On July 30, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported an update on its activities for the quarter ended 30 June 2026 (Q4 FY26).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EFTILAGIMOD ALFA SYSTEMATIC EVALUATION

In May 2026, Immutep announced results from a systematic evaluation of five clinical trials of eftilagimod alfa (efti) in combination with standard-of-care (SOC) therapies in cancer patients, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting1.

The analysis included 592 patients across five independent studies (TACTI-mel, TACTI-002, TACTI-003, AIPAC, and AIPAC-003) spanning four cancer indications (NSCLC, HNSCC, metastatic breast cancer, and melanoma).

Treatment with 30 mg subcutaneous efti plus SOC in these trials resulted in a significant increase in circulating absolute lymphocyte count (ALC), a blood-based measure of immune activity, which was not seen with SOC alone.

Increased ALC was significantly associated with improved clinical outcomes, with ALC responders in the efti plus SOC group showing a clinically meaningful median overall survival (OS) improvement of 7.7 months compared to non-responders (p=0.0017). These effects were observed across tumour types and were independent of the combination partner.

The analysis did not include data from the TACTI-004 study, as immune data collection for that trial had not been completed at the time of the analysis.

LUNG CANCER

TACTI-004 (KEYNOTE-F91) – Phase III Trial in 1L NSCLC

In March 2026, Immutep announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating efti in patients in 1st line non-small cell lung cancer (1L NSCLC) had recommended the discontinuation of the trial following a planned interim futility analysis in accordance with the study protocol.

In response to the IDMC’s recommendation, enrolment in TACTI-004 was halted and Immutep is continuing an orderly wind-down of the study, including appropriate patient follow-up and site close-out.

Immutep is also continuing its thorough review of available data to understand the factors behind the futility outcome, including manufacturing aspects. This root cause analysis is ongoing in Q3 CY 26, as it is dependent on data availability and logistics, and covers TACTI-004 database lock, statistical analysis, and laboratory data review.

Dr. Reddy’s Laboratories Ltd. ("Dr. Reddy’s"), a licensing partner for efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis.

Subsequent to quarter end, Immutep provided an update on aspects of the root cause analysis. In the interim futility analysis (N=173), the objective response rate was 42.9% in the efti arm compared with 55.1% in the control arm, with no superiority observed in any PD-L1 subgroup. Pending final analysis, no new safety signals have been observed. Preliminary immune-monitoring data indicated that patients treated with efti in TACTI-004 showed a different immune-activation profile, with lower circulating lymphocyte and monocyte counts, compared with prior efti studies. While no conclusive causal factor has been established to date, the ongoing analysis is expected to provide further insights, with additional results anticipated in Q3 CY26.

INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC

Patients in the investigator-initiated INSIGHT-003 Phase I trial, in which dosing is now complete, continue to be followed up.

In this study, the combination of efti with KEYTRUDA and chemotherapy has generated strong objective response rates (ORR) and disease control rates (DCR) in 51 evaluable patients with advanced or metastatic non-squamous 1L NSCLC across all PD-L1 expression levels2.

Subsequent to the end of the quarter, Immutep announced mature overall survival (OS) results from INSIGHT-003 (data cut-off 27 March 2026). Median OS was 30.9 months in the overall population (N=51) and in patients with PD-L1 TPS <50% (N=47). Approximately 92% of patients had no or low PD-L1 expression (PD-L1 TPS <1 or PD-L1 TPS 1-49).

These single-arm Phase I results compare favourably with historical benchmarks.

SOFT TISSUE SARCOMA

EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma

The investigator-initiated EFTISARC-NEO Phase II trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary objective, with patients showing strong immune system activation in line with efti’s mode of action, including statistically significant increases in the expression of key cytokines and chemokines in peripheral blood. Patients are continuing to be followed up for disease-free survival.

In April 2026, Immutep announced that it had been granted orphan drug designation for efti in this setting from the FDA.

An abstract containing health-related quality of life (HRQoL) data from the EFTISARC-NEO trial has been accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in October 2026. Consistent with the congress’ embargo policy, the data will be made available by the investigator at the time of presentation.

BREAST CANCER

AIPAC-003 – Phase II Trial in Metastatic Breast Cancer

The AIPAC-003 Phase II trial, evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2 negative/low metastatic breast cancer that is resistant to endocrine-based therapy, as well as in metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy, has been completed. The last patient follow-up visit occurred during the quarter and the trial was accordingly closed effective 30 June 2026.

Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer

As previously announced, a proposed investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and in combination with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer remains on hold pending completion of the root cause analysis related to TACTI-004.

IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE

IMP761 – Phase I Trial

In June 2026, Immutep presented positive interim data from its placebo-controlled, double-blind, randomized, first-in-human Phase I study evaluating IMP761, a first-in-class LAG-3 agonist antibody, at the EULAR 2026 Congress in London.

The single ascending dose part of the study met its primary endpoint, demonstrating favourable safety and tolerability in healthy volunteers, with IMP761 well tolerated across all dose levels tested.

The data also showed statistically significant pharmacodynamic activity, including reduced local inflammatory responses and attenuated T-cell activity compared to placebo, with the 7 mg/kg dose achieving a statistically significant inhibition in skin blood perfusion (p = 0.029).

The pharmacokinetic profile supports once-every-four-weeks dosing. These encouraging results support further clinical evaluation of IMP761 in autoimmune diseases driven by T-cell-mediated inflammation, such as rheumatoid arthritis, with additional trial updates expected in H2 CY26.

INTELLECTUAL PROPERTY

During the quarter, Immutep was granted seven patents.

Four patents were granted directed to an assay for use in measuring the potency of IMP761 as part of a quality control step in production of the agonist LAG-3 antibody. The patents were granted in China, Hong Kong, South Korea, and Canada. A new patent was also granted in Indonesia directed to IMP761.

New patents were also granted during the quarter in the United States and Israel directed to LAG525 (ieramilimab), jointly owned by Immutep S.A.S. and Novartis AG. Subsequent to quarter end, Novartis gave notice terminating the out-license agreement relating to ieramilimab after years of clinical inactivity, effective 9 August 2026. The license is not generating revenue for Immutep and no further milestone or royalty payments are anticipated. Under the terms of the agreement, following termination Novartis is required to assign its ownership interest in the jointly owned LAG-3 patents arising under the collaboration to Immutep S.A.S.

LEGAL PROCEEDINGS

Following the announcement on 13 March 2026 regarding the discontinuation of the TACTI-004 Phase III trial, one putative securities class action was filed in the United States but not served. After the Company sent a Rule 11 letter to the plaintiff, the suit was dismissed voluntarily.

FINANCIAL SUMMARY

During the quarter, Immutep continued to exercise prudent cash management, particularly in light of the TACTI-004 Phase III discontinuation.

The Company is well funded with cash and cash equivalents, and term deposit balance as at 30 June 2026 of approximately A$68.87 million, which is A$29.2 million greater than the FY2026 budget.

The total balance consists of 1) a cash and cash equivalent balance of A$63.67 million and 2) bank term deposits totaling A$5.20 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months.

In Q4 FY26, cash receipts from customers were A$13K, which is mainly due to research material sales. For the very first time the Company also received A$218K (EUR 133K) under Germany’s R&D tax incentive program (Forschungszulage) in relation to eligible R&D activities undertaken in FY22. The Forschungszulage is Germany’s statutory research tax incentive under the Forschungszulagengesetz (FZulG). Under the current regime, eligible companies may claim a tax credit of up to 35% (25% before 28 March 2024) of qualifying internal R&D personnel costs. The timing of receipt of Forschungszulage payments may differ significantly from the period in which the related R&D expenditure is incurred due to the statutory application, assessment and review process. The FY2022 claim was the Company’s first claim under the program and was subject to a detailed review. The allowance is a non-dilutive source of funding for the Company’s German R&D operations (conducted through Immutep GmbH).

The net cash used in G&A activities in the quarter was A$1.5 million compared to A$0.9 million in Q3 FY26. In respect of the US$20 million upfront eftilagimod license fee received from Dr. Reddy’s in January 2026, US$2.7 million (A$4.1 million3) was recognised as revenue and US$17.3 million (A$25.8 million4) as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following discontinuation of TACTI-004, Immutep repaid US$10 million to Dr. Reddy’s in June 2026, reducing unearned revenue accordingly, with the remaining US$7.3 million fully recognised as revenue for the financial year ended 30 June 2026. As previously disclosed, Dr. Reddy’s holds exclusive rights to develop and commercialise efti in the licensed territories, while Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan. Immutep also remains eligible for up to US$349.5 million in potential milestones along with royalties on commercial sales, and retains global manufacturing rights.

Net cash used in R&D activities was A$22.0 million for the quarter, compared with A$11.8 million in Q3 FY26, with the increase primarily reflecting higher payments relating to TACTI-004. Although the Company took immediate action following the discontinuation of TACTI-004 in March 2026, trial activity only began to slow from May 2026, with close-out and root cause analysis activities continuing through the quarter. As invoices are generally payable approximately one month after issue, TACTI-004 payments in Q4 FY26 were approximately A$8 million higher than in Q3 FY26. These payments are expected to decline significantly in subsequent quarters.

Payment for staff costs was A$2.5 million in the quarter, compared to A$2.6 million in Q3 FY26. Total net cash outflows used in operating activities in the quarter were A$38.9 million compared to net cash inflow from operating activities of A$13.5 million in Q3 FY26.

Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$336K.

Total net cash inflow received in investing activities for the quarter was A$21.1 million, which is mainly due to the net decrease of short-term investments. The short-term investments are comprised of term deposits with maturities of greater than 3 months and less than 12 months. During the quarter, the Company transferred back A$21.1 million from short-term investments that had matured to cash at bank.

After the TACTI-004 Phase III futility outcome, the Company has initiated cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions, most of which will become effective following the end of FY26. The discontinuation of TACTI-004 also precipitates a reduction in cash outlays due to the trial activity being wound down. At the time of preparing this report, the Company expects its cash runway to extend well into H1 of CY28.

(Press release, Immutep, JUL 30, 2026, View Source [SID1234669561])

On July 30, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the second quarter ended June 30, 2026, and provided a review of recent program and corporate developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Completed Type A meeting with the FDA to discuss the CRL for bitopertin in erythropoietic protoporphyria (EPP) and aligned that the Phase 3 APOLLO study, if successful, can serve as the basis for CRL response and could potentially support a traditional approval
Presented updated data from the HELIOS open-label extension trial of bitopertin in EPP at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, demonstrating sustained reductions in protoporphyrin IX (PPIX), significant improvement in light tolerance measures, and favorable longer-term safety
Launched an Expanded Access Program (EAP) for bitopertin in the US and select other geographies, providing eligible patients with EPP and XLP access to treatment prior to a regulatory decision
On track to report APOLLO topline results in Q4 2026 and expect to submit CRL response and receive an FDA decision by mid-2027
APOLLO completed enrollment in March 2026 and enrolled ahead of schedule with a final N of 183

Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Shared updated data from RALLY-MF trial of selcodebart in anemia of myelofibrosis (MF) in oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings, solidifying selcodebart’s differentiated emerging profile in MF. Data showed:
Major anemia response rate of 56% and overall anemia response rate of 72% across evaluable patients
Similar, strong response rates across transfusion cohorts and with or without background JAK inhibitor therapy
Additional data from RALLY-MF anticipated in Q4 2026, with an end-of-Phase 2 meeting with the FDA expected to occur by year-end
Received EU Orphan Drug Designation for selcodebart for the treatment of myelofibrosis
Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027

DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Completed enrollment for RESTORE-PV Phase 2 study in patients with polycythemia vera with initial data expected in Q3 2026
Progressing Phase 1b study in patients with sickle cell disease with initial data expected in Q4 2026

Second Quarter 2026 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $717.7 million as of June 30, 2026, which are expected to fund operational plans into 2029.

Research and Development Expenses: R&D expenses were $46.9 million for the three months ended June 30, 2026, as compared to $46.3 million for the three months ended June 30, 2025. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including the advancement of the selcodebart (DISC-0974) and DISC-3405 clinical studies and drug manufacturing, as well as increased headcount. These increases were partially offset by a decrease in manufacturing costs related to bitopertin and a $10.0 million milestone payment incurred upon initiation of the APOLLO study during the comparative period.

Selling, General and Administrative Expenses: SG&A expenses were $18.1 million for the three months ended June 30, 2026, as compared to $15.1 million for the three months ended June 30, 2025. The increase in SG&A expenses was primarily due to increased headcount.

Net Loss: Net loss was $59.5 million for the three months ended June 30, 2026, as compared to $55.2 million for the three months ended June 30, 2025. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, JUL 30, 2026, View Source [SID1234669560])

On July 30, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the first patients have been dosed in DOC-RM, its Phase 1/2 clinical study evaluating DOC1021 (dubodencel) in patients with refractory melanoma, at City of Hope in Duarte, California, and the University of Alabama at Birmingham (UAB).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This milestone follows the presentation of DOC-RM as a trial-in-progress abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and represents the transition of the program into active clinical evaluation.

"Roughly half of melanoma patients progress after checkpoint inhibition, and the options that follow are defined as much by their toxicity and cost as by their benefit," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "We are encouraged that the first patients have received DOC1021 treatment with no significant acute adverse events, consistent with our glioblastoma and pancreatic trials. We look forward to reporting initial preliminary results from DOC-RM by the end of the year."

DOC-RM is a multicenter Phase 1/2 study (NCT07288112) evaluating safety, immune activity, and preliminary clinical efficacy of DOC1021 in patients with unresectable or metastatic melanoma who have progressed after prior therapies, including anti-PD-1 treatment. Patients receive two courses of DOC1021 in combination with pegylated interferon and an optional booster dose approximately six months later. Primary and secondary endpoints include safety, objective response, circulating tumor DNA (ctDNA), and immune biomarkers measured in tumor and peripheral blood.

"Patients whose melanoma progresses following anti-PD-1 therapy continue to face limited treatment options, highlighting the need for new immunotherapeutic strategies," said Yan Xing, MD, PhD, Associate Professor in the Department of Medical Oncology & Therapeutics Research and Principal Investigator at City of Hope. "DOC1021 is designed to utilize each patient’s own tumor antigens to generate an individualized immune response. We’re excited to evaluate this investigational approach and contribute to the clinical development of DOC1021."

"The design of this trial offers the opportunity to study an investigational dendritic cell immunotherapy without the need for preconditioning chemotherapy or high-dose IL-2," said John Dubay, MD, Assistant Professor in the Department of Medicine, Division of Hematology and Oncology, and Principal Investigator at the University of Alabama at Birmingham. "The ability to administer DOC1021 in an outpatient setting may also help streamline treatment delivery and broaden patient access. We’re pleased to begin treating patients and participating in this important study."

DOC-RM is currently enrolling patients at City of Hope, the University of Alabama at Birmingham, Massachusetts General Hospital, Banner MD Anderson Cancer Center, UT Southwestern, HonorHealth Research Institute, University of North Carolina, and Atlantic Health. The trial is supported by Diakonos Oncology and a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

The study builds on preclinical data demonstrating antitumor activity across multiple tumor models, including B16F10 melanoma. DOC1021 received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma in May 2026.

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy designed to generate a broad, personalized anti-tumor immune response. The therapy combines tumor lysate and amplified tumor-derived mRNA prepared from each patient’s tumor with autologous dendritic cells, enabling presentation of the full spectrum of tumor antigens.

The proprietary double-loading approach mimics the natural immune activation that occurs during viral infection, unlocking a synergistic and robust multi-antigen immune response while targeting the complete repertoire of the cancer antigen pool. Unlike many cell therapies, DOC1021 does not require any molecular modification or genetic engineering of immune cells, lymphodepleting chemotherapy, or high-dose IL-2 for administration, allowing for outpatient administration and broad access through community cancer centers.

Diakonos is currently evaluating DOC1021 in three actively enrolling clinical trials: a Phase 1 pancreatic cancer (NCT04157127), a Phase 2 in glioblastoma (GBM) (NCT06805305), and a Phase 1/2 study in refractory melanoma (NCT07288112) supported by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and unresectable or metastatic cutaneous melanoma. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.

(Press release, Diakonos Oncology, JUL 30, 2026, View Source [SID1234669559])

On July 30, 2026 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS04, a CA242-directed ADC, enabling assessment in a Phase 1 trial in patients with gastrointestinal (GI) cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CA242 is a tumour-specific glycotope which is strongly expressed in a variety of GI cancers including the majority of colorectal (CRC), gastric, pancreatic and biliary tract cancers, and around half of bladder, endometrial and lung cancers, with limited expression in normal tissue.

Previous efforts to target CA242 with ADCs carrying tubulin inhibitor payloads have shown limited clinical efficacy, likely due to inherent resistance of GI cancers to this payload mechanism. In addition, there has been limited success to date with ADCs for the treatment of GI cancers such as those of the colon and stomach with topoisomerase I inhibitors, regardless of the target. There is a need for potent ADCs with differentiated cell-killing mechanisms and directed towards novel targets to enable higher efficacy and to overcome resistance.

IKS04 is a novel CA242-targeting ADC comprising an anti-CA242 humanized antibody and a highly potent pyrrolobenzodiazepine (PBD) prodrug payload. Typically, the use of potent payloads such as PBDs can limit the maximum tolerated dose of ADCs due to systemic adverse events, which in turn limits tumour tissue penetration and efficacy, particularly for high-expression targets such as CA242. This can create an antigen barrier that prevents the drug from penetrating deep into the solid tumour.

Thus, in a first for the ADC field, IKS04 will be co-administered with the unconjugated antibody to tackle the challenge of solid tumour penetration for high potency payloads. This innovative dosing approach is akin to a dosing regimen that is already used in radioimmunotherapy.

Preclinical studies have demonstrated potent activity across a range of GI cancers alongside a favourable therapeutic index – the widest preclinical therapeutic index of any PBD-containing ADC for solid tumours. Anti-cancer activity was further enhanced in high-expressing models by co-administration of IKS04 with the anti-CA242 antibody, validating the IKS04 Regimen.

The concept behind IKS04, including its clinical dosing regimen, is consistent with Iksuda’s general ADC-design approach: selecting the most clinically relevant combination of antibody, conjugation chemistry, linker and payload mechanism to deliver optimal therapeutic index for target and indication. IKS04, like all Iksuda’s ADC programs, incorporates pro-drug technology with tumour-selective activation and release of payload through glucuronide triggers. This design concept, which drives improved tolerability over traditional linkers, has now been clinically validated in Iksuda’s in-clinic ADC programs IKS014, (a HER2-directed ADC containing MMAF), and IKS03, Iksuda’s CD19-directed ADC which also contains the PBD prodrug used in IKS04, and is currently in phase 1 clinical development for B-cell malignancies.

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented:
"This IND clearance for IKS04 and the IKS04 Regimen, is another important step for Iksuda and further validation of our approach to designing and developing innovative ADCs with the optimal clinical calibration for a given target and indication. IKS04 will be Iksuda’s third ADC to enter clinical development, a significant milestone for the company, with IKS014 and IKS03 both currently progressing through Phase 1 studies. This demonstrates the value of our expanding, innovative platforms, and further de-risks the clinical advancement of our novel antibodies, linkers and payloads. We look forward to progressing IKS04 into Phase 1 studies for GI cancers, an area of high unmet need with limited effective treatment options."

Leon Pappas (Massachusetts General Hospital), Investigator, added:
"IKS04 is directed at a novel target in difficult-to-treat GI cancers. The co-administration regimen and PBD payload are a distinctive approach, and the clinical program will investigate whether they can thereby deliver a better balance of efficacy and tolerability. I am excited to see if this approach helps patients as IKS04 progresses through clinical development."

About IKS04

IKS04 is a first-in-class CA242-targeting ADC comprising an anti-CA242 humanized antibody and a highly potent pyrrolobenzodiazepine (PBD) prodrug payload, incorporating LigaChem Bio’s ADC platform technology and which is associated with tumour-selective activation and release of payload and drives improved tolerability over traditional linker formats. IKS04 is IKSUDA’s third ADC program to enter the clinic.

(Press release, Iksuda Therapeutics, JUL 30, 2026, View Source [SID1234669558])

On July 30, 2026 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the first quarter of fiscal year 2026 (April 1, 2026 to June 30, 2026), marking a period of disciplined execution and operational momentum. Takeda leveraged the resilient performance of its core in-line portfolio to support its long-term strategy, advancing commercial launch preparations and driving critical R&D pipeline milestones. With a clear operational trajectory established in the first quarter and under a new operating model, Takeda remains on track to deliver its strategic and financial commitments for the fiscal year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FY2026 First Quarter Highlights

Revenue increased by +10.2% versus the prior-year period on an actual exchange rate (AER) basis and decreased by -0.5% on a Constant Exchange Rate (CER) basis as the negative impact of the loss of exclusivity of VYVANSE was largely offset by growth from core in-line brands.
Core Operating Profit increased by +11.5% on an AER basis and decreased by -0.5% on a CER basis, reflecting continued growth investments supported by the transformation program.
Reported Operating Profit increased by +9.1% on an AER basis.
Core EPS increased by +1.5% at AER and decreased by -11.8% at CER, while Reported EPS decreased by -9.8% YoY.
Adjusted Free Cash Flow amounted to JPY 68.6 billion.
Launch preparations for key late-stage pipeline assets (ORZEYFUL, rusfertide and zasocitinib) are progressing on schedule, with the first approval for ORZEYFUL achieved in China.
FY2026 full-year outlook remains unchanged.
A Capital Markets Day will be held on December 11, 2026, in Tokyo, Japan.
Takeda President and Chief Executive Officer, Julie Kim, commented:
"Our solid performance this quarter marks a good start to the fiscal year and keeps us on track to achieve our full-year targets.

"This quarter’s results reflect our unwavering commitment to financial discipline and the progressing execution of our enterprise transformation. The efficiencies unlocked by this ongoing program are directly fueling our highest priorities in Horizon One in our two-horizon growth strategy: the successful launch of three medicines that have the potential to be blockbuster brands, the advancement of our late-stage pipeline, the enduring resilience of our core in-line portfolio and new capabilities and efficiencies gained through transformation. We look forward to sharing the detailed strategic roadmap for these two growth horizons at our Capital Markets Day in December."

Takeda Chief Financial Officer, Milano Furuta, commented:
"Our first-quarter performance is tracking consistently with management guidance, with the resilience of our core in-line brands largely offsetting our mature portfolio decline, and OPEX savings through the transformation program being strategically reinvested to fund future growth opportunities. Our full-year forecast and guidance remain unchanged."

FINANCIAL HIGHLIGHTS for First Quarter Results ended June 30, 2026

(Billion yen, except percentages and per share amounts)

Item

FY2026 Q1

(Billion JPY)

FY2025 Q1

(Billion JPY)

YoY (AER)

Revenue

1,219.9

1,106.7

+10.2%

Operating Profit

201.4

184.6

+9.1%

Margin

16.5%

16.7%

-0.2pp

Net Profit

113.2

124.2

-8.9%

EPS (Yen)

72

79

-9.8%

Operating Cash Flow

127.6

215.4

-40.8%

Adjusted Free Cash Flow (Non-IFRS)

68.6

190.1

-63.9%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

Item

FY2026 Q1

FY2025 Q1

YoY (AER)

YoY (CER)

Revenue

1,219.9

1,106.7

+10.2%

-0.5%

Operating Profit

358.9

321.8

+11.5%

-0.5%

Margin

29.4%

29.1%

+0.3pp

Net Profit

242.9

237.0

+2.5%

-10.9%

EPS (Yen)

154

151

+1.5%

-11.8%

FY2026 Full-year Forecast and Guidance

There are no changes to the FY2026 forecast and management guidance announced on May 13, 2026.

(Billion yen, except percentages and per share amounts)

Item

FY2026 FORECAST

FY2026 MANAGEMENT
GUIDANCE Core change at CER
(Non-IFRS)

Revenue

4,640.0

—

Core Revenue (Non-IFRS)

4,640.0

Low-single digit % decline

Operating Profit

420.0

—

Core Operating Profit (Non-IFRS)

1,160.0

5% to 8% decline

Net Profit

166.0

—

EPS (Yen)

104

—

Core EPS (Yen) (Non-IFRS)

472

Mid-teens % decline

Adjusted Free Cash Flow (Non-IFRS)

650.0 – 750.0

—

Annual dividend per share (Yen)

204

—

Pipeline Progress Building the Foundation for Future Growth
Takeda’s next-generation growth engine is anchored by three, high-potential, late-stage pipeline assets expected to obtain regulatory approvals in the U.S. and other key regions in the coming year. While this represents a pivotal period of strategic investment and commercial launch execution, Takeda is positioned to deliver tangible milestones over the next 12 to 24 months. By establishing a track record of launch excellence today, Takeda is securing the foundation that will underpin the Company’s sustained, long-term growth and meaningful impact for patients globally.

ORZEYFUL

An orexin receptor agonist with a first-in-class mechanism of action, designed to address the orexin deficiency that causes narcolepsy type 1 (NT1).
The first approval of oveporexton was recently granted in China under the brand name ORZEYFUL.
New drug applications are currently under review in the United States and Japan.
Preparations for the expected launches in the U.S., Japan and China in the second half of the year are well underway.
At SLEEP 2026, Takeda presented Phase 3 clinical trial results for ORZEYFUL demonstrating improvements in daily functioning, cognition and nighttime sleep in patients with narcolepsy type 1.
Rusfertide

A potential first-in-class hepcidin mimetic for the treatment of adults with the blood cancer polycythemia vera (PV).
Demonstrated significant improvements in hematocrit control and phlebotomy reduction for patients with PV in a Phase 3 clinical trial.
Granted Priority Review by the U.S. FDA, Takeda is prepared for a commercial U.S. launch expected in the second half of 2026.
Zasocitinib

A next generation, highly selective and potent TYK2 inhibitor that has demonstrated rapid, durable skin clearance in a convenient once-daily oral pill with no fasting restrictions.
Achieved positive topline results across the primary endpoint and all key secondary endpoints in a head-to-head Phase 3 clinical trial against deucravacitinib.
Achieved consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites in Phase 3 psoriasis studies.
Takeda is making the necessary investments with a view toward regulatory submissions in 2026 and a commercial launch anticipated in the first half of 2027.
Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation with the goal of driving growth and enabling the company to deliver returns to shareholders under its progressive dividend policy. The annual dividend forecast for FY2026 is JPY 204 per share.

Additional Information Regarding FY2026 First Quarter Results
Takeda will host a conference call for investors and analysts on Thursday, July 30, 2026, at 19:00 Japan Time / 6:00 U.S. Eastern Time to discuss its FY2026 first quarter results.

A live webcast of the conference call and the presentation materials will be available in the Investor Relations section of Takeda’s website (www.takeda.com/investors). The presentation materials include details on Takeda’s FY2026 first quarter results, business progress and pipeline updates, as well as definitions of non-IFRS measures.

(Press release, Takeda, JUL 30, 2026, View Source [SID1234669557])