Summit Therapeutics Inc. (NASDAQ:SMMT) is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies. The company's current lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody that combines the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound.

Business Overview

In December 2022, Summit entered into a Collaboration and License Agreement with Akeso, Inc. to in-license ivonescimab. Through this agreement, Summit obtained the rights to develop and commercialize ivonescimab in the United States, Canada, Europe, and Japan. Ivonescimab is currently being investigated in two global Phase III clinical trials: HARMONi, evaluating ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI), and HARMONi-3, evaluating ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients.

In addition to the two Phase III trials sponsored by Summit, ivonescimab is also being developed in China and Australia by Akeso in multiple solid tumors and has been dosed in more than 1,600 patients globally. Based on data published by Akeso, ivonescimab treatment was associated with an overall response rate of 68.4%, a median Progression-Free Survival (mPFS) time period of 8.5 months, and a median Overall Survival (mOS) of 22.5 months when combined with doublet chemotherapy in a Phase II study in NSCLC patients who have failed an EGFR-TKI. In a separate Phase II study for first-line advanced or metastatic squamous NSCLC patients, ivonescimab combined with carboplatin and paclitaxel demonstrated a mPFS of 11.1 months, and the median overall survival was not reached after a median follow-up period of 22.1 months.

Summit plans to conduct its current clinical trials, as well as design and conduct additional clinical trial activities for ivonescimab in its licensed territory, to support and submit relevant regulatory filings. Summit also plans to support additional study activities through its investigator initiated study program. Beyond lung cancer, Summit continues to receive a high level of interest from key opinion leaders and other physician leaders for exploring ivonescimab's potential in several other solid tumors, including gynecological tumors, head and neck cancer, triple-negative breast cancer, and colorectal cancer.

Financials

For the first quarter of 2024, Summit reported a net loss of $43.5 million, compared to a net loss of $542.4 million in the same period of the prior year. The significant decrease in net loss was primarily due to the $520.9 million in-process research and development expense recorded in the first quarter of 2023 related to the upfront payment for the Akeso license agreement.

Research and development expenses for the first quarter of 2024 were $30.9 million, compared to $9.9 million in the same period of the prior year. The increase was driven by the company's investment in the clinical development of ivonescimab, including the ongoing Phase III HARMONi and HARMONi-3 trials. General and administrative expenses for the first quarter of 2024 were $11.7 million, compared to $6.9 million in the same period of the prior year, primarily due to an increase in stock-based compensation.

As of March 31, 2024, Summit had cash, cash equivalents, and short-term investments of $156.7 million. The company expects that its current cash and cash equivalents will be sufficient to fund its operations through the first quarter of 2025. To further fund its operating cash needs and repay the $100 million promissory note due in April 2025, Summit intends to raise additional capital.

For the full year 2023, Summit reported an annual net loss of $614.9 million, no revenue, an annual operating cash flow of -$76.8 million, and an annual free cash flow of -$76.9 million.

Summit's operations are primarily focused in the United States and the United Kingdom. As of March 31, 2024, the company's long-lived assets, which include property and equipment and right-of-use assets, were $8.8 million in the United States and $0.7 million in the United Kingdom.

Risks and Challenges

Summit faces several risks and challenges in its pursuit of developing and commercializing ivonescimab. These include the ability to successfully execute the ongoing Phase III clinical trials, obtain regulatory approvals, and effectively commercialize the product, if approved. The company also faces the risk of potential delays or setbacks in the clinical development process, as well as the challenge of securing additional funding to support its operations and future development plans.

Outlook

Summit remains focused on the successful execution of its two ongoing Phase III trials for ivonescimab in NSCLC. The company expects to complete enrollment in the HARMONi trial during the second half of 2024 and is continuing to open sites and expand the reach of the HARMONi-3 trial. Additionally, Summit is eagerly awaiting the data readout from Akeso's Phase II AK112-201 trial, which is expected in the second quarter of 2024 and could serve as a potential catalyst for the development of ivonescimab.

Conclusion

Summit Therapeutics is making significant strides in the development of its lead candidate, ivonescimab, a novel bispecific antibody that combines the effects of immunotherapy and anti-angiogenesis. The company's strategic decision to pursue two registrational Phase III trials in NSCLC, coupled with the promising data from Akeso's earlier-stage studies, underscores its conviction in ivonescimab's potential to improve upon existing treatment options and address the significant unmet needs in lung cancer and potentially other solid tumors. As Summit continues to execute on its clinical development plan and explore additional indications, investors will be closely watching for updates on the progress of the HARMONi and HARMONi-3 trials, as well as the potential impact of Akeso's upcoming data readout.