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Summit Therapeutics Inc.
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NASDAQ: SMMT Healthcare Pharma 🔎 Screen
$12.8B
Market Cap
2.1
P/E
—
PEG
4,059.1%
ROCE
N/M
ROE
0.03
D/E
—
OPM
-34.9%
% from 52W High
42
α RS
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About

Summit Therapeutics Inc., a biopharmaceutical company, focuses on discovery, development, and commercialization of patient, physician, caregiver, and societal friendly medicinal therapies. Its lead development candidate is ivonescimab, a bispecific antibody for immunotherapy through blockade of PD-1 with the anti-angiogenesis for the treatment of non-small lung cancer (NSCLC) and colorectal cancer (CRC). The company has also combined ivonescimab with chemotherapy, which is in phase III clinical trial for the patients with epidermal growth factor receptor, mutated, and locally advanced or metastatic non-squamous NSCLC; first-line metastatic NSCLC; and first-line unresectable metastatic CRC. It markets its products in the United states, Canada, Europe, Japan, Latin America, Middle East, and Africa. The company was founded in 2003 and is headquartered in Miami, Florida.

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⭐ Superinvestors Holding SMMT
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Manager Shares Value % of Fund Period
Steve Cohen Point72 Asset Management 784.2K $14.9M 0.02% Mar 2026

SEC Form 13F data. 45-day lag from quarter end.

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📊 MIXED Summit Therapeutics advances Ivonescimab with BLA filing and HARMONi-3 interim PFS analysis in Q2 2026.
Revenue & Profitability
Summit ended 2025 with a cash position of approximately $713.4 million and no debt. Total GAAP operating expenses for Q4 2025 were $225 million, compared to $234.2 million in Q3 2025. Non-GAAP operating expenses were $113.3 million in Q4 2025, up from $103.4 million in Q3 2025, primarily due to increased R&D spend on HARMONi-3 and HARMONi-7 trials. The company's G&A spend, excluding stock-based compensation, was approximately $43 million for the full year 2025, with a quarterly run rate of $10-11 million. Revenue and net income were not discussed.
Outlook
Management highlighted a total addressable market of over $100 billion globally for checkpoint inhibitors and anti-VEGF therapies, according to TD Cowen. They expressed confidence in Ivonescimab's potential to address high unmet needs across multiple tumor types, including those where PD-1 inhibitors have failed. The FDA's acceptance of the BLA and upcoming PDUFA date reinforce the near-term opportunity, with the company expecting to expand its phase III program in 2026.
Growth Drivers
Key growth drivers include the upcoming interim PFS analysis for the squamous cohort of HARMONi-3 expected in Q2 2026, and potential final PFS/interim OS data in the second half of 2026. The BLA for eGFR mutant NSCLC could lead to first US approval around November 14, 2026. Expansion into head and neck cancer via the ILLUMINE study (phase III) and novel combinations with RAS(ON) inhibitors and B7-H3 ADCs are expected to drive future growth.
Balance Sheet & CapEx
Not discussed in this earnings call.
Margins
Margin trajectory was not discussed. Operating expenses are increasing due to R&D investment, but G&A spend is being managed efficiently with a run rate of approximately $10-11 million per quarter. The company did not provide specific margin guidance.
Key Risks
Key risks include the FDA's requirement for statistically significant overall survival benefit for the BLA, and the company's ability to demonstrate that in the HARMONi trial. Clinical trial outcomes, including the interim PFS analysis for HARMONi-3, are uncertain. Additional risks include manufacturing readiness, competitive dynamics, and the need to expand commercial capabilities. Analysts also raised questions about the impact of interim data disclosure on trial integrity.
Generated by AI · Q4 2025 results · Not investment advice
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✓ 📞 Earnings Call Transcripts (5 quarters) submit a missing quarter
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📞 Earnings Call Transcripts (5)
Q2 2026 Q2 2026 2026-07-23
Ivonescimab continues to demonstrate robust clinical efficacy and safety across global phase III trials, with consistent OS benefit in both Asian and Western populations. Financially, the company maintains a strong cash position and is preparing for a potential U.S. launch pending FDA review.
Q4 2025 Q4 2025 2026-02-23
Ivonescimab's clinical program advanced with completion of HARMONi-3 squamous cohort screening and new phase III studies, while financials showed strong cash reserves and disciplined spending. Regulatory and commercial preparations are underway for a potential U.S. launch in late 2026.
Q3 2025 Q3 2025 2025-10-20
Ivonescimab plus chemotherapy showed significant PFS benefit in phase III HARMONi-6 for advanced squamous NSCLC, supporting a planned BLA submission in Q4 2025. The clinical program expanded to 14 phase III trials, with strong financial reserves and ongoing enrollment ahead of schedule.
Q1 2025 Q1 2025 2025-05-01
Ivonescimab achieved key regulatory milestones, including a second approval in China and strong phase III results in NSCLC, with a robust global clinical pipeline and preparations for commercial launch underway. The company ended Q1 2025 with $361 million in cash and is debt-free.
Q4 2024 Q4 2024 2025-02-24
Major milestones include a new Pfizer collaboration for ivonescimab in solid tumors, expanded phase III trials in NSCLC, and a strong $412M cash position with no debt. Top-line Harmony data is expected mid-2025, with broader pipeline expansion planned.
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Financial Model
Projections are built from each company's audited annual financials (Income Statement, Balance Sheet, Cash Flow) over the last 5 fiscal years. Forward assumptions — revenue growth %, EBITDA margin, D&A (USD millions), interest expense, tax rate, and capex — are AI-generated using historical context and refreshed twice a year: after the December results season and after the September/Q4 results season.

DCF Valuation
Fair Value = Σ(FCFt / (1+WACC)t) + Terminal Value. Terminal Value uses the Gordon Growth Model: FCF5 × (1+g) / (WACC−g). Default WACC: 10% (US risk-free ~4.5%, equity risk premium ~5.5%). Default terminal growth: 3% (long-run US nominal GDP proxy).

CAGR Tracker
Expected 5-year CAGR = (DCF Fair Value / Current Price)1/5 − 1. Assumes fair value is reached in exactly 5 years — a mechanical estimate only.

Data Sources & Limitations
Financial statements sourced from public filings. Prices updated daily. Forward assumptions are AI-generated. All monetary values in USD millions. Non-US ADR companies may have currency conversion inaccuracies. Models are point-in-time and do not update intra-quarter or account for M&A, macro shocks, or extraordinary items.

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Investment Risk:
Investing in securities, including US equities and ETFs, involves inherent risks including the potential loss of principal. All investments are subject to market fluctuations, economic conditions, regulatory changes, and other factors that may affect their value. Past performance is not indicative of future results. This analysis is provided for informational and educational purposes only and should not be construed as investment advice under any circumstances.

No Investment Recommendation:
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Information Sources:
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