Ensysce Biosciences Inc.
ENSC evidence brief
What we can confirm
- BioSniper Score:
- 5.8 / 10
- Market Cap:
- $9.5M
- Lead Asset:
- pf614 (Phase 3)
What it means
What to watch
Prepared research question
What matters most for ENSC—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ENSC
Ensysce Biosciences Inc. (ENSC) is a clinical-stage biotechnology company developing novel opioids with abuse-deterrent and overdose-protection properties, centered on its TAAP™ and MPAR® platforms, with lead candidate PF614 in Phase 3 trials.
Key risk: Low cash runway
BioSniper Score
Based on 4 of 6 signals
Market Cap
$9.5M
Cash Runway
—
Lead Asset
pf614 (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 2 pipeline candidates · 2 clinical trials for Ensysce Biosciences Inc..
Ensysce Biosciences Inc. (ENSC) is a clinical-stage biotechnology company developing novel opioids with abuse-deterrent and overdose-protection properties, centered on its TAAP™ and MPAR® platforms, with lead candidate PF614 in Phase 3 trials.
- Lead candidate PF614 is in Phase 3 for postoperative pain, with a Phase 3 trial initiated and enrollment progressing rapidly [news · published 2026-03-30].
- PF614-MPAR, a combination with nafamostat for overdose protection, has Breakthrough Therapy designation from the FDA and completed enrollment in its final clinical study as of August 2026 [news · published 2026-08-31].
- Cash & equivalents were $0.7M as of 2026-06-30, with total revenue of $1.2M and negative shareholders' equity of -$0.8M [sec].
- The company completed the acquisition of Cy Biopharma, adding CY200 for Complex Regional Pain Syndrome (CRPS) and securing up to $77 million in new funding [news · published 2026-08-13].
- Ensysce is advancing PF9001 for opioid use disorder (OUD) and exploring TAAP™ and MPAR® technologies for additional indications such as ADHD [news · published 2026-03-30].
What works
- PF614-MPAR has Breakthrough Therapy designation from the FDA, which may accelerate development and market entry [news · published 2026-03-30].
- The company has generated data supporting overdose-protection labeling for its MPAR platform, a potential differentiator in opioid safety [news · published 2026-03-30].
- Ensysce has expanded its pipeline through acquisition (Cy Biopharma) and new candidates (PF9001 for OUD), broadening its therapeutic reach [news · published 2026-08-13].
What to weigh
- Cash position is low at $0.7M as of 2026-06-30, with negative shareholders' equity of -$0.8M, indicating potential funding needs [sec].
- The company is pre-revenue from product sales (total revenue $1.2M likely from grants or other sources) and relies on external funding to sustain operations [sec].
- PF614 and PF614-MPAR face a competitive landscape including established abuse-deterrent opioids like OxyContin OP and Extampza ER [pipeline].
From the filings
Quoted directly from source documents.
PF614-MPAR has Breakthrough Therapy designation and completed enrollment in its final clinical study.
“The Second Study Fully Enrolled for Breakthrough Therapy-Designated, First-in-Class Opioid Designed to Protect Against Oral Overdose”
News · August 31, 2026
Ensysce completed acquisition of Cy Biopharma, adding CY200 for CRPS.
“Acquisition of Cy Biopharma Completed, Adding CY200 for Complex Regional Pain Syndrome”
News · August 13, 2026
PF614 is a TAAP prodrug that releases oxycodone only when exposed to trypsin in the gut.
“Trypsin Activated Abuse Protection (TAAP) prodrug that releases oxycodone only when exposed to trypsin in the gut”
Catalyst timeline
- 2024-11-24 · Phase 1 start for PF614 with nafamostat combination study — A single-dose pharmacokinetic study evaluating co-administration of PF614 and nafamostat in healthy subjects.
- 2025-12-09 · Phase 3 start for PF614 in postoperative pain — A multicenter, randomized, double-blind, placebo-controlled efficacy and safety study of PF614 after abdominoplasty.
Risks & what to watch (4)›
Key risks
- Low cash runway — Cash of $0.7M as of 2026-06-30 may be insufficient to fund operations without additional financing [sec].
- Negative shareholders' equity — Shareholders' equity of -$0.8M as of 2026-06-30 indicates liabilities exceed assets [sec].
- Competitive market for abuse-deterrent opioids — PF614 competes with established products like OxyContin OP and Extampza ER [pipeline].
- Dependence on regulatory milestones — Success hinges on FDA interactions and Phase 3 trial outcomes for PF614 and PF614-MPAR [news].
What to watch
- Phase 3 trial results for PF614 (PF614-301) and PF614-MPAR (PF614-MPAR-102), as enrollment has been completed [news · published 2026-08-31].
- FDA feedback on manufacturing pathway and potential NDA submission for PF614 [news · published 2026-03-30].
- Progress of PF9001 for opioid use disorder and CY200 for CRPS, including any clinical trial initiations [news · published 2026-03-30].
- Company's ability to secure additional funding given low cash reserves [sec].
Sources: Catalysts · News · Pipeline · Generated October 4, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
N/A
Lead: Phase 3
2 candidates
No upcoming catalysts tracked
2 buys · 0 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
15
Total value held
$253K
| Holder | Shares | Value |
|---|---|---|
| adage capital partners gp, l.l.c. | 149,711 | $81K |
| perceptive advisors llc | 86,666 | $47K |
| geode capital management, llc | 73,880 | $40K |
| citadel advisors llc | 57,363 | $31K |
| xtx topco ltd | 24,363 | $13K |
| vanguard fiduciary trust co | 23,854 | $13K |
| jane street group, llc | 13,570 | $7K |
| tru independence asset management 2, llc | 13,000 | $7K |
| vanguard capital management llc | 12,854 | $7K |
| ubs group ag | 8,791 | $5K |
Showing top 10 of 15 institutional holders of Ensysce Biosciences Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 21, 2026- % of float
- 0.6%
- Days to cover
- 0.2
- Shares short
- 52,730
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ENSC short interestGovernance
Frequently asked questions
What is the AI investment thesis for Ensysce Biosciences Inc.?
Ensysce Biosciences Inc. (ENSC) is a clinical-stage biotechnology company developing novel opioids with abuse-deterrent and overdose-protection properties, centered on its TAAP™ and MPAR® platforms, with lead candidate PF614 in Phase 3 trials.
What is Ensysce Biosciences Inc.'s lead drug candidate?
Ensysce Biosciences Inc.'s most advanced tracked candidate is pf614 (Phase 3) for Postoperative Pain, Acute; Pharmacokinetics.
Who is the CEO of Ensysce Biosciences Inc.?
Dr. D. Lynn Kirkpatrick Ph.D. is the chief executive officer of Ensysce Biosciences Inc. (ENSC).
Where is Ensysce Biosciences Inc. headquartered?
Ensysce Biosciences Inc. (ENSC) is headquartered in La Jolla, CA, United States.
What therapeutic areas does Ensysce Biosciences Inc. focus on?
Ensysce Biosciences Inc. develops therapies across Pain.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.