Summit Therapeutics Inc Stock Price, News & Analysis

Summit Therapeutics (NASDAQ:SMMT) reported significant progress in Q2 2025, highlighted by positive results from multiple Phase III trials of ivonescimab. The HARMONi trial demonstrated statistically significant improvement in progression-free survival with a hazard ratio of 0.52 (p<0.00001) in EGFR-mutated NSCLC patients.

The company's financial position showed $297.9 million in cash and investments as of June 30, 2025, down from $412.3 million in December 2024. A significant non-cash expense of $466.6 million was recorded due to stock option modifications. The company established a new $360 million ATM offering facility with J.P. Morgan.

Key operational highlights include positive interim survival analysis in the HARMONi-2 study, NMPA approval in China for first-line PD-L1 positive advanced NSCLC, and a new clinical collaboration with Revolution Medicines for RAS(ON) inhibitor combinations.

Summit Therapeutics (NASDAQ: SMMT) has granted inducement stock options to seven new employees, totaling 71,275 shares of common stock. The options were awarded on June 2, 2025, with a ten-year term and an exercise price of $17.72 per share, matching the company's closing stock price on the grant date. These options will vest in equal annual installments over four years and were granted from a pre-approved equity incentive pool established on January 22, 2025. The awards were made in accordance with Nasdaq Listing Rule 5635(c)(4) and received approval from Summit's Compensation Committee.

Summit Therapeutics (NASDAQ: SMMT) has announced its participation in the 46th Annual Goldman Sachs Global Healthcare Conference in Miami, Florida. The company's management team will deliver a fireside chat presentation on June 9, 2025, at 1:20 PM ET. During the presentation, they will provide a corporate overview and updates on their progress, with particular focus on ivonescimab, their innovative investigational bispecific antibody. The presentation will be accessible live through Summit's website www.smmttx.com, with an archived version available afterward.

Summit Therapeutics announced positive topline results from HARMONi, a global Phase III trial evaluating ivonescimab plus chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) patients. The study met its primary endpoint, showing a 48% reduction in disease progression or death risk compared to chemotherapy alone (HR=0.52, p<0.00001). The trial also showed a positive trend in overall survival with a hazard ratio of 0.79, though not reaching statistical significance (p=0.057). The safety profile was manageable, with 56.9% of patients in the treatment arm experiencing Grade 3+ adverse events versus 50.0% in the control arm. The study included patients from both Asian (62%) and Western (38%) countries, demonstrating consistent benefits across regions. Summit is considering the timing of a BLA filing, noting FDA's requirement for statistically significant overall survival benefit for marketing authorization.

Summit Therapeutics (NASDAQ: SMMT) has announced inducement grants of stock options to nine new employees. The options collectively allow for the purchase of up to 94,050 shares of common stock at an exercise price of $22.75 per share, which was the closing price on May 14, 2025. The options have a ten-year term and will vest in equal annual installments over a four-year period. These grants were approved by Summit's Compensation Committee and were awarded in accordance with Nasdaq Listing Rule 5635(c)(4), which allows for inducement grants to new employees.

Summit Therapeutics (SMMT) reported significant progress in Q1 2025 for its lead drug ivonescimab. The company announced that HARMONi-6 Phase III trial met its primary endpoint, showing superior progression-free survival when combining ivonescimab with chemotherapy versus tislelizumab (PD-1 inhibitor) plus chemotherapy in first-line squamous NSCLC treatment. Additionally, ivonescimab received approval in China for first-line NSCLC treatment in PD-L1 positive tumors, with interim overall survival HR of 0.777. The company continues enrollment in global Phase III trials HARMONi-3 and HARMONi-7. Financially, Summit reported cash and investments of $361.3M as of March 31, 2025, with a GAAP net loss of $62.9M ($0.09 per share) for Q1 2025. The company strengthened its leadership by appointing Robert LaCaze as Chief Commercial Officer.

Summit Therapeutics (NASDAQ: SMMT) reports positive interim overall survival analysis results for ivonescimab from the HARMONi-2 Phase III trial in China. The study, conducted by Akeso, compared ivonescimab monotherapy to pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer (NSCLC).

Key findings include:

• Overall survival hazard ratio of 0.777 favoring ivonescimab at 39% data maturity, suggesting a potential 22% reduction in death risk versus pembrolizumab
• Previously reported primary endpoint showed statistically significant improvement in progression-free survival with hazard ratio of 0.51 (p<0.0001)
• Chinese NMPA has approved ivonescimab for this second indication

Summit is currently conducting HARMONi-7, a global Phase III trial evaluating ivonescimab against pembrolizumab in similar patient population, with registrational intent for the US and other regions.

Summit Therapeutics (NASDAQ: SMMT) has announced it will release its first quarter 2025 financial results and provide an operational update after market close on Thursday, May 1, 2025. The company will host a live webcast earnings conference call at 4:30 PM ET on the same day. Investors and interested parties can access the webcast through the company's website at www.smmttx.com. A recorded version of the conference call will be made available on the website for those unable to attend the live session.

Summit Therapeutics (NASDAQ: SMMT) announced positive results from Akeso's Phase III HARMONi-6 clinical trial, where ivonescimab plus chemotherapy demonstrated statistically significant superiority in progression-free survival (PFS) compared to tislelizumab plus chemotherapy in first-line treatment of squamous non-small cell lung cancer (NSCLC).

The trial, conducted in China, showed meaningful PFS benefits across both PD-L1 positive and negative tumors, with no new safety concerns identified. This marks the first known Phase III trial showing significant improvement over PD-(L)1 inhibitor therapy combined with chemotherapy in NSCLC.

Following the success of HARMONi-2, this is the second instance where ivonescimab-based regimens have shown superior results versus standard-of-care PD-(L)1 inhibitor treatments. Summit is currently enrolling patients in HARMONi-3, a global Phase III trial comparing ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic NSCLC.