We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
SMMT's Q2 Loss Wider Than Expected, Ivonescimab Development in Focus
Read MoreHide Full Article
Key Takeaways
SMMT reported a wider-than-expected Q2 loss and ended the quarter with higher cash after ATM fundraising.
Summit submitted updated ivonescimab survival data to the FDA during its ongoing BLA review.
SMMT expanded ivonescimab efforts with late-stage studies and a new Arcus collaboration.
Summit Therapeutics (SMMT - Free Report) reported a second-quarter 2026 loss per share of 28 cents, wider than the Zacks Consensus Estimate of a loss of 26 cents per share. In the year-ago period, the company had incurred a loss of 76 cents per share.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in the quarter.
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.
Image Source: Zacks Investment Research
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 - 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. 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 - Free Report) 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.
Summit Therapeutics PLC Price, Consensus and EPS Surprise
View the Zacks #1 Rank List
Image: Bigstock
SMMT's Q2 Loss Wider Than Expected, Ivonescimab Development in Focus
Key Takeaways
Summit Therapeutics (SMMT - Free Report) reported a second-quarter 2026 loss per share of 28 cents, wider than the Zacks Consensus Estimate of a loss of 26 cents per share. In the year-ago period, the company had incurred a loss of 76 cents per share.
The company currently lacks a marketed product in its portfolio. As a result, it did not record revenues in the quarter.
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.
Image Source: Zacks Investment Research
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 - 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. 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 - Free Report) 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.
Summit Therapeutics PLC Price, Consensus and EPS Surprise
Summit Therapeutics PLC price-consensus-eps-surprise-chart | Summit Therapeutics PLC Quote
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.