Sign in

You're signed outSign in or to get full access.

EB

Ensysce Biosciences, Inc. (ENSC)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024: Net loss attributable to common stockholders was $3.56M and EPS was $(2.90); Federal grants were $1.30M; R&D was $3.80M and G&A was $1.08M .
  • Timelines shifted: PF614 Phase 3 enrollment now expected to start in Q2 2025 versus prior guidance for H2 2024; PF614 NDA submission targeted for 2026 (delay vs prior expectations) .
  • Positive clinical momentum: PF614-MPAR-102 interim data showed overdose protection at the 100 mg dosage; Breakthrough Therapy designation sustained interest; remaining MPAR grant cash funding of $1.6M through May 31, 2025 with an additional $9.0M available for the following two years .
  • Manufacturing/commercial readiness: Strategic partnership signed in January for commercial launch preparation of PF614 and PF614-MPAR, signaling execution progress toward eventual commercialization .
  • Consensus estimates were unavailable via S&P Global due to access limits; therefore, no beat/miss assessment versus Wall Street consensus is included for Q4 2024 [GetEstimates error].

What Went Well and What Went Wrong

What Went Well

  • PF614-MPAR clinical progress: Interim data from PF614-MPAR-102 demonstrated overdose protection at 100 mg, with ongoing evaluation at higher dose limits and limited adverse events reported (“we believe verifying the favorable safety profile”) .
  • Strategic manufacturing partnership: In January, ENSC entered a partnership to manufacture and prepare commercial launch for PF614 and PF614-MPAR—“readiness and a shared commitment to achieving swift regulatory approval” .
  • Financial flexibility aided by grants/financing: Cash increased to $3.50M at year-end; full-year federal grants totaled $5.21M in 2024 vs $2.23M in 2023; financing provided $9.88M in 2024 to fund operations .

What Went Wrong

  • Timeline slippage for PF614 Phase 3: Start of enrollment pushed to Q2 2025 from previously anticipated H2 2024, necessitating recalibration of near-term milestones .
  • QoQ decline in federal grant funding: Q4 grants of $1.30M fell from Q3’s $3.42M, consistent with prior guidance that grant funding would decline in coming quarters .
  • Continued operating losses: Q4 net loss was $3.56M (vs. $3.50M in Q4 2023); Other income/expense swung to a small income in Q4 2024 but remained an FY 2024 expense ($1.26M) due to note-related items .

Financial Results

Quarterly Comparison (Q2–Q4 2024)

MetricQ2 2024Q3 2024Q4 2024
Federal Grants ($USD)$181,797 $3,418,853 $1,303,659
Research & Development ($USD)$947,229 $1,690,674 $3,802,630
General & Administrative ($USD)$1,190,010 $1,083,433 $1,077,505
Total Operating Expenses ($USD)$2,137,239 $2,774,107 $4,880,135
Other Income (Expense), net ($USD)$(12,351) $17,023 $12,054
Net Income (Loss) ($USD)$(1,967,793) $661,769 $(3,564,422)
EPS Basic & Diluted ($USD)$(0.22) $0.07 $(2.90)
Cash & Equivalents (End of Period) ($USD)$1,043,231 $4,153,592 $3,502,077

YoY Comparison (Q4 2024 vs Q4 2023)

MetricQ4 2023Q4 2024
Federal Grants ($USD)$515,032 $1,303,659
Research & Development ($USD)$2,232,760 $3,802,630
General & Administrative ($USD)$1,437,957 $1,077,505
Other Income (Expense), net ($USD)$(348,676) $12,054
Net Loss ($USD)$(3,504,361) $(3,564,422)
EPS Basic & Diluted ($USD)$(16.94) $(2.90)

Notes:

  • Margins/segment breakdowns are not applicable given ENSC’s clinical-stage status and the absence of product revenue.
  • Q3’s net income was a one-time event driven by grant timing (completion of OUD grant funding and start of MPAR grant funding) .

KPIs (Operating & Funding)

KPIQ2 2024Q3 2024Q4 2024
Federal Grants ($USD)$181,797 $3,418,853 $1,303,659
Cash & Equivalents ($USD)$1,043,231 $4,153,592 $3,502,077
R&D ($USD)$947,229 $1,690,674 $3,802,630
G&A ($USD)$1,190,010 $1,083,433 $1,077,505

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
PF614 Phase 3 Start of EnrollmentClinical startH2 2024 start planned ; FDA feedback expected by end-Nov to execute study over the coming year Start of enrollment expected Q2 2025 Lowered / Delayed
PF614 NDA Submission TargetRegulatory filingNot previously specifiedNDA submission targeted for 2026 New guidance
G&A Expense Run-rateNear termG&A expected to approximate current levels G&A expected to approximate current levels Maintained
Federal Grants TrajectoryNear termExpected grant funding to decline from Q3 level Q4 grants below Q3 (decline materialized) Maintained / Realized
Commercial Readiness (Manufacturing)Launch prepNot previously disclosedStrategic partnership for manufacture & commercial launch of PF614/PF614-MPAR signed in January New initiative

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was found; themes derived from press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
PF614 Phase 3 Protocol & StartH2 2024 start planned; protocol finalization; FDA feedback expected by end-Nov Enrollment expected Q2 2025; clinical sites/team being finalized Timeline slipped; execution prep progressing
PF614-MPAR Clinical ProgressPhase 1b PF614-MPAR-102 set up; IRB approval; site initiation; NIH $14M grant secured Interim data shows overdose protection at 100 mg; studying higher doses and multiple ascending dose; limited AEs Positive efficacy/safety momentum
OUD Program (PF9001)Lead candidate selected; IND-enabling to commence; HEAL award up to $15M; scale-up with Purisys Continuing non-clinical work; IND-enabling planned in coming year Steady advancement
Funding & LiquidityCash $1.0M in Q2; equity financings in Feb/Aug; cash $4.2M in Q3; grants expected to decline Cash $3.5M at YE; $1.6M remaining MPAR cash funding through May 31, 2025; +$9.0M following two years Adequate near-term funding via grants/financing
Manufacturing/CommercializationNot highlightedStrategic partnership for manufacture and commercial launch New capability added

Management Commentary

  • “We received feedback from the FDA on our PF614 phase 3 study design and are now taking steps to prepare for the expected start of enrollment of this clinical study in the second quarter of 2025… to remain on track to submit our PF614 New Drug Application in 2026.” — Dr. Lynn Kirkpatrick, CEO .
  • “PF614-MPAR provides overdose protection across our planned dosage range… adverse events have been limited, we believe verifying the favorable safety profile of PF614 and PF614-MPAR as a novel class of opioids to treat severe pain.” — Dr. Kirkpatrick .
  • “In January, we entered into a highly valuable strategic partnership for the manufacture and commercial launch of both our PF614 and PF614-MPAR drug products.” — Dr. Kirkpatrick .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available; thus, Q&A highlights and analyst tone changes could not be assessed [ListDocuments showed none].

Estimates Context

  • S&P Global Wall Street consensus estimates for Q4 2024 (EPS and revenue/federal grants) were unavailable due to access limits at the time of retrieval; therefore, no beat/miss assessment versus consensus is included [GetEstimates error].
  • As a result, near-term estimate revisions are not quantified here; investors should monitor sell-side notes post-press release for any revisions to timelines and R&D cadence .

Key Takeaways for Investors

  • Phase 3 timeline reset: PF614 enrollment now expected in Q2 2025, extending the clinical catalyst window; adjust expectations for pivotal data flow and NDA timing (2026) .
  • Clinical validation for MPAR: Interim data confirming overdose protection at 100 mg and ongoing studies at higher doses strengthen the differentiation thesis for PF614-MPAR; continued NIH funding de-risks development .
  • Funding runway supported by grants/financing: YE cash of $3.50M, MPAR grant cash remaining of $1.6M through May 31, 2025, plus $9.0M for the following two years, provides visibility for planned studies over the next year .
  • Manufacturing partnership is a commercialization milestone: Accelerates readiness for initial commercial supply once regulatory approvals are achieved, potentially shortening the post-approval execution curve .
  • Operating discipline: G&A expected to remain at current levels; monitor R&D cadence as MPAR/OUD activities ramp and PF614 Phase 3 preparation continues .
  • Near-term catalysts: Phase 3 site finalization and enrollment (Q2 2025), additional PF614-MPAR-102 data (higher-dose cohorts, multi-ascending dose), and ongoing regulatory interactions .
  • Trading implications: The timeline shift may temper near-term enthusiasm; however, continued positive MPAR data and tangible commercialization steps can support sentiment into 2025. Absence of consensus estimates limits a beat/miss narrative this quarter [GetEstimates error].

Additional references/read status:

  • Q4 2024 8-K 2.02 press release read in full .
  • Prior quarters for trend analysis: Q3 2024 8-K 2.02 read ; Q2 2024 8-K 2.02 read .
  • No Q4 2024 earnings call transcript or additional Q4 press releases found [ListDocuments searches returned none].