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Celyad Oncology announces non-cash impairment

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Mont-Saint-Guibert, Belgium – 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 announced a non-cash impairment of its goodwill and intangible oncology assets.

This impairment comes as a result of the Company’s strategic shift in focus away from clinical development and the early stage nature of the implementation of the Celyad 2.0 strategy: shifting from an organization focused on clinical development to one prioritizing R&D discovery and the monetization of its intellectual property (IP) portfolio through partnerships, collaborations and license agreements. As, to date, no effective sublicence contract nor collaboration contract was concluded, some uncertainty exists on the timing and amount of the deal flow and associated short, medium and long term revenues.

Given this uncertainty, and per accounting standards, the Company will recognize a full impairment loss on the remaining value of goodwill, In Process Research and Development, and Horizon Discovery’s shRNA platform, resulting in a non-cash impairment of €20.5 million on a statutory basis and €35.1 million on a consolidated basis for the financial year ended December 31, 2022.

This accounting conclusion, which reflects the Company’s financial situation as of December 31, 2022, does not affect the Management’s commitment to continue the potential monetization of the Company’s IP. The conclusion of the impairment analysis and additional details will be provided with the publication of the Company’s fiscal year 2022 results on or around March 23, 2023.

The net assets of the Company as of December 31, 2022, on a BE-GAAP non-consolidated basis, have fallen below half of the Company’s capital. As a result, in accordance with Article 7:228 of the Belgian Code for Companies and Associations, the Board of Directors plans to submit for a vote, at its May 5, 2023 shareholders’ meeting, its business plan including a proposal to continue the Company’s activities. The Board of Directors will publish a detailed report regarding this proposal on or around April 3, 2023, together with the convocation with proposed resolutions for the shareholders’ meeting.

The audit for fiscal year 2022 has not yet been fully completed.

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Letter to Shareholders

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Mont-Saint-Guibert, Belgium – 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 its 2023 Letter to Shareholders.

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 Lussier

Co-Founder, Interim CEO

Hilde Windels

Chair

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Celyad Oncology provides fourth quarter 2022 business update and 2023 outlook

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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)

Mont-Saint-Guibert, Belgium – 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

March 23rd, 2023Full Year 2022 Financial Results
May 5th, 2023First Quarter 2023 Business Update
May 5th, 2023Annual shareholders meeting
August 3rd, 2023First Half 2023 Interim Results
November 9th, 2023Third Quarter 2023 Business Update

The financial calendar is communicated on an indicative basis and may be subject to change.

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Celyad Oncology provides an update on its strategic business model, continuing to focus on opportunities to fully harness the true potential of its proprietary technology platforms and intellectual property

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Mont-Saint-Guibert, Belgium – 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 an update on its Celyad 2.0 business strategy which has been adopted and implemented over the last few months.

In keeping with this strategy, the Company intends to focus on maximizing its valuable intellectual property (IP) estate, and strengthening its research focus.

  • 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.
  • In addition to IP partnering transactions, Celyad 2.0 will prioritize discovery research in areas of expertise where it can leverage the differentiated nature of its platforms. The Company is implementing a differentiated and innovative strategy, tackling the major current limitations of CAR T-cell therapies. This strategy includes:
    • Multiplexing approach of the short hairpin RNA (shRNA) platform, allowing multiple genes, including essential and functional genes, to be modulated simultaneously;
    • Dual CAR development of a next-generation NKG2D-based CAR which may help to overcome resistance and immune escape often observed with traditional single targeting approaches; and
    • Development of B7-H6-targeting immunotherapies as the Company believes that B7-H6 is an underappreciated target that could change the paradigm of cell therapy due to its broad expression in a large variety of cancers.

Celyad Oncology is of the opinion that it will potentially create more shareholder value by licensing its patent estate and further strengthening its research efforts to improve the differentiated nature of its platforms.

Based on a strategic and financial review, the Company has decided to discontinue the development of its remaining clinical program CYAD-211 (the allogeneic shRNA-based, anti-BCMA CAR T candidate for relapsed or refractory multiple myeloma (r/r MM)). There were no safety concerns leading to this decision and all patients previously treated with CYAD-211 will continue to receive their protocol-defined follow-up.

The key data points of the program are as follows:

  • 19 r/r MM patients have been treated with CYAD-211 in the IMMUNICY-1 trial which was developed to validate shRNA technology in the clinic;
  • The observed safety profile, including the lack of observed Graft-versus-Host disease, provides proof-of-concept for the use of shRNA technology for allogeneic CAR Ts;
  • Out of 17 evaluable patients, a partial response was achieved in five patients. One patient was recently re-treated with a second dose of CYAD-211 after having reached stable disease post first infusion; and
  • Enhanced lymphodepletion did not seem to improve clinical activity nor persistence of the cells post-infusion.

Anticipated milestones for 2023

  • The Company will take part in several conferences including The World Oncology Cell Therapy Congress in April and the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting in November; and
  • 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 second quarter of 2023.
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Cellistic and Celyad Oncology Announce GMP Cell Therapy Manufacturing Operations Transaction

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Gosselies and Mont-Saint-Guibert, Belgium – Cellistic, the cell therapy development and manufacturing  business of Ncardia BV, and Celyad Oncology (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, announced today a transaction whereby Cellistic will acquire Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell therapy manufacturing capability, including the existing facility and all related personnel (the “Manufacturing Business Unit”).

Under the terms of an asset purchase agreement between Celyad Oncology and Cellistic, Cellistic agreed to acquire Celyad Oncology’s Manufacturing Business Unit in Mont-Saint-Guibert, Belgium, for a total consideration of €6 million. Celyad Oncology’s experienced manufacturing team will join Cellistic. The transaction is subject to a number of customary conditions precedent and is anticipated to close in the fourth quarter of this year.

“We at Cellistic are incredibly excited to welcome this uniquely talented team into our organization,” said Stefan Braam, founder and CEO of Cellistic. “We’re bringing aboard a group of people whose passion and capabilities align incredibly well with our vision for the future of cell therapy. As a joined force, we have the talent and resources to further accelerate work on our proprietary platforms and the capability to enable Cellistic’s partners to bring iPSC-based allogeneic cell therapies to patients faster.”

Michel Lussier, co-founder and interim CEO of Celyad Oncology, said, “We have focused our efforts on an allogeneic approach for the past few years and our manufacturing facility and staff has been a key element to enable many of our past trials, but has been underutilized in recent years as we mainly used the facility for our autologous candidates. Our current allogeneic programs are better suited for outsourced manufacturing. Through existing materials manufactured at Celyad, we have ensured the means to continue our clinical programs with cryopreserved cells until 2024. Based on this strategy, we are confident that this decision to transfer our manufacturing facility and the staff to Cellistic, who is the perfect company for such an agreement, will allow us to further execute on our business goals in the future.”

Cellistic will invest substantial capital into the newly acquired 11,000 square foot facility, which will be optimized for its iPSC-based allogeneic cell therapy platforms and processes creating the world’s first purpose built facility to support customers from cell reprogramming and master cell banking through clinical trial material manufacturing. A team of more than 30 manufacturing, quality and related personnel from Celyad Oncology, all with substantial cell therapy manufacturing and immune-oncology experience, will join Cellistic as part of this transaction.

Celyad Oncology will provide additional guidance on the future business strategy of the Company in the fourth quarter of this year.

Celyad Oncology to Announce First Half 2022 Financial Results and Host Conference Call

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Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company will report first half 2022 financial and operating results on the morning of Friday, August 5, 2022.

Following the press release, Celyad Oncology management will host a conference call that day Friday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2022 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +1 201 493 6779 (International), + 1 877 407 9716 (United States) or +32 (0) 800 73 904 (Belgium) and ask to be joined into the Celyad Oncology SA call.

To access the live webcast and archived recording, visit the “Events” section of the Celyad Oncology website.

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