– Started construction of in-house manufacturing facilities IMPACT
and SMART
– FDA approved IND for UCARTCS1A product candidate in Multiple Myeloma
– Published novel manufacturing methods to improve allogeneic CAR
T-cell safety and purity
– Cash position1 of $425 million as of March
31, 2019
NEW YORK–(BUSINESS WIRE)–Regulatory News:
Cellectis
(Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a
clinical stage biopharmaceutical company focused on developing
immunotherapies based on allogeneic gene-edited CAR T-cells (UCART),
today announced its results for the three-month period ended March 31,
2019.
“We have been executing against our 2019 plans, securing premises for
our in-house manufacturing facilities in the United States and in France
as well as receiving IND approval by the FDA for UCARTCS1A, our fourth
UCART product candidate,” said Dr. André Choulika, Chairman and CEO of
Cellectis. “This year, Cellectis is planning to enroll patients in three
separate Phase 1 clinical trials covering three major hematologic
diseases, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and
Multiple Myeloma, with our proprietary allogeneic CAR T-cell product
candidates. In 2019, Cellectis and its partners will continue to extend
their first-mover advantage in the field of gene editing and allogeneic,
off-the-shelf CAR-T, with the goal of accelerating our ability to bring
our pioneering cell therapies to patients.”
Q1 Corporate Highlights
Scientific Publication
In February 2019, we announced the publication of a study in The
Journal of Biological Chemistry, identifying Granulocyte Macrophage
Colony Stimulating Factor (GMCSF) secreted by Chimeric Antigen Receptor
(CAR) T-cells as a key factor promoting cytokine release syndrome (CRS).
The report leverages these findings to elaborate an innovative
engineering strategy that potentially paves the way for developing safer
UCART products.
This publication was significant because Cellectis’ engineering strategy
could circumvent toxic side effects such as CRS and neurotoxicity,
thereby aiming to the development of safer, yet equally potent, UCART
product candidates in an effort to improve patients’ quality of life
during treatment.
Manufacturing
In March 2019, we entered into a lease agreement for an 82,000 square
foot commercial-scale manufacturing facility, called IMPACT, which
stands for “Innovative Manufacturing Plant for Allogeneic Cellular
Therapies”. This new site, located in Raleigh, North Carolina, is being
designed to provide GMP manufacturing for clinical supplies and
commercial manufacturing upon potential regulatory approval. The
facility is planned to be operational by 2021.
In addition to IMPACT, Cellectis started building a 14,000 square foot
manufacturing facility in Paris, France, named SMART, which stands for
“Starting Material Realization for CAR-T products”. This facility is
designed to produce Cellectis’ critical starting material supplies for
UCART clinical studies and commercial products, and when combined with
IMPACT, will allow Cellectis to gain autonomy in its manufacturing
operations and consolidate its competitive leadership in the
gene-editing field.
Regulatory
In April 2019, Cellectis announced that the U.S. Food and Drug
Administration (FDA) approved the Company’s Investigational New Drug
(IND) application to initiate a Phase 1 clinical trial with UCARTCS1A in
Multiple Myeloma (MM). Cellectis is the sponsor of the UCARTCS1A
clinical study.
Conference
At the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting,
Cellectis presented data from its Universal CAR T-cell programs in an
oral presentation and poster session.
The oral presentation presented data regarding the potential of
UCARTCS1A as a treatment approach for patients with Multiple Myeloma,
and followed the recent clearance of the UCARTCS1A IND by the FDA. The
poster presentation showcased Cellectis’ allogeneic CAR T-cell
manufacturing expertise, with a focus on a novel, straightforward and
efficient strategy to generate Universal CAR T-cells. This exemplifies
opportunities for Cellectis’ cutting-edge gene-editing and cell
engineering capabilities to be leveraged to improve key features of our
product candidates.
Further presentations were given by Julianne Smith, Ph.D., Vice
President of Translational Sciences and Philippe Duchateau, Ph.D., Chief
Scientific Officer at Cellectis. Dr. Smith participated in a corporate
review session at the Gene Editing Workshop prior to the official start
of the conference, while also presenting a talk entitled “Allogeneic
Gene-Edited CAR T-Cells: From Preclinical to Clinical Proof of Concept”
during the Scientific Symposium “Towards the Holy Grail of Cancer Gene
Therapies: Universal Cells, Targeted Vectors and Solid Tumor CART
Efficacy”. Dr. Duchateau participated in the Scientific Symposium
“Innovation in First Time in Human Study Clinical Studies” with a
presentation titled “Universal Gene-Edited CAR T-Cell Immunotherapy”.
In April 2019, at ASGCT Annual Meeting, we presented a novel method of
manufacturing ultrapure TCR-negative allogeneic CAR T-cells. With
transient expression of an anti-CD3 CAR in addition to the stably
expressed “therapeutic CAR” in the donor T-cells, we programed the cells
to self-eliminate the TCR+ cell population and obtained an ultrapure
TCR-negative population (99%-99.9%) at the end of CAR-T production. The
fitness of the produced cells was not affected by the transient
expression of the anti-CD3 CAR, nor did we see a significant impact in
the CAR T-cell growth rate, T-cell differentiation or exhaustion level
as compared to the non-CD3 CAR counterpart.
Both in vitro and in vivo T-cell killing assay results suggest that the
CD3-CAR treatment did not affect the CAR T-cell killing function.
This novel procedure has the potential to remove a tedious purification
step in TCR-negative CAR T-cell manufacturing.
Financial Results
The interim condensed consolidated financial statements of Cellectis,
which consolidate the results of Calyxt, Inc. of which Cellectis is a
69.5% stockholder, have been prepared in accordance with International
Financial Reporting Standards, or IFRS, as issued by the International
Accounting Standards Board (“GAAP”).
We present certain financial metrics broken out between our two
reportable segments – Therapeutics and Plants – in the appendices of
this Q1 2019 financial results press release.
First quarter 2019 Financial Results
Cash: As of March 31, 2019, Cellectis, including Calyxt had $425
million in consolidated cash, cash equivalents, current financial assets
and restricted cash of which $340 million are attributable to Cellectis
on a stand-alone basis. This compares to $453 million in consolidated
cash, cash equivalents, current financial assets and restricted cash as
of December 31, 2018, of which $358 million were attributable to
Cellectis. This net decrease of $28 million primarily reflects $22
million in net cash flows used by operating activities in the first
quarter of 2019, of which $13 million are attributable to Cellectis. We
believe that the consolidated cash, cash equivalents, current financial
assets and restricted cash position as of March 31, 2019 will be
sufficient to fund operations through 2021.
Revenues and Other Income: Consolidated revenues and other income
were $3 million for the three months ended March 31, 2019 compared to $8
million for the three months ended March 31, 2018. 94% of consolidated
revenues and other income was attributable to Cellectis in the first
quarter of 2019. This decrease between 2019 and 2018 was mainly
attributable to a decrease in recognition of upfront payments already
received and R&D cost reimbursements in relation to the therapeutic
collaborations.
R&D Expenses: Consolidated R&D expenses were $14 million for
the year ended March 31, 2019 compared to $18 million for the year ended
March 31, 2018. 86% of consolidated R&D expenses was attributed to
Cellectis in the first quarter of 2019. The $4 million decrease between
2019 and 2018 was primarily attributed to the reductions of non-cash
stock-based compensation expenses by $4 million and purchases and
external and other expenses by $1 million. This decrease was partially
offset by higher employee expenses and other by $1 million.
SG&A Expenses: Consolidated SG&A expenses were $12 million
for the three months ended March 31, 2019 compared to $14 million for
the three months ended March 31, 2018. 47% of consolidated SG&A expenses
was attributed to Cellectis in the first quarter 2019. The $2 million
decrease was primarily attributable by decreased non-cash stock-based
compensation expenses by $ 3 million which was partially offset by an
increase in purchases and external expenses and other by $1 million.
Net Loss Attributable to Shareholders of Cellectis: The
consolidated Net loss attributable to Shareholders of Cellectis was $15
million (or $0.36 per share) for the three months ended March 31, 2019,
of which $10 million was attributed to Cellectis, compared to $25
million (or $0.71 per share) for the three months ended March 31, 2018,
of which $20 million was attributed to Cellectis. This $10 million
decrease in net loss between 2019 and 2018 was primarily driven by a
significant increase in net financial gains of $8 million and by a
decrease in operating losses of $2 million which was attributed to
Cellectis.
Adjusted Net Loss Attributable to Shareholders of Cellectis: The
consolidated Adjusted net loss attributable to Shareholders of
Cellectis was $11 million (or $0.26 per share) for the three months
ended March 31, 2019, of which $7 million is attributed to Cellectis,
compared to $14 million (or $0.39 per share) for the three months ended
March 31, 2018, of which $11 million was attributed to Cellectis. 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.
We currently foresee focusing on our cash spending on Cellectis for 2019
in the following areas:
-
Supporting the development of our deep pipeline of product candidates,
including the manufacturing and clinical trials expenses of UCART123,
UCART22 and UCARTCS1A; -
Building our state-of-the-art manufacturing capabilities (IMPACT and
SMART); and -
Strengthening our manufacturing and clinical departments, including
hiring talented personnel.
Calyxt plans to focus its cash spending for the remainder of 2019 in the
following areas:
-
Continuing to drive the commercialization of its High-Oleic Soybean
products, including Calyno™ High-Oleic Soybean Oil and High-Oleic
Soybean Meal; - Supporting its innovative products pipeline; and
- Strengthening its commercial and general and administrative support.
|
CELLECTIS S.A. |
||||
| As of | ||||
|
December 31, |
March 31, 2019 |
|||
| ASSETS | ||||
| Non-current assets | ||||
| Intangible assets | 1 268 | 1 222 | ||
| Property, plant, and equipment | 10 041 | 9 689 | ||
| Right-of-use assets | 0 | 36 788 | ||
| Other non-current financial assets | 1 891 | 4 684 | ||
| Total non-current assets | 13 199 | 52 382 | ||
| Current assets | ||||
| Inventories | 275 | 1 054 | ||
| Trade receivables | 2 971 | 2 801 | ||
| Subsidies receivables | 17 173 | 19 327 | ||
| Other current assets | 15 333 | 14 534 | ||
| Cash and cash equivalent and Current financial assets | 451 889 | 421 839 | ||
| Total current assets | 487 641 | 459 555 | ||
| TOTAL ASSETS | 500 840 | 511 938 | ||
| LIABILITIES | ||||
| Shareholders’ equity | ||||
| Share capital | 2 765 | 2 765 | ||
| Premiums related to the share capital | 828 525 | 831 282 | ||
| Treasury share reserve | 0 | 0 | ||
| Currency translation adjustment | (16 668) | (22 385) | ||
| Retained earnings | (326 628) | (405 264) | ||
| Net income (loss) | (78 693) | (15 248) | ||
| Total shareholders’ equity – Group Share | 409 301 | 391 150 | ||
| Non-controlling interests | 40 970 | 41 156 | ||
| Total shareholders’ equity | 450 272 | 432 307 | ||
| Non-current liabilities | ||||
| Non-current lease debts | 1 018 | 30 263 | ||
| Non-current provisions | 2 681 | 2 314 | ||
| Total non-current liabilities | 3 699 | 32 577 | ||
| Current liabilities | ||||
| Current lease debts | 333 | 5 385 | ||
| Trade payables | 15 883 | 15 698 | ||
| Deferred revenues and deferred income | 20 754 | 20 280 | ||
| Current provisions | 1 530 | 1 134 | ||
| Other current liabilities | 8 369 | 4 557 | ||
| Total current liabilities | 46 869 | 47 054 | ||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | 500 840 | 511 938 | ||
|
(*) The 2019 Interim Condensed Consolidated Financial |
||||
|
STATEMENT OF CONSOLIDATED OPERATIONS – |
||||
|
For the three-month period ended |
||||
| 2018 | 2019 | |||
| Revenues and other income | ||||
| Revenues | 6 040 | 1 036 | ||
| Other income | 2 025 | 2 395 | ||
| Total revenues and other income | 8 065 | 3 431 | ||
| Operating expenses | ||||
| Cost of revenue | (579) | (586) | ||
| Research and development expenses | (18 395) | (14 508) | ||
| Selling, general and administrative expenses | (14 013) | (11 488) | ||
| Other operating income (expenses) | 21 | 33 | ||
| Total operating expenses | (32 967) | (26 550) | ||
| Operating income (loss) | (24 902) | (23 119) | ||
| Financial gain (loss) | (2 137) | 5 396 | ||
| Net income (loss) | (27 038) | (17 723) | ||
| Attributable to shareholders of Cellectis | (25 438) | (15 248) | ||
| Attributable to non-controlling interests | (1 600) | (2 476) | ||
|
Basic net income (loss) attributable to shareholders of |
(0.71) | (0.36) | ||
|
Diluted net income (loss) attributable to shareholders of |
(0.71) | (0.36) | ||
|
CELLECTIS S.A.
DETAILS OF KEY PERFORMANCE INDICATORS BY REPORTABLE SEGMENTS – (unaudited) – ($ in thousands) |
||||||||||||
|
For the three-month period ended March |
For the three-month period ended March |
|||||||||||
| Plants | Therapeutics |
Total |
Plants | Therapeutics |
Total |
|||||||
| External revenues | 11 | 6 030 | 6 040 | 158 | 878 | 1 036 | ||||||
| External other income | – | 2 025 | 2 025 | 63 | 2 332 | 2 395 | ||||||
| External revenues and other income | 11 | 8 054 | 8 065 | 220 | 3 211 | 3 431 | ||||||
| Cost of revenue | (5) | (575) | (579) | (34) | (553) | (586) | ||||||
| Research and development expenses | (1 553) | (16 842) | (18 395) | (2 024) | (12 485) | (14 508) | ||||||
| Selling, general and administrative expenses | (5 652) | (8 361) | (14 013) | (6 059) | (5 429) | (11 488) | ||||||
| Other operating income and expenses | (43) | 65 | 21 | 3 | 29 | 33 | ||||||
| Total operating expenses | (7 253) | (25 713) | (32 966) | (8 113) | (18 437) | (26 550) | ||||||
| Operating income (loss) before tax | (7 243) | (17 659) | (24 901) | (7 893) | (15 226) | (23 119) | ||||||
| Financial gain (loss) | 151 | (2 287) | (2 137) | 214 | 5 182 | 5 396 | ||||||
| Net income (loss) | (7 092) | (19 946) | (27 038) | (7 679) | (10 044) | (17 723) | ||||||
| Non controlling interests | 1 600 | – | 1 600 | 2 476 | – | 2 476 | ||||||
|
Net income (loss) attributable to |
(5 492) | (19 946) | (25 438) | (5 203) | (10 044) | (15 248) | ||||||
|
R&D non-cash stock-based expense |
354 | 4 278 | 4 632 | 64 | 1 057 | 1 120 | ||||||
|
SG&A non-cash stock-based expense |
2 191 | 4 453 | 6 644 | 1 558 | 1 701 | 3 259 | ||||||
|
Adjustment of share-based compensation |
2 546 | 8 730 | 11 276 | 1 622 | 2 758 | 4 379 | ||||||
|
Adjusted net income (loss) attributable to |
(2 946) | (11 216) | (14 162) | (3 582) | (7 286) | (10 868) | ||||||
| Depreciation and amortization | (156) | (473) | (629) | (371) | (1 155) | (1 527) | ||||||
| Additions to tangible and intangible assets | 123 | 555 | 677 | 347 | 1 305 | 1 652 | ||||||
| Net cash used in operating activities | (6 565) | (13 414) | (19 979) | (9 335) | (13 063) | (22 398) | ||||||
Note Regarding Use of Non-GAAP Financial Measures
Cellectis S.A. presents adjusted net income (loss) attributable to
shareholders of Cellectis in this press release. Adjusted net income
(loss) attributable to shareholders of Cellectis is not a measure
calculated in accordance with IFRS. We have included in this press
release a reconciliation of this figure to Net income (loss)
attributable to shareholders of Cellectis, which is the most directly
comparable financial measure calculated in accordance with IFRS. Because
adjusted net income (loss) attributable to shareholders of Cellectis
excludes Non-cash stock-based compensation expense—a non-cash expense,
we believe that this financial measure, when considered together with
our IFRS financial statements, can enhance an overall understanding of
Cellectis’ financial performance. Moreover, our management views the
Company’s operations, and manages its business, based, in part, on this
financial measure. In particular, we believe that the elimination of
Non-cash stock-based expenses from Net income (loss) attributable to
shareholders of Cellectis can provide a useful measure for
period-to-period comparisons of our core businesses. Our use of adjusted
net income (loss) attributable to shareholders of Cellectis has
limitations as an analytical tool, and you should not consider it in
isolation or as a substitute for analysis of our financial results as
reported under IFRS. Some of these limitations are: (a) other companies,
including companies in our industry which use similar stock-based
compensation, may address the impact of Non-cash stock-based
compensation expense differently; and (b) other companies may report
adjusted net income (loss) attributable to shareholders or similarly
titled measures but calculate them differently, which reduces their
usefulness as a comparative measure. Because of these and other
limitations, you should consider adjusted net income (loss) attributable
to shareholders of Cellectis alongside our IFRS financial results,
including Net income (loss) attributable to shareholders of Cellectis.
|
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME – First quarter (unaudited) ($ in thousands, except per share data) |
||||
|
For the three-month period ended |
||||
| 2018 | 2019 | |||
| Net income (loss) attributable to shareholders of Cellectis | (25 438) | (15 248) | ||
|
Adjustment:
Non-cash stock-based compensation expense attributable to |
11 276 | 4 379 | ||
|
Adjusted net income (loss) attributable to shareholders of |
(14 162) | (10 868) | ||
|
Basic Adjusted net income (loss) attributable to shareholders |
(0.39) | (0.26) | ||
|
Weighted average number of outstanding shares, basic (units) |
36 034 181 | 42 430 069 | ||
|
Diluted Adjusted net income (loss) attributable to shareholders |
(0.39) | (0.26) | ||
|
Weighted average number of outstanding shares, diluted (units) |
36 586 720 | 42 457 133 | ||
| (1) |
When we have adjusted net loss, in accordance with IFRS, we use |
About Cellectis
Cellectis is a clinical-stage biopharmaceutical company focused on
developing a new generation of cancer immunotherapies based on
gene-edited T-cells (UCART). By capitalizing on its 19 years of
expertise in gene editing – built on its flagship TALEN® technology and
pioneering electroporation system PulseAgile – Cellectis uses the power
of the immune system to target and eradicate cancer cells.
Using its life-science-focused, pioneering genome engineering
technologies, Cellectis’ goal is to create innovative products in
multiple fields and with various target markets.
Cellectis is listed on the Nasdaq (ticker: CLLS) and on Euronext Growth
(ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com
Talking about gene editing? We do it. TALEN® is a registered trademark
owned by Cellectis.
Disclaimer
This press release contains “forward-looking” statements that are based
on our management’s current expectations and assumptions and on
information currently available to management. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements.
Further information on the risk factors that may affect company business
and financial performance is included in Cellectis’ Annual Report on
Form 20-F and the financial report (including the management report) for
the year ended December 31, 2018 and subsequent filings Cellectis makes
with the Securities Exchange Commission from time to time. Except as
required by law, we assume no obligation to update these forward-looking
statements publicly, or to update the reasons why actual results could
differ materially from those anticipated in the forward-looking
statements, even if new information becomes available in the future.
_______________
1 Cash position includes cash, cash
equivalent, current financial assets and restricted cash
Contacts
Media:
Jennifer Moore, VP of Communications, 917-580-1088, media@cellectis.com
Caitlin
Kasunich, KCSA Strategic Communications, 212-896-1241, ckasunich@kcsa.com
IR:
Simon Harnest, VP of Corporate Strategy and Finance,
646-385-9008, simon.harnest@cellectis.com