On July 31, 2025 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2025 (Press release, AbbVie, JUL 31, 2025, View Source [SID1234654664]).

"AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We’re entering the second half of the year with substantial momentum and are once again raising our full-year outlook."

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Second-Quarter Results

•Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis.
◦Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis.
◦Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis.
◦Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis.
◦Global Vraylar net revenues were $900 million, an increase of 16.3 percent.
◦Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis.
◦Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis.
◦Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis.
◦Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent.
◦Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis.
◦Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis.
◦Global Juvederm net revenues were $260 million, a decrease of 24.0 percent.

•On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.7 percent of net revenues.

•Acquired IPR&D and milestones expense was 5.3 percent of net revenues.

•On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent.

•Net interest expense was $678 million.

•On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent.

•Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology.

•AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq’s safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study.

•AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

•AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting.

•AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options.

•AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie’s robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie’s novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

•AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication.

•AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI’s lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM).

•AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis.

•AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie’s expertise in biotherapeutic drug development and commercialization with ADARx’s proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 – $11.87 to $11.88 – $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted.

On July 31, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment for cancer and fibrosis, reported further progress across its small molecule, focal adhesion kinase (FAK) inhibitor program and the release of its Appendix 4C Cash Flow Report (attached) for the quarter ending 30 June 2025 (Press release, Amplia Therapeutics, JUL 31, 2025, View Source [SID1234654649]).

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Key Highlights

• The ACCENT trial achieved a key activity threshold with 17 confirmed partial responses (PRs), showing a 31% response rate for narmafotinib combined with chemotherapy, which is superior to chemotherapy alone (23%).
• Two patients achieved complete responses, including one patient with undetectable cancer lesions for over two months and another with a rare pathological complete response in metastatic pancreatic cancer, garnering significant media attention.
• Progress has been made in initiating a second trial of narmafotinib, combining it with FOLFIRINOX chemotherapy in the USA and Australia, with ethics approvals now secured for both regions.
• Dr Jason Lickliter was appointed Chief Medical Officer in May, bringing extensive experience as a medical oncologist and clinical triallist, having advised Amplia since 2021.
• ACCENT trial data was presented for the initial 26-patient cohort at the prestigious American Association of Cancer Research annual meeting in April. • $27.5m capital raise announced in July 2025, funding the company into 2027

Operations Update

Significant developments in the ACCENT trial were achieved over this quarter. In May we reported that we had achieved the key activity threshold of 15 confirmed partial responses (PRs), demonstrating that the combination of our best-in-class FAK inhibitor narmafotinib with chemotherapy was superior to chemotherapy alone. At the time of writing we now have reported 17 confirmed PR’s, which equates to a response rate of 31%, superior to the 23% response rate observed for chemotherapy alone.

In June we announced that two (2) patients from the trial had achieved complete responses. In one patient, the cancer lesions had decreased in size over the course of treatment to become no longer detectable for over a 2-month period. In the second patient, surgical removal of tissue that appeared to be residual tumour was shown by pathology to be non-malignant tissue, meaning that the patient had achieved a pathological complete response. This latter finding is extremely rare in metastatic pancreatic cancer and resulted in significant media attention for the patient and the hospital where the treatment was delivered.

Further progress has been made towards initiation of the second trial of narmafotinib in pancreatic cancer, this time combining the drug with a different chemotherapy called FOLFIRINOX. This trial, to will be conducted in the USA and Australia, is designed to demonstrate that narmafotinib can also improve the response to FOLFIRINOX. In June we announced that ethics approval had been received from the central US Institutional Review Board (IRB), a critical approval required before sites can initiate patient recruitment. We have now also received similar ethics approval for the Australian sites. The first stage of the trial, where different doses of narmafotinib will be trialled in combination with FOLFIRINOX, is due to start imminently.

In May, the Company announced the appointment of Dr Jason Lickliter as Chief Medical Officer. Dr Lickliter is a highly experienced medical oncologist and clinical triallist and joins the Company in a part- time capacity, whilst retaining a CMO role at clinical trials organisation Nucleus Network. Dr Lickliter has been acting in the role of clinical adviser to Amplia since 2021 and has a deep knowledge of our clinical program and data.

In April, the Company presented ACCENT trial data for the initial cohort of 26 patients at the American Association of Cancer Research annual meeting, a highly prestigious cancer meeting that attracts scientists, clinicians and representatives from pharma and biotech from across the globe.

Outlook and future activities

The Company will continue to collect, analyse and report data from the ongoing ACCENT trial over the coming months. Initiation and progression of the FOLFIRINOX and narmafotinib combination trial, being conducted in the USA and Australia, will also be a major focus of the Amplia team. Interactions with regulatory agencies, in particular the US FDA, is also planned in the coming months.

Capital Raise

On 23 July the Company announced a capital raise of $27.5 million (before costs) to support the ongoing clinical activities and additional planned activities, funding the Company into 2027. The capital raise comprises a successful institutional placement raising $25.0 million (before costs) and a Share Purchase Plan seeking to raise an additional $2.5 million. The Placement was strongly supported by existing and new institutional and sophisticated investors in Australia and offshore.

Financial update

Amplia finished the June 2025 quarter with a cash position of $7.0 million (March 2025: $10.9 million).

During the quarter, the Company had net operating cash outflows of $3.8 million in relation to operating activities (March 2025: $2.7 million). Operating cashflows included:

• Outflows of $0.9 million for staff and administration/corporate costs; and • Outflows of $3.0 million for research and development costs, which primarily related to trial costs, Contract Research Organisation (CRO), manufacturing and other CMC related costs incurred in relation to the ACCENT Phase 2 clinical trial for narmafotinib (AMP945) with gemcitabine and Abraxane and initiation costs with its AMPLICITY Phase 2 study clinical trial for narmafotinib (AMP945) with FOLFIRINOX.

The Company is also expecting to receive its Research and Development Tax Incentive refund for the year ended 31 March 2025 of $3.8m in the September 2025 quarter.

On July 31, 2025 Starpharma (ASX: SPL, US OTC: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its Quarterly Activities Report and Appendix 4C for the quarter ended 30 June 2025 (Q4 FY25) (Press release, Starpharma, JUL 31, 2025, View Source;mc_eid=bf52dd3418 [SID1234654648]).

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Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"Over the past year, we have made meaningful progress across our strategic initiatives, aimed at maximising DEP asset value, accelerating early asset development, and building long-term sustainability. Our primary focus has been on out-licensing Starpharma’s clinical-stage DEP assets, establishing new research partnerships to leverage Starpharma’s dendrimer platform technology, increasing revenue from our marketed products, and enhancing the depth our intellectual property portfolio.

"We are pleased to report a $3.1 million increase in underlying customer receipts this financial year, driven by sales of the Viraleze and VivaGel BV products and Petalion research revenue. We have made notable strides with our research partners and expanded our collaborative model through the strategic Star Navigator program. Our radiotheranostics program is also advancing, and we are diligently making important decisions to shape the future of this program effectively.

"This year has not been without its challenges, particularly given the complex geopolitical environment we are navigating. We have actively sought feedback and technical expertise from global conferences, FDA engagement, key opinion leaders, and extensive interactions with investors and international companies. These efforts and learnings are continuously being integrated with our core strategy.

"Looking ahead to FY26, our approach is rigorous and focused on strategic execution, aiming to develop assets with unparalleled commercial potential. We are dedicated to achieving tangible outcomes and delivering value for our shareholders by realising the full potential of Starpharma’s dendrimer platform in collaboration with partners, and through our internal drug discovery and development efforts. Restoring value for our investors remains a top priority. Starpharma’s platform technology presents multiple opportunities for value creation, and we are confident that the progress made in FY25 has laid the groundwork for a successful year ahead."

Maximising DEP Asset Value

In FY25, our top priority was the out-licensing of Starpharma’s clinical-stage assets, DEP SN38 and DEP cabazitaxel, and throughout the year we have committed extensive internal and external resources to achieving this. We have engaged considerably with small to large-size companies, which have shown interest in the DEP assets. The licensing process has taken longer than anticipated, which we attribute to a range of factors including the evolving oncology landscape shifting towards targeted treatment options and the current geo-political environment, which has impacted the biotechnology industry at large. We remain confident in the potential of these assets and the benefits of the DEP technology highlighted by the available clinical data, and are committed to securing partnerships, employing both internal and external resources.

Starpharma engaged with global biotechnology and pharmaceutical stakeholders at the 2025 BIO International Convention in Boston in June. Starpharma’s business development team actively promoted the company’s innovative DEP platform, highlighting the technology’s potential to provide therapeutic and commercial value in oncology and next-generation therapeutics. During the conference, Starpharma initiated and advanced discussions for potential collaborations and licensing opportunities for Starpharma’s clinical-stage assets, as well as for its commercial products VivaGel BV and Viraleze. With over 20,000 attendees focused on business development and strategic alliances, Starpharma’s presence at this high-profile event provided a valuable platform to showcase its leadership and technical capabilities in dendrimer-based drug delivery and platform innovation. The company also gained important insights into evolving industry needs and emerging healthcare opportunities, all of which help shape Starpharma’s business development strategy and R&D priorities.

Accelerating Early Asset Development

Starpharma is strategically intensifying its focus on enhancing its internal pipeline with novel assets that offer innovation, high commercial potential and a strong competitive advantage. Advancing our radiotheranostics program towards the clinic and exploring other emerging therapeutic areas with potential for significant commercial opportunity are integral to our plans for FY26. By doing so, we aim to better position ourselves for successful partnerships, delivering significant value to our shareholders and advancing our mission to improve patient outcomes through our platform dendrimer technology.

DEP radiotheranostics program

Starpharma is continuing to develop and optimise its DEP radiotheranostics assets through preclinical studies to guide important decisions that will shape the clinical program, which is planned for 2026. Alongside the preclinical program, Starpharma is continuing to identify and engage with potential clinical trial sites, and key opinion leaders in the radiopharmaceuticals field, while connecting with and gathering input and insights into radiotheranostic delivery challenges and needs from potential partners.

During the quarter, Starpharma’s business development team participated in the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in the US. SNMMI is one of the industry’s most influential conferences related to radiopharmaceuticals. Participation in this event enabled Starpharma to connect with global stakeholders and gather valuable insights in the rapidly evolving field of radiopharmaceuticals. These interactions help inform and shape our DEP radiopharmaceuticals program, ensuring that our development pathway aligns with clinical needs and commercial opportunities.

Research collaborations

Alongside advancing existing partnerships this quarter, Starpharma established preliminary research programs with two new potential collaborators through its Star Navigator program. These strategic initiatives aim to explore the potential applications of Starpharma’s proprietary dendrimer technology in emerging therapeutic areas. Should these collaborations prove successful, they may evolve into formal research partnerships, potentially adding significant value to the company’s portfolio.

By providing streamlined and efficient pathways for collaboration, Star Navigator enables a broader spectrum of partners, ranging from early-stage researchers to global pharmaceutical companies, to leverage the unique capabilities of Starpharma’s dendrimer technology. This program provides access to the DEP platform, as well as Starpharma’s technical expertise and collaborative frameworks, designed to accelerate and de-risk the process from discovery to development. Expanding Starpharma’s partnership models with the Star Navigator program is a strategic move to unlock new collaboration opportunities and co-develop novel assets, positioning Starpharma for future platform licensing.

Building Long-Term Sustainability

For FY25, underlying customer receipts grew to $4.9 million, a 165% increase on the prior year, excluding the one-time FY24 receipt related to the VivaGel BV exit from Mundipharma. This result highlights our strategic focus on building sustainable revenue growth.

This quarter, Starpharma received payment for the first delivery of Viraleze to Etqan & Nazahah LLC (E&N), kickstarting the product’s expansion into the Saudi Arabian market. E&N’s phased distribution plan, already in motion, will target a wide array of channels, including chain and hospital pharmacies, e-pharmacies, and major retailers.

During the quarter, Starpharma signed a distribution agreement with Synmosa, a Taiwan-based pharmaceutical company, for VivaGel BV distribution in the Philippines, Malaysia, and Singapore. Synmosa’s established presence in women’s health will position VivaGel BV well in these markets. Starpharma is now working with Synmosa to transfer the product registrations for these territories to Synmosa.

Q4 FY25 Financial Summary

Starpharma’s cash balance at 30 June 2025 was $15.4 million. Customer receipts reached $2.0 million this quarter, a 51% increase from the prior quarter (Q3 FY25), driven by sales of the Viraleze and VivaGel BV products.

Net operating cash outflows for the quarter were $2.0 million, including research and development (R&D) costs of $1.8 million and staffing costs of $2.0 million. The company is anticipating an inflow of ~$3.5 million under the Australian Government’s R&D Tax Incentive scheme in H1FY26.

For the full FY25, customer receipts were $4.9 million, up 165% on an underlying basis compared to FY24. Cash operating payments for FY25 of $18.2 million were lower than FY24 payments of $24.2 million due to the completion of the DEP clinical programs and cost reduction initiatives for administration and corporate costs. These financial results reflect Starpharma’s focus on resource management and its ongoing commitment to sustainable business operations.

Staffing costs for the quarter included payments to non-executive and executive directors of $269,000. Other related party payments included service fees of $1,000 to CBE Pure Solutions Pty Ltd, where Starpharma non-executive director Dr Jeff Davies is also a director and shareholder.

Based on Starpharma’s 4C, which is appended, the company’s cash balance of $15.4 million at 30 June 2025 represents 7.7 quarters of funding. Starpharma remains sharply focused on increasing revenue through product sales and licencing agreements, and optimising resource management to improve shareholder value and deliver on our long-term sustainability goals. Through disciplined cost management and a clear strategy to monetise Starpharma’s portfolio and dendrimer platform technology, the company is well-positioned to deliver on its strategy in the year ahead.

On July 31, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno- oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 June 2025 (Press release, Imugene, JUL 31, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0d0ee6a1-bf9b-f0a7-5414-bc82a36b02ed/IMU_Quarterly_ActivitiesAppendix_4C_Cash_Flow_Report.pdf [SID1234654647]).

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CLINICAL UPDATES

Two Additional Complete Responses and Three Partial Responses in azer-cel CAR T Phase 1b trial

Subsequent to the end of the quarter, Imugene reported further encouraging clinical results from its Phase 1b trial of azer-cel (azercabtagene zapreleucel), an allogeneic "off- the-shelf" CD19-targeting CAR T therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Since the Company’s last update in February 2025, five additional patients have been treated in the trial. Of these, two achieved complete responses (CRs), defined as the disappearance of all signs of cancer, and three achieved partial responses (PRs), where tumours reduced in size by at least 50%. This brings the trial’s total best response rate to six complete responses and three partial responses bringing the overall response rate (ORR) to nine out of twelve patients, corresponding to a 75% ORR and a 55% CR rate.

The first patient treated remains cancer-free 15 months after dosing, while others have sustained responses for periods of greater than 2, 5, and 11+ months. The response durability continues to mature as more data accumulates. These patients had previously failed at least three, and in some cases up to six, prior lines of therapy, including autologous CAR T-cell therapies highlighting the potential of azer-cel in a high unmet- need population that has exhausted conventional treatment options.

Unlike currently approved autologous CD19 CAR T cell products, which require patient- specific manufacturing and face logistical limitations, azer-cel is designed as an allogeneic (donor-derived), off-the-shelf therapy that could significantly improve access and treatment timelines. Patients in this study are treated with a combination of lymphodepletion, azer-cel, and interleukin-2 (IL-2), a cytokine known to enhance CAR T- cell function and longevity.

Given the strength of the data and the FDA Fast Track Designation already granted for DLBCL, Imugene intends to meet with the US Food and Drug Administration in Q4 CY25 for a Type B (End of Phase 1) meeting. This interaction will focus on discussing the design of a pivotal or registrational trial that could lead to market approval.

In parallel with these developments, the azer-cel trial will now expand its scope to include other B-cell lymphomas in CAR T-naïve patients (those who have not previously received CAR T therapy). These include rare and underserved cancers such as primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and Waldenström macroglobulinemia (WM). Each of these indications currently suffers from limited treatment options in the relapsed/refractory setting, especially in patients who are ineligible for or unresponsive to existing therapies.

The trial is ongoing across ten sites in the United States, with up to six Australian sites planned.

First dose level cleared in IV combination arm of Phase 1 onCARlytics trial

In April, the Company announced the clearance of the first dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics clinical trial, known as OASIS. This milestone followed the successful completion of the initial safety observation period and allows the study to progress to the next dose level.

The OASIS trial is a first-in-human study targeting adult patients with advanced or metastatic solid tumours. Its aim is to evaluate both the safety and efficacy of two administration routes; intratumoural (IT) and intravenous (IV), for delivering the onCARlytics therapy. This therapy uses an engineered oncolytic virus (CF33-CD19) to make solid tumours express the CD19 protein, a well-validated target in blood cancers. By enabling CD19 expression in solid tumours, the trial seeks to make them susceptible to treatment with existing CD19-targeted therapies, such as the bispecific monoclonal antibody blinatumomab (Blincyto), which is used in combination with onCARlytics in this trial.

MAST Phase 1 Trial for VAXINIA in Bile Tract Cancer

The Metastatic Advanced Solid Tumours (MAST) trial evaluating CF33-hNIS (VAXINIA) continues to support the potential clinical benefit of our oncolytic virotherapy.

The expansion cohort has completed its first group of three patients without any dose- limiting toxicities, and the cohort remains open. The FDA has granted Orphan Drug Designation (ODD) for VAXINIA in biliary tract cancer, providing a range of regulatory and financial incentives to support ongoing development and potential partnering opportunities.

First Patient Dosed in Australia for PD1-Vaxx Neo-POLEM Phase II trial

In June, the first patient was dosed in Australia at the Queen Elizabeth Hospital in Adelaide as part of the Phase II Neo-POLEM clinical trial investigating its PD1-Vaxx immunotherapy. This investigator-sponsored trial is focused on patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer, a subtype representing approximately 15% of all colorectal cancer cases.

Neo-POLEM is a neoadjuvant study, meaning treatment is administered prior to surgery. The trial is evaluating the potential of PD1-Vaxx, a therapeutic cancer vaccine designed to elicit an immune response against the PD-1 checkpoint protein to improve treatment outcomes in patients with early-stage, resectable disease. The vaccine aims to activate the patient’s immune system to target and reduce tumours before surgery is performed.

The trial is being conducted in collaboration with the Cancer Research UK Southampton Clinical Trials Unit, Royal Surrey Hospital NHS Foundation Trust, and the Australasian Gastro-Intestinal Trial Group (AGITG). Recruitment will span both Australia and the United Kingdom.

The study’s primary objective is to assess major pathological response, specifically tumour reduction post-treatment. Secondary objectives include evaluating safety, identifying biomarkers of immune response, and measuring overall response and survival outcomes.

PATENT PROTECTIONS

US patent issued for onCARlytics

Imugene received a Notice of Allowance from the United States Patent and Trademark Office for its patent application covering the onCARlytics platform. The patent, titled "Oncolytic Virus Expressing a CAR T Cell Target and Uses Thereof," protects both the composition and method of use of the Company’s CD19-expressing oncolytic virus technology. Subsequent to the end of the quarter, Imugene received notice of issue from the USPTO with a patent term extension of 110 days resulting in protection until November 28, 2038.

PD1-Vaxx patent portfolio further strengthened

In June 2025, the PD1-Vaxx cancer vaccine patent portfolio was further strengthened after receiving a Notice of Grant from the US Patent and Trademark Office (USPTO) confirming that US patent application no. 16/966442 has now issued as a patent. The official patent number is 12311019. The patent entitled "Vaccine Composition and Uses Thereof" received a 1110 day patent term extension from the USPTO meaning the patent is in force until February 2042.

On July 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 half year 2025 results and provided a second quarter business update (Press release, argenx, JUL 31, 2025, View Source [SID1234654645]).

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"We continue to make meaningful progress towards our Vision 2030, advancing bold innovation that has already reached more than 15,000 patients globally" said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "VYVGART is delivering strong growth across all indications, formulations and regions. We are still in the early stages of capturing the full market opportunity in MG and CIDP, with the recent launch of the VYVGART SC prefilled syringe driving demand from new patients and prescribers. In MG, we are shaping the market as the fastest growing biologic, moving earlier in the patient treatment paradigm, and working toward the broadest possible label. In CIDP, we continue to see consistent patient growth, with ample runway to reach the 12,000 patients in the U.S. who remain inadequately controlled on standard of care. This is just the beginning of the larger growth opportunity ahead. With six registrational and six proof-of-concept readouts expected by the end of 2026, we are executing on our proven innovation playbook that is delivering pipeline-in-a-product opportunities aimed at transforming care for patients with high unmet need."

Advancing Towards Vision 2030

argenx has established its strategic priorities to advance Vision 2030, aiming to treat 50,000 patients globally with its medicines, secure 10 labeled indications across all approved medicines, and advance five pipeline candidates into Phase 3 development by 2030.

Expand global VYVGART opportunity and launch VYVGART SC as prefilled syringe

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) globally, primary immune thrombocytopenia (ITP) in Japan, and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S., Japan, China, and the EU. The VYVGART-SC prefilled syringe (PFS) is now approved for use in the U.S. and EU.

Generated global product net sales (inclusive of both VYVGART and VYVGART SC) of $949 million in the second quarter of 2025
Strong underlying fundamentals across key patient and prescriber metrics with 97% operational growth in product net sales year-over-year from second quarter 2024, and 19% from the first quarter of 2025
First patient dosed in Germany following European Commission (EC) approval for VYVGART-SC (vial and PFS) for CIDP
PFS decision on approval for gMG and CIDP expected in Japan and Canada by end of year
Evidence generation through label-enabling studies:

Topline results expected in second half of 2025 for seronegative gMG (ADAPT-SERON) and first half of 2026 for ocular MG (ADAPT OCULUS)

Topline results expected in second half of 2026 to support FDA submission of VYVGART IV for primary ITP (ADVANCE-NEXT)
Execute 10 registrational and 10 proof-of-concept studies across efgartigimod, empasiprubart and ARGX-119 to advance the 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 across 15 severe autoimmune diseases, highlighting the broad potential of FcRn biology in neurology, rheumatology, and beyond.

Registrational studies are currently ongoing in idiopathic inflammatory myopathies (IIM or myositis), thyroid eye disease (TED), 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 two registrational UplighTED studies (TED) expected in second half of 2026
Topline results from registrational UNITY study (Sjögren’s disease) expected in 2027
Proof-of-concept studies ongoing in lupus nephritis (LN), systemic sclerosis (SSc) and antibody mediated rejection (AMR); topline results expected for LN in fourth quarter of 2025, SSc in second half of 2026, and AMR in 2027

Empasiprubart Development

Empasiprubart, a first-in-class, humanized, monoclonal antibody that specifically binds to C2, is currently being evaluated in four indications. These include registrational studies in multifocal motor neuropathy (MMN) and CIDP, and proof-of-concept studies in delayed graft function (DGF) and DM.

Topline results from registrational EMPASSION study (MMN) evaluating empasiprubart head-to-head versus IVIg expected in second half of 2026
Registrational EMVIGORATE study ongoing in CIDP evaluating empasiprubart head-to-head versus IVIg
Topline results expected for DGF in the second half of 2025 and for DM in first half of 2026

ARGX-119 Development

ARGX-119, a first-in-class agonist antibody that targets muscle-specific kinase (MuSK), is being evaluated in congenital myasthenic syndromes (CMS), amyotrophic lateral sclerosis (ALS), and spinal muscular atrophy (SMA).

Registrational study to start in CMS in 2026 following positive Phase 1b proof-of-concept data
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 year
ARGX-119 R&D webinar to be hosted on September 16, 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 results from ongoing ARGX-109 study expected in second half of 2025, and from ongoing ARGX-213 and ARGX-121 studies expected in first half of 2026
Entered strategic collaboration with Unnatural Products (UNP) to expand argenx discovery capabilities into the oral peptide space. This partnership reinforces argenx’s commitment to enhance the patient experience and advance its pipeline of precision therapies.

SECOND QUARTER 2025 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Six Months Ended
30 June, 30 June,
(in thousands of $ except per share data) 2025 2024 2025 2024
Product net sales $ 948,594 $ 477,635 $ 1,738,644 $ 875,918
Other operating income* 18,593 11,793 35,913 26,023
Total operating income $ 967,187 $ 489,428 $ 1,774,557 $ 901,941

Cost of sales $ (110,747) $ (52,383) $ (191,552) $ (95,561)
Research and development expenses (327,697) (225,286) (636,767) (450,255)
Selling, general and administrative expenses (324,902) (255,699) (601,150) (491,694)
Loss from investment in a joint venture (2,780) (1,521) (5,087) (3,313)
Total operating expenses $ (766,126) $ (534,889) $ (1,434,556) $ (1,040,823)

Operating profit/(loss) $ 201,061 $ (45,461) $ 340,001 $ (138,882)

Financial income $ 38,399 $ 38,933 $ 75,517 $ 77,828
Financial expense (1,126) (572) (2,261) (1,084)
Exchange gains/(losses) 48,565 (7,903) 76,003 (27,215)

Profit/(Loss) for the period before taxes $ 286,899 $ (15,003) $ 489,260 $ (89,353)
Income tax (expense)/benefit $ (41,541) $ 44,069 $ (74,433) $ 56,822
Profit/(Loss) for the period $ 245,358 $ 29,066 $ 414,827 $ (32,531)
Profit/(Loss) for the period attributable to:
Owners of the parent $ 245,358 $ 29,066 $ 414,827 $ (32,531)
Weighted average number of shares used for basic profit/(loss) per share 61,084,250 59,490,437 61,034,202 59,400,217
Basic profit/(loss) per share (in $) 4.02 0.49 6.80 (0.55)
Weighted average number of shares used for diluted profit/(loss) per share 65,639,446 63,893,007 65,653,007 59,400,217
Diluted profit/(loss) per share (in $) 3.74 0.45 6.32 (0.55)
*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 six months ended June 30, 2025, was $967 million and $1,775 million, respectively, compared to $489 million and $902 million, respectively, for the same periods in 2024, and mainly consists of:

Product net sales of VYVGART and VYVGART SC for the three and six months ended June 30, 2025, were $949 million and $1,739 million, respectively, compared to $478 million and $876 million, respectively, for the same periods in 2024.

Other operating income for the three and six months ended June 30, 2025, was $19 million and $36 million, respectively, compared to $12 million and $26 million, respectively, for the same periods in 2024. The other operating income for the three and six months ended June 30, 2025 and 2024, primarily relates to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and six months ended June 30, 2025 were $766 million and $1,435 million, respectively, compared to $535 million and $1,041 million, respectively, for the same periods in 2024, and mainly consist of:

Cost of sales for the three and six months ended June 30, 2025, was $111 million and $192 million, respectively, compared to $52 million and $96 million for the same periods in 2024, respectively. The cost of sales was related to the sale of VYVGART and VYVGART SC.
Research and development expenses for the three and six months ended June 30, 2025, were $328 million and $637 million, respectively, compared to $225 million and $450 million, respectively, for the same periods in 2024. The research and development expenses mainly relate to:
the clinical development and expansion of efgartigimod in 15 severe autoimmune diseases;
the ramp-up of studies for the development of empasiprubart into MMN, DGF, DM and CIDP;
the investments for ARGX-119 in proof-of-concept studies ongoing in ALS, CMS and SMA; and
other discovery and preclinical pipeline candidates.
Selling, general and administrative expenses for the three and six months ended June 30, 2025, were $325 million and $601 million, respectively, compared to $256 million and $492 million, respectively, for the same periods in 2024. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of VYVGART franchise, and personnel expenses.

Financial income for the three and six months ended June 30, 2025, was $38 million and $76 million, respectively, compared to $39 million and $78 million, respectively, for the same periods in 2024.

Exchange gains for the three and six months ended June 30, 2025, were $49 million and $76 million, respectively, compared to $8 million and $27 million, respectively, of exchange losses for the same periods in 2024. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets denominated in Euro.

Income tax for the three and six months ended June 30, 2025 and 2024 is detailed below:

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $) 2025 2024 2025 2024
Current tax (expense)/benefit $ (41) $ (9) $ (70) $ (16)
Deferred tax (expense)/benefit (1) 53 (4) 72
Income tax (expense)/benefit $ (42) $ 44 $ (74) $ 57
Profit for the three- and six-month periods ended June 30, 2025, was $245 million and $415 million, respectively, compared to a profit of $29 million and a loss of $33 million, respectively, for the same periods in 2024. The basic profit per share was $4.02 for the three months ended June 30, 2025, compared to a basic profit per share of $0.49 for the same period in 2024. The basic profit per share was $6.80 for the six months ended June 30, 2025, compared to a basic loss per share of $0.55 for the same period in 2024.

Cash flow from operating activities for the six months ended June 30, 2025 was $362 million compared to a cash flow used in operating activities for the same period in 2024 of $126 million.

FINANCIAL GUIDANCE

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

EXPECTED 2025 FINANCIAL CALENDAR

October 30, 2025: Third Quarter 2025 Financial Results and Business Update
February 26, 2025: Full-year 2025 Financial Results and Fourth Quarter 2025 Business Update

CONFERENCE CALL DETAILS

The half-year 2025 financial results and second 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.