IMMP
ImmutepDDocument history
Earnings documents stored for IMMP.
Investor releaseQuarter not tagged2026-07-30Immutep Quarterly Activities Report Q4 FY26
GlobeNewswire
Immutep Quarterly Activities Report Q4 FY26
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 CANC…Read full documentShow less
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 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 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. About ImmutepImmutep 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; [email protected] U.S. Investors/Media:Matthew Beck Ph: +1 (917) 415-1750; [email protected]
Investor releaseQuarter not tagged2026-04-30Immutep Quarterly Activities Report Q3 FY26
GlobeNewswire
Immutep Quarterly Activities Report Q3 FY26
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…Read full documentShow less
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 IDMC’s recommendation, enrolment in TACTI-004 has been halted and Immutep is implementing an orderly wind-down of the study, including appropriate patient follow-up and site close-out in accordance with regulatory and ethical obligations. While this is a disappointing outcome, it is important to note that this decision relates specifically to TACTI-004 and does not necessarily mean that efti as a broader development program will be discontinued. Immutep is conducting a thorough review of available data to understand factors behind the futility outcome, examining clinical, operational, analytical, and manufacturing aspects. The process includes collecting and analysing patient samples from TACTI-004 across up to 150 sites and relevant data cleaning. This root cause analysis may extend into Q3 CY2026, depending on data availability and logistics, covering database lock, statistical analysis, and laboratory data review. Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), a key licensing partner for Immutep’s efti, continues to demonstrate support and provide technical expertise to assist with the completion of the root cause analysis. “We continue to work collaboratively with Immutep on the ongoing evaluation of eftilagimod alfa, with a shared focus on determining the appropriate path forward” stated M.V. Ramana, CEO – Global Generics, Dr. Reddy’s. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC Patients in the investigator-initiated INSIGHT-003 trial, in which dosing had been completed, 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 levels.1 SOFT TISSUE SARCOMA EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma The investigator-initiated EFTISARC-NEO Phase II trial was evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS). The study met its primary objective and patients show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ.2,3 Dosing is completed, and patients are being followed up for disease free survival. In April 2026, Immutep announced that it had received an orphan drug designation for efti in this setting from the FDA. BREAST CANCER AIPAC-003 – Phase II Trial in Metastatic Breast Cancer Immutep continues to follow up patients in the AIPAC-003 Phase II trial which is evaluating efti in combination with chemotherapy in hormone receptor positive (HR+), HER2-negative/low metastatic breast cancer resistant to endocrine-based therapy or metastatic triple-negative breast cancer not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 (N=66) to receive either 30 mg or 90 mg efti in combination with chemotherapy to determine the optimal biological dose (OBD) of efti consistent with the FDA’s Project Optimus initiative. Dosing is complete, and patients are being followed up for overall survival. Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer 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 patients is on hold and subject to the root cause analysis related to TACTI-004. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE IMP761 – Phase I Trial In March 2026, Immutep announced an update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. The single ascending portion of the Phase I trial has now been completed, with dosing up to 14 mg/kg and no safety concerns observed. The study is now continuing in the multiple ascending dose (MAD) phase, which is evaluating pharmacokinetics and safety at two dose levels, with completion expected in 3Q CY2026. The Company will present details on IMP761 at the upcoming EULAR 2026 Congress, which will be held in London, from 3–6 June 2026 and plans to release additional data in 2H CY2026. INTELLECTUAL PROPERTY During the quarter, Immutep was granted a new patent in Mexico 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. A new Japanese patent was also granted during the quarter directed to LAG525. The patent is co-owned by Immutep S.A.S. and Novartis AG and exclusively licensed to Novartis AG. 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 a cash and cash equivalent, and term deposit balance as at 31 March 2026 of approximately A$110.6 million, which is better than the FY2026 budget. However, this cash balance will be reduced by the wind down costs of TACTI-004 and associated activities. The total balance consists of 1) a cash and cash equivalent balance of A$84.3 million and 2) bank term deposits totaling A$26.3 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. In Q3 FY26, cash receipts from customers were A$28.85 million, which is mainly due to the US$20 million (A$28.84 million4) upfront payment from Dr. Reddy’s. The net cash used in G&A activities in the quarter was A$0.9 million compared to A$1.3 million in Q2 FY26. In respect of the upfront licence fee of US$20 million received from Dr. Reddy’s in January 2026, US$2.7million (A$4.1 million5) was recognised as revenue and US$17.3 million (A$25.8 million6) was recognised as unearned revenue in the Company’s Half Year Financial Report for the period ended 31 December 2025. Following the discontinuation of TACTI‑004, a payment obligation has arisen under the Company’s licence agreement with Dr. Reddy’s. Under the licence agreement terms, the Company must pay US$10 million to Dr. Reddy’s by June 2026 in these circumstances. No payment has been made to Dr. Reddy’s at the date of this announcement. The expected payment will result in a cash outflow of US$10 million in the June 2026 quarter and corresponding reduction in unearned revenue. The remaining balance of US$7.3 million in unearned revenue is expected to be recognised as revenue for the half-year ending 30 June 2026. As previously disclosed, under the terms of the licensing agreement, Dr. Reddy’s has the exclusive rights to develop and commercialise efti in the licensed territories; Immutep has an entitlement to potential regulatory, development and commercial milestone payments of up to US$349.5 million; royalties on commercial sales in the licensed territories; and Immutep retains global manufacturing rights and will supply the product to Dr. Reddy’s in the licensed markets. The cash used in R&D activities during the quarter was A$11.8 million, compared to A$9.9 million in Q2 FY26. Payment for staff costs was A$2.6 million in the quarter, remaining the same level as in Q2 FY26. Total net cash inflows from operating activities in the quarter were A$13.5 million compared to net cash outflow of A$9.4 million in Q2 FY26. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$515k. Total net cash inflow received in investing activities for the quarter was A$20k, which is mainly the refund of an office security deposit. After the TACTI-004 Phase III futility outcome, the Company has started to initiate cost reduction measures to preserve capital and extend its cash runway. These measures include a targeted reduction in headcount and other operating expense reductions. 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 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. 1. 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)”. 2. ESMO Congress 2025 Proffered Paper presentation, “EFTISARC-NEO: A phase II study of neoadjuvant eftilagimod alpha, pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma”. 3. CTOS 2025 Annual Meeting Oral Presentation, “Primary endpoint and translational correlates from EFTISARC-NEO: Phase II trial of neoadjuvant eftilagimod alfa (efti), pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma”. 4. Translated using the March 2026 quarter average AUD/USD exchange rate 5. Translated using December 2025 average AUD/USD exchange rate 6. Translated using 31 December 2025 AUD/USD closing exchange rate KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Australian Investors/Media: Eleanor Pearson, Sodali & Co. +61 2 9066 4071; [email protected] U.S. Investors/Media: Matthew Beck, astr partners Ph: +1 (917) 415-1750; [email protected] This announcement was authorised for release by the CEO of Immutep Limited.
Investor releaseQuarter not tagged2026-01-29Immutep Quarterly Activities Report Q2 FY26
GlobeNewswire
Immutep Quarterly Activities Report Q2 FY26
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…Read full documentShow less
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 potential milestone payments from the Dr. Reddy’s agreement. SYDNEY, AUSTRALIA, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, provides an update on its activities for the quarter ended 31 December 2025 (Q2 FY26). EFTI DEVELOPMENT PROGRAM IN ONCOLOGY IMMUTEP AND DR. REDDY’S STRATEGIC COLLABORATION Most significantly, in December, Immutep and Dr. Reddy’s announced that their respective wholly-owned subsidiaries, Immutep SAS and Dr. Reddy’s Laboratories SA, entered into a strategic collaboration and exclusive licensing agreement for the development and commercialisation of eftilagimod alfa (efti) in all countries outside North America, Europe, Japan, and Greater China. Efti is Immutep’s first-in-class novel immunotherapy that directly activates the immune system to fight cancer, which is under evaluation in a Phase III trial, TACTI-004 (KEYNOTE-F91). As per the agreement, and after the quarter’s end, Immutep has received from Dr. Reddy’s the upfront payment of USD 20 million (~AUD 30.2 million). It is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus royalties on commercial sales in these markets. Immutep holds the global manufacturing rights to the product across all markets and will supply the product to Dr. Reddy’s in the licensed markets. Immutep retains all rights to the product in the key pharmaceutical markets, including North America, Europe, and Japan. LUNG CANCER TACTI-004 (KEYNOTE-F91) – Ongoing Phase III Trial in 1L NSCLC In December, Immutep reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC), one of the largest indications in oncology. The combination of efti with KEYTRUDA and chemotherapy has the potential to establish a new standard of care in 1L NSCLC by expanding the number of patients who respond to anti-PD-1 therapy, across all PD-L1 expression levels, along with enhancing clinical outcomes and extending patients’ survival. As of mid-December, the registrational TACTI-004 trial had enrolled 289 patients (over 38% of the trial’s targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites exceeded 120 and 27 countries had received full regulatory approvals. As announced in October 2025, TACTI-004 had enrolled the necessary number of patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Immutep anticipates reaching 50% of the patient enrolment target for TACTI-004 soon. Additionally, with the completion of Project Optimus as discussed below, TACTI-004 has started to open sites in the United States. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC In October, Immutep announced promising data from the investigator-initiated INSIGHT-003 trial, which is evaluating the same immunotherapy/chemotherapy combination used in TACTI-004 (KEYNOTE-F91), was detailed in a poster presented by Dr. med. Akin Atmaca, Head of the Thoracic Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany at the ESMO Congress 2025. In this multi-centre study, the novel combination of efti with KEYTRUDA and chemotherapy (carboplatin/pemetrexed) 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 levels. Notably, the ORR and DCR reported in INSIGHT-003 outperforms historical controls irrespective of PD-L1 levels (e.g., TPS <1%, TPS 1-49%, and TPS >50%). This is particularly important for patients with low and no PD-L1 (TPS <50%), who represent over two-thirds of the 1L NSCLC patient population and for whom PD-(L)1 inhibitors typically perform suboptimally. In patients with TPS <50% (N=47), the combination with efti has achieved a strong and improved 61.7% ORR compared to historical control of 40.8%.1,2 Further to the strong efficacy data from INSIGHT-003, the combination with efti continues to have a favourable safety profile. SOFT TISSUE SARCOMA EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma In October, Immutep announced that positive data from the EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA in the neoadjuvant setting for resectable soft tissue sarcoma (STS) was shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland at the ESMO Congress 2025 in Berlin, Germany. The EFTISARC-NEO trial met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis with a median 51.5% tumour hyalinization/fibrosis (p<0.001) in the evaluable patient population (N=38).3 This may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with improved survival in STS patients.4 Disease-free survival and overall survival data are immature at this stage and will be presented in the future. In November, early translational data from the EFTISARC-NEO trial were detailed in an oral presentation by Paweł Sobczuk, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting held in Boca Raton, Florida. Results from the initial twenty patients who underwent surgery in the trial show a strong immune system activation in line with efti’s mode of action, with statistically significant increases in the expression of key cytokines and chemokines in peripheral blood — specifically CXCL9, CXCL10, IL-23, and IFN-γ. The increase on treatment of immune response biomarkers like IFN-γ correlated with pathologic responses in this study, meaning patients with a biomarker increase during treatment also had a higher probability of a good clinical response at surgery. Additionally, during the quarter, the EFTISARC NEO trial was awarded second place in the distinguished Golden Scalpel Award competition in Poland. This competition recognises the most innovative solutions in Polish medicine and is presented by independent experts to initiatives that set new standards in advancing healthcare. EFTISARC-NEO was the only oncology project to receive this accolade, underscoring its leadership and breakthrough potential in cancer treatment. BREAST CANCER AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer Immutep continues to execute the AIPAC-003 trial, which has enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low patients resistant to endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or triple-negative breast cancer patients. Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. In October, Immutep announced that positive feedback had been received from the US Food and Drug Administration (“FDA”) regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for efti. The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of efti, including the global TACTI-004 (KEYNOTE-F91) Phase III trial. In December, Immutep announced that new data from the AIPAC-003 trial was presented by Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas. The data presented shows that both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). New Investigator-Initiated Phase II Trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer Immutep continues to progress with a new 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 patients. The trial aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC). The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget. UROTHELIAL CANCER INSIGHT-005 The investigator-initiated INSIGHT-005 Phase I study, conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) to evaluate the safety and efficacy of efti in combination with avelumab in up to 30 patients with metastatic urothelial cancer, was discontinued by IKF after the end of the quarter. This decision was made, as significant changes in the treatment landscape created challenges with patient recruitment. Only 3 patients were recruited in total. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE IMP761 – Phase I Trial In December, Immutep announced a positive update from the placebo-controlled, double-blind first-in-human Phase I study in healthy participants evaluating IMP761, a first-in-class LAG-3 agonist antibody for autoimmune diseases. The single-ascending dose escalation portion of the trial successfully completed the 2.5 and 7 mg / kg dosing levels of IMP761 with continued positive safety and efficacy data. IMP761 was tolerated well with no treatment-related adverse reactions beyond mild intensity. Additionally, evidence of dose dependent immunosuppressive effects with IMP761 was observed with significant, long-lasting inhibition of the three T-cell-mediated intradermal reactions to a strong foreign antigen on day 2, 9 and 23. Given the encouraging efficacy and safety to date, the trial will continue as planned and additional updates are anticipated in the first half of CY2026 including a planned presentation of data at a major medical conference. INTELLECTUAL PROPERTY During the quarter, Immutep was granted four patents. The New Zealand Patent Office granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein. The assay is used in the characterisation of efti in GMP-grade manufacturing. Three new patents directed to IMP761 were also granted. Two were granted in Brazil and one in Japan. CORPORATE & FINANCIAL SUMMARY Annual General Meeting Immutep successfully held its Annual General Meeting (AGM) during the quarter, with all resolutions put forward to shareholders strongly approved. The Company appreciates the continued support and engagement of its shareholders as it advances its strategic and operational objectives. Cash Flow Summary During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 31 December 2025 of approximately A$99.1 million, which is in line with budget as at the beginning of FY2026, while progressing our clinical programs within announced timeframes. The total balance consists of 1) a cash and cash equivalent balance of A$72.7 million and 2) bank term deposits totaling A$26.4 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. This amount is topped up by the upfront payment (~A$30.2 million) from Dr. Reddy’s received in January 2026, leading to a pro-forma balance of A$129.3 million at the time of preparing this report. In Q2 FY26, cash receipts from customers were A$4k. The net cash used in G&A activities in the quarter was A$1.3 million, compared to A$578k in Q1 FY26. During the quarter, Immutep received EUR2.59 million (~ A$4.6 million) R&D tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR) to support the ongoing and planned global clinical development of efti and IMP761. The cash used in R&D activities during the quarter was A$9.9 million, compared to A$15.8 million in Q1 FY26. The higher figure in the prior quarter was primarily due to the large prepaid clinical trial expenses and higher milestone‑based manufacturing payments made in Q1 FY26. Payment for staff costs was A$2.6 million in the quarter, compared to A$3.4 million in Q1 FY26. Total net cash outflows used in operating activities in the quarter were A$9.4 million compared to A$19.0 million in Q1 FY26. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$474k. Total cash outflow used in investing activities for the quarter was A$144k, which is mainly for the acquisition of office and lab equipment. Furthermore, during the quarter, a long-term vendor* agreed to defer payment of ~A$30 million which would be payable by Immutep for future services related to Biologics License Application (BLA) readiness by up to 30 months. This provides strong external validation of Immutep’s development strategy and long-term value creation potential. The current funds available to the Company at the time of this report provide an expected cash reach well into Q2 CY2027, not including receipt of any future potential milestone payments to be received. About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. 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. Australian Investors/Media: Eleanor Pearson, Sodali & Co. +61 2 9066 4071; [email protected] U.S. Investors/Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; [email protected] ------------------------------------ *Immutep does not consider the arrangement with or the identity of the vendor to be information that a reasonable person would expect to have a material effect on the price or value of the entity’s securities and considers that this disclosure contains all materially relevant and accurate information in assessing the impact on the value of Immutep’s securities. The long-term vendor is recognised internationally as one of the leaders in its sector, supporting a broad portfolio of biotechnology and pharmaceutical companies across multiple regions. The vendor operates multiple state-of-the-art facilities across Asia, North America, and Europe and is recognised for its strong financial position, robust global infrastructure, and industry-leading quality systems. It is publicly listed on a major international exchange.
Investor releaseQuarter not tagged2026-01-22Dr. Reddy's Laboratories Q3 Earnings Call Highlights
MarketBeat
Dr. Reddy's Laboratories Q3 Earnings Call Highlights
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…Read full documentShow less
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 cited several drivers behind the compression, including lower lenalidomide sales, price erosion in unbranded generics, adverse product mix in the PSA segment, and the labor-code provision. Adjusted for the one-off, gross margin was 54.1%. Reported gross margin was 57.4% for global generics and 17.3% for PSA. → Riot Platforms: A $311M AMD Deal Changes the HPC Game Drugmaker GSK: Becoming a Healthier Value Stock SG&A increased 12% year over year to ₹2,692 crore ($300 million), accounting for about 31% of revenue. MVN said the increase reflected targeted investments to support branded franchises, including the acquired nicotine replacement therapy (NRT) consumer healthcare business and branded generics, along with foreign exchange effects and the labor-code provision. Excluding the one-time cost, SG&A was about 30% of revenue. R&D spend was ₹615 crore ($68 million), down 8% year over year and largely flat sequentially, which MVN attributed to lower biosimilar development spend as “a large part of investment related to Abatacept has been completed.” R&D was 7% of revenue (6.8% excluding the one-off). → AMD Rebound Begins: It’s Not Too Late to Get In Profit after tax attributable to equity holders was ₹1,210 crore ($135 million), down 14% year over year and 16% sequentially, with diluted EPS of ₹14.52. The company ended the quarter with a net cash surplus of ₹3,069 crore ($342 million) and reported free cash flow of ₹374 crore ($42 million). Chief Executive Officer Erez Israeli said performance remained consistent with Dr. Reddy’s strategic priorities: growing the base business, driving efficiencies, advancing key pipeline programs (including “Magnota and Abatacept”), and pursuing selective business development. Israeli highlighted a strategic collaboration with Immutep for commercialization of the immunotherapy oncology drug eftilagimod alpha in “a key global market outside of North America, Europe, and Japan, and Greater China.” He said the deal includes a $20 million upfront payment, potential milestones of up to $350 million, and royalties. Israeli also said the company launched a “novel recombinant vaccine for the prevention of hepatitis E virus infection” in India. Additionally, he said the integration of the acquired NRT business is progressing as planned, with 85% of the business by value now under operational controls and integration expected to be largely completed by the end of the fiscal year. On semaglutide, Israeli said Dr. Reddy’s received marketing authorization for semaglutide injection in India from the DCGI, secured necessary local manufacturing licenses, and began filing in emerging markets via the COPP route. Israeli also discussed a Health Canada “notice of non-compliance” received in October 2025 regarding semaglutide injection. He said the company responded by mid-November and is awaiting a regulatory response. In Q&A, management said Canada has a goal date in May (six months from the response), but an approval could come anytime before then. Israeli said the company is preparing for a potential Canadian launch in Q4, with an alternative scenario of Q1, and suggested a launch could occur “anytime between end of February to May.” He added that no Health Canada plant inspection is expected for the submission. For India, Israeli said the company plans to launch on March 21, describing the initial launch as the generic version of Ozempic (diabetes indication). He said additional products and strengths are expected later, and that the equivalent of Wegovy (weight management) would follow after regulatory approvals. In Q&A, management discussed pricing expectations for semaglutide across markets, indicating the previously discussed $20–$70 range still applies, while noting most markets are expected to be “on the lower end of the spectrum” and that competition could compress pricing over time. Israeli said the company completed the BLA filing for the IV presentation of an abatacept biosimilar candidate in December 2025. He also said Dr. Reddy’s received European Commission approval for its ustekinumab biosimilar in Q3 FY26, along with approval from the U.K.’s MHRA, and launched the product in Germany in December with additional European launches in preparation. However, Israeli said the company received a complete response letter (CRL) from the U.S. FDA for the ustekinumab biosimilar BLA developed by partner Alvotech, citing observations from a pre-license inspection at Alvotech’s Reykjavik facility. On manufacturing compliance, Israeli said a U.S. FDA GMP inspection of the company’s CTO SEZ API facility in Srikakulam concluded with zero observations. He also said the U.S. FDA issued a Form 483 with five observations following a GMP and pre-approval inspection at the company’s FTO ACZ PE1 facility in Srikakulam; management said it responded within the required timeframe. Israeli added that the company received a post-application action letter related to observations from a September 2025 inspection at the Bachupally biologics facility for rituximab biosimilars and is working to resolve them. Management also provided timelines and expectations during Q&A: Denosumab (U.S.): Management said Alvotech must respond to a deficiency letter and that approval timing is uncertain, with Israeli indicating it is “likely” in the second quarter of FY27 or later. Rituximab (U.S.): Israeli said the company expects to respond within about two weeks on one outstanding item tied to a fill-finish line, after which the FDA may reinspect; he suggested approval is unlikely within the next six months and may take longer. Abatacept: Israeli said he does not see an impact from denosumab-related issues because manufacturing lines differ. For the U.S., he said the company expects IV approval toward the end of calendar 2026 and anticipates subcutaneous approval aligned with patent timing in January or February 2028. For Europe, he said the company plans to submit in July 2026 with an expected 12-month review and a potential launch in July 2027; he estimated the European abatacept market at about $2 billion. By geography, North America generics revenue was $338 million, down 16% year over year and 9% sequentially, which management attributed primarily to lower lenalidomide sales and price erosion in certain products. Israeli said the company launched six new products in the quarter. Europe generics revenue was $140 million, up 4% year over year and sequentially, supported by NRT performance and new product launches, which helped offset generic price erosion. The company launched 10 new generics across European markets during the quarter. Emerging markets revenue rose 32% year over year to ₹1,896 crore, with Israeli citing new launches and favorable foreign exchange. The company introduced 30 new products across countries. Within the segment, Israel said Russia grew 21% year over year and 16% sequentially in constant currency terms despite adverse macroeconomic conditions, and he told analysts that healthy double-digit growth is sustainable even if quarterly growth rates vary. India revenue increased 19% year over year to ₹1,603 crore, driven by the innovation franchise, new brand launches, price increases, volumes, and contributions from the acquired Stugeron portfolio. In Q&A, Israeli said organic growth excluding acquisitions was “more than 17%,” and indicated the innovative portfolio is “somewhere between 10%–15%” of India sales. He said the strong India growth reflects the maturation of innovative brands in their second and third years post-launch and called mid-teens growth “very sustainable.” The PSA business generated $92 million in revenue, down 5% year over year and 15% sequentially. The company filed 31 drug master files globally and completed 28 global generic filings during the quarter. Looking ahead, management reiterated its focus on execution, including advancing semaglutide and abatacept, improving base business growth, driving operational efficiencies, and pursuing value-accretive acquisitions and partnerships. On cost trends, Israeli said SG&A growth should moderate, with the pace of cost growth expected to be “less than half” of top-line growth. Dr. Reddy's Laboratories Ltd. is an India‐based multinational pharmaceutical company that develops, manufactures and markets a wide range of pharmaceutical products and services. Established in 1984 by the late Dr. Kallam Anji Reddy, the company has grown into a diversified healthcare enterprise offering generic and proprietary medicines, active pharmaceutical ingredients (APIs), biosimilars and custom research and manufacturing services (CRAMS). Its portfolio spans therapeutic areas such as oncology, cardiovascular care, dermatology, gastroenterology and pain management. The company's core activities include the development and commercialization of cost‐effective generic treatments for branded drugs that have lost patent protection, along with in‐house research into innovative molecule development. The article "Dr. Reddy's Laboratories Q3 Earnings Call Highlights" was originally published by MarketBeat.
Investor releaseQuarter not tagged2025-10-29Immutep Quarterly Activities Report Q1 FY26
GlobeNewswire
Immutep Quarterly Activities Report Q1 FY26
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…Read full documentShow less
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 Society for Medical Oncology (ESMO) Congress 2025 which took place 17- 21 October in Berlin, Germany. In September, Immutep presented a Trial in Progress poster presentation for TACTI-004 at the IASLC 2025 World Conference on Lung Cancer (WCLC), in Barcelona, Spain, where physician feedback continued to be encouraging. The Trial in Progress poster included an overview and study design of the trial. Subsequent to the end of the quarter, the Company announced in October that this global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysis, which remains on track for completion in the first quarter of CY2026. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC In July, Immutep announced that data from the INSIGHT-003 Phase I investigator-initiated trial in 1L NSCLC had been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025 which took place 17- 21 October in Berlin, Germany. The multi-centre INSIGHT-003 study is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA® and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous 1L NSCLC. This is the same immunotherapy/chemotherapy combination being used in the pivotal TACTI-004 Phase III in 1L NSCLC. Encouraging data from this trial has been presented at ESMO 2025. HEAD AND NECK CANCER TACTI-003 (KEYNOTE-C34) Cohort B – Phase IIb Trial in 1L HNSCC with CPS <1 In August, Immutep received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future late-stage clinical development of efti in first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1. Based on its review of the encouraging data in 1L HNSCC with CPS <1 from TACTI-003 (KEYNOTE-C34), the FDA agreed on the potential of efti in combination with KEYTRUDA® to address the high unmet need in this CPS <1 patient segment and is supportive of the combination’s further development. Paths for future clinical development and potential accelerated approval in light of the FDA’s Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA® against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 – 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data. SOFT TISSUE SARCOMA EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma In July, Immutep announced that an abstract for the EFTISARC-NEO Phase II investigator-initiated trial evaluating efti with radiotherapy plus KEYTRUDA® in the neoadjuvant setting for resectable soft tissue sarcoma (STS) had been accepted as a Proffered Paper oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025 which took place 17- 21 October in Berlin, Germany. Additionally, in September, Immutep announced that an abstract for the EFTISARC-NEO Phase II trial had been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida, USA. As previously announced, the investigator-initiated EFTISARC-NEO Phase II trial has met its primary endpoint. The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable STS. Encouraging data from this trial has been presented at ESMO 2025. BREAST CANCER AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer Immutep continues to execute the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30 mg or 90 mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. Patient follow up, data cleaning and analysis is ongoing, and an update will be provided at the San Antonio Breast Cancer Symposium in San Antonio, Texas, USA in December 2025. New Investigator-Initiated Phase II trial for Neoadjuvant Efti in HR+/HER2-negative Breast Cancer In September, the Company announced the launch of an 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 patients. The trial, led by Dr. Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at The George Washington (GW) University Cancer Center, aims to assess pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC). The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The GW University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE IMP761 – Phase I Trial Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. Following previously reported positive initial efficacy data and continued favourable safety data from the first-in-human Phase I study in June, additional data from the Phase I study is expected to follow in Q4 CY2025. INTELLECTUAL PROPERTY During the quarter, Immutep was granted four new patents. The Israel and New Zealand Patent Office each granted a new patent protecting Immutep’s intellectual property for a binding assay for determining MHC Class II binding activity of LAG-3 protein used in characterisation of efti in GMP-grade manufacturing. A new patent was also granted for IMP761 in New Zealand. For LAG525, which is exclusively licensed to Novartis by Immutep, a new patent was granted in Taiwan. CORPORATE & FINANCIAL SUMMARY Senior Management Changes As previously reported Stephan Winckels M.D, Ph.D., has been appointed to the permanent position of Chief Medical Officer effective 1 July 2025. Stephan has over 15 years of experience in oncology drug development and has been working on efti trials as Medical Monitor or Data Monitoring Committee member for more than nine years. Cash Flow Summary During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 30 September 2025 of approximately A$109.85 million, which is in line with budget as at the beginning of FY2026, while progressing our clinical programs within announced timeframes. The total balance consists of: 1) a cash and cash equivalent balance of A$83.41 million and 2) bank term deposits totaling A$26.44 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. In Q1 FY26, cash receipts from customers were A$15k. The net cash used in G&A activities in the quarter was A$578k, compared to A$1.44 million in Q4 FY25. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$720k. The net cash used in R&D activities during the quarter was A$15.83 million, compared to A$15.66 million in Q4 FY25. The increase is in line with increased clinical trial activities. Payment for staff costs was A$3.4 million in the quarter, compared to A$2.5 million in Q4 FY25. Total net cash outflows used in operating activities in the quarter were A$19.04 million compared to A$18.92 million in Q4 FY25. Total cash inflow from investing activities for the quarter was A$35.46 million, 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$40.46 million from short-term investments that had matured to cash at bank and invested A$5 million in short-term investments. About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. 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. Australian Investors/Media: Eleanor Pearson, Sodali & Co +61 (0)400 886 722; [email protected] U.S. Investors/Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; [email protected]
Investor releaseQuarter not tagged2025-07-30Immutep Quarterly Activities Report Q4 FY25
GlobeNewswire
Immutep Quarterly Activities Report Q4 FY25
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…Read full documentShow less
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., 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 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. In late May, Immutep presented a Trial-in-Progress poster for TACTI-004 at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in the United States. We have observed encouraging support from the investigators participating in the study in our meetings to date including those held at ASCO 2025, ELCC 2025, and an investigator meeting in Budapest, Hungary. Consistent feedback has been that the efficacy and the safety data collected thus far from the TACTI-002 and INSIGHT-003 trials are impressive and address the unmet medical needs seen by many key opinion leaders. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC In May, Immutep announced a high 60.8% response rate and 90.2% disease control rate (N=51), according to RECIST1.1, had been achieved in the investigator-initiated INSIGHT-003 trial as of the data cut-off date of 6 May 2025. INSIGHT-003 is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA® and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). In patients with TPS <50% (N=47), who represent a high unmet need and over two-thirds of the 1L NSCLC population, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8% from KEYTRUDA® and chemotherapy.3 Safety continues to be favourable with no new safety signals. Data from this trial are expected to be presented at a medical conference later in CY2025. HEAD AND NECK CANCER TACTI-003 (KEYNOTE-C34) Cohort B – Phase IIb Trial in 1L HNSCC with CPS <1 In May, Immutep announced an excellent median Overall Survival (OS) of 17.6 months had been achieved in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the Phase II study evaluates efti in combination with KEYTRUDA® as first line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below one (Combined Positive Score [CPS] <1). The mature 17.6-months median OS in evaluable patients (N=31) with a data cut-off of 31 March 2025 compares favourably to historical results from the two current standard-of-care approaches in the United States for 1L HNSCC patients with CPS <1 including 10.7-months from cetuximab + chemotherapy and 11.3-months from anti-PD-1 therapy + chemotherapy, as well as 7.9-months from anti-PD-1 monotherapy.1,2 Immutep requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps including potential paths to approval for 1L HNSCC with PD-L1 CPS <1. SOFT TISSUE SARCOMA EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma In May, Immutep announced 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 endpoint. The novel combination significantly exceeded the study’s prespecified median of 35% tumour hyalinization/fibrosis versus 15% for historical data from radiotherapy alone in patients with resectable STS. The EFTISARC-NEO study is primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program. The trial’s investigators at the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, plan to present results from the study at a medical meeting later in CY2025. BREAST CANCER AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer Immutep is continuing the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. Patient follow up, data cleaning and analysis is ongoing and an update is anticipated later in CY2025. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE IMP761 – Phase I Trial Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class LAG-3 agonist antibody designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. In June, Immutep announced positive initial efficacy data and continued favourable safety data from the first-in-human Phase I study. Through the highest dosing level of IMP761 to date (0.9 mg/kg), there have been no treatment-related adverse events in healthy participants. Additionally, pharmacodynamic data at this dosing level show that the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge has already reached 80%. The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases. Immutep is continuing with single ascending dose levels of 2.5, 7 and 14 mg/kg. Additional data from the Phase I is expected to follow later in CY 2025. INTELLECTUAL PROPERTY During the quarter, Immutep was granted four new patents. Immutep was granted two new patents for efti in combination with a PD-1 pathway inhibitor by the New Zealand Intellectual Property Office. In addition, two new patents were granted for IMP761, one by the Intellectual Property Office of the Philippines and the other by the Korean Intellectual Property Office. CORPORATE & FINANCIAL SUMMARY Senior Management Changes Immutep’s Acting Chief Medical Officer, Stephan Winckels M.D, Ph.D., has been appointed to the permanent position of Chief Medical Officer. Stephan has over 15 years of experience in oncology drug development and has been working on efti trials as Medical Monitor or Data Monitoring Committee member for more than nine years. Cash Flow Summary During the quarter, Immutep continued to exercise prudent cash management as it advanced its clinical trial programs for efti and for IMP761. The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 30 June 2025 of approximately A$129.69 million, which is greater than budgeted as at the beginning of FY2025, while progressing our clinical programs within announced timeframes. The total balance consists of: 1) a cash and cash equivalent balance of A$67.41 million and 2) bank term deposits totalling A$62.28 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 FY25, cash receipts from customers were A$6k. The net cash used in G&A activities in the quarter was A$1.44 million, compared to A$704k in Q3 FY25. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$307k. The net cash used in R&D activities during the quarter was A$15.66 million, compared to A$13.6 million in Q3 FY25. The increase is in line with increased clinical trial activities. Payment for staff costs was A$2.5 million in the quarter, the same as for Q3 FY25. Total net cash outflows used in operating activities in the quarter were A$18.92 million compared to A$16.26 million in Q3 FY25. Total cash outflows used in investing activities for the quarter was A$8.16 million, mainly due to the net increase 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$12.92 million from short-term investments that had matured to cash at bank and invested A$21.05 million in short-term investments. In July, US-based Ridgeback Capital Investments L.P. exercised its last remaining convertible notes and warrants in the Company. The cashless exercise resulted in the issuance of 7,475,208 ordinary shares. The Company is now free of any convertible debt, warrants or options. About Immutep Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s ability to stimulate or suppress the immune response. 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. Australian Investors/Media: Eleanor Pearson, Sodali & Co +61 (0)400 886 722; [email protected] U.S. Investors/Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; [email protected]
Investor releaseQuarter not tagged2025-04-29Immutep Quarterly Activities Report Q3 FY25
GlobeNewswire
Immutep Quarterly Activities Report Q3 FY25
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…Read full documentShow less
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 Budapest, Hungary. Consistent feedback has been that the efficacy and safety data collected thus far from the TACTI-002 and INSIGHT-003 trials are impressive and address the unmet medical needs seen by many key opinion leaders. Recruitment in TACTI-004 is underway at a growing number of activated clinical sites and countries with approvals from regulatory authorities expanded to now 19 countries including Australia, Austria, Belgium, Bulgaria, Canada, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Lithuania, Portugal, Spain, and the United Kingdom. TACTI-003 (KEYNOTE-C34) – Phase IIb Trial in 1L HNSCC Immutep continued to follow patients in the TACTI-003 (KEYNOTE-C34) Phase IIb trial, which is evaluating efti in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC), during Q3 FY25. Immutep most recently reported positive results from Cohort B of the trial in 1L HNSCC patients with PD-L1 negative tumours (CPS <1) who typically do not respond well to anti-PD-1 therapy alone, at the ESMO Immuno-Oncology Annual Congress in December 2024. Immutep will continue to follow the maturing data from TACTI-003 and plans to engage with regulatory authorities regarding potential paths forward by mid of this year. AIPAC-003 – Phase II/III Trial in Metastatic Breast Cancer Immutep continues to execute the AIPAC-003 trial, which enrolled 71 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Immutep completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial in late 2024. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of efti in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative and prior regulatory interaction with FDA. Patient follow up, data cleaning and analysis is ongoing and an update is anticipated in CY2025. INSIGHT-003 – Phase I Trial in Non-Squamous 1L NSCLC In January 2025, Immutep announced that patient enrolment has been completed for the ongoing investigator-initiated INSIGHT-003 trial. INSIGHT-003 is evaluating efti in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first line treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC). The Phase I trial has reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF. Positive first Overall Survival results and other data points from INSIGHT-003 were reported in late 2024. Data updates from INSIGHT-003 are expected in CY2025. EFTISARC-NEO – Phase II Trial in Soft Tissue Sarcoma In January 2025, Immutep announced that patient enrolment has been completed in the ongoing investigator-initiated EFTISARC-NEO trial. EFTISARC-NEO is evaluating efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for patients with resectable soft tissue sarcoma (STS). The Phase II trial being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) in Warsaw, the national reference centre for STS in Poland, reached its enrolment target of 40 patients. Encouraging data from EFTISARC-NEO was presented at the Connective Tissue Oncology Society (CTOS) Annual Meeting in November 2024. Data updates from EFTISARC-NEO are expected in CY2025. IMP761 DEVELOPMENT PROGRAM FOR AUTOIMMUNE DISEASE Immutep is progressing with the ongoing Phase I trial of its autoimmune candidate IMP761. IMP761 is a first-in-class agonist LAG-3 antibody designed to restore balance to the immune system by enhancing the “brake” function of LAG-3 to silence dysregulated self-antigen-specific memory T cells that cause many autoimmune diseases. Following previously reported favourable initial safety data in December 2024, additional safety data and assessment of pharmacokinetic/pharmacodynamic (PK/PD) relationships are expected to be reported in CY2025. INTELLECTUAL PROPERTY During the quarter, Immutep was granted two new patents for LAG525 in in the Philippines and the United States. Immutep was also granted a Russian patent directed to an assay for use in measuring the potency of IMP761, for example, as part of a quality control step in production of the agonist LAG-3 antibody. CASH FLOW SUMMARY During the quarter, Immutep continued to advance its clinical trial programs for efti and for IMP761 with prudent cash management. The Company is well funded with a strong cash and cash equivalent, and term deposit balance as at 31 March 2025 of approximately A$146.25 million, which is greater than budgeted as at the beginning of the current financial year, whilst delivering on our announced goals. The total balance consists of: 1) a cash and cash equivalent balance of A$92.45 million and 2) bank term deposits totaling A$53.80 million, which have been recognised as short-term investments due to having maturities of more than 3 months and less than 12 months. In Q3 FY25, cash receipts from customers were A$12k. The net cash used in G&A activities in the quarter was A$704k, compared to A$566k in Q2 FY25. Payments to Related Parties comprises Non-Executive Directors’ fees and Executive Directors’ remuneration of A$363k. The net cash used in R&D activities during the quarter was A$13.6 million, compared to A$16.2 million in Q2 FY25. The decrease is mainly due to: the prepayment of TACTI-004 clinical trial related “kick-off costs” to initiate the trial in the previous quarter; and the completion of enrolment in the Phase II portion of the AIPAC-003 trial and the cost-efficient investigator initiated EFTISARC-NEO and INSIGHT-003 trials, which like TACTI-003 are all now focused on patient follow up. As such the Company is incurring significantly lower burn rates from those trials. Payment for staff costs was A$2.5 million in the quarter, which was the same as for Q2 FY25. Total net cash outflows used in operating activities in the quarter were A$16.26 million compared to A$19.0 million in Q2 FY25. Total cash inflow from investing activities for the quarter was A$32.34 million, mainly due to the maturity 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$32.34 million from short-term investments that had matured to cash at bank, resulting in a positive cashflow in investing activities. About Immutep Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. 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. Australian Investors/Media: Catherine Strong, Sodali & Co +61 (0)406 759 268; [email protected] U.S. Investors/Media: Chris Basta, VP, Investor Relations and Corporate Communications +1 (631) 318 4000; [email protected]

