Executive Summary

Adial did not issue a standalone Q4 2024 8‑K 2.02 or host a Q4 call in our document set; instead, FY 2024 results and business updates were provided on March 4, 2025, alongside multiple Q4 period press releases (PK topline, IP expansion, CFO hire) that drove the quarter’s narrative .
Operationally, Q4 culminated in successful completion of the AD04 PK study confirming relative bioavailability, dose proportionality, and no food effect—meeting a key FDA requirement for Phase 3 and supporting a 505(b)(2) path; FDA subsequently confirmed Adial’s bridging strategy, and the company began Phase 3 clinical supply manufacturing for 2025 .
Financing runway remains a focus: cash and equivalents were $3.8M at year‑end 2024 with runway into 2H25 under current plans; earlier in 2H24, Adial raised ~$3.8M via ATM execution (Q3 disclosure) .
Key Q4 catalysts centered on regulatory de‑risking (PK completion, FDA bridging confirmation), IP expansion (patent issuance covering broader genotype combinations), and strengthening the finance bench (new CFO), which together position AD04 to enter Phase 3 in 2025 and may drive partnership momentum and sentiment into the next catalysts window .

What Went Well and What Went Wrong

What Went Well

PK success and regulatory de‑risking: PK confirmed relative bioavailability vs. reference, dose proportionality, and no food effect, satisfying an FDA requirement for Phase 3; FDA later confirmed the proposed 505(b)(2) bridging strategy .
Positive FDA alignment toward Phase 3 and execution readiness: “FDA positive response confirms that design of data package would meet the requirements necessary to allow for the progression of AD04 into Phase 3 clinical trials,” and the company began manufacturing clinical supplies for the 2025 Phase 3 program .
Management tone on Phase 3 path: “We are well‑positioned to initiate our Phase 3 clinical trials in 2025,” with planned micro‑dosing regimen supported by PK and bridging .

What Went Wrong

Higher FY net loss vs. prior year, driven by non‑cash items and increased R&D: FY24 net loss was $13.2M vs. $5.1M in FY23, due to non‑cash inducement expense ($4.5M), equity‑method loss ($0.6M), and higher R&D (PK, CMC), partially offset by lower G&A .
Quarterly loss pressure continued before year‑end: Q3 2024 net loss rose to $2.2M vs. $1.4M YoY, mainly from higher PK and CMC expenses as the study ramped .
No Q4 financial line item breakout in a standalone release or transcript in our document set, limiting precision of period‑over‑period modeling into year‑end .

Financial Results

Note: Adial did not publish a separate Q4 2024 8‑K 2.02 in our document set, and the March 4, 2025 FY release did not include Q4 granular breakouts; quarterly comparables below reflect available disclosures.

Quarterly snapshot (available items)

Metric	Q2 2024	Q3 2024
Cash and Cash Equivalents ($M)	$3.3	$5.2
Net Loss ($M)	$(2.5)	$(2.2)
R&D YoY Δ ($)	+$583K	+$825K
G&A YoY Δ ($)	+$228K	+$29K

Year-over-year fiscal comparison

Metric	FY 2023	FY 2024
Cash and Cash Equivalents ($M, year-end)	$2.8	$3.8
Net Loss ($M)	$(5.1)	$(13.2)
R&D YoY Δ ($)	—	+$1.9M (+155%) vs. FY23
G&A YoY Δ ($)	—	$(0.491)M (−9%) vs. FY23

KPIs and financing

KPI	Detail
PK study status	Completed; met FDA‑required elements for Phase 3 (bioavailability, dose proportionality, no food effect)
505(b)(2) bridging	FDA confirmed proposed bridging strategy
Phase 3 readiness	Manufacturing clinical supplies commenced for 2025 program
ATM proceeds	~$3.8M gross in Q3 2024
Cash runway	Into 2H25 under current plans

No segment breakdown is applicable (clinical‑stage).

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	FY24/Q3 update	“Fund operating expenses into 2H25” (as of 9/30/24)	“Fund operating expenses into 2H25” (as of 12/31/24)	Maintained
FDA/bridging	Pre‑PK	Plan to engage FDA with PK data in Q4 2024	FDA confirmed 505(b)(2) bridging strategy	Achieved/De‑risked
Phase 3 timing	Q3 outlook	Regulatory prep and design informed by PK; FDA engagement planned	Initiate Phase 3 in 2025; clinical supply manufacturing commenced	Advanced/Clarified

No revenue, margin, OpEx, OI&E, or tax rate quantitative guidance was provided in these documents .

Earnings Call Themes & Trends

(Adial did not post a Q4 2024 call transcript in our document set; themes reflect company disclosures across Q2–Q4 period releases.)

Topic	Previous Mentions (Q2 2024)	Previous Mentions (Q3 2024)	Current Period (Q4/FY)	Trend
Regulatory path (FDA)	PK initiated to satisfy FDA guidance; CDx plan with Boudicca Dx	Database lock; expecting topline soon; broader NIAAA “recovery” definition supportive	PK completed; FDA confirmed 505(b)(2) bridging; Phase 3 supplies underway	Improving visibility/de‑risking
Clinical execution (PK → P3)	PK study enrolled; completion targeted Q4	DB lock; topline imminent	PK positive topline; P3 initiation planned 2025	On track
Companion diagnostic (CDx)	Boudicca Dx collaboration initiated	Boudicca Dx supports FDA‑compliant plan	CDx alignment cited as part of FDA interaction	Strengthening
IP estate	New application to extend exclusivity to 2044	Notice of Allowance (10/17)	Granted patent broadening genotype coverage (12/3)	Expanding/protective
Financing	Cash $3.3M; ATM post‑Q2	Cash $5.2M; ~$3.8M ATM proceeds	Cash $3.8M YE24; runway into 2H25	Adequate near‑term runway
Management bench	—	—	New CFO appointed (effective 11/16/24)	Enhanced finance capability

Management Commentary

“We achieved meaningful milestones in 2024, leading to positive feedback from the U.S. Food and Drug Administration (FDA) regarding our proposed 505(b)(2) bridging strategy and the initiation of clinical supply manufacturing for our upcoming Phase 3 trial this year.” — CEO, FY results PR .
“Completion of this study achieves our goal to obtain the data we needed to design a more precise and informed Phase 3 trial protocol… intended to enhance the likelihood of success in our upcoming Phase 3 trial.” — CEO on PK topline .
“By aligning with [NIAAA’s] comprehensive definition [of recovery], we are optimistic that it will stimulate additional support for programs like AD04.” — CEO, Q3 update .

Q&A Highlights

No Q4 2024 earnings call transcript was located in our document set; as a result, there were no disclosed analyst Q&A exchanges to clarify guidance or timelines in Q4 .

Estimates Context

We were unable to retrieve S&P Global consensus estimates for Q4 2024 (EPS and Revenue) at this time due to a data access limit. If desired, we will refresh and compare results to consensus upon availability.
Given the absence of a Q4 2024 8‑K 2.02 and call transcript in our document set, Street‑versus‑print comparison for Q4 is not possible from primary sources here .

Key Takeaways for Investors

Regulatory de‑risking progressed in Q4: PK success and FDA bridging confirmation reduce Phase‑3‑start risk, a constructive setup for 2025 trial initiation and potential partner engagement .
Execution readiness improved: Clinical supply manufacturing is underway, which shortens the path to first‑patient‑in post‑protocol agreement .
Strengthened IP and genetics strategy: Patent granted in December broadens protection for genotype‑targeted use, supporting a precision‑medicine differentiation and potential lifecycle management .
Financing runway is finite but visible: YE24 cash of $3.8M with runway into 2H25 provides time to secure partnership, non‑dilutive support, or raise capital ahead of Phase 3 scale‑up .
Leadership reinforced: New CFO with capital markets and pharma experience should aid financing strategy and investor communications into Phase 3 .
Near‑term catalysts: Final FDA feedback on Phase 3 protocol details, Phase 3 initiation logistics, business development updates, and any CDx/regulatory interactions—all potential stock movers as execution milestones are met .

Appendix: Source documents

FY 2024 results and business update PR (Mar 4, 2025) .
Q3 2024 financial results PR (Nov 13, 2024) .
PK topline PR (Nov 14, 2024) .
Patent grant PR (Dec 3, 2024) .
CFO appointment PR (Nov 5, 2024) .

ADIAL PHARMACEUTICALS, INC. (ADIL)·Q4 2024 Earnings Summary