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what it is
Summit is a cancer-drug company trying to turn one lead asset into its first real sales.
how it gets paid
FY2025: still $0 U.S. product sales on the P&L — development and partnership milestones, not a marketed U.S. drug yet.
what just happened
Q4 2025: GAAP EPS $(0.29); non-GAAP EPS $(0.14) (company reconciliation). FY2025 GAAP loss ~$(1.44)/share and net loss ~$1.08B per full-year results recap tied to the Feb 23, 2026 filing cycle.
At a glance
B balance sheet — gets the job done, barely
40/100 earnings predictability — expect surprises
~$713M cash · $0 debt · Dec 31, 2025 (company materials)
BLA accepted · PDUFA goal Nov 14, 2026
xvary composite: 32/100 — weak
FY2025 GAAP loss ~$(1.44)/sh · net loss ~$1.08B
What they do
Summit is a cancer-drug company trying to turn one lead asset into its first real sales.
Its moat is thin and obvious: ivonescimab is the lead asset, and you are paying for that single shot. Ownership is highly concentrated — chairman Bob Duggan alone beneficially holds on the order of ~70%+ of common stock in recent public summaries; read the latest DEF 14A beneficial-ownership table for the exact group percentage.
How they make money
$0
annual revenue
The products that matter
lead oncology drug candidate
Ivonescimab
1 lead asset · U.S. BLA submitted Q4 2025
This is the stock: $0 U.S. product revenue today. The FDA set a PDUFA goal date of November 14, 2026 for the ivonescimab BLA (EGFRm NSCLC post-TKI, with chemo) — that date is what stands between a development story and a U.S. commercial business.
entire thesis
pivotal clinical program
HARMONi trials
3 Phase 3 trials running
three Phase 3 trials running at once sounds ambitious because it is. These studies are the evidence package the market is paying for before the company has any revenue to point at.
proof first
balance sheet runway
Cash position
~$713M cash
With no U.S. product sales, cash is not a footnote. The company reported ~$713.4M cash as of Dec 31, 2025 and $0 debt in its Q4/FY2025 materials — runway for trials and regulatory prep.
time to execute
Key numbers
~$713M
Cash (YE 2025)
Cash balance per company Q4/FY2025 earnings materials — compare to quarterly GAAP operating expenses (~$225M in Q4 2025 per the same deck).
$0
Debt
Company-reported no debt as of Dec 31, 2025 in the same presentation.
$(0.29)
Q4 GAAP EPS
Three months ended Dec 31, 2025 — non-GAAP EPS was $(0.14) after excluding stock-based comp (company reconciliation).
Nov 14
2026 PDUFA
FDA goal date for the ivonescimab BLA — the central calendar catalyst for the U.S. story.
Financial health
B
strength
- balance sheet grade B — adequate — nothing special
- risk rank 4 — safer than 20% of stocks
- price stability 5 / 100
- cash & investments ~$713M · Dec 31, 2025 (company)
- debt $0 reported · YE 2025
- Q4 2025 GAAP net loss ~$219M · pre-revenue P&L
B — functional but not a standout on the balance sheet.
Total return vs. market
Return history for SMMT is not verified on this page to a single vendor series.
source: not asserted · use your broker or index total-return data
What just happened
Q4 / FY 2025
Q4 2025 $0 product revenue · GAAP EPS $(0.29)
Feb 23, 2026 results cycle: Q4 GAAP net loss ~$219.2M; GAAP EPS $(0.29); non-GAAP EPS $(0.14) after stock-based compensation adjustments. Press summaries flagged Q4 adjusted EPS wider than some consensus screens (e.g. FactSet ~$(0.09)). FY2025 GAAP loss ~$(1.44)/share and net loss ~$1.08B per S&P Capital IQ recap of the full-year filing.
$0
revenue
-$0.29
eps
$(1.44)
FY GAAP EPS
the line that mattered
With $0 U.S. sales, the entire debate is PDUFA Nov 14, 2026, HARMONi-3 timing, and whether operating spend stays inside the ~$713M cash cushion.
-
Feb 23, 2026 — Q4 & full year 2025 results + operational updateCompany posted Q4 GAAP net loss ~$219M, FY2025 net loss ~$1.08B, cash ~$713M, $0 debt; reiterated BLA path with PDUFA goal Nov 14, 2026 and HARMONi-3 timelines (interim PFS squamous cohort Q2 2026, etc.).
-
Jan 29, 2026 — FDA accepted the ivonescimab BLAAcceptance letter set the PDUFA clock; indication: ivonescimab + chemotherapy in EGFR-mutant NSCLC after progression on a third-generation TKI (post-TKI setting).
-
Jan 12, 2026 — BLA submitted to FDASubmission for the same post-TKI EGFRm NSCLC combination regimen; filing completed the late-2025 BLA milestone referenced in prior snapshots.
source: Summit Q4/FY2025 earnings materials (SEC ex-99) · Feb 23, 2026; FY totals via S&P Capital IQ recap
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What could go wrong
the #1 risk is clinical failure for ivonescimab against keytruda.
med
ivonescimab fails to beat or match keytruda
This is a one-asset equity story. If the lead drug misses in lung cancer, there is no approved portfolio underneath the valuation.
An $11B market cap supported by $0 revenue can reprice brutally if the lead readout disappoints.
med
fda pushback on the current data package
The BLA is in and the PDUFA goal date is November 14, 2026 — but FDA review can still bring delays, RTF risk, or a narrow label.
A delay or restrictive label pushes U.S. revenue further out while the company is still funding itself with cash, not product sales.
med
commercial launch against merck is harder than approval
Beating Keytruda in a trial and taking share from Merck in the real world are different jobs. One requires data. The other requires execution, access, and physician adoption.
Even with approval, the revenue curve could lag the valuation if uptake is slower than investors expect.
med
cash burn eventually turns into dilution if timelines slip
~$713M in cash matters, but pre-revenue biotech timelines rarely get easier as programs get larger. More time without U.S. sales usually means more financing or ATM use.
If approval or launch slips, new capital could come from issuing more shares rather than selling more medicine.
U.S. product revenue is still $0 — a clinical, regulatory, or competitive stumble hits a large market cap with almost no operating business to cushion the fall.
source: institutional data · regulatory filings · risk analysis
Pay attention to
calendar
Nov 14, 2026 PDUFA goal date
FDA target action date for the ivonescimab BLA — the fixed calendar anchor for the U.S. commercial thesis.
metric
cash balance versus spending pace
~$713M cash at YE 2025 sounds comfortable until R&D and G&A (~$225M GAAP operating expense in Q4 alone per company deck) keep compounding. Watch the balance every quarter.
risk
any signal of fda discomfort with the filing
For a one-drug story, a regulator asking for more work is not a footnote. It changes the whole duration math.
trend
whether the selloff stabilizes or keeps compounding
Volatility tends to spike around HARMONi-3 readouts and any FDA communication. Price stability here is weak (5/100 on the provider screen) — size positions accordingly.
Analyst rankings
short-term outlook
bottom 5%
momentum score 5. in human-speak, analysts expect this stock to lag badly in the near term.
risk profile
below average
risk rank 4 on the provider screen (not the same field as price stability 5/100). Binary biotech: regulatory and data headlines dominate.
chart momentum
average
technical score 3 is not a bullish signal. The chart is not rescuing the fundamentals here.
earnings predictability
40 / 100
low predictability matters less for revenue and more for timeline headlines. Expect volatility when updates land.
source: institutional data
Institutional activity
Institutional ownership flows for SMMT are not verified line-by-line on this snapshot. Use 13F seasonality and your data terminal if you need buyer/seller counts.
source: institutional data
Price targets
analyst target range
n/a
n/a
$14.96
illustrative price on snapshot date · not live
n/a
consensus target · not pinned on this page
Want the deeper analysis?
The full deep dive: dcf model, scenario analysis, competitive moat breakdown, and quarterly tracking — everything on this page, taken further.
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