Celyad Oncology Announces Third Quarter 2022 Financial Results and Recent Business Highlights
November 10 2022 - 12:01AM
Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the “Company”), a
biotechnology company focused on the discovery and development of
chimeric antigen receptor T cell (CAR T) therapies for cancer,
today provided an update on its financial results and recent
business developments for the fiscal quarter ended September 30,
2022.
“This past quarter has been a pivotal moment for
the Company as we focus on a new Celyad 2.0 strategy as we seek to
monetize our valuable IP estate and leverage our dynamic shRNA
technology for our R&D programs. We’ve bolstered our cash
runway with an asset purchase agreement for our manufacturing
business unit and we believe we are well-positioned to unleash the
power of our IP estate and potentially redefine the cell therapy
space,” said Michel Lussier, interim Chief Executive Officer of the
Company.
Recent Highlights
- The Company
entered into a €6 million asset purchase agreement with Cellistic
whereby Cellistic acquired Celyad Oncology’s Good Manufacturing
Practice (GMP) grade cell therapy manufacturing facility
- Based on a
strategic, financial and medical review, taking into account the
costs associated with the pursuit of the program and the delays to
reach key medical milestones following the resolution of the
previously announced clinical hold, the Company has decided to
discontinue the development of CYAD-101
Update on Business Model and Research
Programs
As previously announced, with Celyad 2.0, Celyad
Oncology is implementing a strategic shift from an organization
focused on clinical development to one prioritizing R&D
discovery and the monetization of its IP estate through
partnerships, collaborations and license agreements. The Company
intends to focus its R&D efforts on areas of expertise where it
believes it can leverage the differentiated nature of its platform
technology and continue to bolster its IP estate.
The Company possesses key technology and
controls IP which covers the potential development of
next-generation therapies, including those using short hairpin RNA
(shRNA) and T cell receptor Inhibitor Molecule (TIM). Celyad
Oncology has expanded the IP estate in-licensed from Dartmouth
College with additional patents to broadly cover aspects of
allogeneic cell therapy. Current discovery programs have the
potential to create additional independent IP. The Company is
developing a potential next-generation NKG2D Type I receptor CAR T
candidate and a technology to potentially utilize this receptor as
a basis for dual CAR technology. The Company is also considering
the potential to focus R&D efforts on either B7-H6 CAR T or
bispecific antibody candidates for a powerful new antigenic target
in the oncology field.
In addition, the Company is seeking to advance
its shRNA platform through multiplexing technology that allows it
to modulate multiple genes simultaneously. This technology is
potentially complementary to the Company’s All-in-One Vector
approach, which allows for the expression of multiple shRNAs in a
single construct within a single transduction step. Combining
multiplexed shRNAs with CARs and additional genes of choice
provides potential for broad therapeutic functionality.
Update on Clinical 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).
- CYAD-211 was
developed to demonstrate potential proof of concept of shRNA
technology in the clinic. Our other clinical studies of shRNA
disclosed to date have demonstrated encouraging safety and
bioactivity signals, and its use as a technology to avoid
Graft-versus-Host disease of allogeneic CAR Ts could be a viable
approach
- Clinical updates
are expected by year end
Third Quarter 2022 Financial
Review
As of September 30, 2022, the Company had cash
and cash equivalents of €13.4 million ($13.1 million). Net cash
burn during the first quarter of 2022 amounted to €1.0 million
($1.0 million), in line with expectations. The Company confirms its
previous guidance that its existing cash and cash equivalents
should be sufficient to fund operating expenses and capital
expenditure requirements up to mid-2023. This guidance does not
include any potential proceeds from the equity purchase agreement
established with Lincoln Park Capital Fund, LLC.
After due consideration of detailed budgets and
estimated cash flow forecasts for the years 2022 and 2023 which
reflect the current strategy of the Company and include expenses
and cash outflows estimations in relation to the development of
discretionary research programs and pipeline of products
candidates, the Company continues to project that its existing cash
and cash equivalents will not be sufficient to fund its estimated
operating and capital expenditures over at least the next 12 months
from the date that the release is issued.
About Celyad Oncology
SA
Celyad Oncology is a biotechnology company
focused on the research and discovery of chimeric antigen receptor
T cell (CAR T) therapies for cancer. The Company is focusing on
opportunities to fully harness the true potential of its
proprietary technology platforms and intellectual property and
support the development of next-generation CAR T candidates in
solid tumors and hematological malignancies. Celyad Oncology is
based in Mont-Saint-Guibert, Belgium and New York, NY. For more
information, please visit
www.celyad.com.
Forward-looking statements
This release may contain forward-looking
statements, within the meaning of applicable securities laws,
including the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, statements regarding
beliefs about and expectations for the Company’s updated strategic
business model, including associated costs, cost savings and
timing, statements concerning CYAD-211, including its therapeutic
potential and the timing of clinical data, and statements
concerning the financial position and cash burn of the Company,
including the financial guidance concerning the sufficiency of cash
to fund operations into mid-2023. The words “will,” “expect,”
“believe,” “potential,” “continue,” “target”, “intend”, “could”,
“should” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements in this release are based on management’s current
expectations and beliefs and are subject to a number of known and
unknown risks, uncertainties and important factors which might
cause actual events, results, financial condition, performance or
achievements of Celyad Oncology to differ materially from those
expressed or implied by such forward-looking statements. Such risks
and uncertainties include, without limitation, risks related to the
material uncertainty about the Company’s ability to continue as a
going concern; the Company’s ability to realize the expected
benefits of its updated strategic business model; the Company’s
ability to develop its IP assets and enter into partnerships with
outside parties; risks related to the Company’s ability to execute
on its plans regarding its clinical programs; and other risks
identified 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 by 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 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.
Investor and Media Contact:
Celyad Oncology investors@celyad.com
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