HONG KONG, Feb. 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that its partner on ivonescimab, Summit Therapeutics Inc. (NASDAQ: SMMT) has entered into a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate ivonescimab, a novel, investigational PD-1 / VEGF bispecific antibody, in combination with several of Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings. "Rapidly developing novel mechanisms that go beyond what is cur ...

Financial Data and Key Metrics Changes - The company ended 2024 with a strong cash position of approximately $412 million and is now debt-free [37] - GAAP R&D expenses for 2024 were $150.8 million, up from $59.4 million in the previous year, reflecting the expansion of clinical trials related to Ivonescimab [39] - Non-GAAP R&D expenses were $134.8 million in 2024 compared to $55 million in 2023 [39] - GAAP G&A expenses increased to $60.5 million in 2024 from $30.3 million in the previous year, primarily due to stock-based compensation charges [41] - Overall, non-GAAP operating expenses decreased to $175.3 million in 2024 from $596.5 million in 2023, mainly due to a reduction in acquired in-process R&D expenses [42] Business Line Data and Key Metrics Changes - The company has completed enrollment in four Phase III trials, with two awaiting top-line data readout, including the HARMONi trial [16] - Five Phase III trials are currently ongoing, with two sponsored by the company in first-line non-small cell lung cancer [17] Market Data and Key Metrics Changes - The addressable market for non-small cell lung cancer could approach $20 billion for checkpoint inhibitors, with a broader market potential of approximately $90 billion globally across all checkpoint inhibitor indications [30][32] Company Strategy and Development Direction - The company aims to expand its clinical development plan beyond non-small cell lung cancer in 2025 and 2026, with ongoing engagement in investigator-sponsored trials [24] - A collaboration with Pfizer was announced to evaluate Ivonescimab in combination with multiple Pfizer antibody drug conjugates in various solid tumor settings [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Ivonescimab to improve patient lives and emphasized the importance of addressing serious unmet medical needs [34] - The company is focused on rapidly developing novel mechanisms to enhance treatment options for patients facing significant challenges from cancer [10] Other Important Information - The company has committed $15 million to a collaboration with MD Anderson to explore additional opportunities for Ivonescimab [21] - Clinical trials associated with the Pfizer collaboration are expected to start in mid-2025 [22] Q&A Session Summary Question: Timing for HARMONi-2 OS data - Management indicated that Akeso expects to reach the number of events required for interim analysis by the end of 2025 [49] Question: Need for statistical significance in OS data for approval - Management stated that while they would prefer to achieve statistical significance for OS, previous approvals in this space have not always required it [52] Question: Timing for top-line readout for HARMONi-3 - Management noted it is too early to provide clarity on the completion of enrollment for HARMONi-3 until all sites are activated [55] Question: Details on the Pfizer collaboration - Management confirmed that multiple ADCs from Pfizer will be involved, with trials expected to be Phase 1b/2 level [58] Question: Confidence in ADC targets - Management expressed confidence in the potential of ADCs across solid tumor oncology, noting that data outside of lung cancer has been stronger [66] Question: Plans for future business development opportunities - Management indicated that the Pfizer collaboration does not preclude additional partnerships or business development activities [115]

Summit Therapeutics Q4 & YE 2024 Earnings Call February 24, 2025 9:00am ET Any statements in this presentation about the Company's future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company's product candidates, entry into and actions related to the Company's partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company's product candidates, the potential commerci ...

Financial Performance - For the year ended December 31, 2024, total operating expenses were $226.3 million, a decrease of $384.3 million from $610.6 million in 2023[441]. - The operating loss for 2024 was $226.0 million, improving by $383.6 million compared to a loss of $609.6 million in 2023[441]. - Net loss for the year ended December 31, 2024, was $221.3 million, a reduction of $393.6 million from a net loss of $614.9 million in 2023[441]. - The company incurred a net loss of $221.3 million for the year ended December 31, 2024, compared to a net loss of $614.9 million in 2023[458][469]. Research and Development Expenses - Research and development expenses increased by $91.4 million to $150.8 million in 2024, primarily due to investments in oncology clinical trials for ivonescimab[441][445]. - Oncology clinical trial related costs for ivonescimab amounted to $100.9 million in 2024, up from $35.2 million in 2023, reflecting a $65.7 million increase[443]. - The company anticipates continued increases in research and development expenses as it progresses with the development of ivonescimab[445]. - Research and development tax credits decreased by $0.7 million in 2024, totaling $0.3 million[450]. - The company has $1.3 million of research and development tax credits outstanding as of December 31, 2024, which are highly likely to be collected[501]. General and Administrative Expenses - General and administrative expenses rose to $60.5 million in 2024, an increase of $30.2 million from $30.3 million in 2023[441]. - General and administrative expenses increased by $30.2 million in 2024, primarily due to a $25.3 million rise in stock-based compensation[449]. Cash Flow and Financing Activities - Cash flows used in operating activities were $142.1 million in 2024, up from $76.8 million in 2023[468][469]. - Net cash used in investing activities was $205.3 million in 2024, significantly lower than $587.8 million in 2023[470]. - Net cash provided by financing activities was $381.2 million in 2024, compared to $86.5 million in 2023[471]. - Net cash provided by financing activities for the year ended December 31, 2023, was $86.5 million, primarily due to net proceeds of $104.1 million from the 2023 Rights Offering[472]. - The company extinguished $395.3 million of principal and accrued interest under the $400 million Duggan Promissory Note as part of the Rights Offering[472]. Debt and Interest - Interest expense on promissory notes payable decreased to $8.7 million in 2024 from $16.5 million in 2023[454]. - Interest on the Duggan Promissory Notes accrues at an initial rate of 7.5%[476]. - The Duggan February Note was amended to extend the maturity date from September 6, 2024, to April 1, 2025[479]. - As of October 1, 2024, the company repaid the Duggan September Note in full, totaling $100 million in principal payments and $7.3 million in accrued cash interest[480]. Future Expectations - The company expects to continue incurring significant operating losses for the foreseeable future[456]. - The company expects to finance operations through public or private equity or debt financings until significant revenue from product sales is generated[498]. Tax and Regulatory Matters - The company has unrecognized tax positions of $2.1 million and $1.1 million as of December 31, 2024, and 2023, respectively[495]. - Additional potential milestone payments to Akeso could total $4.56 billion, including regulatory and commercial milestones[461]. Currency and Interest Rate Risks - The company is exposed to foreign currency exchange rate risk, particularly with the pound sterling and euro, but currently does not consider the impact material[499]. - The company maintains a portfolio of cash, cash equivalents, and short-term investments to minimize interest rate risk, with no material exposure to changes in fair value due to interest rate fluctuations[500]. - A hypothetical 10% increase or decrease in overall interest rates would not have a material impact on the company's operating results or portfolio fair value[500]. - The company monitors its exposure to foreign currency exchange rate risk and manages it through natural hedging[499]. Dividend Policy - The company has not paid and does not intend to pay dividends, based on its history and expectations[496]. - The company’s expected volatility is calculated based on historical volatility of its share price[496].

Clinical Trials and Development - Ivonescimab has 9 total Phase III trials, with 3 fully enrolled, 4 currently enrolling, and 2 imminently starting[6]. - Ivonescimab has treated over 2,300 patients in clinical trials, with 14 publications in 2024 across 7 tumor types[13]. - The anticipated first patient for a new trial in China is expected in early 2025[20]. - The enrollment for the studies was completed, with topline data expected in mid-2025[44]. - The enrollment for the HARMONi-6 clinical trial is expected to be completed by the end of 2024, with global clinical trial results anticipated in mid-2025[69]. - Akeso plans to initiate additional Phase III clinical trials for Ivonescimab in various indications beyond NSCLC, including pancreatic cancer[69]. Financial Performance - The company reported a stock performance increase of 584% in 2024, with unaudited financial results showing $435 million in financial assets at year-end[10]. - The current debt stands at $31.8 million, with principal payments made in Q4 2024[10]. - The company has committed $15 million to expand its clinical development pipeline, including 30+ approved trials being initiated[18]. Efficacy and Safety - The HARMONI trial demonstrated a statistically significant improvement in progression-free survival (PFS) compared to Pembrolizumab[7]. - Ivonescimab demonstrated a median progression-free survival (mPFS) of 11.14 months compared to 5.82 months for pembrolizumab, showing a 5.3 month improvement[27]. - The hazard ratio for progression-free survival (PFS) between Ivonescimab and pembrolizumab was 0.51, with a p-value of <0.0001, indicating a statistically significant advantage for Ivonescimab[27]. - In a Phase III study, Ivonescimab showed a clinically meaningful improvement in PFS across major clinical subgroups, with a stratified hazard ratio of 0.46[28]. - The safety profile of Ivonescimab was consistent with prior studies, with treatment-related adverse events (TRAEs) reported at 29.9% for Ivonescimab and 28.1% for pembrolizumab[36]. - In the 2L+ EGFRm NSCLC study, Ivonescimab combined with chemotherapy resulted in an mPFS of 7.1 months compared to 4.8 months for placebo plus chemotherapy, with a hazard ratio of 0.46 and a p-value of <0.001[48]. - Ivonescimab demonstrated a 43.6% pathologic complete response (pCR) rate in Phase II studies for perioperative resectable non-small cell lung cancer (NSCLC) with a median progression-free survival (PFS) of 80.3% at 12 months[58]. - In the first-line setting for metastatic colorectal cancer (CRC), Ivonescimab achieved an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100% with a 9-month PFS rate of 81.4%[60]. - For first-line PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), Ivonescimab reported an ORR of 60% and a DCR of 90% with a median PFS of 7.1 months[65]. - In the first-line triple-negative breast cancer (TNBC) setting, Ivonescimab achieved an ORR of 79.3% and a 6-month PFS rate of 83.3%[67]. - The safety profile of Ivonescimab in the HARMONi-A study was generally well tolerated, with a low rate of treatment discontinuation and no unexpected adverse events reported[23]. Regulatory Status and Market Potential - Ivonescimab is approved in China and is expected to have top-line data available by mid-2025[20]. - Ivonescimab is currently not approved by any regulatory authority other than China's National Medical Products Administration (NMPA)[27]. - Ivonescimab is currently only approved by China's National Medical Products Administration (NMPA) and is still under investigation in other markets[61]. - The global market opportunity for checkpoint inhibitors (CPI) in NSCLC is projected to exceed $90 billion by 2028, with Ivonescimab positioned to capture significant market share[70]. Company Strategy - The company emphasizes a mission to improve quality of life and address serious unmet medical needs[3]. - The company is actively pursuing collaborations and potential acquisitions to enhance its drug development pipeline[2]. - Akeso is expanding its global clinical development plan for Ivonescimab, indicating a strong commitment to advancing its pipeline[69].

Core Insights - The biotech industry saw strong performance in 2024, particularly for Viking Therapeutics and Summit Therapeutics, with both companies' shares more than doubling due to significant clinical advancements [1] Group 1: Viking Therapeutics - Viking Therapeutics gained attention with promising phase 2 results for VK2735, a potential weight loss therapy, which is a dual GLP-1/GIP medicine [2] - The company plans to initiate phase 3 trials for VK2735 and VK2809, a treatment for metabolic dysfunction-associated steatohepatitis (MASH), which also showed strong phase 2 results [2][3] - The weight loss market is expected to grow significantly, and there is a high unmet need in the MASH therapy space, with Viking's progress outpacing larger competitors [3] - Viking Therapeutics is developing multiple weight loss options, including an oral version of VK2735 in phase 1 studies and a solid candidate in preclinical testing [4] - Although the company is not expected to launch a product or become profitable in 2025, its progress could attract investors and lead to strong stock performance [5] Group 2: Summit Therapeutics - Summit Therapeutics has a potential blockbuster drug, ivonescimab, which is already approved in China and has shown positive phase 3 results for treating non-small cell lung cancer (NSCLC) [6][7] - Ivonescimab outperformed Merck's Keytruda in clinical trials, which is significant as Keytruda is the best-selling drug globally [8] - The company is conducting phase 3 studies in the U.S. for ivonescimab, with fast track designation from the FDA, and plans to release top-line data in mid-2025 [9] - Summit Therapeutics will initiate additional phase 3 studies and continue trials in China, with expectations of solid clinical progress that could enhance stock performance in 2025 [10]

Core Viewpoint - Summit Therapeutics has experienced a significant increase in valuation, rising over 500% in the past year, driven by excitement around its cancer drug ivonescimab, but its future performance remains uncertain due to regulatory challenges and high valuation risks [2][4][7]. Company Overview - Summit Therapeutics is currently valued at nearly $18 billion, despite not generating consistent revenue or having approved products [4]. - The stock's valuation is higher than established healthcare companies like Quest Diagnostics ($17.3 billion) and Moderna ($15.9 billion) [5]. Drug Development Insights - The excitement around Summit Therapeutics is primarily due to ivonescimab, which showed promising results in a phase 3 clinical trial, outperforming Merck's Keytruda in treating advanced non-small cell lung cancer [2]. - The median progression-free survival for ivonescimab was reported at 11.14 months, compared to 5.82 months for Keytruda [2]. Regulatory Considerations - The trial data for ivonescimab was based solely on Chinese patients, raising concerns about the need for more diverse data to satisfy regulatory requirements [3]. - The approval of ivonescimab is not guaranteed, and the stock is currently priced as if approval is a certainty, which poses significant risks [5][7]. Market Sentiment and Risks - Investors are speculating on the potential approval of ivonescimab, which could lead to further stock price increases if future trial data is positive [6]. - Conversely, if the drug does not receive approval, the stock could face a drastic sell-off due to its inflated valuation [6][8]. - The stock is considered speculative, and it may be too early to invest without confirmed approval for ivonescimab [8].

Shares of Summit Therapeutics (SMMT 15.95%) had jumped 14.3% at 11:31 a.m. ET on Tuesday. The nice gain came after reports that H.C. Wainwright analyst Mitchell Kapoor maintained a "buy" rating for the stock with a 12-month price target of $44. Kapoor's target price reflects an upside potential for Summit of over 100%. Other Wall Street analysts are also bullish about the biotech stock, although not to the same extent. The average price target for Summit is roughly 52% above the current share price. Undersc ...

Core Insights - Summit Therapeutics' stock surged 583.7% in 2024, driven by positive trial results for its monoclonal antibody drug Ivonescimab for lung cancer [1][6] - The stock's gains were primarily realized in May and September, following the release of phase 3 trial data [2] Group 1: Trial Results - In May, the HARMONi-A phase 3 trial showed a 54% reduction in disease progression or death for Ivonescimab combined with chemotherapy in patients with EGFR-mutated non-small cell lung cancer [3] - In September, the HARMONi-2 trial demonstrated that Ivonescimab achieved a progression-free survival (PFS) rate of 11.14 months, significantly outperforming Keytruda's 5.82 months [4][5] - The FDA granted Ivonescimab a "fast track" designation in October, indicating potential for expedited approval [5] Group 2: Market Potential - Analysts estimate the market for PD-L1 lung cancer drugs to be around $50 billion, positioning Ivonescimab as a potential blockbuster [6] - Despite a decline from its 52-week high of $33.89 to $19.51 per share by year-end, the stock remains attractive for future growth [6] - Truist analyst predicts Ivonescimab could generate annual sales in the "double-digit billions," making Summit a potential acquisition target [7][8]

Core Insights - Summit Therapeutics' ivonescimab has received fast-track designation from the FDA for treating metastatic non-squamous NSCLC, indicating a significant unmet medical need [2] - The company plans to release top-line data from its phase 3 study next year and is conducting multiple late-stage trials [2][4] - Ivonescimab has shown promising results in a late-stage study in China, outperforming Merck's Keytruda in treating first-line NSCLC patients with PD-L1 overexpression [4] Company Overview - Summit Therapeutics has a market capitalization of $14 billion, reflecting high investor expectations despite not having any drugs on the market [7] - The company is pursuing a broad range of indications for ivonescimab, which could lead to significant revenue generation exceeding $1 billion annually by 2030 [5][11] - The drug is already approved in China, and Summit has rights to commercialize it in various regions outside of China [8] Clinical Development - Summit is conducting two phase 3 clinical trials in the U.S. to support ivonescimab's approval [4] - The company is optimistic about the drug's potential, with expectations for rapid uptake following its first approval within the next two-and-a-half years [10] - Positive results from ongoing clinical trials, especially those comparing ivonescimab to Keytruda, could further enhance the company's market valuation [6] Market Performance - Summit's stock has increased by 340% since January 2023, indicating strong market confidence in its pipeline candidate [7] - The market has already factored some positive outcomes into the stock price, but there remains significant upside potential if clinical trials yield consistent positive results [6]