UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of May 2018

Commission File Number: 001-37452

 

 

CELYAD SA

(Translation of registrant’s name into English)

 

 

Rue Edouard Belin 2

1435 Mont-Saint-Guibert, Belgium

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


Celyad SA

On April 27, 2018 and May 3, 2018, the Company issued press releases, copies of which are attached hereto as Exhibits 99.1 and 99.2 and are incorporated by reference herein.

The information contained in this Current Report on Form 6-K, including Exhibits 99.1 and 99.2, except for the quotes of Frédéric Lehmann and David Sallman contained in Exhibit 99.1 and the quotes of Christian Homsy and Frédéric Lehmann contained in Exhibit 99.2, is hereby incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-220285) and S-8 (File No. 333-220737).


EXHIBITS

 

Exhibit

  

Description

99.1    Press release issued by the registrant on April 27, 2018
99.2    Press release issued by the registrant on May 3, 2018


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  CELYAD SA
Date: May 3, 2018   By:   /s/ Patrick Jeanmart
    Patrick Jeanmart
    Chief Financial Officer

Exhibit 99.1

 

 

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Press Release

27 April 2018

08:30 am CEST

Haematologica publishes Celyad THINK Study

Case Report of CYAD-01 Induced Complete

Remission in Relapsed/Refractory AML Patient

 

Case report details first ever reported complete morphologic remission with gene

engineered T-cells in a relapsed/refractory AML patient without preconditioning

Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, announces the publication later today of a patient case study from the hematological arm of its THINK Phase I trial in the journal Haematologica 1 . The publication, entitled “ NKG2D-based Chimeric Antigen Receptor Therapy Induced Remission in a Relapsed/Refractory Acute Myeloid Leukemia Patient ” is authored by the trial investigators at the Moffitt Cancer Center and Research Institute in Tampa, Fla. and by Celyad’s scientific team.

The publication details the first objective response to CAR-T in relapsed/refractory AML using CYAD-01, Celyad’s Natural Killer Group 2D (NKG2D) chimeric antigen receptor T-cell therapy, without pre-conditioning lymphodepletion. The patient received CYAD-01 infusions at the initial dose level of 3x10 8 cells every 2 weeks for 3 administrations, achieving a morphologic leukemia-free state (MLFS 2 ) at 3-months which enabled the patient to benefit from an allo-hematopoietic stem cell transplant (allo-HSCT). The patient achieved a complete molecular remission and remains in remission 9 months post study enrollment. CYAD-01 was well tolerated with no significant toxicities. The demonstrated first objective response to any CAR-T in relapsed/refractory AML without preconditioning chemotherapy highlights the potential of CYAD-01 as a treatment for AML.

“Our results demonstrate the validity of NKG2D as a target, in particular in the context of refractory AML and without other intervening treatments nor preconditioning”, commented Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad . “We look forward to continue our clinical development plan for our NKG2D CAR based platform and explore the various conditions within which this therapy could provide benefits to patients with end stage cancers.”

 

 

1   http://www.haematologica.org/content/early/recent
2   MLFS : Morphologic Leukemia-Free State

 

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Press Release

27 April 2018

08:30 am CEST

 

Dr.  David Sallman, Assistant Member in the Malignant Hematology Department of Moffitt Cancer Center , added: “The THINK study case report provides the first clinical validity of CYAD-01 as a tumor-specific antigen-receptor and AML as a disease sensitive to gene-engineered cell therapies. As antigen targeting offers significant challenges in AML, this outcome brings hope for the further use of gene-engineered T-cells for patients with AML that have run out of therapeutic options. It’s all the more striking that this outcome was observed without any prior lymphodepletion highlighting the potential of using a physiologic antigen-receptor.”

***END***

About Celyad

Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies. Celyad utilizes its expertise in cell engineering to target cancer. Celyad’s CAR-T cell platform has the potential to treat a broad range of solid and hematologic tumors. Its lead oncology candidate, CYAD-01 (CAR-T NKG2D), has been evaluated in a single dose escalation Phase I clinical trial to assess the safety and clinical activity of multiple administrations of autologous CYAD-01 cells in seven refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). Celyad was founded in 2007 and is based in Mont-Saint-Guibert, Belgium, and New York, NY. Celyad’s ordinary shares are listed on the Euronext Brussels and Euronext Paris exchanges, and its American Depository Shares are listed on the NASDAQ Global Market, all under the ticker symbol CYAD.

About the THINK Trial

THINK ( TH erapeutic I mmunotherapy with NK G2D) is a multinational (EU/US) open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous CYAD-01 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast, and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). The trial test three dose levels: up to 3x10 8 , 1x10 9 , and 3x10 9 CYAD-01 cells per injection. At each dose-level, the patients will receive three successive adminitrations of CYAD-01 cells, two weeks apart. The dose-escalation part of the study will enroll up to 24 patients while the extension phase would enroll up to 86 additional patients.

About Celyad’s CAR-T cell Platform

Celyad is developing a unique CAR T-cell platform, transducing Natural Killer Receptors (NKR) onto T lymphocytes. Unlike traditional CAR T-cell therapy, which targets only one tumor antigen, each natural killer (NK) cell receptor recognizes multiple antigens.

Celyad’s lead candidate, CYAD-01, is a CAR T-cell engineered to express the human NK receptor, NKG2D, which is an activating receptor. CYAD-01 triggers cell killing through the binding of NKG2D to any of its eight naturally occurring ligands, which are known to be overexpressed on more than 80% of tumors. Preclinical results

 

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Press Release

27 April 2018

08:30 am CEST

 

indicate that CYAD-01 has multiple mechanisms of actions and goes beyond direct cancer cell killing. It inhibits the mechanisms that enable tumors to evade the immune system, activates and recruit anti-tumor immune cells, and disrupts the blood supply to the tumor. These mechanisms promote the induction of adaptive immunity, enabling the development of long-term immune memory against specific tumor antigens.

Celyad is developing both autologous and allogeneic CAR T-cell NKG2D approaches. CYAD-01 is an autologous therapy where Celyad collects the patient’s own T cells and engineers them to express NKG2D in order to target cancer cells effectively. Celyad’s allogeneic platform (CYAD-101) engineers the T cells of healthy donors, to express NKG2D as well as TCR Inhibitory Molecules (TIMs), to avoid having the donor cells rejected by the patient’s immune system (Graft vs. Host Disease). The preclinical research underlying this technology was originally conducted at Dartmouth College by Dr. Charles Sentman and has been described extensively in peer-reviewed publications.

For more information, please contact:

 

Celyad

Christian Homsy, CEO and Patrick Jeanmart CFO - T: +32(0) 10 39 41 00 – investors@celyad.com

Nicolas Van Hoecke, Director, Investor Relations & Communications - T: +32(0) 10 39 41 48 – nvanhoecke@celyad.com

For Belgium: Comfi

Gunther De Backer and Sabine Leclercq - T : +32 (0)2 290 90 90 - celyad@comfi.be

For France: NewCap

Pierre Laurent and Nicolas Mérigeau - T: + 33 (0)1 44 71 94 94 - celyad@newcap.eu

For the rest of Europe and the USA: Lifesci Advisor

Investor Relations: Daniel Ferry - T: +1 (617) 535 7746 – daniel@lifesciadvisors.com

Public Relations: Allison Blum - T:+1 (646) 627 8383 - allison@lifescipublicrelations.com

 

Subscribe to Celyad’s newsletter at www.celyad.com

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Forward-looking statements

In addition to historical facts or statements of current condition, this press release contains forward-looking statements, including statements about the potential safety, activity, efficacy and feasibility of CYAD-01 cell therapy and other product candidates, including current and planned preclinical studies and clinical trials and regulatory filings for Celyad’s product candidates; the clinical and commercial potential of these product candidates and the adequacy of Celyad’s financial resources; the strength of Celyad’s intellectual property portfolio and plans related thereto; Celyad’s expectations regarding its strategic collaborations and license agreements with third parties, including Novartis, Celdara Medical, and Dartmouth College, and the potential impact of such collaborations on Celyad’s future financial condition, including anticipated milestones and royalties and the timing thereof; Celyad’s expected cash burn, which reflect Celyad’s current expectations and projections about future events; and the anticipating timing of Celyad’s 2017 annual report, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements are further qualified by important factors and risks, which could cause actual results to differ materially from those in the forward-looking statements, including risks associated with conducting clinical trials; the risk that safety, bioactivity, feasibility and/or efficacy demonstrated in earlier clinical trials or preclinical studies may not be replicated in subsequent trials or studies; risks associated with the timely submission and approval of anticipated regulatory filings; the successful initiation and completion of clinical trials, including its clinical trials for CYAD-01; risks associated with the successful manufacture of drug product for its clinical trials; risks associated with the satisfaction of regulatory and other requirements; risks associated with the actions of regulatory bodies and other governmental authorities; risks associated

 

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Press Release

27 April 2018

08:30 am CEST

 

with obtaining, maintaining and protecting intellectual property, Celyad’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks associated with competition from others developing products for similar uses; risks associated with Celyad’s ability to manage operating expenses; and risks associated with Celyad’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and business initiatives. A further list and description of these risks, uncertainties and other risks can be found in Celyad’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on April 4, 2017 and subsequent filings and reports by Celyad. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Celyad 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.

 

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Exhibit 99.2

 

 

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Press Release

3 May 2018

07:00 am CEST

Celyad successfully administers CYAD-01

in first patients in SHRINK and LINK trials

 

 

Celyad achieves important milestone in CYAD-01 treatment evaluation of metastatic colorectal cancer:

 

    No toxicity observed to date in first patient enrolled in the SHRINK 1 trial (concurrent administration of CYAD-01 with standard chemotherapy)

 

    No toxicity observed to date in first patient enrolled in the LINK 2 trial (hepatic transarterial administrations)

Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced the successful injection of the first patients in the SHRINK trial and the LINK trial, both targeting metastatic colorectal patients.

Dr.  Christian Homsy, CEO of Celyad commented : “ The infusion of a first patient in a new trial is always an important moment. CYAD-01, concurrently administered with standard chemotherapy FOLFOX in SHRINK, or administered through hepatic transarterial injections in LINK appears to have been well–tolerated to date. We are particularly satisfied with the lack of on target/off tumor toxicity observed to date in the context of the combination of CYAD-01 with chemotherapy. This bolstered our belief that, based on a careful and exhaustive clinical development plan, our product candidate will lead the path towards a therapy for cancer patients.

After the promising signals of clinical activity of CYAD-01 reported in 2017 and validation of the use of the NKG2D receptor, Celyad designed a clinical development plan which aims at defining the best of the following approaches for CYAD-01 in patients with Acute Myeloid Leukemia (AML) and colorectal (CRC) cancers:

- CYAD-01 as a stand-alone investigational therapy, currently being evaluated in the THINK trial with relapsed refractory AML and CRC patients. Results have already been reported: the world’s first complete response by a CAR-T cell therapy in a patient with refractory and relapsed AML as well as stable diseases reported in colorectal and ovarian cancer patients.

 

 

1   S tandard C H emotherapy  R egimen and  I mmunotherapy with  NK G2D
2   L oco-regional I mmunotherapy with NK G2D

 

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Press Release

3 May 2018

07:00 am CEST

 

- CYAD-01 administered concurrently with standard of care treatments. The SHRINK trial was initiated with CRC patients earlier in 2018. We expect that the EPITHINK trial will be initiated soon with AML patients.

- CYAD-01 administered after preconditioning of the patients using lymphodepletion. We expect trials in AML (DEPLETHINK AML) and CRC (DEPLETHINK CRC) patients to be initiated in the coming weeks.

Our objective is to continue with the above approach that offers the best observed safety/efficacy profile and to move forward in later phase clinical trials in both AML and CRC indications.

Dr.  Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad added: Today’s announcement reflects Celyad’s commitment to develop the potential of CYAD-01 and is the result of our strong collaborations with key academic institutions in both the USA and Europe. Our clinical strategy aims to build on the favorable tolerability profile of CYAD-01 observed to date, and evaluate CYAD-01 in multiple settings to find the best approach for cancer patients. We are making good progress and look forward to sharing further results on SHRINK, LINK and other trials.

SHRINK is an open-label Phase I trial evaluating the safety and clinical activity of multiple doses of CYAD-01, administered concurrently with the neoadjuvant FOLFOX treatment in patients with resectable liver metastases from colorectal cancer. The dose escalation design of SHRINK includes three dose levels: 1x10 8 , 3x10 8  and 1x10 9  of CYAD-01. At each dose, the patients will receive three successive administrations, two weeks apart at the specified dose. No adverse events have been reported in the first injection of the first patient enrolled.

LINK is an open-label Phase I trial evaluating the safety and clinical activity of CYAD-01, adopting a loco-regional approach in treating patients with multiple CYAD-01 administration through hepatic transarterial injections to colorectal cancer patients diagnosed with unresectable liver metastases. The dose escalation design of LINK includes three dose levels: 3x10 8 , 1x10 9  and 3x10 9  of CYAD-01. At each dose, the patients will receive three successive administrations, two weeks apart at the specified dose. No adverse events have been reported in the first patient enrolled, who has received his three consecutive CYAD-01 administrations at the first dose level.

***END***

 

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Press Release

3 May 2018

07:00 am CEST

 

About Celyad

Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies. Celyad utilizes its expertise in cell engineering to target cancer. Celyad’s CAR-T cell platform has the potential to treat a broad range of solid and hematologic tumors. Its lead oncology candidate, CYAD-01 (CAR-T NKG2D), has been evaluated in a single dose escalation Phase I clinical trial to assess the safety and clinical activity of multiple administrations of autologous CYAD-01 cells in seven refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). Celyad was founded in 2007 and is based in Mont-Saint-Guibert, Belgium, and New York, NY. Celyad’s ordinary shares are listed on the Euronext Brussels and Euronext Paris exchanges, and its American Depository Shares are listed on the NASDAQ Global Market, all under the ticker symbol CYAD.

For more information, please contact:

 

Celyad

Christian Homsy, CEO and Patrick Jeanmart CFO - T: +32(0) 10 39 41 00 – investors@celyad.com

Nicolas Van Hoecke, Director, Investor Relations & Communications - T: +32(0) 10 39 41 48 – nvanhoecke@celyad.com

For Belgium: Comfi

Gunther De Backer and Sabine Leclercq - T: +32 (0)2 290 90 90 celyad@comfi.be

For France: NewCap

Pierre Laurent and Nicolas Mérigeau - T: + 33 (0)1 44 71 94 94 – celyad@newcap.eu

For the rest of Europe and the USA: Lifesci Advisor

Investor Relations: Daniel Ferry - T: +1 (617) 535 7746 – daniel@lifesciadvisors.com

Public Relations: Allison Blum - T:+1 (646) 627 8383 – allison@lifescipublicrelations.com

Subscribe to Celyad’s newsletter at www.celyad.com

LOGO Follow us on LinkedIn & Twitter @CelyadSA

 

Forward-looking statements

In addition to historical facts or statements of current condition, this press release contains forward-looking statements, including statements about the potential safety, activity, efficacy and feasibility of CYAD-01 cell therapy and other product candidates, including current and planned preclinical studies and clinical trials and regulatory filings for Celyad’s product candidates; the clinical and commercial potential of these product candidates and the adequacy of Celyad’s financial resources; the strength of Celyad’s intellectual property portfolio and plans related thereto; Celyad’s expectations regarding its strategic collaborations and license agreements with third parties, including Novartis, Celdara Medical, and Dartmouth College, and the potential impact of such collaborations on Celyad’s future financial condition, including anticipated milestones and royalties and the timing thereof; Celyad’s expected cash burn, which reflect Celyad’s current expectations and projections about future events; and the anticipating timing of Celyad’s 2017 annual report, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These forward-looking statements are further qualified by important factors and risks, which could cause actual results to differ materially from those in the forward-looking statements, including risks associated with conducting clinical trials; the risk that safety, bioactivity, feasibility and/or efficacy demonstrated in earlier clinical trials or preclinical studies may not be replicated in subsequent

 

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Press Release

3 May 2018

07:00 am CEST

 

trials or studies; risks associated with the timely submission and approval of anticipated regulatory filings; the successful initiation and completion of clinical trials, including its clinical trials for CYAD-01; risks associated with the successful manufacture of drug product for its clinical trials; risks associated with the satisfaction of regulatory and other requirements; risks associated with the actions of regulatory bodies and other governmental authorities; risks associated with obtaining, maintaining and protecting intellectual property, Celyad’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks associated with competition from others developing products for similar uses; risks associated with Celyad’s ability to manage operating expenses; and risks associated with Celyad’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and business initiatives. A further list and description of these risks, uncertainties and other risks can be found in Celyad’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on April 4, 2017 and subsequent filings and reports by Celyad. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Celyad 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.

 

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