Research analysts covering IMMUTEP.
Recent press releases and 8-K filings for IMMP.
Immutep Announces Strategic Collaboration with Dr. Reddy's and Strong Q2 FY26 Clinical Progress
IMMP
New Projects/Investments
Guidance Update
- Immutep entered a strategic collaboration with Dr. Reddy's for the commercialization of eftilagimod alfa (efti) in certain regions, receiving an upfront payment of ~A$30 million in January 2026 and eligible for up to ~A$528 million in potential milestones plus royalties.
- The company reported strong operational progress for the TACTI-004 Phase III trial in first-line non-small cell lung cancer (1L NSCLC), with futility analysis on track for Q1 CY2026, and positive data from INSIGHT-003 showing a 61.7% objective response rate (ORR) in low & no PD-L1 patients.
- The FDA agreed on 30 mg as the optimal biological dose for efti, following the successful completion of Project Optimus requirements.
- Immutep maintained a strong cash, cash equivalent, and term deposit position of A$99.1 million as of December 31, 2025, with a pro-forma balance of A$129.3 million after the Dr. Reddy's payment, extending its cash reach well into Q2 CY2027.
- The IMP761 Phase I study for autoimmune diseases showed positive safety and dose-dependent immunosuppressive effects at 2.5 and 7 mg/kg dosing levels.
Jan 30, 2026, 12:49 AM
Immutep Enters Strategic Collaboration with Dr. Reddy's for Oncology Drug Commercialisation
IMMP
New Projects/Investments
Product Launch
- Immutep Limited has entered into a strategic collaboration and exclusive licensing agreement with Dr. Reddy's Laboratories Ltd. for the development and commercialisation of its innovative oncology drug, Eftilagimod Alfa (efti).
- Under the terms, Immutep will receive an upfront payment of USD 20 million and is eligible for potential regulatory development and commercial milestone payments of up to USD 349.5 million, along with double-digit royalties on commercial sales.
- Dr. Reddy's gains exclusive rights for efti in all countries outside North America, Europe, Japan, and Greater China, while Immutep retains global manufacturing rights and full rights in key markets including North America, Europe, and Japan.
- Eftilagimod Alfa (efti) is a first-in-class novel immunotherapy currently in a registrational Phase III trial for non-small cell lung cancer and has received Fast Track designation from the FDA for certain indications.
Dec 9, 2025, 11:00 AM
Immutep to Present New AIPAC-003 Phase II Data at SABCS 2025
IMMP
New Projects/Investments
Guidance Update
- Immutep will present new data from its AIPAC-003 Phase II trial at the 2025 San Antonio Breast Cancer Symposium (SABCS) from December 9-12, 2025.
- The trial successfully completed FDA’s Project Optimus requirements, leading to the selection of 30 mg as the optimal biological dose (OBD) for eftilagimod alfa (efti).
- The study demonstrated strong objective response rates (ORR) and disease control rates (DCR) for efti in combination with paclitaxel in heavily pretreated metastatic breast cancer patients, with 41.9% ORR and 87.1% DCR for the 30 mg efti dose.
- This OBD determination is strategically important for ongoing and future oncology clinical programs, including the global TACTI-004 Phase III trial for first-line non-small cell lung cancer (NSCLC).
Dec 2, 2025, 11:15 PM
Immutep Limited Reports FY 2025 AGM Highlights
IMMP
New Projects/Investments
Management Change
Proxy Vote Outcomes
- Immutep Limited reported a strong financial position for FY 2025, ending with AUD 129.7 million in cash and term deposits, providing a cash runway through to the end of calendar year 2026.
- The lead immuno-oncology candidate, eftilagimod alpha (EFTI), advanced into the registrational Phase III TACTI-004 trial for first-line non-small cell lung cancer (1L NSCLC), with the first patient dosed in March 2025 and over 170 patients enrolled; a futility analysis is anticipated in the first quarter of calendar year 2026. EFTI also received positive FDA feedback for future late-stage clinical development in first-line head and neck squamous cell carcinoma (1L HNSCC).
- In autoimmune diseases, the first-in-human Phase I trial of IMP761 demonstrated a favorable safety profile and an 80% reduction in T cell activity in skin tissue at the highest dose tested.
- The company achieved significant corporate milestones, including being added to the S&P/ASX 300 Index in September 2024 and being granted 17 new patents in FY 2025.
Nov 27, 2025, 12:30 AM
Immutep Advances Lead Candidate to Phase III and Reports Strong Financials in FY 2025
IMMP
New Projects/Investments
Guidance Update
- Immutep Limited successfully transitioned into a phase III biotechnology company in FY 2025, with its lead immuno-oncology candidate, eftilagimod alpha (efti), advancing into the registrational Phase III TACTI-004 trial for first-line non-small cell lung cancer (1L NSCLC). The first patient was dosed in March 2025, and over 170 patients have been enrolled and randomized, with a futility analysis on track for completion in Q1 2026.
- The company maintained a strong financial position, ending FY 2025 with AUD 129.7 million in cash and term deposits, providing a cash runway through to the end of calendar year 2026.
- Immutep received positive FDA feedback for future late-stage clinical development of efti in first-line head and neck squamous cell carcinoma (1L HNSCC) , and its first-in-human Phase I trial for IMP761 in autoimmune diseases showed a favorable safety profile and 80% reduction in T cell activity at the highest dose tested.
- A significant corporate milestone was achieved with the company's inclusion in the S&P/ASX 300 Index in the September 2024 review.
Nov 27, 2025, 12:30 AM
Immutep Limited Provides FY 2025 AGM Update, Highlights Phase III Progress and Strong Financial Position
IMMP
Guidance Update
New Projects/Investments
- Immutep Limited reported a strong financial position for FY 2025, ending with AUD 129.7 million in cash and term deposits, providing a cash runway through to the end of calendar year 2026. As of the end of September, cash and cash equivalents were close to AUD 110 million.
- The company's lead immuno-oncology candidate, eftilagimod alpha (EFTI), advanced into the registrational Phase III TACTI-004 trial for first-line non-small cell lung cancer (1L NSCLC) in March 2025, with over 170 patients enrolled and randomized. A futility analysis is on track for completion in the first quarter of calendar year 2026.
- Immutep received positive feedback from the US Food and Drug Administration (FDA) regarding future late-stage clinical development of EFTI in first-line head and neck squamous cell carcinoma (1L HNSCC) for patients with PD-L1 expression below one.
- The INCITE-003 trial in 1L NSCLC showed a 62.7% objective response rate and 90.2% disease control rate, particularly in patients with PD-L1 expression below 50%. Additionally, the EFTI-SARC-NEO trial in soft tissue sarcoma met its primary endpoint.
- Immutep was added to the S&P/ASX 300 Index in the September 2024 review, marking a significant corporate milestone.
Nov 27, 2025, 12:30 AM
Immutep Provides Updates on Clinical Trials and Financial Outlook
IMMP
New Projects/Investments
Guidance Update
- Immutep's lead drug candidate, eftilagimod alpha, is currently in a global Phase III clinical trial (TACTI-004) for non-small cell lung cancer (NSCLC).
- A futility analysis for the TACTI-004 trial is anticipated in Q1 2026, with the last patient expected to be enrolled in Q3 2026. The first readout for progression-free survival (PFS) from this trial is projected for late 2026 to mid-2027.
- The company has a cash runway until the end of 2026.
- Immutep is also developing IMP761 for autoimmune conditions, with a Phase I dose escalation update expected by the end of 2025.
Nov 19, 2025, 10:00 PM
Immutep Details Progress of Lead Drug Candidate in Phase 3 NSCLC Trial
IMMP
New Projects/Investments
Guidance Update
- Immutep's lead drug candidate, eftilagimod alpha, is in a global Phase 3 clinical trial for non-small cell lung cancer (NSCLC), with key upcoming catalysts including a futility analysis in Q1 2026 and the last patient in Q3 2026. The first readout for progression-free survival is anticipated between end of 2026 and mid-2027.
- The company has a significant clinical trial collaboration and supply agreement with Merck, who is providing Keytruda for the Phase 3 trial, representing an approximate $100 million USD commercial value.
- The addressable market for anti-PD-1 drugs in NSCLC, which eftilagimod alpha aims to improve, is currently up to $25 billion USD annually and is projected to exceed $40 billion USD by the early 2030s.
- Immutep reported AUD 110 million in cash at its last quarterly update, providing a cash runway until the end of 2026.
Nov 19, 2025, 10:00 PM
Immutep Provides Update on Phase Three Lung Cancer Trial and Financial Outlook
IMMP
New Projects/Investments
Guidance Update
- Immutep's lead drug candidate, eftilagimod alpha, is in a global phase three clinical trial for non-small cell lung cancer (NSCLC), targeting a market estimated at $25 billion annually and projected to exceed $40 billion by the early 2030s.
- Key upcoming catalysts for the phase three NSCLC trial include a futility analysis in Q1 2026 and the last patient in Q3 2026, with the first readout for progression-free survival (PFS) expected by end of 2026 to mid-2027.
- The company has a clinical trial collaboration and supply agreement with Merck, which includes Merck supplying Keytruda, valued at approximately $100 million USD, and assistance in designing the phase three study.
- Immutep reported AUD 110 million in cash at its last quarterly update, providing a cash runway until the end of 2026.
Nov 19, 2025, 10:00 PM
IMMUTEP Limited Announces Positive Phase II Data for EFTISARC-NEO Trial
IMMP
- The EFTISARC-NEO Phase II study evaluating eftilagimod alfa (efti) in resectable soft tissue sarcoma (STS) met its primary endpoint, achieving a median 51.5% tumour hyalinization/fibrosis in the evaluable patient population (N=38).
- Early translational data from the trial showed a strong immune system activation, with statistically significant increases in key cytokines and chemokines (CXCL9, CXCL10, IL-23, and IFN-g) in peripheral blood, correlating with pathologic responses.
- The observed tumour hyalinization/fibrosis rate, which is over 3X greater than standard-of-care radiotherapy based on historical data, is an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.
- The EFTISARC-NEO project was recognized with the Golden Scalpel Award in Poland for its innovation and impact in medical research and clinical practice.
Nov 14, 2025, 1:39 AM
Quarterly earnings call transcripts for IMMUTEP.
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