Non - small cell lung cancer (NSCLC) treatment

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SMMT Q2 Loss Wider Than Expected, Ivonescimab Studies in Focus
ZACKSยท 2025-08-12 16:46
Core Insights - Summit Therapeutics (SMMT) reported a second-quarter 2025 loss per share of $0.76, significantly wider than the Zacks Consensus Estimate of a loss of $0.10, and compared to a loss of $0.09 in the same period last year [1][7] - The company currently has no marketed products, resulting in no recorded revenues for the quarter [2] - Year-to-date, SMMT shares have increased by 58.3%, outperforming the industry average increase of 5.3% [2] Financial Performance - Adjusted research and development expenses reached $79.4 million, a 190.8% increase year-over-year, primarily due to higher costs for expanding clinical studies for ivonescimab [4] - Adjusted general and administrative expenses rose by 64.5% year-over-year to $10.2 million, driven by costs associated with developing infrastructure for ivonescimab [4] - As of June 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $297.9 million, down from $361.3 million as of March 31, 2025 [5] Pipeline Developments - Summit's only pipeline drug, ivonescimab, is a first-in-class bispecific antibody targeting PD-1 and VEGF, currently undergoing three late-stage studies for non-small cell lung cancer (NSCLC) [8] - The phase III HARMONi study showed that ivonescimab plus chemotherapy reduced the risk of disease progression by 48% compared to chemotherapy alone, but did not achieve statistically significant overall survival benefits [9][10] - The company plans to file for approval of the ivonescimab-chemo combination for previously treated EGFR-mutated NSCLC, pending further discussions with the FDA regarding the need for statistically significant overall survival benefits [10] Recent Study Results - Positive results were reported from the Akeso-sponsored phase III HARMONi-6 study, where ivonescimab plus chemotherapy showed significant improvement in progression-free survival compared to BeiGene's PD-1 inhibitor [11] - The HARMONi-3 study is evaluating ivonescimab against Merck's Keytruda in first-line metastatic NSCLC patients [12] - The HARMONi-2 study previously demonstrated that ivonescimab outperformed Keytruda in patients with positive PD-L1 expression [13] Collaborations and Approvals - Akeso has secured approval for ivonescimab in a second indication for front-line PD-L1 positive advanced NSCLC based on HARMONi-2 results [14] - Summit has entered clinical trial collaborations with Pfizer and Revolution Medicines to evaluate ivonescimab in combination with their drugs across various solid tumor settings [15]