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 Transcript