CORRECTION - Celyad Oncology Announces First Quarter 2022 Financial Results and Recent Business Highlights
06 May 2022 - 8:12AM
In a release issued under the same headline earlier today
by Celyad Oncology SA (Euronext & Nasdaq: CYAD), please
note that in the First Quarter 2022 Financial Review section, the
figures for cash and cash equivalents and net cash burn during the
first quarter of 2022 should have been stated as €20.5 million
($22.9 million) and €9.5 million ($10.6 million),
respectively, not €20.6 million ($23.0 million) and €9.4
million ($10.5 million), respectively. The corrected release
follows:
- Enrollment continues in Phase 1
dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic
CAR T candidate, CYAD-211, for relapsed/refractory multiple myeloma
(r/r MM)
- Dialogue continues with regulatory agencies concerning
CYAD-101-002 Phase 1b trial, which remains on clinical hold
Celyad Oncology SA (Euronext & Nasdaq: CYAD)
(the “Company”), a clinical-stage biotechnology company focused on
the discovery and development of chimeric antigen receptor T cell
(CAR T) therapies for cancer, today announced an update on its
financial results and recent business developments for the fiscal
quarter ended March 31, 2022.
“The first quarter of 2022 brought us both
challenges and opportunities that we are facing head-on. While we
continue to investigate the recent developments in the CYAD-101
Phase 1b trial, we are making great progress with our shRNA-based
allogeneic programs, including CYAD-211, for which we anticipate
announcing additional data during the second half of the year,”
commented Filippo Petti, Chief Executive Officer of the Company.
“We are truly thankful for our hardworking team and the support of
our shareholders while we advance towards our milestones for the
year and further enhance our allogeneic CAR T investigational
therapies with our proprietary non gene edited technologies.”
Update on Clinical and Preclinical Programs
CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR
T candidate for r/r MM
- The
dose-escalation Phase 1 IMMUNICY-1 trial is evaluating the
tolerability and clinical activity of a single infusion of CYAD-211
following preconditioning with CyFlu (cyclophosphamide and
fludarabine) in patients with relapsed / refractory multiple
myeloma (r/r MM).
- The current
segment of the IMMUNICY-1 study is evaluating CYAD-211 following
enhanced lymphodepleting (eLD) regimens with the aim to improve
cell expansion and persistence and potentially maximize the
clinical activity of CYAD-211. In addition, the IMMUNICY-1 protocol
allows for redosing of CYAD-211 in certain patients.
- Enrollment in
the eLD cohorts of the IMMUNICY-1 trial continues with additional
data expected from the program in the second half of 2022.
CYAD-101 – Allogeneic TIM-based, NKG2D CAR T
Candidate for Metastatic Colorectal Cancer (mCRC)
- In February 2022, the Company
voluntarily paused the Phase 1b trial of CYAD-101 after two
fatalities occurred that presented with similar pulmonary findings.
Subsequently, in March 2022, the Company was informed by the U.S.
Food and Drug Administration that the CYAD-101-002 Phase 1b trial
had been placed on clinical hold.
- The Company continues to investigate
these findings in the CYAD-101-002 Phase 1b trial and is evaluating
any similar events in additional patients treated in the study,
while also working with appropriate regulatory authorities. The
Company expects to provide additional updates on the trial in the
future.
shRNA Armored CAR (shARC) Franchise
- Research
continues in multiple discovery programs focused on the
co-expression of Interleukin-18 (IL-18) in conjunction with our
short hairpin RNA (shRNA) technology platform, also known as our
shARC (shRNA Armored CAR) franchise.
- In April, the
Company decided to stop the development of CYAD-203, an allogeneic
shRNA-based, IL-18-armored NKG2D CAR T candidate following the
analysis of preclinical data from multiple investigational new drug
application (IND)-enabling studies. The Company continues to
explore back-up allogeneic NKG2D receptor CAR T candidates
currently in discovery stage that leverage the Company’s shARC
platform.
First Quarter 2022 Financial
Review
As of March 31, 2022, the Company had cash and
cash equivalents of €20.5 million ($22.9 million). Net cash burn
during the first quarter of 2022 amounted to €9.5 million ($10.6
million), in line with expectations. The Company confirms its
previous guidance that its existing cash and cash equivalents,
combined with the remaining access to the equity purchase agreement
established with Lincoln Park Capital Fund, LLC, should be
sufficient to fund operating expenses and capital expenditure
requirements until mid-2023.
Financial Calendar
First Half
2022 Financial Results |
August 5,
2022 |
|
Third Quarter 2022 Financial Results |
November 10, 2022 |
|
|
|
|
About Celyad Oncology
SA
Celyad Oncology SA is a clinical-stage
biotechnology company focused on the discovery and development of
chimeric antigen receptor T cell (CAR T) therapies for cancer. The
Company is developing a pipeline of allogeneic (off-the-shelf) and
autologous (personalized) CAR T cell therapy candidates for the
treatment of both hematological malignancies and solid tumors.
Celyad Oncology was founded in 2007 and is based in
Mont-Saint-Guibert, Belgium and New York, NY. The Company has
received funding from the Walloon Region (Belgium) to support the
advancement of its CAR T cell therapy programs. For more
information, please visit www.celyad.com.
Forward-looking statements
This release contains forward-looking
statements, within the meaning of applicable securities laws,
including the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements include, without limitation,
statements regarding: the CYAD-101-002 trial, including the
clinical hold, the timing and outcomes of additional data from
Phase 1 IMMUNICY-1 trial of CYAD-211, safety and clinical activity
of the product candidates in Celyad Oncology’s pipeline, Celyad
Oncology’s financial condition and cash runway, and expected
results of operations and business outlook. The words “may,”
“might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,”
“intend,” “believe,” “expect,” “estimate,” “future,” “potential,”
“continue,” “target” and similar words or expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements are based on management's current
expectations and may involve known and unknown risks and
uncertainties which might cause actual results, financial
condition, performance or achievements of Celyad Oncology to differ
materially from those expressed or implied by such forward-looking
statements. Such risk and uncertainty includes, without limitation:
the timing, duration and outcome of the clinical hold on the
CYAD-101-002 Phase 1b trial, Celyad Oncology’s ability to continue
to access to the equity purchase agreement with Lincoln Park
Capital Fund, LLC, our financial and operating results, the
duration and severity of the COVID-19 pandemic, and global economic
uncertainty, including with respect to geopolitical conditions and
attendant sanctions resulting from the conflict in Ukraine. A
further list and description of these risks, uncertainties and
other risks can be found in Celyad Oncology’s U.S. Securities and
Exchange Commission (SEC) filings and reports, including in the
latest Annual Report on Form 20-F filed with the SEC, and
subsequent filings and reports of Celyad Oncology. These
forward-looking statements speak only as of the date of publication
of this document and Celyad Oncology’s actual results may differ
materially from those expressed or implied by these forward-looking
statements. Celyad Oncology expressly disclaims any obligation to
update any 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.Investor and
Media Contact:
Sara ZelkovicCommunications & Investor Relations
DirectorCelyad Oncology investors@celyad.com
Celyad Oncology (EU:CYAD)
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