Immutep Quarterly Activities Report Q4 FY26
Rhea-AI Summary
Immutep (NASDAQ: IMMP) reported Q4 FY26 activities, highlighting new clinical, IP and financial developments. A pooled analysis of five efti trials (592 patients, four tumour types) showed increased lymphocyte counts with efti plus standard of care and a 7.7‑month median overall survival benefit for biological responders versus non‑responders.
The TACTI‑004 Phase III 1L NSCLC trial was discontinued after interim futility; efti arm ORR was 42.9% vs 55.1% for control, with no new safety signals and root‑cause work ongoing. INSIGHT‑003 reported median OS of 30.9 months, EFTISARC‑NEO met its primary immune‑activation objective and efti received FDA orphan drug designation in soft tissue sarcoma. First‑in‑human IMP761 data met its primary safety endpoint and showed significant pharmacodynamic activity. Immutep ended the quarter with A$68.87 million in cash, cash equivalents and term deposits, has implemented cost‑reduction measures, and expects its cash runway to extend into H1 CY28.
Positive
- Pooled efti analysis: 7.7‑month median OS improvement for ALC responders across four tumour types
- INSIGHT‑003 1L NSCLC: median overall survival 30.9 months in 51‑patient population
- EFTISARC‑NEO: Phase II neoadjuvant STS trial met primary immune‑activation objective; efti granted FDA orphan drug designation
- IMP761 Phase I: met primary safety endpoint with statistically significant pharmacodynamic activity and Q4W dosing‑supportive PK profile
- IP expansion: seven patents granted globally, including new protection for IMP761 and LAG525 assets
- Cash position: A$68.87m at 30 June 2026, A$29.2m above FY26 budget; runway expected into H1 CY28
- Dr. Reddy’s license: US$7.3m recognised as FY26 revenue; Immutep remains eligible for up to US$349.5m in milestones plus royalties and retains global manufacturing rights
Negative
- TACTI‑004 Phase III: trial discontinued after interim futility; ORR 42.9% (efti) vs 55.1% (control), with no superiority in any PD‑L1 subgroup
- Repayment to Dr. Reddy’s: US$10m of upfront license fee repaid in June 2026, reducing unearned revenue
- R&D cash outflow: A$22.0m net cash used in R&D in Q4 FY26 vs A$11.8m in Q3, mainly from TACTI‑004 payments
- Operating cash flow: A$38.9m net cash outflow from operating activities in Q4 FY26 vs A$13.5m inflow in Q3
- Cost‑cutting: targeted headcount and operating expense reductions initiated following TACTI‑004 discontinuation
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 24 | ESMO abstract acceptance | Neutral | -2.0% | EFTISARC-NEO quality-of-life abstract accepted for ESMO Congress 2026 presentation |
| Jul 14 | U.S. patent grant | Positive | -3.9% | Fourth U.S. patent granted for efti combinations with PD-1 pathway inhibitors |
| Jul 13 | Clinical update | Positive | +7.5% | INSIGHT-003 reported mature overall survival results alongside TACTI-004 futility analysis |
| Jun 04 | Phase I data | Positive | -4.5% | IMP761 met its safety endpoint and showed significant pharmacodynamic activity |
| May 28 | Pooled clinical data | Positive | +2.3% | Pooled efti analysis linked immune activation with improved overall survival |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive clinical and development updates produced mixed outcomes, with two aligned gains and two divergent declines.
Key Terms
lag-3 agonist antibody medical
pharmacodynamic activity medical
pharmacokinetic profile medical
orphan drug designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Media Release
- Pooled analysis of five efti trials (presented at ASCO 2026) reinforced efti's mechanism of action, tying immune activation to a 7.7-month median overall survival benefit in biological responders across four tumour types.
- IMP761, the only LAG-3 agonist antibody in clinical development, delivered encouraging first-in-human results (presented at EULAR 2026), meeting its primary safety endpoint and showing significant pharmacodynamic activity.
- Investigation into the futility outcome from TACTI-004 continues with an update expected in Q3 CY26, spanning clinical, operational, analytical, and manufacturing factors, supported by licensing partner Dr. Reddy's.
- Well-funded with A
$68.87 million in cash, cash equivalents, and term deposits at 30 June 2026, with cost-reduction measures underway to preserve a runway extending into H1 CY28.
SYDNEY, AUSTRALIA, July 30, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, provides an update on its activities for the quarter ended 30 June 2026 (Q4 FY26).
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) 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
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 <
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 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
The total balance consists of 1) a cash and cash equivalent balance of A
In Q4 FY26, cash receipts from customers were A
The net cash used in G&A activities in the quarter was A
Net cash used in R&D activities was A
Payment for staff costs was A
Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A
Total net cash inflow received in investing activities for the quarter was A
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.
About Immutep
Immutep is a clinical-stage biotechnology company developing novel immunotherapies for cancer and autoimmune diseases. The Company is a pioneer in the understanding and advancement of therapeutics related to the Lymphocyte Activation Gene-3 (LAG-3)/MHC Class II immune control mechanism, and its diversified product portfolio harnesses the ability of this mechanism to stimulate or suppress the immune system. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
- Immutep press release – 28 May 2026.
- ESMO Congress 2025 Poster Presentation, “Eftilagimod alpha (soluble LAG-3 protein) combined with 1st line chemo immunotherapy in metastatic non-squamous non-small cell lung cancer (NSCLC) – Updates from INSIGHT-003 (IKF s614)”.
- Translated using December 2025 average AUD/USD exchange rate.
- Translated using 31 December 2025 AUD/USD closing exchange rate.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
U.S. Investors/Media:
Matthew Beck
Ph: +1 (917) 415-1750; matthew.beck@astrpartners.com
