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Ensysce Biosciences, Inc. (ENSC)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally constructive: Ensysce reported higher grant revenue ($1.32M) and a narrower net loss per share (-$1.39), with EPS materially above consensus and revenue above a zero baseline, driven by stepped-up MPAR grant activity . EPS beat S&P Global consensus (-$1.39 vs -$3.02), and revenue exceeded a $0 consensus baseline (two estimates) (S&P Global data)*.
  • Management advanced pipeline catalysts: PF614 Phase 3 is targeted to start “mid‑year 2025” (slight timing shift from prior “Q2 2025”), PF614‑MPAR-102 Part 1 confirmed overdose protection, and a Notice of Allowance was received for OUD candidate PF9001 . Q4 commentary had guided to Phase 3 enrollment “in the second quarter of 2025” and NDA submission in 2026 .
  • Liquidity: Cash was $3.05M at quarter-end; subsequent warrant exercises added ~$2.2M gross proceeds. Management guides cash runway into Q3 2025 absent additional financing, with $9.2M of remaining non‑dilutive MPAR grant funding available through May 2027 .
  • Near‑term stock catalysts: PF614 Phase 3 initiation, PF614‑MPAR Part 2/3 readouts, OUD patent protection (PF9001), and further funding actions (grants or equity/warrant monetization). Liquidity actions and regulatory/clinical progress are likely to drive sentiment and estimate revisions .

What Went Well and What Went Wrong

  • What Went Well
    • Positive clinical/regulatory momentum: “Part 1 of our PF614‑MPAR‑102 clinical study…confirmed protection from the risk of overdose” and Phase 3 PF614 is targeted to start mid‑year 2025 . CEO: “We are pleased with the meaningful strides…to deliver…‘Next Generation’ opioid analgesics with both abuse and overdose protection” .
    • IP strengthening in OUD: Received a Notice of Allowance for PF9001 (enzyme‑cleavable methadone prodrugs), bolstering the OUD platform .
    • Estimate beat: EPS (-$1.39) topped consensus (-$3.02) and revenue ($1.32M) exceeded a $0 consensus (two estimates), reflecting timing of reimbursable MPAR grant activity (S&P Global)* and grant revenue recognition .
  • What Went Wrong
    • Guidance timing drift: PF614 Phase 3 start moved from “expected start…in the second quarter of 2025” (Q4) to “mid‑year 2025” (Q1), implying a modest schedule slip .
    • Ongoing losses and going‑concern language: Management reiterated substantial doubt about going concern without new financing; runway extends into Q3 2025 absent a capital raise .
    • Increased R&D burn: R&D rose to $1.89M vs $0.78M YoY, as PF614‑MPAR work accelerated; while strategic, higher burn tightens the financing window ahead of Phase 3 .

Financial Results

P&L and EPS vs prior periods and estimates

MetricQ3 2024Q4 2024Q1 2025Q1 2025 vs Est.
Federal Grants Revenue ($USD)$3,418,853 $1,303,659 $1,319,772 $0* (consensus) vs $1,319,772 actual (beat)*
Net Income (Loss) ($USD)$661,769 $(3,564,422) $(1,945,573) —
Diluted EPS ($)$0.07 $(2.90) $(1.39) $(3.02)* consensus mean vs $(1.39) actual (beat)*

Notes: Ensysce recognizes “Federal grants” as revenue under ASC 606 analogy; no product revenue. Asterisked estimate values from S&P Global.*

Operating expenses and cash

MetricQ3 2024Q4 2024Q1 2025
R&D Expense ($USD)$1,690,674 $3,802,630 $1,885,528
G&A Expense ($USD)$1,083,433 $1,077,505 $1,401,756
Cash & Equivalents (Period End) ($USD)$4,153,592 $3,502,077 $3,052,491

Margins/KPIs

KPIQ3 2024Q4 2024Q1 2025
Net Income Margin (% of Grants)19.4% (=$0.662M/$3.419M) -273.7% (=$(3.564M)/$1.304M) -147.4% (=$(1.946M)/$1.320M)
Net Cash Used in Ops ($USD)—$(7,502,700) FY’24 $(1,707,412)
Remaining MPAR Grant Funding ($USD)——$9.2M remaining (thru May 2027)

Segment breakdown: single reportable segment .

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
PF614 Phase 3 start2025“Expected start of enrollment…in the second quarter of 2025” (Q4 release) “Working towards initiating the trial in mid‑year 2025” (Q1 release) Slightly later (slip)
PF614 NDA timing2026“Remain on track to submit…in 2026” (Q4 release) 2026 still targeted implicitly; no change referenced in Q1 Maintained
PF614‑MPAR-1022025Part 1 ongoing; higher dose/food effects planned (Q4) Part 1 completed (overdose protection confirmed); progressing to Parts 2 and 3 Advanced
G&A OpEx levelOngoingExpect to approximate current levels (Q4) Expect to approximate current levels (Q1) Maintained
R&D trajectory2025Increase with MPAR/OUD activity (Q4) Expect R&D to increase once PF614 Phase 3 begins; timing dependent on financing Clarified (contingent)
Financial guidance2025None providedNone providedUnchanged

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available in company filings; key themes drawn from Q3/Q4 press releases and the Q1 10‑Q.

TopicQ3 2024 (Q‑2)Q4 2024 (Q‑1)Q1 2025 (Current)Trend
PF614 Phase 3 timingProtocol submitted to FDA; expecting feedback by end Nov 2024 “Expected start…in Q2 2025” “Initiating…mid‑year 2025” Slight delay, still near‑term
PF614‑MPAR clinicalIRB‑approved PF614‑MPAR‑102; initiation planned; NIH $14M grant awarded Interim PF614‑MPAR‑102 data positive at 100mg PF614‑MPAR‑102 Part 1 completed; overdose protection confirmed; Parts 2/3 commencing Advancing
OUD (PF9001)Lead candidate selected; HEAL award up to $15M IND‑enabling planned in coming year Notice of Allowance received for PF9001 patent Strengthening IP
Manufacturing/commercial readiness—Strategic manufacturing/commercial partnership announced Galephar agreement details (equity/milestone‑based consideration) Building readiness
Liquidity/funding$5M August financing; grant inflows drove Q3 profit FY24 operating cash burn $(7.5)M; cash $3.5M Cash $3.05M; April warrant exercise ~$2.2M gross; runway into Q3’25 Tight runway; active financing

Management Commentary

  • Strategic focus: “We are pleased with the meaningful strides…to deliver…‘Next Generation’ opioid analgesics with both abuse and overdose protection.” — Dr. Lynn Kirkpatrick, CEO .
  • PF614‑MPAR progress: “Part 1…finished enrollment and confirmed protection from the risk of overdose when PF614‑MPAR…is consumed accidentally or deliberately.” .
  • OUD platform/IP: “Notice of Allowance…for our lead OUD candidate, PF9001…designed to have…overdose protection…and reduced cardiotoxicity.” .
  • Commercial ambition: “We believe Ensysce is set to disrupt the analgesic opioid market with PF614 and PF614‑MPAR.” .

Q&A Highlights

  • No Q1 2025 earnings call transcript or Q&A was filed; clarifications came via the press release and 10‑Q. Key points: Phase 3 timing shifted to mid‑year 2025; PF614‑MPAR‑102 advanced to Parts 2/3; runway into Q3 2025 absent financing; remaining MPAR grant funding $9.2M through May 2027 .

Estimates Context

  • S&P Global consensus (two estimates) for Q1 2025 EPS: -$3.02*; actual: -$1.39 (beat). Consensus revenue: $0*; actual: $1.32M (beat). A relatively light coverage universe and zero revenue baseline amplified the magnitude of the beat (S&P Global data)* .
  • Implications: With Phase 3 impending, analysts may lift near‑term R&D spend assumptions and maintain negative EPS trajectories, while increasing grant revenue visibility tied to MPAR as study activity continues (directional—anchor to filings ).
Q1 2025Consensus*Actual
EPS ($)-3.015*-1.39
Revenue ($)0*1,319,772
EPS Estimates (#)2*—
Revenue Estimates (#)2*—

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Near‑term clinical catalysts: PF614 Phase 3 start (mid‑year 2025) and PF614‑MPAR‑102 Parts 2/3 are primary stock drivers; successful execution would de‑risk the platform and support the 2026 PF614 NDA plan .
  • Liquidity watch: Runway into Q3 2025 and subsequent warrant exercise (~$2.2M gross) suggest continued need for capital ahead of Phase 3; monitor additional financings and non‑dilutive grants .
  • IP/strategy strengthening: OUD patent allowance for PF9001 adds optionality beyond pain and supports a broader platform value proposition .
  • Expense cadence: Expect R&D to rise with Phase 3 start; G&A to remain around current levels—key for cash budgeting and dilution scenarios .
  • Estimate setup: Thin coverage and grant‑driven revenue recognition can create estimate volatility; EPS beats may reflect timing of reimbursable activity rather than core profitability (S&P Global; filings)* .
  • Manufacturing readiness: Galephar partnership and milestone‑based consideration align commercial enablement with regulatory progress—watch milestone triggers and potential share issuance .
  • Risk balance: Going‑concern disclosure persists; program execution, FDA interactions, and financing terms remain central to the risk/reward .

Additional Q1 2025 and Prior-Quarter References

  • Q1 2025 8‑K (press release) and 10‑Q provide full financials, program updates, and going‑concern disclosures .
  • Q4 2024 press release highlighted Phase 3 readiness, positive MPAR interim data, and 2026 NDA plan .
  • Q3 2024 press release captured the $14M MPAR grant award and the PF614‑MPAR‑102 initiation, as well as grant‑timing‑driven quarterly profitability .

*Estimates are from S&P Global (Capital IQ).