2018 Operational Highlights as of the date of this report
Progress made in Acute Myeloid Leukemia (AML)
In theTHINK trial, interim results demonstrate signs of clinical activity ranging from complete responses to stable disease at lower doses in AML patients receiving one cycle ofCYAD-01 per protocol. The first ever reported complete response by an investigationalCAR-T cell therapy without preconditioning in a patient with refractory and relapsed AML was published as a case study inHaematologica.
The recruitment of the last patients of the third and last dose is ongoing at the date of this report. A second cycle of therapy at the second dose level (1x109) was administered in an AML patient to evaluate the activity of additional cycles of administration on clinical response. No dose-limiting toxicity has been observed to date.
Clinical results are expected to be reported in December at the American Society for Hematology (ASH) Annual Meeting.
Based on feedback from Belgian and US regulatory authorities, we finalized the protocols of the EPITHINK and DEPLETHINK AML trials and we initiated these two Phase I clinical trials involving AML patients.
Progress made in Colorectal Cancer (CRC)
In theTHINKtrial, the dose-escalation part of the trial is completed. One dose-limiting toxicity (DLT) was reported in one of the first three patients triggering enrollment of 3 additional patients.Clinical results are expected to be reported in November during the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
At the date of this report, the enrollment of the patients in the first dose of theSHRINK andLINK trials is ongoing. No dose-limiting toxicity has been reported to date.
TheDEPLETHINK CRC protocol was finalized and the first patient has been registered. This trial aims to evaluate the administration ofCYAD-01 after a traditional preconditioning regimen in patients suffering from CRC.
Subsequent Other Operational Events to First Half
In July, Celyad’s Investigational New Drug (IND) application went into effect with the U.S. Food and Drug Administration (FDA) forCYAD-101, the world’s firstnon-gene edited allogeneicCAR-T clinical program.CYAD-101 is the first of a family of investigationalnon-gene edited allogeneicCAR-T cell therapies that will draw on the experience from the SHRINK autologousCAR-T program to target colorectal cancer. The FDA also indicated that theAllo-SHRINK trial, evaluating the safety and clinical activity ofCYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is safe to proceed.
Corporate and Financial Highlights
In May, Celyad successfully completed a global offering with gross proceeds of approximately $54.4 million (approximately €46.1 million), resulting in cash proceeds for an amount of approximately €43 million net of bank fees and transaction costs. At the end of June 2018, the Company reported €62.4 million in cash and cash equivalents, which are expected to be sufficient to support its operating capital expenditure intomid-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 allogeneicT-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, 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.
Operating Capital Requirements
We believe that our existing cash position is sufficient to continue operating at least for the next 12 months. We also believe that it will enable us to fund our operating expenses and capital expenditure requirements, based on the current scope of our activities, intomid-2020. We have based the latter estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. In any event, we will require additional capital to pursue preclinical and clinical activities, obtain regulatory approval for, and commercialize our product candidates.
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