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Summit Therapeutics (SMMT)
NASDAQ:SMMT
US Market

Summit Therapeutics (SMMT) AI Stock Analysis

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SMMT

Summit Therapeutics

(NASDAQ:SMMT)

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Neutral 55 (OpenAI - 5.2)
Rating:55Neutral
Price Target:
$16.00
▲(3.90% Upside)
The score is held back primarily by weak financial performance (large and worsening losses with accelerating cash burn) and bearish technicals (below all major moving averages with negative momentum). Offsetting these are strong clinical/regulatory catalysts highlighted in the earnings call and corporate events (BLA submission/acceptance and positive Phase III results), while valuation is difficult to assess given ongoing losses and no dividend.
Positive Factors
BLA acceptance by FDA
Regulatory acceptance establishes a formal U.S. review pathway and a defined timeline, materially reducing regulatory uncertainty. This durable milestone positions the company for potential approval-driven commercialization and partner/market planning if efficacy/safety are sustained through review.
Strong Phase III efficacy
Convincing Phase III efficacy supports clinical differentiation versus existing therapies and underpins regulatory filings and label claims. Durable trial efficacy increases the probability of adoption across indications and strengthens bargaining power with partners and payers if safety and OS benefits validate clinical value.
Collaboration with GSK
Partnering with a major pharma provides development capacity, operational execution support, and access to additional mechanisms and indications. This durable strategic alliance can accelerate combination trials, broaden clinical footprint, and lower execution risk versus going it alone.
Negative Factors
Accelerating cash burn
Rising negative operating cash flow shortens runway and forces ongoing external financing need. Over the medium term this constrains strategic flexibility, increases dilution or covenant risk, and could slow or reprioritize costly Phase III programs if capital markets or partner funding become limited.
Deep and widening operating losses
Very large, growing losses without material commercial revenue mean the company remains dependent on financing, milestone payments, or partners. This persistent negative profitability reduces resilience to trial setbacks and makes long-term viability contingent on successful approvals or sizable partner/licensing arrangements.
Balance-sheet sensitivity
While current leverage is low, the sharp decline in equity erodes the financial buffer and elevates reliance on new capital. That sensitivity limits downside protection, raises refinancing risk for multiple Phase III trials, and can constrain ability to fund simultaneous global development programs without dilution or partner exits.

Summit Therapeutics (SMMT) vs. SPDR S&P 500 ETF (SPY)

Summit Therapeutics Business Overview & Revenue Model

Company DescriptionSummit Therapeutics Inc., a biopharmaceutical company, discovers, develops, and commercializes medicines to treat infectious diseases in the United States and Latin America. It conducts clinical programs focusing on Clostridioides difficile infection (CDI). The company's lead product candidate is ridinilazole, an orally administered small molecule antibiotic that is in Phase III clinical trials for the treatment of CDI. It also offers SMT-738, for combating multidrug resistant infections primarily carbapenem-resistant Enterobacteriaceae infections; and DDS-04 series for the potential treatment of infections caused by the Enterobacteriaceae. The company was founded in 2003 and is based in Cambridge, Massachusetts.
How the Company Makes MoneySummit Therapeutics generates revenue primarily through collaboration and licensing agreements with other pharmaceutical companies. These partnerships often involve upfront payments, milestone payments, and royalties based on the commercial success of the developed products. Additionally, the company may receive government grants and funding from nonprofit organizations that support research and development of new antibiotics. As a clinical-stage company, Summit Therapeutics does not yet generate revenue from product sales, as its products are still in the development phase.

Summit Therapeutics Earnings Call Summary

Earnings Call Date:Oct 20, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Positive
The earnings call highlighted strong clinical trial results and expansion plans with multiple Phase III trials, indicating significant progress and potential for ivonescimab in various cancer treatments. However, financial concerns and increased expenses were noted as challenges.
Q3-2025 Updates
Positive Updates
Positive Results from HARMONi-6 Study
The HARMONi-6 trial demonstrated a significant progression-free survival benefit for ivonescimab plus chemotherapy with a hazard ratio of 0.60 and a p-value of less than 0.0001. Median progression-free survival was 11.14 months compared to 6.90 months for the control arm, showing a difference of 4.24 months.
Expansion of Phase III Clinical Development Programs
Summit Therapeutics announced the expansion of their Phase III clinical development programs with the initiation of the global Phase III HARMONi-GI3 trial, evaluating ivonescimab in first-line unresectable colorectal cancer, expanding beyond lung cancer.
Upcoming BLA Submission for Ivonescimab
Summit plans to submit a Biologics License Application (BLA) for ivonescimab in Q4 2025 based on the results of the HARMONi study, aiming for approval in the United States.
Negative Updates
Increased Non-GAAP Operating Expenses
Non-GAAP operating expenses increased to $103.4 million in Q3 2025 from $89.6 million in the previous quarter, primarily due to higher R&D expenses related to the HARMONi-3 and HARMONi-7 trials.
Potential Financial Concerns
Discussions on funding strategies were highlighted, indicating the need for additional capital with the use of an ATM facility of around $350 million and considerations for future investments.
Company Guidance
During the Summit Therapeutics Q3 2025 Earnings and ESMO Data Update Call, significant guidance was provided regarding the company's clinical developments and financial status. The company announced the expansion of its Phase III clinical development programs, notably the global Phase III study in first-line colorectal cancer. The successful Phase III HARMONi-6 study was discussed, revealing a 4.24-month improvement in median progression-free survival for ivonescimab plus chemotherapy over tislelizumab plus chemotherapy in advanced squamous non-small cell lung cancer, with a hazard ratio of 0.60 and p-value <0.0001. The company intends to submit a Biologics License Application (BLA) for ivonescimab this quarter based on these results. Financially, Summit ended Q3 2025 with a cash position of $238.6 million, with non-GAAP operating expenses at $103.4 million, reflecting increased R&D expenses. The clinical trial expansion includes 14 Phase III trials across various solid tumors, emphasizing a strategic focus on lung, colorectal, breast, head and neck, biliary tract, and pancreatic cancers.

Summit Therapeutics Financial Statement Overview

Summary
Income statement and cash flow are weak with minimal revenue, deeply negative profitability, and accelerating cash burn (TTM net income about -$922M; TTM operating cash flow about -$272M). The balance sheet is a relative positive with low leverage (debt-to-equity ~0.03 TTM), but equity has declined materially, increasing reliance on future financing.
Income Statement
18
Very Negative
Across the history provided, the company generates little to no revenue (including 2024 annual and 2025-09-30 TTM (Trailing-Twelve-Months)), and profitability remains deeply negative. Losses expanded sharply in TTM (Trailing-Twelve-Months) with net income around -$922M versus -$221M in 2024 annual, indicating a significant increase in operating spend and/or non-operating charges. A positive is that this profile is not unusual for a clinical-stage biotech, but the current earnings trajectory is clearly deteriorating and offers limited near-term visibility from the income statement alone.
Balance Sheet
62
Positive
Leverage looks conservative in the most recent periods, with low total debt and a low debt-to-equity ratio in TTM (Trailing-Twelve-Months) (~0.03) and 2024 annual (~0.02), which supports financial flexibility. However, equity has declined meaningfully from 2024 annual (~$389M) to TTM (Trailing-Twelve-Months) (~$192M), consistent with heavy losses and cash burn, and return on equity is strongly negative in TTM (Trailing-Twelve-Months). The longer-term picture also shows prior balance-sheet stress (very high leverage in 2022 and 2023), so while the balance sheet is currently cleaner, it remains sensitive to ongoing funding needs.
Cash Flow
24
Negative
Cash generation is weak, with operating cash flow and free cash flow negative in every period shown. Burn increased materially in TTM (Trailing-Twelve-Months) (operating cash flow about -$272M) versus 2024 annual (~-$142M), implying a faster runway consumption rate. A modest positive is that free cash flow broadly tracks net income (free cash flow to net income ~1.0), suggesting the losses are largely cash-based rather than being masked by non-cash items—but that also means funding requirements are real and recurring.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.00704.29K1.81M860.00K
Gross Profit-15.04M-15.01M-2.05M-1.81M1.81M860.00K
EBITDA-921.46M-212.85M-69.45M-73.12M-85.91M-50.65M
Net Income-921.62M-221.31M-614.93M-78.78M-88.60M-52.70M
Balance Sheet
Total Assets261.73M435.56M202.95M664.17M113.37M102.50M
Cash, Cash Equivalents and Short-Term Investments238.88M412.35M186.24M348.61M71.79M66.42M
Total Debt5.43M7.22M106.10M518.76M2.78M465.00K
Total Liabilities69.47M46.81M125.26M537.51M30.09M23.05M
Stockholders Equity192.26M388.75M77.69M126.65M83.28M79.45M
Cash Flow
Free Cash Flow-272.11M-142.25M-76.89M-42.21M-72.89M-48.53M
Operating Cash Flow-271.60M-142.11M-76.76M-41.58M-72.59M-48.11M
Investing Cash Flow393.11M-205.34M-587.77M-624.00K-306.00K-421.00K
Financing Cash Flow20.95M381.23M86.51M620.24M77.92M50.55M

Summit Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price15.40
Price Trends
50DMA
17.45
Negative
100DMA
18.60
Negative
200DMA
21.63
Negative
Market Momentum
MACD
-0.55
Positive
RSI
37.33
Neutral
STOCH
8.64
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SMMT, the sentiment is Negative. The current price of 15.4 is below the 20-day moving average (MA) of 17.24, below the 50-day MA of 17.45, and below the 200-day MA of 21.63, indicating a bearish trend. The MACD of -0.55 indicates Positive momentum. The RSI at 37.33 is Neutral, neither overbought nor oversold. The STOCH value of 8.64 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for SMMT.

Summit Therapeutics Risk Analysis

Summit Therapeutics disclosed 71 risk factors in its most recent earnings report. Summit Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Summit Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
81
Outperform
$19.86B16.9630.39%18.09%3563.21%
76
Outperform
$20.12B17.7320.04%13.50%17.16%
76
Outperform
$20.13B14.0528.20%24.98%127.06%
55
Neutral
$11.64B-12.40-292.49%-348.63%
53
Neutral
$27.93B-44.41-2.94%7.04%-25.24%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
46
Neutral
$13.59B-52.73103.32%47.55%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
SMMT
Summit Therapeutics
15.40
-4.58
-22.92%
INCY
Incyte
101.08
27.34
37.08%
UTHR
United Therapeutics
467.70
113.12
31.90%
ASND
Ascendis Pharma
223.95
98.86
79.03%
GMAB
Genmab
33.35
14.24
74.52%
BNTX
BioNTech SE
116.77
-3.05
-2.55%

Summit Therapeutics Corporate Events

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Summit Therapeutics’ Ivonescimab BLA Accepted by FDA
Positive
Jan 29, 2026

On January 29, 2026, Summit Therapeutics announced that the U.S. Food & Drug Administration accepted for filing its Biologics License Application for ivonescimab in combination with chemotherapy for patients with EGFR‑mutated locally advanced or metastatic non-squamous non-small cell lung cancer who have progressed after third-generation tyrosine kinase inhibitor therapy. The application, supported by results from the global Phase III HARMONi trial, has been assigned a Prescription Drug User Fee Act goal action date of November 14, 2026, and targets a setting with a significant unmet need, with more than 14,000 eligible U.S. patients annually. Ivonescimab, a novel bispecific antibody that blocks PD‑1 and VEGF, has been tested in numerous Phase III studies worldwide, including multiple Summit-sponsored global trials in lung and colorectal cancers, and already has commercial experience in China through partner Akeso, positioning Summit as a potential new competitor in the U.S. oncology market if approval is granted.

The most recent analyst rating on (SMMT) stock is a Hold with a $16.50 price target. To see the full list of analyst forecasts on Summit Therapeutics stock, see the SMMT Stock Forecast page.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Summit Therapeutics Expands Ivonescimab Program With GSK Collaboration
Positive
Jan 12, 2026

On January 12, 2026, Summit Therapeutics presented at the 44th Annual J.P. Morgan Healthcare Conference and disclosed that it had submitted a Biologics License Application in the fourth quarter of 2025 to the U.S. Food and Drug Administration for ivonescimab in combination with chemotherapy as a second-line or later treatment for patients with epidermal growth factor receptor-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer, underscoring a key regulatory milestone for its lead asset in the U.S. market. On the same date, the company announced a clinical trial collaboration with GSK to evaluate ivonescimab in combination with GSK’s investigational B7-H3–targeting antibody-drug conjugate risvutatug rezetecan across multiple solid tumor settings, including small cell lung cancer, a move that expands ivonescimab’s development footprint and strengthens Summit’s strategic positioning in global oncology through high-profile partnerships and broader combination-therapy opportunities for cancer patients.

The most recent analyst rating on (SMMT) stock is a Hold with a $18.00 price target. To see the full list of analyst forecasts on Summit Therapeutics stock, see the SMMT Stock Forecast page.

Product-Related Announcements
Summit Therapeutics Reports Positive Phase III Trial Results
Positive
Nov 7, 2025

On November 7, 2025, Summit Therapeutics announced that Akeso, its partner, published results from the Phase III HARMONi-A trial conducted in China. The trial demonstrated that ivonescimab combined with platinum-doublet chemotherapy significantly improved overall survival in patients with EGFR-mutated non-small cell lung cancer compared to chemotherapy alone. The study, which was the first Phase III trial for ivonescimab, showed a median overall survival of 16.8 months versus 14.1 months for chemotherapy alone, achieving a hazard ratio of 0.74. This result highlights ivonescimab’s potential to address high unmet medical needs in cancer treatment, offering a favorable risk-benefit profile and demonstrating efficacy where other PD-1 therapies have not succeeded.

The most recent analyst rating on (SMMT) stock is a Buy with a $30.00 price target. To see the full list of analyst forecasts on Summit Therapeutics stock, see the SMMT Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jan 29, 2026