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 the first half of 2019 and provided its second quarter business update. The full interim financial report is available on Celyad’s website in the “Investors” section.
Filippo Petti, CEO of Celyad commented“As we enter the second half of the year, we continue to execute on our strategic plan for becoming a leader in the field of CAR-T development. Over the past few months we have presented encouraging data from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of hematological malignancies and solid tumors. We also received positive feedback from the FDA regarding our proposal to utilize the OptimAb manufacturing process with CYAD-01 under the current IND. In addition, the FDA recently cleared the IND application for our next-generation NKG2D-based CAR-T candidate CYAD-02, another testiment of our team’s focus on operational excellence. We are excited about our recent achievements and look to build upon our momentum as we approach several clinical milestones expected over the next several months.”
Second Quarter 2019 and Recent Business Highlights
- In June, the Company announced a strategic update to its autologous relapse/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) program, including that the U.S. Food and Drug Administration (FDA) accepted the Company’s proposal to utilize the OptimAb manufacturing process with CYAD-01 under the current Investigational New Drug (IND) application.
The OptimAb manufacturing process utilizes a shortened eight-day cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype while maintaining the high level of manufacturing reliability required to support clinical development. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive AML model compared to CYAD-01 produced with the previous mAb manufacturing process.
Following additional assessment of the r/r AML and MDS program for CYAD-01, Celyad plans to treat the first patient using the recently accepted OptimAb manufacturing process for CYAD-01 in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial.
- The Company also announced that the FDA accepted the IND application for CYAD-02, a next-generation, autologous NKG2D-based CAR-T candidate, and permitted it to go into effect. CYAD‑02 incorporates short hairpin RNA (shRNA) technology to target the NKG2D ligands MICA and MICB. The single shRNA modulates the expression of both ligands, which translates to encouraging increases in in vitro proliferation, in vivo engraftment and anti-tumor activity in preclinical studies. CYAD-02 also incorporates the OptimAb manufacturing process.
CYAD-01 – Autologous NKG2D-based CAR-T
The Company’s lead asset, CYAD-01 continues to advance in the Phase 1 THINK and DEPLETHINK clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). In June, Celyad presented preliminary data at the European Hematology Association (EHA) meeting that demonstrated that a denser schedule of infusions of CYAD-01 without preconditioning in Cohort 10 (Schedule Optimization) of the THINK trial was well tolerated and led to better time-averaged engraftment of the CAR-T cells compared to biweekly injections of CYAD-01 without preconditioning. Also at EHA, the Company reported that a single infusion of low dose CYAD-01 (100 million cells) following preconditioning chemotherapy consisting of cyclophosphamide and fludarabine was well-tolerated and led to better time-averaged engraftment of the CAR-T cells compared to the dose-escalation segment of the THINK trial.
In July, the Company also provided an update on CYAD-01 for the treatment of patients with metastatic colorectal cancer (mCRC) at the European Society for Medical Oncology (ESMO) 21st World Congress on Gastrointestinal Cancer (WCGIC) in Barcelona. Professor Dr. Eric Van Cutsem from the University Hospital of Leuven (Universitair Ziekenhuis Leuven, UZ Leuven) presented preliminary data from the ongoing Phase 1 SHRINK trial assessing safety and clinical activity of CYAD-01 infused concurrently with FOLFOX chemotherapy for the treatment of mCRC. Data from the trial showed the regimen to be generally well-tolerated and with initial observations of disease control.
CYAD-101 – Allogeneic NKG2D-based CAR-T
Celyad’s first-in-class, non-gene edited clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial. At the 21st ESMO-WCGIC, the Company presented preliminary data from the ongoing alloSHRINK trial assessing safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with relapsed or refractory mCRC. Preliminary data showed no clinical evidence of Graft-versus-Host Disease post-infusion of allogeneic candidate CYAD-101. In addition, the regimen demonstrated encouraging anti-tumor activity with one patient experiencing a partial response and three patients experiencing stable disease at the three-month assessment.
CYAD-200 Series – shRNA-based Allogeneic CAR-Ts
The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform and progress towards the IND applications for the CYAD-200 series of shRNA-based allogeneic CAR-T candidates, including CYAD-211, the Company’s CAR-T therapy targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma.
Key Upcoming Milestones
- Treatment of the first patient with CYAD-01 (300 million cells) produced with the OptimAb manufacturing process in the Phase 1 DEPLETHINK trial is expected by the end of September
- Results from Cohort 11 (Schedule Optimization) of THINK Phase 1 trial and Cohort 3 of DEPLETHINK Phase 1 trial evaluating CYAD-01 produced with the mAb manufacturing process for the treatment of r/r AML and MDS are anticipated by year-end 2019
- Additional results from the dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 for the treatment of mCRC are anticipated by year-end 2019
- Initiation of the Phase 1 dose-escalation trial evaluating CYAD-02, following preconditioning chemotherapy, for the treatment of r/r AML and MDS is expected in early 2020
- Submission of IND application for CYAD-211 (shRNA-based allogeneic BCMA CAR-T candidate) for the treatment of patients with multiple myeloma is anticipated during first half 2020
First Half 2019 Financial Review
The Company ended the quarter with a treasury position of €33.7 million ($38.3 million). Net cash burn over the first half of 2019 amounted to €16.1 million, in line with our financial planning. The Company confirms its previous position that its treasury position should be sufficient, based on the current scope of activities, to fund operating and capital expenditure requirementsuntil mid-2020.
Key financial figures for the first six months of 2019 compared with the same period of the previous year are summarized below:
|Selected key financial figures (€ millions)||Half Year|
As of June 30, 2019
As of June 30, 2018
|Research and development expenses||(12.7)||(11.1)|
|General and administrative expenses||(4.5)||(5.5)|
|Loss for the period/year||(16.0)||(18.5)|
|Net cash used in operations||(16.1)||(13.9)|
- 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 have generated no revenue in the first half of 2019 compared to €2.5 million during first half 2018. Research and Development expenses totalled €12.7 million during first half 2019, a €1.6 million increase compared to first half 2018, driven by increased spending related to our key clinical studies for CYAD-01 and CYAD-101 as well as an increased spending associated with the development of our allogeneic platform (CYAD-200 series). Over the same period, General and Administrative expenses were €4.5 million for first half 2019, a decrease of €1.0 million compared to first half 2018, driven primarily by the decrease of non-cash expense associated with the vesting of warrants and by 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) related to the advancement in the Company’s NKG2D-based CAR-T candidates. Overall, the Company has posted €0.4 million in net income for first half 2019, against a €3.9 million net loss for first half 2018.
Due to the increase in net income, the Company’s loss for the period decreased to €16.0 million for the first half 2019 compared to €18.5 million for the first half of 2018.
Net operational cash burn, which excludes non-cash effects, was €16.1 million for first half 2019, compared to €13.9 million for first half 2018, driven primarily by an increase in Research and Development spend as described above.
Conference Call and Webcast Details
Celyad will host a conference call on Friday, 23 August at 2:00 pm CEST / 8:00 am EDT accessible through the following numbers:
Belgium +32 (0) 24 01 70 35
France +33 (0)1 76 72 89 28
United States: +1 917 720 0181
International: +44 (0) 2071 928501
Conference ID: 3547725
The event will also be archived and available on the “Events & Webcasts” section of the Company’s website.
Third quarter 2019 business update November 19, 2019
Full-year results 2019 March 25, 2020
Annual shareholders meeting May 5, 2020