Immutep Limited (NASDAQ:IMMP) is one of the Best Micro-Cap Stocks to Invest in According to Analysts. Immutep Limited (IMMP): Firm Reports Positive Data from Trials In mid-November, Immutep Limited (NASDAQ:IMMP) reported positive data from two clinical trials of its drug candidate eftilagimod alpha, or efti. The firm revealed that a Phase 2 study of efti in combination with radiotherapy and Merck’s Keytruda showed significant efficacy in treating patients with soft tissue sarcoma in the neoadjuvant setti ...

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]

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 Insights - Immutep Limited has reported a 60.8% response rate and a 90.2% disease control rate in the INSIGHT-003 trial for its immunotherapy treatment in advanced non-small cell lung cancer [1][7] Group 1: Trial Results - The INSIGHT-003 trial evaluated eftilagimod alpha (efti) in combination with KEYTRUDA® and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer [1] - The trial showed a significant improvement in overall response rates compared to historical controls, with a 60.8% response rate versus 48.0% in previous registrational trials [4] - In patients with PD-L1 expression below 50%, the response rate was 59.6%, compared to a historical control of 40.8% [5] Group 2: Patient Demographics - Approximately 92% of evaluable patients in the INSIGHT-003 study had PD-L1 Tumor Proportion Score (TPS) below 50%, indicating a high unmet medical need [3][7] - The breakdown of PD-L1 expression levels among evaluable patients included 49% with TPS of 1-49% and 43% with TPS below 1% [3] Group 3: Safety and Future Steps - The safety profile of the triple combination therapy remains favorable, with no new safety signals reported [9] - Additional data updates from the INSIGHT-003 trial are expected to be presented at a medical conference later in 2025 [10] Group 4: Company Background - Immutep is a late-stage biotechnology company focused on developing novel immunotherapies for cancer and autoimmune diseases, leveraging its expertise in LAG-3 [14] - Eftilagimod alpha (efti) is a proprietary soluble LAG-3 protein that stimulates both innate and adaptive immunity for cancer treatment [12]