Key 2015 highlights:
- Completion of CHART-1 patient enrolment and treatment, confirming availability of Phase III data results by end of June 2016.
- CHART-2 IND approval by the FDA – trial initiation in H2 2016.
- Acquisition of NKR-T immuno-oncology platform – Phase I/IIa trial ongoing.
- €120 million raised in 2015.
Management guidance for 2016:
- Top line data of CHART-1 Phase III trial by end of June 2016.
- Initiation of CHART-2 in H2 2016.
- Completion of NKR-2 dose escalation study.
- Initiation of a solid tumor clinical program with NKR-2.
Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today provided an update on its recent operations and reported consolidated financial results for the twelve-month period ended 31 December 2015, prepared in accordance with IFRS.
Commenting on the 2015 results, Dr. Christian Homsy, CEO of Celyad: “2015 was another great year for Celyad, with tremendous progress made in our clinical programs and successful fund raisings that provide us the means to further develop the potential of our technology platforms. The Company has technologies that have the potential to position it as a fully integrated biotechnology leader, and we are looking forward to many value creation steps over the course of the next few months.”
Conference call details
A conference call will be held on Thursday, March 24, 2016 at 6:00 p.m. (CET) / 1:00 p.m. (EDT) to review the financial results. Christian Homsy, Chief Executive Officer, and Patrick Jeanmart, Chief Financial Officer will deliver a brief presentation followed by a Q&A session. Participants are asked to call the assigned number approximately five minutes before the conference call begins.
The call can be accessed by dialing the numbers below and quoting conference ID 78283186:
- Participants International Dial-In : ……… +44 (0)1452 560304
- Belgium : ………………………………………. 02 401 70 52
- France : ………………………………………… 01 70 70 07 85
- UK : ……………………………………………… 0844 871 9299
- US: ………………………………………………. 1 631 621 5256
2015 Financial and operating results
2015 was another transformational year for Celyad. In 2015, Celyad built the foundations for great accomplishments in the near future by realizing significant strategic, operational and financial milestones.
The acquisition of OnCyte LLC and its portfolio of clinical and preclinical assets in immuno-oncology in January 2015, positioned Celyad as an important international cell therapy player, making the transition from Belgian cell therapy company specialized in ischemic heart failure into an internationalised group that has the potential to develop clinical programs both in cardiovascular disease and in immuno-oncology, across Europe, U.S. and Asia.
On the operational side, we completed the enrolment and treatment of the last patient of our CHART-1 European phase III trial. We also received authorization from the U.S. FDA for clinical testing of C-Cure®, allowing the initiation of the CHART-2 Phase III clinical trial in the U.S with the use of our proprietary catheter C-CATHez™.
On the financing side, we raised more than EUR 120 million (gross proceeds) through a private placement and an Initial Public Offering on NASDAQ, respectively closed in March and June 2015. Based on its current scope of activities, the Company estimates its cash position is sufficient to secure the funding of all our preclinical and clinical development programs until end of 2017.
Here are the important operational and financial highlights of 2015:
Clinical Developments in Cardiology – C-Cure®
- Recommendation from the Data Safety Monitoring Board, or DSMB, to not discontinue the CHART-1 Phase III trial for C-Cure® based on its review of unblinded safety and efficacy data from treated and control patients. The DSMB determined that the data did not support discontinuation of the trial on the basis of futility. Furthermore, the DSMB recommended continuation of the trial with no protocol changes.
- Completion of patient enrolment and dosing in the CHART-1 clinical trial for C-Cure® conducted in Europe and Israel, triggering the 9-month follow-up period. Top line data of CHART-1 will be disclosed in June 2016.
- European Medicines Agency (EMA) delivered product-specific paediatric waiver for C-Cure® for the treatment of ischemic heart failure.
- Initiation of the certification by the EMA of the non-clinical data of C-Cure® aimed to prepare the submission of a marketing-authorization application.
- U.S. Food and Drug Administration (FDA) authorized the Company’s Investigational New Drug (IND) application to proceed thus allowing the clinical testing of C-Cure® cardiopoietic cells delivered by Celyad’s proprietary catheter C-CATHez™ in U.S. Phase III trial, CHART-2.
Clinical Developments in Oncology
- Entering into the immune-oncology field with the acquisition of OnCyte LLC CAR T-Cell portfolio from Celdara Medical. Portfolio includes three autologous CAR T-Cell cell therapy products and an allogeneic T-Cell platform, targeting a broad range of cancer indications.
- Issuance of the US Patent 9,181,527 relating to allogeneic human primary T-Cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR). This patent significantly strengthens Celyad’s intellectual property portfolio.
- Completion of the 30-day safety follow-up of first cohort in NKR-T Phase I/IIa trial demonstrating the absence of toxic response of NKR-T in the first dose tested ever in humans.
- Infusion and 30 day-safety follow-up of the first patient of the second cohort in NKR-T-cell Phase I/IIa trial conducted at the Dana Farber Cancer Institute in Boston, USA.
Corporate and financial highlights
- Change of corporate name and branding to reflect investment and diversification strategy – Cardio3 BioSciences became Celyad on 5 May 2015.
- New collaboration and distribution agreement with Hong-Kong based partner, Medisun International Limited (“Medisun”). Under the terms of the new license agreement, Celyad will conduct all clinical development and undertake any regulatory steps necessary for market approval in China, Hong-Kong, Taiwan and Macau (collectively “Greater China”). With a minimum of €20 million, these activities will be funded by Medisun.
- Appointment of 6 senior executives and directors to strengthen the Group’s managing bodies in order to support the Group’s ambitions to become a global leader in specialty therapeutics and reinforce its position in both cardiology and oncology.
- Completion of a €32 million gross proceeds private placement of ordinary shares to institutional investors in the U.S. and Europe.
- Completion of a $100 million gross proceeds IPO on the NASDAQ by issuance of American Depositary Shares and ordinary shares to institutional investors in the U.S. and Europe, respectively.
- Cash of €108 million as of 31 December 2015.
Highlights of 2016
The momentum generated by our progress during 2015 has carried through into the start of 2016. Most notably, the Group has reported the following highlights in oncology:
- A strategic partnership with Inserm’s “Cancer and Immunity” Unit of Institut Curie in Paris, France, to further develop our NKR-T pipeline in cellular immunotherapies for cancer. Through this partnership, Celyad and Institut Curie will pool their expertise to progress Celyad’s immuno-oncology pipeline aimed at bringing novel cellular immunotherapies to cancer patients. The partnership will build on Institut Curie’s first-in-class expertise and state of the art translational, preclinical and clinical know-how in cancer biology and immunology, and Celyad’s well recognized cell therapy and cell manufacturing capabilities.
- Issuance of United States Patent No. 9,273,283 relating to a method of producing allogeneic primary human T cells that are engineered to be T-Cell Receptor (TCR)-deficient and express a Chimeric Antigen Receptor (CAR). The US Patent 9,273,283 is the second patent of Celyad’s allogeneic intellectual property portfolio that is awarded by the United States Patent and Trademark Office (USPTO). This new patent strengthens Celyad’s Intellectual Property position for its proprietary CAR T cells by adding broadly protecting methods for making these modified allogeneic T cells, and providing them as medicines. By reinforcing the Company’s patent portfolio within the CAR-T field, Celyad confirms its leadership in engineered cell therapy, and in the allogeneic CAR T space.
- Completion of the 21-day safety follow-up of the last patient enrolled in the second dose level and the treatment of the first patient from the third dose, in the Phase I/IIa clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy using T-cells with NKG2D receptor in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM). Data readouts from the first 12 patients treated in the Phase I portion are expected in mid-2016.
Finally, on the cardiology side, we notified the European Medicines Agency (EMA) of our intent to submit a Marketing Authorization Application (MAA) for C-Cure® in November 2016.
Annual Report 2015
Celyad will publish its audited Annual Report for the year ended 31 December 2015 on or around 7 April 2016. The statutory auditor, PwC – Réviseurs d?Entreprises, represented by Patrick Mortroux, has confirmed that the audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the financial information as at and for the year ended 31 December 2015 included in the Company’s annual announcement.