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Celyad Oncology Provides Fourth Quarter 2023 Business Update and 2024 Outlook

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Celyad Oncology's 2023 business update highlights the progress made in broadening the range of cancer indications targeted by CAR T-cells and overcoming the main limitations of current CAR T-cell therapies. The company obtained commitments for a capital increase of up to €9.8 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2025. The company also shared data validating its shRNA multiplexing approach and multispecific NKG2D-based CAR T-cell platform. As of December 31, 2023, the company had cash and cash equivalents of €3.0 million and short-term investments of €4.0 million, projected to be sufficient for funding operating expenses and capital expenditure requirements into the second quarter of 2025. The outlook for 2024 includes the sharing of more data and evidence in the context of the multispecific CAR T-cell platform and shRNA multiplexing approach.
Positive
  • Commitments for a capital increase of up to €9.8 million obtained
  • Cash and cash equivalents of €3.0 million and short-term investments of €4.0 million as of December 31, 2023
  • Data validating shRNA multiplexing approach and multispecific NKG2D-based CAR T-cell platform shared
  • Outlook for 2024 includes sharing more data and evidence in the context of the multispecific CAR T-cell platform and shRNA multiplexing approach
Negative
  • None.

Insights

Reviewing the recent update from Celyad Oncology, the focus on proprietary non-gene editing technology platforms and the development of multispecific CAR-T cells is a significant stride in the biotechnology sector, particularly in the field of cancer treatment. The company's approach to multiplexing shRNA sequences is an innovative method to enhance the effectiveness of CAR-T therapies, which have historically faced challenges such as limited target range and T-cell exhaustion. By targeting multiple genes simultaneously, Celyad may potentially improve the efficacy and durability of these therapies.

Furthermore, the development of multispecific CAR-T cells that can target both hematological malignancies and solid tumors addresses a critical need in oncology. The ability to counteract relapses due to antigen loss could significantly reduce the recurrence of cancer post-treatment. The financial stability indicated by the company's cash runway extending into Q2 2025 provides it with a strategic advantage to continue its research and development without the immediate pressure of additional fundraising.

The capital increase of €9.8 million in two tranches, supported by key investors, reflects confidence in Celyad Oncology's strategic direction and technological advancements. This financial backing is crucial for the company's sustainability and allows for the continuation of its R&D pipeline. The company's cash position, with €3.0 million in cash and cash equivalents and €4.0 million in short-term investments as of December 31, 2023, coupled with the projection of funding sufficiency until Q2 2025, provides a buffer against market volatility and economic downturns. This financial health is an essential factor for investor confidence and can impact the company's stock performance.

The anticipation of more data in the first half of 2024 and the potential initiation of clinical trials, could act as catalysts for the company's stock. Strategic partnerships may also play a pivotal role in accelerating development and commercialization efforts, which could lead to an uptick in market valuation.

Celyad's emphasis on a robust and broad IP portfolio is a defensive and offensive business strategy that can create significant barriers to entry for competitors. The IP estate not only protects the company's scientific advancements but also provides leverage in potential licensing deals or collaborations. Given the competitive nature of the CAR-T space, a strong IP position is a valuable asset that can contribute to the company's long-term market share and revenue potential.

As the biotechnology industry is highly dependent on innovation, the company's focus on securing its IP and presenting new data at scientific conferences is a strategic move to maintain its position at the forefront of the field. This approach could lead to future monetization opportunities through partnerships or licensing agreements, which would be beneficial for the company's growth and profitability.

Three main pillars to unlock the potential of proprietary technology platforms and intellectual property:

  • A proprietary non-gene editing technology platform based on multiplexing of short hairpin ribonucleic acid (shRNAs)-derived sequences to broaden the capacities of CAR-Ts
  • Differentiated targets to widen the range of indications and the development of multispecific CARs to overcome the main limitations of current CAR-T therapies
  • A robust and broad Intellectual Property (IP) portfolio

MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)-- Celyad Oncology (Euronext: CYAD) (the “Company”), today provides a fourth quarter 2023 business update and an outlook for 2024.

Michel Lussier, interim Chief Executive Officer of Celyad Oncology, commented: “2023 has been a very important year for Celyad Oncology, after the changes that occurred in 2022. Our research team has made a remarkable progress to broaden the range of cancer indications that could be targeted by chimeric antigen receptor (CAR) T-cells and to tackle the main limitations of current CAR T-cell therapies. We have shared new data at several scientific and business conferences along the year, and published in high impact peer-reviewed journals. We are eager to see the impact of our efforts to unleash the power of our IP estate and stay at the forefront of next-generation CAR T-cell development.

2023 corporate accomplishments

  • On August 24, 2023, the Company announced that it obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million in 2 tranches:
    • A first tranche of 2.0 million was disbursed in the context of authorized capital as of September 4, 2023; and
    • A second tranche subscribed by Fortress was approved by the extraordinary shareholders’ meeting of November 14, 2023. Following this private placement, the Company believes that its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the second quarter of 2025.

2023 operational highlights

  • Multiplex short hairpin ribonucleic acid (shRNA) non-gene edited technology – All along 2023, we have collected and presented data validating our shRNA multiplexing approach:
    • We developed a chimeric micro-RNA (miRNA) cluster to enable multiplexing of shRNAs, designed for easy, efficient, and tunable downregulation of up to four target genes simultaneously in CAR T-cells;
    • Results detailing the technical aspects of the development of this platform have been published in Molecular Therapy – Nucleic Acids (Mol Ther Nucleic Acids. 2023, 34:102038). This publication has raised much interest from the community and was subjected to an editorial comment in the same volume of the Journal (Mol Ther Nucleic Acids. 2023, 34:102077);
    • Additional data which demonstrate feasibility of this approach in the context of allogeneic cell therapies or with the aim to create therapies able to overcome the coinhibitory effects of exhaustion markers were presented at several scientific conferences. Posters are available on the company’s website, at https://celyad.com/our-science-technology/publications/.
  • Multispecific NKG2D-based CAR T-cell platform – In 2023, we have compiled and presented data validating our multispecific approach targeting NKG2D ligands (NKG2DL):
    • We have developed different CD19/NKG2DL, BCMA/NKG2DL and PSMA/NKG2DL multispecific CAR T-cells, utilizing both tandem constructs – that encompass the extracellular domain of the natural NKG2D receptor fused to a scFv targeting CD19, BCMA or PSMA, or dual constructs – that co-express the NKG2D-based CAR with an anti-CD19, anti-BCMA or anti-PSMA CAR, respectively;
    • Our data provides the proof-of-concept that NKG2DL are valuable targets in a multispecific CAR approach and demonstrate our CD19/NKG2DL multispecific CAR T-cells are highly effective to counteract relapses due to CD19 antigen loss in vivo. In vitro data generated with BCMA/NKG2DL and PSMA/NKG2DL multispecific CAR T-cells further validate this approach in other hematological and solid indications. Posters are available on the company’s website, at https://celyad.com/our-science-technology/publications/.

Financial highlights

As of December 31, 2023, the Company had cash and cash equivalents of €3.0 million and short-term investments of €4.0 million. The Company projects that its existing cash, cash equivalents and short-term investments should be sufficient to fund operating expenses and capital expenditure requirements into the second quarter of 2025. Therefore, the Company continues to project that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date of this press release.

Outlook for 2024

  • More data and evidence in the context of the multispecific CAR T-cell platform and shRNA multiplexing approach will be shared in the first half of 2024, with the aim to develop assets ready for a potential initiation of clinical trials either by the Company and/or through strategic partnerships afterwards.
  • Celyad Oncology will attend the 7th CAR-TCR Europe summit in London, UK (February 27-29, 2024), the must-attend forum to brainstorm and stay at the forefront of cell therapy innovations.

Financial Calendar 2024

  • April 5th, 2024
     
  • Full Year 2023 Financial Results
  • May 6th, 2024
     
  • Annual shareholders meeting
  • August 6th, 2024
     
  • First Half 2024 Interim Results

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

About Celyad Oncology

Celyad Oncology is a cutting-edge biotechnology company dedicated to pioneering the discovery and advancement of revolutionary technologies for chimeric antigen receptor (CAR) T-cells. Its primary objective is to unlock the potential of its proprietary technology platforms and intellectual property, enabling to be at the forefront of developing next-generation CAR T-cell therapies. By fully leveraging its innovative technology platforms, Celyad Oncology aims to maximize the transformative impact of its candidate CAR T-cell therapies and redefine the future of CAR T-cell treatments. Celyad Oncology is based in Mont-Saint-Guibert, Belgium. 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 continuation of the Company’s existence, its cash and cash runway. The words “will,” “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.

Source: Celyad Oncology SA

Celyad Oncology Contacts:

Investor & Media Contact:

David Georges, VP Finance and Administration

investors@celyad.com

communications@celyad.com

Source: Celyad Oncology

FAQ

What is Celyad Oncology's financial status as of December 31, 2023?

As of December 31, 2023, Celyad Oncology had cash and cash equivalents of €3.0 million and short-term investments of €4.0 million.

What are the highlights of Celyad Oncology's 2023 business update?

The 2023 business update highlights the progress made in broadening the range of cancer indications targeted by CAR T-cells and overcoming the main limitations of current CAR T-cell therapies.

What is the outlook for 2024 for Celyad Oncology?

The outlook for 2024 includes the sharing of more data and evidence in the context of the multispecific CAR T-cell platform and shRNA multiplexing approach.

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Mont-Saint-Guibert