Summit Therapeutics Posts Wider-Than-Expected Loss in Q3, Nil Sales

Financial Performance - Summit Therapeutics reported a third-quarter 2024 loss per share of 8 cents, wider than the Zacks Consensus Estimate of a loss of 7 cents, and compared to a loss of 3 cents per share in the year-ago period [1] - The adjusted loss per share, excluding stock-based compensation expenses, was 5 cents, also wider than the year-ago adjusted loss of 3 cents [1] - The company did not record any quarterly revenues as it lacks marketed products [1] Expenses - Adjusted research and development expenses totaled $31.9 million, up from $15.2 million in the year-ago period, primarily due to increased clinical costs for pipeline development [2] - Adjusted general and administrative expenses amounted to $6.8 million, reflecting a 42% increase year-over-year [2] Cash Position - As of September 30, 2024, Summit had cash, cash equivalents, and short-term investments worth $487 million, an increase from $326 million as of June 30, 2024, following a $235 million private financing round [3] Pipeline Developments - Summit has one pipeline drug, ivonescimab, a bispecific antibody targeting PD-1 and VEGF, currently undergoing two late-stage studies, HARMONi and HARMONi-3, for metastatic non-small cell lung cancer (NSCLC) [4] - The design of the HARMONi-3 study is being amended to include patients with nonsquamous histologies and now has two primary endpoints: overall survival (OS) and progression-free survival (PFS) [5] Study Updates - The HARMONi study has completed enrollment, focusing on patients with EGFR-mutated, locally advanced or metastatic nonsquamous NSCLC who have progressed after third-generation EGFR TKI treatment, with data expected in mid-2025 [8] - Results from the HARMONi-2 study indicated that ivonescimab reduced the risk of disease progression or death by nearly half compared to Merck's Keytruda, supporting the drug's efficacy [10] - A late-stage study, HARMONi-7, is planned to start in early 2025, comparing ivonescimab with Keytruda in patients with metastatic NSCLC and high PD-L1 expression, with data expected in 2027 [11] Stock Performance - Shares of Summit Therapeutics have increased over 600% year to date, contrasting with a 4.4% decline in the industry [6]