Celyad Oncology SA - Letter to Shareholders
01 March 2023 - 3:16AM
The following is a statement by Celyad Oncology:
Dear Shareholder,
2022 has been a crossroad year for Celyad
Oncology (the “Company”), with important changes and turning
points. Whilst our clinical programs had clear potential, as we
pursued clinical development over the years, we systematically
discovered more effective ways of furthering our goal to impact
cancer with CAR-T cell therapy. Also, Celyad transitioned from
autologous to allogeneic approaches, which changed our company
dynamic. We faced challenges stemming from insufficient clinical
efficacy: our allogeneic program, CYAD-211, as evaluated in the
IMMUNICY-1 trial, did not demonstrate sufficient clinical efficacy
to be pursued into Phase II studies without changing the treatment
scheme or eligibility criteria. In addition, serious adverse events
were reported in the KEYNOTE-B79 trial of our lead allogeneic
program, CYAD-101, which resulted in a temporary suspension of the
trial. Here, as with CYAD-211, we could only pursue the program
with a change of the eligibility criteria, which would have
resulted in additional delays and costs.
This stream of events in the first months of
2022 led to the decision by the board of directors to reshape the
strategy of the Company, to focus on its core assets, its world
class research unit and intellectual property. A re-organization
plan was put in place in June, under the leadership of Michel
Lussier, who stepped down as chairman of the board and assumed the
position of CEO ad interim, succeeding our then-CEO and CFO,
Filippo Petti. Hilde Windels, a member of our board since 2017,
stepped in as Chair.
The Company executed an in-depth organizational
transformation in the second half of the year:
- Significant cost cutting and cost
saving initiatives have been implemented in order to strictly
allocate the resources of the Company to the activities and
programs that could potentially bring maximum value to
shareholders. To that end, Celyad discontinued non-strategic
R&D programs and opted not to begin any new clinical trial
development;
- A hiring freeze was implemented as
of March 2022;
- 26 employees and four contractors
were transferred in October to Cellistic™ (a division of Ncardia)
following the acquisition of Celyad’s Cell Therapy Manufacturing
Unit (CTMU) by Ncardia Belgium SA;
- Effective 9 January 2023, the
clinical team (eight employees) joined the organization of
ProPharma Group Holdings LLC, a global reputed CRO with whom Celyad
has simultaneously entered into a service agreement for support
relating to the closing of its clinical trials. The clinical trials
remain under the Company’s responsibility as sponsor while the
clinical workforce has been transferred to said partner to secure a
seamless closing of the clinical studies, preserving the best
interests of the patients and investigational sites; and
- The Company also sold several
assets (e.g. equipment & refurbishment for 1,3Mi€ in order to
relocate to a nearby facility, better suited to the Company’s
future needs).
All initiatives undertaken by the Company since
spring 2022 have created a projected cash burn reduction that would
allow a forecasted cash runway extension by approximately 12
months, up to the fourth quarter of 2023, without any external
financing.
Starting in 2023, Celyad Oncology will now
entirely focus on its new business strategy, moving forward with an
adapted organization and, we believe, the right headcount to
successfully deliver on it.
On the financing side, in the third quarter of
2022, the Company engaged Van Lanschot Kempen N.V. to evaluate
several financing options.
In summary, while our clinical results have not
lived up to expectations, we are hopeful for the many patients who
have been successfully treated in these programs and the solid
foundation it has created to move these therapies further. We
believe that our clinical accomplishments, strengthened with the
current and future research efforts, can lead to commercially
successful products.
Having dealt with the 2022 challenges, Celyad
has now successfully reinvented itself as a leaner, more agile
organization with three clear objectives:
1) Strengthen its research focus
centered around NKG2D, B7-H6 and shRNA platforms;
2) Maximize its valuable IP
estate and
3) Drive innovation through
strategic collaborations.
We believe that Celyad is well prepared and has
the relevant unique assets and know how to create significant
shareholder value in the next few years.
Michel LussierCo-Founder, Interim CEO |
Hilde WindelsChair |
About Celyad Oncology
Celyad Oncology is a biotechnology company
focused on the discovery and development of innovative technologies
for 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.
Source: Celyad Oncology SA
Investor Contact: David Georges. investors@celyad.comMedia
Contact: Caroline Lonez. communications@celyad.com
PDF available:
http://ml.globenewswire.com/Resource/Download/350227c5-0e77-4806-8162-70facdd7a724
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