Summit Therapeutics Q1 Loss Narrower Than Expected, Sales Nil

Summit Therapeutics SMMT reported first-quarter 2025 loss per share of 9 cents, narrower than the Zacks Consensus Estimate of a loss of 10 cents. In the year-ago period, the company incurred a loss of 6 cents.

The reported loss included stock-based compensation expenses. Excluding these expenses, the adjusted loss per share was 7 cents, wider than the year-ago adjusted loss of 5 cents.

As the company lacks any marketed product in its portfolio, it did not record quarterly revenues. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar)

SMMT Stock Performance

The stock has surged 38% year to date against the industry’s 2% decline.

More on SMMT’s Earnings

Adjusted research and development expenses totaled $47.1 million, up 65% year over year. This was mainly due to an increase in clinical costs to support the company’s pipeline development.

Adjusted general and administrative expenses surged 95% year over year to $8.6 million. This uptick was attributed to higher headcount and commercial readiness efforts.

As of March 31, 2025, Summit had cash, cash equivalents and short-term investments worth $361.3 million compared with $412.3 million as of Dec. 31, 2024.

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. The company is currently conducting three late-stage studies, HARMONi, HARMONi-3 and HARMONi-7, evaluating ivonescimab in separate settings for the non-small cell lung cancer (NSCLC) indication. While top-line results from the HARMONi study are expected in mid-2025, the other two studies are currently enrolling patients. The drug is being developed in collaboration with China-based Akeso.

Last week, SMMT reported positive results from the Akeso-sponsored phase III HARMONi-6 study, which evaluated ivonescimab plus chemotherapy against BeiGene’s PD-1 inhibitor Tevimbra plus chemotherapy in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. The study met its primary endpoint of progression-free survival (PFS) — patients treated with the ivonescimab regimen showed statistically significant and clinically meaningful improvement over those who received the Tevimbra combination regimen.

The above results make HARMONi-6 the first known late-stage study in NSCLC to show significant improvement over a PD-(L)1 inhibitor combined with chemotherapy in a head-to-head setting. Building upon this success, Summit is conducting the HARMONi-3 study, which evaluates ivonescimab plus chemo against Merck’s MRK blockbuster drug Keytruda combined with chemotherapy in patients with first-line metastatic, squamous and non-squamous NSCLC.

Given that both studies target similar patient populations, the positive outcomes from HARMONi-6 bolster confidence in HARMONi-3's potential to establish ivonescimab as a superior alternative to existing PD-(L)1-based therapies across a broader NSCLC spectrum.

The HARMONi-6 study marks the second time that an ivonescimab-based regimen has demonstrated a statistically significant benefit over PD-(L)1 inhibitor-based regimens, also the current standard of care. Last year, Summit reported results from the Akeso-sponsored HARMONi-2 study, which showed that treatment with ivonescimab outdid Merck’s Keytruda in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. Based on these results, Summit is conducting the HARMONi-7 across several countries based on the same design as HARMONi-2.

Last week, Summit also announced that Akeso has secured approval for ivonescimab in a second indication — front-line PD-L1 positive advanced NSCLC — based on HARMONi-2 results. As part of the review process, the Chinese health authorities requested an interim overall survival (OS) analysis. While the results demonstrated a clinically meaningful trend favoring ivonescimab at 39% data maturity, they were not statistically significant.

Summit is also working to expand ivonescimab development across multiple disease areas. In this regard, it has been exploring partnership opportunities with global institutions, which are either conducting or planning investigator-initiated studies across solid tumors. In February, SMMT announced a partnership with Pfizer PFE to evaluate ivonescimab in combination with several of Pfizer’s antibody-drug conjugates across multiple solid tumor settings. The studies under this collaboration are expected to start later in 2025.

SMMT’s Zacks Rank

Summit currently has 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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This article originally published on Zacks Investment Research (zacks.com).

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