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EB

Enveric Biosciences, Inc. (ENVB)·Q4 2024 Earnings Summary

Executive Summary

  • ENVB reported Q4 2024 net loss of $3.20M and basic/diluted loss per share of $4.83; cash-on-hand was $2.20M, with development focused on lead neuroplastogen EB-003 and out-licensing to bolster non-dilutive funding .
  • Management reiterated the plan to complete pre-IND activities and file an IND for EB-003 in 2025, positioning for Phase 1 after the pre-IND meeting; the company highlighted a large potential market opportunity for neuroplastogens .
  • Business development advanced: multiple out-licenses with milestone potential (Aries up to $61M; MycoMedica up to $62M plus royalties; Restoration Biologics up to $61M pharma and $21M non-pharma), and a $5M public offering closed in Q1 2025 to support operations .
  • Street consensus for Q4 2024 EPS and revenue was unavailable via S&P Global (no estimates returned); estimate comparisons are therefore not possible for this quarter.
  • Near-term catalysts include IND submission readiness for EB-003, additional licensing agreements, and IP expansion supporting non-hallucinatory neuroplastogen development .

What Went Well and What Went Wrong

  • What Went Well

    • EB-003 advanced with confirmation of oral bioavailability and significant brain exposure; preclinical safety/pharmacology showed receptor selectivity and minimized off-target risks, supporting expedited development .
    • IP expansion: additional U.S. patents for EVM301 and EVM201 portfolios, plus unveiling of EVM401 series broadened pipeline of potential non-hallucinogenic molecules .
    • Non-dilutive financing potential via out-licensing: Aries ($61M milestones, 2.5%-10% royalties), MycoMedica (up to $62M milestones + tiered single-digit royalties), Restoration Biologics ($61M pharma + $21M non-pharma milestones) .

  • What Went Wrong

    • Continued losses: Q4 net loss of $3.20M and EPS of ($4.83), higher EPS loss versus Q3 due to share count effects; cash declined to $2.20M at year-end, underscoring funding needs .
    • No revenue disclosed; margin metrics unavailable given pre-revenue status, limiting traditional financial comparability vs estimates .
    • IND timing specificity reduced vs prior quarter (Q3 had “second half of 2025”), with Q4 reiterating filing after pre-IND meeting but without quarter-level specificity .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Net Loss ($USD Millions)$1.70 $2.10 $3.20
Diluted EPS ($USD)$0.23 loss $0.24 loss $4.83 loss
Cash-on-Hand ($USD Millions)$3.50 $3.10 $2.20
Non-cash expense/(income) ($USD Millions)$0.40 $0.50 $1.00 expense; prior-year Q4 had $1.50 income
Revenue vs EstimatesQ4 2024 ActualQ4 2024 Consensus (S&P Global)
Revenue ($USD Millions)Not disclosed Unavailable (no estimates returned)
EPS ($USD)$4.83 loss Unavailable (no estimates returned)
MarginsQ2 2024Q3 2024Q4 2024
Gross Margin %N/A (not disclosed) N/A (not disclosed) N/A (not disclosed)
EBITDA Margin %N/A (not disclosed) N/A (not disclosed) N/A (not disclosed)

Segment breakdown: Not applicable; ENVB is a development-stage biotech and did not disclose segment revenues .

KPIs and Corporate Highlights:

KPIQ2 2024Q3 2024Q4 2024
EB-003 oral bioavailability & brain exposureConfirmed Confirmed Reaffirmed
Safety/pharmacology selectivity (off-target minimized)—Confirmed (no adverse CV/CNS events) Reaffirmed
Licensing – Aries (Radiation Dermatitis)Agreement signed Executed Up to $61M milestones; 2.5%-10% royalties
Licensing – MycoMedica (EVM201/EB-002)Term sheets Executed Up to $62M milestones; tiered single-digit royalties
Licensing – Restoration Biologics (Cannabinoid-COX-2)——Milestones up to $61M pharma + $21M non-pharma
IP expansion (EVM301/EVM201/EVM401)—5 additional US patents New U.S. patent for EVM401; additional patent notices for EB-003
Financing——Closed $5M public offering

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EB-003 IND FilingFY 2025Pre-IND early 2025; IND by Q3 2025; initiate first-in-human by end of 2025 File IND in 2025 post pre-IND meeting; poised for Phase 1 thereafter Maintained timeline; specificity reduced vs prior quarter
EB-003 IND FilingFY 2025IND filing and first patient dosed expected in 2025; “second half of 2025” File IND in 2025 post pre-IND meeting Maintained; language streamlined
Financial Guidance (Revenue/Margins/OpEx)FY/Q4 2024Not provided Not provided Maintained (no financial guidance)

Earnings Call Themes & Trends

(Note: No Q4 2024 earnings call transcript available; themes based on company press releases.)

TopicPrevious Mentions (Q-2: Q3 2024)Previous Mentions (Q-1: Q2 2024)Current Period (Q4 2024)Trend
IND timeline & regulatory pathIND filing and first patient dosed expected in 2025; “second half of 2025” Pre-IND early 2025; IND by Q3 2025; first-in-human by end of 2025 File IND in 2025 following pre-IND meeting Reiterated; specificity streamlined
AI/Psybrary discovery platformHighlighted as enabling EB-003 and IP expansion Strategic elevation of EB-003; Psybrary platform central Used to uncover new candidate classes; broadened pipeline Expanding use
Safety/pharmacologySelective serotonergic targeting; minimized CV/CNS risks Oral bioavailability; brain exposure Positive safety and PK studies; no hallucination-like behavior; strong brain penetration Strengthening dataset
Out-licensing & non-dilutive fundingAries & MycoMedica agreements executed Multiple term sheets; Aries agreement signed Additional deals (Restoration Biologics); detailed milestone/royalty terms More agreements; clearer economics
IP expansion5 additional US patents for EVM301; allowances noted —New patents and notice of allowance for EB-003; EVM401 patent Broader coverage
Financing runway—Cash $3.5M at Q2 end Cash $2.2M at Q4 end; closed $5M offering Managed via offering; cash down QoQ

Management Commentary

  • “Enveric is entering 2025 with a clear mission – enhance shareholder value by cementing our leadership position in the promising neuroplastogen field with the continued development of EB-003.” – Joseph Tucker, Ph.D., CEO .
  • “We are now focused on completing the data package needed to file an Investigational New Drug (IND) application for EB-003… we will be poised to advance EB-003 into Phase 1 clinical trials” .
  • On EB-003 differentiation: “preclinical safety and pharmacology studies confirmed that EB-003 targets desired serotonergic receptors while minimizing potentially harmful, off-target interactions” .
  • On trial feasibility: minimizing hallucinations enables “truly blinded placebo-controlled clinical trials and… outpatient setting without psychotherapy support” .
  • Q2 positioning: “pre-Investigational New Drug meeting… early 2025… IND by the third quarter of 2025 and initiation of a first-in-human clinical trial by the end of 2025” .

Q&A Highlights

  • No Q4 2024 earnings call transcript found in the document library; therefore, no Q&A themes or clarifications are available for this period.

Estimates Context

  • S&P Global consensus for Q4 2024 EPS and revenue was unavailable (no estimates returned), so comparisons vs Street are not possible this quarter.
  • Given development-stage status and lack of disclosed revenue, future estimate frameworks will likely center on cash runway, R&D timing, and licensing economics rather than traditional margin or EBITDA metrics.

Key Takeaways for Investors

  • EB-003 remains the central value driver with reinforced preclinical safety, pharmacology, and PK data, supporting IND filing in 2025 and potential Phase 1 advancement thereafter .
  • Non-dilutive capital potential from multiple licensing agreements provides diversified optionality while ENVB focuses on EB-003 (Aries, MycoMedica, Restoration Biologics) with sizable milestone and royalty structures .
  • IP position continues to strengthen across EVM301/EVM201/EVM401, enhancing defensibility and broadening pipeline prospects within non-hallucinatory neuroplastogens .
  • Cash declined to $2.20M at year-end Q4, but the $5M offering closed post-quarter provides incremental runway; monitoring future funding actions remains critical .
  • Lack of disclosed revenue and margin metrics aligns with development-stage profile; investor focus should be on regulatory milestones (pre-IND, IND), early clinical execution, and partnership monetization .
  • Street consensus data was unavailable via S&P Global for Q4 2024; modeling updates will hinge on IND timing clarity and additional licensing announcements rather than near-term P&L beats/misses.
  • Near-term catalysts: completion of IND-enabling activities, pre-IND meeting outcomes, and additional licensing/IP developments that can improve funding visibility and validate platform strategy .