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Introduction & Market Context
Summit Therapeutics (NASDAQ:SMMT) presented its Q3 2024 earnings call on October 30, 2024, highlighting significant clinical progress for its lead compound ivonescimab, a novel PD-1/VEGF bispecific antibody. The company’s stock has shown strong performance, with fundamentals data indicating a 2.65% increase to $27.07 as of August 1, 2025, and a 52-week range of $8.88 to $36.91, reflecting investor confidence in the company’s pipeline.
Executive Summary
Summit Therapeutics reported a GAAP net loss of $56.3 million for Q3 2024, an improvement from the $60.4 million loss in Q2 2024. The company maintains a strong cash position of $487 million as of October 29, 2024, bolstered by a $235 million financing round from leading biotech investors. The presentation emphasized breakthrough clinical results for ivonescimab, particularly in the HARMONI-2 trial where it demonstrated superior progression-free survival (PFS) compared to pembrolizumab in first-line non-small cell lung cancer (NSCLC).
As shown in the following comprehensive overview of the quarter’s achievements:
Clinical Development Highlights
Summit’s lead compound, ivonescimab, is positioned as the only Phase III PD-1/VEGF bispecific antibody in the company’s license territories, which include North America, South America, Japan, Europe, Middle East, and Africa. The company has an extensive clinical development program with more than 25 clinical trials across 17 tumor settings, with over 1,800 patients treated.
The following slide illustrates the breadth of Summit’s global clinical trial program for ivonescimab:
HARMONI-2 Trial Results
The most significant highlight from the presentation was the positive results from the HARMONI-2 trial, an Akeso-sponsored Phase III study comparing ivonescimab with pembrolizumab in patients with advanced or metastatic PD-L1-positive NSCLC. The trial demonstrated a statistically significant improvement in progression-free survival with ivonescimab.
As shown in the following Kaplan-Meier curve, ivonescimab achieved a median PFS of 11.14 months compared to 5.82 months for pembrolizumab, representing a 49% reduction in the risk of disease progression (HR 0.51, p<0.0001):
The benefit of ivonescimab was consistent across key patient subgroups, including those with low and high PD-L1 expression as well as squamous and non-squamous histology. The following subgroup analyses further illustrate the broad efficacy profile:
While demonstrating superior efficacy, ivonescimab showed a manageable safety profile, though with a higher incidence of Grade≥3 treatment-related adverse events (TRAEs) compared to pembrolizumab (29.4% vs. 15.6%). The most common TRAEs included proteinuria, increased aspartate aminotransferase, hypercholesterolemia, increased blood bilirubin, and hypertension.
The following chart details the safety profile comparison between ivonescimab and pembrolizumab:
Expanding Clinical Program
Building on the positive HARMONI-2 results, Summit is expanding its clinical development program. The company has completed enrollment in the global HARMONI Phase III trial, with topline data expected in mid-2025. Additionally, the HARMONI-3 trial has been expanded to include patients with non-squamous histology in addition to squamous tumors.
Summit also announced plans to initiate the HARMONI-7 global Phase III trial in early 2025, which will compare ivonescimab monotherapy versus pembrolizumab monotherapy in NSCLC patients with high PD-L1 expression (TPS ≥ 50%).
The design of the upcoming HARMONI-7 trial is outlined in the following slide:
Beyond NSCLC, Summit presented promising Phase II data for ivonescimab in multiple cancer types, including colorectal cancer (CRC), triple-negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), and early-stage NSCLC. These results support the potential for broader clinical development of ivonescimab across various oncology indications.
The following slide summarizes the encouraging efficacy data from these Phase II studies:
Financial Performance
For Q3 2024, Summit reported total GAAP operating expenses of $58.1 million, slightly down from $59.8 million in Q2 2024. Research and development expenses increased to $37.7 million from $30.8 million in the previous quarter, reflecting the company’s continued investment in its clinical programs. General and administrative expenses also rose to $20.4 million from $14.0 million.
The company’s financial position remains strong, with $487 million in cash, cash equivalents, and short-term investments as of September 30, 2024, following the completion of a $235 million private financing round. With a market capitalization of $16.1 billion, Summit appears well-positioned to fund its ongoing and planned clinical trials.
Forward-Looking Statements
Looking ahead, Summit Therapeutics is focused on advancing its clinical development program for ivonescimab. Key upcoming milestones include:
1. Topline data from the global HARMONI Phase III trial expected in mid-2025
2. Initiation of the HARMONI-7 global Phase III trial in early 2025
3. Continued exploration of ivonescimab in additional cancer indications beyond NSCLC
The company’s strong cash position provides runway to pursue these initiatives while maintaining operational flexibility. With ivonescimab already approved in China by the National Medical (TASE:BLWV) Products Administration (NMPA) and showing promising results in global trials, Summit is positioning itself as a significant player in the oncology space, particularly in the treatment of NSCLC.
While the clinical data presented is encouraging, investors should note that ivonescimab is still an investigational therapy not yet approved by regulatory authorities outside of China, and further clinical trial results will be critical for the company’s long-term success.
Full presentation:
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