Summit Therapeutics SMMT reported third-quarter 2024 loss per share of 8 cents, wider than the Zacks Consensus Estimate of a loss of 7 cents. In the year-ago period, the company posted a loss of 3 cents per share.
The reported loss included stock-based compensation expenses. Excluding these expenses, the adjusted loss per share was 5 cents, wider than the year-ago adjusted loss of 3 cents.
As the company lacks any marketed product in its portfolio, it did not record quarterly revenues.
More on SMMT’s Earnings
Adjusted research and development expenses totaled $31.9 million compared with $15.2 million in the year-ago period. This surge was primarily due to an increase in clinical costs to support the company’s pipeline development.
Adjusted general and administrative expenses amounted to $6.8 million, up 42% on a year-over-year basis.
As of Sept. 30, 2024, Summit had cash, cash equivalents and short-term investments worth $487 million compared with $326 million as of June 30, 2024. This cash balance rose after management raised $235 million in private financing from multiple leading biotech institutional investors and insiders last month.
SMMT’s Pipeline Updates
Summit has only one pipeline drug in its portfolio, ivonescimab, a first-in-class bispecific antibody that targets two proteins, namely PD-1 and VEGF. Summit is currently conducting two late-stage studies, HARMONi and HARMONi-3, evaluating ivonescimab in separate settings for metastatic non-small cell lung cancer (NSCLC) indication.
Alongside the earnings update, Summit announced that it is amending the design of the HARMONi-3 study, which is evaluating ivonescimab plus chemotherapy in first-line metastatic squamous NSCLC patients against the combination of Merck’s MRK blockbuster oncology drug Keytruda and chemotherapy. The study that previously enrolled NSCLC patients with squamous histologies will now also enroll patients with non-squamous histologies. Earlier there was only one primary endpoint in the study — overall survival (OS). The study has two primary endpoints — OS and progression-free survival (PFS) — now.
Shares of Summit have skyrocketed more than 600% year to date against the industry’s 4.4% decline.
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Earlier this month, management announced that the HARMONi study has completed enrolment. The study is evaluating ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). Data from the study is expected in mid-2025.
Ivonescimab is being developed in collaboration with China-based Akeso, the drug's original developer. Summit acquired an exclusive license from Akeso in 2022 to develop and market the drug in the United States, Canada, Europe and Japan. The company expanded its licensing deal in June and now covers Latin America, the Middle East and Africa.
Last month, Summit reported additional results from the Akeso-sponsored HARMONi-2 study, which evaluated ivonescimab against Merck’s Keytruda in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. Data from the study showed that the treatment with the drug cut the risk of disease progression or death by nearly half compared to Merck’s drug. This data also conforms with the initial results (reported by SMMT in May), wherein treatment with the drug demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival.
Based on HARMONi-2 results, Summit announced plans to sponsor a late-stage study called HARMONi-7 across several countries, expected to start in early 2025. This study will compare ivonescimab with Merck’s Keytruda in patients with metastatic NSCLC whose tumors have high PD-L1 expression. Based on details posted on a government website, data from this study can be expected in 2027.
Some better-ranked stocks from the sector are Castle Biosciences CSTL and Elevation Oncology ELEV, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from $1.28 to 58 cents. Year to date, shares of Castle Biosciences have surged 60.0%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 132.32%.
In the past 60 days, estimates for Elevation Oncology’s 2024 loss per share have narrowed from 86 to 82 cents. Loss per share estimates for 2025 have narrowed from 90 to 86 cents during the same time. Year to date, shares of ELEV have rallied 11.7%.
ELEV’s earnings beat estimates in three of the trailing four quarters and missed the same in one, the average surprise being 12.05%.
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