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olivLaw · US equity research

Summit Therapeutics Inc. SMMT

Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)

16.17USD+2.34% · 1 dayClose 04 Nov 2026

Summit Therapeutics is a biopharmaceutical company developing ivonescimab, a bispecific PD-1 and VEGF antibody in Phase III trials for non-small cell lung cancer and colorectal cancer. The company has filed for FDA approval with a decision date of November 2026, and its net loss of 1079.6 million USD in 2025 shows the business is still in development with no significant commercial revenue.

The AI analysis may be outdated: new filings came after its sources (see the «AI analysis» section).

At the close of 04 Nov 2026, Summit Therapeutics Inc. (SMMT) stock was 16.17 USD (+2.34% on the day), with market capitalisation 12.9 bn USD, dividend yield 0.00%, beta 1.68, 52-week range 12.43–26.38 USD. Latest reported quarter (Q3 2026): net income of -208.4 m USD, diluted EPS -0.26 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
12.9 bn USD
shares as of 30 Oct 2026
P/E (TTM)
unavailable
Diluted EPS TTM -1.07 · TTM to 30 Sept 2026
E/P (TTM)
-6.59%
TTM to 30 Sept 2026
Dividend yield
0.00%
DPS 12m 0.00
Beta (2y)
1.68
Volatility (1y) 73%
52-week range
12.4326.38

Price history

Loading chart…

Technical reading

RSI (14)
52.0
neutral
Bollinger (20, 2)
14.20 – 17.36
in the upper half of the band · %B 0.62 · band width 20.0%
SMA 50 / 200
16.21 / 16.15
mixed trend
MACD (12, 26, 9)
-0.14 / -0.18
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month−6.4%−1.1%−5.3 pp—
3 months+19.5%−0.5%+20.0 pp—
6 months−9.4%+4.4%−13.8 pp—
Year to date−7.5%+12.3%−19.9 pp—
1 year−7.5%+13.5%−21.1 pp+8.9%
3 years+704.5%+76.4%+628.1 pp+15.7%
5 years+186.7%+63.7%+123.0 pp—
Max drawdown (1y)
−52.9%
21 Apr 2026 → 20 Aug 2026
Max drawdown (5y)
−87.7%
08 Nov 2021 → 01 Dec 2022
Compound annual growth (5y)
+23.4%
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q3 2026 · 30 Sept 2026

Revenue
unavailable USD
unavailable YoY
Net income
-208.4 m USD
unavailable YoY
Diluted EPS
-0.26
unavailable YoY
net / operating
unavailable / unavailable

Quarterly statements · USD

Fiscal yearQ4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26Q3 '26
Revenue0———————
Research & development—51.3 m208.0 m131.1 m—132.6 m157.7 m169.1 m
Operating income-65.6 m———————
Interest expense9.0 k0000———
Net income-61.2 m-62.9 m-565.7 m-231.8 m-219.2 m-189.4 m-215.7 m-208.4 m
Diluted EPS-0.08 ≈-0.09-0.76-0.31-0.29 ≈-0.24-0.28-0.26
Operating cash flow-48.7 m-61.2 m-66.7 m ≈-93.1 m ≈-101.9 m-122.3 m-141.1 m ≈-159.8 m ≈
Capex14.0 k422.0 k0 ≈71.0 k ≈164.0 k245.0 k909.0 k ≈396.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year2018⚠ 2019202020212022202320242025
Revenue25.4 m57.1 m860.0 k1.8 m705.0 k00unavailable
Revenue YoY+1,003.3%—−98.5%+110.3%−61.0%−100.0%unavailableunavailable
Net income-20.2 m10.9 m-52.7 m-88.6 m-78.8 m-614.9 m-221.3 m-1.1 bn
Net income YoYunavailable—−584.8%unavailableunavailableunavailableunavailableunavailable
Diluted EPS-0.310.63-0.76-0.67-0.41-0.99-0.31-1.44
Diluted EPS YoYunavailable—−220.6%unavailableunavailableunavailableunavailableunavailable
net %-79.3%19.0%-6,127.6%-4,897.8%-11,174.8%unavailableunavailableunavailable
Free cash flow-14.9 m-35.3 m-48.5 m-72.9 m-42.2 m-76.9 m-142.2 m-323.6 m

The series breaks before 2019: earlier years come from the original reports of the issuer of that time, later years from a subsequent filing that restated the perimeter (a separation, discontinued operations). The year-on-year change across the break is not shown.

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
225.3 m USD
Financial debt
unavailable USD
Net debt
unavailable USD
Equity
658.9 m USD
Total assets
751.2 m USD
Debt / equity
unavailable
Current ratio
9.87x
ROE
-206.1%
ROA
-181.9%
FCF margin
unavailable

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
0
2024
0
2025
—

SEC (XBRL)· 24 Feb 2025verified

Research & development
2023
59.5 m
2024
—
2025
—

SEC (XBRL)· 20 Feb 2024verified

Operating income
2023
-609.7 m
2024
-226.0 m
2025
—

SEC (XBRL)· 24 Feb 2025verified

Interest expense
2023
16.5 m
2024
8.7 m
2025
0

SEC (XBRL)· 23 Feb 2026verified

Pre-tax income
2023
-614.9 m
2024
-221.3 m
2025
-1.1 bn

SEC (XBRL)· 23 Feb 2026verified

Income tax
2023
0
2024
0
2025
0

SEC (XBRL)· 23 Feb 2026verified

Net income
2023
-614.9 m
2024
-221.3 m
2025
-1.1 bn

SEC (XBRL)· 23 Feb 2026verified

Diluted EPS
2023
-0.99
2024
-0.31
2025
-1.44

SEC (XBRL)· 23 Feb 2026verified

Weighted average diluted shares
2023
619.6 m
2024
718.5 m
2025
747.7 m

SEC (XBRL)· 23 Feb 2026verified

Balance sheet · USD

Cash
2023
71.4 m
2024
104.9 m
2025
225.3 m

SEC (XBRL)· 23 Feb 2026verified

Receivables
2023
0
2024
—
2025
—

SEC (XBRL)· 20 Feb 2024verified

Current assets
2023
189.7 m
2024
423.8 m
2025
720.3 m

SEC (XBRL)· 23 Feb 2026verified

Property, plant & equipment, net
2023
204.0 k
2024
254.0 k
2025
1.1 m

SEC (XBRL)· 23 Feb 2026verified

Goodwill
2023
1.9 m
2024
1.9 m
2025
2.0 m

SEC (XBRL)· 23 Feb 2026verified

Intangibles (excl. goodwill)
2023
0
2024
0
2025
—

SEC (XBRL)· 24 Feb 2025verified

Total assets
2023
202.9 m
2024
435.6 m
2025
751.2 m

SEC (XBRL)· 23 Feb 2026verified

Accounts payable
2023
2.7 m
2024
4.6 m
2025
20.3 m

SEC (XBRL)· 23 Feb 2026verified

Current liabilities
2023
20.4 m
2024
41.7 m
2025
73.0 m

SEC (XBRL)· 23 Feb 2026verified

Total liabilities
2023
125.3 m
2024
46.8 m
2025
92.3 m

SEC (XBRL)· 23 Feb 2026verified

Equity
2023
77.7 m †
2024
388.7 m †
2025
658.9 m †

SEC (XBRL)· 23 Feb 2026verified

Cash flow · USD

Operating cash flow
2023
-76.8 m
2024
-142.1 m
2025
-322.9 m

SEC (XBRL)· 23 Feb 2026verified

Capex
2023
128.0 k
2024
139.0 k
2025
657.0 k

SEC (XBRL)· 23 Feb 2026verified

Free cash flow
2023
-76.9 m ≈
2024
-142.2 m ≈
2025
-323.6 m ≈

SEC (XBRL)· 23 Feb 2026derived

Investing cash flow
2023
-587.8 m
2024
-205.3 m
2025
-174.3 m

SEC (XBRL)· 23 Feb 2026verified

Financing cash flow
2023
86.5 m
2024
381.2 m
2025
617.5 m

SEC (XBRL)· 23 Feb 2026verified

Dividends paid
2023
—
2024
—
2025
—

SEC (XBRL)· 31 Mar 2021verified

Computed indicators

Growth

Revenue growth (YoY)
unavailable
the base of the ratio is not positive
Revenue CAGR 3Y
unavailable
the base of the ratio is not positive
Revenue CAGR 5Y
unavailable
the base of the ratio is not positive
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
the base of the ratio is not positive
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
the base of the ratio is not positive
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
input data missing
EBIT margin
unavailable
input data missing
Net margin
unavailable
input data missing
FCF margin
unavailable
input data missing

Returns

ROE
-220.0%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
ROA
-174.5%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
ROIC
unavailable
input data missing
ROCE
unavailable
input data missing
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
unavailable
input data missing
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
input data missing
Interest coverage
unavailable
input data missing

Liquidity

Current ratio
6.0x
computed by olivLawbalance sheet at 30 Sept 2026
Quick ratio
unavailable
input data missing
Cash ratio
1.4x
computed by olivLawbalance sheet at 30 Sept 2026

Cash

Operating cash flow
-525.2 m USD
computed by olivLawTTM to 30 Sept 2026
Capital expenditure
1.7 m USD
computed by olivLawTTM to 30 Sept 2026
Free cash flow
-526.9 m USD
computed by olivLawTTM to 30 Sept 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
12.9 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-6.6%
computed by olivLawTTM to 30 Sept 2026
P/B
22.9x
computed by olivLawbalance sheet at 30 Sept 2026
P/S
unavailable
input data missing
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-4.1%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Dividend yield
0.0%
computed by olivLawTTM to 30 Sept 2026
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 2 of at least 6
  • score weight coverage: 12.5% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

16.17 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 12.9 bn USD

Key indicators

Market capitalisation
12.9 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
P/E (TTM)
unavailable
insufficient data
P/B
22.9x
computed by olivLawbalance sheet at 30 Sept 2026
EV/EBITDA
unavailable
input data missing
ROE
-220.0%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Net margin
unavailable
input data missing
Revenue growth (YoY)
unavailable
the base of the ratio is not positive
Dividend yield
0.0%
computed by olivLawTTM to 30 Sept 2026

Coverage and freshness

26/37 reporting lines present
Latest full fiscal year: 2024
Latest reported period: 30 Sept 2026
Latest balance sheet date: 30 Sept 2026
Share count (cover of the latest filing), as of: 30 Oct 2026
Source: SEC (XBRL)published 04 Nov 2026
verified 880derived 54

Score by group

13% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · input data missing
  • Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the base of the ratio is not positive

no valuation method could be computed

Multiple comparisons use the SIC vertical: Pharmaceutical Preparations (SIC 2834)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Qualityunavailableunavailable—
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growthunavailableunavailable—
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheetunavailableunavailable—
Current ratio · Balance sheet6.0x100 (on a fixed band)33%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-4.1%0 (on a fixed band)67%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet· partial100/100 · 1/3 factors with a value
  • Growth· partialunavailable · 0/2 factors with a value
  • Quality· partialunavailable · 0/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

Summit Therapeutics Inc. (SMMT). Latest full fiscal year: 2024; data up to 2026-09-30.

Figures computed from the financial statements: revenue 0 USD in 2024; ROE -220.0%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 2 of at least 6; score weight coverage: 12.5% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Current ratio: 6.0x

What contradicts it

  • FCF yield: -4.1%

Not assessed (insufficient data or a ratio without meaning): ROIC, Net margin, FCF conversion, Revenue CAGR 3Y, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 38.6x
EV/EBITDA
—
vertical median 20.2x
P/S
—
vertical median 5.5x
P/B
22.9x
vertical median 4.1x
above median (+454.6%)
ROE
-220.0%
vertical median -6.2%
below median
Net margin
—
vertical median 9.7%
EBIT margin
—
vertical median 10.2%
Revenue YoY
—
vertical median 5.4%
Net debt/EBITDA
—
vertical median -0.2x
Dividend yield
0.0%
vertical median 2.2%
below median (−100.0%)

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
LLYEli Lilly And Company1,334.0 bn46.086.1%31.9%+44.7%+32% / +140%
JNJJohnson & Johnson665.2 bn41.920.0%16.2%+6.0%+34% / +79%
ONCBeone Medicines Ltd.558.4 bn869.914.7%10.7%+40.2%+11% / +102%
ABBVAbbVie Inc.521.1 bn50.7—15.7%+8.6%+29% / +107%
MRKMerck & Co., Inc.370.7 bn154.75.1%3.6%+1.3%+43% / +47%
ABTAbbott Laboratories200.1 bn43.09.2%9.7%+5.7%−10% / +11%
PFEPfizer Inc175.5 bn43.94.4%6.3%−1.6%+20% / +1%
VRTXVertex Pharmaceuticals Inc139.2 bn35.320.8%30.7%+8.9%+27% / +55%
BMYBristol-Myers Squibb Company131.2 bn14.244.1%18.5%−0.2%+30% / +30%
TEVATeva Pharmaceutical Industries Limited48.8 bn97.46.6%3.6%+4.3%+56% / +326%
ZTSZoetis Inc.36.9 bn14.764.4%27.5%+2.3%−30% / −50%
ROIVRoivant Sciences Ltd.27.6 bn—-6.2%-3,535.0%−71.6%+84% / +300%
RPRXRoyalty Pharma plc26.2 bn47.76.9%25.7%+5.1%+69% / +150%
UTHRUnited Therapeutics Corporation25.9 bn23.019.1%38.6%+10.6%+25% / +154%
INSMInsmed Inc24.1 bn—-72.5%-39.9%+66.7%−47% / +340%
VTRSViatris Inc.22.1 bn—-23.6%-23.9%−3.0%+80% / +109%
ALNYAlnylam Pharmaceuticals, Inc.21.6 bn8.1126.6%52.8%+65.2%−64% / −4%
ORKAOruka Therapeutics, Inc.6.7 bn—-18.2%—unavailable+237% / +364%
HRMYHarmony Biosciences Holdings, Inc.2.0 bn11.418.7%18.1%+21.5%−2% / +18%
OMEROmeros Corp1.3 bn10.5——−34.0%+88% / +730%
VSTMVerastem, Inc.892.0 m—-471.2%-231.6%+209.1%−7% / +43%
COLLCollegium Pharmaceutical, Inc.770.6 m19.117.6%5.9%+23.6%−49% / −8%
IBOImpact BioMedical, INC.442.1 m560.3371.3%2,254.3%unavailable−27% / unavailable
KMDAKamada Ltd428.0 m21.27.6%11.2%+12.1%+11% / +57%
EPRXEupraxia Pharmaceuticals Inc.240.9 m—-66.8%—unavailable+9% / unavailable

1- and 3-year price returns: for SMMT from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Scenarios are not available. input data missing

AI analysis

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

Possibly outdated: the newest document it read is from 23 Jul 2026; since then the company filed 8-K (04 Nov 2026 · results), 10-Q (04 Nov 2026).

In brief

Summit Therapeutics is a biopharmaceutical company developing ivonescimab, a bispecific PD-1 and VEGF antibody in Phase III trials for non-small cell lung cancer and colorectal cancer. The company has filed for FDA approval with a decision date of November 2026, and its net loss of 1079.6 million USD in 2025 shows the business is still in development with no significant commercial revenue.

SWOT

Strengths

  • The company has a Phase III program with positive progression-free survival results and a clear focus on one product.
  • Exclusive rights across several major territories provide a framework for commercialization without sharing the market with the licensor.
  • The HARMONi-6 results from China are supported by a favorable statistical analysis of overall survival.

Weaknesses

  • The company has no significant commercial revenue and depends on external financing.
  • Dependence on a single product means clinical or regulatory setbacks would have a major impact.
  • The HARMONi study did not reach statistical significance for overall survival, which limits the case for approval.

Opportunities

  • A favorable FDA decision could open access to the US market and support other filings.
  • Expanding the program into other tumors and collaborations could diversify risk.
  • Updated survival data in the western population could strengthen the argument for approval.

Threats

  • An FDA rejection or requests for more data could delay commercialization.
  • Competition from anti-PD-1 therapies and other bispecifics could reduce potential market share.
  • Volatile market conditions and high development costs could limit access to capital.

Risks

  • Regulatory decisionhigh

    The application for HARMONi has no decision yet, and the FDA said a statistically significant overall survival benefit is needed.

  • Funding needhigh

    Large net losses and contingent payments to Akeso could require new financing, with dilution effects.

  • Single-product dependencehigh

    The whole program depends on ivonescimab, so a clinical failure could seriously affect the company.

  • Safety profilemedium

    Grade 3 or higher adverse events and bleeding could limit use and influence the regulatory decision.

  • Geopolitical risksmedium

    Conflicts in Europe and the Middle East could affect trial enrollment and drug supply.

Investment thesis

What would need to be true (bull case)

  • If the FDA approves ivonescimab, the company could become the first to commercialize a PD-1/VEGF bispecific in the United States.
  • The HARMONi-6 results and updated survival data could support differentiation from anti-PD-1 therapies.
  • Collaborations with other companies could extend use of the product to several tumor types.

What would break the thesis

  • If the FDA rejects the application or requests more studies, commercialization could be delayed by years.
  • Large net losses and payment obligations to the partner could force costly financing.
  • If overall survival benefit fails to hold in western studies, the commercial case could be weak.

What to watch

  • FDA decision on ivonescimab application in EGFR-mutated NSCLCNovember 2026
  • HARMONi-3 squamous cohort interim analysis results2026
  • PFS analysis for HARMONi-3 non-squamous cohortFirst half of 2027
  • Revenue and net loss in the next annual reportNext 10-K

Products, market & competition

AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

Possibly outdated: the newest document it read is from 23 Jul 2026; since then the company filed 8-K (04 Nov 2026 · results), 10-Q (04 Nov 2026).

The business

Summit Therapeutics Inc. is a biopharmaceutical company that discovers, develops and commercializes oncology therapies, with its lead product ivonescimab, a bispecific antibody that the company says could combine immunotherapy effects with VEGF inhibition 1. It in-licensed rights from Akeso covering the United States, Canada, Europe, Japan, Latin America, the Middle East and Africa 1. Activity so far is mostly clinical development, and the company has no significant commercial revenue.

In May 2025 the HARMONi Phase III study showed a statistically significant progression-free survival improvement with a hazard ratio of 0.52, though overall survival did not reach statistical significance 1. The FDA accepted the biologics license application in January 2026, with a decision date of November 14, 2026 1. A Chinese study run by partner Akeso, HARMONi-6, later reported a statistically significant overall survival improvement over an anti-PD-(L)1 regimen 3.

Beyond the lead therapy, the company has expanded through clinical collaborations, including one with Arcus Biosciences in renal cell carcinoma and one with Revolution Medicines combining ivonescimab with RAS inhibitors 3. The business depends heavily on one product, and net losses remain substantial 1.

Segments

Ivonescimab in non-small cell lung cancer

The most advanced indication is HARMONi, for EGFR-mutated NSCLC after TKI therapy, for which the FDA accepted the application 1. HARMONi-3 and HARMONi-7 continue in first-line treatment.

Ivonescimab in colorectal and other tumors

The company is developing HARMONi-GI3 for first-line unresectable metastatic colorectal cancer and has signaled possible Phase III studies in other tumor types 3. These programs are early or still enrolling.

Market context

The targeted market is oncology, where the company describes unmet medical needs, especially after TKI failure in EGFR-mutated NSCLC 1. Commercial success depends on regulatory approval and acceptance by physicians, payers and reimbursement systems 1.

Trends

  • Bispecific PD-1/VEGF antibodiestailwind

    Interest in combining PD-1 blockade with VEGF inhibition in one molecule could open a new class of treatments if clinical results hold 1.

  • Overall survival requirementsheadwind

    The FDA indicated that a statistically significant overall survival benefit is needed, which the HARMONi study did not reach 1.

  • Unstable economic and geopolitical conditionsheadwind

    Geopolitical conflicts and volatile capital markets could make financing harder and affect clinical trials 1.

  • Need for additional fundingmixed

    Payments to Akeso and development costs require new financing through equity, debt or partnerships, which could dilute existing shareholders 1.

Competitive position

Competition includes anti-PD-1 and anti-PD-L1 therapies used in first-line treatment, such as pembrolizumab, as well as other anti-VEGF or bispecific agents in development. The company acknowledges it must compete with approved therapies, which requires strong comparative data 13.

Over the longer term, the competitive edge could depend on head-to-head results and on a safety profile the company considers acceptable and manageable 2.

  • Merck (pembrolizumab)MRK

    Pembrolizumab is the comparator in the HARMONi-3 first-line NSCLC study.

  • Akeso (ivonescimab in China)

    The partner that holds ivonescimab rights in China and other territories.

  • Arcus Biosciences

    Collaboration partner for a combination with a HIF-2α inhibitor in renal cell carcinoma.

  • Revolution Medicines

    Collaboration partner for combinations with RAS inhibitors in solid tumors.

News & filings

In the press

SEC filings

  • Current report04 Nov 2026
    Other events · Financial statements and exhibits
  • Quarterly report04 Nov 2026
  • Current report04 Nov 2026
    Results of operations · Amendments to articles or bylaws · Shareholder vote · Financial statements and exhibits
  • Proxy statement19 Oct 2026
  • Current report29 Sept 2026
    Material agreement · Item 3.02 · Amendments to articles or bylaws · Other events · Financial statements and exhibits
  • Current report15 Sept 2026
    Other events · Financial statements and exhibits
  • Current report14 Sept 2026
    Other events · Financial statements and exhibits
  • Current report03 Sept 2026
    Other events · Financial statements and exhibits
  • Current report26 Aug 2026
    Other events · Financial statements and exhibits
  • Current report05 Aug 2026
    Other events · Financial statements and exhibits

Sources

  1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Summit Therapeutics Inc. · 23 Feb 2026
  2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Summit Therapeutics Inc. · 23 Jul 2026
  3. [3] Form 8-K, results release (exhibit 99.1) · SEC / Summit Therapeutics Inc. · 23 Jul 2026

Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.