Executive Summary

Avenue reported Q1 2024 net loss of $4.3M and diluted EPS of $(15.40); operating expenses were $3.7M, reflecting higher R&D as AJ201 and BAER-101 advanced .
Cash and equivalents rose to $3.19M at March 31, 2024, supported by ~$9.4M gross proceeds from warrant exercises in January and May; an additional $4.4M was raised in May via warrant inducement .
Pipeline milestones were emphasized: AJ201 topline data targeted for mid-2024; IV tramadol Phase 3 safety study protocol agreed with FDA, with completion and submission to FDA expected within 12 months of study initiation; BAER-101 Phase 2a planned subject to financing/partnership .
The company effected a 1-for-75 reverse split in April to address Nasdaq bid-price compliance and received a Nasdaq Panel extension to May 20, 2024 for compliance on bid price and stockholders’ equity, highlighting ongoing listing risk as a catalyst .
No Q1 2024 earnings call transcript was found; Wall Street consensus estimates via S&P Global were unavailable at the time of query, limiting beat/miss assessment [functions.ListDocuments] [functions.GetEstimates].

What Went Well and What Went Wrong

What Went Well

AJ201 progressed with anticipated topline Phase 1b/2a data in mid-2024; CEO: “We made significant strides advancing our lead clinical program, AJ201…” .
FDA alignment on IV tramadol Phase 3 safety study design and statistical analysis; company believes the study can be completed and submitted to FDA within 12 months of initiation .
BAER-101 preclinical data showed full seizure suppression in the GAERS model at 0.3 mg/kg (PO), supporting Phase 2a initiation pending financing/partnership .

What Went Wrong

Continued losses and reliance on external financing; net loss of $4.3M in Q1 2024 and accumulated deficit of $(95.3)M underscore ongoing funding needs .
Nasdaq listing risk persisted; Panel granted extension through May 20, 2024 to regain compliance with bid-price and equity rules; reverse split executed to aid bid-price but equity compliance remained a hurdle .
No revenues and no earnings call transcript this quarter, limiting investor visibility into management’s real-time commentary and Q&A clarifications [functions.ListDocuments].

Financial Results

Sequential Comparison (Quarterly)

Metric	Q3 2023	Q4 2023	Q1 2024
Revenues ($USD Millions)	$0.00	N/A (not disclosed separately)	$0.00
Total Operating Expenses ($USD Millions)	$2.07	N/A (not disclosed separately)	$3.71
Net Income (Loss) ($USD Millions)	$0.51	N/A (not disclosed separately)	$(4.35)
Diluted EPS ($USD)	$0.06	N/A (not disclosed separately)	$(15.40)

Notes: Q4 2023 reported on a full-year basis; quarter-specific figures were not provided in filings/press releases .

Year-over-Year Comparison (Q1)

Metric	Q1 2023	Q1 2024
Revenues ($USD Millions)	$0.00	$0.00
R&D Expenses ($USD Millions)	$1.22	$2.39
R&D – Licenses Acquired ($USD Millions)	$4.23	$0.00
G&A Expenses ($USD Millions)	$0.98	$1.32
Loss from Operations ($USD Millions)	$(6.43)	$(3.71)
Net Income (Loss) ($USD Millions)	$(7.60)	$(4.35)
Diluted EPS ($USD)	$(101.57)	$(15.40)
Weighted Avg Shares (Thousands)	74.2	562.0

Balance Sheet / KPIs

Metric	Dec 31, 2023	Mar 31, 2024
Cash and Cash Equivalents ($USD Millions)	$1.78	$3.19
Accounts Payable & Accrued Expenses ($USD Millions)	$0.29	$0.65
Accounts Payable & Accrued – Related Party ($USD Millions)	$0.32	$0.35
Warrant Liability ($USD Millions)	$0.59	$0.41
Total Assets ($USD Millions)	$1.85	$3.31
Total Stockholders’ Equity ($USD Millions)	$0.65	$1.90
Common Shares Outstanding (Thousands)	341.3	590.2

Segment breakdown: Not applicable; Company is pre-revenue with R&D-driven operating model .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
AJ201 topline Phase 1b/2a data timing	2024	“Topline data… in second quarter of 2024” (FY 2023 update, Mar 18)	“Topline data… in the middle of 2024” (May 15)	Maintained (minor wording shift from Q2 to mid-2024)
IV tramadol Phase 3 safety study	Initiation + timeline	“Final agreement reached with FDA; aims to initiate as soon as feasible”	“Final agreement… aims to initiate as soon as feasible; study can be completed and submitted to FDA within 12 months of initiation”	Clarified timeline (added 12-month completion/filing expectation)
BAER-101 Phase 2a	2024	“Plans to initiate Phase 2a subject to financing/partnership”	Same; reiteration of financing dependency	Maintained
Nasdaq compliance	Through May 20, 2024	Extension granted through May 20, 2024 (Panel decision)	1-for-75 reverse split implemented in April; expectation to aid $1.00 bid price compliance	Executed action to address bid-price; compliance pending

Earnings Call Themes & Trends

No Q1 2024 earnings call transcript was found in the document catalog, so themes rely on company press releases and 8-Ks [functions.ListDocuments].

Topic	Previous Mentions (Q3 2023, Q4 2023)	Current Period (Q1 2024)	Trend
R&D execution (AJ201)	Trial enrollment completed; topline data expected Q2 2024 ; enrollment on track; KOL/meeting visibility	“Look forward to reporting topline data in the middle of 2024”	On track; timing reiterated
Regulatory/legal (IV tramadol)	Reached agreement on Phase 3 safety study design/statistics	Final agreement with FDA; study can be completed and submitted within 12 months of initiation	Greater clarity; execution pending financing
Financing/liquidity	Follow-on offering $5.0M gross (Nov 2023) ; cash $1.78M at YE 2023	Warrant exercises raised ~$9.4M gross (Jan & May); cash $3.19M at 3/31/24	Improved liquidity; still pre-revenue
Nasdaq listing	Panel extension through May 20, 2024	1-for-75 reverse split in April to address $1 bid price	Actions taken; compliance risk persists
BAER-101 (technology)	Preclinical data presented; supports Phase 2a	Preclinical efficacy reiterated; Phase 2a subject to financing/partnership	Consistent narrative; funding gate

Management Commentary

CEO on Q1 execution: “The first quarter was incredibly productive… significant strides advancing our lead clinical program, AJ201… continued to showcase the potential of BAER-101… reached agreement with the U.S. FDA on the safety study design… setting this program up for a successful Phase 3 study as soon as the necessary funding is acquired.”
FY 2023 CEO context: “Within nine months of acquiring… AJ201, we dosed the first patient… and completed trial enrollment… remain on track to report topline data for AJ201 in the second quarter of 2024.”
Q3 2023 CEO remarks: “We… reached alignment with the U.S. FDA on key aspects of the Phase 3 safety study design for IV tramadol… positive study results have the potential to support an approval in acute post-operative pain.”

Q&A Highlights

No earnings call transcript for Q1 2024 was found; therefore, no analyst Q&A highlights or clarifications to report [functions.ListDocuments].

Estimates Context

Attempts to retrieve S&P Global Wall Street consensus for Q1 2024 EPS and revenue failed due to request limits; consensus appears unavailable at time of query, limiting beat/miss analysis [functions.GetEstimates].
Avenue remains pre-revenue; investor focus centers on R&D milestones and financing cadence rather than near-term revenue/EPS comparisons .

Key Takeaways for Investors

Near-term catalysts: AJ201 topline data targeted for mid-2024; positive safety/efficacy could be stock-moving in a rare disease with unmet need .
IV tramadol Phase 3 safety study is operationally ready; management believes it can complete and submit to FDA within 12 months of initiation—timeline clarity adds value if financing is secured .
Liquidity improved via ~$9.4M gross proceeds from warrant exercises; cash rose to $3.19M at quarter end, but continued cash burn and program funding needs persist .
Nasdaq compliance actions (reverse split) executed; extension through May 20, 2024 underscores binary listing risk as an overhang/catalyst .
BAER-101 preclinical profile supports Phase 2a; partnering could de-risk financing while enabling development in epilepsies .
No revenues; results driven by operating expenses and fair value changes; valuation/disclosures hinge on clinical/regulatory progress and capital access .
Absence of an earnings call limits qualitative color; watch for subsequent updates, KOL events, or filings to refine timelines and funding plans [functions.ListDocuments].

AVENUE THERAPEUTICS, INC. (ATXI)·Q1 2024 Earnings Summary