On March 3, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported financial results for the full year 2021 and provided a fourth quarter business update (Press release, argenx, MAR 3, 2022, View Source [SID1234609465]).

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"2021 was a transformational year for argenx, culminating with the FDA approval of VYVGART, our first-in-class FcRn blocker, in December. We carried this momentum into 2022 with the official U.S. launch of VYVGART and the Japan approval. We were well-prepared to launch VYVGART at the time of approval and are encouraged by the early response of the medical community, the engagement from patients, and the coverage decisions that have been made by payers. We continue to expect steady launch progress in 2022 as we aim to deliver this new therapy to patients living with generalized myasthenia gravis," said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

"In addition to executing the global commercial launch of VYVGART, we are primed to deliver several upcoming catalysts through our development pipeline in high-value autoimmune indications. We expect multiple registrational trial readouts for efgartigimod in the next four quarters, the first of which is the SC bridging study in gMG this month. We are expanding the scope of development for efgartigimod to 10 indications and ARGX-117 to two indications by the end of this year, and will also advance ARGX-119 into first-in-human studies. We remain focused on all components of our integrated business so that we can continue to redefine immunology on behalf of patients and deliver shareholder value," continued Mr. Van Hauwermeiren.

FOURTH QUARTER 2021 AND RECENT BUSINESS UPDATE

U.S. commercial launch ongoing for VYVGART, the first FDA-approved FcRn blocker for adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive

VYVGART U.S. salesforce launched in early January; team interacted with over 60% of the 1,000 top priority neurologist targets as of end of February
VYVGART-specific payer policies have been published in plans covering approximately 25% of U.S. commercial lives; expected to have broad coverage in place by end of second quarter 2022
Commercial launch preparedness enabled immediate activation of key launch activities
My VYVGART Path, a personalized patient support system, was active at time of approval; approximately 90% of enrollment forms have come in through this program
Distribution channels stocked within one week following FDA approval

On track with global launch strategy to make VYVGART available in Japan, Europe, China and Canada, as well as additional regions through license and distribution agreements

VYVGART approved for adult patients with gMG on January 20, 2022 by Japan’s Ministry of Health, Labour and Welfare with expected launch to occur in second quarter 2022
Decision from European Medicines Agency on Marketing Authorization Application expected in second half of 2022
argenx Canada established in preparation for potential Health Canada approval and commercial launch
Medison to file for approval in Israel in second quarter of 2022
Zai Lab to file for approval in China in mid-2022
Entered into commercial and distribution agreement with GenPharm for VYVGART commercialization in the Middle East
Additional license and distribution agreements expected in 2022 to expand global patient reach

Topline data expected from five ongoing efgartigimod registrational trials by end of first quarter of 2023

Neuromuscular franchise
ADAPT-SC: Topline data from bridging study of SC efgartigimod for gMG expected in first quarter of 2022
ADHERE: Topline data of SC efgartigimod for chronic inflammatory demyelinating

polyneuropathy expected in first quarter of 2023

Hematology franchise
ADVANCE: Topline data of intravenous efgartigimod for primary immune thrombocytopenia (ITP) expected in second quarter of 2022
ADVANCE-SC: Topline data of SC efgartigimod for primary ITP expected in first quarter of 2023
Dermatology franchise
ADDRESS: Timing of topline data of SC efgartigimod for pemphigus foliaceous and vulgaris is currently under review given geopolitical events in Ukraine

argenx’s leadership position in FcRn blockade to be solidified through expansion of efgartigimod development portfolio into ten total autoimmune conditions by end of 2022

BALLAD: Registrational trial ongoing of SC efgartigimod for bullous pemphigoid with interim analysis planned of first 40 patients
ALKIVIA: Registrational trial on track to start in first quarter of 2022 for idiopathic inflammatory myopathy (myositis); interim analysis planned of first 30 patients of each subtype (immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis)
Zai Lab to launch proof-of-concept trials in lupus nephritis and membranous nephropathy in 2022 with argenx to lead global registrational programs for each potential indication
Entered strategic collaboration with IQVIA to leverage its global clinical development capabilities and accelerate expansion of efgartigimod into additional potential indications
Proof-of-concept trials in primary Sjogren’s syndrome expected to initiate in second half of 2022 and COVID-19-mediated postural orthostatic tachycardia syndrome (POTS) in mid-2022

ARGX-117, a novel C2 inhibitor, has potential to be second pipeline-in-a-product for multiple autoimmune indications

Ongoing proof-of-concept trial to evaluate safety, tolerability, and potential dosing regimen in multifocal motor neuropathy (MMN)
Phase 2 proof-of-concept trial expected to start in 2022 for prevention of delayed graft function and/or allograft failure after kidney transplantation
Continued investment in Immunology Innovation Program (IIP) to broaden autoimmune pipeline for sustained value creation opportunities

Phase 1 dose-escalation trial of ARGX-119, an agonist SIMPLE Antibody to muscle-specific kinase (MuSK), expected to start after Clinical Trial Application filing in fourth quarter of 2022
Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers, and also early signal detection in patients
Strengthened leadership team with appointment of Malini Moorthy as General Counsel

Ms. Moorthy brings to argenx over 20 years of global legal and compliance experience in the pharmaceutical and medical device industries
DETAILS OF THE FINANCIAL RESULTS

Cash, cash equivalents and current financial assets totaled $2,336.7 million as of December 31, 2021, compared to $1,996.5 million on December 31, 2020. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering of shares, which resulted in the receipt of $1,092.1 million in net proceeds in February 2021 and the net receipt of a $73.1 million non-creditable, non-refundable development cost-sharing payment from Zai Lab as part of the strategic collaboration for efgartigimod in Greater China in part offset by the payment of $98.0 million related to the purchase of the priority review voucher from Bayer HealthCare Pharmaceuticals, and other net cash flows used in operating activities.

Revenue increased by $456.0 million for the twelve months ended December 31, 2021 to $497.3 million, compared to $41.2 million for the twelve months ended December 31, 2020. The increase was primarily due to the recognition of the transaction price as a consequence of the termination of the collaboration agreement with Janssen resulting in the one-time recognition of $315.1 million, and the recognition of $177.5 million in collaboration revenue related to the strategic collaboration with Zai Lab, including the cost-sharing payment and the development milestone, triggered by the FDA approval of VYVGART.

Other operating income increased by $18.5 million to $42.1 million for the year ended December 31, 2021, compared to $23.7 million for the year ended December 31, 2020. The increase was primarily driven by (i) the increase in research and development incentives, as a result of the increased research and development costs incurred, (ii) the increase in payroll tax rebates, as a direct result of the increase in the employment of highly qualified research and development personnel eligible for specific payroll tax rebates, and (iii) the increase in fair value of argenx’s profit share in AgomAb Therapeutics NV.

Research and development expenses increased by $209.6 million for the twelve months ended December 31, 2021 to $580.5 million, compared to $370.9 million for the twelve months ended December 31, 2020. The increase resulted primarily from higher external research and development expenses, mainly related to the efgartigimod program in various indications and other clinical and preclinical programs. Furthermore, the research and development personnel expenses increased due to a planned increase in headcount and the increased costs of the share-based payment compensation plans related to the grant of stock options.

Selling, general and administrative expenses totaled $307.6 million for the twelve months ended December 31, 2021, compared to $171.6 million for the twelve months ended December 31, 2020. The increase resulted primarily from higher personnel expenses, including the costs of the share-based payment compensation plans related to the grant of stock options, and consulting fees linked to the preparation for a commercialization of VYVGART.

Exchange losses totaled $50.1 million for the twelve months ended December 31, 2021, compared to $126.2 million for the twelve months ended December 31, 2020 and are mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial assets position in Euro.

FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses and capital expenditures, argenx expects to utilize up to half of its available cash, cash equivalents and current financial assets in 2022. The increased spend will support the global VYVGART launches, clinical development of efgartigimod in 10 indications and ARGX-117 in two indications, investment in the global supply chain, and continued focus on pipeline expansion through the Immunology Innovation Program.

US SEC AND STATUTORY FINANCIAL REPORTING
argenx’s primary accounting standard for quarterly earnings releases and annual reports is International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). Quarterly summarized statements of profit or loss based on IFRS as issued by the IASB are available on www.argenx.com.

In addition to reporting financial figures in accordance with IFRS as issued by the IASB, argenx also reports financial figures in accordance with IFRS as adopted by the EU for statutory purposes. The consolidated statements of financial position, the consolidated statements of profit or loss, the consolidated statements of comprehensive income / loss, the consolidated statements of cash flows, and the consolidated statements of changes in equity are not affected by any differences between IFRS as issued by the IASB and IFRS as adopted by the EU.

The consolidated statements of profit or loss of argenx SE for the year ended December 31, 2021, as presented in this press release are unaudited.

EXPECTED 2022 FINANCIAL CALENDAR:

May 5, 2022: Q1 2022 financial results and business update
July 28, 2022: HY 2022 financial results and business update
October 27, 2022: Q3 2022 financial results and business update

CONFERENCE CALL DETAILS
The full year 2021 results and fourth quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.

On March 3, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported impactful data on the Primary Immune Response (PIR) test at the IASLC 2022 Targeted Therapies of Lung Cancer Meeting (Press release, Biodesix, MAR 3, 2022, View Source [SID1234609464]). In this body of work, the PIR test provided two classifications of PIR-Not Resistant and PIR-Resistant predictive of likely response to immune checkpoint inhibitors (ICIs). The data showed that the Biodesix PIR test was predictive for survival outcomes when tested at baseline (HR=2.36, p=0.02) or 3 weeks after ICI treatment initiation (HR=3.53, p=0.001). Furthermore, the data suggested that patients classified as PIR-Resistant were more likely to experience rapid onset of immune related adverse events (irAE) when treated with ICIs (HR=2.40, p=0.08).

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The PIR test is a serum-based proteomic assay that utilizes mass spectrometry and machine learning. The study, titled Serum Proteomics Analysis as a Potential Predictive Biomarker for Survival Outcomes and Immune-related Adverse Events in Non-Small Cell Lung Cancer Receiving Immune Checkpoint Inhibitors was authored by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, Evanston, Illinois, Myungwoo Nam, MD, Lincoln Medical and Mental Health Center, Bronx, New York, and Dong-Uk Lee, MD and Young Kwang Chae, MD, MPH, MBA from Northwestern University Feinberg School of Medicine, Chicago IL. The PIR test was validated on samples from patients receiving second-line nivolumab (Bristol Myers Squibb) and was shown to stratify patients based on their outcomes to immunotherapy.

"This data is meaningful for patients with non-small cell lung cancer who are being considered for treatment with ICIs. Immune Checkpoint inhibitor drugs have gained interest in oncology because of their ability to boost a person’s immune response against cancer cells. It was recently estimated that nearly half of US patients with cancer are eligible for ICI therapy, however only about 1 in 8 will respond," said Scott Hutton, CEO, Biodesix. "Developing tools that provide a better understanding of a patient’s likely overall outcome and adverse events prior to treatment with ICIs will be critical for both the physician and patient, which is the true benefit of the PIR test."

While the PIR test is not yet commercially available, it is being studied further in multiple ongoing clinical studies and is expected to launch commercially in 2023.

On March 3, 2022 Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, reported it has secured £30.75 million ($41.20 million) in an oversubscribed Series B financing round (Press release, Epsilogen, MAR 3, 2022, View Source [SID1234609463]). The round was led by new investor Novartis Venture Fund and joined by new investors 3B Future Health Fund and British Patient Capital, Schroders Capital and Caribou Property. The new syndicate joins founding Series A investor Epidarex Capital and Series A investor ALSA Ventures both of whom also committed further capital in this Series B fundraising round. In connection with the closing of the financing, Dr Marianne Uteng of Novartis Venture Fund and Dr Marianne Bjordal of 3B Future Health Fund will join Epsilogen’s Board of Directors.

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The proceeds from the financing will enable Epsilogen to establish clinical proof of concept for lead drug candidate MOv18 IgE in a phase Ib trial in platinum-resistant ovarian cancer, an aggressive cancer with poor treatment alternatives. MOv18 IgE targets the folate receptor alpha (FR alpha) antigen and is the world’s first IgE antibody to enter the clinic. Previously announced data from a phase I trial shows MOv18 IgE to be safe and well tolerated with early signs of clinical activity also seen.

The financing will also enable Epsilogen to progress the development of its proprietary IGEGTM antibody platform which combines elements from both IgE and IgG antibodies into novel and proprietary antibody molecules with enhanced functionality.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: "This significant, new financing round will not only fund demonstration of clinical Proof of Concept for MOv18 but also allow Epsilogen to maintain its position as the leading pioneer in the development of IgE therapeutic antibodies for the treatment of cancer. We are very pleased to have attracted new investors of the calibre of Novartis Venture Fund, 3B Future Health Fund, British Patient Capital, Schroders Capital and Caribou Property. We also appreciate the continued support and investment from our existing investors Epidarex Capital and ALSA Ventures."

On March 3, 2022 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported that it has scheduled its fourth quarter and year-end 2021 financial results conference call and webcast on Thursday, March 10, 2022, after the U.S. financial markets close (Press release, Regulus, MAR 3, 2022, View Source [SID1234609462]).

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In connection with the earnings release, Regulus’ management team will host a live conference call and webcast at 5:00 PM ET on Thursday, March 10, 2022, to discuss the Company’s financial results and provide a corporate update. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 3786683. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), conference ID 3786683. The webcast and telephone replay will be archived on the Company’s website at www.regulusrx.com following the call.

On March 3, 2022 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop potentially life-saving cell and gene therapies, reported its results for the fourth quarter of 2021, and full year ending December 31, 2021 (Press release, Cellectis, MAR 3, 2022, View Source [SID1234609461]).

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"In 2021, Cellectis presented encouraging preliminary data from patients who received fludarabine, cyclophosphamide and alemtuzumab preconditioning in the BALLI-01 study at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 annual meeting. BALLI-01 supports our mission to develop products for patients who remain in dire need of effective treatment options. These results showed that our preconditioning regimen, that included alemtuzumab, was well tolerated and promoted the expansion and clinical activity of UCART22 in patients with advanced B-cell Acute Lymphoblastic Leukemia. Both our Raleigh and Paris manufacturing facilities are now fully operational, with Paris producing plasmids, mRNA and viral vectors, and Raleigh manufacturing UCART22 and UCART20x22." said Dr. André Choulika, CEO of Cellectis.

"In 2022, we are focusing on patient recruitment into our three ongoing Phase 1 clinical trials BALLI-01, AMELI-01, MELANI-01, (evaluating UCART22, UCART123, and UCARTCS1 respectively) and plan to file an investigational new drug application (IND) in the U.S. for our first allogeneic dual CAR T-cell therapy, UCART20x22. To further support our clinical trials, and with both manufacturing sites now fully operational, we will start dosing patients with investigational medicinal products made in-house."

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1 Cash position includes cash, cash equivalent, current financial assets and restricted cash. Restricted cash was $5million as of December 31, 2021.

Pipeline highlights

UCART Clinical Development Programs

BALLI-01 (evaluating UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

In December 2021, the Company reported preliminary results from the FCA arm of the BALLI-01 study of UCART22, for patients with r/r B-ALL at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (ASH 2021).

Overall, UCART22 after FCA lymphodepletion regimen demonstrated promising signs of anti-leukemic activity at Dose Level 2 (DL2) and Dose Level 2 Intermediate (DL2i), without unexpected or significant treatment-related toxicity. The preliminary data shows that adding alemtuzumab to the fludarabine and cyclophosphamide (FC) lymphodepletion regimen did not adversely affect the overall safety profile and sustained host lymphocyte suppression and promoted expansion of UCART22.

BALLI-01 is currently enrolling patients at Dose Level 3 (DL3) with FCA preconditioning regimen and Cellectis plans to initiate dosing with a UCART22 product candidate manufactured in-house in H2 2022.
AMELI-01 (evaluating UCART123) in relapsed or refractory acute myeloid leukemia (r/r AML)

UCART123 is an allogeneic CAR T-cell product candidate targeting CD123 and being evaluated in patients with r/r AML in the AMELI-01, multi-center dose-escalation clinical study.

AMELI-01 is currently enrolling patients at DL2 with FCA preconditioning regimen.
MELANI-01 (evaluating UCARTCS1) in relapsed or refractory multiple myeloma (r/r MM)

UCARTCS1 is an allogeneic CAR T-cell product candidate targeting CS1 and is being evaluated in patients with r/r MM in the MELANI-01, multi-center dose-escalation clinical study.

In May 2021, early preliminary data from the first patients enrolled in the MELANI-01 trial were presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th annual meeting. The data validated CS1 as a target for allogeneic CAR T-cells in r/r MM. Moreover, UCARTCS1 expansion and persistence was observed and correlated with changes in relevant serum cytokines and with anti-myeloma activity.

Cellectis is currently enrolling patients at Dose Level 1 (DL1) with FC preconditioning regimen.
UCART Preclinical Programs

UCART20x22 in relapsed or refractory non hodgkin’s lymphoma (r/r NHL)

UCART20x22 is our first allogeneic dual CAR T-cell product candidate being developed for patients with r/r NHL. The dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, is designed both for better tumor cell killing and to prevent antigen escape. Further, UCART20x22 is designed to be active against malignant B-cells that express one or both of the target antigens and to offer an alternative to CD19-directed therapies.

UCART20x22 will also be Cellectis’ first product candidate fully designed, developed and manufactured in-house, showcasing the Company’s transformation into an end-to-end cell and gene therapy platform from discovery, product development, GMP manufacturing, to clinical development.

An Investigational New Drug application (IND) for UCART20x22 is expected to be filed in 2022.
Licensed Allogeneic CAR-T Cell Development Programs

Allogene Therapeutics, Inc.’s CAR T programs utilize Cellectis technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S. while Servier retains exclusive rights for all other countries. Allogene’s anti-BCMA and anti-CD70 programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these programs.

On January 10, 2022, Allogene announced that the U.S. Food and Drug Administration (FDA) had removed the clinical hold on all of Allogene’s clinical trials which had been announced on October 7, 2021. After extensive investigation by Allogene, it was determined that the chromosomal abnormality detected in a single patient treated with ALLO-501A was unrelated to TALEN gene editing or Allogene’s manufacturing process and had no clinical significance.

Servier and Allogene: anti-CD19 programs

Allogene presented Phase 1 data from the ALPHA trial with ALLO-501 and ALPHA2 trial with ALLO-501A for the treatment of r/r NHL at the 2021 ASH (Free ASH Whitepaper) Annual Meeting. According to Allogene, data from these trials continue to support the promise of its platform to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients.

Enrollment in the Phase 1 ALLO-501 ALPHA trial in r/r NHL has completed accrual. Allogene disclosed that its focus remains on preparing for the pivotal Phase 2 ALPHA2 trial of ALLO-501A in R/R Large B Cell Lymphoma (LBCL), which Allogene reports to be on track to begin mid-year 2022 subject to ongoing discussions with the FDA.

As part of a concurrent development plan, Allogene intends to launch a separate registrational trial for ALLO-647, Allogene’s anti-CD52 monoclonal antibody, at the time of the ALLO-501A pivotal Phase 2 trial. This trial is intended to demonstrate the safety of ALLO-647 along with its contribution to the overall benefit of the lymphodepletion regimen.
Allogene: anti-BCMA and anti-CD70 programs

Following the FDA’s clinical hold, Allogene had announced that it has resumed clinical study activities on ALLO-715 and ALLO-605 for r/r MM, and ALLO-316 for advanced or metastatic clear cell renal cell carcinoma (RCC), and began enrolling patients earlier in February 2022.

Allogene’s anti-BCMA strategy includes its Phase 1 UNIVERSAL trial, which has cohorts evaluating ALLO-715 as a monotherapy, consolidated dosing of ALLO-715 using ALLO-647 to selectively extend the window of lymphodepletion, and ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat.

Data from Allogene’s UNIVERSAL trial with ALLO-715 as a monotherapy for the treatment of r/r MM was also presented at ASH (Free ASH Whitepaper) 2021, with Allogene reporting that response rates that are similar to the approved autologous CAR T therapy.
Manufacturing Facilities

Cellectis’ starting materials manufacturing facility in Paris, France is now fully operational, focusing on the production of starting materials including plasmids and mRNA for our TALEN gene editing technology, and viral vectors for use in clinical manufacturing.

Cellectis’ UCART GMP manufacturing facility in Raleigh, North Carolina is now fully operational, focusing on Cellectis’ clinical and commercial UCART manufacturing operations as well as manufacturing and release testing of batches of product candidates UCART22 and UCART20x22.
Partnerships

Cytovia Therapeutics

On February 12, 2021, we entered into a research collaboration and non-exclusive license agreement with Cytovia Therapeutics, Inc., or Cytovia to develop induced Pluripotent Stem Cell (iPSC) iPSCderived Natural Killer (NK) and CAR-NK cells edited with our TALEN (the "Cytovia Agreement").
Pursuant to the Cytovia Agreement, as expanded in November 2021 to include a new CAR target and development in China by Cytovia’s joint venture entity, CytoLynx Therapeutics, Cellectis is eligible to receive an upfront cash payment or equity stake in Cytovia of $20 million, if certain conditions (the "Cytovia Conditions") were met by December 31, 2021, as well as aggregate additional payments of up to $805 million of development, regulatory and sales milestones from Cytovia. Cellectis is also eligible to receive single-digit royalty payments on the net sales of the partnered products commercialized by Cytovia. Cellectis also received an option to participate in certain future financing rounds by Cytovia. Cellectis is currently in discussions with Cytovia to grant a waiver and to extend the deadline for the Cytovia Conditions, which had not yet been achieved as of December 31, 2021.
Following Cellectis’ previously announced partnership with Iovance Biotherapeutics in tumor-infiltrating lymphocytes, the collaboration with Cytovia in another cell therapy modality highlights TALEN as a gene editing technology of choice for cell therapy applications.
2021 Corporate Highlights

Cellectis’ Innovation Days

In May 2021, Cellectis held a week-long virtual event, providing an inside look into the Company’s current and new product candidates pipeline, manufacturing and technologies. To watch a replay of all Cellectis Innovation Days episodes, click here.

Appointments

On November 4, 2021, Cellectis announced the appointment of Donald A Bergstrom, M.D., Ph.D., as an Observer on the Company’s Board of Directors. Dr. Bergstrom, serves as Executive Vice President, Head of Research and Development at Relay Therapeutics, Inc., a clinical-stage precision medicines company. He brings with him over 15 years of experience in the biopharmaceutical and medical industries.
On February 10, 2022, Cellectis announced the appointment of Bing Wang, Ph.D, MBA as Chief Financial Officer and member of Cellectis’ executive committee. Dr. Wang is a highly accomplished biotechnology executive who brings extensive global finance experience in the biotechnology industry including a background with global public companies in corporate finance, mergers and acquisitions, operations management systems, and financial planning and analysis. He joins Cellectis to oversee the company’s global finance team reporting directly to Chief Executive Officer, André Choulika, PhD.
ATM program

On March 29, 2021, Cellectis announced the commencement of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $125.0 million of American Depositary Shares ("ADS"). Each ADS represents one ordinary share of the Company.
On April 9, 2021, the Company announced that it completed sales of approximately $47 million of ADS pursuant to the ATM program, comprising an aggregate of 2,415,630 new ADSs and the same number of underlying new ordinary shares were issued to existing and new investors at an at-the-market price of $19.50 per new ADS.
2021 Financial Results

The condensed consolidated financial statements of Cellectis, which consolidate the results of Calyxt, Inc. of which Cellectis is a 61.8% stockholder (as of December 31, 2021) and 56.1% as of March 3, 2022, have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board ("IFRS").

We present certain financial metrics broken out between our two reportable segments – Therapeutics and Plants – in the appendices of this Q4 2021 and Full Year 2021 financial results press release.

Fourth Quarter and Full Year 2021 Financial Results

Cash: As of December 31, 2021, Cellectis, including Calyxt, had $191 million in consolidated cash, cash equivalents, current financial assets and restricted cash of which $177 million are attributable to Cellectis on a stand-alone basis. This compares to $274 million in consolidated cash, cash equivalents, current financial assets and restricted cash as of December 31, 2020, of which $244 million was attributable to Cellectis on a stand-alone basis. This net decrease of $83 million primarily reflects (i) $116 million of net cash flows used in operating, investing and lease financing activities of Cellectis, (ii) $20 million of net cash flows used in operating, capital expenditures and lease financing activities of Calyxt and (iii) $6 million of unfavorable FOREX impact which was partially offset by (iv) $49 million of equity proceeds raised from sales under the Company’s "At-The-Market" (ATM) program in April 2021 and Calyxt ATM program during the fourth quarter of 2021 and (v) $10 million of proceeds from stock options exercises at Cellectis. Based on the current operating plan and financial projections, Cellectis excluding Calyxt anticipates that the cash, cash equivalents, and restricted cash of $177 million as of December 31, 2021 will fund its operations into early 2024.

Revenues and Other Income: Consolidated revenues and other income were $14 million for the three months ended December 31, 2021 compared to $16 million for the three months ended December 31, 2020. Consolidated revenues and other income were $67 million for the year ended December 31, 2021 compared to $82 million for the year ended December 31, 2020. 58% of consolidated revenues and other income was attributable to Cellectis in the full year of 2021. This decrease between the year ended December 31, 2021 and 2020 was mainly attributable to a $29 million upfront payment received in March 2020 and the recognition of $20 million of other previously-received upfront and milestone payments on the five released targets based on the March 2020 amendment of the License, Development and Commercialization Agreement signed with Servier. That was partially offset by (i) the recognition of a $20.0 trade receivable obtained as consideration for a license granted to Cytovia, (ii) $10.0 million related to the recognition of two Allogene milestones, (iii) the increase in sales of soybean products at Calyxt for $4 million, and (iv) Calyxt’s Paycheck Protection Program loan forgiveness obtained in April 2021 for 1.5 million, and is partially offset by a decrease in licenses revenues of $2 million.

Cost of Revenues: Consolidated cost of revenues were $2 million for the three months ended December 31, 2021 compared to $19 million for the three months ended December 31, 2020. Consolidated cost of revenues was $31 million for the year ended December 31, 2021 compared to $36 million for the year ended December 31, 2020. This decrease was primarily explained by the cost of products sold during the period by Calyxt.

R&D Expenses: Consolidated R&D expenses were $32 million for the three months ended December 31, 2021 compared to $23 million for the three months ended December 31, 2020. Consolidated R&D expenses were $129 million for the year ended December 31, 2021 compared to $87 million for the year ended December 31, 2020. 91% of consolidated R&D expenses was attributable to Cellectis in the full year of 2021. The $42 million increase between the full year of 2021 and 2020 was primarily attributable to (i) higher wages and salaries and social charges on stock option grants of $14 million, to (ii) higher purchases, external and other expenses of $25 million and to (iii) higher non-cash stock-based compensation expenses of $3 million.

SG&A Expenses: Consolidated SG&A expenses were $10 million for the three months ended December 31, 2021 compared to $12 million for the three months ended December 31, 2020. Consolidated SG&A expenses were $38 million for the year ended December 31, 2021 compared to $44 million for the year ended December 31, 2020. 60% of consolidated SG&A expenses was attributable to Cellectis in the full year of 2021. The $6 million decrease was mainly attributable to lower non-cash stock-based compensation expenses of $6 million and a decrease in wages and salaries of $1 million partially offset by an increase in social charges on stock option grants and purchases, external expenses and other of $1 million.

Net Income (loss) Attributable to Shareholders of Cellectis: The consolidated net loss attributable to shareholders of Cellectis was $25 million (or $0.55 per share) for the three months ended December 31, 2021, of which $21 million was attributed to Cellectis, compared to $41 million (or $0.95 per share) for the three months ended December 31, 2020, of which $34 million was attributed to Cellectis. The consolidated net loss attributable to shareholders of Cellectis was $114 million (or $2.55 per share) for the year ended December 31, 2021, of which $97 million loss was attributed to Cellectis, compared to a loss of $81 million (or $1.91 per share) for the year ended December 31, 2020, of which $54 million was attributable to Cellectis. This $33 million increase in net loss between full year 2021 and 2020 was primarily driven by a decrease in revenues and other income of $15 million and by an increase in operating expenses of $30 million and a decrease in non controlling interests of $5 million partially offset a by $18 million increase in net financial gain.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: The consolidated adjusted net loss attributable to shareholders of Cellectis was $22 million (or $0.48 per share) for the three months ended December 31, 2021, of which $19 million is attributed to Cellectis, compared to a net loss of $37 million (or $0.88 per share) for the three months ended December 31, 2020, of which $31 million was attributed to Cellectis. The consolidated adjusted net loss attributable to Shareholders of Cellectis was $102 million (or $2.27 per share) for the year ended December 31, 2021, of which $85 million loss was attributable to Cellectis, compared to a loss of $67 million (or $1.57 loss per share) for the year ended December 31, 2020, of which $44 million was attributable 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 our cash spending at Cellectis for 2022 in the following areas:

Supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of UCART123, UCART22, UCARTCS1, UCART20x22, and
Operating our manufacturing capabilities in Paris (France), and Raleigh (North Carolina, U.S.A);
and continuing to strengthen our manufacturing and clinical departments, including hiring talented, highly-qualified individuals
(1) When we have adjusted net loss, in accordance with IFRS, we use the Weighted average number of outstanding shares, basic to compute the Diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share). When we have adjusted net income, in accordance with IFRS, we use the weighted average number of outstanding shares, diluted to compute the diluted adjusted net income (loss) attributable to shareholders of Cellectis ($/share).

Conference Call and Webcast Details
Cellectis will host a live conference call and live audio webcast on March 4th, 2022 at 8AM EDT / 2:00PM CET to discuss fourth quarter and full year 2021 results and provide a business update.Webcast
Webcast link: View Source;tp_key=c23a20c39e

The webcast audio will be made available for one year on Cellectis’ website, linked here.