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SMMT Incurs Wider-Than-Expected Q4 Loss, Pipeline Progress in Focus
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Key Takeaways
SMMT reported a wider Q4 loss of 29 cents per share, with no revenues recorded in 2025.
Summit Therapeutics boosted R&D 117% to advance ivonescimab across late-stage NSCLC studies.
SMMT's FDA-accepted BLA for ivonescimab in NSCLC faces a decision by Nov. 14, 2026.
Summit Therapeutics (SMMT - Free Report) reported fourth-quarter 2025 loss per share of 29 cents, wider than the Zacks Consensus Estimate of 22 cents. In the year-ago period, the company had incurred a loss of 8 cents per share.
The reported loss included stock-based compensation. Excluding this, the adjusted loss per share was 14 cents, wider than the year-ago adjusted loss of 7 cents.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in 2025.
More on SMMT’s Q4 Results
Adjusted research and development (R&D) expenses totaled $102 million, up 117% year over year. The sharp increase was primarily due to higher clinical study costs related to advancing the company’s pipeline and initiating new clinical studies.
Adjusted general and administrative expenses surged 50.6% year over year to $11.3 million. The uptick was due to higher costs related to building the infrastructure to support the development of ivonescimab.
As of Dec. 31, 2025, Summit Therapeutics had cash, cash equivalents and short-term investments worth $713.4 million compared with $238.6 million as of Sept. 30, 2025.
SMMT’s Full-Year 2025 Results
For full-year 2025, Summit Therapeutics recorded a net loss of $1.44 per share, higher than a net loss of 31 cents reported in 2024.
Over the past year, the stock has lost 11.1% against the industry’s increase of 2.6%.
Image Source: Zacks Investment Research
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 final decision is expected by Nov. 14, 2026.
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 and overall survival as primary endpoints.
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.
Summit Therapeutics PLC Price, Consensus and EPS Surprise
Over the past 60 days, estimates for Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have risen 1.5% over the past year.
Assertio’s earnings beat estimates in one of the trailing four quarters and missed in the remaining three quarters, with the average negative surprise being 35.21%.
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SMMT Incurs Wider-Than-Expected Q4 Loss, Pipeline Progress in Focus
Key Takeaways
Summit Therapeutics (SMMT - Free Report) reported fourth-quarter 2025 loss per share of 29 cents, wider than the Zacks Consensus Estimate of 22 cents. In the year-ago period, the company had incurred a loss of 8 cents per share.
The reported loss included stock-based compensation. Excluding this, the adjusted loss per share was 14 cents, wider than the year-ago adjusted loss of 7 cents.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in 2025.
More on SMMT’s Q4 Results
Adjusted research and development (R&D) expenses totaled $102 million, up 117% year over year. The sharp increase was primarily due to higher clinical study costs related to advancing the company’s pipeline and initiating new clinical studies.
Adjusted general and administrative expenses surged 50.6% year over year to $11.3 million. The uptick was due to higher costs related to building the infrastructure to support the development of ivonescimab.
As of Dec. 31, 2025, Summit Therapeutics had cash, cash equivalents and short-term investments worth $713.4 million compared with $238.6 million as of Sept. 30, 2025.
SMMT’s Full-Year 2025 Results
For full-year 2025, Summit Therapeutics recorded a net loss of $1.44 per share, higher than a net loss of 31 cents reported in 2024.
Over the past year, the stock has lost 11.1% against the industry’s increase of 2.6%.
Image Source: Zacks Investment Research
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 final decision is expected by Nov. 14, 2026.
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 and overall survival as primary endpoints.
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.
Summit Therapeutics PLC Price, Consensus and EPS Surprise
Summit Therapeutics PLC price-consensus-eps-surprise-chart | Summit Therapeutics PLC Quote
SMMT’s Zacks Rank and Stock to Consider
Summit Therapeutics currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Assertio Holdings (ASRT - 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 Assertio’s 2026 loss per share have narrowed from 30 cents to 28 cents. ASRT shares have risen 1.5% over the past year.
Assertio’s earnings beat estimates in one of the trailing four quarters and missed in the remaining three quarters, with the average negative surprise being 35.21%.