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SMMT Q1 Loss Narrower Than Expected, Stock Down on Ivonescimab Setback
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Key Takeaways
SMMT reported a Q1 loss of 24 cents per share, which beat estimates but widened from the year-ago loss.
SMMT saw costs surge as R&D and G&A expenses rose due to higher clinical studies and stock compensation.
Ivonescimab study continues as planned, crushing early approval hopes and sending shares down 25%.
Summit Therapeutics (SMMT - Free Report) reported first-quarter 2026 loss per share of 24 cents, narrower than the Zacks Consensus Estimate of a loss of 33 cents. In the year-ago period, the company had incurred a loss of 9 cents per share.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in 2025.
More on SMMT’s Q1 Results
Research and development (R&D) expenses rose significantly to $132.6 million, reflecting a 159% year-over-year increase. General and administrative expenses surged 301% year over year to $62.6 million. The substantial growth in operating costs was primarily due to higher stock-based compensation and increased clinical study costs and expenses related to building the infrastructure to support the development of ivonescimab.
As of March 31, 2026, Summit Therapeutics had cash, cash equivalents and short-term investments worth $598.7 million compared with $713.4 million as of Dec. 31, 2025.
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 its biologics license application (BLA), seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with third-generation EGFR-TKIs. The BLA filing was based on encouraging results from the phase III HARMONi study. The FDA decision is expected by Nov. 14, 2026.
Summit Therapeutics PLC Price, Consensus and EPS Surprise
The company is currently enrolling patients in three late-stage studies on ivonescimab — two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).
HARMONi-3 is evaluating the drug against Merck’s (MRK - Free Report) 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.
Summit Therapeutics had planned to perform an interim PFS analysis from one part of its HARMONi-3 study — the squamous patient group — in the second quarter of 2026. If the data from the interim analysis were strong, it would have allowed Summit to begin discussions with regulators, including the FDA, instead of waiting for the final planned analysis later in 2026.
However, an Independent Data Monitoring Committee (iDMC) reviewed the results of the interim analysis and recommended that the study should continue as planned, with the final PFS results still expected in the second half of 2026. The iDMC found no safety concerns. This eliminated hopes of an early regulatory path, which led the stock to fall 25% on Friday.
Year to date, shares of SMMT have lost 3.8% compared with the industry’s 2.1% decline.
Image Source: Zacks Investment Research
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.
In January 2026, Summit Therapeutics announced a collaboration with GSK plc (GSK - Free Report) to evaluate ivonescimab in combination with risvutatug rezetecan, GSK’s novel investigational B7-H3-targeting antibody-drug conjugate, across multiple solid tumor settings, including small cell lung cancer. Each company will retain full rights to its respective products. Patient dosing is expected to commence in mid-2026.
SMMT’s Zacks Rank & Stock to Consider
Summit Therapeutics currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 36.2% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
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SMMT Q1 Loss Narrower Than Expected, Stock Down on Ivonescimab Setback
Key Takeaways
Summit Therapeutics (SMMT - Free Report) reported first-quarter 2026 loss per share of 24 cents, narrower than the Zacks Consensus Estimate of a loss of 33 cents. In the year-ago period, the company had incurred a loss of 9 cents per share.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in 2025.
More on SMMT’s Q1 Results
Research and development (R&D) expenses rose significantly to $132.6 million, reflecting a 159% year-over-year increase. General and administrative expenses surged 301% year over year to $62.6 million. The substantial growth in operating costs was primarily due to higher stock-based compensation and increased clinical study costs and expenses related to building the infrastructure to support the development of ivonescimab.
As of March 31, 2026, Summit Therapeutics had cash, cash equivalents and short-term investments worth $598.7 million compared with $713.4 million as of Dec. 31, 2025.
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 its biologics license application (BLA), seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with third-generation EGFR-TKIs. The BLA filing was based on encouraging results from the phase III HARMONi study. The FDA decision is expected by Nov. 14, 2026.
Summit Therapeutics PLC Price, Consensus and EPS Surprise
Summit Therapeutics PLC price-consensus-eps-surprise-chart | Summit Therapeutics PLC Quote
The company is currently enrolling patients in three late-stage studies on ivonescimab — two in NSCLC (HARMONi-3 and HARMONi-7) and one in CRC (HARMONi-GI3).
HARMONi-3 is evaluating the drug against Merck’s (MRK - Free Report) 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.
Summit Therapeutics had planned to perform an interim PFS analysis from one part of its HARMONi-3 study — the squamous patient group — in the second quarter of 2026. If the data from the interim analysis were strong, it would have allowed Summit to begin discussions with regulators, including the FDA, instead of waiting for the final planned analysis later in 2026.
However, an Independent Data Monitoring Committee (iDMC) reviewed the results of the interim analysis and recommended that the study should continue as planned, with the final PFS results still expected in the second half of 2026. The iDMC found no safety concerns. This eliminated hopes of an early regulatory path, which led the stock to fall 25% on Friday.
Year to date, shares of SMMT have lost 3.8% compared with the industry’s 2.1% decline.
Image Source: Zacks Investment Research
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.
In January 2026, Summit Therapeutics announced a collaboration with GSK plc (GSK - Free Report) to evaluate ivonescimab in combination with risvutatug rezetecan, GSK’s novel investigational B7-H3-targeting antibody-drug conjugate, across multiple solid tumor settings, including small cell lung cancer. Each company will retain full rights to its respective products. Patient dosing is expected to commence in mid-2026.
SMMT’s Zacks Rank & Stock to Consider
Summit Therapeutics currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Castle Biosciences (CSTL - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.42 to $1.40. Over the same period, loss per share estimates for 2027 have also narrowed from 79 cents to 78 cents. CSTL shares have lost 36.2% year to date.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.