Name: Anebulo Pharmaceuticals, Inc. Q1 2025 Earnings Call
Start: 2024-11-13T00:00:00.000Z

Executive Summary

Q1 FY2025: Net loss of $2.20M and diluted EPS of $(0.08); total operating expenses were $2.41M, helped by $0.25M in grant income recognized from the NIDA award .
Year-over-year improvement: net loss narrowed from $2.48M and EPS from $(0.10) in Q1 FY2024, driven by lower operating expenses versus prior year .
Pipeline execution: management reiterated timelines to complete IND-enabling and IV scale-up around calendar year-end 2024 and enroll the first healthy adult volunteer in H1 2025, supported by the NIH/NIDA grant .
Liquidity: cash was $1.40M at quarter-end; the company maintains access to up to $10M via its Loan and Security Agreement (LSA), providing near-term runway while advancing IV selonabant .

What Went Well and What Went Wrong

NIH/NIDA non-dilutive funding: Anebulo recognized $0.25M grant income in Q1 and holds a two-year cooperative grant of up to ~$1.9M, validating the medical need for a pediatric emergency antidote for cannabis toxicity .
Clear execution milestones: management expects IV IND-enabling and scale-up completion around year-end 2024 and first healthy adult volunteer enrollment in H1 2025, providing tangible clinical catalysts .
Strategic focus on pediatric IV: prioritizing a faster approval path in a vulnerable population aligns with FDA feedback and market need, with continued emphasis since Q3 FY2024 .

Higher quarterly opex vs Q4: total operating expenses rose to $2.41M in Q1 from $1.34M in Q4, reflecting increased activity to progress IV formulation; net loss widened sequentially to $2.20M from $1.35M .
Cash drawdown: cash decreased to $1.40M at 9/30 from $3.09M at 6/30 and $5.15M at 3/31, increasing reliance on the $10M LSA and grant funding to support operations .
Limited revenue visibility: the company remains pre-revenue and expects continued operating losses, underscoring external funding needs and execution risk into and beyond H1 2025 .

Metric	Q3 FY2024 (Mar 31, 2024)	Q4 FY2024 (Jun 30, 2024)	Q1 FY2025 (Sep 30, 2024)
Revenues ($USD)	$0	$0	$0
Net Loss ($USD Millions)	$1.65	$1.35	$2.20
Diluted EPS ($USD)	$(0.06)	$(0.05)	$(0.08)
Total Operating Expenses ($USD Millions)	$1.66	$1.34	$2.41
R&D Expense ($USD Millions)	$0.75	$0.47	$1.31
G&A Expense ($USD Millions)	$0.92	$0.87	$1.10
Other Income (Net) ($USD Millions)	$(0.01)	$0.01	$(0.21)
Grant Income ($USD Millions)	$0.00	$0.00	$0.25
Cash & Equivalents ($USD Millions)	$5.15	$3.09	$1.40

Notes:

Q1 FY2025 includes $0.25M grant income from NIDA; interest expense relates to amortization of loan commitment fees under LSA .
Anebulo has not generated revenue since inception .

Metric	Period	Previous Guidance	Current Guidance	Change
IV selonabant IND-enabling & scale-up	Around calendar year-end 2024	“Currently scaling up IV formulation” (Q3 FY2024)	“Aims to complete IND-enabling and scale-up around year-end 2024” (Q4 & Q1)	Maintained/Specified timeline
First healthy adult volunteer enrollment	H1 2025	Not specified (Q3 FY2024)	“Expects to enroll first healthy adult volunteer in H1 2025” (Q4 & Q1)	Introduced then maintained
Liquidity outlook	Next 12+ months	Cash $3.09M; access to $10M LSA (Q4 FY2024)	Cash $1.40M; access to $10M LSA; management expects funding sufficiency for at least 12 months from filing date	Maintained sufficiency with lower cash
NIDA grant (two-year, up to ~$1.9M)	Year 1: $0.9M; Year 2: ~$1.0M subject to IND proceed/no unresolved hold	Award announced July 2024	$0.25M recognized in Q1; receivable $0.25M; Year 2 contingent milestones reiterated	Progressed (partial recognition)

Topic	Q3 FY2024 (Previous Mentions)	Q4 FY2024 (Previous Mentions)	Q1 FY2025 (Current Period)	Trend
Pediatric IV focus	Prioritized IV selonabant for pediatric poisoning; rationale tied to DOJ rescheduling and FDA feedback	Reiterated prioritization; highlighted unmet need and faster timeline	Continued prioritization and timelines; quotes emphasizing pediatric CNS depression risk	Maintained/increasing clarity
Regulatory/macro (DOJ rescheduling)	DOJ support for rescheduling cited as tailwind	Reaffirmed macro backdrop and pediatric need	Continued context on pediatric risk and unmet need	Stable tailwind narrative
R&D execution (IV scale-up, IND-enabling)	Scaling up IV for safety studies	Aims to complete IND-enabling & scale-up around year-end 2024	Same timelines; first volunteer targeted H1 2025	On track
Funding/liquidity	Cash $5.15M; LSA access	Cash $3.09M; LSA access	Cash $1.40M; LSA access; 12+ months sufficiency expected	declining cash; reliance on LSA/grant
Grants/non-dilutive funding	N/A	NIDA grant announced	$0.25M grant income recognized; receivable recorded	Positive development

“We are excited to have the support of NIDA to advance our development of a rapid and clinically impactful emergency treatment for acute cannabis-induced toxicities, including cannabis-induced Central Nervous System (CNS) depression in children.” – CEO Richie Cunningham .
“This grant…provides further momentum for advancing the intravenous formulation towards clinical testing…If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of accidental cannabis ingestion in children.” – CEO Richie Cunningham .
“We believe this important grant from NIDA recognizes the progress we have already made with the successful Phase 2 proof of concept study of oral selonabant…” – Q4 FY2024 press release .
“We are honored to receive this cooperative grant award from NIDA to support the further development of intravenous selonabant.” – CSO Ken Cundy .

No earnings call transcript was available; insights are derived from the press release and the 10-Q filed for Q1 FY2025 .

Wall Street consensus (S&P Global) for EPS and revenue was unavailable for ANEB this quarter; as a pre-revenue, clinical-stage micro-cap, formal coverage may be limited. Comparisons vs estimates are not provided.

Near-term clinical catalysts: completion of IV IND-enabling and scale-up around calendar year-end 2024; first healthy adult volunteer enrollment targeted for H1 2025 .
Funding runway: cash of $1.40M at quarter-end plus access to up to $10M under the LSA; management expects funding sufficiency for at least 12 months from the filing date, but continued non-dilutive grants or draws may be needed to support timelines .
Operating momentum: Q1 opex increased to $2.41M as IV program advances; grant income ($0.25M) partially offset expenses; watch sequential opex trends as clinical work ramps .
Execution risk: company remains pre-revenue and anticipates continued operating losses; timely IND clearance and initial enrollment are critical for value inflection .
Pediatric unmet need: macro/regulatory backdrop (DOJ rescheduling) and clinical risk profile in children continue to support the IV pediatric strategy; narrative is consistent across Q3–Q1 disclosures .
Liquidity sensitivity: sequential cash declines (Q3: $5.15M → Q4: $3.09M → Q1: $1.40M) heighten reliance on LSA/grants; monitor grant milestones and potential Advances under LSA .
Potential stock catalysts: NIDA grant progression (second tranche contingent on IND proceed), IND acceptance, first-volunteer enrollment, and any clinical data readouts or regulatory updates .