Cellectis Reports Financial Results for 3rd Quarter and First Nine Months 2018

UCART123 in Phase 1 clinical trial for AML and BPDCN patients;

UCART22 Phase 1 study protocol approved by FDA for B-ALL patients;

UCART19 ASH abstract by partner Servier shows continued progress of first clinical allogeneic CAR T-cell program for ALL patients;

UCARTCS1 clinical trial expected to start in 2019 for Multiple Myeloma patients;

Cash[1] position of $476M as of September 30, 2018 compared to $297M as of December 31, 2017

 

New York, N.Y. – November 13, 2018 – Cellectis S.A. (Euronext Growth: ALCLS - Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced its results for the three-month period ended September 30, 2018 and for the nine-month period end September 30, 2018.

 

Third Quarter 2018 and Recent Highlights

UCART123 (wholly controlled) – AML & BPDCN patients

The Phases 1 dose escalation studies of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients at MD Anderson Cancer Center and Weill Cornell Medical Center remain ongoing.   

For the AML clinical trial, the current dose level of 2.5x10⁵ UCART123 cells per kilogram will be followed by dose levels 2 and 3 with 6.25x10⁵ and 5.05x10⁶ UCART123 cells per kilogram. We are expecting to dose 2-4 patients per dose cohort, with a treatment follow-up period of 4 weeks per patient as well as an option to re-dose responding patients.

 

UCART22 (wholly controlled) – B-ALL patients

The FDA approved an IND for UCART22, with a first Phase 1 clinical study in B-cell acute lymphoblastic leukemia (B-ALL) adult patients.

UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR T-cell product candidate developed by Cellectis to enter clinical trials.

UCART22 is designed for the treatment of CD22-expressing cancer cells. Like CD19, CD22 is a cell surface antigen expressed from the pre-B-cell stage of development through mature B-cells and is expressed in more than 90% of patients with B-ALL. Approximately 85% of ALL cases involve precursor B-cells (B-ALL). The clinical research for UCART22 will be led by Dr. Nitin Jain, Assistant Professor at The University of Texas MD Anderson Cancer Center in Houston, and Prof. Hagop Kantarjian, Professor and Chair in the Department of Leukemia and University Chair in Cancer Medicine, at The University of Texas MD Anderson Cancer Center in Houston.

 

UCARTCS1 (wholly controlled) – Multiple Myeloma patients

A clinical trial for UCARTCS1 is expected to start in 2019 in Multiple Myeloma patients.

UCARTCS1 is our first allogeneic CAR T-cell product candidate for the treatment of Multiple Myeloma (MM) patients. We have chosen CS1 (also known as SLAMF7) as the targeted antigen for this program, based on the high levels of expression of CS1 in MM patients on malignant cells relative to the low level of expression on non-malignant cells as well as on the results of third parties’ proof of concept for this high value target achieved with the elotuzumab monoclonal antibody in MM patients.

 

UCART19 (partnered, exclusively licensed to Servier) – ALL patients

Recently, an abstract titled “896 Preliminary Data on Safety, Cellular Kinetics and Anti-Leukemic Activity of UCART19, an Allogeneic Anti-CD19 CAR T-Cell Product, in a Pool of Adult and Pediatric Patients with High-Risk CD19⁺ Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia” for oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting, was published online, showing the continued progress of UCART19 in Phase 1 clinical trials, for both pediatric and adult ALL patients.

After UCART19 infusion, 88% of evaluable patients (14/16) achieved a complete remission (CR) or complete remission with incomplete blood cell recovery (CRi) by day 28 or day 42 post UCART19 infusion and 86% (12/14) of these patients were ‘measurable residual disease’ (MRD) negative (MRD^- stands for less than 1 leukemic cell among 10⁴ normal cells) assessed by flow or qPCR.

We are pleased to see continued progress for UCART19 under the management of our partner Servier.

Under the collaboration agreement with Servier from 2014, Cellectis is entitled to receive up to $350 million in clinical and regulatory milestone payments, as well as tiered royalties in the high single digits on worldwide sales.

 

ALLO-715 (BCMA) and ALLO-819 (Flt3) (partnered, exclusively licensed to Allogene)

In addition, Allogene has released (i) an abstract for oral presentation at ASH 2018 annual meeting, describing pre-clinical research on ALLO-715, an allogeneic BCMA CAR T therapy possessing an off-switch for the treatment of Multiple Myeloma, and (ii) an abstract for a poster presentation for ALLO-819, an allogeneic Flt3 CAR T therapy possessing an off-switch for the treatment of acute myeloid leukemia (AML).

ALLO-715 and ALLO-819 were progressed under a joint research collaboration with Allogene, and are directed to targets that were licensed exclusively from Cellectis. Allogene holds the exclusive global development and commercial rights for these product candidates.

Cellectis remains eligible to receive clinical and commercial milestone payments of up to $2.8 billion, or $185 million per target for 15 targets, and tiered royalties in the high single digits on worldwide sales of any products that are developed by Allogene, as originally agreed to under the June 17, 2014 Collaboration Agreement with Pfizer.

 

Manufacturing

We are currently in the process of internalizing large parts of our proprietary manufacturing chain for clinical supplies and we are planning to build a proprietary cGMP, commercial scale manufacturing facility in the United States.

 

Corporate Governance

On August 2, 2018, Cellectis announced the appointment of Dr. Stefan Scherer, M.D., Ph.D., to the role of Senior Vice President Clinical Development and Deputy Chief Medical Officer.

On September 19, 2018, Cellectis announced that Stephan A. Grupp, MD, Ph.D., a leading pediatric oncologist at Children's Hospital of Philadelphia and Chief of the Section of Cellular Therapy and Transplant at the Children's Hospital of Philadelphia (CHOP) joined the Company’s Clinical Advisory Board (CAB).

 

Financial Results

 

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board (“GAAP”).

 

Third Quarter and Nine-months 2018 Financial Results

Cash: As of December 31, 2017, Cellectis had $297.0 million in total cash, cash equivalents and current financial assets compared to $475.9 million as of September 30, 2018. This increase of $178.9 million primarily reflects $227.4 million net cash proceeds provided by follow-on offerings completed by Cellectis and Calyxt, partially offset by the net cash flows used by operating activities of $47.5 million.

We believe that our cash, cash equivalents and current financial assets of $475.9 million as of September 30, 2018 will be sufficient to fund our operations until 2022.

Revenues and Other Income: Total revenues and other income were $2.2 million for the three months ended September 30, 2018 compared to $7.3 million for the three months ended September 30, 2017. Total revenues and other income were $18.5 million for the nine months ended September 30, 2018 compared to $26.7 million for the nine months ended September 30, 2017. The decrease in both periods was primarily attributable to a decrease in recognition of upfront fees already paid to Cellectis and research and development cost reimbursements in relation to collaborations.

R&D Expenses: Total R&D expenses were $18.7 million for the three months ended September 30, 2018 compared to $20.3 million for the three months ended September 30, 2017. Total R&D expenses were $55.2 million for the nine months ended September 30, 2018 compared to $58.5 million for the nine months ended September 30, 2017. The decrease in both periods was primarily driven by decreased non-cash stock-based compensation expenses partially offset by increased wages and salaries.

SG&A Expenses: Total SG&A expenses were $11.6 million for the three months ended September 30, 2018 compared to $12.2 million for the three months ended September 30, 2017. The decrease was primarily attributable by decreased non-cash stock-based compensation expenses partially offset by increased in purchases and external expenses. Total SG&A expenses were $36.8 million for the nine months ended September 30, 2018 compared to $31.8 million for the nine months ended September 30, 2017. The increase was primarily driven by increased purchases and external expenses and wages and salaries partially offset by a decrease in non-cash stock-based compensation.

Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to Shareholders of Cellectis was $22.8 million (or $0.54 per share) for the three months ended September 30, 2018 compared to $26.2 million (or $0.73 per share) for the three months ended September 30, 2017. Net loss attributable to Shareholders of Cellectis was $55.4 million (or $1.38 per share) for the nine months ended September 30, 2018 compared to 72.3 million (or $2.03 per share) for the nine months ended September 30, 2017. The decrease in both periods was primarily driven by financial gains and decrease in non-cash stock-based compensation expense, partially offset by decreased revenues and other income and increased purchases and external expenses and wages and salaries.

Adjusted Net Loss Attributable to Shareholders of Cellectis: Net loss attributable to Shareholders of Cellectis was $15.1 million ($0.36 per share), for the three months ended September 30, 2018 compared to $14.3 million ($0.40 per share) for the three months ended September 30, 2017. Net loss attributable to Shareholders of Cellectis was $28.0 million ($0.70 per share) for the nine months ended September 30, 2018 compared to $34.3 million ($0.96 per share) for the nine months ended September 30, 2017. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.