Media Release SYDNEY, AUSTRALIA, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep“ or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, is pleased to announce it has received a €2,588,954 (~ A$4,567,769 ) research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR). The “Crédit d’Impôt Recherche” (CIR), meaning “Research Tax Credit”, is a French government ...

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]

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]