On August 23, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported its consolidated financial results for the six-month period ending 30 June 2018 prepared in accordance with IFRS as endorsed by the European Union (Press release, Celyad, AUG 23, 2018, View Source [SID1234532511]). The full interim financial report is available on Celyad’s website in the "Investors" section. The half year 2018 consolidated financial statements were subject to a limited review by the company’s statutory auditors.
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"We are very pleased with the progress made by Celyad in the first half of 2018, with significant advancement of our clinical programs for CYAD-01 across a number of programs in which, to date, we have observed preliminary signs of activity and a favorable tolerability profile", commented Dr. Christian Homsy, CEO of Celyad. "We are particularly encouraged by the progress we have made in the hematological arm of our THINK trial and are thrilled that last month the FDA permitted our IND application to go into effect for CYAD-101, the world’s first non-gene edited allogeneic CAR-T clinical program. We are confident that 2018 will be a milestone year for Celyad as we continue to advance our platform across multiple indications."
Operational Highlights
Progress made in Acute Myeloid Leukemia (AML)
THINK Trial
Interim results demonstrate signs of clinical activity ranging from complete responses to stable diseases at lower doses in AML patients receiving one cycle of CYAD-01 per protocol.
Twelve patients[6] have been enrolled to date. Enrollment for the highest dose (3×109) is expected to be completed in September 2018.
A complete second cycle of investigational therapy was administered in the first AML patient enrolled into the second dose level (1×109). A second AML patient at the third dose level (3×109) has received the first injection of the second cycle. The second cycle is administered to determine the impact of the clinical benefit of additional CYAD-01 administrations. No dose-limiting toxicity has been observed to date.
The first ever reported complete response by an investigational CAR-T cell therapy without preconditioning in a patient with refractory and relapsed AML was published as a case study in Haematologica.
Preliminary results of the dose escalation segment will be reported in December during the American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (December 1-4, San Diego).
EPITHINK Trial
Based on feedback from the FDA, we finalized the EPITHINK protocol – a trial evaluating the synergetic effect of the concurrent administration of CYAD-01 (CAR-T NKG2D) with a standard of care hypomethylating agent (HMA) i.e. 5-azacytidine (AZA) in treatment-naïve Acute Myeloid Leukemia (AML) or myelodysplastic syndrome (MDS) patients not candidates for intensive therapy.
DEPLETHINK AML Trial
Based on feedback from the FDA, we finalized the DEPLETHINK AML protocol – a trial to evaluate administration of CYAD-01 after a traditional preconditioning regimen in refractory/relapsing AML and MDS patients.
Progress made in Colorectal Cancer (CRC)
THINK Trial
Fourteen solid cancer patients (one pancreas, two ovarian and eleven CRC) completed the three dose-levels evaluated in the dose escalation segment.
One dose-limiting toxicity (DLT) was reported at the highest dose-level (3×109) triggering the enrollment of three additional patients. No other DLT was reported in the three additional patients treated at the third dose level.
Preliminary results will be reported during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (November 7-11, Washington).
SHRINK Trial
Three CRC patients were treated at the first dose level (1×108) with no dose-limiting toxicity reported to date in combination with current standard of care.
LINK Trial
One CRC patient has received three local hepatic transarterial injections at the first dose level (3×108) with no dose-limiting toxicity reported to date.
DEPLETHINK CRC Trial
This study evaluates the administration of CYAD-01 after traditional preconditioning regimen in patients suffering from colorectal cancer. The first patient has been registered.
Subsequent Operational Events to First Half
In July, Celyad’s Investigational New Drug (IND) application went into effect with the FDA for CYAD-101, the world’s first non-gene edited allogeneic CAR-T clinical program. CYAD-101 is the first of a family of investigational non-gene edited allogeneic CAR-T cell therapies that will draw on the experience from the SHRINK autologous CAR-T program to target colorectal cancer. The FDA also indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.
Corporate and Financial Highlights for the First Half of 2018
In May, Celyad successfully completed a global offering with gross proceeds of approximately $54.4 million (approximately €46.1 million). At the end of June 2018, the Company reported total cash and short-term investments of €63 million, which are expected to be sufficient to support its operating capital expenditure into mid-2020.
In early August, Margo Roberts, Ph.D., joined Celyad’s Board of Directors and scientific committee. Dr. Roberts was Chief Scientific Officer at Kite Pharma, Inc., before becoming Senior Vice President of Discovery Research where she focused on next therapeutic approaches including Kite’s allogeneic T-cell programs. With Dr. David Gilham, Celyad’s VP of R&D, she will provide input into the scientific strategy of the company.
Also, in August, the Company announced the appointment of Filippo Petti as Chief Financial Officer as from 3 September, succeeding Patrick Jeanmart. Prior to joining Celyad, Mr. Petti served as VP of Healthcare Investment Banking at Wells Fargo Securities and William Blair & Company. His deep industry expertise, experience in oncology and connectivity within the U.S. investor community will help Celyad’s development in the U.S. capital and financial market.
Commenting on the 2018 half year results, Patrick Jeanmart, Chief Financial Officer of Celyad, said: "Thanks to the successful capital raise made last May, we reported a comfortable cash position which we expect will be sufficient to support Celyad’s operating expenses and capital expenditure requirements, based on the current scope of our activities, into mid-2020. We are committed to careful oversight of our cash and resource management allowing the meaningful advancement of our preclinical and clinical CAR-T platform across multiple indications."
Conference Call Details
Celyad’s management will host a conference call on Thursday, 23 August 2018 at 2:00 p.m. (CEST) / 8:00 a.m. (EDT) to comment on the mid-year operational and financial results. Patrick Jeanmart, CFO, will deliver a brief presentation followed by a Q&A session.
Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.
The call can be accessed by dialling the numbers below and using the passcode: 1835859
International:
+44 (0) 2071 928338
Belgium:
02 793 3847
France:
0805 101465
UK:
0800 2796619
US:
1 877 870 9135