Executive Summary

Q1 FY2026 (quarter ended September 30, 2025) delivered zero revenue and a narrower loss per share: net loss was $8.97M and diluted EPS was $(0.22), better than consensus EPS of $(0.356); operating expenses were $9.80M, up year over year on elevated G&A . Consensus: EPS $(0.356), revenue $0.0.
Clinical execution was a clear positive: BB-301 achieved a 100% responder rate across Cohort 1 interim data and received FDA Fast Track designation; first Cohort 2 patient was treated in Q4 CY2025 .
Balance sheet strengthened: $94.5M cash at quarter-end and approximately $100M gross equity raised on November 5, 2025 to fund BB-301 registrational activities and regulatory filings .
Operating expense mix shifted: R&D declined year over year (to $3.37M) as programs transitioned, while G&A increased (to $6.43M), driving total OpEx higher YoY .
Near-term stock catalysts are clinical and regulatory: FDA collaboration on pivotal study design for BB-301 in 2026, continued Cohort 2 enrollment/dosing, and durability/readouts from the Phase 1b/2a trial .

What Went Well and What Went Wrong

What Went Well

BB-301 efficacy/responder signal: “All 6 patients in Cohort 1 met the formal statistical criteria for response,” representing a 100% responder rate; Fast Track Designation granted based on interim clinical results and proprietary responder analysis .
Execution milestones: First Cohort 2 patient treated in Q4 CY2025, and DSMB previously recommended continuing enrollment after Cohort 1 low-dose completion .
Financing and leadership: ~$100M gross raised at $13.50/share and appointment of veteran biotech leader Dr. Sharon Mates to the Board, supporting registrational path and governance depth .

What Went Wrong

Operating expenses elevated YoY: Total OpEx rose to $9.80M from $5.79M YoY, driven by G&A at $6.43M vs $2.21M YoY, pressuring net loss despite interest income .
No product revenue and ongoing losses: Revenue remained $0 and net loss was $8.97M; EPS $(0.22), reflecting a pre-commercial profile and investment phase .
Limited quantitative guidance: The company did not provide formal revenue/margin/OpEx guidance; investors must rely on clinical/regulatory milestones and financing disclosures to infer trajectory .

Financial Results

Metric (USD)	Q4 2024 (Dec 31, 2024)	Q3 2025 (Mar 31, 2025)	Q1 2026 (Sep 30, 2025)
Revenue ($M)	$0.00	$0.00	$0.00
R&D Expense ($M)	$5.07	$5.98	$3.37
G&A Expense ($M)	$3.54	$4.21	$6.43
Total Operating Expenses ($M)	$8.61	$10.19	$9.80
Net Loss ($M)	$7.36	$9.35	$8.97
Diluted EPS ($)	$(0.33)	$(0.24)	$(0.22)
Cash & Cash Equivalents ($M)	$78.28	$103.58	$94.48

Versus Wall Street consensus (Q1 2026):

Metric	Consensus	Actual
Revenue ($M)	$0.00*	$0.00
EPS ($)	$(0.356)*	$(0.22)

Values marked with * are from S&P Global (Capital IQ).
Result: EPS beat; revenue inline.

KPIs (Clinical/Operational)

KPI	Q4 2024	Q3 2025	Q1 2026
Cohort 1 responder rate (%)	n/a	Interim data anticipated Q4 CY2025	100% responders (6/6)
Cohort 2 status	n/a	Plan to begin higher dose later CY2025	First patient treated (Q4 CY2025)
Regulatory status	Late-breaking oral abstract at MDA conf.	n/a	FDA Fast Track; FDA/EMA Orphan
Financing	Warrants boosted cash to $78.3M	Cash $103.6M	~$100M gross equity offering at $13.50/share

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
BB-301 pivotal study planning	2026	Anticipated interim Cohort 1 update in Q4 CY2025; begin Cohort 2 higher dose in CY2025	Plan to meet with FDA in 2026 to confirm pivotal study design	Clarified timing (maintained)
Use of proceeds	Near term	n/a	Use net proceeds + cash to fund BB-301 registrational program, working capital	New (post-offering)
Financial guidance (rev/margins/OpEx/tax)	FY26	Not provided	Not provided	Maintained (none)
Dividends	Ongoing	None indicated	None indicated	Maintained

Earnings Call Themes & Trends

(Note: No Q1 FY2026 earnings call transcript found; themes derived from press releases and webcast materials.)

Topic	Previous Mentions (Q4 2024)	Previous Mentions (Q3 2025)	Current Period (Q1 2026)	Trend
R&D execution (BB-301 dosing)	4th and 5th subjects treated at low dose; DSMB supported continuation	6th subject safely treated; plan for higher dose Cohort 2 later in year	First Cohort 2 patient treated; 100% responder rate in Cohort 1	Strengthening
Regulatory/legal	Late-breaking oral presentation accepted at MDA conference	n/a	FDA Fast Track; Orphan (FDA/EMA)	Positive momentum
Funding strategy	Warrants exercised; cash $78.3M	Cash $103.6M	~$100M equity raised; supports registrational work	Strengthened
Clinical endpoints/analysis	Natural history informing endpoint design	Continued interim follow-up planned	Proprietary Responder Analysis used; multiple VFSS/SSQ endpoints improved	Maturing framework
Leadership/Governance	n/a	n/a	Dr. Sharon Mates appointed to Board	Added expertise

Management Commentary

“We previously announced positive interim clinical study results from the Phase 1b/2a trial of BB-301, with a 100% responder rate… BB-301 was also granted Fast Track Designation by the FDA, and we completed a significant capital raise to fund the advancement of BB-301…” – Jerel A. Banks, M.D., Ph.D., Executive Chairman & CEO .
“Securing Fast Track designation for BB-301 reflects the strength of our clinical data and the urgency of the unmet need in OPMD… we look forward to continued collaboration with the FDA as we advance toward a pivotal clinical trial.” – Jerel A. Banks, M.D., Ph.D. .
“We look forward to continued collaboration with the FDA in 2026 to advance the development of BB-301.” – Jerel A. Banks, M.D., Ph.D. .
“Dr. Mates brings exceptional leadership experience… her extensive track record… will be invaluable as we continue progressing our BB-301 program… and expanding the potential of our ddRNAi platform.” – Jerel A. Banks, M.D., Ph.D. .

Q&A Highlights

No formal Q1 FY2026 earnings call transcript was available; the company hosted a November 3 webcast focused on interim BB-301 data and the proprietary responder analysis. No published Q&A transcript was found .

Estimates Context

Q1 FY2026 EPS beat: $(0.22) actual vs $(0.356)* consensus; revenue inline at $0.0 actual vs $0.0* consensus. The beat was driven by interest income and a lower R&D spend versus prior quarter, partially offset by higher G&A; management discussed clinical progress and financing rather than financial guidance .
Values marked with * are from S&P Global (Capital IQ).
Implications for estimates: Continued absence of revenue and fluctuating OpEx mix suggest EPS visibility remains tied to trial cadence and G&A normalization; consensus may lift near-term EPS following a narrower loss, but trajectory will depend on Cohort 2 dosing costs, regulatory interactions, and cash income .

Key Takeaways for Investors

Clinical de-risking: The 100% responder rate across Cohort 1 and Fast Track status materially de-risk BB-301’s path to pivotal study; durability and Cohort 2 higher-dose data are next-readouts to watch .
Funded to key milestones: ~$100M gross offering plus $94.5M Q-end cash should support BB-301 registrational activities and regulatory filings; financing reduces near-term balance sheet risk .
Near-term catalysts: FDA meeting in 2026 on pivotal design, additional interim data (including Cohort 2), and evolving endpoint framework using VFSS/SSQ measures; these are likely stock movers .
Cost discipline and mix: Monitor G&A normalization after the recent step-up and the R&D profile as Cohort 2 scales; OpEx mix will drive EPS variance absent revenue .
Governance upgrade: Dr. Sharon Mates’ appointment adds commercialization and scaling experience critical for registrational and potential launch planning .
Risk factors: Pre-commercial status, regulatory uncertainty, trial enrollment/dosing timing, and manufacturing/execution risks remain; no quantitative financial guidance provided .
Strategy: Position sizing should reflect binary clinical/regulatory milestones; consider catalysts calendar (data updates, FDA interactions) and balance sheet strength in trading plans .

Additional Relevant Q1 FY2026 Press Releases and Materials

Fast Track designation and interim Cohort 1 results webcast (slides) .
Equity offering at $13.50/share; ~$100M gross proceeds (underwritten + registered direct) .
Board appointment of Dr. Sharon Mates .

Prior Two Quarters (for Trend)

Q2 FY2025 (quarter ended Dec 31, 2024): Net loss $7.36M; EPS $(0.33); OpEx $8.61M; cash $78.28M; milestones included late-breaking MDA presentation, additional subjects treated .
Q3 FY2025 (quarter ended Mar 31, 2025): Net loss $9.35M; EPS $(0.24); OpEx $10.19M; cash $103.58M; 6th Cohort 1 subject treated, higher-dose Cohort 2 planned later in year .

Footnote: Values marked with * are retrieved from S&P Global (Capital IQ).

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