Executive Summary

ENVB delivered a preclinical/operational quarter: pre-IND FDA written feedback for EB-003, completion of dose range finding (MTD established), and key CMC milestones (pharmaceutically compatible salt and 1-kg batch) advancing toward an IND in 2026 .
Financials reflected ongoing R&D investment: Q3 net loss widened to $3.4M (vs. $2.5M in Q2 and $2.1M in Q3’24) and diluted EPS loss of $10.81; cash was $3.8M at quarter-end; YTD net proceeds raised were $7.9M .
Corporate actions and IP: board effected a 1-for-12 reverse stock split (effective Oct 28, post-quarter) following an Oct 22 Nasdaq bid-price deficiency; ENVB also prepared to defend key IP in a PGR relating to claims potentially relevant to AbbVie’s Bretisilocin deal .
No Q3 Wall Street consensus (S&P Global) available for revenue/EPS; comparison vs estimates not possible. Management’s 2026 IND timeline for EB-003 is maintained, with incremental preclinical and manufacturing de-risking as catalysts for 2026 .

What Went Well and What Went Wrong

What Went Well

Pre-IND momentum: ENVB received FDA written feedback to its pre-IND request, reinforcing path to a 2026 IND filing for EB-003; management cited “preparations are sufficiently advanced to proceed to IND submission” .
Execution on CMC and scale: identification of a pharmaceutically compatible salt form, scalable synthesis, and successful 1-kg batch production to support GLP tox and formulation work—critical steps to de-risk program readiness .
Positive preclinical efficacy readouts: EB-003 significantly reduced context-induced freezing at 1-hour post-dose in a PTSD model (p<0.05), in line with MDMA control findings, bolstering translational rationale without hallucinogenic effects by design .

What Went Wrong

Losses widened: Q3 net loss increased to $3.4M vs. $2.5M in Q2 and $2.1M in Q3’24; diluted EPS loss was $10.81 (reverse-split adjusted comps reflect higher prior-period per-share loss but absolute net loss increased) .
Listing pressure and capital markets overhang: Nasdaq bid-price deficiency determination (Oct 22) triggered a 1-for-12 reverse split; ENVB remains reliant on external financing to fund operations (gross and net raises this year) .
Estimates/visibility: No S&P Global consensus for Q3 revenue/EPS limits “beat/miss” framing and narrows near-term trading catalysts to program milestones and balance sheet actions [GetEstimates: Q3 2025 returned no data].

Financial Results

Metric	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Net Loss ($USD Millions)	$2.1	$2.2	$2.5	$3.4
Diluted EPS ($)	-$43.10 (rev-split adj.)	-$1.22	-$0.97	-$10.81
Cash & Equivalents ($USD Millions)	N/A	$4.3	$2.8	$3.8
Net Proceeds Raised YTD ($USD Millions)	N/A	N/A	$4.9	$7.9

Notes:

ENVB did not disclose quarterly revenue in Q3 2025 press release; margins/segment data are not applicable for a pre-revenue, preclinical biotech .
No S&P Global consensus for Q3’25 EPS/Revenue; estimate comparisons unavailable (S&P Global consensus data not available via GetEstimates).

KPIs and Operational Milestones

KPI / Milestone	Q1 2025	Q2 2025	Q3 2025
IND timing (EB-003)	Aim to submit IND by end of Q1 2026	IND submission anticipated early 2026	Plans for 2026 IND submission; FDA pre-IND response received
Preclinical toxicology (DRF/MTD)	N/A	N/A	DRF completed; MTD established (two species)
CMC readiness	N/A	N/A	Salt form identified; scalable synthesis; 1-kg batch produced
PTSD model efficacy	N/A	PTSD single-dose extinction effect disclosed in Q2 highlights	Positive PTSD model (p<0.05) reiterated
HQ relocation	N/A	N/A	Moved HQ to Cambridge, MA (9/2)
Capital actions	$5M public offering closed	YTD net proceeds $4.9M	YTD net proceeds $7.9M; reverse split 1-for-12 effective 10/28 (post-Q3)
IP developments	EB-003 composition claims progressing; EVM401 patent issued	Additional IP grants/allowances across EVM-301/401	Issued patents in EVM-301/401; defense of U.S. Patent No. 12,138,276 (PGR) planned

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
EB-003 IND Submission Timing	Regulatory (EB-003)	“Early 2026” IND anticipated (Q2’25)	“2026” IND submission plans maintained; pre-IND FDA response received (Q3’25)	Maintained (timeline reaffirmed)
First-in-Human Study	Clinical Start	Prepare for first-in-human in 2026 (Q2’25)	Continue preparations for first-in-human in 2026 (Q3’25)	Maintained

No financial (revenue/margin/OpEx) guidance was issued; the company remains pre-revenue and focused on IND-enabling work .

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was available in our document set or common repositories as of Nov 20, 2025; themes below reflect disclosures across Q1–Q3 press releases.

Topic	Previous Mentions (Q-2 and Q-1)	Current Period (Q3 2025)	Trend
R&D Execution (EB-003 pharmacology)	Dual 5-HT2A/5-HT1B mechanism disclosed; pre-IND data supporting daily oral use	Positive PTSD model efficacy reiterated (p<0.05)	Improving (broadening preclinical efficacy set)
Regulatory Path (IND)	IND anticipated early 2026; building IND-enabling package	FDA pre-IND written response; 2026 IND plan reaffirmed	De-risking (process clarity)
CMC/Manufacturing	N/A	N/A	Salt form identified; scalable route; 1-kg batch produced
Intellectual Property	Additional grants/allowances (EVM-301/401)	Patent issuances; plan to defend U.S. Patent No. 12,138,276 (PGR related to Bretisilocin)	Active defense/expansion
Financing/Treasury	$5M offering closed (Q1) ; YTD net proceeds $4.9M by Q2	YTD net proceeds $7.9M; exploring Digital Asset Treasury opportunities (Board authorization)	Continued financing; exploring alternatives
Listing/Corporate Actions	N/A	N/A	Nasdaq bid-price deficiency (10/22); 1-for-12 reverse split effective 10/28

Management Commentary

“The third quarter of 2025 marked another highly productive period as we continue to advance our lead candidate EB-003 towards clinical trials in 2026… completed key CMC milestones… and dose range studies that helped to establish a maximum tolerated dose of EB-003.” — Joseph Tucker, Ph.D., CEO .
“Our research showed significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) indicating a positive therapeutic effect in a well-established translational rodent model for PTSD.” — Joseph Tucker, Ph.D., CEO .
“Intellectual property remains a cornerstone… we announced plans to contest a PGR petition… The IP in question concerns claims that may be relevant to the Bretisilocin molecule, which was recently acquired by AbbVie in $1.2 billion deal.” — Joseph Tucker, Ph.D., CEO .
“Identified and produced a pharmaceutically compatible salt form… developed and implemented a scalable, reproducible synthetic process… successfully produced a 1-kilogram batch of EB-003…” .

Q&A Highlights

No Q3 2025 earnings call transcript was available; management updates for the quarter were delivered via press releases, limiting visibility into Q&A clarifications and tone changes [ListDocuments: no earnings-call-transcript; InternetSearch index only].

Estimates Context

S&P Global consensus estimates for Q3 2025 EPS and revenue were not available; therefore, we cannot assess beats/misses versus Street expectations (S&P Global consensus data not returned by GetEstimates for Q3 2025).
Directionally, quarter-over-quarter net loss increased with ongoing IND-enabling spend and corporate activities; absent consensus, investor models will likely focus on cash runway, financing cadence, and the 2026 IND timeline .

Key Takeaways for Investors

2026 IND remains the central catalyst; pre-IND FDA response, DRF/MTD completion, and CMC scale (1-kg batch) reduce execution risk ahead of GLP tox and IND submission .
Positive PTSD preclinical data (p<0.05) strengthen the EB-003 thesis across neuropsychiatric indications without hallucinogenic effects by design—supportive for broader clinical opportunity .
Cash of $3.8M and YTD net proceeds of $7.9M underscore ongoing reliance on external financing; treasury optionality (DAT exploration) introduces non-core volatility but could diversify sources if pursued prudently .
Listing/compliance actions (1-for-12 reverse split after Nasdaq deficiency) mitigate immediate delisting risk but do not alter fundamentals; share dynamics may elevate trading volatility near-term .
Active IP posture (planned PGR defense; continued issuances) is strategically important given competitive serotonergic landscape and potential relevance to third-party assets (e.g., Bretisilocin) .
With no Q3 consensus and no call transcript, near-term stock moves may hinge on incremental preclinical/CMC disclosures, financing updates, and any regulatory interactions; eyes now on GLP tox initiation/progress and IND package build .

Additional Source Citations (for completeness):

Q3 2025 8-K press release: net loss, EPS, cash, YTD proceeds, FDA response; reverse split reference .
Q2 2025 8-K press release: net loss, EPS, cash, YTD proceeds, dual mechanism, IND timing .
Q1 2025 8-K press release: net loss, EPS, cash, $5M offering, IP updates .
Reverse split details (post-quarter): ratio, mechanics .
CMC manufacturing milestones detail .
DRF/MTD detail .
PTSD preclinical result detail .
Digital Asset Treasury exploration .

Enveric Biosciences, Inc. (ENVB)·Q3 2025 Earnings Summary