Executive Summary

Q3 2025 net loss narrowed to $1.8M, driven by lower R&D; cash was $4.6M with runway into Q2 2026, while the company advanced toward registrational Phase 3 for AD04 following a successful EOP2 FDA meeting .
EPS beat Wall Street consensus: reported EPS of -$0.08 versus -$0.14 consensus (3 estimates) — a significant beat likely to be viewed favorably by investors given expense control and reduced quarterly losses [Q3 2025 estimates: Primary EPS Consensus Mean -$0.14; Actual -$0.08*].
Precision companion diagnostic progress: FDA confirmed the AG+ cheek-swab test in Phase 3 is Non-Significant Risk (no IDE required), reducing regulatory friction and supporting Phase 3 initiation preparedness .
Strategic context strengthened by bipartisan U.S. Senate support for broader AUD endpoints beyond abstinence, aligning with AD04’s focus on reduced cravings/use and potentially easing regulatory paths .

What Went Well and What Went Wrong

Regulatory clarity and momentum: “We are now implementing the FDA’s recommendations… positioning us to advance confidently toward registrational Phase 3 development” .
Companion diagnostic validated and de-risked: “Completed the analytical validation of a cheek swab collection method… FDA also confirmed… Non-Significant Risk (NSR), meaning an IDE is not required” .
Expense discipline: Net loss improved to $1.8M from $2.2M YoY, primarily from lower R&D spend; G&A was stable with only modest timing-related increase .

Ongoing pre-revenue status; no product revenue reported, continuing reliance on external financing and careful cash burn management .
Nasdaq bid-price compliance risk persists; the company received a 180-day extension to March 2, 2026 to regain compliance with the $1.00 minimum bid price requirement .
Clinical timeline not yet converted into explicit start dates; guidance focuses on preparedness and implementation rather than firm Phase 3 initiation dates, which may temper near-term catalysts .

Metric	Q1 2025	Q2 2025	Q3 2025
Net Loss ($USD Millions)	$2.23*	$1.96*	$1.79*
Diluted EPS ($USD)	-$0.341*	-$0.184*	-$0.081*
Cash and Equivalents ($USD Millions)	$2.4	$5.9	$4.6

Values marked with * retrieved from S&P Global.

Metric	Q3 2024	Q3 2025	YoY Change
Net Loss ($USD Millions)	$2.2	$1.8	-$0.4 (improvement)

KPI	Q3 2025 YoY Change	Commentary
R&D Expense	-$0.511M (-50%)	Lower clinical activity vs. Q3 2024
G&A Expense	+$0.063M (+5%)	Timing of annual meeting (Q3’25 vs. Q4’24)

Metric	Consensus	Actual	Surprise
Primary EPS (USD)	-$0.14 (3 estimates)*	-$0.08*	Beat by $0.06
Revenue (USD)	$0.0 (3 estimates)*	N/A	N/A

Values marked with * retrieved from S&P Global.

Segment revenue and margin breakdown: Not applicable (clinical-stage, pre-commercial) .

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	As of Q3 2025	Into Q2 2026 (Q2 2025 PR)	Into Q2 2026	Maintained
Phase 3 Initiation Preparedness	2025	“Well-positioned to initiate Phase 3 in 2025” (FY 2024 PR)	Implementing FDA EOP2 recommendations; prepared to advance to registrational Phase 3	Maintained (no explicit date)
Companion Diagnostic (AG+ test)	Q3 2025	N/A	FDA deemed NSR; no IDE required in Phase 3	New de-risking update

No revenue, margin, OpEx level, OI&E, or tax rate quantitative guidance provided in Q3 materials .

No Q3 2025 earnings call transcript was found in filings; themes below reflect press releases and 8-Ks.

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3 2025)	Trend
Regulatory/Phase 3 design	FDA confirmed 505(b)(2) bridging; preparing EOP2 in July	EOP2 successful; implementing FDA recommendations for registrational Phase 3	Positive, accelerating
Companion Diagnostic (AG+)	Partnered with Boudicca Dx (FY); precision targeting framework	Genomind cheek swab analytically validated; NSR classification (no IDE)	Positive, de-risked
Manufacturing (CMC)	Thermo Fisher & Cambrex agreements; demonstration batches completed	Ongoing preparations aligned with Phase 3 readiness	Stable-progressing
Strategic Partnerships	Discussions expected post-EOP2	Expect acceleration as milestones achieved	Positive, building
Intellectual Property	Multiple patents granted in FY 2024–Q1 2025	Provisional patent update filed; protection expected to 2045	Strengthening
Nasdaq Compliance	Regained Rule 5550(b)(1) stockholders’ equity compliance	180-day extension to regain $1.00 bid; deadline Mar 2, 2026	Mixed: equity compliant; bid-price risk remains

“We continue to achieve meaningful milestones on our path toward FDA approval and eventual commercialization of AD04… implementing the FDA’s recommendations… positioning us to advance confidently toward registrational Phase 3 development.” — Cary Claiborne, CEO .
“Together, we have completed the analytical validation of a cheek swab… to identify eligible patients… During our recent EOP2 meeting, the FDA also confirmed that use of this test in the Phase 3 study represents a Non-Significant Risk (NSR), meaning an IDE… is not required.” .
“With the successful completion of our End of Phase 2 meeting… we have received critical input… designed to increase the likelihood of success and support a streamlined path to approval.” .
“We made meaningful progress… completing foundational steps that position us to advance swiftly toward the initiation of our Phase 3 clinical trial for AD04.” .

No Q3 2025 earnings call transcript or Q&A session was available in filings during the period reviewed; no call-derived clarifications/guidance updates found [earnings-call-transcript search returned no documents].

EPS beat: Reported -$0.08 vs. consensus -$0.14 (3 estimates) — driven by lower quarterly net loss tied to reduced R&D spend; estimate models may need to reflect continued expense control and potential trial-related timing effects in 2026 if Phase 3 initiates [Q3 2025: Primary EPS Consensus Mean -$0.14; Actual -$0.08*] .
Revenue: Consensus $0.0 reflects pre-revenue status; company reported no commercial revenue in the quarter [Q3 2025 Revenue Consensus Mean $0.0*] .
Values marked with * retrieved from S&P Global.

Regulatory de-risking and diagnostic validation support Phase 3 readiness; NSR classification for the companion diagnostic reduces regulatory friction and cost/timeline risk .
Expense discipline is tangible: net loss improved YoY by ~$0.4M; EPS beat consensus by $0.06, reflecting R&D moderation ahead of Phase 3 [Q3 2025 EPS: -$0.08 vs. -$0.14 consensus*].
Cash runway to Q2 2026 provides operational flexibility to execute Phase 3 planning and partnership engagements; monitor any incremental financing tied to trial start .
Legislative tailwinds (broader endpoints beyond abstinence) align with AD04’s therapeutic approach and may ease future regulatory reviews and support labeling outcomes .
Near-term catalysts: formal Phase 3 initiation plans, partnership agreements, and additional diagnostic progress; stock reaction likely tied to visibility on trial start and partner economics .
Risk factors: continued pre-revenue status, Nasdaq minimum bid-price compliance requirement, and financing needs inherent to Phase 3 trial execution .
Estimate revisions: models may lower near-term losses if R&D remains disciplined before Phase 3 spend ramps; reassess 2026 expense curves post-trial initiation timing announcements .