IMMP

Following IDMC recommendation after interim futility analysis the decision was made to discontinue the TACTI-004 Phase III trial Root cause analysis is ongoing and implications for the broader eftilagimod alfa development program are under review Phase I IMP761 data demonstrates favourable safety profile; trial progressing to multiple ascending dose phase; data expected at EULAR conference in June CY2026 Cash, cash equivalent and term deposit position of A$110.6 million, providing an expected cash reach into H1 CY2028 based on current assumptions. SYDNEY, AUSTRALIA, April 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 31 March 2026 (Q3 FY26). 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 eftilagimod alfa (“efti”) in patients in first-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. The futility analysis was based on data from approximately 170 patients and included a review of baseline disease characteristics, safety, and overall response rate (“ORR”). After carefully considering the recommendation of the IDMC, as well as conducting its own internal review of the data, Immutep has followed the IDMC’s recommendation and decided to discontinue TACTI-004. Notably, Immutep’s review included additional data such as early interim progression-free survival data. More specifically, the Company decided that it was necessary to discontinue TACTI-004 because patients receiving a combination of efti, KEYTRUDA and chemotherapy (the “efti arm”) were underperforming relative to patients receiving a combination of placebo, KEYTRUDA and chemotherapy (the “control arm”). This outcome was unexpected, given that efti combined with standard of care has typically produced higher response rates when compared to historical studies or controls. In particular, this outcome was notably inferior to results observed in INSIGHT-003 which was testing the same combinations in non-squamous 1L NSCLC patients. In response to the...

Media Release Entered into strategic collaboration with Dr. Reddy’s for commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China In January 2026, Immutep received ~A$30 million upfront payment from Dr. Reddy’s and is eligible to receive up to ~A$528 million in potential milestones, plus royalties on commercial sales of efti Strong operational progress reported for TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in first line non-small cell lung cancer (1L NSCLC), with completion of the futility analysis on track for the first quarter of CY2026 Data from INSIGHT-003 at ESMO Congress 2025 show combination of efti with KEYTRUDA® and chemotherapy generates strong response rates across all PD-L1 expression levels in 1L NSCLC, including 61.7% ORR in low & no PD-L1 (TPS <50%), well above 40.8% from historical controls Primary endpoint met in EFTISARC-NEO Phase II evaluating neoadjuvant efti in soft tissue sarcoma detailed in Proferred Paper oral presentation at ESMO Congress 2025 Translational data from EFTISARC-NEO shared in an oral presentation at CTOS 2025 demonstrate efti’s strong immune system activation with statistically-significant increases in multiple cytokines / chemokines and correlation between key immune proteins and pathologic responses Positive feedback received from the FDA regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for efti Strong response rates and immune activation in heavily pretreated metastatic breast cancer patients from AIPAC-003 Phase II presented at 2025 San Antonio Breast Cancer Symposium IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases, completed 2.5 and 7 mg / kg dosing levels in a Phase I study; dose dependent immunosuppressive effect against a strong foreign antigen observed with continued favourable safety profile Immutep received A$4.6 million R&D tax incentive from the French government to support the ongoing and planned global clinical development of efti and IMP761 Strong cash, cash equivalent and term deposit position of A$99.1 million as at 31 December 2025. Receipt of the ~A$30 million upfront payment subsequent to the quarter’s end leading to a pro-forma balance of A$129.3 million which extends Immutep’s cash reach well into Q2 CY2027, not including any pot...

Q3 results: Consolidated revenue rose 4.4% YoY to ₹8,727 crore ($971m) while reported EBITDA margin was 23.5% (24.8% excluding a one‑time labor‑code provision); profit after tax fell 14% YoY to ₹1,210 crore, pressured by lower lenalidomide sales and pricing erosion in U.S./Europe despite double‑digit growth in the base business excluding lenalidomide. Pipeline and deals: Dr. Reddy’s advanced key programs—semaglutide has India marketing authorization with a planned launch on March 21 and a potential Canada launch between end‑Feb and May pending Health Canada, abatacept IV BLA was filed in Dec 2025 and EU/US timelines were outlined—and the company struck a commercialization collaboration with Immutep for eftilagimod alpha with $20m upfront and up to $350m in milestones. Regional mix: North America generics revenue fell 16% YoY (mainly lenalidomide and price erosion), while India grew 19% and emerging markets jumped 32%, helping offset the U.S. decline; the company continues to add new launches and file numerous global filings to support growth. Interested in Dr. Reddy's Laboratories Ltd? Here are five stocks we like better. Teva Pharmaceuticals Stock: Unlock Value in This Generic Drug Gem Dr. Reddy's Laboratories (NYSE:RDY) reported a “resilient performance” in its fiscal third quarter of FY26, with revenue growth and steady profitability despite what management described as product-specific headwinds, led by lower lenalidomide sales and continued pricing pressure in U.S. and European generics. On the company’s earnings call, Chief Financial Officer M.V. Narasimham (MVN) said consolidated revenue rose 4.4% year over year to ₹8,727 crore ($971 million), though it declined 0.9% sequentially. Management attributed the quarter’s performance to double-digit growth in base businesses excluding lenalidomide, as well as favorable foreign exchange movements, partially offset by weaker lenalidomide contributions and generic price erosion. → Lemonade’s Tesla Deal Could Rewrite How Auto Insurance Is Priced 2 overlooked stocks that crushed earnings but traded lower MVN said reported EBITDA margin was 23.5%, which included a one-time provision tied to changes in employee benefit obligations under new labor codes in India. Excluding that provision, EBITDA margin was 24.8%. Gross margin fell to 53.6%, down 505 basis points year over year and 104 basis points sequentially. MVN...

Media Release Pivotal TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in first line non-small cell lung cancer continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries Trial in Progress poster for TACTI-004 presented at the World Conference on Lung Cancer (WCLC) 2025, where physician feedback continued to be encouraging Positive feedback received from the FDA regarding future late-stage clinical development of efti in first line head and neck cancer patients with PD-L1 expression below 1 (CPS <1) New investigator-initiated Phase II trial evaluating neoadjuvant efti as monotherapy and with chemotherapy prior to surgery in early-stage HR+/HER2-negative breast cancer patients Three abstracts for clinical trials evaluating efti were accepted and presented at the European Society for Medical Oncology (ESMO) Congress 2025 Strong cash, cash equivalent and term deposit position of A$109.85 million, providing an expected cash reach to the end of CY2026 SYDNEY, AUSTRALIA, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune disease, provides an update on its activities for the quarter ended 30 September 2025 (Q1 FY26). EFTI DEVELOPMENT PROGRAM IN ONCOLOGY LUNG CANCER TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC Immutep’s pivotal TACTI-004 (KEYNOTE-F91) Phase III trial continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries. There are now over 100 clinical sites open for enrollment and 24 countries that have received regulatory approval. The TACTI-004 trial evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® and chemotherapy as first line treatment for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomise approximately 756 patients at more than 150 clinical sites and trial results will inform a potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology. In July, Immutep announced that a Trials in Progress ePoster had been accepted at the European Socie...

Media Release The pivotal TACTI-004 Phase III trial in first line non-small cell lung cancer (1L NSCLC) continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries Trial-in-Progress poster for TACTI-004 presented at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting Novel combination of efti with KEYTRUDA® (pembrolizumab) and chemotherapy in INSIGHT-003 trial achieves high response rate of 60.8% and 90.2% disease control rate (N=51) in 1L NSCLC In high unmet need patients with TPS <50% (N=47), who represent over two-thirds of 1L NSCLC population, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8%. Efti in combination with KEYTRUDA® achieved strong 17.6-months median Overall Survival (OS) in first line head and neck cancer patients with PD-L1 expression below one (CPS <1) 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 endpoint In autoimmune diseases, initial pharmacological data from the placebo-controlled, double-blind Phase I study of IMP761, a first-in-class LAG-3 agonist antibody, shows significant T cell suppression and a favourable safety profile at dosing level of 0.9 mg/kg Strong cash position of A$129.69 million, providing an expected cash reach to the end of CY2026 SYDNEY, AUSTRALIA, July 30, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 30 June 2025 (Q4 FY25). EFTI DEVELOPMENT PROGRAM IN ONCOLOGY LUNG CANCER TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC Immutep’s pivotal TACTI-004 Phase III trial is on track and continues to build momentum and is recruiting patients at a growing number of activated clinical sites and countries, with now 78 sites and 23 countries having received regulatory approval, following the successful dosing of the first patient at Calvary Mater Newcastle Hospital in Australia in March 2025. The TACTI-004 trial evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., I...

Media Release First patient safely dosed in TACTI-004 Phase III lung cancer trial, marking a significant milestone Pivotal TACTI-004 trial design presented at the European Lung Cancer Congress (ELCC) 2025 Patient enrolment completed for the EFTISARC-NEO Phase II trial evaluating efti with radiotherapy and KEYTRUDA® in resectable soft tissue sarcoma Patient enrolment completed for the INSIGHT-003 Phase I trial evaluating efti with KEYTRUDA® and chemotherapy as first-line treatment of advanced or metastatic 1L NSCLC Strong cash position of A$146.25 million, providing an expected cash reach to the end of CY2026 SYDNEY, AUSTRALIA, April 29, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, provides an update on its activities for the quarter ended 31 March 2025 (Q3 FY25). EFTI DEVELOPMENT PROGRAM FOR CANCER TACTI-004 – First Patient Successfully Dosed in Pivotal Phase III Trial in 1L NSCLC In March 2025, Immutep announced the first patient in the Company’s pivotal TACTI-004 Phase III trial was successfully dosed at Calvary Mater Newcastle Hospital in Australia. TACTI-004 evaluates eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) and chemotherapy as first line treatment of patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global Phase III trial with efti will randomize approximately 756 patients at more than 150 clinical sites and trial results will inform a potential marketing approval application in non-small cell lung cancer, one of the largest indications in oncology. Immutep also presented the pivotal TACTI-004 Phase III trial as a Trial-in-Progress poster at the European Lung Cancer Congress (ELCC) 2025, in Paris, France, in late March. The poster included an overview and study design of the TACTI-004 Phase III trial. Informed by the Company’s AIPAC-003 study, Immutep has determined to move forward with 30 mg efti dosing as the optimal biological dose. We have observed encouraging support from the investigators participating in the study in our meetings to date including those held at ELCC 2025 and after quarter end at the investigator meeting in Budap...