Executive Summary

VERU reported Q3 FY2025 with continued operating losses but improving OpEx: R&D fell to $3.02M and SG&A to $5.01M; operating loss narrowed to $7.55M from $10.55M YoY as the Phase 2b QUALITY study wound down . EPS was effectively in line with consensus at -$0.53 vs -$0.53 (S&P Global)*. Cash and equivalents declined to $15.01M, underscoring funding risk ahead of Phase 3 .
Clinical execution remained the quarter’s highlight: final topline from QUALITY and the Maintenance Extension showed 100% average lean mass preservation at 3mg, greater fat loss, fewer GI side effects vs semaglutide alone, and markedly lower weight/fat regain upon GLP‑1 discontinuation .
The company selected a novel modified‑release oral enobosarm formulation with a distinct PK profile (lower Cmax, delayed Tmax, secondary peak) and IP runway potentially to 2046, supporting Phase 3 and commercialization plans .
Key near‑term catalyst: FDA End‑of‑Phase‑2 clarity on endpoint/population/design expected in the Aug–Sep timeframe; management emphasized physical function as primary, and a two‑part design with de‑challenge/rescue elements for durability readouts .
Balance sheet and listing maintenance remain watch items: management said cash at issuance date is not sufficient for 12 months, though enough into next calendar year; reverse split (1‑for‑10) executed August 8 to help maintain Nasdaq compliance .

What Went Well and What Went Wrong

What Went Well
- QUALITY and Maintenance Extension: 3mg enobosarm + semaglutide achieved 100% average lean mass preservation; dose‑dependent added fat loss; fewer GI side effects; after GLP‑1 discontinuation, enobosarm monotherapy significantly reduced weight regain and prevented fat regain, preserving lean mass .
- Clear differentiation narrative: “The efficacy and safety of Veru’s oral agent enobosarm looks better than any of the injectable myostatin inhibitors... Unlike our competitors, enobosarm has positive physical function data measured by stair climb power.” — Mitchell Steiner, CEO .
- Formulation/IP step forward: Selected modified‑release oral enobosarm (lower Cmax, delayed Tmax, secondary peak, similar AUC to IR) with patents filed; planned for Phase 3 and commercialization; collaboration with Laxxon/SPID® strengthens defensibility .
What Went Wrong
- Cash runway/funding overhang: Cash fell to $15.01M; management stated cash is not sufficient for the next 12 months, requiring additional capital to fund Phase 3 .
- Persistent losses with no product revenue: Operating loss of $7.55M and net loss from continuing ops of $7.32M; P&L remains OpEx‑driven post sale of FC2 business .
- Listing risk mitigation signals fragility: Reverse split (1‑for‑10) to regain/maintain Nasdaq bid compliance underscores equity sensitivity amid upcoming capital needs .

Financial Results

Quarterly P&L vs estimates and prior periods

Metric	Q1 2025	Q2 2025	Q3 2025
EPS (Actual, $)	-0.713*	-0.603*	-0.533*
EPS (Consensus, $)	-0.750*	-0.600*	-0.533*
EPS Surprise ($)	+0.037*	-0.003*	+0.000*
Revenue (Consensus, $M)	2.975*	0.000*	0.000*

Notes: EPS comparisons anchored to S&P Global consensus. Company did not report product revenue; operations reflect R&D/SG&A with gains and other income post-FC2 sale . Values marked with * are from S&P Global.

Operating metrics (company-reported)

Metric ($USD Millions unless noted)	Q1 2025	Q2 2025	Q3 2025
Research & Development	5.717	3.932	3.021
Selling, General & Administrative	5.227	5.164	5.011
Operating Loss	(10.249)	(8.122)	(7.546)
Net Loss from Continuing Ops	(1.810)	(7.852)	(7.323)
Net Loss per Share ($)	(0.01)	(0.05)	(0.50)
Cash & Equivalents (period end)	26.607	20.018	15.010

Additional context and non-operating items (YTD through Q3): gain on ENTADFI asset sale $2.15M; gain on extinguishment of debt $8.62M (terminated royalty agreement) .

Important per-share comparability note: Reverse split (1‑for‑10) effective Aug 8, 2025; Q3 financials reflect retroactive adjustment in the 6/30/25 statements; Q1/Q2 press releases predate the split presentation .

Segment breakdown: Not applicable (no revenue‑generating segments reported) .

KPIs (operational/financial health)

KPI	Q1 2025	Q2 2025	Q3 2025
OpEx (R&D + SG&A, $M)	10.944	9.096	8.031
Cash Burn from Ops (YTD, $M)	(11.333)	(19.069)	(24.552)
Cash & Equivalents ($M)	26.607	20.018	15.010

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (revenue, EPS, margins)	FY/Q3 2025	None given	None given	Maintained
Regulatory milestone	Q3 2025	Plan to request EOP2 (Q1); expect EOP2 in 3Q25 (Q2)	FDA EOP2 meeting granted; clarity expected Aug–Sep	Maintained/updated timing
Phase 3 design	Post-EOP2	Proposed 24‑wk function primary; longer‑term body comp	Reiterated physical function primary; de‑challenge/rescue, durability (to ~68w)	Clarified design elements
Formulation	2025	MR formulation planned; Phase 1 BA H1’25	MR formulation selected; PK objectives met; planned for Phase 3	Advanced
Capital markets/Nasdaq	Aug 2025	—	1‑for‑10 reverse split effective Aug 8 to help maintain bid compliance	New

Earnings Call Themes & Trends

Topic	Previous Mentions (Q1 2025)	Previous Mentions (Q2 2025)	Current Period (Q3 2025)	Trend
Regulatory pathway (EOP2)	Positive Phase 2b; will seek EOP2; Phase 3 likely similar to Phase 2b	EOP2 request/meeting anticipated in 3Q25	EOP2 meeting granted; clarity Aug–Sep; physical function endpoint emphasized	Increasing clarity
Phase 3 design	24‑wk function primary; extended to 52–68w for durability	24‑wk function; track long‑term endpoints to 68w	Two‑part design: de‑challenge and rescue arms, long‑term safety/efficacy	More detail provided
Formulation/IP	MR formulation planned; Phase 1 BA H1’25	MR on track for Phase 3/commercialization	MR formulation selected; PK goals met; IP to 2046 if issued	Executed milestone
Clinical differentiation	Topline: 100% lean mass preservation at 3mg; shift to fat loss; function benefit	Reinforced; safety data to come; maintenance data expected	Extension: reduced weight regain; fat regain prevented; fewer GI side effects vs sema alone	Strengthening
Partnering strategy	—	—	Active dialogues with GLP‑1 leaders and entrants; FDC potential with oral GLP‑1s	Building optionality
Capital/Runway	FC2 sale proceeds; cash $26.6M	Cash $20.0M	Cash $15.0M; not sufficient for 12 months; Phase 3 could cost ~$40M/18 months (subject to FDA design)	Deteriorating cash; funding needed
Listing maintenance	—	—	1‑for‑10 reverse split to meet bid price	Addressed compliance

Management Commentary

“We have now reported all the positive efficacy and safety topline results from our Phase 2b QUALITY and Maintenance Extension study, and are looking forward to FDA feedback on the regulatory pathway for enobosarm...” — Mitchell Steiner, CEO .
“The efficacy and safety of Veru’s oral agent enobosarm looks better than any of the injectable myostatin inhibitors now under development by our competitors. Unlike our competitors, enobosarm has positive physical function data measured by stair climb power.” — Steiner .
“The company... effected a one for 10 reverse stock split... All share and per share amounts presented in our financial statements as of 06/30/2025 have been retroactively adjusted for all periods presented.” — Michele Greco, CFO .
“Our cash... is not sufficient for the company to fund operations for the next twelve months. However, we have sufficient capital to take the company into the next calendar year, which is beyond obtaining regulatory clarity...” — Greco .
On formulation: “The new [MR] formulation demonstrated... lower Cmax, delayed Tmax... and similar AUC... planned to be available for the Phase 3 clinical study and for commercialization.” — Company press release .

Q&A Highlights

Fixed‑dose combos and partnering: Management said MR enobosarm is compatible with fixed‑dose combinations, including potential oral GLP‑1 combinations; active discussions span incumbents and new entrants for non‑dilutive funding .
FDA EOP2 expectations and communication: CSO expects FDA to require a physical function measurement and potentially expand population scope beyond ≥60 years; company guides to Aug–Sep timing for clarity .
Phase 3 design details: Two buckets of efficacy—short‑term (lean/fat mass, function) and long‑term (incremental weight loss, bone). Design includes initial randomized double‑blind phase followed by re‑randomization with de‑challenge and rescue cohorts to demonstrate durability and causality .
MR formulation rationale: Lower Cmax/delayed Tmax expected to sustain safety with similar AUC for efficacy; a formal relative bioavailability study will support bridging .
Capital needs: Depending on FDA feedback, management preliminarily framed Phase 3 at ~~400 patients (~~$40M over ~18 months), but will refine post‑EOP2 .

Estimates Context

Q3 FY2025 EPS was essentially in line: Actual -$0.533 vs consensus -$0.533 (surprise ≈ $0.000). Q2: slight miss (-$0.603 vs -$0.600); Q1: beat (-$0.713 vs -$0.750). Revenue expectations were $0.0 in Q2 and Q3, aligning with the pre‑commercial profile.
Given an OpEx‑driven P&L and upcoming Phase 3, street models are likely to focus on R&D ramp, financing path, and timing/size of pivotal program rather than near‑term revenue. Updates post‑EOP2 and any partnering could drive estimate revisions .

Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

Clinical differentiation is the core long: enobosarm preserves lean mass, enhances fat loss, and improves physical function on top of GLP‑1s—now with durability after GLP‑1 discontinuation; this is a tangible clinical narrative vs myostatin approaches .
Near‑term catalyst path is clear: FDA EOP2 feedback (endpoint/population/design) in Aug–Sep should frame Phase 3 scope, cost, and partnering options—key stock drivers .
Funding overhang persists: Cash of $15.0M and management’s “<12 months” sufficiency comment imply the need for capital; potential non‑dilutive sources (partners) are in discussion, but timing and terms are uncertain .
MR formulation/IP improves strategic value: Selected MR formulation with supportive PK and potential IP to 2046 could enable FDCs and extend exclusivity, strengthening partnership appeal .
Execution focus shifts to registrational readiness: Expect clearer primary endpoint (physical function), inclusion criteria (≥60 likely, possibly broader), and a two‑part design capturing long‑term outcomes—trial specifics will influence timelines and cash needs .
Watch listing/compliance optics: The reverse split stabilizes bid price optics but does not alleviate financing needs; consider dilution scenarios in risk‑reward .
Trading setup: Into EOP2 readout and potential Obesity Week data presentation window, headline risk is two‑sided; upside on clear, manageable Phase 3 path/partner; downside on expanded scope/cost without funding clarity .

Appendix: Source Data Details

Q3 FY2025 8‑K (Item 2.02) and attached press release: financial schedules (R&D $3.02M; SG&A $5.01M; operating loss $7.55M; net loss from cont. ops $7.32M; EPS -$0.50; cash $15.01M) and clinical results .
Q3 FY2025 earnings call transcript: reverse split disclosure; EOP2 timing; Phase 3 design; partnering; capital runway .
Q2 FY2025 press release: R&D $3.93M; SG&A $5.16M; operating loss $8.12M; EPS -$0.05; cash $20.02M .
Q1 FY2025 press release: R&D $5.72M; SG&A $5.23M; operating loss $10.25M; EPS -$0.01; cash $26.61M .
Reverse split press release: 1‑for‑10 effective Aug 8, 2025 .
Modified‑release formulation press release (Aug 11): PK profile and IP .

S&P Global estimates and actuals used for EPS/revenue comparisons are denoted with an asterisk in tables. Values retrieved from S&P Global.

VERU INC. (VERU)·Q3 2025 Earnings Summary