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]

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.

Core Insights - Immutep Limited announced positive results from the EFTISARC-NEO trial, demonstrating significant efficacy in treating resectable soft tissue sarcoma (STS) with a novel combination of eftilagimod alfa (efti), radiotherapy, and KEYTRUDA [1][2] Study Results - The Phase II study showed a median 51.5% tumor hyalinization/fibrosis in the evaluable patient population (N=38), significantly exceeding the prespecified pathologic response rates (p<0.001) [2] - The trial included patients with ten different STS subtypes, including aggressive tumors with poor prognosis such as myxofibrosarcoma (N=16) and undifferentiated pleomorphic sarcoma (N=10) [3] Immune Response - Early data indicated strong immune system activation, with significant increases in key cytokines and chemokines, including CXCL9 (2.5x, p<0.01), CXCL10 (1.8x, p<0.0001), IL-23 (2.2x, p<0.05), and IFN-γ (2.5x, p<0.05) [4][5] - The increase in immune response biomarkers correlated with pathologic responses, suggesting a higher probability of favorable clinical outcomes [5] Clinical Implications - The achieved tumor hyalinization/fibrosis rate is over three times greater than standard-of-care radiotherapy based on historical data, indicating potential for improved overall survival and recurrence-free survival in STS patients [6] - The findings support the hypothesis that efti's activation of antigen-presenting cells enhances both adaptive and innate immunity, which is crucial for effective cancer treatment [7][10] Future Directions - The results suggest that efti may have applications beyond advanced or metastatic cancer, potentially benefiting patients with localized and resectable tumors [10] - Ongoing translational studies aim to further explore the correlation between immune responses and clinical outcomes [6] Recognition - The EFTISARC-NEO trial received the Golden Scalpel Award in Poland, highlighting its innovation and impact in medical research and clinical practice [9][12] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [15]

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]

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]

Financial Performance - For the fiscal years ended June 30, 2025, and 2024, the company reported net losses of A$61.4 million and A$42.7 million, respectively[28]. - The company has no medicinal products approved for commercial sale and has not generated material revenue from product sales to date[32]. - The company anticipates significant losses from ongoing clinical trials and research, particularly for efti and IMP761, and expects costs to increase as more patients are recruited[30]. - The company has historically financed operations through public and private financing, and future net losses will depend on the rate of expenditures and ability to secure funding[39]. - The company may experience difficulties in obtaining reimbursement for its products, which could impact market acceptance and revenue[84]. - The company has never paid dividends and does not intend to do so in the foreseeable future, meaning shareholders may not receive returns from dividends[140]. - The company is subject to significant compliance costs estimated at US$210,000 per annum since the fiscal year ended June 30, 2022, which may lead to a potential delisting from NASDAQ if costs become excessively high[132]. Research and Development - The company is developing five LAG-3 product candidates, with the most advanced being eftilagimod alfa (efti), which is in collaboration with Merck & Co. for Phase II and III clinical trials[34]. - The company has a dedicated R&D laboratory in Paris and generates modest income from sales of LAG-3 research reagents[35]. - The company is developing eftilagimod alfa ("efti" or "IMP321") as a first-in-class antigen-presenting cell agonist for cancer treatment, with ongoing Phase III and Phase IIb trials[165][166]. - Immutep's clinical pipeline includes four candidates: eftilagimod alfa, IMP761, IMP701, and IMP731, focusing on cancer and autoimmune diseases[164]. - The investigator-initiated EFTISARC-NEO trial showed that 67% of patients had near-complete pathological responses, significantly exceeding historical data from standard radiotherapy alone[216]. Clinical Trials - The company may face challenges in enrolling patients for clinical trials, which could delay or increase the costs of these trials[43]. - Positive results from preclinical studies do not guarantee success in clinical trials, and setbacks can significantly impact development timelines and financial prospects[52]. - Clinical trials may not demonstrate sufficient safety or efficacy, potentially hindering regulatory approval and revenue generation[55]. - Immutep's ongoing TACTI-002 trial has shown deep, durable responses for patients regardless of PD-L1 expression, with favorable safety profiles[192]. - The TACTI-003 trial achieved an objective response rate (ORR) of 35.5% and a disease control rate (DCR) of 58.1% in patients with PD-L1 negative tumors (CPS <1)[200]. - Immutep initiated the pivotal TACTI-004 Phase III trial for 1st line metastatic non-small cell lung cancer (NSCLC) with regulatory approval from the Australian Therapeutic Goods Administration[211]. Regulatory and Compliance Risks - Regulatory approval for product candidates is uncertain, and various factors could delay or prevent commercialization[54]. - The company must navigate rapid technological changes in the biotechnology and pharmaceutical industries to remain competitive[75]. - The company is subject to the auditor attestation requirement under the Sarbanes-Oxley Act due to its voting equity held by non-affiliates exceeding US$75.0 million as of June 30, 2022[129]. - The SEC rules exclude foreign private issuers from the definition of "smaller reporting companies," which limits the company's options to avoid the auditor attestation requirement[130]. - The company may face challenges in protecting its intellectual property rights in certain jurisdictions, potentially diminishing their value[122]. Market and Competitive Landscape - Market acceptance of the company's products among physicians, patients, and the medical community is uncertain, which could adversely affect future sales[77]. - Competition from multinational pharmaceutical companies and specialized biotechnology firms poses a challenge, as many competitors have greater resources and experience[79]. - The company is exposed to foreign currency exchange rate fluctuations, which may impact its revenues and costs[132]. - Macroeconomic factors, including inflation and geopolitical events, have led to volatility in trading prices for the company's securities, affecting capital raising efforts[93]. Intellectual Property and Legal Risks - The company's ability to protect its intellectual property is critical for its success, as failure to do so could limit competitive advantages[96]. - Third-party intellectual property rights could hinder the company's ability to commercialize products, potentially leading to costly litigation[104]. - The company may become involved in expensive and time-consuming lawsuits to protect its patents or other intellectual property[112]. - Changes in patent laws or jurisprudence could impair the company's ability to protect its products or product candidates[119]. Human Resources and Organizational Structure - As of June 30, 2025, the company employed 51 people, managing finances, business development, and clinical development internally while utilizing outside contractors for manufacturing and trials[172]. - Retaining key personnel and fostering academic collaborations are essential for research and development efforts, with competition for qualified employees being intense[73][74]. Financial Instruments and Shareholder Issues - The market price of the company's ordinary shares on the Australian Securities Exchange has fluctuated between A$0.223 and A$0.485 over the last two fiscal years[127]. - The market price of the company's ADSs on NASDAQ has ranged from US$1.320 to US$3.335 during the same period[127]. - The company's American Depository Shares (ADSs) traded on NASDAQ between a low of US$1.32 and a high of US$2.72 during the fiscal year ended June 30, 2025, categorizing them as "penny stocks" under SEC regulations[133]. - The company may face challenges in making distributions to ADS holders due to currency conversion issues or legal impracticalities[151].

Core Insights - Immutep Limited is focusing on changing the treatment paradigm for first-line non-small cell lung cancer (1L NSCLC) through innovative immunotherapy approaches [1][5]. Clinical Trial Results - The INSIGHT-003 trial demonstrated strong objective response rates (ORR) and disease control rates (DCR) for the combination of eftilagimod alfa (efti) with KEYTRUDA (pembrolizumab) and chemotherapy in patients with advanced or metastatic non-squamous 1L NSCLC [2][5]. - The ORR for patients with low and no PD-L1 expression (TPS <50%) reached 61.7%, significantly higher than the historical control of 40.8% [3][5]. - The combination therapy showed high ORR and DCR across all PD-L1 expression levels, with specific rates of 54.5% (no PD-L1), 68.0% (low PD-L1), and 75.0% (high PD-L1) [4]. Safety and Efficacy - The combination of efti with KEYTRUDA and chemotherapy has a favorable safety profile and has shown promising clinical responses, particularly in patients with low or absent PD-L1 expression [3][5]. - Efti is expected to set a new standard of care for 1L NSCLC patients, supported by data from multiple clinical trials, including the pivotal TACTI-004 Phase III trial [5][8]. Future Developments - The TACTI-004 Phase III trial is a global study enrolling approximately 756 patients with advanced/metastatic 1L NSCLC, evaluating the same immunotherapy/chemotherapy combination used in INSIGHT-003 [5][6]. - Efti is under evaluation for various solid tumors, including head and neck squamous cell carcinoma and breast cancer, and has received Fast Track designation from the FDA for first-line treatments [8]. Company Overview - Immutep is a late-stage biotechnology company specializing in novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in Lymphocyte Activation Gene-3 (LAG-3) [9].

Core Insights - Immutep Limited has received positive feedback from the FDA regarding the completion of Project Optimus and has agreed on 30mg as the optimal biological dose for eftilagimod alfa (efti) [1][2] Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging Lymphocyte Activation Gene-3 (LAG-3) [5] Clinical Development - The agreement on efti's optimal biological dosing is strategically important for ongoing and future clinical development, including the TACTI-004 (KEYNOTE-F91) Phase III trial, which evaluates efti in combination with KEYTRUDA and chemotherapy for advanced or metastatic non-small cell lung cancer [2][4] - The TACTI-004 trial is currently in the process of opening clinical sites in the United States [7] Efti Overview - Efti is a novel immunotherapy that activates antigen-presenting cells via the MHC Class II pathway, engaging both the adaptive and innate immune systems to initiate a broad anti-cancer immune response [3] - Efti is being evaluated for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer, and has received Fast Track designation from the FDA for first-line treatments in HNSCC and NSCLC [4]

Core Insights - Immutep Limited is advancing its TACTI-004 Phase III trial for eftilagimod alfa (efti) in combination with KEYTRUDA and chemotherapy for advanced non-small cell lung cancer (NSCLC) [1][4] Company Updates - The TACTI-004 trial has enrolled over 170 patients, surpassing the required number for a futility analysis [2][8] - There are now over 100 active clinical trial sites across 24 countries, indicating strong recruitment momentum [2][8] - The futility analysis is scheduled for the first quarter of CY2026, to be conducted by an independent data monitoring committee [3][8] Product Information - Efti is a first-in-class MHC Class II agonist that activates antigen-presenting cells to enhance anti-cancer immune responses [10][11] - The trial aims to enroll approximately 756 patients, focusing on those with advanced or metastatic NSCLC without specific genomic aberrations [7][9] Market Context - Lung cancer is the leading cause of cancer-related deaths, with an expected increase to approximately 3 million cases globally by 2030 [5] - NSCLC accounts for about 80-85% of lung cancer diagnoses, highlighting a significant unmet need for effective treatment options [5]

Core Insights - Immutep Limited has initiated a Phase II trial for neoadjuvant eftilagimod alfa (efti) in early-stage HR+/HER2-negative breast cancer patients, evaluating its use as a monotherapy and in combination with standard chemotherapy prior to surgery [1][4] Group 1: Trial Details - The study will involve up to 50 evaluable patients and is primarily funded by grants from The George Washington University Cancer Center, with Immutep providing efti at no cost and limited funding [2] - The trial is a single-arm interventional study focusing on the pathological complete response (pCR) after treatment with efti and neoadjuvant chemotherapy [4] - Patients will receive efti monotherapy for three weeks before starting chemotherapy in combination with efti [4] Group 2: Efti Mechanism and Benefits - Efti is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity, leading to the activation of various immune cells, including CD8+ T cells and dendritic cells [5][6] - The unique mechanism of efti may result in high rates of pathologic complete responses and improved disease-free survival in patients with stronger immune systems [3][4] Group 3: Company Overview - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [8] - The company aims to expand its clinical pipeline for neoadjuvant efti in areas of high unmet need, reflecting its commitment to innovative treatment options [4][8]