Celyad Oncology Provides Fourth Quarter 2022 Business Update and 2023 Outlook
February 03 2023 - 1:00AM
Business Wire
Celyad Oncology has implemented a strategic shift from an
organization focused on clinical development to one fully
harnessing the true potential of its proprietary technology
platforms and intellectual property
- The company is now prioritizing internal discovery endeavors to
tackle the major current limitations of CAR T-cell therapies
- As of December 31, 2022, the Company ended the year with an
unaudited treasury position of €12.4 million ($13.3 million)
Regulatory News:
Celyad Oncology (Euronext & Nasdaq: CYAD) (the “Company”), a
biotechnology company focused on the discovery and development of
innovative technologies for chimeric antigen receptor (CAR) T-cell
therapies, today provides a fourth quarter 2022 business update and
an outlook for 2023.
Michel Lussier, interim Chief Executive Officer of Celyad
Oncology, said: “The second half of 2022 has been a pivotal time
for the Company as we have engaged in a new Celyad 2.0 strategy to
leverage our innovative technologies and R&D platforms and
focus on IP partnering transactions. We’ve stretched our cash
runway by divesting our manufacturing business unit, and
discontinued our clinical programs to focus on selected, critical
R&D efforts to mitigate the current limitations of CAR T-cell
therapy. We believe we are now well-positioned to unleash the power
of our IP estate and to help making the cell therapy approach a
success.”
Operational highlights
- The Company announced a strategic shift in October 2022 to
prioritize discovery research in areas of expertise where it can
leverage the differentiated nature of its platforms. The Company
has implemented a differentiated and innovative strategy, which it
believes has the potential to tackle the major current limitations
of CAR T-cell therapies. This strategy includes a multiplexing
approach of the short hairpin RNA (shRNA) platform, a dual CAR
development of a next-generation NKG2D-based CAR, and the
development of B7-H6-targeting immunotherapies.
- In October 2022, the Company decided to discontinue the
development of CYAD-101, the allogeneic TIM-based, NKG2D-based CAR
T-cell candidate for metastatic colorectal cancer (mCRC), based on
a strategic, financial and medical review, taking into account the
costs associated with the pursuit of the program. There were no new
safety concerns leading to this decision. The clinical hold
announced in March 2022 on the CYAD-101-002 Phase 1b trial had been
lifted in July 2022 by the FDA.
- Data collected in the IMMUNICY-1 trial of the clinical program
CYAD-211, the allogeneic shRNA-based, anti-BCMA CAR T candidate for
relapsed or refractory multiple myeloma (r/r MM), which was
developed to validate shRNA technology in the clinic, have shown a
favorable safety profile for CYAD-211 across all dose-levels and
cohorts, with 19 patients treated in total. The lack of observed
graft-versus-host disease (GvHD) despite engraftment of CYAD-211
provided proof-of-concept for the use of shRNA as a technology to
control GvHD of allogeneic CAR T-cells.
- In December 2022, the Company decided to discontinue the
development of its remaining clinical program CYAD-211 based on a
strategic and financial review. There were no safety concerns
leading to this decision and all patients previously treated with
CYAD-211 still continue to receive their protocol-defined
follow-up.
Corporate highlights
- In September 2022, the Company entered into a €6 million asset
purchase agreement with Cellistic, the cell therapy development and
manufacturing business of Ncardia BV, whereby Cellistic acquired
Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell
therapy manufacturing business unit.
- Since October 2022, the Company has implemented a strategic
shift from an organization focused on clinical development to one
prioritizing R&D discovery and leveraging its IP estate through
partnerships, collaborations and license agreements. The Company
has compiled a foundational and broad IP estate that controls key
aspects of developing therapies in the allogeneic cell therapy
space. The patents around allogeneic CAR T-cell therapies and
NKG2D-based therapies provide an avenue to develop intellectual
property programs and to partner with outside parties around the
licensing of these patents.
Financial highlights
As of December 31, 2022, the Company had cash and cash
equivalents of €12.4 million ($13.3 million). Net cash burn during
the fourth quarter of 2022 amounted to €1.0 million, in line with
expectations. The Company projects that its existing cash and cash
equivalents should be sufficient to fund operating expenses and
capital expenditure requirements into the fourth quarter of
2023.
After due consideration of detailed budgets and estimated cash
flow forecasts for the year 2023, which reflect the new strategy of
the Company and include expenses and cash outflows estimations in
relation to the development of its proprietary technology platforms
and intellectual property, 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 this release is issued.
Outlook for 2023
- Celyad Oncology is increasing 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 will continue to leverage the dynamic potential
of the shRNA platform, and to explore options to tackle the major
current limitations of CAR T-cell therapies through its dual
targeting CARs with NKG2D capabilities and B7-H6 targeting cell
therapies.
- The Company will provide updates on the potential
proof-of-concept of the dual CAR and multiplexing research programs
and on business development in the course of 2023 and will take
part in several conferences to share these data.
Financial Calendar 2023
Full Year 2022 Financial Results
First Quarter 2023 Business Update
Annual shareholders meeting
First Half 2023 Interim Results
Third Quarter 2023 Business Update
The financial calendar is communicated on an indicative basis
and may be subject to change.
About Celyad Oncology Celyad Oncology is a biotechnology
company focused on the discovery and development of innovative
technologies chimeric antigen receptor (CAR) T-cell therapies. 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.
Celyad Oncology Forward-Looking Statement 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 potential benefits, transactions and partnerships,
statements regarding the potential value of the Company’s IP, and
statements regarding the Company’s cash and cash runway. The words
“will,” “believe,” “potential,” “continue,” “target,” “project,”
“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; the Company’s ability to enforce its patents and
other IP rights; the possibility that the Company may infringe on
the patents or IP rights of others and be required to defend
against patent or other IP rights suits; the possibility that the
Company may not successfully defend itself against claims of patent
infringement or other IP rights suits, which could result in
substantial claims for damages against the Company; the possibility
that the Company may become involved in lawsuits to protect or
enforce its patents, which could be expensive, time-consuming, and
unsuccessful; the Company’s ability to protect its IP rights
throughout the world; the potential for patents held by the Company
to be found invalid or unenforceable; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230202005604/en/
Celyad Oncology Contacts:
Investor Contact: David Georges VP Finance and
Administration investors@celyad.com
Media Contact: Caroline Lonez R&D Communications and
Business Development communications@celyad.com
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