On August 1, 2018 Cellectis SA (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company specializing in the development of engineered CAR-T cell-based immunotherapies (UCART), reported its results for the second quarter of 2018 and for the first six months month of the year 2018 (Press release, Cellectis, AUG 1, 2018, View Source [SID1234528302]).
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During this first semester, we worked to accelerate the clinical development of our allogeneic CAR-T product candidates. The modified UCART123 Phase I clinical trial protocol will accelerate the development of this product candidate. We have been authorized to conduct a Phase I clinical trial for UCART22 in B-cell LLA. Recruitment of patients for this clinical trial is planned to begin in the second half of 2018. UCART22 is the third product candidate developed by Cellectis and based on allogeneic CAR-T cells to enter the clinic. Following the completion of our recent ADS offer,
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1 Including an investment of $ 8.3 million from Cellectis.
2 The cash position includes cash, cash equivalents and current financial assets.
Second quarter of 2018 and recent highlights
UCART123
In May, the FDA approved an amendment to the UCART123 Phase I clinical trial protocol for patients with acute myeloblastic leukemia. This amendment makes it possible to multiply the level of dose 1 by four, from 6.25×10 4 to 2.5×10 5 UCART123 cells per kilogram. The steps of doses 2 and 3 are now respectively at 6.25×10 5 and 5.05×10 6. The interval of administration of the UCART123 product candidate between the first and second patients for each new dose tested decreased from 42 days to 28 days (42 days in case of aplastic anemia), then to 14 days for subsequent patients. A second potential administration of the UCART123 product candidate is allowed in the new protocol. The MD Anderson Cancer Center has been added as a new clinical site for the current LAM study at Weill Cornell Medical Center.
UCART22
In June, the FDA approved Cellectis’ Phase I clinical trial application for UCART22, the second product candidate exclusively controlled by Cellectis. UCART22 is an allogeneic product candidate engineered with TALEN genome editing technology targeting acute B-cell lymphoblastic leukemia (B-cell ALL) in adult patients. This authorization for UCART22 is the third granted by the FDA to initiate a clinical trial in the United States for a product candidate based on engineered allogeneic rack-mount AT-cells. UCART22 has been designed to target and eradicate CD22 expressing cells. Like CD19, CD22 is an antigen on the surface of the cell that expresses itself from the pre-development stage of B cells to the time of maturation. CD22 is expressed in more than 90% of B-cell ALL cases. About 85% of ALL cases involve precursor B cells (B-cell ALL).
Cellectis plans to initiate this Phase I clinical trial in the second half of 2018. The clinical study will be led by Dr. Nitin Jain, Assistant Professor, and Professor Hagop Kantarjian, Director of Leukemia Department at MD Anderson Cancer Center. from the University of Texas to Houston in the United States.
UCART19 and Corporate Collaboration
In April, Allogene Therapeutics, Inc. (Allogene), a new biotechnology company co-founded by Dr. Arie Belldegrun, former President and CEO of Kite, and David Chang, former Executive Vice President, Research and Development and Medical Director of Kite, announced the signing with Pfizer, Inc. (Pfizer) of a partial asset contribution agreement. Allogene thus acquired Pfizer’s portfolio of allogeneic CAR-T assets, including the Research and Licensing Agreement signed between Pfizer and Cellectis on June 17, 2014, as amended. Cellectis remains eligible for clinical and commercial milestone payments of up to $ 2.8 billion, or $ 185 million per target for 15 targets, as well as royalties based on high single-digit percentages applied to the net sales of products marketed by Allogene under the collaboration agreement. As part of the partial asset transfer, Allogene acquired Pfizer’s rights in UCART19, which was sub-licensed to Pfizer by Les Laboratoires Servier (Servier), which holds an exclusive license of Cellectis to UCART19 under the terms of the contract. product development agreement concluded between Servier and Cellectis on February 17, 2014.
Increase in capital
In April, Cellectis made an offer of 6,146,000 American Depositary Shares (ADS) at a price of US $ 31.00 per ADS, for gross proceeds of $ 190.5 million. In May, Calyxt made an offer of 4,057,500 American Depositary Shares (ADS) at US $ 15.00 per ADS, for gross proceeds of $ 60.9 million. Cellectis has purchased 550,000 common shares of Calyxt at the public offering price of US $ 15.00 per ADS.
R & D
In June, Cellectis announced the publication of a study in Nature Publishing’s Scientific Reports , describing the CubiCAR, an all-in-one RAC architecture that incorporates a multi-functional component for purification, detection and detection. elimination of CAR-T cells. This versatility has the potential to streamline the manufacture of CAR-T cells to enable their tracking and effectively eliminate CAR-T cells in a clinical setting. This new architecture was developed in collaboration with Allogene scientists.
Academic collaboration
In May, Cellectis and Harvard University’s Wyss Institute for Biologically Inspired Engineering announced that the two entities will begin a collaboration to use the company’s TALEN genome editing tool to rewrite the genome human cell lines but also other species, which is part of the Genome Project-Write , led by Professor George Church, faculty member of the Wyss Institute, Professor of Genetics at Harvard Medical School (HMS) and Health Sciences and Technology at Harvard and the Massachusetts Institute of Technology (MIT). The Recode projectestablishes the technical foundations for extensively and functionally modifying the genomes of whole cells and organisms. This project aims to convert them into research tools as well as clinical and biotechnological products. As part of the collaboration with Cellectis, George Church and his team will have access to TALEN genome editing technology.
Finance
Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).
Financial results for the second quarter of 2018
Cash position : As at June 30, 2018, Cellectis had $ 491.1 million in cash, cash equivalents and current financial assets compared to $ 282.1 million as at March 31, 2018.
This increase of $ 209.0 million reflects in particular the net cash generated by the financing activities of $ 230.9 million of which (i) the net proceeds, after deduction of the subscription rebates and fees and expenses, of 178.6 $ M in connection with Cellectis’ offering of securities, (ii) the net proceeds, after deduction of the subscription discounts and commissions and fees, and the purchase price for 550,000 Calyxt shares purchased by Cellectis at the time of the offer of securities of $ 48.8 million for the Calyxt offering and (iii) the exercise of Cellectis and Calyxt stock options during the five-year period. , $ 1 million partially offset by (i) net cash used by operating activities for 12,$ 5 million; and (ii) the favorable foreign exchange effect related to interest rate fluctuations on cash and cash equivalents and current financial assets of $ 9.2 million.
Cellectis expects cash, cash equivalents and current financial assets of $ 491.1 million as at June 30, 2018 to be sufficient to fund its operations until 2022.
Sales and other operating income : During the second quarter of 2017 and 2018, we recorded $ 9.0 million and $ 8.3 million, respectively, in sales and other operating income. This decrease of $ 0.7 million is mainly due to the decrease in revenue from collaboration agreements for $ 1.5 million including a $ 0.4 million decrease in the recognition of upfront payments already paid to Cellectis and a decrease of 1, $ 1 million of research and development expense reimbursements partially offset by a $ 0.8 million increase in the research tax credit.
Total operating expenses : Total operating expenses and other operating income for the second quarter of 2017 were $ 28.8 million compared to $ 30.0 million for the second quarter of 2018. These amounts include non-cash related stock-based compensation expense of $ 12.4 million and $ 9.1 million, respectively.
Research and development costs: During the second quarters of 2017 and 2018, research and development expenses decreased by $ 0.6 million ($ 18.6 million in 2017 compared to $ 18.0 million in 2018). Personnel costs decreased by $ 0.8 million (from $ 9.2 million in 2017 to $ 8.4 million in 2018), primarily as a result of lower stock-based compensation expense with no impact on employee benefits. cash of $ 1.5 million partially offset by a $ 0.7 million increase in salaries and wages. Purchases, external charges and other expenses increased by $ 1.1 million (from $ 8.9 million in 2017 to $ 10.0 million in 2018), due to the increase in expenses related to payments to third parties participating product development, purchases of organic raw materials and costs associated with use of laboratories and other facilities. Other expenses, related to the continuation of leases and other commitments, decreased by $ 0.9 million in the second quarter of 2018 compared to the second quarter of 2017.
Administrative and selling expenses : During the second quarters of 2017 and 2018, we recorded $ 10.0 million and $ 11.2 million, respectively, of administrative and selling expenses. The increase of $ 1.2 million mainly reflects an increase of $ 1.9 million in purchases, external charges and other expenses and an increase of $ 0.3 million in expenses related to taxes, depreciation and amortization, partially offset by a decrease in personnel expenses of $ 1.0 million (from $ 7.9 million in 2017 to $ 6.9 million in 2018). This decrease in payroll costs is attributable to a $ 1.9 million decrease in non-cash compensation-based share-based compensation expense partially offset by a $ 0.9 million increase in salaries and wages.
Financial result : The financial gain is $ 12.0 million for the second quarter of 2018 compared to a financial loss of $ 6.7 million for the second quarter of 2017. This variation is mainly attributable to the effect of fluctuations in foreign exchange rates. $ 19.7 million in cash and interest received for $ 1.7 million partially offset by the fair value adjustment on derivatives and current financial assets of $ 2.7 million.
Net profit attributable to Cellectis shareholders : During the second quarter of 2017 and 2018, we recorded respectively a net loss attributable to shareholders of Cellectis of $ 26.5 million (or $ 0.75 per share) and a net loss attributable to shareholders of Cellectis. Cellectis shareholders of $ 7.3 million (or $ 0.17 per share).
The adjusted net loss attributable to Cellectis shareholders for the second quarters of 2017 and 2018 amounted to $ 14.1 million ($ 0.40 per share) and a profit of $ 1.3 million ($ 0.03 million). dollars per share), respectively. These net adjusted results attributable to Cellectis shareholders for the second quarters of 2017 and 2018 exclude non-cash-based share-based compensation expense of $ 12.4 million and $ 8.5 million, respectively. Please refer to the "Note on the Use of Non-IFRS Financial Measures" for a reconciliation of Cellectis ‘shareholders’ IFRS results to non-IFRS net income attributable to Cellectis shareholders.
Financial results for the first six months of 2018
Cash position: At June 30, 2018, Cellectis had $ 491.1 million in cash, cash equivalents and current financial assets compared to $ 297.0 million as at December 31, 2017. This increase of $ 194.1 million mainly reflects net cash generated by financing activities of $ 234.4 million, including (i) the net proceeds, after deduction of subscription rebates and fees and expenses, of $ 178.6 million in connection with the offer of securities of Cellectis, (ii) the net proceeds, after deducting the subscription discounts and commissions and fees, and the purchase price for 550,000 Calyxt shares purchased by Cellectis at the time of the offering of securities, of $ 48.8 million in the framework of Calyxt’s offer of securities and (iii) theexercise of Cellectis and Calyxt stock options during the period for $ 8.4 million partially offset by (i) net cash used by operating activities for $ 32.5 million and (ii) ) the unfavorable foreign exchange effect of interest rate fluctuations on cash and cash equivalents and current financial assets of $ 7.1 million; and (iii) the net cash flows generated by investment for $ 0.7 million.$ 5 million and (ii) unfavorable foreign currency translation impact from interest rate fluctuations on cash and cash equivalents and current financial assets of $ 7.1 million and (iii) cash flows net income from investing activities for $ 0.7 million.$ 5 million and (ii) unfavorable foreign currency translation impact from interest rate fluctuations on cash and cash equivalents and current financial assets of $ 7.1 million and (iii) cash flows net income from investing activities for $ 0.7 million.
Sales and other operating income : During the first six months of 2017 and 2018, we recorded $ 19.3 million and $ 16.4 million, respectively, in sales and other operating revenues. This decrease of $ 2.9 million is mainly due to the decrease in revenue from collaboration agreements for $ 2.3 million corresponding to a decrease in the reimbursement of research and development expenses and a $ 0.7 million decrease in research tax partially offset by a $ 0.1 million increase in license revenue.
Total Operating Expenses : Total operating expenses for the first six months of 2017 were $ 58.9 million, compared to $ 63.0 million for the first six months of 2018. These amounts include expenses related to operating expenses. non-cash-based share-based compensation of $ 26.1 million in 2017 and $ 21.0 million in 2018.
Research and development costs: During the first six months of 2017 and 2018, research and development expenses amounted to $ 38.2 million and $ 36.4 million, respectively. Personnel costs decreased by $ 2.6 million (from $ 19.7 million in 2017 to $ 17.1 million in 2018), mainly as a result of lower stock-based compensation expense with no impact on equity. cash position of $ 4.3 million partially offset by an increase of $ 1.7 million in salaries and wages. Purchases, external charges and other expenses increased by $ 1.4 million (from $ 17.5 million in 2017 to $ 18.9 million in 2018) mainly due to an increase in expenses paid to suppliers involved in the development of products, in the purchase of biological raw materials, in the development of manufacturing processes and in expenses associated with the use of laboratories and other facilities. Other expenses, related to the continuation of leases and other commitments, decreased by $ 0.6 million for the first six months of 2018 compared to the first six months of 2017.
Administrative and Commercial Expenses : During the first six months of 2017 and 2018, administrative and selling expenses were $ 19.8 million and $ 25.2 million, respectively. The increase of $ 5.5 million mainly reflects (i) a $ 3.5 million increase in purchases, external charges and other expenses, (ii) a $ 0.5 million increase in other taxes and duties charges , depreciation and amortization and (iii) a $ 1.5 million increase in personnel costs from $ 15.5 million to $ 17.0 million due to a $ 2.2 million increase in salaries and wages partially offset a $ 0.8 million decrease in non-cash-based share-based compensation expense.
Financial result : The financial loss was $ 6.6 million for the first six months of 2017 compared to a financial gain of $ 10.0 million for the first six months of 2018. This variation is mainly attributable to the impact of interest rate fluctuations. exchange rate of $ 18.8 million and a $ 2.0 million increase in interest received partially offset by a $ 3.8 million decrease in the fair value adjustment on derivative instruments and financial assets and a $ 0.2 million decrease in the gain on the repositioning of instruments.
Net income attributable to Cellectis shareholders: During the first six months of 2017 and 2018 we recorded a net loss attributable to Cellectis shareholders of $ 46.2 million ($ 1.30 per share) and a net loss attributable to Cellectis shareholders of $ 32.4 million. $ (or $ 0.83 per share), respectively. The adjusted net loss attributable to Cellectis shareholders for the first six months of 2017 amounted to $ 20.1 million ($ 0.57 per share) compared to an adjusted net loss attributable to Cellectis shareholders for the first six months. 2018 of $ 12.7 million ($ 0.32 per share). These adjusted net results attributable to Cellectis shareholders for the first six months of 2017 and 2018, excludes non-cash-based share-based compensation expense of $ 26.1 million and $ 19.7 million, respectively. Please refer to the "Note on the Use of Non-IFRS Financial Measures" for a reconciliation of Cellectis ‘shareholders’ IFRS results to non-IFRS net income attributable to Cellectis shareholders.
Note on the use of non-IFRS financial measures
In this press release, Cellectis SA presents an adjusted net income attributable to Cellectis shareholders that is not an aggregate defined by IFRS. We have included in this press release a reconciliation of this aggregate with the result attributable to Cellectis shareholders, the most comparable item calculated in accordance with IFRS. This adjusted result attributable to Cellectis shareholders excludes non-cash-based share-based compensation expense. We believe that this financial aggregate, when compared with the IFRS financial statements, can enhance Cellectis’ overall understanding of financial performance. Furthermore,
In particular, we believe that the elimination of non-cash-based share-based compensation expense attributable to Cellectis ‘shareholders can provide useful information on the comparison of Cellectis’ activities from one period to another. Our use of this adjusted net income attributable to Cellectis shareholders is limited to analytical use and should not be considered alone or substituted for the analysis of our financial results presented in accordance with IFRS. Some of these limitations are: (a) other companies, including companies in our industries that benefit from the same types of share-based compensation, could address the impact of non-cash-based stock-based compensation expense in a different way, and (b) other companies could report adjusted net income attributable to shareholders or other similar but calculated aggregates. in a different way, which would reduce their utility for comparative purposes. In view of all these limitations, you should consider the adjusted net income attributable to Cellectis shareholders in the same terms as our IFRS financial results, including the result attributable to Cellectis shareholders. and (b) other companies may report adjusted net income attributable to shareholders or other similar aggregates but calculated differently, which would reduce their usefulness for comparative purposes. In view of all these limitations, you should consider the adjusted net income attributable to Cellectis shareholders in the same terms as our IFRS financial results, including the result attributable to Cellectis shareholders. and (b) other companies may report adjusted net income attributable to shareholders or other similar aggregates but calculated differently, which would reduce their usefulness for comparative purposes. In view of all these limitations, you should consider the adjusted net income attributable to Cellectis shareholders in the same terms as our IFRS financial results, including the result attributable to Cellectis shareholders.