* First patient successfully dosed in expansion cohort of autologous CYAD-01 THINK trial for patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)
* CYCLE-1 trial of autologous CYAD-02 for the treatment of r/r AML and MDS ongoing
* Expansion cohort of alloSHRINK trial evaluating allogeneic CYAD-101 for metastatic colorectal cancer (mCRC) on target to begin in second half 2020
* Submission of IND for short hairpin RNA (shRNA)-based allogeneic CYAD-211 candidate for multiple myeloma (MM) expected in mid-2020
* Treasury position of EUR 39.3 million ($44.0 million) as of December 31, 2019
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 its consolidated financial results for fiscal year 2019 ended December 31, 2019 and provided a business update.
"This is an exciting time for us as we advance Celyad as an innovative leader in the industry which is focused on developing CAR-T therapies for cancer patients. The progress we made throughout 2019 positions Celyad with a balanced pipeline of clinical and preclinical CAR-T candidates as we enter the new decade with several milestones on the horizon," commented Filippo Petti, Chief Executive Officer of Celyad. "We now have two autologous clinical CAR-T candidates in development for the treatment of r/r AML and MDS and a portfolio of promising allogeneic CAR-T candidates, led by CYAD-101, for the treatment of mCRC. We look forward to providing key updates on our clinical progress throughout 2020. Over the past year, we also progressed our shRNA platform for next-generation CAR-T candidates, including our preclinical allogeneic BCMA-targeted candidate, CYAD-211. I am extremely proud of our team's achievements over the past twelve months and look forward to a productive 2020."
Recent Business Highlights and Pipeline Updates
CYAD-01 - Autologous NKG2D CAR-T for r/r AML and MDS
The Company's lead NKG2D CAR-T clinical candidate CYAD-01 continues to advance in Phase 1 trials for the treatment of patients with r/r AML or MDS. In December 2019, the Company presented the latest data from the CYAD-01 Phase 1 THINK and DEPLETHINK clinical trials at the American Society of Hematology annual meeting. In February 2020, the Company began recruitment in the expansion cohort of the THINK trial evaluating CYAD-01 as a monotherapy. Both the expansion cohort of the THINK trial and the dose-esclation DEPLETHINK trial are now assessing CYAD-01 produced with the Company's proprietary OptimAb manufacturing process.
CYAD-02 - Autologous NKG2D CAR-T for r/r AML and MDS
In January 2020, the Company announced the first patient has been dosed in the Phase 1 dose-escalation CYCLE-1 trial evaluating the next-generation NKG2D-based CAR-T candidate for the treatment of r/r AML and MDS. The CYCLE-1 trial will evaluate the safety and clinical activity of a single infusion of CYAD-02 produced with the OptimAb manufacturing process following preconditioning chemotherapy with cyclophosphamide and fludarabine. The trial will evaluate three dose levels of CYAD-02 up to one billion cells per infusion.
CYAD-101 - Allogeneic TIM-based, NKG2D CAR-T for mCRC
The Company's allogeneic NKG2D CAR-T clinical candidate CYAD-101, which incorporates the non-gene edited T-cell receptor Inhibitory Molecule (TIM) technology, continues to advance in the dose-escalation alloSHRINK trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with r/r mCRC. In November 2019, preliminary data from the ongoing alloSHRINK trial were presented at the Society for Immunotherapy of Cancer annual meeting and showed no clinical evidence of Graft-versus-Host Disease post-infusion of CYAD-101. In addition, encouraging anti-tumor activity with two out of 12 patients experiencing a partial response and five patients experiencing stable disease with a minimum of three months of duration. Based on the preliminary data from the Phase 1 alloSHRINK trial, the Company plans to expand the trial to confirm initial safety and clinicial activity of CYAD-101 with chemotherapy in refractory mCRC patients.
CYAD-211 - Allogeneic shRNA-based, BCMA CAR-T for r/r MM
The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform through the CYAD-200 series of product candidates. The Company's lead preclinical CAR-T candidate from the series, CYAD-211, targets B-cell maturation antigen (BCMA) for the treatment of relapsed / refractory multiple myeloma (r/r MM). The Company continues to progress towards submitting an Investigational New Drug (IND) application for CYAD-211.
Update on COVID-19 Pandemic
In light of the outbreak of the novel coronavirus, COVID-19, the Company has implemented strong measures to help prevent the spread of the virus and protect our employees. In addition, we have put into practice our business continuity plan to minimize the impact on our operations. While the Company is not currently experiencing any major disruptions in its business related to COVID-19, given the recent developments associated with the virus both in Belgium and in the United States and due to recently adopted government policies, the Company does anticipate enrollment delays within our r/r AML and MDS program. The Company is continuing to monitor the impact of COVID-19 on both our clinical and non-clinical planned milestones below and will adjust accordingly as the pandemic continues to rapidly evolve.
Upcoming MilestonesReport additional data from the dose-escalation segment of the CYAD-101 alloSHRINK Phase 1 trial during the second quarter of 2020Submit IND application for an shRNA-based allogeneic BCMA CAR-T candidate, CYAD-211, for the treatment of patients with r/r MM by mid-2020Report preliminary data from expansion cohort of the Phase 1 THINK and dose-escalation Phase 1 DEPLETHINK trials evaluating CYAD-01 produced with OptimAb manufacturing process during second half of 2020, due to enrollment delays caused by the COVID-19 pandemicBegin expansion segment of the CYAD-101 alloSHRINK Phase 1 trial during the second half of 2020Report preliminary data from the dose-escalation Phase 1 CYCLE-1 trial for CYAD-02 by year-end 2020
2019 Financial Results
As of December 31, 2019, Celyad had a treasury postion of approximately EUR 39.3 million ($44.0 million). The Company expects that the existing treasury position will be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements through the first half of 2021.
Key financial figures for full-year 2019, compared with full-year 2018, are summarized below:
Selected key financial figures (EUR millions)
Full-Year 2019
Full-Year 2018
Revenue
-
3.1
Research and Development expenses
(25.2)
(23.6)
General and Administrative expenses
(9.1)
(10.4)
Other income/(expenses)
5.4
(7.3)
Operating loss
(28.9)
(38.2)
Loss for the year
(28.6)
(37.4)
Net cash used in operations
(28.2)
(27.2)
Treasury position(1)
39.3
49.7 1. Treasury position' is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS.
The Company's license and collaboration agreements generated no revenue for the year ended December 31, 2019, compared to EUR 3.1 million for the year ended December 31, 2018.
Research and development expenses were EUR 25.2 million for the year ended December 31, 2019, compared to EUR 23.6 million for the year ended December 31, 2018. The EUR 1.6 million increase was primarily driven by spending related to the Company's preclinical product candidates and its investments in process development, scale-up and automation of its manufacturing processes.
General and administrative expenses were EUR 9.1 million for the year ended December 31, 2019, compared to EUR 10.4 million for the year ended December 31, 2018. The difference of EUR 1.3 million was primarily due to the decrease of non-cash expense associated with the vesting of warrants and lower consulting fees for the period.
The Company's other income/other expenses mainly include:
* Non-cash expenses relating to liability reassessment, required by International Financial Reporting Standards (IFRS), associated with the advancement in the Company's NKG2D CAR-T candidates. Overall, the Company posted EUR 0.3 million in net profit for the year ended December 31, 2019, compared to a net loss of EUR 6.6 million for the year ended December 31, 2018;
* Government grant income of EUR 3.3 million for the year ended December 31, 2019, primarily due to new grants from the Walloon Region received in the fourth quarter of 2019, compared to grant income of EUR 0.8 million for the year ended December 31, 2018;
* R&D tax credit, recognized as income, of EUR 1.6 million for the year ended December 31, 2019, compared to income of EUR 0.3 million for the year ended December 31, 2018.
Net loss was EUR 28.6 million, or EUR (2.29) per share, for the year ended December 31, 2019, compared to a net loss of EUR 37.4 million, or EUR (3.36) per share, for the same period in 2018. The decrease in net loss between periods was primairly due to the increase in net other income.
Net cash used in operations, which excludes non-cash effects, for the year ended December 31, 2019 amounted to EUR 28.2 million, compared to EUR 27.2 million for the same period in 2018. The difference was driven primarily by an increase in spend associated with Research and Development described above.
Annual Report 2019
The Annual Report for the year ended December 31, 2019 will be published tomorrow, March 25, 2020, and will be available on the Company's website, www.celyad.com. The Company's statutory auditor, BDO Reviseurs d'Entreprises SCRL (BDO), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. BDO also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.
Conference Call and Webcast Details
A conference call will be held on Wednesday, 25 March at 1:00 p.m. CET / 8:00 a.m. ET to review the financial and operating results for full year 2019. Please dial-in five to ten minutes prior to the call start time using the number and conference ID below:
Conference ID: 1392585
International: +44 (0) 2071 928501
Belgium +32 (0) 24 01 70 35
France +33 (0)1 76 72 89 28
Netherlands + 31 (0) 20 71 88 527
United States: +1 917 720 0181
Financial Calendar
Annual shareholders meeting May 5, 2020
First quarter 2020 business update May 7, 2020
Half-year results 2019 August 6, 2020
Third quarter 2020 business update November 10, 2020
.
CELYAD ONCOLOGY SA 
