Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing with a decision expected by Nov. 14.
Summit Therapeutics has just over $690 million in cash, equivalents and short-term investments—a sum that the company says is not enough to keep it going for another year.
“The company’s cash and cash equivalents and short-term investments are not sufficient to fund the company’s planned operations for a period of at least one year,” Summit said in its second quarter earnings filing with the SEC on Thursday. In the first half of the year, the biotech’s losses topped $405 million. For the same time period, the biotech spent around $290 million on R&D. The company said it “expects to continue to generate operating losses for the foreseeable future.”
As of publication, Summit has not responded to BioSpace‘s request for comment.
Summit’s cash crunch comes as the FDA’s verdict for its PD-1/VEGF bispecific antibody ivonescimab nears. The biotech is proposing ivonescimab for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations and prior treatment with a TKI therapy.
The application is currently under regulatory review, with a decision expected on or before Nov. 14.
Ivonescimab first made waves in September 2024, when Summit and its Chinese partner Akeso—which originally developed the investigational antibody—claimed victory over Merck’s mega-blockbuster Keytruda in a Phase 3 NSCLC study, eliciting significantly better progression-free survival in a Chinese study.
Since then, however, ivonescimab has been hounded by questions about its efficacy in Western patients. In September 2025, a combination of ivonescimab and chemotherapy elicited a 22% overall survival benefit, which fell short of statistical significance.
Earlier this week, however, Summit disclosed longer-term data for ivonescimab, touting a 24% decrease in the overall risk of death in patients who were treated with the bispecific plus chemotherapy, as compared with those on standard of care. The biotech did not say whether this effect was statistically significant, but analysts were bullish on the readout.
“The risk that China data would not translate has been a lingering bear argument,” Stifel wrote in a July 22 note, adding that these new data present a “strong counter” to that argument.
“Bears can still point to the lack of explicit statistical-significance language, but in our view the more relevant FDA question is whether the global data are consistent, and this update directly addresses that concern,” the firm added.
Summit is also testing ivonescimab in a Phase 3 study for first-line metastatic NSCLC, with a readout for the subgroup of patients with squamous disease planned for later this year, according to the Thursday release. Data from the non-squamous cohort are expected in the first half of 2027.
Back in January 2025, Truist analysts pegged peak ivonescimab sales at $7 billion, noting that the estimate was “based almost entirely on lung cancer, and is highly conservative in our view.” Keytruda, meanwhile, continues its reign as the best-selling drug, bringing in nearly $32 billion across more than 40 indications in 2025.
“[T]he potential to dethrone Keytruda and capture some of its sales makes ivonescimab highly attractive,” Truist analysts wrote in a Jan. 8, 2025 note.
