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Immutep(IMMP) - 2025 FY - Earnings Call Transcript
2025-11-27 01:32
Financial Data and Key Metrics Changes - The company ended the financial year 2025 with a cash and term deposit balance of AUD 129.7 million, providing a cash runway through to the end of calendar year 2026, indicating strong financial management [12][31] - The latest figures for cash and cash equivalents at the end of September 2025 were close to AUD 110 million, reflecting a solid balance sheet [31] Business Line Data and Key Metrics Changes - The lead immuno-oncology candidate, eftilagimod alpha (EFTI), advanced into the TACTI-004 KEYNOTE F59/1 phase III trial in first-line non-small cell lung cancer, with over 170 patients enrolled, surpassing the number needed for a futility analysis [6][40] - The INCITE-003 trial showed a high 62.7% objective response rate and a 90.2% disease control rate across all PD-L1 expression levels, particularly impressive in patients with PD-L1 expression below 50% [9] Market Data and Key Metrics Changes - The company was added to the S&P/ASX 300 Index in September 2024, indicating increased investor confidence and visibility in the market [12][58] - The company continues to face challenges from supply chain disruptions and geopolitical instability, affecting market access and investment flows [13] Company Strategy and Development Direction - The company aims to maintain its leadership in LAG-3 immunotherapy, focusing on clinical trials for EFTI in oncology and autoimmune diseases [5][11] - The strategic collaboration with Merck for the TACTI-004 trial is a critical component of the company's strategy to address high unmet medical needs in first-line non-small cell lung cancer [30][34] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the complex challenges in the biotechnology sector but expressed confidence in navigating these hurdles through strong clinical data and operational skills [12][13] - The company anticipates continued momentum in clinical trials and updates on various studies, including TACTI-004 and APEX-003, in the upcoming financial year [14][59] Other Important Information - The company received positive feedback from the FDA regarding the late-stage clinical development of EFTI in head and neck squamous cell carcinoma patients with low PD-L1 expression [8] - The first-in-human phase I trial of IMP761 showed a promising 80% reduction in T cell activity, supporting its potential in autoimmune diseases [11] Q&A Session Summary Question: Are there copies of the annual report here? - Yes, copies of the annual report are available [16] Question: Any other questions regarding the financial and other reports? - No further questions were submitted regarding the financial and other reports [60]
Immutep(IMMP) - 2025 FY - Earnings Call Transcript
2025-11-27 01:32
Financial Data and Key Metrics Changes - The company ended the financial year 2025 with a cash and term deposit balance of AUD 129.7 million, providing a cash runway through to the end of calendar year 2026 [12] - Cash and cash equivalents at the end of September 2025 were close to AUD 110 million, indicating strong cash reserves for research and development [31] Business Line Data and Key Metrics Changes - The lead immuno-oncology candidate, eftilagimod alpha (efti), advanced into the TACTI-004 KEYNOTE F9/1 phase III trial in first-line non-small cell lung cancer, with over 170 patients enrolled [6][36] - The multicenter INSIGHT-003 trial showed a high 62.7% objective response rate and 90.2% disease control rate across all PD-L1 expression levels [9] - The phase II AIPAC-003 trial in metastatic breast cancer completed enrollment, with updates expected at the San Antonio Breast Cancer Symposium in December 2025 [10] Market Data and Key Metrics Changes - The company was added to the S&P/ASX 300 Index in September 2024, reflecting investor confidence in its growth trajectory [12] - The company is conducting trials in 24 countries, with over 100 clinical sites open for enrollment [7][40] Company Strategy and Development Direction - The company aims to develop and commercialize innovative immunotherapies targeting cancer and autoimmune diseases, with a focus on eftilagimod in combination with KEYTRUDA and chemotherapy [14][30] - The strategy includes navigating challenges in the biotechnology sector, such as supply chain disruptions and geopolitical instability, while maintaining a focus on clinical trial execution [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the changing global regulatory environment and emphasized the importance of timely execution of clinical trials [12][13] - The company anticipates meaningful progress in financial year 2026, with continued momentum for TACTI-004 and updates from other trials [14] Other Important Information - The company received positive feedback from the FDA regarding the late-stage clinical development of efti for head and neck cancer patients with low PD-L1 expression [8] - The company was granted 17 new patents across 10 territories for both efti and IMP761 during the financial year 2025 [11] Q&A Session Summary Question: Are there copies of the annual report here? - Yes, copies of the annual report are available [16] Question: Any questions or comments on the management of the company? - No questions were submitted in advance, and no further questions were raised during the meeting [60]
Immutep(IMMP) - 2025 FY - Earnings Call Transcript
2025-11-27 01:30
Financial Data and Key Metrics Changes - The company ended FY 2025 with a cash and term deposit balance of AUD 129.7 million, providing a cash runway through to the end of calendar year 2026 [12] - The latest figures for cash and cash equivalents at the end of September 2025 were close to AUD 110 million, indicating a strong balance sheet [25] Business Line Data and Key Metrics Changes - The lead immuno-oncology candidate, eftilagimod alpha (EFTI), advanced into the TACTI-004 KEYNOTE F59/1 phase III trial in first-line non-small cell lung cancer, with over 170 patients enrolled [6][34] - The INCITE-003 trial showed a high 62.7% objective response rate and a 90.2% disease control rate across all PD-L1 expression levels [9] - The phase II trial for IMP761, a first-in-class LAG-3 agonist antibody, showed an 80% reduction in T cell activity in skin tissue at the highest dose tested [11] Market Data and Key Metrics Changes - The company has opened over 100 clinical sites for enrollment across 24 countries for the TACTI-004 trial [7] - The company was added to the S&P/ASX 300 Index in September 2024, indicating strong investor confidence [12] Company Strategy and Development Direction - The company aims to develop and commercialize innovative immunotherapies targeting cancer and autoimmune diseases, with a focus on executing clinical trials [14] - The collaboration with Merck for the TACTI-004 trial is a strategic move to address high unmet medical needs in oncology [24][28] - The company is navigating challenges in the biotechnology sector, including supply chain disruptions and geopolitical instability, while maintaining a focus on clinical trial execution [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate regulatory challenges and operational hurdles while maintaining strong clinical data [13] - The company anticipates continued momentum in FY 2026 with updates from various clinical trials, including TACTI-004 and APEX-003 [14] - Management highlighted the importance of the upcoming futility analysis for the TACTI-004 trial as a de-risking event [52] Other Important Information - The company received positive feedback from the FDA regarding the late-stage clinical development of EFTI in head and neck cancer patients with low PD-L1 expression [8] - The company was granted 17 new patents across 10 territories for both EFTI and IMP761 during FY 2025 [11] Q&A Session Summary Question: Are there copies of the annual report here? - Yes, copies of the annual report are available [16] Question: Any questions from the floor about the remuneration report? - No questions were submitted regarding the remuneration report [17] Question: Are there any questions from the floor about the resolution concerning the reelection of Mr. Pete Myers? - No questions were raised regarding Mr. Myers' reelection [18] Question: Are there any questions from the floor about the resolution concerning performance rights to Mr. Pete Myers? - No questions were submitted regarding this resolution [19] Question: Are there any questions from the floor about the resolution concerning performance rights to Dr. Russell Howard? - No questions were raised regarding Dr. Howard's performance rights [20] Question: Are there any questions or comments on the management of the company? - No questions were submitted in advance of the meeting [53]
Immutep(IMMP) - 2025 FY - Earnings Call Presentation
2025-11-27 00:30
Immutep Overview - Immutep has approximately A$109.85 million in cash and cash equivalents, providing a runway to the end of CY2026[14] - Immutep is developing four clinical-stage assets, including eftilagimod alfa (efti) and IMP761, designed to empower the immune system to fight cancer and autoimmune diseases[14] TACTI-004 (KEYNOTE-F91) Phase III Trial - The NSCLC drug market is expected to reach US$48 billion in sales in 2031[14,24] - The TACTI-004 Phase III trial has activated over 100 clinical sites across 24 countries and enrolled over 170 patients as of October 2025[25,30] - MSD is supplying KEYTRUDA for the TACTI-004 trial, with a typical ICI supply value of approximately US$100 million[30,32] Efficacy and Safety - In the INSIGHT-003 trial, a 62.7% objective response rate and a 90.2% disease control rate were observed across all PD-L1 expression levels in first-line NSCLC patients[52] - The EFTISARC-NEO trial in soft tissue sarcoma met its primary endpoint, demonstrating a median 51.5% tumor hyalinization/fibrosis rate (p<0.001) with neoadjuvant efti + KEYTRUDA + radiotherapy[52,70] Financials - Immutep's total revenue and other income were A$10.3 million in FY25, compared to A$7.8 million in FY24[79,80] - Research and development and intellectual property expenses increased to A$61.4 million in FY25[79,80] - The company reported a net loss of A$61.4 million in FY25[79] Intellectual Property - In FY24, seven patents were granted for efti, including six patents for efti in combination with a PD-1 pathway inhibitor[84] - Seven patents were granted for IMP761 in FY24[84] Anti-PD-(L)1 Therapies Sales - KEYTRUDA sales were approximately $29.5 billion in 2024[50,51] - OPDIVO sales were approximately $9.3 billion in 2024[50,51]
Immutep (NasdaqGM:IMMP) 2025 Conference Transcript
2025-11-19 23:02
Summary of Immutep's Conference Call Company Overview - **Company**: Immutep - **Industry**: Biotechnology, specifically focused on immunotherapy for cancer and autoimmune diseases - **Lead Drug Candidate**: Eftilagimod alpha, currently in phase three clinical trials for lung cancer [1][2] Key Points and Arguments Clinical Trials and Drug Mechanism - Eftilagimod alpha activates the immune system via the LAG-3 pathway, enhancing the immune response against cancer cells [3] - The drug is currently being evaluated in a global phase three trial for non-small cell lung cancer, a leading cause of cancer death [2][4] Market Potential - The addressable market for non-small cell lung cancer therapies is approximately $25 billion annually, projected to exceed $40 billion by the early 2030s [4] INSIGHT-003 Trial Results - The INSIGHT-003 trial involved 50 patients and demonstrated a tumor shrinkage response rate of 61.7% in patients not responding to Keytruda, significantly higher than the expected 40% [5][6] - Median overall survival was reported at 32 months, with a progression-free survival of around 12 months [7] Phase Three Trial Design - The phase three trial involves 756 patients across 150 sites globally, aiming to change treatment practices for first-line non-small cell lung cancer [9][10] - The trial is designed with stratification factors to ensure balanced patient recruitment [10] Recruitment and Timeline - Recruitment is on track, with expectations to complete by Q3 next year and the first readout for progression-free survival anticipated between late 2026 and mid-2027 [12][11] Futility Analysis - A futility analysis is scheduled for Q1 next year, conducted by an Independent Data Monitoring Committee to assess the trial's viability [13][14] Collaboration with Merck - Immutep has a collaboration with Merck for the supply of Keytruda, valued at approximately $100 million, which is crucial for the trial's financial and operational aspects [15][16] Other Indications - Immutep is also developing IMP761 for autoimmune conditions, currently in phase one trials, with potential applications in diseases like rheumatoid arthritis and psoriasis [23][24] Financial Position - The company reported AUD 110 million in cash, providing a runway until the end of the next calendar year, with ongoing discussions for potential partnerships [26] Upcoming Catalysts - Key upcoming events include the futility analysis for the phase three trial, last patient enrollment, and data updates from other clinical trials, including those in metastatic breast cancer and soft tissue sarcoma [27][28] Additional Insights - The company emphasizes the importance of regulatory interactions and is preparing for multiple data releases in the coming year [28] This summary encapsulates the critical aspects of Immutep's current status, clinical trials, market potential, and future outlook based on the conference call.
Immutep Receives A$4.6 million R&D Tax Incentive from French Government
Globenewswire· 2025-11-03 13:00
Core Insights - Immutep Limited has received a cash payment of €2,588,954 (~ A$4,567,769) from the French Government under the Crédit d'Impôt Recherche (CIR) scheme, which supports R&D activities [1][3] - The CIR allows French companies to be reimbursed 30% of their eligible R&D expenditures, benefiting Immutep through its subsidiary in France [2][3] - The funds will be allocated to the global clinical development of Immutep's products, specifically eftilagimod alfa and IMP761 [4] Company Overview - Immutep is a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 therapeutics [5] - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [5]
Immutep Quarterly Activities Report Q1 FY26
Globenewswire· 2025-10-29 12:00
Core Insights - Immutep Limited is advancing its clinical trials for eftilagimod alfa (efti) in oncology and autoimmune diseases, with significant progress reported in multiple trials [2][3][31] Oncology Development Programs - The TACTI-004 (KEYNOTE-F91) Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with over 100 clinical sites activated across 24 countries, aiming to enroll approximately 756 patients [3][4] - The trial has successfully enrolled and randomized over 170 patients, surpassing the number required for a futility analysis, which is expected to be completed in Q1 CY2026 [6] - Positive feedback from the FDA has been received regarding the late-stage clinical development of efti for head and neck cancer patients with low PD-L1 expression [9][11] - The INSIGHT-003 Phase I trial is also evaluating efti in combination with KEYTRUDA® and chemotherapy for non-squamous NSCLC, with data presented at ESMO 2025 [7][8] Soft Tissue Sarcoma and Breast Cancer Trials - The EFTISARC-NEO Phase II trial for soft tissue sarcoma has met its primary endpoint, showing significant tumor hyalinization compared to historical data [16] - The AIPAC-003 trial for metastatic breast cancer has enrolled 71 patients, with ongoing follow-up and data analysis expected to be reported at the San Antonio Breast Cancer Symposium in December 2025 [17][19] Financial Position - As of September 30, 2025, Immutep reported a strong cash position of approximately A$109.85 million, consisting of A$83.41 million in cash and cash equivalents and A$26.44 million in term deposits [27] - The net cash used in R&D activities during Q1 FY26 was A$15.83 million, reflecting increased clinical trial activities [28] Intellectual Property Developments - Immutep was granted four new patents during the quarter, enhancing its intellectual property portfolio related to LAG-3 and its therapeutic applications [24]
Immutep Quarterly Activities Report Q4 FY25
Globenewswire· 2025-07-30 12:00
Core Viewpoint - Immutep Limited is advancing its clinical-stage biotechnology programs focused on LAG-3 immunotherapies for cancer and autoimmune diseases, with significant progress in multiple trials and a strong financial position as of June 30, 2025 [2][21]. Oncology Development Program - The TACTI-004 Phase III trial for advanced non-small cell lung cancer (NSCLC) is ongoing, with 78 sites across 23 countries activated for patient recruitment [3][4]. - The trial evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® and chemotherapy, aiming to randomize approximately 756 patients [4]. - Immutep reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 Phase I trial for non-squamous 1L NSCLC [6]. - In patients with TPS <50%, the triple combination achieved a 59.6% response rate compared to a historical control of 40.8% [7][8]. - The TACTI-003 Phase IIb trial for head and neck cancer showed a median overall survival of 17.6 months, outperforming historical standards of care [9][10]. - The EFTISARC-NEO Phase II trial for soft tissue sarcoma met its primary endpoint, significantly exceeding historical data for tumor hyalinization/fibrosis [12][13]. Autoimmune Disease Development Program - The Phase I trial of IMP761, a LAG-3 agonist antibody, demonstrated significant T cell suppression with a favorable safety profile at a dosing level of 0.9 mg/kg [16][17]. - Initial pharmacodynamic data indicated an 80% reduction in T cell activity, highlighting the potential efficacy of IMP761 in treating autoimmune diseases [18]. Intellectual Property - Immutep was granted four new patents during the quarter, including two for efti in combination with a PD-1 pathway inhibitor and two for IMP761 [19]. Corporate & Financial Summary - The company appointed Stephan Winckels as Chief Medical Officer, bringing over 15 years of oncology drug development experience [20]. - As of June 30, 2025, Immutep reported a cash position of approximately A$129.69 million, exceeding budget expectations [22]. - The net cash used in R&D activities during the quarter was A$15.66 million, reflecting increased clinical trial activities [23].
Immutep Announces Positive Update from Phase I Study of IMP761, a First-in-Class LAG-3 Agonist Antibody for Autoimmune Diseases
Globenewswire· 2025-06-23 12:00
Core Insights - Immutep Limited announces positive initial efficacy and safety data from the Phase I study of IMP761, a first-in-class LAG-3 agonist antibody targeting autoimmune diseases [1][4][7] - The study shows significant T cell suppression and a favorable safety profile at the highest dosing level of 0.9 mg/kg, with no treatment-related adverse events reported [2][7] - The company plans to continue escalating the dosing levels to 2.5, 7, and 14 mg/kg, with additional data expected in the second half of CY2025 [5][7] Company Overview - Immutep is a late-stage biotechnology company focused on developing immunotherapies for cancer and autoimmune diseases, particularly leveraging the LAG-3 immune checkpoint [3][8] - The company aims to address the root causes of autoimmune diseases by silencing dysregulated memory T cells, potentially offering a more targeted treatment approach with fewer side effects [4][6] Market Potential - The LAG-3 immune checkpoint is identified as a promising target for treating major autoimmune diseases such as rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, which represent multi-billion dollar markets [3][4] - IMP761 has shown encouraging pre-clinical results, indicating its potential to inhibit T cell proliferation and reduce effector cytokines in conditions like oligoarticular juvenile idiopathic arthritis [6]