SMMT Q2 Loss Wider Than Expected, Ivonescimab Studies in Focus

Summit Therapeutics SMMT reported second-quarter 2025 loss per share of 76 cents, much wider than the Zacks Consensus Estimate of a loss of 10 cents. In the year-ago period, the company had incurred a loss of 9 cents.

The reported loss included stock-based compensation expenses. Excluding these expenses, the adjusted loss per share was 12 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 the quarter.

Year to date, shares of Summit Therapeutics have rallied 58.3% compared with the industry’s increase of 5.3%.

SMMT’s Q2 Earnings in Detail

Adjusted research and development expenses totaled $79.4 million, up 190.8% year over year. This was mainly due to higher costs associated with the expansion of clinical studies and development activities for ivonescimab.

Adjusted general and administrative expenses surged 64.5% year over year to $10.2 million. This uptick was due to higher costs related to building the infrastructure to support the development of ivonescimab.

As of June 30, 2025, Summit had cash, cash equivalents and short-term investments worth $297.9 million compared with $361.3 million as of March 31, 2025.

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. The candidate is being developed in collaboration with China-based Akeso.

The company announced mixed data from the phase III HARMONi study, which evaluated ivonescimab in certain patients with NSCLC in May.

While data from this study showed that the treatment with ivonescimab plus chemotherapy cut the risk of disease progression by 48% compared with chemotherapy alone, it did not achieve “a statistically significant benefit” in the overall survival (OS) endpoint, which is considered the “gold standard” in oncology studies.

Based on the data from the HARMONi study, the company intended to file for approval of the ivonescimab-chemo combination in previously treated EGFR-mutated NSCLC. However, the FDA indicated that a statistically significant OS benefit is required to support marketing authorization. Management stated that it would consider the study results and ongoing discussions with the agency to determine the timing of its filing.

In April, 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.

Besides this, Summit is conducting the HARMONi-3 study, which evaluates ivonescimab plus chemotherapy against Merck’s MRK blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), combined with chemotherapy, in patients with first-line metastatic, squamous, and non-squamous NSCLC.

The HARMONi-6 study marks the second time that an ivonescimab-based regimen has demonstrated a statistically significant benefit over a PD-L1 inhibitor-based regimen. 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.

In April, 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. Ivonescimab is already approved in China in combination with chemotherapy for patients with EGFR-mutated NSCLC whose tumors have progressed after treatment with an EGFR TKI.

Earlier this year, Summit entered into separate clinical trial collaborations with Pfizer PFE and Revolution Medicines to evaluate ivonescimab in combination with Pfizer/Revolution Medicines’ drugs across multiple solid tumor settings.

Summit Therapeutics PLC Price, Consensus and EPS Surprise

Summit Therapeutics PLC price-consensus-eps-surprise-chart | Summit Therapeutics PLC Quote

SMMT’s Zacks Rank & Stock to Consider

Summit Therapeutics currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the biotech sector is CorMedix CRMD, carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CorMedix’s earnings per share have increased from 93 cents to 97 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.64 to $1.65. Year to date, shares of CRMD have rallied 24%.

CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

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

Zacks Investment Research