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]

Core Insights - Biotech stocks experienced significant gains in after-hours trading on September 9, 2025, driven by clinical updates, insider buying, and investor conference appearances across several small- and mid-cap companies [1] Company Summaries - **Immutep Ltd. (IMMP)**: Shares rose by 4.37% to $1.67 after-hours, following a decline of 6.98% during regular trading. The stock's rebound was fueled by the acceptance of data from its EFTISARC-NEO Phase II trial for oral presentation at CTOS 2025, focusing on a rare cancer with high unmet need [2][3] - **Nautilus Biotechnology Inc. (NAUT)**: Shares surged by 12.25% to $0.7521 after-hours, recovering from a 4.42% decline in regular trading. The increase was attributed to insider buying by CEO Sujal M. Patel, who purchased 83,500 shares, signaling confidence in the company [4][5] - **Pliant Therapeutics Inc. (PLRX)**: The stock ended regular trading at $1.75, up 1.16%, and jumped 16.00% to $2.03 after-hours. The upcoming third-quarter earnings report on November 6, 2025, is expected to provide updates on its lead candidate targeting idiopathic pulmonary fibrosis [6][7] - **Jin Medical International Ltd. (ZJYL)**: Shares closed at $0.6532, gaining 3.65% during regular trading and rising 7.15% to $0.6999 after-hours. The catalyst for this movement was the announcement of expanded production capabilities in China, aimed at enhancing global delivery of medical equipment [7][8] - **Phio Pharmaceuticals Corp. (PHIO)**: The stock rose 8.20% to $2.64 after-hours, building on a 13.49% increase during regular trading. The momentum was driven by participation in the H.C. Wainwright 27th Annual Global Investment Conference, where updates on its Phase 1b clinical trial for PH-762 will be presented [8][9] - **Kura Oncology Inc. (KURA)**: Shares increased by 6.12% to $8.50 after-hours, following a 1.60% decline in regular trading. The rally was linked to the company's presentation at the H.C. Wainwright conference, highlighting key developments and upcoming regulatory milestones for Ziftomenib [10][11][12]

Core Viewpoint - Immutep Limited is set to present findings from the EFTISARC-NEO Phase II trial at the CTOS 2025 Annual Meeting, highlighting the potential of eftilagimod alpha in treating soft tissue sarcoma [1][2]. Group 1: Trial Overview - EFTISARC-NEO is the first study to assess eftilagimod alpha in a neoadjuvant setting, combined with radiotherapy and KEYTRUDA for soft tissue sarcoma patients [2]. - The trial is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland, and is primarily funded by a Polish government grant [5]. Group 2: Disease Context - Soft tissue sarcoma (STS) is classified as an orphan disease with significant unmet medical needs and poor patient prognosis [4]. - In the United States, approximately 13,520 new STS cases are expected in 2025, with around 5,420 deaths projected [4]. Group 3: Company Background - Immutep is a late-stage biotechnology company focused on developing innovative immunotherapies for cancer and autoimmune diseases, particularly leveraging LAG-3 [6]. - The company aims to maximize shareholder value while providing new treatment options for patients in need [6].

Financial Performance - Revenue from ordinary activities remained unchanged at zero for FY2025, while other income increased from A$7.84 million in FY2024 to A$10.33 million in FY2025, representing a growth of 31.5%[3] - Loss from ordinary activities after tax increased from A$42.72 million in FY2024 to A$61.43 million in FY2025, reflecting a rise of 43.8%[3] - The overall loss after tax for FY2025 was A$61,434,165, compared to A$42,716,625 in FY2024, primarily due to planned increases in clinical trial activities[91] - Total revenue and other income increased to A$10.33 million in FY2025, up from A$7.84 million in FY2024[90] - Immutep's cash and cash equivalents as of June 30, 2025, totaled approximately A$67.41 million, with bank term deposits of A$62.28 million, exceeding initial budget expectations[88] - The closing share price on June 30, 2025, was $0.24, down from $0.30 in FY24, reflecting a decrease of approximately 20%[186] - Total ordinary shares increased from 29,196,831 at the start of FY25 to 35,243,278 at the end of the year, representing an increase of about 20.6%[183] - The highest share price during FY25 was $0.41, while the lowest was $0.23, indicating significant volatility in share performance[186] - The company has not paid any dividends in the last five years, focusing instead on growth and shareholder value[185] Clinical Development - The lead immuno-oncology candidate, eftilagimod alfa (efti), advanced into a global registrational Phase III trial in non-small cell lung cancer, with the first patient dosed in March 2025[16] - Median overall survival of 17.6 months was reported in the Phase IIb trial for head and neck squamous cell carcinoma, significantly higher than current standards of care[17] - A 60.8% objective response rate and 90.2% disease control rate were observed in the INSIGHT-003 trial for non-squamous NSCLC[19] - TACTI-004 Phase III trial is designed to evaluate efti in combination with KEYTRUDA and chemotherapy in approximately 750 patients with 1L NSCLC, with dual primary endpoints of progression-free survival and overall survival[35] - In December 2024, Immutep received the first regulatory approval for TACTI-004 from the Australian Therapeutic Goods Administration[35] - Cohort B of TACTI-003 achieved a 35.5% objective response rate in patients with PD-L1 negative tumours (CPS <1), which is among the highest for non-chemotherapy treatments in this population[43] - In May 2025, Cohort B reported a median overall survival of 17.6 months, significantly better than historical results from current standard-of-care approaches[45] - AIPAC-003 trial enrolled 71 metastatic breast cancer patients, with patient follow-up and data analysis ongoing, and an update expected in CY2025[49] - INSIGHT-003 trial reported a median overall survival of 32.9 months and a 24-month overall survival rate of 81.0% in patients with a minimum follow-up of 22 months[63] - The EFTISARC-NEO trial demonstrated a median 50% tumour hyalinization/fibrosis rate, significantly exceeding the historical median of 15% from radiotherapy alone[56] - Immutep has received FDA Fast Track designation for the combination of efti with KEYTRUDA in 1L HNSCC, indicating potential for expedited development[41] - TACTI-004 is on track for futility analysis readout by the end of CY2025/Q1 CY2026[36] - The company plans to present detailed results from the EFTISARC-NEO study at the ESMO Congress 2025 in Berlin[60] Intellectual Property - The company was granted 17 new patents in FY2025, enhancing its intellectual property estate[22] - Immutep has a robust patent portfolio, adding 17 new patents for efti, IMP761, and LAG525 in various territories[82] Management and Governance - The board of directors held 9 meetings in the year ended 30 June 2025, with all directors attending every meeting[114] - CEO Marc Voigt holds 13,676,945 ordinary shares and 4,800,000 performance rights in Immutep[112] - Non-Executive Director Ms. Lis Boyce holds 256,621 ordinary shares and 333,334 performance rights in Immutep[111] - The company has a strong focus on clinical development, with Christian Mueller leading multiple successful clinical studies in oncology[117] - Immutep's management team includes experienced professionals with extensive backgrounds in finance, law, and biotechnology[116] - The company is actively pursuing new product development and market expansion strategies in the biotech sector[106] Remuneration and Incentives - Total remuneration for key management personnel amounted to $4,404,745 for the year ending June 30, 2025[141] - Dr. Marc Voigt, CEO, received total remuneration of $1,174,480, including a cash salary of $546,230 and a performance rights component of $324,850[141] - The Company’s remuneration policy is not directly based on financial performance but rather on industry practices, focusing on long-term research and development goals[130] - At the 2024 AGM, 92.63% of votes were in favor of adopting the remuneration report for the 2024 financial year[138] - Executives have the opportunity to earn short-term incentives (STIs) based on individual and group performance milestones[131] - The Company aims to align executive remuneration with shareholder interests through equity-based components in the remuneration structure[140] - Non-cash STIs are granted under the Executive Incentive Plan (EIP), which was approved by shareholders at the 2024 AGM[132] - The total remuneration for Dr. Frédéric Triebel, Chief Scientific Officer, was $945,878, including share-based payments of $243,637[141] - The Company’s executive remuneration framework includes base pay, short-term incentives, and long-term incentives through performance rights[134] - The relative proportions of remuneration linked to performance for Mr. Marc Voigt are 55% fixed, 17% at risk – STI, and 28% at risk – LTI for 2025[160] - The company has a cash bonus scheme where Mr. Voigt, Dr. Triebel, and Ms. Miller are entitled to a cash bonus of A$300,000 each, conditional on meeting predetermined KPIs[163] - Performance rights are subject to accelerated vesting according to agreed terms in each person's contract[156] - Key management personnel have no entitlement to termination payments in the event of removal for misconduct or gross negligence[164] - No shares were directly issued to directors and key management personnel as part of compensation during the year ended 30 June 2025, but 6,816,947 performance rights were exercised resulting in the issuance of 6,816,947 ordinary shares[165] - The total number of performance rights granted includes 1,500,000 for LTI Tranche 1, 1,500,000 for LTI Tranche 2, and 1,500,000 for LTI Tranche 3, with values per right at grant date of $0.490 and $0.315[169] - Performance rights granted to Dr. Russell Howard on 23 November 2023 included 178,356 rights vesting over four tranches, with the first tranche of 28,356 rights vesting on 24 October 2023[175] - The company plans to issue 1,573,646 performance rights to Dr. Russell Howard if approved at the 2025 AGM, with the first tranche vesting on the grant date[176] - The percentage of performance rights that vested for Dr. R Howard in 2021 was 100% for 113,207 rights, while 44% of 50,000 rights vested in 2023[174] - The company has no options granted in prior years affecting remuneration in the current financial year[166] - Performance rights are subject to vesting contingent upon continuous employment in good standing through the vesting period[179] - The total value of performance rights at grant date for Dr. R Howard in 2021 was $74,717, with 100% of the rights vested[174] - There were no shares granted during the reporting period as compensation to key management personnel[180]

Core Insights - Immutep Limited has received positive feedback from the FDA regarding the clinical development of its MHC Class II agonist, eftilagimod alfa (efti), for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression below 1 [1][2][4] Clinical Development - The FDA acknowledged the potential of efti in combination with Merck's KEYTRUDA (pembrolizumab) for patients with CPS <1, indicating support for further development of this combination therapy [2][4] - Future clinical development paths may include a randomized registrational trial comparing efti with KEYTRUDA against standard-of-care therapy or a smaller single-arm study focusing on safety and response rates, followed by a confirmatory randomized study [3][6] Market Need - Patients with CPS <1 in 1L HNSCC represent a significant unmet medical need, with up to 20% of these patients not benefiting from current anti-PD-1 therapies, which are only approved for those with PD-L1 expression (CPS >1) [7] - Current treatment options for patients with PD-L1 CPS <1 are limited to chemotherapy [7] Company Focus - The primary focus of Immutep remains on the pivotal TACTI-004 Phase III trial evaluating efti as first-line therapy for non-small cell lung cancer, with positive feedback from physicians regarding its progress [5] - The company is considering future collaborative clinical development paths for head and neck cancer based on FDA feedback [4][5] About Immutep - Immutep is a late-stage biotechnology company specializing in immunotherapies for cancer and autoimmune diseases, particularly focusing on Lymphocyte Activation Gene-3 (LAG-3) [8] - The company aims to leverage its expertise to provide innovative treatment options and maximize shareholder value [8]

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].

Core Insights - Immutep Limited is set to present the pivotal TACTI-004 Phase III trial at the IASLC 2025 World Conference on Lung Cancer, highlighting its focus on advanced non-small cell lung cancer treatment [1][2] Company Overview - Immutep is a late-stage biotechnology company specializing in immunotherapies for cancer and autoimmune diseases, particularly focusing on Lymphocyte Activation Gene-3 (LAG-3) [7] - The company aims to leverage its expertise to develop innovative treatment options and maximize shareholder value [7] Trial Details - The TACTI-004 Phase III trial evaluates the efficacy of Immutep's antigen presenting cell (APC) activator, eftilagimod alfa (efti), in combination with Merck's KEYTRUDA® and chemotherapy for first-line treatment of advanced or metastatic non-small cell lung cancer [2][4] - The trial will enroll approximately 750 patients across over 150 clinical sites in more than 25 countries, regardless of PD-L1 expression [2] Eftilagimod Alfa (efti) Profile - Efti is a first-in-class APC activator that stimulates both innate and adaptive immunity, enhancing the immune response against cancer [5] - It has a favorable safety profile and is being evaluated for various solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and metastatic breast cancer [6] - Efti has received Fast Track designation from the FDA for first-line treatment in both head and neck squamous cell carcinoma and non-small cell lung cancer [6] Engagement with Medical Community - Immutep has received positive feedback from the lung cancer community regarding efti's safety and efficacy, indicating strong potential to change treatment paradigms for patients with advanced non-small cell lung cancer [3]

Core Insights - Immutep Limited, a late-stage immunotherapy company, announced that three abstracts for clinical trials of its MHC Class II agonist, eftilagimod alfa, have been accepted for presentation at the ESMO Congress 2025 in Berlin, Germany [1][2]. Group 1: Clinical Trials and Presentations - A Proffered Paper oral presentation will detail results from the EFTISARC-NEO Phase II trial in resectable soft tissue sarcoma, scheduled for October 19, 2025 [2]. - Data from the INSIGHT-003 Phase I trial in first-line non-small cell lung cancer (1L NSCLC) will be presented as a poster on October 18, 2025 [2]. - An abstract on the pivotal TACTI-004 Phase III trial in 1L NSCLC has been accepted for a Trials in Progress ePoster presentation [2]. Group 2: Company Overview - Immutep is focused on developing novel immunotherapies for cancer and autoimmune diseases, particularly leveraging the LAG-3 pathway to stimulate or suppress immune responses [4]. - The company aims to provide innovative treatment options and maximize shareholder value through its diversified product portfolio [4].

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]