Celyad Oncology

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD) (“Celyad” or the “Company”), 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 it has entered into a subscription agreement with an affiliate of Fortress Investment Group (such affiliate “Fortress”) for the private placement of 6,500,000 ordinary shares for gross proceeds of USD 32.5 million (about EUR 28.7 million). The subscription will take place within the framework of the authorized capital and it is expected to close on or about December 8, 2021, subject to satisfaction of customary closing conditions.

Pursuant to the terms of the private placement, the Company will issue the ordinary shares at a price of USD 5.00 (about EUR 4.42) per share, which represents a 18.5% premium to the 30-day volume weighted average price (“VWAP”). The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property.

As a result of the transaction, Fortress will hold 28.8% of the Company’s shares.

Filippo Petti, CEO of Celyad Oncology, commented, “This transformative investment provides an important springboard for the Company and further strengthens our corporate initiatives to advance our novel allogeneic CAR T product candidates. In addition, Fortress’s expertise in the intellectual property domain further validates our robust patent portfolio and emphasizes our position within the allogeneic CAR T field. The growth financing will be essential for us to expand our current allogeneic CAR T pipeline by continuing to exploit our differentiated, non-gene edited technologies and armored CAR T franchise.”

“Celyad Oncology offers a unique optionality around its technology and intellectual property,” said Christopher LiPuma, Director at Fortress. “In particular, the Company’s strong IP position around allogeneic CAR T stands out as a key asset that we believe will provide the foundation for the Company to strategically develop both novel cell therapy candidates and potential partnerships within the exciting off-the-shelf cell therapy landscape.” 

SVB Leerink acted as the exclusive placement agent for the private placement, Goodwin Procter LLP and Harvest acted as legal counsel to the Company. Skadden, Arps, Slate, Meagher & Flom LLP and Eubelius acted as legal counsel to Fortress.

The Company believes that following the close of the private placement, its existing cash and cash equivalents combined with access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the first half of 2023.

In the framework of this investment, Fortress and the Company have entered into a shareholders’ rights agreement. Pursuant to this agreement, Fortress will be subject to a customary lock-up obligation and standstill obligation, in each case for nine months following the closing of the private placement. Furthermore, as long as Fortress holds 10% of the shares of the Company, it will benefit from a right of first offer on any new indebtedness to be incurred by Celyad and on any new equity securities to be issued, pro-rata its shareholding, as well as of the right to nominate two individuals to Celyad’s board of directors. In addition, as long as Fortress holds 15% or more of the outstanding shares of the Company, certain intellectual property transactions will be subject to a 90% board majority for approval. Celyad will propose an amendment to its articles of association to reflect this qualified right.

The securities to be issued in the private placement have not been registered under the Securities Act of 1933 or applicable state securities laws and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements. The Company has agreed to customary registration rights covering the resale of the ordinary shares (in the form of American Depositary Shares) sold in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

• Preclinical data support armoring NKG2D CAR T cells with IL-18 to drive improved anti-tumor activity of the product candidate
• Development continues for second-generation multiplexing shRNA scaffold for novel non-gene edited CAR T candidates with desired phenotypes
• KEYNOTE-B79 Phase 1b trial evaluating CYAD-101 with KEYTRUDA^® (pembrolizumab) in patients with microsatellite stable mCRC set to start in fourth quarter 2021

MONT-SAINT-GUIBERT, Belgium, November 12, 2021 – 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 three poster presentations on the Company’s allogeneic CAR T therapy programs at the Society for Immunotherapy of Cancer (SITC) Annual Meeting taking place in Washington D.C. and virtually November 10-14, 2021.

“With these presentations, we demonstrate how we continue to execute on our strategic vision to develop differentiated next generation CAR Ts using our non-gene edited allogeneic approaches which are intended to provide multiple real-world benefits to patients,” said David Gilham, Ph.D., Chief Scientific Officer of Celyad Oncology. “We believe our CAR T cells are the only allogeneic CAR T cells currently in human clinical trials that avoid generating double-strand DNA breaks. Combining with multiplexed shRNA and cytokine armoring, we believe this approach provides us with a dynamic platform for the generation of future allogeneic candidates.”

Charles Morris, M.D., Chief Medical Officer of Celyad Oncology said, “In addition to the encouraging preclincal data presented, we are also on the cusp of initiating the KEYNOTE-B79 Phase 1b clinical trial in collaboration with MSD. We believe that KEYNOTE-B79 will be the first clinical trial to evaluate an allogeneic CAR T with an anti-PD-1 therapy in solid tumors. We look forward to evaluating whether the expected highly complementary mechanism of actions of CYAD-101 and KEYTRUDA^® could help to drive important clinical benefit in patients with refractory metastatic colorectal cancer with microsatellite stable disease where a high unmet medical need exists. We look forward to initiating the study in the coming weeks and providing clinical updates to the CYAD-101 program in 2022.”

Key Highlights from SITC Annual Meeting

Poster 107 – Armoring NKG2D CAR T cells with IL-18 improves in vitro and in vivo anti-tumor activity

• This poster demonstrates the key role of Interleukin-18 (IL-18) in driving increased effector function of the NKG2D CAR T cells.
• These data support the ongoing development of the Company’s shRNA-based allogeneic, IL-18-armored CAR T candidate CYAD-203 as well as future allogeneic IL-18-armored CAR T candidates.

Poster 146 – Evolving multiplexed shRNA to generate tailored CAR T cell therapy

• Multiplexing short hairpin RNA (shRNA) within a single vector format ensures co-linked expression of the shRNA with therapeutic transgenes.
• We continue to develop second-generation shRNA scaffold using multiplexed technology to produce novel allogeneic clinical candidates with bespoke, desired phenotypes and function produced using methods that avoid the generation of double strand DNA breaks.

Poster 407 – A Phase 1b KEYNOTE-B79 trial evaluating non-gene edited allogeneic CAR T-cells, CYAD-101, post FOLFOX preconditioning, followed by pembrolizumab, in refractory metastatic colorectal cancer patients

• Clinical and translational results from the alloSHRINK Phase 1 trial evaluating the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T-cell product candidate CYAD-101 (NCT03692429) in patients with metastatic colorectal (mCRC) cancer suggest that treatment with sequential checkpoint inhibition following CYAD-101 with FOLFOX preconditioning could drive more durable clinical responses.
• The KEYNOTE-B79 trial will therefore evaluate the safety and clinical activity of multiple infusions of CYAD-101 administered post FOLFOX preconditioning chemotherapy, followed by treatment with KEYTRUDA^® (pembrolizumab) in mCRC patients with microsatellite stable disease, according to a Simon’s two stage trial design.
• The KEYNOTE-B79 clinical trial is expected to begin in fourth quarter 2021.

These ePosters will be available on the SITC website starting today at 1 p.m. CET / 7 a.m. ET and in the Scientific Publications section of Celyad Oncology’s website.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

• Phase 1b KEYNOTE-B79 trial set to evaluate CYAD-101 followed by KEYTRUDA^® in metastatic colorectal cancer (mCRC) patients with microsatellite stable disease on track to begin by year-end 2021
• Enrollment continues at the highest dose level in Phase 1 IMMUNICY-1 trial evaluating CYAD-211 in relapsed/refractory multiple myeloma (r/r MM); next clinical update will be presented at the 63^rd American Society of Hematology (ASH) Annual Meeting
• Additional data from CYCLE-1 trial evaluating CYAD-02 in relapsed/refractory acute myeloid leukemia/myelodysplastic syndromes (r/r AML / MDS) will be presented at the 63^rd ASH Annual Meeting
• Exclusive patent license agreement signed with the University of Pennsylvania for an engager targeting Glypican 3 (GPC3)
• Company awarded €3.5 million Grants and Non-Dilutive Funding by the Walloon Region

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the “Company”), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced an update on its financial results and recent business developments for the fiscal quarter ended September 30, 2021.  

“Our team continues to take major strides towards the development of a differentiated, next-generation CAR T pipeline based on novel non-gene edited technologies which we believe offer potential advantages over gene-editing approaches. During our R&D Day in the third quarter, we provided an in-depth review of our platforms, including our proprietary shRNA and TIM technologies, as well as our ‘armored’ CAR franchise focused on the co-expression of secreting IL-18. These key capabilities are reflected across our allogeneic clinical programs and highlight the advancements we’re making. Overall, we’ve treated more than 30 patients with our allogeneic CAR T product candidates without evidence of GvHD while observing encouraging early signals of clinical activity, which we believe is a promising validation that our non-gene edited strategy for allogeneic CAR T has the potential to be a game-changer for the field,” commented Filippo Petti, Chief Executive Officer of Celyad Oncology. “There are several data readouts scheduled at this year’s ASH and SITC annual meetings, and we believe the updates from the Phase 1 IMMUNICY-1 trial of CYAD-211, as well as the pending initiation of the Phase 1b KEYNOTE-B79 trial will further position us as leaders in the allogeneic CAR T space.”

Recent Highlights

• Research & Development Day held on July 20, 2021, during which the management team provided:
  • Updates on the allogeneic CAR T clinical candidates CYAD-211 and CYAD-101.
  • Highlights from the latest research from the Company’s proprietary short hairpin RNA (shRNA) platform, including the introduction of CYAD-203 – a novel allogeneic, Interleukin-18 (IL-18)-armored CAR T candidate currently in IND-enabling studies.
• Acquisition of an exclusive patent license from the University of Pennsylvania for an engager targeting Glypican 3 (GPC3), which will be tested with the Company’s proprietary shRNA technology platform.
• Three abstracts to be presented at the Society for Immunotherapy of Cancer (SITC) 36^th Annual Meeting, which will include information about:
  • Celyad Oncology’s multiplexing capabilities using shRNA technology.
  • The Company’s first non-gene edited allogeneic, IL-18-armored CAR T candidate CYAD-203.
  • Phase 1b KEYNOTE-B79 trial of CYAD-101 followed by KEYTRUDA^® (pembrolizumab) in refractory metastatic colorectal cancer patients.
• Two abstracts to be presented at the 63^rd ASH Annual Meeting to be held from December 11-14, 2021, which will include additional data for CYAD-211 and CYAD-02.

Third Quarter 2021 Financial Review

As of September 30, 2021, the Company had cash and cash equivalents of €6.1 million ($7.1 million), representing a decrease in cash and cash equivalents of €5.9 million as compared to June 30, 2021. The Company believes that its existing cash and cash equivalents combined with the remaining access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements to the end of the third quarter of 2022.

Update on Clinical and Preclinical Programs

CYAD-101 – Allogeneic TIM-based, NKG2D CAR T for mCRC

• CYAD-101 is the Company’s allogeneic CAR T candidate engineered to co-express a chimeric antigen receptor (CAR) based on the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM).
• To the Company’s knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.
• The Phase 1b KEYNOTE-B79 trial, which will evaluate CYAD-101 following FOLFOX preconditioning chemotherapy, with MSD’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) in refractory mCRC patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease, is on track to begin by year-end 2021.
• This KEYNOTE-B79 trial is part of a clinical trial collaboration involving Celyad Oncology and MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, through a subsidiary.

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM

• CYAD-211 comprises a B cell maturation antigen (BCMA) targeting CAR co-expressed with a shRNA that targets the CD3ζ component of the T-cell receptor (TCR) complex.
• 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 cyclophosphamide and fludarabine given for three consecutive days.
• In July 2021, preliminary data from the Phase 1 IMMUNICY-1 trial was presented from a total of seven patients (three patients at dose level one, three patients at dose level two and one patient at dose level three) demonstrating no evidence of Graft-versus-Host disease (GvHD) along with initial evidence of clinical response in the form of two partial responses. Importantly, CYAD-211 cells were detected within the peripheral blood of all patients analyzed with an apparent stepwise engraftment across the three dose levels.
• Enrollment in the trial is ongoing with plans to explore higher doses of preconditioning regimens in future cohorts. A clinical update will be presented at the upcoming ASH meeting in December 2021.

CYAD-203 – Allogeneic shRNA-based, IL-18-armored NKG2D CAR T for Solid Tumors

• CYAD-203 is the Company’s first armored CAR T candidate engineered to co-express the cytokine IL-18 with the NKG2D CAR receptor. To the Company’s knowledge, CYAD-203 is the first allogeneic IL-18 secreting CAR T candidate.
• Investigational New Drug (IND)-enabling studies are currently in progress alongside production of the clinical grade vector.
• Submission of the IND application for CYAD-203 is expected in mid-2022.
• At the SITC 36^th Annual Meeting, preclinical data will be presented demonstrating the enhanced anti-tumor activity of NKG2D CAR T cells armored with IL-18.

CYAD-02 – Autologous NKG2D receptor CAR T for r/r AML / MDS

• CYAD-02, the Company’s autologous CAR T candidate with shRNA technology that targets the NKG2D ligands MICA and MICB, is currently being evaluated for the treatment of r/r AML / MDS in the Phase 1 CYCLE-1 dose-escalation trial.
• Additional safety and efficacy data from the trial will be presented at the upcoming ASH meeting in December 2021.

Upcoming Anticipated Milestones

• Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA^® in mCRC patients with MSS/pMMR disease is anticipated by year-end 2021.
• Additional data from the Phase 1 IMMUNICY-1 trial of CYAD-211 and the Phase 1 CYCLE-1 trial of CYAD-02 are expected at the upcoming ASH meeting in December 2021.
• Submission of the IND application for CYAD-203 for treatment of solid tumors is expected in mid-2022.

• Two abstracts will be presented in a pre-recorded poster presentation and oral session

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 two abstracts have been accepted for a poster presentation and an oral session at the 63^rd American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held in person in Atlanta, Georgia and virtually from December 11-14, 2021. The poster will focus on the Company’s shRNA-based anti-BCMA allogeneic CAR T candidate CYAD-211 for the treatment of relapsed/refractory (r/r) multiple myeloma (r/r MM). The oral session will focus on the Company’s autologous NKG2D receptor-based CAR T candidate CYAD-02 for the treatment of r/r acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). In addition, the abstracts will be published online in the November supplemental issue of peer-reviewed journal Blood.

ASH 2021 Presentation Details:

The following abstracts published today are now available on the ASH conference website. Following their presentation at the meeting, the posters will be available in the Scientific Publications section of Celyad Oncology’s website.

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 plans to participate virtually in the following conference in November 2021:

Jefferies London Healthcare Conference

Dates: Thursday, November 18 & Friday, November 19, 2021

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, announced today, a capital increase of 300,000 new shares of the Company to Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor. As a result, the Company’s share capital is increased to 55,964,224.33 EUR and is represented by 16,093,956 shares.

This information is published in accordance with Article 15 of the Belgian Law of 2 May 2007 on the disclosure of major participations in issuers whose shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

Figures – Modified on 29 October 2021 following the Capital Increase:

Total amount of share capital (EUR)	55,964,224.33
Total Number of shares with single voting rights	13,725,931
Total Number of shares with double voting rights	2,368,025
Total Number of Shares	16,093,956
Total of voting rights	18,461,981
Total number of attributed warrants	1,901,773
Total number of shares with voting rights that could be created following the exercise of the attributed warrants	1,901,773
Total number of diluted shares (Outstanding shares + Warrants)	17,995,729
Total number of diluted shares with voting rights	20,363,754

Contact person for regulated information (financial, transparency)

By law, any transparency declaration must be sent to our Company by email to the attention of Filippo Petti, Chief Executive Officer (CEO): investors@celyad.com.

Further questions about the content of this release can be sent to investors@celyad.com.