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Pipeline (6 active programs)

Technology platforms

Capital (as filed)

Cash

$151M cash and cash equivalents · Sep 30, 2026 (10-Q)

Short-term investments

$479M Sep 30, 2026

Operating cash flow

−$160M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)

As stated in coverage

$630M cash per the update of Nov 4, 2026 — the company's own words as read there, not the filed figure

Offering documents (3)

• 2026-07-23 424B5 · At-the-market program up to $380M
• 2026-06-10 424B5 · Preliminary prospectus
• 2026-06-09 S-3ASR · Shelf registration

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (20)

• 2026-10-27 UPDATE: Summit Therapeutics (SMMT) - The Biliary Number Arrives 🔒 Paid
• 2026-10-02 UPDATE: Summit Therapeutics (SMMT) - The MOU Gets a Phase III 🔒 Paid
• 2026-09-30 UPDATE: Summit Therapeutics (SMMT) - The Fine Print Behind the $2 Billion 🔒 Paid
• 2026-09-29 UPDATE: Summit Therapeutics (SMMT) - AstraZeneca Writes a $2 Billion Check 🔒 Paid
• 2026-09-16 UPDATE: Summit Therapeutics (SMMT) - The Western Confidence Interval Crosses One 🔒 Paid
• 2026-09-15 UPDATE: Summit Therapeutics (SMMT) - The Hazard Ratio Arrives 🔒 Paid
• 2026-09-02 UPDATE: Summit Therapeutics (SMMT) - Keytruda Just Lost a Head-to-Head on Survival 🔒 Paid
• 2026-08-25 UPDATE: Summit Therapeutics (SMMT) - The Drug Escapes the Lung 🔒 Paid
• 2026-08-13 UPDATE: Summit Therapeutics (SMMT) - China Says Yes, Round Three 🔒 Paid
• 2026-07-23 UPDATE: Summit Therapeutics (SMMT) - The Form 4s Landed 🔒 Paid
• 2026-07-22 UPDATE: Summit Therapeutics (SMMT) - The Western OS Number Just Caught Up 🔒 Paid
• 2026-06-11 UPDATE: Summit Therapeutics (SMMT) - The Deal Got Pulled
• 2026-06-09 UPDATE: Summit Therapeutics (SMMT) - The $500M Bait-and-Switch
• 2026-06-03 UPDATE: Summit Therapeutics (SMMT) - The Insiders Got the Green Light
• 2026-06-02 UPDATE: Summit Therapeutics (SMMT) - The Plenary Delivered. The Tape Didn’t. 🔒 Paid
• 2026-05-02 UPDATE: Summit Therapeutics (SMMT) - The 25% Panic Into ASCO 🔒 Paid
• 2026-05-01 UPDATE: Summit Therapeutics (SMMT) - Q1 2026 Earnings, an iDMC Pass, and an ASCO Plenary Slot 🔒 Paid
• 2026-03-29 UPDATE: Summit Therapeutics (SMMT) - ELCC 2026 Data 🔒 Paid
• 2026-03-01 UPDATE: Summit Therapeutics (SMMT) - EoY 2025 Update 🔒 Paid
• 2026-02-20 Summit Therapeutics (SMMT): Scientific Deep Dive for Ivonescimab and Pipeline Products 🔒 Paid

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (20 calls)

Every verdict Biotech Distilled has published on Summit Therapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.

1. 2026-02-20 Buy core Summit Therapeutics (SMMT): Scientific Deep Dive for Ivonescimab and Pipeline Products Strong science, pristine cash runway, and historic insider conviction justify buying, with the primary risk being FDA regulatory friction over geographic slicing of OS data in 2L+ EGFRm NSCLC.
2. 2026-03-01 Buy core UPDATE: Summit Therapeutics (SMMT) - EoY 2025 Update Accelerated HARMONi-3 squamous interim PFS catalyst in Q2 2026 and pristine balance sheet maintain the buy thesis.
3. 2026-03-29 Buy core UPDATE: Summit Therapeutics (SMMT) - ELCC 2026 Data Compelling intracranial efficacy data from ELCC strengthens the FDA approval case on unmet medical need grounds.
4. 2026-05-01 Buy core UPDATE: Summit Therapeutics (SMMT) - Q1 2026 Earnings, an iDMC Pass, and an ASCO Plenary Slot HARMONi-6 OS ASCO Plenary slot is a major catalyst escalation, but asymmetry is shifting at $21.46 so prefer entering on dips rather than chasing.
5. 2026-05-02 Buy core UPDATE: Summit Therapeutics (SMMT) - The 25% Panic Into ASCO 25% single-session crash overdiscounts FDA risk; at $16.11 the asymmetry has flipped back in the buyer's favor ahead of the May 31 ASCO Plenary OS readout.
6. 2026-06-02 Buy core UPDATE: Summit Therapeutics (SMMT) - The Plenary Delivered. The Tape Didn't. HARMONi-6 OS HR 0.66 published in The Lancet validates the cooperative-binding mechanism; at $15.71 the entry compensates for FDA risk more than at $16.11 on May 1.
7. 2026-06-03 Buy core UPDATE: Summit Therapeutics (SMMT) - The Insiders Got the Green Light Board clearing Duggan, Zanganeh, and Soni to buy through the ATM at ~$15 is the strongest available insider signal that the post-Plenary drawdown is mispriced.
8. 2026-06-09 Hold UPDATE: Summit Therapeutics (SMMT) - The $500M Bait-and-Switch $500M underwritten public offering at a punitive discount six days after the insider-buy signal damages credibility and creates near-term technical supply overhang, warranting a downgrade to HOLD while dilution reprices.
9. 2026-06-11 Buy core UPDATE: Summit Therapeutics (SMMT) - The Deal Got Pulled Withdrawal of the $500M offering removes the dilution trigger that caused the HOLD downgrade; at $13.08 the asymmetry tilts back toward the buyer, though management credibility and going-concern overhang warrant caution.
10. 2026-07-22 Buy core UPDATE: Summit Therapeutics (SMMT) - The Western OS Number Just Caught Up Western HARMONi OS HR converging to 0.76 at 23.2 months of follow-up, matching the global ITT, removes the post-hoc geographic slicing critique and materially de-risks the FDA approval case.
11. 2026-07-23 Buy core UPDATE: Summit Therapeutics (SMMT) - The Form 4s Landed $52.2M of confirmed insider buying at $13.17 weighted average, combined with a fresh $380M ATM and bulletproof runway, validates the June thesis and confirms the asymmetry argument.
12. 2026-08-13 Buy core UPDATE: Summit Therapeutics (SMMT) - China Says Yes, Round Three Third NMPA approval validates the HARMONi-6 dataset through regulatory audit and adds real-world safety data from 70,000+ commercial patients, though it does not fix the FDA geography problem.
13. 2026-08-25 Buy core UPDATE: Summit Therapeutics (SMMT) - The Drug Escapes the Lung HARMONi-GI1 OS win over durvalumab in biliary tract cancer and Lancet Oncology publication of HARMONi primary analysis strengthen the platform case; at $13.36 near insider cost basis the asymmetry favors buyers.
14. 2026-09-02 Buy core UPDATE: Summit Therapeutics (SMMT) - Keytruda Just Lost a Head-to-Head on Survival HARMONi-2 OS win over pembrolizumab monotherapy is the third head-to-head OS win over a checkpoint inhibitor and the first against Keytruda itself, narrowing the range of bad outcomes even in a CRL scenario.
15. 2026-09-15 Buy core UPDATE: Summit Therapeutics (SMMT) - The Hazard Ratio Arrives HARMONi-2 OS HR 0.73 against pembrolizumab with 0.58 in PD-L1-high subgroup directly de-risks HARMONi-7; at $18.42 after a 26% run the asymmetry is less generous but the science is materially stronger.
16. 2026-09-16 Hold UPDATE: Summit Therapeutics (SMMT) - The Western Confidence Interval Crosses One Western HARMONi subgroup CI of 0.52–1.10 crosses 1.0 and global p-value is nominal on a pre-specified analysis that already missed; at $17.40 the price no longer compensates for the FDA coin-flip 60 days out.
17. 2026-09-29 Buy core UPDATE: Summit Therapeutics (SMMT) - AstraZeneca Writes a $2 Billion Check AstraZeneca's $2B convertible preferred at $18.36 (19% premium) transforms the CRL downside from a busted binary to 'delay with a war chest,' restoring the asymmetry in the buyer's favor.
18. 2026-09-30 Buy core UPDATE: Summit Therapeutics (SMMT) - The Fine Print Behind the $2 Billion AstraZeneca's fine print is better than feared: no veto on M&A, one-year lockup removes supply overhang through PDUFA, and the $2B committed capital is intact.
19. 2026-10-02 Buy core UPDATE: Summit Therapeutics (SMMT) - The MOU Gets a Phase III AstraZeneca-Daiichi Sankyo Phase III in TNBC with Datroway expands the platform into breast cancer on capital-efficient terms, reinforcing the 'delayed not broken' downside case without changing the November binary.
20. 2026-10-27 Buy core UPDATE: Summit Therapeutics (SMMT) - The Biliary Number Arrives HARMONi-GI1 OS HR 0.75 with tight CI against durvalumab in biliary cancer, plus EA2251 U.S. registration trial, strengthens the 'delayed not broken' downside case 19 days before the PDUFA.

• Long call · opened Feb 20, 2026 at $15.94 · +2.4% vs XBI +22.0% (Nov 6, 2026)

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (6 quotes from 5 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

• 2026-11-04 10-Q in filings ↓

  • “The FDA provided a Prescription Drug User Fee Act (“PDUFA”) goal action date of November 14, 2026.”

    matched to ivonescimab (2L+ EGFRm NSCLC) · regulatory decision · read as November 14, 2026
• 2026-09-15 8-K in filings ↓

  • “Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.”

    matched to ivonescimab (2L+ EGFRm NSCLC) · regulatory decision · read as November 14, 2026

  • “Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.”

    matched to ivonescimab (2L+ EGFRm NSCLC, HARMONi) · regulatory decision · read as November 14, 2026
• 2026-09-03 8-K in filings ↓

  • “Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.”

    matched to ivonescimab (2L+ EGFRm NSCLC) · regulatory decision · read as November 14, 2026
• 2026-08-26 8-K in filings ↓

  • “Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.”

    matched to ivonescimab (2L+ EGFRm NSCLC) · regulatory decision · read as November 14, 2026
• 2026-07-23 8-K in filings ↓

  • “The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.”

    matched to ivonescimab (2L+ EGFRm NSCLC, HARMONi) · regulatory decision · read as November 14, 2026

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (55)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Apr 30, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

• Nov 4, 2026ReleaseSummit Therapeutics Reports Financial Results and Operational Progress for the Third Quarter and Nine Months Ended September 30, 2026Summary on the 8-K
• Nov 4, 20268-KCurrent report: results of operations, charter / bylaws / fiscal year, shareholder vote · EX-99.1Summary on the 8-K
• Nov 4, 20268-KCurrent report: other eventsWith the authorized-share vote cleared today and the PDUFA 10 days out, Summit enters its most consequential window yet — a fortified balance sheet, imminent HARMONi-3 squamous data, and a binary FDA decision all stacking into the same fortnight.
• Nov 4, 2026424B7Prospectus supplementSummary on the 8-K
• Nov 4, 202610-QQuarterly reportSummary on the 8-K
• Oct 25, 2026ReleaseIvonescimab Plus Chemotherapy Demonstrates Overall Survival Superiority Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer in HARMONi-GI1 S→ BD updateThe HARMONi-GI1 blank I flagged in August finally got filled at ESMO 2026's Presidential Symposium — OS HR 0.75, p=0.0031, PFS HR 0.61, ORR 53.8% — and Summit simultaneously announced a Western registration-enabling BTC trial via ECOG-ACRIN, even as the stock continues bleeding ahead of the November 14 PDUFA.BD extracted 1 program update from this document → SMMT pipeline
• Oct 23, 2026ReleaseSummit Therapeutics and Lunit Announce Agreement to Apply AI-powered SCOPE IO Platform for Tumor Microenvironment Analysis in Immuno-Oncology Development
• Oct 22, 2026ReleaseIvonescimab Data Sets across Multiple Tumor Types to Be Featured at ESMO 2026HARMONi-GI1's OS hazard ratio lands at ESMO tomorrow — the topline we've been waiting on since August — while a new U.S.-based ECOG-ACRIN biliary trial directly addresses the FDA's geography problem, and 10 ivonescimab presentations across 8 tumor types hit Madrid this week, 23 days before the November 14 PDUFA.
• Oct 21, 2026ReleaseSummit Therapeutics and ECOG-ACRIN Cancer Research Group Enter into Phase II / III Clinical Trial Collaboration to Evaluate Ivonescimab in First-Line Biliary Tract Cancer
• Oct 19, 2026ReleaseSummit Therapeutics Announces Opening of Global Phase II Study of Ivonescimab-Based Regimens in Advanced Clear Cell Renal Cell CarcinomaBD extracted 1 program update from this document → SMMT pipeline
• Oct 19, 2026DEF 14AProxy statement
• Oct 5, 2026ReleaseAstraZeneca Completes $2 Billion Equity Investment in Summit TherapeuticsAstraZeneca's $2.0B preferred-stock investment in Summit has officially closed, putting over $2.5B in pro-forma liquidity on the balance sheet 40 days before the November 14 PDUFA — the going-concern overhang that spooked the tape in May is now mathematically extinct.
• Oct 2, 2026ReleaseSummit Therapeutics Announces Clinical Trial Collaboration with AstraZeneca and Daiichi Sankyo to Evaluate Ivonescimab in Combination with TROP2-Directed ADC Datroway→ BD updateSummit, AstraZeneca, and Daiichi Sankyo just signed a three-way collaboration to run a Phase III trial of ivonescimab + Datroway in first-line triple-negative breast cancer — the first breast cancer push for ivonescimab, and the seventh capital-efficient partnership that expands the "pipeline in a product" thesis without Summit footing the whole bill.
• Sep 29, 20268-KCurrent report: material agreement, unregistered sale of equity, charter / bylaws / fiscal year · EX-99.1→ BD updateAstraZeneca just wrote a $2 billion check at $18.36/share — a premium to market — and signed a clinical collaboration on Claudin 18.2 ADC combinations with ivonescimab. The going-concern overhang that haunted this name since May is now functionally dead, and a top-tier pharma oncology team has put its balance sheet behind the same data the FDA will rule on in 47 days.
• Sep 28, 2026ReleaseAstraZeneca Makes $2 Billion Strategic Equity Investment in Summit Therapeutics→ BD updateAstraZeneca just wrote a $2 billion check for Summit at $18.36/share — a 19% premium to today's close — validating the ivonescimab thesis in the strongest possible currency, 47 days before the FDA's decision.
• Sep 22, 2026ReleaseHARMONi-GI1, a Phase III Trial Featuring Ivonescimab Plus Chemotherapy Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer from China, to BeHARMONi-GI1's full dataset — ivonescimab's first non-lung Phase III OS win over a checkpoint inhibitor — gets the ESMO 2026 Presidential Symposium slot on October 25, putting hazard ratios and medians on the table 20 days before the November 14 PDUFA.BD extracted 1 program update from this document → SMMT pipeline
• Sep 15, 2026ReleaseUpdated HARMONi Data Presented at WCLC 2026 Demonstrate Consistent Overall Survival Results with Ivonescimab Plus Chemotherapy in Western and Asian Patients→ BD updateSummary on the 8-K
• Sep 15, 20268-KCurrent report: other events · EX-99.1→ BD updateThe WCLC data Summit's FDA reviewers have been waiting for just landed: HARMONi's Western OS hazard ratio has converged to 0.76 at 23.2 months of follow-up, matching the global ITT exactly — and the full HARMONi-2 numbers vs. Keytruda arrived with them. The stock is selling off anyway, and that disconnect deserves a close read.BD extracted 1 program update from this document → SMMT pipeline
• Sep 14, 20268-KCurrent report: other events · EX-99.1→ BD updateThe HARMONi-2 OS numbers have landed at WCLC 2026: HR 0.73 (95% CI 0.57–0.95; p=0.009), median OS 30.8 vs. 22.6 months — a 27% reduction in the risk of death vs. pembrolizumab, with the PD-L1-high subgroup posting an HR of 0.58 that speaks directly to HARMONi-7's design.BD extracted 1 program update from this document → SMMT pipeline
• Sep 13, 2026ReleaseIvonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso’s HARMONi-2 Study Condu→ BD updateSummary on the 8-K of Sep 14, 2026BD extracted 1 program update from this document → SMMT pipeline
• Sep 3, 20268-KCurrent report: other events · EX-99.1HARMONi-2's preplanned OS analysis confirms ivonescimab monotherapy beats pembrolizumab monotherapy on survival in PD-L1-positive NSCLC — the first time Keytruda has lost a head-to-head survival comparison in a randomized Phase III — sending SMMT up 17.3% to $17.13 and resetting the thesis into the September 15 WCLC catalyst 12 days out.BD extracted 1 program update from this document → SMMT pipeline
• Sep 2, 2026ReleaseIvonescimab Monotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in HARMONi-2 Study Conducted by Akeso in→ BD updateAkeso's HARMONi-2 just delivered what no trial has done before: ivonescimab monotherapy beat Keytruda monotherapy on overall survival in PD-L1-positive NSCLC — the third OS win over an approved checkpoint inhibitor, 73 days before the FDA PDUFA.BD extracted 1 program update from this document → SMMT pipeline
• Aug 26, 20268-KCurrent report: other events · EX-99.1
• Aug 25, 2026ReleaseIvonescimab Plus Chemotherapy Global Phase III HARMONi Primary Analysis Results Published in The Lancet Oncology→ BD updateSummary on the releaseBD extracted 1 program update from this document → SMMT pipeline
• Aug 25, 2026ReleaseIvonescimab Plus Chemotherapy Demonstrates Statistically Significant Overall Survival Benefit Compared to Durvalumab Plus Chemotherapy in First-Line Advanced Biliary Tract Cancer in Single-Region Tria→ BD updateTwo catalysts landed today: HARMONi goes peer-reviewed in The Lancet Oncology with the WCLC updated OS presentation now confirmed for September 15, and Akeso's HARMONi-GI1 becomes the first ivonescimab Phase III win outside NSCLC — OS superiority over an active PD-L1 in biliary tract cancer. Five-for-five on Phase III readouts, 81 days before the PDUFA that counts.
• Aug 12, 2026ReleaseIvonescimab in Combination with Chemotherapy Approved in China by NMPA for First-Line Treatment of Patients with Squamous Non-Small Cell Lung CancerBD extracted 2 program updates from this document → SMMT pipeline
• Aug 5, 2026ReleaseSummit Therapeutics Further Expands Ivonescimab Global Development Program with Phase II/III HARMONi-GU1 Study in 1L Bladder Cancer
• Aug 5, 20268-KCurrent report: other events · EX-99.1
• Jul 23, 2026ReleaseSummit Therapeutics to Host Second Quarter 2026 Financial Results & Operational Progress Call on July 23, 2026
• Jul 23, 20268-KCurrent report: results of operations, Reg FD disclosure · EX-99.1
• Jul 23, 20268-KCurrent report: material agreementBD extracted 1 program update from this document → SMMT pipeline
• Jul 23, 2026424B5Prospectus supplement (offering)
• Jul 23, 202610-QQuarterly reportBD extracted 1 program update from this document → SMMT pipeline
• Jul 22, 2026ReleaseIvonescimab Plus Chemotherapy Shows Consistent, Favorable Overall Survival Results in Western and Asian Patients in Updated Analysis from Global Phase III HARMONi Study
• Jul 22, 2026ReleaseArcus Biosciences and Summit Therapeutics Enter into Clinical Trial Collaboration to Evaluate Casdatifan Combined with Ivonescimab in Kidney CancerBD extracted 1 program update from this document → SMMT pipeline
• Jul 22, 20268-KCurrent report: other events · EX-99.1BD extracted 1 program update from this document → SMMT pipeline
• Jul 14, 2026ReleaseSummit Therapeutics Signs Agreement to Sell Phase III Asset Ridinilazole to Biossil, Inc.
• Jun 12, 20268-KCurrent report: shareholder vote
• Jun 11, 20268-KCurrent report: Reg FD disclosure
• Jun 10, 2026424B5Prospectus supplement (offering)
• Jun 9, 2026S-3ASRAutomatic shelf registration
• Jun 9, 2026ReleaseSummit Therapeutics Announces Proposed Public Offering of Common Stock
• Jun 4, 2026ReleaseSummit Therapeutics to Participate in the 47th Annual Goldman Sachs Global Healthcare Conference
• Jun 3, 20268-KCurrent report: other events
• Jun 1, 20268-KCurrent report: other events · EX-99.1BD extracted 1 program update from this document → SMMT pipeline
• May 31, 2026ReleaseIvonescimab with Chemotherapy Demonstrated a Statistically Significant Overall Survival Benefit Compared to Tislelizumab Plus Chemotherapy in 1L Treatment of Patients with Squamous NSCLC in the HARMON
• May 30, 2026ReleaseEncouraging Global Phase II Ivonescimab Data in First-Line Metastatic Colorectal Cancer Presented at ASCO 2026
• Apr 30, 2026ReleaseShare on Facebook (opens in new window)
• Apr 30, 2026ReleaseShare on Linkedin (opens in new window)
• Apr 30, 2026ReleaseShare on Twitter (opens in new window)
• Apr 30, 2026ReleaseShare on Whatsapp (opens in new window)
• Apr 30, 20268-KCurrent report: results of operations · EX-99.1
• Apr 30, 202610-QQuarterly report
• Apr 17, 2026DEFA14AProxy soliciting material
• Apr 17, 2026DEF 14AProxy statement