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Celcuity closes $575M convertible note offering at 0.250% due 2032, repays $137.5M loan
Issued $575M aggregate principal of 0.250% Convertible Senior Notes due 2032; net proceeds ~$557M.
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Gedatolisib doubles PFS vs alpelisib in PIK3CA mutant HR+/HER2- ABC Phase 3 trial
Gedatolisib-triplet reduced risk of progression or death by 50% (HR=0.50; p<0.0001); median PFS 11.1 vs 5.6 months.
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Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant
Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).
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Celcuity Phase 3 VIKTORIA-1 PIK3CA mutant cohort meets primary endpoint with significant PFS improvement
Gedatolisib triplet (plus fulvestrant and palbociclib) showed statistically significant PFS improvement vs alpelisib+fulvestrant.
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Celcuity reports Q4 loss $0.97/share; FDA grants Priority Review for gedatolisib, PDUFA July 17, 2026
Net loss Q4 $51.0M ($0.97), FY $177.0M ($3.79); adjusted net loss Q4 $38.4M ($0.73), FY $150.8M ($3.22).
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Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program
NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.
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Celcuity Q3 net loss $43.8M; gedatolisib NDA on track for Q4 2025
Q3 net loss $43.8M ($0.92 loss per share) vs $29.8M ($0.70 loss) in prior year.
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Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC
Median PFS 9.3mo for gedatolisib triplet vs 2.0mo for fulvestrant (HR=0.24); incremental 7.3mo improvement.
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Celcuity upsizes senior secured facility to $500M, receives $30M immediate funding
Total facility increased to $500M ($350M committed + $150M discretionary); $30M funded, total outstanding $130M.
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Celcuity reports Phase 3 gedatolisib milestone; NDA filing on track for Q4 2025
Phase 3 VIKTORIA-1: gedatolisib triplet reduced risk of progression/death by 76% (HR=0.24); median PFS 9.3 mo vs 2.0 mo.
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Celcuity issues $201.25M of 2.750% convertible notes due 2031; net proceeds ~$194.5M
Issued $201.25M aggregate principal of 2.750% Convertible Senior Notes due 2031; initial conversion price ~$51.30/share.
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Celcuity prices $175M convertible notes and stock offering; net proceeds ~$248.7M
$175M of 2.750% convertible senior notes due 2031 priced; initial conversion price ~$51.30/share (35% premium to stock offering).
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Celcuity launches $150M convertible notes + $75M common stock offerings; also to draw $30M loan
Concurrent underwritten offerings: $150M convertible notes due 2031 and $75M common stock; 30-day over-allotment options for additional $22.5M notes and $11.25M stock.
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Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)
Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.
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Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2
Phase 1 mCRPC (gedatolisib + darolutamide): 66% six-month rPFS; no treatment-related discontinuations or Grade 3 hyperglycemia; Grade 2-3 stomatitis in 10.5% of patients.
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Celcuity posts Q4 net loss $36.7M, cash $235M, key trial data anticipated in 2025
Q4 net loss $36.7M ($0.85/share) vs $18.8M ($0.65/share) in Q4 2023; full year net loss $111.8M ($2.83/share).
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Celcuity establishes new $125M at-the-market equity offering program
New ATM facility with Jefferies allows up to $125M additional common stock sales.
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Celcuity Q3 net loss $29.8M ($0.70/sh); VIKTORIA-1 wild-type cohort 100% enrolled
PIK3CA wild-type cohort of VIKTORIA-1 100% enrolled; topline data expected late Q1 2025 or Q2 2025.
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Celcuity Q2 net loss widens to $23.7M; VIKTORIA-1 PIK3CA WT cohort enrollment delayed to Q4 2024
Net loss of $23.7M ($0.62/share) vs $14.6M ($0.66/share) YoY; non-GAAP adjusted loss per share $0.58.
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Celcuity prices $60M common stock offering of 3.871M shares at $15.50
3,871,000 shares priced at $15.50 per share; gross proceeds $60.0M, net ~$56.2M.
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Celcuity secures up to $180M debt financing, plans Phase 3 gedatolisib trial in HR+/HER2- breast cancer
New A&R Loan Agreement with Innovatus and Oxford provides up to $180M; $100M funded including $61.7M new borrowings.
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Celcuity Q1 net loss $21.6M; Phase 3 VIKTORIA-1 on track for H2 2024 data
Net loss $21.6M ($0.64/sh) vs $11.9M ($0.55/sh) in Q1 2023; cash $177.7M expected runway into H1 2026.
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Celcuity Q4 net loss $18.8M; FY net loss $63.8M; cash into H1 2026; VIKTORIA-1 topline data H2 2024
Net loss Q4 2023 $18.8M ($0.65 loss per share) vs $11.6M ($0.69) in Q4 2022.
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Celcuity Q3 net loss $18.4M; raises $50M; advances gedatolisib in prostate cancer
Q3 net loss $18.4M ($0.83 loss per share) vs $10.9M ($0.75) YoY; non-GAAP adjusted loss $17.3M ($0.78).
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Celcuity raises $50M via private placement of pre-funded warrants
Gross proceeds of ~$50M from sale of pre-funded warrants to institutional investor.
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Celcuity adjusts executive compensation; CEO base salary down, CFO base up ~22% with stock options
CEO base salary decreased slightly; CSO base up <10%; CFO base up ~22% partially paid in stock options.
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Celcuity to start Phase 1b/2 trial of gedatolisib + darolutamide in mCRPC; Bayer supplies drug free
FDA cleared IND for gedatolisib in combination with darolutamide; trial to begin Q1 2024.
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Celcuity Q2 net loss $14.6M; Phase 1b gedatolisib data shows 48.6-month median PFS
Net loss $14.6M ($0.66/share) vs $10.0M ($0.67) Q2 2022; non-GAAP adjusted net loss $12.8M.
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Celcuity Q1 2023 net loss $11.9M; Phase 1b gedatolisib shows median PFS 48.6 months
Net loss of $11.9M ($0.55 loss per share) vs $7.9M ($0.53 loss per share) in Q1 2022.
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Celcuity closes $20M term loan from Innovatus under existing credit facility
Closed $20.0M Term B Loan on Dec 22, 2022; part of previously disclosed $75M facility.
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Celcuity Q3 net loss $10.9M ($0.75/sh); Phase 3 VIKTORIA-1 site activation underway
Net loss $10.9M ($0.75/sh) vs $6.0M ($0.41/sh) in Q3 2021; adjusted net loss $9.5M ($0.63/sh).
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Celcuity appoints Dr. Polly Murphy to Board; reduces warrant shares to 70K
Warrant amended: shares reduced from 138,000 to 70,000; exercise period extended to Sept 19, 2025.
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Celcuity expands debt to $75M, Q2 net loss $10M, gedatolisib gets Breakthrough Therapy
Debt facility amended to up to $75M ($50M increase); $15M drawn, $20M due on private placement close; other tranches tied to clinical milestones.
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Celcuity grants stock options to execs in lieu of salary, reprices outstanding options to $5.50
CEO Brian Sullivan granted options for 250,000 shares in lieu of 14-month base salary starting June 1, 2022.