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Celyad Oncology

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Uncategorized

Celyad Oncology Announces March 2021 Conference Schedule

March 1, 2021 By Celyad Oncology

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 at the following virtual investor conferences in March 2021:

H.C. Wainwright Global Life Sciences Conference

Date: Tuesday, March 9 – Wednesday, March 10, 2021

Time: 7:00 a.m. ET / 1:00 p.m. CET

Webcast: A webcast of the presentation will be available in the Events section of the Celyad Oncology website for approximately 90 days from the start of the event.

BioCapital Europe

Date: Thursday, March 11, 2021

Time: 9:50 a.m. ET / 3:50 p.m. CET

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Letter to Shareholders – February 2021

February 10, 2021 By Celyad Oncology

Dear Shareholder,


As I reflect on the past year, I’m proud of our team’s dedication to advancing the Company’s goals while facing head-on the challenges associated with the COVID-19 global pandemic. Our team’s commitment has truly been unparalleled during this time.

Despite these unprecedented times, I firmly believe this was a pivotal year in our Company’s history as we worked to further unlock the full potential of allogeneic CAR T therapy with learnings that we will take into 2021.

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Celyad Oncology Announces February 2021 Conference Schedule

February 2, 2021 By Celyad Oncology

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 at the following conferences in February 2021:

CAR-TCR Digital Summit Europe

Date: Wednesday, February 17, 2021

Time: 2:00 p.m. GMT / 3 p.m. CET

SVB Leerink Partners Global Healthcare Conference

Date: Thursday, February 25, 2021

Time: 4:20 p.m. – 4:50 p.m. ET / 10:20 p.m. – 10:50 p.m. CET

Webcast: A live and archived webcast of the presentation will be available in the Events section of the Celyad Oncology website

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Celyad Oncology Presents Data Update from Phase 1 alloSHRINK Trial for CYAD-101 in mCRC at ASCO-GI Symposium

January 18, 2021 By Celyad Oncology

  • Median overall survival and median progression free survival from the dose-escalation segment of the trial were 10.6 months and 3.9 months, respectively
  • Tumor burden decrease observed in eight of 15 refractory unresectable mCRC patients, including six of nine patients at the highest dose level of 1×109 cells per infusion
  • Emergence of new T cell clones in the peripheral blood T cell repertoire four months after therapy was observed in patients analyzed from the highest dose level who experienced either a confirmed partial response or stable disease suggesting that modulation of the endogenous immune response may be an important mechanism of action of CYAD‑101 in mCRC patients
  • Preliminary data from the ongoing expansion cohort of the Phase 1 alloSHRINK expected in the first half of 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, today announced updates from the  Phase 1 alloSHRINK trial evaluating CYAD-101, the Company’s allogeneic NKG2D-receptor and T cell receptor (TCR) inhibitory molecule (TIM)-based, non-gene edited CAR T candidate administered concurrently with FOLFOX chemotherapy for the treatment of refractory metastatic colorectal cancer (mCRC), presented at the American Society of Clinical Oncology 2021 Gastrointestinal Cancers Symposium (ASCO-GI), held virtually from January 15-17, 2021.

“We continue to build on the promise of CYAD-101, a highly differentiated cell therapy investigational candidate which has delivered preliminary evidence of clinical benefit for an allogeneic CAR T in solid tumors,” said Filippo Petti, Chief Executive Officer of Celyad Oncology. “At ASCO-GI, we highlighted the encouraging median progression free-survival data from alloSHRINK which complements the previously reported tolerability, objective response rate for CYAD-101 in patients with mCRC. Moreover, translational data from the trial suggests that immune modulation underpins the clinical responses observed in the alloSHRINK trial and supports further development of CYAD-101 with therapies with complementary mechanisms of action including checkpoint inhibitors. We’re excited about the next steps for the CYAD-101 program for the treatment of advanced colorectal cancer and we look forward to future updates from the alloSHRINK trial as well as initiating the upcoming Phase 1b KEYNOTE-B79 trial.”

Phase 1 alloSHRINK Trial Update

Background

  • A total of 15 patients with relapsed/refractory mCRC who progressed after previous treatment with oxaliplatin-based or irinotecan-based chemotherapies were treated in the dose-escalation segment of the alloSHRINK trial evaluating three dose levels of CYAD-101 (1×108, 3×108, 1×109 cells per infusion) administered concurrently with FOLFOX as preconditioning chemotherapy. The number of prior therapies received by patients enrolled in the trial ranged from one to six with a mean of three.
  • Previously reported data for primary and secondary safety and clinical activity endpoints include:
  • Two patients achieved a confirmed partial response (PR) according to RECIST 1.1 criteria, including one patient with a KRAS-mutation
  • Nine patients achieved stable disease (SD), with seven patients demonstrating disease stabilization lasting more than or equal to three months of duration
  • Median progression free survival (mPFS) for the dose-escalation segment of the trial was 3.9 months
  • No clinical evidence of Graft-versus-Host Disease (GvHD)
  • Treatment was observed to be well-tolerated with no treatment-related adverse events greater than Grade 3
  • The recommended dose of 1×109 CYAD-101 cells per infusion will be further evaluated in the expansion cohort of the alloSHRINK trial concurrently with FOLFIRI chemotherapy

Updated Clinical and Translational Data

  • Recent analysis of the dose-escalation segment of the alloSHRINK trial showed median overall survival (mOS) was 10.6 months
  • Tumor burden decrease was observed in eight of 15 patients, including six of nine patients at dose level 3 (1×109 cells per infusion)
  • Of four patients treated at the highest dose level of 1×109 CYAD-101 cells per infusion available for analysis, three patients who achieved either a confirmed PR or SD also showed hyper-expanded TCR repertoire post-treatment through the emergence of new T cell clones in the peripheral blood T cell repertoire, while the patient with progressive disease displayed no evidence of new T cell clones
  • Cytokine modulation was also observed after the first and second infusions of CYAD-101 in the patient who achieved a confirmed PR from the highest dose level

Next Steps

  • Preliminary data from the expansion cohort of the Phase 1 alloSHRINK trial are expected during the first half of 2021
  • Initiation of the Phase 1b KEYNOTE-B79 trial of CYAD-101 following FOLFIRI, with Merck’s KEYTRUDA® in refractory mCRC patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease is expected to be initiated during the first half of 2021
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Celyad Oncology Appoints Marina Udier, Ph.D., to Board of Directors

January 11, 2021 By Celyad Oncology

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 Marina Udier, Ph.D., has been appointed to its Board of Directors.

“I am very pleased to welcome Marina to our Board of Directors,” stated Filippo Petti, CEO of Celyad Oncology.  “As a highly regarded leader in the biopharmaceutical industry, we look forward to benefiting from Marina’s wealth of experience as we continue to advance key elements of our pipeline with the goal of developing innovative cell therapies against cancer.”

Dr. Marina Udier said, “Celyad Oncology is at a pivotal moment in its company history with multiple candidates in the clinic and a promising array of significant milestones expected in 2021. I am honored to be part of the Celyad Oncology Board and look forward to working with the talented team to execute on the company’s strategic vision of establishing itself as an industry leader in the CAR T space.”

Dr. Udier currently serves as CEO of Nouscom, a private oncology company developing next-generation immunotherapies, after joining as Chief Operating Officer in 2016 from Versant Ventures, where she was Operating Principal. Prior to Versant, she held various senior development and commercial roles at Novartis Pharma in Basel. As the Global Commercial Head, she developed the global strategy for a point of care diagnostics platform. Her experience in molecular diagnostics includes In Vitro Diagnostics development; she led development of a Companion Diagnostics for RYDAPTTM, the first approved AML drug in over three decades. Marina managed the Global Neurodegeneration portfolio for Novartis driving her brands to a blockbuster status. She spent five years with McKinsey & Company in Chicago, working with Healthcare Fortune 500 companies in areas of marketing, strategy and pricing. Dr. Udier received her Ph.D. in Organic Chemistry from Yale University. She authored peer-reviewed publications covering HIV/AIDS research.

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Celyad Oncology Announces Equity Purchase Agreement for up to $40 Million with Lincoln Park Capital

January 7, 2021 By Celyad Oncology

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 it has entered into a committed equity purchase agreement (“Purchase Agreement”) for up to $40 million with Lincoln Park Capital Fund, LLC (“LPC”), a Chicago-based institutional investor.

Over the 24-month term of the Purchase Agreement, the Company will have the right to direct LPC to purchase up to an aggregate amount of $40 million American Depositary Shares (“ADSs”), each of which represents one ordinary share of the Company. LPC’s maximum obligation under any single regular purchase will not exceed $2.5 million, unless both parties mutually agree to increase the maximum amount of such purchase. The purchase price for the ADSs to be purchased by LPC under a regular purchase will be the equal to the lower of (i) the lowest sale price for ADSs on the applicable purchase date, and (ii) the average of the three lowest closing sale prices for ADSs during the ten business days prior to the purchase date. There are no upper limits to the price LPC may pay to purchase common stock from the Company. Celyad Oncology controls the timing and amount of any future sales of ADSs to LPC. As part of the Purchase Agreement, LPC has agreed not to cause or engage in any manner whatsoever any direct or indirect short selling or hedging of Celyad Oncology’s shares of common stock. The Purchase Agreement may be terminated by Celyad Oncology at any time, at its sole discretion, without any additional cost or penalty.

In consideration for entering into the Purchase Agreement, at the signing of the Purchase Agreement, LPC received a commitment fee of $1 million comprised of $600,000 in cash and $400,000 in the form of a discount on the initial purchase of $2 million of ADSs under the equity facility.

Celyad Oncology currently intends to use the net proceeds from sales of ADSs under the Purchase Agreement with LPC for general corporate purposes, including but not limited to the research and development of Company’s clinical and preclinical CAR T cell therapy candidates.

“We are thrilled to announce today’s agreement with Lincoln Park, as the committed equity facility is expected to strengthen our current balance sheet while also providing us with access to future capital on an as needed basis,” commented Filippo Petti, Chief Executive Officer of Celyad Oncology. “In addition, the Company now has greater flexibility to further advance our pipeline of clinical and preclinical next-generation CAR T candidates for the treatment of cancers through several potential value-creating milestones over the next several quarters.”

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor will there be any sale of these securities in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction. Additional information regarding the Purchase Agreement with LPC is available in Celyad Oncology’s Form 6-K filed with the SEC on January 7, 2021. The ADSs covered by the Purchase Agreement are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-248464) that was declared effective by the SEC on September 4, 2020. A prospectus supplement relating to the offering was filed by Celyad Oncology with the SEC on January 7, 2021 and is available on the SEC’s website at www.sec.gov or by request from Celyad Oncology S.A., Rue Edouard Belin 2, 1435 Mont-Saint-Guibert, Belgium.

Financial Update

As of December 31, 2020, the Company ended the year with an unaudited treasury position of €17.2 million ($21.2 million). The Company confirms its previous guidance that its existing treasury position, without proceeds from the LPC purchase agreement, should be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, into the third quarter of 2021.

In addition, the Company expects that the net proceeds from the $40 million purchase agreement with LPC should help to extend the Company’s cash runway beyond the third quarter of 2021.

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