Financial Data and Key Metrics Changes - For Q3 2025, the company reported R&D expenses of $10.3 million, an increase from $6.8 million in the same period last year, primarily due to expenses related to the DRAGON and Phoenix trials [5] - G&A expenses rose to $12.7 million from $2.9 million year-over-year, driven by increased share-based compensation expenses [5] - The net loss for Q3 2025 was $21.7 million, compared to a net loss of $8.7 million for the same period last year [5] - Total operating cash outflow for Q3 was approximately $9.3 million, similar to $8.6 million in Q2 [6] - At the end of Q3, the company had $275.6 million in cash and liquidity from time deposits and US Treasury bills [6] Business Line Data and Key Metrics Changes - The company completed enrollment for the phase 3 Phoenix trial with 530 subjects and the phase 3 DRAGON trial, with approximately 35 subjects enrolled out of a targeted 60 [3][4] - Positive feedback was received from regulatory authorities, including China's NMPA and the U.K.'s MHRA, regarding the DRAGON trial [4] Market Data and Key Metrics Changes - The company is preparing for submissions in multiple regions, including the U.S., Japan, and the U.K., with a focus on maintaining a consistent data package across regulatory agencies [8][14] - The company plans to submit applications in the first half of 2026 for regulatory approval in China and the U.K. [8] Company Strategy and Development Direction - The company is focused on advancing clinical trials and preparing for commercialization, with a strong balance sheet to support these efforts [6] - The U.S. market is prioritized for commercialization, with plans to apply for NDA in all regions, while seeking partnerships for other markets [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong foundation provided by the DRAGON trial for global submissions and potential approvals [4] - The company estimates that approximately $200 million will be needed for the commercialization of Saga in the U.S. [25] Other Important Information - The company completed a $50 million registered direct offering and a $125 million private placement, with potential for an additional $165 million upon full bond exercise [4] - The increase in share-based compensation expenses was a significant factor in the overall expense increase [6] Q&A Session Summary Question: Has the application been submitted to regulatory agencies in China and the U.K.? - The company plans to submit applications in the first half of 2026 [8] Question: What is the current amount of shares outstanding? - The total outstanding shares are approximately 35 million [10] Question: When will the application be submitted in Japan? - The expected timeline for submission in Japan is also the first half of 2026 [14] Question: Will there be an interim analysis for the Phoenix trial similar to the DRAGON trial? - Yes, an interim analysis is planned for the second half of next year [16] Question: What should be assumed as the baseline level for SG&A expenses going forward? - It is difficult to estimate a clear baseline due to the variability related to share price and ESOP [18] Question: What steps are being taken to prepare for potential approval and launch? - The focus is on the U.S. market, with plans to start with a sales force of 20 to 40 people [23] Question: Is the current cash sufficient for commercial preparation and launch? - The company estimates that $200 million will be needed for commercialization, and believes current cash should be sufficient [25] Question: Did the U.K. request the same interim information as the U.S. FDA? - Yes, the same dataset was presented to both the U.K. and China [30]

Core Viewpoint - Yiming Anke-B (01541) experienced a significant stock increase of over 10%, closing at 14 HKD with a trading volume of 82.2247 million HKD, following the release of its interim results for the six months ending June 30, 2025, which showed a remarkable revenue increase of 49,285.71% year-on-year [1] Financial Performance - The company reported a revenue of 38.027 million RMB for the interim period, marking a substantial increase compared to the previous year [1] - Research and development expenses amounted to 168 million RMB, reflecting a year-on-year increase of 41.05% [1] Strategic Developments - The revenue growth is primarily attributed to recent payments received from a licensing and collaboration agreement with Axion Bio, Inc. [1] - Pacific Securities highlighted that the company has achieved preliminary safety and efficacy data from its Phase II clinical trial of IMM2510 for first-line treatment of NSCLC patients in China, with plans to initiate a Phase III clinical trial [1] Future Outlook - The company is set to launch a Phase I clinical trial for IMM2510 as a monotherapy for recurrent/refractory solid tumors in the United States in the second half of 2025 [1] - Projected revenues for the company from 2025 to 2027 are estimated at 151 million RMB, 139 million RMB, and 675 million RMB respectively, indicating a positive growth trajectory [1] - The valuation of the core pipeline is expected to further increase, with a maintained "buy" rating from analysts [1]