Mont-Saint-Guibert, Belgium – Celyad (formerly known as Cardio3 BioSciences, Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, today announced its consolidated financial results for the six-month period ending 30 June 2015 prepared in accordance with IFRS as endorsed by the European Union. The full interim financial report (regulated information) is available on our website in the Investors section. The Half Year 2015 consolidated financial statements were subject to a limited review by the company’s statutory auditors.
operational Highlights
- Clinical Developments in Cardiology – C-Cure®
- European Medicines Agency (EMA) delivered product-specific pediatric waiver for C-Cure® for the treatment of ischemic heart failure.
- 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 enrollment and dosing in the CHART-1 clinical trial for C-Cure® conducted in Europe and Israel.
- Clinical Developments in Oncology
- Investment in the immuno-oncology space with the acquisition of the OnCyte CAR T-cell portfolio through our purchase of OnCyte, LLC, a wholly-owned subsidiary of Celdara Medical, LLC.
- Infusion and 30 day-safety follow-up of the first patient of the NKG2D Phase I clinical trial conducted in the U.S.
corporate and financial Highlights
- Corporate
- Appointment of Dr. Vincent Brichard, former global head of immuno-oncology at GSK Vaccines, as Vice President Immuno-Oncology to lead the clinical development of Celyad’s oncology asset portfolio.
- Change of corporate name and branding to reflect investment and diversification strategy – Cardio3 BioSciences became Celyad on 5 May 2015.
- Finance
- 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 €124 million as of 30 June 2015.
Dr. Christian Homsy, CEO of Celyad, said: “The first half of 2015 was a significant period for Celyad. It began with the diversification of our business through the acquisition of the OnCyte CAR T-Cell portfolio in January and culminated in the completion of our U.S. IPO in June. We continued to deliver on our development objectives for both C-Cure and NKG2D CAR T-cell and reached important clinical milestones in both programs. We believe the steps we have taken over the last six months well-position Celyad to become a global leader in engineered cell therapies and the funds raised provide the Company with a solid financial foundation for us to continue to advance our vision of changing the outcome of serious disease for patients through the development of best-in-class and first-in-class therapies.”
selected FIRST HALF 2015 FINANCIAL RESULTS
| In million euros | H1 2015 | H1 2014 |
| Research and Development expenses | 11,5 | 6,5 |
| General and Administration expenses | 3,6 | 2,0 |
| Operating loss | (15,2) | (6,4) |
| Loss of the period | (15,3) | (6,4) |
| Loss per share (in €) | (2,10) | (0,99) |
| Change in net cash and cash equivalent | 88,5 | 16,0 |
| Cash and short term investment | 123,8 | 40,1 |
A conference call will be held at 2:00pm CET / 8:00am 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 11186221.
| International: | +44 (0) 1452 555566 |
| Belgium: | 0800 40 864 (free) – 081 700 061 (local) |
| France: | 0805 632 056 (free) – 01 76 74 24 28 (local) |
| United States: | 1 866 966 9439 (free) – 1 631 510 7498 (local) |
