July 2017, Celyad initiated the SHRINK trial,
an open-label Phase 1 study 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. The trial
includes a dose escalation and an extension stage. The dose
escalation design will include three dose levels adjusted to body
weight: up to 1x108, 3x108 and 1x109 CYAD-01 cells. At each dose,
patients will receive three successive administrations, two weeks
apart, at the specified dose. The dose escalation portion of the
study will enroll up to 18 patients and the extension phase will
enroll 21 additional patients. SHRINK is being conducted in
oncology centers in Belgium.
In August 2017, Celyad amended its existing
agreements with Celdara Medical LLC and Dartmouth College. Under
the amended agreements, Celyad will receive an increased share of
future revenues generated by these assets, including revenues from
its sublicensees. In return, Celyad paid Celdara Medical and
Dartmouth College an upfront payment of $12.5 million (€10.6
million) and $12.5 million worth of Celyad shares at a share price
of €32.35 corresponding to a 14% premium versus the prior trading
day.
Patrick Jeanmart, CFO of Celyad,
added, “Our revised agreements with Celdara Medical and
Dartmouth College reflect our strong belief in the value-creating
potential of our allogeneic CAR-T cell patent portfolio and our
ongoing confidence in CYAD-01. By shifting some of the value of the
original deal upfront, we have increased our share of potential
future revenues from sublicenses.”
The Company ended the quarter with €40 million
in cash. Use of cash over the third quarter of 2017 amounted to €29
million, of which €18 million paid to Celdara Medical and Dartmouth
College as a result of our new license agreements. The cash burned
by our operations was €11 million over the third quarter and €27
million over 2017, in line with our expectations. The company
confirms its previous guidance, that existing cash, cash
equivalents and short-term investments are sufficient to fund
operating expenses and capital expenditure requirements, based on
the current scope of activities, through to the first half
2019.
EVENTS SUBSEQUENT TO
QUARTER-END
In October 2017, Celyad announced a first ever
morphologic complete response (MLFS3) with gene-engineered T-cells
without prior pre-conditioning chemotherapy for a patient with
relapsed refractory AML. At the first dose-level, 3x108, CYAD-01
T-cells were administered without any prior conditioning
chemotherapy to a cohort of three patients with hematologic cancer
(two with AML and one with multiple myeloma): One AML patient
achieved a MLFS administered at the H. Lee Moffitt Cancer Center
and Research Institute in Tampa, Florida. A second AML patient
treated also reached a Complete Response (CR) and more precisely a
Complete Response with incomplete hematologic recovery. Unlike the
patient that reached MLFS, this second patient progressed after a
while and has since moved to another treatment.
The first AML patient treated at the second
dose-level (1x109) was reported as Stable Disease with improvement
of his hematological parameters at 2-month follow-up post
treatment.
To date, all AML patients have shown varying
clinical responses that are attributed to the CYAD-01
treatment.
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, please contact: |
|
Celyad |
Christian Homsy, CEO and Patrick Jeanmart CFO
- T: +32(0) 10 39 41 00 –
investors@celyad.com |
Nicolas Van Hoecke, Director, Investor Relations &
Communications - T: +32(0) 10 39 41 48 –
nvanhoecke@celyad.com |
For Europe: Consilium Strategic
Communications |
Chris Gardner and Chris
Welsh - 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 and Sabine Leclercq
- T.: +32 (0)2 290 90 90 – celyad@comfi.be |
For the U.S.: Stern Investor Relations |
Will O’Connor and Michael Schaffzin
– T.: +1 212.362.1200 –
celyad@sternir.com |
|
For more information, 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.
1 THINK: THerapeutic
Immunotherapy with CAR-T
NKG2D
2 SHRINK: Standard
CHemotherapy Regimen and
Immunotherapy with CAR-T
NKG2D
3 MLFS « Morphological Leukemia-Free
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