SMMT's Q2 Loss Wider Than Expected, Ivonescimab Development in Focus

More on SMMT’s Q2 Results

Research and development (R&D) expenses were $157.7 million, down 24.2% year over year. General and administrative expenses plunged 82.6% year over year to $62.8 million. The substantial decline in operating costs was primarily due to a significant reduction in stock-based compensation expenses. However, total operating expenses increased 13% sequentially, reflecting higher R&D spending associated with the continued clinical development of ivonescimab.

As of June 30, 2026, Summit had cash, cash equivalents and short-term investments totaling $690.7 million, compared with $598.7 million as of March 31, 2026.

During the second quarter of 2026, Summit raised $230.8 million in gross proceeds through its at-the-market (ATM) facility, followed by an additional $68.4 million in gross proceeds after quarter-end, further strengthening its liquidity position.

SMMT’s Pipeline Updates

The lead program in the company’s pipeline is ivonescimab, a dual PD-1/VEGF inhibitor being evaluated in multiple late-stage studies across different settings in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). SMMT is developing ivonescimab in collaboration with China-based Akeso. Ivonescimab is currently approved only in China for two distinct NSCLC indications.

In January, the FDA accepted the company's biologics license application (BLA) seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutant, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with third-generation EGFR-TKIs. The BLA filing was based on encouraging September 2025 results from the phase III HARMONi study. The FDA decision is expected by Nov. 14, 2026.

In July 2026, Summit reported more favorable OS data from the HARMONi study, with longer follow-up, demonstrating a consistent survival benefit with ivonescimab across Western and Asian patient populations. The analysis showed a hazard ratio (HR) of 0.76 in the overall intent-to-treat population, with the same HR of 0.76 observed independently in both the Western and Asian subgroups, reinforcing the geographic consistency of the treatment benefit.

The updated OS data have been submitted to the FDA as part of the ongoing BLA review, which could extend the FDA’s review timeline.

Year to date, shares of SMMT have lost 14.4% compared with the industry’s 3.9% decline.

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The company is evaluating ivonescimab in three late-stage studies, two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).

HARMONi-3 is evaluating the drug against Merck’s MRK blockbuster PD-L1 drug Keytruda (pembrolizumab) as a first-line treatment for metastatic squamous or non-squamous NSCLC, while HARMONi-7 is evaluating ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

In the HARMONi-3 study, under the revised design, squamous and non-squamous NSCLC cohorts are being analyzed separately, with progression-free survival (PFS) and overall survival as primary endpoints. Patient enrollment in both cohorts has been completed. The final PFS results are expected in the second half of 2026 and in the first half of 2027 for the squamous and non-squamous NSCLC cohorts, respectively.

Patient enrollment in the phase III HARMONi-GI3 study, evaluating the candidate in combination with chemotherapy against bevacizumab plus chemotherapy in first-line unresectable metastatic colorectal cancer, is ongoing.

The company agreed to divest its investigational antibiotic, ridinilazole to Toronto-based Biossil Inc. in mid-July. The late-stage asset is being developed for the treatment of patients with clostridioides difficile infection, a serious bacterial infection of the colon. Per the agreement, Biossil will assume responsibility for the further development and commercialization of ridinilazole. In return, Summit will receive an upfront payment of $500,000 and will be eligible for up to $104.5 million in regulatory and commercial milestones, plus tiered royalties on net sales.

In July, Summit announced a collaboration with Arcus Biosciences RCUS to evaluate RCUS' investigational HIF-2α inhibitor, casdatifan, in combination with ivonescimab for the treatment of clear cell renal cell carcinoma, including first-line metastatic disease. Arcus will sponsor and conduct the study, while both companies will share development costs and retain commercial rights to their respective therapies. Initial study data are expected by mid-2027.

SMMT’s Zacks Rank  

Summit currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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