Akeso (AKESF) announced the approval of its innovative PD-1/VEGF bispecific antibody, ivonescimab, by the National Medical Products Administration. This approval allows ivonescimab to be used as a monotherapy for the first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) in patients without epidermal growth factor receptor or anaplastic lymphoma kinase gene mutations. This marks the second major approval for ivonescimab, emphasizing its potential in oncology therapeutics.
The supplementary New Drug Application (sNDA) was granted following the successful outcomes of the AK112-303/HARMONi-2 Phase III clinical trial. This study was a randomized, double-blind, controlled trial directly comparing ivonescimab to pembrolizumab. Ivonescimab demonstrated a significant improvement in median progression-free survival (PFS), achieving a median PFS of 11.14 months and reducing the risk of disease progression or death by 49% with a hazard ratio of 0.51. Furthermore, an interim overall survival analysis at 39% data maturity showed a meaningful boost in survival, with a 22.3% reduction in the risk of death compared to pembrolizumab.
Ivonescimab is recognized as the first therapy to outperform pembrolizumab in a head-to-head Phase III trial setting, proving its efficacy and safety. Akeso's leadership noted that this milestone underscores the rigorous efforts of researchers and participants and acknowledges the swift regulatory review that facilitates access to this novel treatment in China.
The scope of ivonescimab's efficacy extends beyond lung cancer, showing promise as a first-line treatment in other major cancers, including breast, head and neck, biliary tract, and colorectal cancers, backed by over 12 active Phase III trials. Akeso, in collaboration with Summit, is focused on promoting ivonescimab as a central component of global cancer immunotherapy, striving to deliver safer and more effective treatment solutions worldwide.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 9 analysts, the average target price for Summit Therapeutics Inc (SMMT, Financial) is $31.00 with a high estimate of $44.00 and a low estimate of $5.00. The average target implies an upside of 33.56% from the current price of $23.21. More detailed estimate data can be found on the Summit Therapeutics Inc (SMMT) Forecast page.
Based on the consensus recommendation from 10 brokerage firms, Summit Therapeutics Inc's (SMMT, Financial) average brokerage recommendation is currently 1.7, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Summit Therapeutics Inc (SMMT, Financial) in one year is $0.39, suggesting a downside of 98.32% from the current price of $23.21. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Summit Therapeutics Inc (SMMT) Summary page.
SMMT Key Business Developments
Release Date: February 24, 2025
- Cash Position: Approximately $412 million at the end of 2024.
- Debt Status: Debt-free as of the end of 2024.
- GAAP R&D Expenses: $150.8 million for the full year 2024, up from $59.4 million in the previous year.
- Non-GAAP R&D Expenses: $134.8 million for the full year 2024, compared to $55 million in the previous year.
- Acquired In-Process R&D Expenses: $15 million for 2024, down from $520.9 million in the previous year.
- GAAP G&A Expenses: $60.5 million for the full year 2024, compared to $30.3 million in the previous year.
- Non-GAAP G&A Expenses: $25.5 million for the full year 2024, compared to $20.6 million in the prior year.
- Non-GAAP Operating Expenses: $175.3 million for the full year 2024, down from $596.5 million in the previous year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Summit Therapeutics Inc (SMMT, Financial) announced a clinical trial collaboration with Pfizer to evaluate Ivonescimab in combination with multiple Pfizer antibody drug conjugates in unique solid tumor settings.
- The company completed enrollment and received Fast Track designation for its global Phase III trial, HARMONi, targeting EGFR mutated advanced non-small cell lung cancer.
- Summit Therapeutics Inc (SMMT) expanded the HARMONi-3 trial to include a larger patient population, addressing both squamous and non-squamous histologies.
- The company has a strong cash position of approximately $412 million and is debt-free, providing a solid financial foundation for ongoing and future trials.
- Ivonescimab has been featured in numerous publications and presentations, indicating strong interest and recognition in the medical community.
Negative Points
- The company's R&D expenses increased significantly to $150.8 million in 2024 from $59.4 million in the previous year, reflecting the expansion of clinical trials.
- There is uncertainty regarding the timing of the HARMONi-2 overall survival data, which is crucial for regulatory approval processes.
- Summit Therapeutics Inc (SMMT) faces challenges in providing a clear timeline for the top-line readout of the HARMONi-3 trial due to ongoing site activations.
- The company has not disclosed specific details about the Pfizer collaboration, such as which ADCs will be used or the tumor types targeted, leaving some strategic aspects unclear.
- The competitive landscape in non-small cell lung cancer is intense, with multiple ongoing Phase III studies by other companies, which could impact market share and approval timelines.
