On March 24, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer (the Company), reported its consolidated financial results for fiscal year 2020 ended December 31, 2020 and provided a business update (Press release, Celyad, MAR 24, 2021, View Source [SID1234577160]).
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"The past twelve months have proven to be an evolutionary period in our Company’s history, as we prioritized our resources for the advancement of our allogeneic portfolio and technology platforms. We believe the development of our differentiated non-gene edited allogeneic therapies to treat both solid tumors and hematological malignancies offers the biggest potential opportunity for patients and our shareholders by potentially expediting and expanding patient access to novel treatment options," commented Filippo Petti, Chief Executive Officer of Celyad Oncology SA. "This past January, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Symposium, we presented encouraging translational data from our ongoing alloSHRINK study, which complements the previously reported tolerability and clinical activity data for CYAD-101 in patients with advanced mCRC. Today, we are excited to disclose initial data from our lead shRNA-based allogeneic program CYAD-211 for relapsed/refractory multiple myeloma. As we look ahead, we expect a data rich calendar year with updates across all three of our clinical candidates as well as the start of the Phase 1b KEYNOTE-B79 trial, positioning 2021 to be a defining year for the advancement of our clinical pipeline."
Recent Highlights
Entered into a committed equity purchase agreement for up to $40 million with Lincoln Park Capital Fund, LLC, a Chicago-based institutional investor
Appointed Marina Udier, Ph.D., a highly regarded leader in the biotechnology industry, to the Company’s Board of Directors
Update on Clinical and Preclinical Program
CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM
CYAD-211 is a first-in-class, allogeneic CAR T candidate engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex. In November 2020, the Company initiated the first-in-human, open-label, dose-escalation Phase 1 IMMUNICY-1 trial to evaluate the safety and efficacy of a single infusion of CYAD-211 following preconditioning chemotherapy cyclophosphamide and fludarabine in patients with relapsed/refractory (r/r) multiple myeloma (MM). The trial seeks to determine the recommended dose of CYAD-211 for the treatment of patients with r/r MM for further development as well as to establish proof-of-concept that single shRNA-mediated knockdown can generate allogeneic CAR T cells in humans without inducing Graft-versus-Host Disease (GvHD).
To date, no safety concerns or evidence of GvHD have been reported in the first three patients treated at dose level 1 (30×106 million cells per infusion) of CYAD-211 in the IMMUNICY-1 trial. Enrollment in dose level 2 (100×106 million cells per infusion) is currently ongoing.
CYAD-101 – Allogeneic TIM-based NKG2D CAR T for mCRC
The Company’s first-in-class, non-gene edited clinical candidate, CYAD-101, which co-expresses the NKG2D receptor and the novel inhibitory peptide TIM (TCR Inhibitory Molecule), continues to advance in the expansion segment of the alloSHRINK Phase 1 trial for the treatment of advanced metastatic colorectal cancer (mCRC). In January 2021, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Gastrointestinal Cancers Symposium, the Company presented additional positive data from the alloSHRINK trial including median overall survival (mOS) of 10.6 months for the dose-escalation segment of the study as well as tumor burden decrease, according to RECIST 1.1 criteria, observed in eight of 15 patients, including six of nine patients at dose level 3. To our knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication.
In December 2020, the Company initiated the expansion segment of the alloSHRINK trial, which is evaluating CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. The Company also plans to initiate the Phase 1b KEYNOTE-B79 trial, which will evaluate CYAD-101, following FOLFIRI preconditioning chemotherapy, with Merck’s PD-1 therapy, KEYTRUDA (pembrolizumab), in refractory mCRC patients with microsatellite stable (MSS) / proficient mismatch repair (pMMR) disease. The Company believes the mechanism of actions of CYAD-101 and KEYTRUDA are highly complementary and could help to drive additional clinical benefit in patients with advanced metastatic colorectal cancer.
CYAD-02 – Autologous NKG2D receptor-based CAR T for r/r AML and MDS
In November 2019, the Company initiated the dose-escalation Phase 1 CYCLE-1 trial, evaluating the safety and clinical activity of the next-generation, autologous NKG2D receptor-based CAR T candidate CYAD-02 following preconditioning chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The next-generation, NKG2D receptor-based CAR T candidate CYAD-02 incorporates a single shRNA to target the NKG2D ligands MICA and MICB.
To date, nine patients have received treatment with CYAD-02 in the CYCLE-1 trial. Treatment with CYAD-02 has been generally well-tolerated. Of seven patients evaluable for clinical activity, five patients demonstrated anti-leukemic activity (at least 50% bone marrow blasts decrease), including a very-high risk MDS patient treated at dose level 3 who achieved a marrow complete response, which is still ongoing. Enrollment in dose level 3 of the CYCLE-1 trial is currently ongoing.
Next-generation shRNA Multiplex Platform
In 2020, the Company began developing a proprietary shRNA platform utilizing a novel framework to optimize and expand the expression of multiple shRNAs with our All-in-One Vector approach. Our novel framework has the capability to knockdown or silence up to six genes simultaneously, while providing several key advantages beyond our first-generation approach. We believe our next-generation shRNA multiplex platform will form the backbone for our future allogeneic CAR T candidates, including several programs which are in the discovery phase of development.
Upcoming Milestones
Additional proof-of-concept data from the initial dose cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected by the end of Q2 2021
Preliminary data from the expansion segment of the alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients are expected in Q2 2021
Initiation of the Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA in mCRC patients with MSS/pMMR disease is anticipated by in the first half of 2021
Additional data from dose level 3 of Phase 1 CYCLE-1 trial of CYAD-02 for r/r AML and MDS are anticipated in the first half of 2021
Full Year 2020 Financial Results
As of December 31, 2020, the Company had a treasury position of approximately €17.2 million ($21.2 million).
On January 8, 2021, the Company entered into a committed equity purchase agreement (the Purchase Agreement) for up to $40 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor. Over the 24-month term of the Purchase Agreement, the Company will have the right to direct LPC to purchase up to an aggregate amount of $40 million American Depositary Shares (ADSs), each of which represents one of the ordinary shares of the Company. This equity facility is expected to strengthen the Company’s current statement of financial position while also providing the Company with access to future capital on an as needed basis and to ensure sufficient funding to cover its operations for the next 12 months from the date the financial statements are issued.
Based on the Company’s current scope of activities, the Company estimates that its cash and cash equivalents as of December 31, 2020 combined with the $40 million that the Company has access to from the equity purchase agreement established with LPC should be sufficient to fund operations until mid-2022.
Key financial figures for full-year 2020, compared with full-year 2019, are summarized below:
Selected key financial figures (€ millions) Full year 2020 Full year 2019
Revenue - -
Research and development expenses (21.5 ) (25.2 )
General and administrative expenses (9.3 ) (9.1 )
Change in fair value of contingent consideration 9.2 0.4
Other income/(expenses) 4.6 5.0
Operating loss (17.0 ) (28.9 )
Loss for the period/year (17.2 ) (28.6 )
Net cash used in operations (27.7 ) (28.2 )
Treasury position(1) 17.2 39.3
(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 in 2020 and in 2019.
The Research and Development (R&D) expenses show a year-over-year decrease of €3.7 million. The decrease is mainly driven by the decrease in preclinical activities, including process development and clinical development of the autologous programs associated with its r/r AML and MDS product candidates.
General and administrative expenses were €9.3 million in 2020 as compared to €9.1 million in 2019, an increase of €0.2 million. This increase primarily relates to higher insurances costs partly compensated by savings on the travel and living expenses due to COVID-19 pandemic travel restrictions.
The fair value adjustment (€9.2 million) relating to the contingent consideration and other financial liabilities as of December 31, 2020, mainly driven by updated assumptions associated with the timing of the potential commercialization of our autologous AML and MDS program as compared to year-end 2020. The decrease of the liability is also driven by the devaluation of the USD foreign exchange rate as of December 31, 2020.
The Company’s other income is associated with grants received from the Walloon Region mainly in the form of recoverable cash advances (RCAs) and R&D tax credit income:
Grant income (RCAs): additional grant income has been recognized in 2020 on grants in the form of recoverable cash advances (RCAs) for contracts, numbered 7685, 8087, 8088, 8212, 8436 and 1910028. According to IFRS standards, the Company has recognized grant income for the period amounting to €2.3 million and a liability component of €1.3 million accounted as a financial liability;
Grant income (Others): additional grant income has been recognized in 2020 on grants received from the Federal Belgian Institute for Health Insurance INAMI (€0.2 million) and from the regional government (contract numbered 8066 for €0.6 million), not referring to RCAs and not subject to reimbursement;
The remeasurement income on the RCAs of €0.9 million which is mainly related to the Company’s decision to update assumptions associated with the timing of the potential commercialization of our autologous AML and MDS program; and,
With respect to R&D tax credit, the decrease compared to 2020 is mainly related to a catch-up effect for €0.7 million which occurred in 2019 and a decrease on the current year income for €0.2 million due to global decrease on R&D expenses in 2020.
Net loss for the year ended December 31, 2020 was €17.2 million, or €1.23 per share, compared to a net loss of €28.6 million, or €2.29 per share, for the same period in 2019. The decrease in net loss between periods was primarily due to the increase change in fair value of contingent consideration combined with the decrease on the R&D expenses.
Net cash used in operations for the year ended December 31, 2020, which excludes non-cash effects, amounted to €27.7 million, which is in line with net cash used in operations of €28.2 million for the year ended December 31, 2019.
Annual Report 2020
The Annual Report for the year ended December 31, 2020 will be published tomorrow, March 25, 2021, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, EY Bedrijfsrevisoren BV/Reviseurs d’Entreprises SRL (EY), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. EY 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 Thursday, 25 March at 1:00 p.m. CET / 8:00 a.m. EDT to review the financial and operating results for full year 2020. Please dial-in five to ten minutes prior to the call start time using the number and conference ID below: