Executive Summary

Benitec reported Q3 FY2024 (quarter ended March 31, 2024) with $0 revenue, total operating expenses of $4.1M, net loss of $4.3M, and diluted EPS of $-1.64; cash and equivalents were $14.1M at quarter-end, followed by ~$37.2M gross proceeds received post-quarter from the April 22 PIPE, extending runway through 2025 .
Clinical execution advanced: two OPMD subjects dosed with BB-301; Subject 1 showed clinically meaningful improvement at Day 90 across radiographic swallowing endpoints and patient-reported outcomes; no SAEs observed; transient Grade 2 GERD occurred and was managed per protocol .
Financing de-risked: oversubscribed $40.0M private placement at $4.80 per share (and pre-funded warrants at $4.7999), led by Suvretta Capital with participation from Adage, Franklin and others, with registration rights and board designation agreement for Kishen Mehta; Benitec guides runway through 2025 .
Guidance/milestones: additional interim safety/efficacy data expected in 2H 2024; DSMB processes continuing; enrollment progressing (23 NH subjects); potential multi-subject, longer follow-up in 2025 and pivotal pathway dialogue in early 2026 if data trends persist .
Street estimates coverage was not available via S&P Global for Q3 FY2024, so beat/miss vs consensus could not be assessed (limited coverage) [GetEstimates error—S&P Global unavailable].

What Went Well and What Went Wrong

What Went Well

Positive clinical signal: “The interim clinical trial results for the first subject… demonstrated consistent, clinically meaningful improvements in each of the central study endpoints,” including radiographic and patient-reported swallowing measures at Day 90 .
Safety profile acceptable: No SAEs observed in two dosed subjects; transient Grade 2 GERD managed with short courses of medication, aligning with protocol-managed steroid-related AEs .
Capital strengthened: Closed oversubscribed $40.0M PIPE financing led by high-quality institutions, supporting BB-301 development and extending cash runway through 2025 .

What Went Wrong

No revenue; continued losses: Q3 FY2024 revenue was $0; net loss was $4.3M and cash declined to $14.1M prior to PIPE proceeds, highlighting ongoing financing needs typical of clinical-stage biotech .
Dose-limiting toxicity rule triggered cohort expansion: Protocol characterization of a Grade 2 AE requiring >14 days of management as a DLT mandated expansion of Cohort 1 from 3 to 6 subjects, which could lengthen timelines .
R&D spend variability and scale-up needs: R&D expenses fell to $2.6M in Q3 vs $5.1M in Q2 amidst clinical execution; continued manufacturing/process development and trial operations will require disciplined allocation of the newly raised capital .

Financial Results

Quarterly P&L and EPS (FY2024)

Metric	Q1 FY2024 (Sep 30, 2023)	Q2 FY2024 (Dec 31, 2023)	Q3 FY2024 (Mar 31, 2024)
Revenues ($USD Millions)	$0.00	$0.00	$0.00
Total Operating Expenses ($USD Millions)	$5.87	$6.93	$4.14
Net Loss ($USD Millions)	$5.95	$6.80	$4.28
Diluted EPS ($USD)	$-2.76	$-2.64	$-1.64

Operating Expense Breakdown

Metric	Q1 FY2024	Q2 FY2024	Q3 FY2024
R&D Expense ($USD Millions)	$4.43	$5.10	$2.57
G&A Expense ($USD Millions)	$1.55	$1.82	$1.58

Cash & Liquidity

Metric	Q1 FY2024	Q2 FY2024	Q3 FY2024
Cash & Cash Equivalents ($USD Millions)	$25.86	$20.37	$14.14
Post-Quarter PIPE Gross Proceeds ($USD Millions)	—	—	~$37.2 received April 22, 2024

YoY Comparison (Q3 FY2024 vs Q3 FY2023)

Metric	Q3 FY2023	Q3 FY2024
Revenues ($USD Millions)	$0.054	$0.00
Total Operating Expenses ($USD Millions)	$4.40	$4.14
Net Loss ($USD Millions)	$4.40	$4.28
Diluted EPS ($USD)	$-2.67	$-1.64

Actuals vs Estimates (Q3 FY2024)

Metric	Actual	Consensus	Delta
Revenue ($USD Millions)	$0.00	N/A (S&P Global consensus unavailable)	N/A
Diluted EPS ($USD)	$-1.64	N/A (S&P Global consensus unavailable)	N/A

Street consensus was unavailable via S&P Global for BNTC this quarter, so beats/misses cannot be determined.

KPIs and Clinical Execution

KPI	Q1 FY2024	Q2 FY2024	Q3 FY2024
OPMD NH Subjects Enrolled (cumulative)	19	23	23
BB-301 Subjects Dosed (cumulative)	—	1 (Nov 2023)	2 (Feb 2024 second subject)
Interim Data Timing Guidance	12-month rolling after dosing	Mid-2024	2H 2024 updates

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Not specified	Extended through 2025	Raised
Interim Safety/Efficacy Updates	2024	“Mid-2024”	“2H 2024”	Maintained/clarified timeline
DSMB Process	2024	DSMB met post-Day 28 for Subject 1; continuation recommended	Next DSMB anticipated June 2024 after third subject in Cohort 1	Maintained procedural cadence
Enrollment Targets	Trial Design	Treat 21–30 subjects	Continued NH enrollment (23) and rollovers to treatment cohorts	Maintained; progressing
Potential Regulatory Path	2025–2026	N/A	Multi-subject, longer follow-up in 2025; possible FDA dialogue re pivotal study in early 2026 if data support	New forward-looking color

Earnings Call Themes & Trends

(No Q3 FY2024 earnings call transcript available; analysis based on press releases and R&D Day.)

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
R&D Execution	Q1: IND cleared; NH enrollment 19; planning first dosing . Q2: First subject dosed; DSMB continuation; second subject scheduled .	Two subjects dosed; Day 90 efficacy signal in Subject 1 across VFSS and SSQ	Improving clinical momentum
Safety	Q2: No DLTs in first subject; DSMB continuation	No SAEs; transient Grade 2 GERD in two subjects; protocol DLT characterization triggered cohort expansion	Manageable, protocol-driven adjustments
Enrollment	Q1: 19 NH subjects	23 NH subjects; multiple eligible for treatment	Steady progress
Financing & Runway	—	Oversubscribed $40M PIPE; runway through 2025	Strengthened balance sheet
Clinical Milestones	Q2: Interim data mid-2024	Interim updates 2H 2024; broader follow-up expected in 2025	On track

Management Commentary

“The interim clinical trial results for the first subject… demonstrated consistent, clinically meaningful improvements… with significant improvements noted across radiographic assessments of swallowing and corresponding improvements… We look forward to presenting… accruing data for additional study subjects, later this year.” – Jerel A. Banks, MD, PhD, CEO .
“We are highly encouraged by these early clinical trial results… BB-301 facilitated improvements across multiple measures of swallowing function…” – Jerel A. Banks, MD, PhD .
“No dose-limiting toxicities have been observed in the first subject… DSMB recommended continuation… We look forward to reporting interim safety and efficacy data in mid-2024.” – Jerel A. Banks, MD, PhD (Q2 press release) .

Q&A Highlights

No Q3 FY2024 earnings call transcript found; Benitec held a live virtual R&D Day on April 18, 2024 outlining interim BB-301 data, endpoint methodology, and milestones, with replay available via the investor site .

Estimates Context

S&P Global consensus estimates for revenue and EPS were unavailable for BNTC for Q3 FY2024, likely reflecting limited coverage for a microcap clinical-stage company. As such, beat/miss analysis vs consensus cannot be performed this quarter (S&P Global data unavailable).

Key Takeaways for Investors

Clinical signal de-risks BB-301: Day 90 improvements across VFSS and SSQ in Subject 1 suggest biological activity at low dose; further subjects and longer follow-up are key near-term catalysts in 2H 2024 .
Safety profile acceptable so far: No SAEs observed; steroid-associated GERD manageable; protocol-driven cohort expansion should be factored into timelines .
Balance sheet fortified: $40M oversubscribed PIPE from high-quality investors and runway guided through 2025 reduce near-term financing risk and support trial execution .
Execution milestones: Enrollment and dosing cadence continue; DSMB processes intact; expect broader multi-subject data visibility in 2025 and potential regulatory dialogue in early 2026 if trends persist .
Revenue/EPS not decision drivers: With $0 revenue and ongoing losses, stock drivers remain clinical data, safety updates, and financing/regulatory path; current quarter’s financials are typical of clinical-stage biotech .
Watch for data in thin liquids/solids endpoints: VFSS improvements in thin liquids and solids are clinically meaningful and could be focal points for future readouts and investor reaction .
Position sizing: Consider trial readout risk and protocol adjustments (cohort expansion) against improved funding and emerging efficacy signal; catalysts clustered in 2H 2024–2025 .

Supporting Documents Read

Q3 FY2024 8-K 2.02: “Releases Third Quarter 2024 Financial Results and Provides Operational Update” (full press release and financials) .
Q2 FY2024 8-K 2.02: “Releases Second Quarter 2024 Financial Results and Provides Operational Update” .
Q1 FY2024 8-K 2.02: “Releases First Quarter 2024 Financial Results and Provides Operational Update” .
8-K: “Reports Positive Interim Clinical Trial Data… BB-301 Phase 1b/2a” + R&D Day Presentation (Exhibits 99.1, 99.2) .
8-K: “Oversubscribed Private Placement Financing of $40.0 Million” and transaction documents .

Benitec Biopharma Inc. (BNTC)·Q3 2024 Earnings Summary