On October 27, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that it will report financial results and provide business updates for the third quarter ended September 30, 2022, before the US markets open on Tuesday, November 8, 2022 (Press release, Adaptimmune, OCT 27, 2022, View Source [SID1234622517]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) that same day.

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The press release will be available in the investor section of Adaptimmune’s corporate website. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)- 319-4610 (US or Canada) or +1 (416)- 915-3239 (International and additional options available HERE).

On October 27, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported plans to release its financial results for the third quarter ended September 30, 2022 on Thursday, November 3, 2022 following the close of financial markets (Press release, Akebia, OCT 27, 2022, View Source [SID1234622516]).

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Akebia will host a conference call on Thursday, November 3 at 4:30 p.m. ET to discuss its financial results and recent company highlights. To access the call by phone via a new process, please click on this Registration Link and you will be provided with dial in details. To avoid delays, we encourage dialing into the conference call fifteen minutes ahead of the scheduled start time.

A live webcast of the conference call will be available via the Investors section of Akebia’s website at: View Source An online archive of the webcast can be accessed via the Investors section of Akebia’s website at View Source

On October 27, 2022 Mustang Bio, Inc. ("Mustang") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that results from the Waldenstrom macroglobulinemia ("WM") cohort and other interim data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy being conducted at Fred Hutchinson Cancer Center ("Fred Hutch"), will be presented at the 11th International Workshop for Waldenstrom’s Macroglobulinemia ("IWWM-11") taking place in Madrid, Spain (Press release, Mustang Bio, OCT 27, 2022, View Source [SID1234622515]). MB-106 is being developed in a collaboration between Mustang and Fred Hutch to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL").

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Details of the presentation are as follows:

Title: CD20 CAR-T therapy for WM and other B-NHLs
Session: Session XVI – Novel Treatment Approaches to WM-Clinical III
Session Date and Time: Saturday, October 29, 2022, 14:00-15:00 Central European Summer Time
Presenter: Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington

"We are very pleased with the advancement of the MB-106 clinical program which includes the recently announced multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating its safety and efficacy, the first MB-106 clinical trial under Mustang’s Investigational New Drug Application. Additionally, we are grateful that the Fred Hutch team continues to present compelling data from its ongoing Phase 1/2 clinical trial that demonstrate high efficacy and a favorable safety profile across CLL and B-NHLs including WM, a rare form of this cancer," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "Finally, having been granted Orphan Drug Designation by the FDA for WM, we are looking forward to treating additional WM patients in the Mustang-sponsored Phase 1 portion of our trial in order to support a fast-to-market Phase 2 strategy for this indication."

As previously reported, highlights from the interim data of 28 patients treated in an ongoing Phase 1/2 clinical trial at Fred Hutch continue to support MB-106 as a viable CAR T cell therapy for B-NHLs and CLL. As of September 2022, the interim data show:

An overall response rate ("ORR") of 96% and complete response ("CR") rate of 75% observed in a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL")
A 100% ORR and CR in the two patients with WM
Twelve patients have experienced CR for more than 12 months (10 ongoing); four patients with CR for more than two years and the longest patient with CR is at 33 months
Six patients with partial response ("PR") improved to CR and all remain in ongoing CR
All three patients previously treated with CD-19 CAR T cell therapy have responded to treatment
A favorable safety profile for MB-106 as an outpatient therapy remains with no CRS or ICANS ≥ Grade 3
CAR-T persistence results in deepening responses following initial 28-day assessments
For more information about IWWM-11, please click here.

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About Waldenstrom Macroglobulinemia
Waldenstrom macroglobulinemia ("WM"), also known as lymphoplasmacytic lymphoma, is a rare type of non-Hodgkin lymphoma ("NHL"), a malignant disorder of the bone marrow and lymphatic tissues. The proliferation of cancer cells can crowd out normal cells in these tissues, leading to low levels of red blood cells, white blood cells, and platelets which, in turn, causes fatigue, shortness of breath, infections, bruising, and bleeding. In addition, the cancer cells make large amounts of the large antibody protein immunoglobulin M, or IgM, which cause the blood to become thick. This hyperviscosity of the blood affects its flow through the smaller blood vessels, leading to some of the other manifestations of the disease, such as visual and neurological symptoms. WM is a rare disorder with an incidence of approximately 3 per million people per year, and 1,400 new cases are diagnosed in the U.S. each year. The median age at diagnosis is 70 years.

About the MB-106 Phase 1/2 clinical trial
The six-center Phase 1/2 clinical trial is a three-arm study targeting chronic lymphocytic leukemia ("CLL") and B-cell non-Hodgkin lymphomas ("B-NHL") including follicular lymphoma ("FL"), diffuse large B-cell lymphoma and mantle cell lymphoma and will enroll patients who have relapsed after treatment with CD19 CAR-T cell therapy. Additionally, the FL arm will evaluate other indolent histologies including Waldenstrom macroglobulinemia, a rare type of B-NHL that the U.S. Food and Drug Administration recently granted MB-106 Orphan Drug Designation to treat. Given the Mustang-IND clinical trial is using the same lentiviral vector as other clinical trials evaluating MB-106, the FDA has allowed dose escalation to begin at a higher dose than what was originally conducted at Fred Hutch.

An estimated 287 patients are anticipated to be enrolled in the trial. All patients must have evidence of CD20 expression in both phases of the clinical trial. In Phase 1, escalating MB-106 dose levels will be tested independently in each arm using a 3+3 design. Patients will be enrolled in one of three arms, based on their primary diagnosis.

A total of up to 18 patients are anticipated to be treated in each Phase 1 arm, including six patients at the maximum tolerated dose, prior to proceeding to the Phase 2 portion of the study for each respective arm, where a total of up to 71 patients will participate in each independent arm. Safety of each dose level will be reviewed for each arm until the maximum tolerated dose has been reached, and the recommended Phase 2 dose ("RP2D") has been established for each arm. An assessment of the safety and tolerability of the dose will be made by the Safety Review Committee based on the data from the 28-day dose-limiting toxicity observation period.

In Phase 2, specific arms of relapsed or refractory CD20-positive B-cell NHL or CLL patients will be treated with MB-106 at the respective RP2D for each arm. Each arm will initially include up to 20 patients. Based on the results of the interim analysis, an additional 51 patients may be added to each of the arms.

Additional information about the trial can be found on clinicaltrials.gov using the identifier NCT05360238.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and was exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody. MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the multicenter Phase 1/2 clinical trial under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on these trials can be found at View Source using the identifier NCT05360238 for the Mustang multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.

On October 27, 2022 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2022 and updated full-year 2022 financial guidance (Press release, West Pharmaceutical Services, OCT 27, 2022, View Source;utm_medium=Email&utm_campaign=Investors_Email&utm_content=27_October_2022&utm_source=West+Pharmaceutical+Services%2C+Inc.&utm_campaign=9da5732e6a-EMAIL_CAMPAIGN_2022_03_31_10_50_COPY_01&utm_medium=email&utm_term=0_4b4b77d239-9da5732e6a-584006100&ct=t(EMAIL_CAMPAIGN_5_12_2022_16_15_COPY_01)#west-announces-third-quarter-2022-results-updates-full-year-2022-guidance-and-declares-fourth-quarter-2022-dividend [SID1234622513]).

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Third-Quarter 2022 Summary (comparisons to prior-year period)

Net sales of $686.9 million declined 2.8%; organic net sales growth was 4.3%.
Reported-diluted EPS of $1.59 declined 31.2%.
Adjusted-diluted EPS of $2.03 declined 1.5%.
Company is updating full-year 2022 net sales guidance to a new range of $2.830 billion to $2.840 billion, compared to a prior range of $2.950 billion to $2.975 billion.
Company is updating full-year 2022 adjusted-diluted EPS guidance to a new range of $8.15 to $8.20, compared to a prior range of $9.00 to $9.15.
The Company also announced that its Board of Directors has approved a fourth-quarter 2022 dividend of $0.19 per share, a 5.6% increase over the $0.18 per share paid in each of the four preceding quarters. This is the thirtieth consecutive annual increase in the Company’s dividend. The dividend will be paid on November 16, 2022, to shareholders of record as of November 9, 2022.
"Adjusted-diluted EPS" and "organic net sales" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"While our base, non-COVID-19 demand continues to grow, we have had multiple constraints that impacted our financial results," said Eric M. Green, President, Chief Executive Officer and Chair of the Board. "Delays in expansion projects as well as customer delivery timing and mix-shift related productivity impacts resulted in lower-than-expected overall high-value product (HVP) net sales. We expect to resolve these issues in early 2023."

Mr. Green concluded, "We project our full-year 2023 base business, led by our Biologics market unit, to exceed our financial construct of 7% to 9% annual organic net sales growth. While we expect a further decline in COVID-19-related net sales, our base business growth will more than offset the decline, resulting in overall organic net sales growth in 2023."

Proprietary Products Segment
Net sales declined by 1.7% to $567.0 million. Organic net sales growth was 5.5%, with currency translation decreasing net sales growth by 720 basis points. HVP net sales represented over 70% of segment net sales and generated mid-single digit organic net sales growth, led by customer demand for NovaPure, Westar and Envision components and self-injection devices.

The Biologics and Generics market units had mid-single digit organic net sales growth, and the Pharma market unit had low-single digit organic net sales growth.

Contract-Manufactured Products Segment
Net sales declined by 7.5% to $120.0 million. Organic net sales declined by 1.2% with currency translation decreasing net sales growth by 630 basis points. Segment performance was affected by a decline in components for healthcare diagnostic devices.

Financial Highlights (first nine months of 2022)
Operating cash flow was $493.2 million, an increase of 16.5%. Capital expenditures were $189.7 million, an increase of 7.2% over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $303.5 million, an increase of 23.2%.

During the first nine months of 2022, the Company repurchased 563,334 shares for $202.9 million at an average share price of $360.03 under its share repurchase program.

Full-Year 2022 Financial Guidance

Full-year 2022 net sales are expected to be in the range of $2.830 billion to $2.840 billion, compared to a prior guidance range of $2.950 billion to $2.975 billion.
Organic net sales growth is expected to be approximately 7%, compared to a prior guidance range of approximately 11%.
The Company expects a full-year decline in COVID-19 related net sales of approximately $85 million, unchanged from prior guidance.
Net sales guidance, based on current foreign currency exchange rates, includes an estimated fourth-quarter 2022 headwind of approximately $60 million.
Full-year 2022 adjusted-diluted EPS is expected to be in the range of $8.15 to $8.20, compared to a prior guidance range of $9.00 to $9.15.
Based on current foreign currency exchange rates, fourth-quarter adjusted-diluted EPS guidance includes a $0.17 headwind.
The revised guidance includes a $0.16 EPS positive impact from the first nine-months 2022 tax benefits from stock-based compensation.
For the fourth-quarter 2022, our EPS guidance range assumes a tax rate of 23% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first nine months of 2022 would provide a positive adjustment to our full-year adjusted-diluted EPS guidance.
Full-year 2022 capital spending is expected to be in a range of $300 million to $320 million, compared to prior guidance of $380 million.
Third-Quarter 2022 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. The live audio-only webcast will be made available via the Company’s Investor Relations website at https://bit.ly/3cgSM9S.

To participate and ask questions during the conference call, you must register in advance at https://bit.ly/3eipdG3. Upon registration, all telephone participants will receive the dial-in number along with a unique PIN number that will be used to access the call.

Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

On October 27, 2022 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported its third quarter 2022 financial results and provided a business update and outlook for the remainder of the year (Press release, argenx, OCT 27, 2022, View Source,the%20same%20periods%20in%202021. [SID1234622512]).

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"We had a strong third quarter of our global VYVGART launch now underway in our priority territories of the U.S., Japan and the EU. I am proud of what our teams have achieved, working cross-functionally to set a new treatment standard in gMG and serve as many patients as possible. Looking ahead, we are ready to support a SC efgartigimod launch in the first half of 2023 so that gMG patients can have multiple ways to individualize their treatment," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "gMG is also just the beginning and we are committed to advancing our immunology pipeline of efgartigimod, ARGX-117 and ARGX-119 with eight ongoing clinical trials in severe autoimmune diseases and more to start by the end of the year. We believe we are well on our way to realizing our goal of becoming a leading, multi-product immunology company and that we have the right team, a differentiated pipeline, and a sustainable discovery engine to continue innovating on behalf of patients."

THIRD QUARTER 2022 AND RECENT BUSINESS UPDATE

VYVGART Launch
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the European Union (EU). VYVGART is approved in the United States (U.S.) and the EU for the treatment of adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for adult gMG patients who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

Generated global net VYVGART revenues of $131 million in the third quarter of 2022
Received European Commission (EC) approval on August 11, 2022; commercial launch in Germany initiated on September 1, 2022
Approval decisions expected in 2023 in Canada, China through Zai Lab, and Israel through Medison
Expanded large-scale manufacturing capabilities and capacity through collaboration with FUJIFILM Diosynth Biotechnologies to provide drug substance manufacturing of efgartigimod
Efgartigimod Research and Development
argenx is positioned to expand its leadership position in FcRn blockade to include ten total autoimmune indications in the pipeline by the end of 2022

Neuromuscular franchise
Submitted BLA to the U.S. Food and Drug Administration (FDA) for SC efgartigimod for gMG; approval decision and commercial launch expected in first half of 2023
Topline data from registrational ADHERE trial of SC efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) on track for first quarter of 2023
Registrational ALKIVIA trial ongoing of SC efgartigimod for three subtypes of idiopathic inflammatory myopathies (myositis), including immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis; interim analysis planned of first 30 patients of each subtype
Hematology franchise
Topline data from second registrational ADVANCE-SC trial of SC efgartigimod for primary immune thrombocytopenia (ITP) expected in second half of 2023
Dermatology franchise
Topline data from registrational ADDRESS trial of SC efgartigimod for pemphigus vulgaris and foliaceus expected in second half of 2023
Registrational BALLAD trial ongoing of SC efgartigimod for bullous pemphigoid with interim analysis planned of first 40 patients
Proof-of-concept trials to launch in 2022 in collaboration with Zai Lab and IQVIA
Zai Lab to launch trials in lupus nephritis and membranous nephropathy with argenx to lead global registrational programs for each potential indication
IQVIA to launch trial in primary Sjogren’s syndrome; trial ongoing in COVID-19-mediated postural orthostatic tachycardia syndrome (POTS)
Pipeline Progress
argenx is developing ARGX-117 and ARGX-119, which both have pipeline-in-a-product potential for multiple autoimmune indications. Additional candidates that emerged from the Immunology Innovation Program are in development by partners or spin-off companies.

ARGX-117 (C2 inhibitor)
Proof-of-concept ARDA trial ongoing to evaluate safety, tolerability, and potential dosing regimen in multifocal motor neuropathy (MMN)
Proof-of-concept trial expected to start following regulatory discussions for prevention of delayed graft function and/or allograft failure after kidney transplantation
ARGX-119 (muscle-specific kinase (MuSK) agonist)
Phase 1 dose-escalation trial in healthy volunteers expected to start after Clinical Trial Application filing in fourth quarter of 2022 with subsequent Phase 1b trial to assess early signal detection in patients
LEO Pharma exercised exclusive, worldwide option to ARGX-112 targeting IL22 receptor; decision triggered €5 million payment to argenx
Hans de Haard, Ph.D. to retire as CSO on January 1, 2023 and transition to consultant within Immunology Innovation Program and strategic advisor to Research and Development Committee of argenx Board of Directors

Succession plans underway for Peter Ulrichts, Ph.D., Head of Clinical Science at argenx, to assume CSO role

Nomination of Ana Cespedes as non-executive director to Board of Directors
Ana Cespedes’s appointment is pending approval, which is expected to occur at an extraordinary general meeting of shareholders to be held in December 2022. She is Chief Operating Officer of IAVI, a global organization dedicated to developing accessible vaccines and antibodies for infectious diseases. She brings robust experience across a broad range of critical areas for commercialization and access, as well as for organizational effectiveness.

Total operating income for the third quarter and year-to-date in 2022 was $146.5 million and $263.2 million, respectively, compared to $7.1 million and $505.7 million for the same periods in 2021, and consists of:

Product net sales from the sales of VYVGART for the three months ended September 30, 2022 were $131.3 million. The product net sales in the nine months ended September 30, 2022 were $227.3 million. No product net sales were recognized during the same period in 2021.
Collaboration revenue for the third quarter and year-to-date in 2022 was $6.7 million and $9.3 million, respectively, compared to $0.1 million and $471.3 million for the same periods in 2021. The collaboration revenue during the three months ended September 30, 2022 primarily relates to milestone revenue of the €5 million triggered by the option exercised by LEO Pharma to enter into a commercial license for ARGX-112. The collaboration revenue for the three and nine months ended September 30, 2021 was primarily attributable to the recognition of the transaction price as a consequence of the termination of the collaboration agreement with Janssen, resulting in the recognition of $315.1 million and the closing of the strategic collaboration for efgartigimod with Zai Lab, resulting in the recognition of $151.9 million in collaboration revenue.
Other operating income for the third quarter and year-to-date in 2022 was $8.5 million, and $26.6 million, respectively, compared to $6.2 million and $34.5 million for the same periods in 2021. During the nine months ended September 30, 2022, and September 30, 2021, the fair value of the argenx profit share in AgomAb Therapeutics NV increased by $4.3 million and $11.2 million respectively. The increase is a result of the extension of a Series B financing round by AgomAb for which argenx maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE Antibody platform.

Total operating expenses for the third quarter and year-to-date in 2022 were $355.1 million and $869.1 million, respectively, compared to $220.1 million and $623.6 million for the same periods in 2021, and consists of:

Cost of sales for the third quarter and year-to-date in 2022 was $10.3 million and $16.6 million, respectively. The cost of sales were recognized with respect to the sale of VYVGART during 2022. There were no cost of sales recognized in the comparable prior year periods.
Research and development expenses for the third quarter and year-to-date in 2022 were $236.7 million and $515.6 million, respectively, compared to $139.4 million and $413.3 million for the same periods in 2021. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. The increase in research and development expense during the third quarter 2022 is mainly driven by the recognition of the priority review voucher submitted with the BLA filing for SC efgartigimod for the treatment of gMG, which resulted in an expense of $99.1 million.
Selling, general and administrative expenses for the third quarter and year-to-date in 2022 were $108.2 million and $336.8 million, respectively, compared to $80.6 million and $210.2 million for the same periods in 2021. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART in the U.S., Japan and the EU and personnel expenses.

Exchange losses for the third quarter and year-to-date in 2022 were $39.6 million and $93.0 million, respectively, compared to $17.6 million and $36.0 million for the same periods in 2021. Exchange losses are mainly attributable to unrealized exchange rate losses on cash, cash equivalents and current financial assets position in Euro.

Income tax for the third quarter and year-to-date in 2022 was $6.0 million and $17.1 of tax income, respectively, compared to $2.7 million and $15.6 million of tax expense for the same periods in 2021. Tax income for the three months ended September 30, 2022 consists of $7.3 million of income tax expense and $13.3 million of deferred tax income, compared to $4.3 million of income tax expense and $1.6 million of deferred tax income for the same period in 2021.

Net loss for the third quarter and year-to-date in 2022 was $235.0 million and $671.0 million, respectively, compared to net loss of $233.6 million and $170.4 million for the same periods in 2021.

Cash, cash equivalents and current financial assets totaled $2,385.5 million as of September 30, 2022, compared to $2,336.7 million as of December 31, 2021. Cash and cash equivalents and current financial assets increased primarily as a result of the closing of a global offering of shares, which resulted in the receipt of $761.0 million in net proceeds in March 2022, offset by net cash flows used in operating activities.

FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses and capital expenditures, argenx continues to expect its 2022 cash burn to be up to $1 billion. This 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.

EXPECTED 2023 FINANCIAL CALENDAR

March 2, 2023: FY 2022 financial results and business update
May 4, 2023: Q1 2023 financial results and business update
July 27, 2023: HY 2023 financial results and business update
October 27, 2023: Q3 2023 financial results and business update
CONFERENCE CALL DETAILS
The third quarter 2022 financial results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/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.