What EPIK Biosciences does

EPIK Biosciences is a preclinical-stage psychedelic medicine company developing a proprietary platform of ketamine-based, synergistic co-delivery formulations for mental health disorders, addiction and substance use disorders, and severe chronic pain. The platform is rooted in NMDA receptor modulation and combines ketamine with other FDA-recognized ingredients selected to amplify therapeutic effect and reduce side effects relative to standalone ketamine. The pipeline consists of six named candidates (EPK 001 through EPK 006), with EPK 001 in preclinical animal testing, EPK 002 and EPK 003 planned for preclinical testing in Fall 2026, and EPK 004 through EPK 006 in discovery. Delivery modalities include sublingual, topical, and intravenous options, most designed for at-home use without clinic supervision, with human Phase 1 clinical trials targeted for early to mid 2027 under the FDA 505(b)(2) expedited pathway.

The company pursues a development-led, asset-light model currently funded by a $30 million SAFE round open to accredited investors, with proceeds directed toward preclinical work, LabCorp validation, global public relations, and a planned Nasdaq listing under the reserved ticker EPIK. EPIK's strategic differentiator versus Schedule I psychedelic peers such as MindMed, Compass Pathways, and ATAI is its use of already-FDA-approved compounds and the 505(b)(2) regulatory pathway, which the company frames as a faster and lower-cost route to approval. Formulation validation is conducted in partnership with LabCorp, which delivered three medicine blends and five-plus delivery systems in April 2026 and reports involvement in over 85% of FDA drug approvals in 2025. There is no commercial product, no revenue, and no disclosed institutional investors at this stage; go-to-market beyond the SAFE round is concentrated on a planned Summer 2026 outreach to major biotech partners and a direct-to-patient or telemedicine-style distribution model enabled by the home-use delivery formats.

The leadership team is small and founder-led. Founder and CEO Brandon Romanek brings 25+ years of biotech investing on Wall Street and began studying ketamine mechanisms in 2012; Chief Medical Officer Dr. Tyler Dunn trained at Mayo Clinic Arizona and previously advised Pacira Biosciences (Nasdaq: PCRX); and Chief Clinical Officer Dr. David Wiegmann is a board-certified anesthesiologist with multi-institution co-investigator experience. The company is headquartered in Austin, Texas, and is incorporated as Epik Biosciences, Inc. in Arizona.

Name

EPIK Biosciences

Legal name

Epik Biosciences, Inc.

Website

https://epikbio.com

Company type

Private

Founded year

2012

Operating status

Operating

Short description

EPIK Biosciences is a preclinical-stage psychedelic medicine company developing ketamine-based synergistic co-delivery formulations for mental health disorders, addiction, and chronic pain, advancing through the FDA 505(b)(2) pathway with home-use delivery formats.

Ownership category

akta.pro rank

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Pharmaceutical Product Sales: Once FDA approved, the company will generate revenue through sales of proprietary ketamine-based co-delivery medicines targeting mental health disorders, addiction, substance use disorders, and chronic pain.
2. Investment Capital Raise: Currently raising $30 million via SAFE (Simple Agreement for Future Equity) agreements with accredited investors at 30% discount to first priced round valuation. Minimum investment of $55,000. Reserved Nasdaq ticker EPIK.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

EPIK Biosciences develops a proprietary platform of ketamine-based, synergistic co-delivery formulations combining ketamine with FDA-recognized ingredients that amplify therapeutic effects. The company's drug candidates target mental health disorders (depression, anxiety, PTSD), opioid use disorder and substance use disorders, as well as acute and chronic pain, with most delivery formats engineered for at-home use without requiring clinic supervision. EPIK is leveraging the FDA's 505(b)(2) regulatory pathway and a development partnership with LabCorp to advance preclinical candidates toward human trials targeted for early-to-mid 2027.

Product overview

EPIK Biosciences operates as a pharmaceutical company with a single proprietary platform for ketamine-based, synergistic co-delivery formulations. The platform underlies multiple named drug candidates (EPK 001-006) at various developmental stages, from discovery through preclinical testing. Delivery methods include sublingual formulations, topical application, and intravenous options, with most designed for home use. The company is developing treatments targeting depression, anxiety disorders, opioid use disorder, chronic pain, PTSD, and acute pain.

Differentiator

Problem solved

Functional benefit

Products and services

• EPK 001 Preclinical drug candidate in animal testing phase being developed to treat depression, anxiety disorders, opioid use disorder, and/or chronic pain using EPIK's proprietary ketamine-based co-delivery platform.
• EPK 002 R&D stage drug candidate being developed using EPIK's proprietary ketamine-based co-delivery platform, with preclinical animal testing planned for Fall 2026.
• EPK 003 R&D stage drug candidate being developed using EPIK's proprietary ketamine-based co-delivery platform, with preclinical animal testing planned for Fall 2026.
• EPK 004-006 Group of three discovery-stage drug candidates in early development using EPIK's proprietary ketamine-based co-delivery platform.

Quantifiable outcome

• Over 85% FDA approval success rate for LabCorp's accepted programs
• +1 more outcomes

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• LabCorpcoreStrategic or Co-development Partner · 1 April 2026EPIK works with Labcorp, a global life sciences leader, for the development and validation of formula combinations. Their expertise contributed to over 85% of FDA drug approvals in 2025. This collaboration offers EPIK top-tier testing and regulatory support, enhancing their efficient and economical route to FDA authorization. LabCorp delivered validation formulations in April 2026 and has a greater than 85% FDA approval success rate for accepted programs.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Spravato (Janssen / Johnson & Johnson): Established ketamine-derived esketamine nasal spray for treatment-resistant depression, generating over $1B in sales. Direct same-mechanism incumbent that EPIK aims to disrupt with next-generation combination formulations and home-use delivery.
• Sage Therapeutics: Biopharmaceutical company developing CNS therapeutics including Zurzuvae for postpartum depression. Comparable CNS pipeline focus and depression treatment positioning with broader modality portfolio than psychedelic-only players.

Direct peers

• Gilgamesh Pharmaceuticals: Psychiatric drug discovery company developing novel psychedelic-inspired medicines for mental health conditions. Acquired for $1.2B in August 2025, validating the psychedelic medicine space and serving as a direct sector comparable.
• MindMed: Clinical-stage psychedelic medicine biotech developing novel therapies for mental health and addiction. Direct competitor using psychedelic compounds and explicitly named by EPIK as a competitor in the same regulatory and commercial space.
• Compass Pathways: Mental health care company developing psilocybin therapy for treatment-resistant depression. Explicitly named by EPIK as a competitor using Schedule 1 substances versus EPIK's 505(b)(2) regulatory approach.
• ATAI Life Sciences: Clinical-stage biopharmaceutical company developing psychedelic and non-psychedelic compounds for mental health disorders. Explicitly named by EPIK as a direct competitor pursuing overlapping CNS indications.

Others

• Pacira Biosciences: Specialty pharmaceutical company focused on non-opioid pain management with commercial-stage products. Comparable pain management market focus; connected to EPIK through CMO Dr. Tyler Dunn's prior advisory role at Pacira.

Regional players

• Field Trip Health: Mental health company operating psychedelic-assisted therapy clinics across North America. Adjacent psychedelic medicine player focused on clinic-based delivery model that EPIK's home-use formulation approach aims to disrupt and bypass.

Emerging players

• Beckley Psytech: Clinical-stage psychedelic medicine company developing psilocybin-based therapies for neurological and psychiatric conditions. Comparable psychedelic pipeline focus but using Schedule 1 substances and requiring clinic administration.
• BetterLife Pharma: Mental health and psychedelic therapeutics company developing treatments for depression, anxiety, and addiction. Comparable psychedelic medicine focus but at an earlier pipeline stage with narrower resource base than EPIK.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about EPIK Biosciences