Highest-materiality recent filing
Ivonescimab: 70.8% ORR in mCRC Phase II; HARMONi-6 OS HR 0.66 vs tislelizumab
Phase II AK112-206 in 1L mCRC: ORR 70.8%, DCR 100.0% in evaluable patients (n=48); 9-month PFS rate 76.1% for 20 mg/kg arm.
Summit Q1 net loss $189.4M, cash $598.7M; ivonescimab OS data at ASCO plenary
GAAP net loss $189.4M ($0.24/sh) vs $62.9M ($0.09/sh) YoY; non-GAAP net loss $116.6M ($0.15/sh).
Summit FY25 GAAP net loss $1.08B, BLA accepted with PDUFA Nov 14, HARMONi-3 interim PFS Q2 2026
GAAP net loss $1,079.6M ($1.44/sh) vs $221.3M ($0.31/sh) FY24; non-GAAP net loss $347.2M ($0.46/sh).
Summit Therapeutics BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA; PDUFA Nov 14, 2026
FDA accepted BLA for ivonescimab + chemotherapy in EGFR-mutated non-squamous NSCLC post-TKI therapy.
Summit submits BLA for ivonescimab in EGFRm NSCLC; $710M cash; GSK collaboration
BLA submitted to FDA for ivonescimab + chemo in 2L+ EGFR-mutated NSCLC based on Phase III HARMONi; FDA decision expected Q4 2026.
Ivonescimab + chemo shows OS benefit in EGFRm NSCLC; HR 0.74 in HARMONi-A final analysis
Final OS analysis: ivonescimab+chemo vs chemo achieved HR 0.74 (95% CI: 0.58-0.95, p=0.019); median OS 16.8 vs 14.1 months.
Summit Therapeutics raises $500M in private placement at $18.74/share; insiders invest $282M
Raised $500M gross and net proceeds from sale of 26.68M shares at $18.74 each, the closing price on Oct 21, 2025.
Summit plans BLA for ivonescimab in Q4 2025; HARMONi-6 meets endpoint
Plans to submit BLA for ivonescimab plus chemotherapy in EGFRm NSCLC in Q4 2025 based on HARMONi study.
Ivonescimab HARMONi trial shows improved OS trend in longer follow-up; North American HR=0.70
Longer-term follow-up of Western patients: OS HR=0.78 (nominal p=0.0332); median OS 16.8 vs 14.0 months.
Summit Therapeutics expands ATM offering capacity by $360M to total $450M
Increased ATM equity offering capacity by $360M; total authorized up to $450M under agreement with J.P. Morgan.
Ivonescimab HARMONi PFS HR 0.52, NMPA approval; Summit Q2 net loss $565.7M
HARMONi PFS HR 0.52 (p<0.00001); OS trend HR 0.79 (p=0.057); BLA filing planned.
Summit's ivonescimab meets PFS endpoint in global Phase III HARMONi; OS trend positive
Ivonescimab + chemo reduced risk of progression or death by 48% vs chemo alone (HR 0.52; p<0.00001).
Summit Therapeutics Q1 net loss widens to $62.9M; ivonescimab gets second China approval
GAAP net loss $62.9M ($0.09/share) vs $43.5M ($0.06) in Q1 2024; R&D expenses rose to $51.2M.
Summit: Ivonescimab gets second NMPA approval in China; OS hazard ratio 0.777
NMPA approved ivonescimab for front-line PD-L1+ advanced NSCLC based on HARMONi-2 Phase III trial.
Ivonescimab + chemo beats tislelizumab + chemo in Phase III squamous NSCLC trial (HARMONi-6)
Primary endpoint PFS met: statistically significant and clinically meaningful improvement by BICR versus tislelizumab combo.
Summit Therapeutics reports FY2024 net loss $221.3M; HARMONi enrollment complete, data mid-2025
Cash & short-term investments $412.3M at Dec 31, 2024, up from $186.2M at Dec 31, 2023.
Summit Therapeutics discloses ~$412M cash balance, awards $540K bonuses to CEO/CFO
Preliminary unaudited cash, equivalents, and short-term investments ~$412M as of Dec 31, 2024, including $31.8M loan repayment.
Summit reports Q3 net loss $56.3M; ivonescimab HARMONi-2 shows 49% risk reduction vs Keytruda
Cash and short-term investments $487M (vs $186.2M Dec 2023) after $235M private financing in Sep 2024.
Summit Therapeutics raises $235M in private placement led by insiders at $22.70/share
Sold 10.35M shares at $22.70, the closing price on Sept 11; aggregate gross proceeds ~$235M.
Summit reports ivonescimab beats Keytruda in Phase 3 NSCLC trial; PFS HR=0.51 p<0.0001
Ivonescimab vs pembrolizumab in 1L PD-L1+ advanced NSCLC: mPFS 11.14 vs 5.82 months (HR 0.51, p<0.0001).
Summit Therapeutics Q2 net loss $60.4M; ivonescimab achieves first Phase III win over Keytruda
GAAP net loss $60.4M ($0.09/sh) vs $14.7M ($0.02) in Q2 2023; non-GAAP loss $34.3M.
Ivonescimab plus chemo gets NMPA approval in China for EGFRm NSCLC; PFS HR 0.46 in HARMONi-A
NMPA approved ivonescimab + chemo for 2L+ EGFR-mutant non-squamous NSCLC based on HARMONi-A Phase III trial sponsored by Akeso.
Summit raises $200M, expands ivonescimab license to LAMEA regions
Raised $200M via private placement of 22.2M shares at $9.00/share, a premium to the prior close.
Summit: Ivonescimab beats pembrolizumab in Phase III HARMONi-2 for PD-L1+ NSCLC
Ivonescimab met primary endpoint PFS with statistically significant and clinically meaningful superiority over pembrolizumab.
Summit partner Akeso wins China NMPA approval for ivonescimab in EGFR-mutated NSCLC
NMPA approved ivonescimab + chemo for EGFR-mutated advanced non-squamous NSCLC after TKI failure.
Summit Therapeutics enters $90M ATM equity distribution agreement with JPMorgan
Up to $90M of common stock may be sold at-the-market through J.P. Morgan Securities LLC as sales agent.
GAAP net loss $43.5M ($0.06/sh) vs $542.3M ($1.43/sh) prior year; non-GAAP net loss $34.0M ($0.05/sh).
Effective June 12, 2024, Ujwala Mahatme informed Summit Therapeutics Inc. (the “Company”) that she was resigning from her role as a member of the Board of Directors (the “Board”) of the Company, and from each committee of the Board, to focus on her increasing professional commitments outside the Company.
Max materiality 0.90 · Median 0.75 · Most common event other_material