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including Calyxt, the group had $135m in cash and cash equivalents as of 6/30

(Boursier.com) — Cellectis a clinical-stage biotechnology company that is using its pioneering genome-editing technology TALEN to develop potential innovative therapies for the treatment of serious diseases, today reports its financial results for the second quarter of 2022.

“We are living in exceptional times at Cellectis: we are proud to announce that the FDA has approved our request for authorization to start a clinical trial in the United States (IND) for UCART20x22, our product candidate for patients with non-surgical lymphoma. -Hodgkinian in relapse or refractory” declares doctor André Choulika, CEO of Cellectis. “UCART20x22 is a very promising product candidate. The dual targeting of CD20 and CD22, two targets validated in B-cell malignancies, constitutes a potential therapeutic alternative to therapies targeting the CD19 antigen. In 2018, Cellectis made the decision to to internalize the manufacturing of its product candidates, to provide the Company with independence regarding its manufacturing processes. UCART20x22 illustrates this achievement by being our first product candidate designed and developed entirely in-house. Cellectis is today a cell therapy platform and end-to-end gene development, from discovery, to product development, to manufacturing and clinical development. We look forward to starting the clinical trial for patients with relapsed or refractory non-Hodgkin’s lymphoma in the second half of the year. 2022. We continue to make progress in enrolling patients in our three Phase 1 trials at escalad e dose and we are reaching key milestones in our partnership programs. This good news demonstrates our progress in the field of allogeneic CAR T cell therapy.”

The interim condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis owns approximately 51.3% of the outstanding common shares as of June 30, 2022, have been prepared in accordance with International Financial Reporting Standards or IFRS, as issued by the International Accounting Standards Board (“IFRS”).

Second quarter 2022 financial results

Cash position: As of June 30, 2022, Cellectis, including Calyxt, had $135 million in consolidated cash, cash equivalents, current financial assets and blocked cash, of which $123 million is attributable to Cellectis excluding Calyxt. This compares to $191m of consolidated cash, cash equivalents, current financial assets and blocked cash as of December 31, 2021, of which $177m was attributable to Cellectis excluding Calyxt. This net decrease of $56 million mainly reflects (i) a net cash flow of $47 million used by Cellectis’ operating, investing and finance leasing activities, (ii) $13 million of net cash used in operating activities and acquisitions of property, plant and equipment and finance leases of Calyxt partially offset by (i) $10 million of net proceeds from the capital increase at Calyxt and a favorable foreign exchange gain of 6 M$. “Based on the current operating plan, we estimate that the consolidated cash, cash equivalents, current financial assets and blocked cash accounts of Cellectis excluding Calyxt amounting to $123 million as of June 30, 2022 will be sufficient to finance our activities until the beginning of 2024″.

Sales and other operating income: Consolidated sales and other operating income amounted to $7 million for the first six months of 2022, compared to $43 million for the first six months of 2021. 99 % of consolidated revenue and other operating income was attributable to Cellectis for the first six months of 2022. This decrease between the first six months of 2022 and 2021 is mainly explained by (i) a decrease in revenue related to the recognition of a convertible note of $15 million obtained as financial compensation for the right-of-use license granted to Cytovia and a milestone payment of $5 million from Allogene, while the revenue corresponding to the contracts collaboration for the six months ended June 30, 2022 includes two milestone payments for $1.5 million from Cytovia and the recognition of the Change of Control of a licensee (Genesis Repertoire) in accordance with the terms of the license agreement with Cellectis (extensi term of the Option) for $1 million and (ii) the decrease in other income of $5 million attributable to a change in Calyxt’s business model, for which no significant income has yet been recognized.

Cost of revenues: Consolidated cost of revenues amounted to $0.7 M for the first six months of 2022, compared to $20 M for the first six months of 2021. This decrease is due to the change in Calyxt’s business model.

Research and development expenses: Consolidated research and development expenses amounted to $59 million for the first six months of 2022 compared to $62 million for the first six months of 2021. 89% of consolidated research and development expenses are attributable to Cellectis for the first six months of 2022. The decrease of $3 million between the first six months of 2022 and 2021 is mainly attributable to (i) the decrease in purchases, external expenses and other expenses of $4.5 million (from $36 million in 2021 to $31 million in 2022), (ii) the decrease in payroll taxes related to the allocation of stock options for $0.9 million, (iii) a decrease of $0.9 million in non-cash stock-based compensation expense, partially offset by higher wages and salaries of $3 million from higher research and development staff in Therapeutics.

Administrative and selling expenses: Consolidated administrative and selling expenses amounted to $17.7 million for the first six months of 2022 compared to $18.2 million for the first six months of 2021. 62% of consolidated administrative and selling expenses are attributable to Cellectis for the first six months of 2022. The decrease of $0.5 million is attributable to (i) the decrease of $3 million in wages and salaries, (ii) the decrease of $0.3 million in social charges related to the allocation of stock options and (iii) the $0.5 million decrease in purchases, external expenses and other expenses (from $9.2 million in 2021 to $8.7 million in 2022) partially offset by (i) the $3m increase in non-cash stock-based compensation expense primarily due to the favorable impact in 2021 following the resignation of the former Calyxt CEO from his stock subscription options, free shares and performance shares not still acquired following his departure.

Net profit (loss) attributable to shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis is $51 million (or $1.12 per share) for the first six months of 2022, of which $47 million is attributable to Cellectis , compared to a loss of $52 million (or $1.17 per share) for the first six months of 2021, of which $43 million was attributable to Cellectis. This decrease in net loss of $1M between the first six months of 2022 and 2021 is mainly related to (i) the increase in financial gain of $14.7M, (ii) the decrease in cost of income of $19M $ and (iii) lower research and development expenses of $3.8 million partially offset by lower revenues and other income of $36 million.

Adjusted net earnings (loss) attributable to shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis is $46 million (or $1.00 per share) for the first six months of 2022, of which $43 million is attributable to Cellectis, compared to a loss of $48 million (or $1.08 per share) for the first six months of 2021, of which $38 million was attributable to Cellectis.

“We plan to spend our expenses on Cellectis for the year 2022 in the following areas:

  • Supporting the development of our pipeline of product candidates, including manufacturing and clinical trial expenses of UCART123, UCART22, UCARTCS1 and UCART20x22 as well as new product candidates;
  • Use of our state-of-the-art manufacturing capabilities in Paris and Raleigh;
  • Continued strengthening of our manufacturing and clinical departments” concludes the group.

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