On October 30, 2025 Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, reported preliminary clinical and preclinical findings across its Helicon peptide pipeline at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts.

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The findings reinforce the broad potential of FOG-001, the company’s lead investigational therapy and the first-ever direct Wnt/β-catenin:TCF inhibitor, to act across a range of rare and more prevalent solid tumors linked by the same dysregulated biology of the Wnt/β-catenin pathway. Single-agent activity resulting in tumor shrinkage by at least 30% (partial response (PR)) was observed in five low-complexity tumor types, with strong scientific support as well for FOG-001’s potential in combination therapy for more complex tumors, including microsatellite-stable colorectal cancer (MSS CRC).

Together with positive preclinical read-outs demonstrating pharmacologic proof of concept for the company’s discovery-stage Helicon peptides in prostate cancer targeting the ERG and active androgen receptor (ARON) targets, these data highlight how the company’s Helicon platform can repeatably target high-impact "undruggable" targets long considered inaccessible to conventional therapeutic approaches.

"Just one week after presenting the first clinical proof that β-catenin:TCF can be drugged, we are showing the breadth of what this breakthrough could mean for science and for patients," said Mathai Mammen, M.D., Ph.D., Chairman and CEO of Parabilis Medicines. "FOG-001 is demonstrating meaningful signs of clinical activity across multiple Wnt/β-catenin-driven tumors, supporting its continued development in both simpler and more biologically complex Wnt-driven cancers through both monotherapy and combination therapy approaches."

He added, "Together with our preclinical advances in prostate cancer, the data illustrate the potential of Helicons to take on some of the toughest problems in oncology and bring forward transformative medicines that could meaningfully improve outcomes for patients."

FOG-001 Clinical and Preclinical Findings

The Wnt/β-catenin pathway — first identified as a key cancer driver over 30 years ago — is implicated in millions of cancer cases annually, spanning many rare and prevalent solid tumors as well as diseases like familial adenomatous polyposis (FAP) that predispose individuals to certain cancers, including colorectal cancer and desmoid tumors. Despite its central role in cancer biology, the pathway’s critical β-catenin:TCF transcription complex has long been considered "undruggable."

Preliminary data from the ongoing Phase 1/2 trial of FOG-001 (NCT05919264), as of mid-August 2025, show that the therapy is well tolerated with no Grade 4/5 treatment-related adverse events or discontinuations and exhibits a favorable pharmacokinetic profile. As of this early data cut, an objective response rate (ORR) of 43% and a disease control rate (DCR) of 83%, per RECIST 1.1, were observed in non-CRC patients with Wnt pathway activating mutations (WPAM). Evidence of single-agent activity was observed across numerous Wnt/β-catenin–driven tumors, particularly in those with low mutational burden, including desmoid, adamantinomatous craniopharyngioma (ACP), ameloblastoma, salivary gland cancer, and solid pseudopapillary neoplasm (SPN).

In MSS CRC, a 50% DCR was achieved within the efficacious monotherapy dose range, with molecular data confirming on-target pathway inhibition and reprogramming of the tumor microenvironment toward a more immune-active state. Complementary preclinical studies demonstrated that FOG-001 enhances the effects of standard and emerging therapies for MSS CRC—showing in these preclinical models additive or synergistic activity with each of 5-fluorouracil and anti-VEGF regimens, synergy with anti–PD-1 therapy, and combination benefit with pan-RAS and KRAS G12D inhibitors.

Together, these findings highlight FOG-001’s broad pipeline potential — warranting continued development in Wnt pathway–activated low-complexity tumors, and as a backbone for rational combination regimens in more complex cancers. The Phase 1/2 study remains ongoing across a wide range of Wnt-driven rare and common cancers, with additional data readouts expected over the coming months.

Prostate cancer pipeline expansion

Parabilis also presented preclinical data advancing its prostate cancer franchise, focused on two long-standing oncogenic drivers that currently lack effective therapies. ERG-degrading Helicon peptides potently and durably reduced ERG protein levels —overexpressed in 40–50% of prostate cancers — showing in vivo pharmacologic proof-of-concept demonstrating tumor growth inhibition and efficacy comparable to or exceeding standard of care in challenging prostate cancer models.

In parallel, allosteric ARON Helicon degraders that bind a conserved site distinct from the androgen ligand pocket, were designed to selectively target the active, agonist-bound androgen receptor. These Helicon degraders block proliferation in AR-amplified prostate cancer cells, offering a strategy to overcome resistance driven by AR mutations or amplification. Importantly, this approach also allows for effective combinations with approved and emerging treatments that target the testosterone ligand pocket. Together, these data demonstrate the repeatability of the Helicon platform in addressing high-value, historically undruggable targets in oncology.

"Our Helicons are delivering against three of the most challenging and compelling targets in oncology, from β-catenin:TCF to ERG to ARON," said Fawzi Benzaghou, M.D., Chief Medical Officer of Parabilis Medicines. "By pursuing bold science that makes the undruggable druggable, we’re opening new therapeutic possibilities for patients with few or no options. These data reinforce the power of our α-helical peptide platform to repeatedly unlock difficult targets and advance medicines with the potential for extraordinary patient impact."

About the Phase 1/2 trial of FOG-001
FOG-001 is being evaluated in a first-in-human Phase 1/2 multicenter, open-label study (NCT05919264) assessing its safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity. The trial includes dose-escalation and dose-expansion phases and is testing FOG-001 both as a monotherapy and in combination with other anticancer agents in patients with advanced or metastatic solid tumors likely or known to harbor a Wnt pathway–activating mutation (WPAM).

About FOG-001
FOG-001 is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors and is currently in clinical development. By directly targeting the β-catenin:TCF protein-protein interaction, FOG-001 is intended to block the Wnt signaling pathway irrespective of the various APC and β-catenin mutations that typically drive disease.

FOG-001 combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and FOG-001 blocks the Wnt pathway at the key downstream node, disrupting the interaction between β-catenin and the TCF transcription factors, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis.

FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors.

(Press release, Parabilis Medicines, OCT 30, 2025, View Source [SID1234657179])

On October 30, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported the presentation of new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

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CLD-401 is a tumor-tropic oncolytic virus designed to home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).

"The RedTail platform represents a major advance in virotherapy and genetic medicines," said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "RedTail allows for systemically administered genetic medicines that avoid immune clearance, are tropic for tumor cells, induce tumor lysis and immunologically prime the TME, and can deliver a genetic payload."

"In our syngeneic models, CLD-401 can reach metastatic sites when administered systemically where it can destroy tumor cells through a novel mechanism that also induces an immune priming effect," added Eric Poma, PhD, Chief Executive Officer. "CLD-401 builds on these mechanisms by also delivering high levels of IL-15 superagonist to the TME to activate a potent T-cell and NK cell response to the tumor."

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

CLD-401 Presentation

Meeting: SITC (Free SITC Whitepaper) 40th Anniversary Annual Meeting, November 7–9, 2025, National Harbor, MD
Title: In Situ Tumor Delivery of IL-15 Superagonist via RedTail Gene Therapy Achieves Durable Tumor Clearance
Abstract Number: 1175
Presentation Time: Friday, November 7, 2025, 12:15–1:45 PM and 5:35–7:00 PM

(Press release, Calidi Biotherapeutics, OCT 30, 2025, View Source [SID1234657145])

On October 30, 2025 Nuvalent, Inc.(Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline progress, reiterated key anticipated milestones, and announced third quarter 2025 financial results.

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"The third quarter of 2025 marked the achievement of a significant milestone with the completion of our NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC. We look forward to working closely with the FDA throughout the review process, as well as continuing to engage with the agency on potential opportunities for line-agnostic expansion," said Darlene Noci, A.L.M., Chief Development Officer of Nuvalent. "We remain on track to share topline pivotal data this quarter from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC, and continue to progress ALKAZAR, our global Phase 3 randomized, controlled trial of neladalkib for TKI-naïve patients with advanced ALK-positive NSCLC."

"Our commercial preparedness activities are well underway as we carry forward the momentum from these exciting development milestones and continue our efforts to transition toward becoming a fully integrated commercial-stage biopharmaceutical company," said Alex Balcom, Chief Financial Officer of Nuvalent. "Combined with a strong financial position with cash runway anticipated into 2028, we believe we are well positioned to achieve our goal of delivering a new and potential best-in-class option for all patients with ROS1 or ALK-positive NSCLC."

"We are also pleased to have recently shared the first report of preliminary clinical data demonstrating the potential for neladalkib to address medical needs for patients with ALK-positive solid tumors beyond NSCLC, and new preclinical data further demonstrating the potential for NVL-330 to offer a differentiated profile for HER2-altered NSCLC," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "With a portfolio anchored by complementary indications in biomarker-driven NSCLC and supported by a robust development and discovery pipeline, we continue to build towards our long-term vision of Nuvalent as a sustainable company capable of designing, developing and delivering precisely targeted therapies for patients with cancer."

Recent Pipeline Achievements and Anticipated Milestones

ROS1 Program

•
The company has completed its rolling NDA submission for zidesamtinib in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC).

•
Data supporting the NDA submission were presented in September as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer.
•
The company continues to engage with the FDA on potential opportunities for line-agnostic expansion.
ALK Program

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Evaluation of neladalkib is ongoing in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive NSCLC and other solid tumors:
o
The company presented preliminary data from the ongoing ALKOVE-1 Phase 1/2 clinical trial of neladalkib in patients with advanced ALK-positive solid tumors outside of NSCLC during a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025. Neladalkib demonstrated encouraging preliminary activity across a diverse set of advanced ALK-positive solid tumors, and was generally well-tolerated with a preliminary overall safety profile consistent with its ALK-selective, TRK sparing design, and with previously reported data.
o
The company is on track to report topline pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025.
•
Enrollment is ongoing in ALKAZAR, the company’s global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients are randomized 1:1 to receive neladalkib or alectinib, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies.
HER2 Program

•
Nuvalent presented new preclinical data for its novel HER2-selective inhibitor, NVL-330, at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), further supporting its potentially differentiated brain-penetrant profile. Compared to several currently available and investigational HER2 TKIs in the same preclinical assays, NVL-330 demonstrated a favorable efflux ratio and brain partitioning, metrics that are potentially positive predictors of brain exposure in humans. In preclinical models of intracranial activity, NVL-330 induced deep intracranial regression in mice. In the same models, the approved therapies T-DXd and zongertinib did not induce intracranial regression at their clinically relevant doses. Additionally, NVL-330 induced intracranial tumor regression in mice that had progressed in the CNS on zongertinib. These data add to the preclinical characterization of NVL-330 as a brain penetrant TKI that is broadly active against HER2 oncogenic alterations and selective over wild-type EGFR, and the company believes the data support its investigation in patients with advanced HER2-altered NSCLC.
•
Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025.

Upcoming Events

•
Jefferies 2025 Global Healthcare Conference in London: Management will be participating in a fireside chat on Wednesday, November 19, 2025, at 5:00 p.m. GMT. A live webcast will be available in the Investors section of Nuvalent’s website at www.nuvalent.com, and will be archived for 30 days following the conference.

Third Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents and marketable securities were $943.1 million as of September 30, 2025. Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
•
R&D Expenses: Research and development (R&D) expenses were $83.8 million for the third quarter of 2025.
•
G&A Expenses: General and administrative (G&A) expenses were $28.9 million for the third quarter of 2025.
•
Net Loss: Net loss was $122.4 million for the third quarter of 2025.

(Press release, Nuvalent, OCT 30, 2025, View Source [SID1234657162])

On October 30, 2025 NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, reported it will present new research at the International Society of Liquid Biopsy (ISLB) Annual Congress 2025 demonstrating high concordance between its RaDaR ST and RaDaR 1.0 assays for detecting molecular residual disease (MRD) in solid tumors. NeoGenomics will also present on the progress of its NextGen (whole genome-based) MRD research program, as well as three additional posters highlighting the company’s work in liquid biopsy and genomic profiling across solid tumor types.

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The bridging study, "Performance Comparison of RaDaR 1.0 and RaDaR ST Assays for Circulating Tumor DNA Detection Across Solid Tumor Types" (PP.41), evaluated matched samples from 166 patients representing 15 solid tumor types. RaDaR ST demonstrated 97% concordance and maintained equivalent sensitivity with RaDaR 1.0. This study provides analytical confirmation that RaDaR ST maintains the performance of RaDaR 1.0, supporting continuity in MRD assessment as the platform is updated. RaDaR ST is currently covered by Medicare for HR+/HER2- breast cancer (>5 years after diagnosis, recurrence monitoring) and HPV- head and neck carcinoma (adjuvant and recurrence monitoring) and has demonstrated utility across multiple tumor types.

"MRD has become an important part of a patient’s journey for cancer surveillance and monitoring," said Tony Zook, CEO. "This study shows that RaDaR ST delivers equivalent sensitivity as compared to RaDaR 1.0. We are excited to offer clinicians and patients MRD testing optionality with the expected launch of RaDaR ST in Q1 2026. As we continue to invest in novel MRD technologies for the future, the expanding portfolio of MRD solutions will help address unmet needs for sensitive and accurate residual disease detection and monitoring in patients with cancer."

In addition to the RaDaR ST bridging study, NeoGenomics will present four other posters at ISLB:

Performance Characterization of a Novel Whole Genome Sequencing Informed MRD Assay (PP.15), evaluating a whole genome-informed, tumor-specific approach to detect ctDNA at very low levels in solid tumors.
Genomic Profiles of Early-Stage Non-Small Cell Lung Cancer Patients, and Association with Pre-Treatment Blood Circulating Tumor DNA Detection and Levels (PP.74), analyzing genomic features of early-stage lung cancers and investigating the relationship between tumor genomics, ctDNA detectability, and clinical outcomes in these patients.
Validation of NEO │ PanTracer LBx, a Liquid Biopsy Precision Oncology Pan-Solid Tumor Comprehensive Genomic Profiling Assay (PP.05), presenting analytical and clinical validation findings for therapy selection using liquid biopsy.
Non-invasive identification of actionable biomarkers in advanced solid tumors by comprehensive genomic profiling with NEO | PanTracer LBx assay (PP.04), assessing liquid biopsy-based comprehensive genomic profiling to detect actionable variants and support treatment decisions in late-stage cancers.
These presentations contribute to NeoGenomics’ growing body of research in liquid biopsy for MRD detection and genomic profiling. The findings reinforce the company’s strategy to advance next-generation molecular testing platforms and expand the role of ctDNA in clinical research and patient management.

(Press release, NeoGenomics Laboratories, OCT 30, 2025, View Source [SID1234657180])

On October 30, 2025 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 2025 financial results and provided a business update.

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"argenx continues to deliver on our bold innovation agenda, driving transformational impact for patients worldwide," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "This year, we expanded our global reach with VYVGART in two blockbuster indications, advanced five registrational programs, and are on track to complete our goal of four Phase 1 molecules by year-end, reflecting our ongoing investment in innovation. VYVGART is redefining expectations for people living with gMG and CIDP, and we see continued growth potential driven by strong patient demand for better outcomes, earlier use in the treatment paradigm, and our commitment to pursuing the broadest possible labels for our medicines. We aim to leverage the successful innovation playbook of MG and CIDP as we prepare for five registrational readouts next year. Building on this momentum, our pipeline is positioned to expand into new indications and reach tens of thousands more patients—bringing us closer to our Vision 2030 goal."

Vision 2030 Strategic Priorities

argenx is advancing its Vision 2030 strategic priorities, anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications across approved medicines, and progress five pipeline candidates into Phase 3 development by 2030.

Expand global VYVGART opportunity

VYVGART (IV: efgartigimod alfa-fcab and SC: efgartigimod alfa and hyaluronidase-qvfc) is a first-and-only IgG Fc-antibody fragment that targets the neonatal Fc receptor (FcRn). It is approved in three indications, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan.

Delivered $1.13 billion in global product net sales in the third quarter of 2025, an increase of $554 million year-over-year and $178 million quarter-over-quarter, reflecting strong fundamentals and continued confidence from patients and prescribers.
VYVGART SC prefilled syringe (PFS) for self-injection approved in Japan in September 2025; Canada decision on approval expected by end of 2025
Supplemental Biologics License Application (sBLA) for VYVGART in three anti-acetylcholine receptor antibody negative (AChR-Ab seronegative) gMG subtypes (MuSK+, LRP4+, triple seronegative) on track for filing with U.S. Food and Drug Administration (FDA) by year-end 2025
Pursuing label expansion through ongoing registrational studies:
Topline results expected in first half of 2026 for ocular MG (ADAPT OCULUS)
Topline results expected in the second half of 2026 for primary ITP (ADVANCE-NEXT)
Expanded partnership with FUJIFILM to include new manufacturing site in North Carolina, strengthening global supply chain and supporting anticipated growth in efgartigimod and pipeline assets
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance next wave of launches

argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple first-in-class product candidates with potential across high-need indications.

Efgartigimod Development

Efgartigimod is being studied in severe IgG-mediated autoimmune diseases, highlighting the broad potential of FcRn biology across several therapeutic areas including neurology, rheumatology and endocrinology.

Registrational studies are currently ongoing in two rheumatology indications, including idiopathic inflammatory myopathies (IIM or myositis) and Sjögren’s disease
Topline results from ALKIVIA study evaluating three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS) and dermatomyositis (DM)) expected in second half of 2026
Topline results from UNITY study (Sjögren’s disease) expected in 2027
Registrational study in Graves’ disease (GD) to initiate in first half of 2026, expanding development in thyroid-driven autoimmunity, including ongoing registrational studies in thyroid eye disease (TED)
Topline results from UplighTED studies expected in second half of 2026
Proof-of-concept studies ongoing in systemic sclerosis (SSc) and antibody mediated rejection (AMR)
Topline Phase 2 data from lupus nephritis do not support advancing to registrational study

Empasiprubart Development

Empasiprubart, a first-in-class, monoclonal antibody that specifically binds to C2, is currently being evaluated in three indications, including multifocal motor neuropathy (MMN), CIDP and delayed graft function (DGF).

Topline results from registrational EMPASSION study (MMN) expected in second half of 2026
Registrational EMVIGORATE and EMNERGIZE studies ongoing (CIDP)
Topline data from Phase 2 VARVARA study (DGF) expected around year-end 2025
Stopped development of empasiprubart in DM due to operational challenges with enrollment of proof-of-concept EMPACIFIC study
ARGX-119 Development

ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is now a registrational asset following positive proof-of-concept data in congenital myasthenic syndromes (CMS). ARGX-119 is also being evaluated in amyotrophic lateral sclerosis (ALS) and spinal muscular atrophy (SMA).

CMS registrational study on track to start in 2026
Phase 2a proof-of-concept study ongoing in ALS; topline results expected in first half of 2026
SMA proof-of-concept study on track to start by end of 2025

Advance four new pipeline molecules and generate sustainable value through continued investment in Immunology Innovation Program

argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this biology; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and a fourth pipeline candidate, a first-in-class sweeping antibody for which the target has not yet been disclosed.

Phase 1 study for ARGX-109 expected to complete by end of 2025; Phase 1 studies for ARGX-213 and ARGX-121 expected to complete in first half of 2026
THIRD QUARTER 2025 FINANCIAL RESULTS

argenx SE

UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Nine Months Ended
September 30, September 30,
(in thousands of $ except for per share data) 2025 2024 2025 2024
Product net sales $ 1,126,961 $ 572,997 $ 2,865,605 $ 1,448,915
Other operating income* 24,377 15,881 60,290 41,904
Total operating income $ 1,151,338 $ 588,878 $ 2,925,895 $ 1,490,819

Cost of sales $ (109,426) $ (59,072) $ (300,978) $ (154,633)
Research and development expenses (355,651) (235,940) (992,418) (686,195)
Selling, general and administrative expenses (336,291) (277,698) (937,441) (769,392)
Loss from investment in a joint venture (3,776) (1,981) (8,863) (5,294)
Total operating expenses $ (805,144) $ (574,691) $ (2,239,700) $ (1,615,514)

Operating profit/(loss) $ 346,194 $ 14,187 $ 686,195 $ (124,695)

Financial income $ 42,700 $ 40,586 $ 118,217 $ 118,414
Financial expense (993) (676) (3,254) (1,760)
Exchange (losses)/gains (1,848) 33,927 74,155 6,712

Profit/(loss) for the period before taxes $ 386,053 $ 88,024 $ 875,313 $ (1,329)
Income tax (expense)/benefit $ (41,795) $ 3,386 $ (116,228) $ 60,208
Profit for the period $ 344,258 $ 91,410 $ 759,085 $ 58,879
Profit for the period attributable to:
Owners of the parent $ 344,258 $ 91,410 $ 759,085 $ 58,879
Weighted average number of shares used for basic profit per share 61,371,508 60,087,498 61,147,873 59,633,179
Basic profit per share (in $) 5.61 1.52 12.41 0.99
Weighted average number of shares used for diluted profit per share 66,441,326 65,636,686 65,944,952 65,024,955
Diluted profit per share (in $) 5.18 1.39 11.51 0.91
*Comparative figures have been presented to be consistent with the one adopted in the current period with respect to the combination of collaboration revenue and other operating income.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three and nine months ended September 30, 2025 was $1.2 billion and $2.9 billion, respectively, compared to $0.6 billion and $1.5 billion, respectively, for the same periods in 2024, and mainly consisted of:

Product net sales of VYVGART for the three and nine months ended September 30, 2025, were $1.1 billion and $2.9 billion, respectively, compared to $0.6 billion and $1.4 billion, respectively, for the same periods in 2024.

Other operating income for the three and nine months ended September 30, 2025 was $24 million and $60 million, respectively, compared to $16 million and $42 million, respectively, for the same periods in 2024. The other operating income in these periods primarily related to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and nine months ended September 30, 2025 were $805 million and $2.2 billion, respectively, compared to $575 million and $1.6 billion, respectively, for the same periods in 2024, and mainly consisted of:

Cost of sales for the three and nine months ended September 30, 2025 was $109 million and $301 million, respectively, compared to $59 million and $155 million, respectively, for the same periods in 2024. The cost of sales related to the sale of VYVGART.

Research and development expenses for the three and nine months ended September 30, 2025 were $356 million and $992 million, respectively, compared to $236 million and $686 million, respectively, for the same periods in 2024. The research and development expenses mainly related to:

Advancing efgartigimod across multiple severe autoimmune indications, supporting ongoing registrational and expansion studies;
Progressing empasiprubart into multiple indications namely in MMN, DGF and CIDP;
Executing studies for ARGX-119 in rare neuromuscular diseases, including a registrational study in CMS and proof-of-concept studies in ALS and SMA; and
Early-stage discovery and preclinical programs to sustain long-term pipeline growth.

Selling, general and administrative expenses for the three and nine months ended September 30, 2025 were $336 million and $937 million, respectively, compared to $278 million and $769 million, respectively, for the same periods in 2024. The selling, general and administrative expenses mainly related to professional and marketing fees linked to global commercialization of the VYVGART franchise, and personnel expenses.

Financial income for the three and nine months ended September 30, 2025 was $43 million and $118 million, respectively, compared to $41 million and $118 million, respectively, for the same periods in 2024.

Exchange losses/gains for the three and nine months ended September 30, 2025 were a $2 million loss and a $74 million gain, respectively, compared to $34 million and $7 million gains, respectively, for the same periods in 2024. Exchange losses/gains were mainly attributable to unrealized exchange rate fluctuations on the cash, cash equivalents and current financial assets denominated in Euros.

Income tax for the three and nine month periods ended September 30, 2025 and 2024 is detailed below:

Three Months Ended Nine Months Ended
30 September, 30 September,
(in millions of $) 2025 2024 2025 2024
Current tax expense $ (52) $ (13) $ (122) $ (29)
Deferred tax benefit 10 17 6 89
Income tax (expense)/benefit $ (42) $ 3 $ (116) $ 60
Profit for the three and nine month periods ended September 30, 2025 was $344 million and $759 million, respectively, compared to $91 million and $59 million, respectively, for the same periods in 2024. On a per weighted average share basis, the basic earnings per share was $12.41 for the nine months ended September 30, 2025 compared to $0.99 for the nine months ended September 30, 2024.

Cash, cash equivalents and current financial assets1 consisted of $2.6 billion in cash and cash equivalents and $1.7 billion in current financial assets which totals $4.3 billion as of September 30, 2025 compared to $1.5 billion in cash and cash equivalents and $1.9 billion in current financial assets which totals $3.4 billion as of December 31, 2024.

FINANCIAL GUIDANCE

The financial guidance on the combined research and development and selling, general and administrative remains unchanged at approximately $2.5 billion.

REMAINING KEY DATES

February 26, 2026: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update

CONFERENCE CALL DETAILS

The third quarter 2025 financial results and business update will be discussed during a conference call and webcast presentation today at 1:30 pm CET/8:30 am ET. A webcast of the live call and replay may be accessed on the Investors section of the argenx website at argenx.com/investors.

(Press release, argenx, OCT 30, 2025, View Source [SID1234657115])