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Benitec: FDA requests more BB-301 data; pivotal design due 1Q 2027, enrollment mid-2027
FDA formal feedback after a 3Q 2026 Type C meeting asked Benitec for additional available data, including results from the company-sponsored OPMD Natural History Study.
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Benitec engages Ernst & Young as auditor for fiscal year ending June 30, 2027
EY completed its client acceptance process on September 28, 2026, and executed the engagement letter with Benitec on September 29, 2026.
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Benitec Biopharma dismisses Baker Tilly, appoints Ernst & Young as auditor
Dismissed Baker Tilly on Sept 18, 2026; appointed EY for fiscal year ending June 30, 2027.
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Benitec FY2026 net loss $45.5M; BB-301 cohorts complete follow-up, FDA meeting held
FY2026 net loss attributable to shareholders was $45.5M ($0.98/share), vs $37.9M ($1.05/share) in FY2025.
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Benitec Biopharma appoints David Friedman to board; Megan Boston resigns as director but remains CFO
David Friedman joined board as Class III director effective May 22, 2026; term until 2028 annual meeting.
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Benitec Q3 net loss $0.24/shr, cash $184.8M; BB-301 clinical progress continues
Net loss $11.9M ($0.24/shr) vs $14.5M ($0.38/shr) in prior year quarter; total expenses $13.6M.
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Benitec Q2 FY2026 net loss $11.8M; all Cohort 1 patients respond to BB-301 at 12 months
Net loss of $11.8M ($0.26 per share) vs $9.6M YoY; total expenses $13.4M (up from $10.8M).
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Benitec Biopharma stockholders elect directors and ratify auditor at 2025 annual meeting
22,327,761 shares present (85.06% of outstanding); all proposals passed.
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Benitec Q1 net loss $9.0M; BB-301 100% responder rate; FDA Fast Track; raised $100M
Net loss of $9.0M ($0.22/sh) vs $5.1M ($0.18) YoY; total expenses $9.8M, up from $5.8M.
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Benitec Biopharma prices $100M equity offering at $13.50/share (7.4M shares total)
Underwritten public offering of 5,930,000 shares plus 889,500-share underwriter option; concurrent registered direct offering of 1,481,481 shares to Suvretta Capital affiliates.
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Benitec gets FDA Fast Track for BB-301 in OPMD; 100% response rate in Cohort 1
FDA granted Fast Track Designation to BB-301 for OPMD with dysphagia; BB-301 also has Orphan Drug Designation from FDA and EMA.
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Benitec Biopharma FY2025 net loss $37.9M ($1.05/sh); BB-301 DSMB clears Cohort 2 enrollment
Net loss $37.9M ($1.05/share) vs $22.4M ($1.22/share) in FY2024; total expenses $41.8M (up 86%).
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Benitec restates Q2 and Q3 FY2025 financials for stock-comp understatement; prior filings unreliable
Audit Committee concluded Dec 31, 2024 and Mar 31, 2025 unaudited financials should no longer be relied upon.
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Benitec Biopharma reports DSMB recommends continuation of BB-301 Phase 1b/2a study after Cohort 1
Sixth and final subject of Cohort 1 safely treated with low dose of BB-301 in April 2025.
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Benitec Biopharma reports Q3 FY2025 net loss of $9.4M; cash $103.6M; BB-301 low-dose cohort completed
Net loss of $9.4M ($0.24/share) vs $4.3M ($0.23/share) in prior year; expenses rose to $10.2M on higher R&D and G&A.
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Benitec Biopharma closes ~$30.5M equity offering; issues 2.043M shares and pre-funded warrants
Gross proceeds ~$30.5M from underwritten offering of 1.143M shares + 300K pre-funded warrants at $13.00/$12.999 per share.
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Benitec Biopharma enters registration rights agreement with Averill funds related to direct offering
Registration Rights Agreement with Averill Master Fund and Averill Madison Master Fund dated March 26, 2025.
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Benitec Biopharma raises ~$30M in underwritten and direct common stock offering at $13/share
Underwritten offering of 1,143,000 shares and 300,000 pre-funded warrants at $13.00/$12.9999 per unit.
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Benitec reports durable improvements in swallowing function with BB-301 in OPMD interim results
Three subjects treated with low-dose BB-301 showed significant, clinically meaningful improvements in swallowing function at 12 months (Subjects 1,2) and 3 months (Subject 3) post-treatment.
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Benitec reports positive Phase 1b/2a BB-301 data; three OPMD subjects show durable swallowing improvements
Subject 1: 41% reduction in total dysphagic symptom burden (SSQ) 12-months post-treatment; VFSS improvements across consistencies.
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Benitec Biopharma reports Q2 FY2025 net loss of $7.4M, cash at $78.3M; five patients treated with BB-301 in Phase 1b/2a
Net loss $7.4M ($0.33/sh) vs $6.8M ($2.64/sh) year ago; basic shares rose from 2.6M to 22.1M on warrant exercises.
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Benitec Biopharma grants COO Sophie Mukadam 300,000 options at $12.00
Sophie Mukadam appointed COO effective Jan 1, 2025; receives 300,000 nonqualified stock options.
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Benitec appoints Sophie Mukadam as COO, Megan Boston as CFO; grants stock options to executives
Sophie Mukadam appointed COO effective Jan 1, 2025; base salary $500K, target bonus 40%.
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Benitec Biopharma authorizes 5M shares of preferred stock, effective Dec 9, 2024
Stockholders approved at Dec 4, 2024 annual meeting; amendment effective Dec 9, 2024.
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Benitec Biopharma stockholders elect directors and approve preferred stock authorization at 2024 annual meeting
Directors J. Kevin Buchi and Peter Francis elected with 17.3M and 16.5M votes respectively.
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Benitec Biopharma approves $360k CEO bonus, $162k Exec Director bonus for FY2024
Compensation Committee approved discretionary bonus of $360,360 for CEO Jerel Banks for FY ending June 30, 2024.
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Benitec reports Q1 FY2025 net loss $5.1M; positive clinical data for BB-301 in OPMD
Net loss $5.1M ($0.48/sh) vs $5.9M ($3.05/sh) prior year; cash $67.8M.
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Benitec reports positive interim data from BB-301 Phase 1b/2a: swallowing improvements in two OPMD subjects
Subject 1 at Day 270: 35% SSQ Total Score reduction, 33% VFSS TPR reduction for thin liquids.
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Benitec Biopharma enters ATM sales agreement for up to $75 million common stock offering
Up to $75M in common stock may be sold at-the-market through agent Leerink Partners.
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Benitec Biopharma gets ~$21.1M from Suvretta warrant exercise; shares outstanding rise to 17.9M
Suvretta Capital waived 19.99% beneficial ownership limit on warrants; new cap set at 49.9%.
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Benitec Biopharma FY2024 net loss $22.4M, cash $50.9M; BB-301 shows swallowing improvement
Net loss of $22.4M ($5.51 per share) for FY2024; cash and equivalents $50.9M as of June 30, 2024.
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Benitec stockholders approve Nasdaq-related proposal and equity plan amendment at special meeting
5,947,860 shares (58.97% of outstanding) present at August 29 special meeting.
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Benitec reports durable swallowing improvements at 180 days for first BB-301 subject in Phase 1b/2a
Post-dose Total Pharyngeal Residue meaningfully reduced at 180 days vs pre-dose average for Subject 1.
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Benitec appoints Kishen Mehta to board; Suvretta Capital portfolio manager
Appointed as Class I director effective June 26, 2024, term through 2026 annual meeting.
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Benitec reports Q3 net loss $4.3M, positive OPMD data, $40M PIPE closed
Net loss of $4.3M ($1.64 EPS) vs $4.4M ($2.67 EPS) in Q3 2023; revenue $0.
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Benitec Biopharma raises $40M in oversubscribed PIPE financing at $4.80/share
Gross proceeds of $40M from sale of 5,749,152 shares at $4.80 and pre-funded warrants for 2,584,239 shares at $4.7999.
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Benitec reports positive interim clinical data for BB-301 in OPMD first subject at 90 days
First subject showed improvements in videofluoroscopic swallowing studies and Sydney Swallow Questionnaire at Day 90 vs. pre-dose baseline.
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Benitec Biopharma grants 666,558 stock options to CEO and executive director at $5.21
Compensation Committee approved nonqualified options for CEO Jerel Banks (466,554 shares) and Exec. Director Megan Boston (200,004 shares).
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Benitec Q2 net loss $6.8M; first BB-301 subject cleared DSMB review – enrollment continues
Net loss of $6.8M ($2.64 per share) for quarter ended Dec 31, 2023 vs $5.4M ($3.34) a year ago.
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Benitec Biopharma stockholders approve all four proposals at 2023 Annual Meeting
Stockholders elected Edward Smith as director: 1,324,883 for, 54,894 withhold, 496,015 broker non-votes.
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Benitec dosed first subject in Phase 1b/2a trial of BB-301 for OPMD dysphagia
BB-301 is a gene therapy candidate using Silence and Replace ddRNAi platform for Oculopharyngeal Muscular Dystrophy (OPMD).
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Benitec Biopharma Q1 net loss $6M; 19 OPMD subjects enrolled; BB-301 dosing expected Dec/Jan
Net loss of $6.0M ($2.76 per share) vs $5.1M ($7.98 per share) in Q1 FY2023; higher share count reduced per-share loss.
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Benitec Biopharma approves $273K bonus for CEO and $117K for Executive Director
Compensation Committee approved discretionary bonus of $273,000 for CEO Jerel Banks for FY 2023.
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Benitec Biopharma regains Nasdaq compliance with $28.6M equity offering
Regained compliance with Nasdaq minimum stockholders' equity rule via $28.6M net proceeds from August 2023 offering.
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Benitec Biopharma reports FY2023 net loss of $19.6M; FDA cleared BB-301 IND; completed $30.9M offering
Net loss $19.6M ($14.12/share) vs $18.2M ($37.88/share) prior year; cash $2.5M at June 30, 2023.
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Benitec Biopharma increases CEO base salary to $655,200, Executive Director to $350,784
Dr. Jerel Banks' (CEO) base salary raised to $655,200, effective Oct 1, 2023.
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Benitec Biopharma raises ~$30.9M gross in underwritten public offering; Series 2 warrants exercise price reset to $1.93
Offering included 875,949 common shares, 15.1M pre-funded warrants, 16.0M common warrants; net proceeds ~$28.3M.
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Benitec Biopharma regains Nasdaq minimum bid price compliance
Received Nasdaq notice on Aug 9, 2023, confirming compliance with Bid Price Rule 5550(a)(2).
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Benitec Biopharma effects 1-for-17 reverse stock split to meet Nasdaq minimum bid price
Reverse stock split of common stock at 1-for-17 ratio effective July 26, 2023 at 12:01 a.m. ET.
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Benitec Biopharma receives FDA IND clearance for BB-301 gene therapy for OPMD
FDA cleared IND for BB-301, a silence-and-replace gene therapy for Oculopharyngeal Muscular Dystrophy (OPMD).