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.

On October 27, 2022 Orion Research Foundation reported that it is awarding EUR 1 million in grants and two EUR 100,000 special grants (Press release, Orion , OCT 27, 2022, View Source [SID1234622511])

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The Board of Directors of the Orion Research Foundation will today award grants on the basis of applications amounting to a total of EUR 1 million for 2023. This year, the Board of the Research Foundation will also award two special grants of EUR 100,000 to mid-career researchers. The grants will be awarded to Associate Professor Tiina Sikanen from the Division of Pharmaceutical Chemistry and Technology at the University of Helsinki, and to Professor of Cancer Biology Jukka Westermarck from the Institute of Biomedicine and
Research Director at the Turku Bioscience Centre at the University of Turku.

Each year, the Orion Research Foundation distributes its investment income and the donation it receives from Orion Corporation as grants to young researchers and researchers who have recently gained doctorates to enable them to continue their research. In recent years, the Foundation has awarded grants by application amounting to a total of approximately EUR 1 million annually to researchers in the fields of medicine, veterinary medicine, pharmacy and related natural sciences such as chemistry and physics. This year, two special awards, which could not be applied for, will also be awarded. The two special grants will be awarded to mid-career researchers both for their valuable research work and for speaking publicly in support of research funding, thus promoting the cause of all researchers.

In the past, the Research Foundation has granted three special awards on the basis of various award criteria to Hannes Lohi, research group leader, in 2012, and to Academy Professor Johanna Ivaska and Professor of Pharmacogenetics Mikko Niemi in 2017.

Seeking a drug that is harmless for humans and the environment

Tiina Sikanen is Associate Professor at the Division of Pharmaceutical Chemistry and Technology at the University of Helsinki. She earned a PhD in pharmacy from the University of Helsinki in 2007 and a Master of Science in Technology degree in chemical engineering from Aalto University in 2010.

Associate Professor Sikanen’s research group develops microchip-based methods for studying the metabolism of pharmaceutical ingredients, in other words, their transformation, in the body using the enzymes of various animal species and humans. Sikanen’s aim is to develop methods that enable rapid and patient-specific metabolite analytics to support personalised treatments. Patient-specific metabolite analytics can reduce the side effects of medicines as well as drug residues that burden the environment.

"I want to form an overall idea of how research can provide a better understanding in the future of the environmental impacts and risks associated with pharmaceuticals ending up in the environment," Sikanen says. In her appearances and publications, she has improved the public understanding of the environmental risks posed by active pharmaceutical ingredients and the need to reduce these risks among decision-makers, pharmaceutical and healthcare professionals and consumers.

Sikanen has received a number of major awards for her research, including the Award for Scientific Courage from the Academy of Finland in 2019 and the L’Orèal For Women in Science award in 2020. She has published more than 60 scientific articles.

Identifying the signalling mechanisms of cancer cells

Jukka Westermarck is Professor of Cancer Biology at the Department of Medical Biochemistry in the Faculty of Medicine and Research Director at the Turku Bioscience Centre at the University of Turku. He earned the degree of licentiate of medicine in 1996 and a doctorate in medicine with distinction in 1998 from the University of Turku.

His research team has endeavoured to identify the signalling mechanisms in cancer cells that promote malignancy in cancer. The group’s most significant achievement has been the identification of the CIP2A oncoprotein. This has provided new outlooks regarding the future opportunities of cancer treatment. CIP2A overproduction is one of the changes most commonly seen in cancer. "In about 70 per cent of all cancer samples, in almost all cancers, this mechanism is in operation.
Over the last 4 to 5 years, the biology associated with phosphatases has also received attention in drug development. We are now starting to get closer to being able to bring new treatment to patients," says Westermarck.

Westermarck has received many awards for his successful scientific work, the most significant of which are the Young Investigator Award from the Finnish Medical Society Duodecim in 2007 and the Anders Jahre Young Scientist Award in 2009. He has published 116 original papers and 14 review articles.

On October 27, 2022 Neuren Pharmaceuticals (ASX: NEU) reported its quarterly activity and cash flow report for Q3 2022 (Press release, Neuren, OCT 27, 2022, View Source;[email protected] [SID1234622510]).

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Neuren CEO Jon Pilcher commented: "Neuren continued to achieve the planned milestones during the quarter, remaining on track for the transforming catalysts still to come, notably the FDA target action date for trofinetide in Rett syndrome on 12 March 2023, followed by Phase 2 results for NNZ-2591 in multiple indications.

"Commentary on events since 30 June and outlook
Trofinetide for Rett syndrome In September 2022 the US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for trofinetide to treat Rett syndrome in adults and pediatric patients two years of age and older, that was submitted in July by Neuren’s North America partner Acadia Pharmaceuticals (Nasdaq: ACAD). The FDA granted a Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of 12 March 2023. The FDA also informed Acadia that at that time they were not planning to hold an Advisory Committee meeting. The trofinetide program has Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA. If approved, trofinetide will be the first drug for the treatment of Rett syndrome.

Acadia has exclusive rights to develop and commercialize trofinetide in North America, which is fully funded by Acadia.

Acceptance of the NDA earned a milestone payment of US$10 million from Acadia, which Neuren received in October. In 2023, if the NDA is approved by the FDA, Neuren expects to earn revenue for Rett syndrome in the US alone of A$112 million plus royalties. The next potential milestone payment to Neuren would be US$40 million (A$61 million at an assumed exchange rate of 0.65), payable following the first commercial sale of trofinetide in the United States. Subsequently, Neuren is eligible to receive double-digit percentage royalties on net sales of trofinetide in North America, plus milestone payments of up to US$350 million (A$538 million) on achievement of a series of four thresholds of total annual net sales, plus one third of the market value of a Rare Pediatric Disease Priority Review Voucher if awarded by the FDA upon approval of the NDA, with the one third share estimated by Neuren as US$33 million (A$51 million). No royalties or similar costs are payable by Neuren to third parties, which means that Neuren’s revenue from Acadia will flow through to pre-tax profit.

Neuren retains all rights to trofinetide for all countries outside North America and has a fully paid-up, irrevocable licence for use in those countries to all data generated by Acadia. Rett syndrome is a devastating condition with no approved therapies and there is urgent unmet need around the world for a treatment. Neuren has received strong interest for potential commercial partnerships and discussions are continuing under a process to secure the optimum outcome for shareholders and for patients. NNZ-2591 for multiple neurodevelopmental disorders During Q3 Neuren commenced its Phase 2 clinical trials of NNZ-2591 in each of Angelman syndrome (AS), Phelan-McDermid syndrome (PMS) and Pitt Hopkins syndrome (PTHS).

The open label Phase 2 trials will each enrol up to 20 children to examine safety, tolerability, pharmacokinetics and efficacy over 13 weeks of treatment with NNZ-2591. All subjects will receive NNZ-2591 as an oral liquid dose twice daily, with titration up to the target mg/kg dose during the first 6 weeks of treatment, subject to safety and tolerability. The treatment period is preceded by 4 weeks of observation to thoroughly examine the baseline characteristics prior to treatment, against which safety and efficacy will be assessed for each child. A follow-up assessment will be made 2 weeks after end of treatment. For each trial there are three age cohorts. Safety and tolerability is assessed in the oldest cohort before proceeding with the middle cohort and then safety and tolerability is assessed in the middle cohort before proceeding with the youngest cohort.

Neuren is also planning a Phase 2 trial in a fourth disorder, Prader-Willi syndrome, with an Investigational New Drug (IND) Application to be submitted to the FDA in Q4 2022. Neuren has Orphan Drug designation from the FDA for NNZ-2591 in all four syndromes, which are serious neurodevelopmental disorders with no approved medicines. The estimated number of potential patients being targeted across these four disorders is more than five times larger than Rett syndrome. Neuren retains all global rights to NNZ-2591. The overall aim of these first trials in patients is to expedite the generation of data that will enable the subsequent trials to be designed as registration trials. Prioritising fast enrolment of subjects, the AS trial is being conducted in Australia, whilst the PMS and PTHS trials are being conducted in the US.

In order to expedite the overall development plan, in parallel with conducting the Phase 2 trials Neuren is executing the additional development work required to be ready for Phase 3 development. This includes non-clinical toxicity studies to support longer clinical trials and commercial use of the product, as well as optimisation of the drug product and drug substance manufacturing arrangements. Neuren is well funded from current cash reserves to execute the Phase 2 trials and Phase 3 preparation, notwithstanding the anticipated material cash flows from trofinetide. Investor relations In September, Neuren was added into the S&P/ASX 300 index. Since 30 June, Neuren has presented at the healthcare conferences of Evans & Partners, Euroz Hartleys and Goldman Sachs, as well as at the ASX Small and Mid-Cap conference. Presentations are scheduled at the Wilsons and Bell Potter healthcare conferences. Neuren will also present at the Jefferies London Healthcare Conference in November.

Human resources In July, Neuren’s skills and experience in pediatric neurology and orphan drug development were further enhanced by the appointment of Liza Squires M.D. to the new position of Chief Medical Officer, based in the United States. Dr Squires is a board-certified physician in General Pediatrics and Neurology with Special Competence in Child Neurology. Over the past 20 years, she has held positions of increasing responsibilities in both early and late-stage development at Johnson and Johnson, Shire Pharmaceuticals, Lumos Pharma, Aevi Genomic Medicine and Origin Biosciences. She has led and contributed to multiple New Drug Applications resulting in global regulatory approvals and has extensive experience in orphan drug development.Financials Cash reserves at 30 September 2022 were $27.3 million, compared with $31.1 million at 30 June 2022. In Q3 net cash of $4.0 million was used in operating activities, with R&D payments of $2.8 million mainly relating to the NNZ-2591 Phase 2 clinical trials and the foundational work to prepare for Phase 3 development of NNZ-2591 across multiple indications.

The carrying value in AUD of USD cash held to mitigate exchange rate risk for USD expenditure increased by $0.2m for the quarter, due to the strengthening of the USD against the AUD. Payments to related parties of approximately $194,000 comprised the Managing Director’s executive remuneration and non-executive directors’ fees.

On October 27, 2022 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell and gene therapies with a focus on immuno-oncology, reported it entered into a Standby Equity Purchase Agreement (the "SEPA") with YA II PN, LTD, a partnership managed by Yorkville Advisors Global LP, a global investment manager, to sell up to $8 million of the Company’s stock at any time during the 24 months following the date of the SEPA, subject to the effectiveness of a registration statement with the Securities and Exchange Commission and other conditions (Press release, Kiromic, OCT 27, 2022, View Source [SID1234622509]).

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The SEPA gives Kiromic the right, but not the obligation, to sell up to $5 million of shares of common stock, which may be increased by an additional $3 million of shares of common stock, at the Company’s request, subject to terms and limitations set forth in the agreement. The number of shares issuable under the SEPA is limited to a number equivalent to 19.99 % of the outstanding common stock of the Company as of the date of the SEPA agreement unless certain pricing conditions are met, which could have the effect of limiting the total proceeds under the SEPA.

Kiromic separately also secured $2 million in gross proceeds from a new investor through the issuance of a secured convertible promissory note. The convertible note converts into the Company’s common stock at a conversion price equal to $0.35 per share.

Following the close of the two financings, Kiromic also announced the completed settlement of its prior litigation with Sabby Capital Management, another institutional shareholder and certain affiliates.

"This equity facility is an important piece of our financing strategy that not only provides flexibility and additional runway towards achieving our clinical milestones, but also enables us to settle a key prior legal issue," stated Pietro Bersani, Chief Executive Officer of Kiromic. "We believe Yorkville Advisors will be a strong financial partner for us. With the combination of both financings, we have the facilities in place whereby we have the potential to raise up to $10 million of financing, subject to certain conditions, of which $2 million has already been secured, and we look forward to ongoing discussions with additional potential investors," continued Mr. Bersani.

For further information on the SEPA or convertible note, including important terms and conditions, please see Company’s filings with the Securities and Exchange Commission, including the Company’s Current Reports on Form 8-K filed with the Securities and Exchange Commission.

On October 27, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it will report its third quarter 2022 financial results after market close on Thursday, November 3, 2022 (Press release, Rigel, OCT 27, 2022, View Source [SID1234622508]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

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Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.