AP
Anebulo Pharmaceuticals, Inc. (ANEB)·Q3 2025 Earnings Summary
Executive Summary
- Q3 FY2025 narrowed losses sequentially and beat the single-analyst EPS estimate: EPS of $(0.04) vs $(0.05)* consensus and $(0.09) in Q2; OpEx declined to $1.9M from $2.6M in Q2 .
- Strategic focus sharpened on pediatric IV selonabant: FDA acknowledged unmet need and Anebulo now targets initiating the Phase 1 SAD in healthy adults in Q3 calendar 2025 (a shift from prior 1H25) .
- Liquidity: Cash was $13.3M at 3/31/25 (down from $15.0M at 12/31/24); loan availability reduced to ~$3M following LSA amendment in Feb’25 (vs $10M availability disclosed in Q1) .
- Near-term stock catalysts: Phase 1 SAD start in Q3 CY2025; progress on pediatric observational study (amended to focus on pediatric patients) .
Values with an asterisk (*) are retrieved from S&P Global.
What Went Well and What Went Wrong
-
What Went Well
- EPS beat vs consensus and improved sequentially: $(0.04) vs $(0.05)* and vs $(0.09) in Q2 *.
- Cost discipline: Total operating expenses fell to $1.9M from $2.6M in Q2 .
- FDA engagement and program clarity: “We anticipate initiating our Phase 1 SAD study of intravenous selonabant in healthy adults aged 18 to 25 years in the third quarter of calendar 2025” . Management emphasized “a significant and growing unmet medical need” for pediatric cannabis toxicity treatment .
-
What Went Wrong
- Timeline slippage: Start of Phase 1 SAD moved from “1H25” to “Q3 calendar 2025” .
- Liquidity trend: Cash declined to $13.3M (3/31/25) from $15.0M (12/31/24), and loan capacity was cut to ~$3M (from $10M previously) .
- Mix shift in OpEx: G&A rose YoY to $1.254M from $0.916M, partially offset by lower R&D .
Financial Results
Quarterly comparison (oldest → newest):
Q3 FY2025 vs Estimates (S&P Global):
Values with an asterisk (*) are retrieved from S&P Global.
Notes:
- Company is pre-revenue; statements of operations present operating expenses and other income items but no revenue line .
- No non-GAAP metrics were provided in the releases .
Guidance Changes
Earnings Call Themes & Trends
No Q3 FY2025 earnings call transcript was located; theme tracking below uses Q1–Q3 press releases.
Management Commentary
- “We anticipate initiating our Phase 1 SAD study of intravenous selonabant in healthy adults aged 18 to 25 years in the third quarter of calendar 2025.” — Richie Cunningham, CEO .
- “There is a significant and growing unmet medical need for an emergency antidote to acute cannabis-induced toxicity… children are much more sensitive to the toxic effects of cannabis…” — Richie Cunningham, CEO .
- FDA “confirmed our belief that there is an unmet need for a treatment for children exposed to cannabis toxicity and suggested a close collaboration with Anebulo to facilitate an efficient development plan” .
Q&A Highlights
- No earnings call transcript for Q3 FY2025 was available in the document set; commentary is based on the 8‑K/press release disclosures .
- Key clarifications from disclosures: program timing (Q3 CY2025 Phase 1 SAD start), pediatric focus, and liquidity/LSA changes .
Estimates Context
- EPS: Single-analyst consensus for Q3 FY2025 was $(0.05); actual was $(0.04), a small beat reflecting lower OpEx QoQ .
- Revenue: Consensus was $0.0* and the company reported no revenue in Q3 *.
- Trajectory vs prior quarters: Q1 FY2025 EPS $(0.08) vs $(0.05); Q2 FY2025 EPS $(0.09) vs $(0.08); Q3 FY2025 $(0.04) vs $(0.05)* — sequential improvement in reported EPS through Q3 *.
Quarterly estimates vs actuals (oldest → newest):
Values with an asterisk (*) are retrieved from S&P Global.
Key Takeaways for Investors
- Anebulo delivered a modest EPS beat and sequentially lower OpEx, narrowing net loss to $(1.68)M and $(0.04) EPS in Q3 *.
- The pivotal near-term catalyst is Phase 1 SAD for IV selonabant targeted to begin in Q3 CY2025; any further slippage would likely weigh on sentiment .
- Liquidity remains adequate for near-term milestones (cash $13.3M at 3/31/25), but the LSA availability reduction to ~$3M and cash decline from $15.0M QoQ reduce flexibility; financing overhang is a watch item .
- The sharpened pediatric strategy (FDA engagement, observational study amended to pediatric focus) strengthens the regulatory narrative and potential path to approval .
- Expense mix bears monitoring: G&A is up YoY while R&D dipped, consistent with corporate and regulatory build-out; maintaining OpEx control was a positive this quarter .
- With no revenue and a single-analyst model driving estimates, stock reaction will be driven by execution milestones (Phase 1 start, pediatric study insights) and balance sheet moves *.
- Overall, the quarter supports a “show-me” but improving setup: execution on the Q3 CY2025 start and sustained OpEx discipline are key to sustaining momentum .
Values with an asterisk (*) are retrieved from S&P Global.