Reset Pharmaceuticals

What Reset Pharmaceuticals does

Reset Pharmaceuticals, Inc. (dba Reset Pharma) is a clinical-stage neuro-biotechnology company developing psilocybin-inspired therapies for mental illness in patients with life-threatening diseases, with an initial focus on demoralization syndrome in cancer patients. The company's sole product candidate is RSTP1000, an oral psilocybin formulation that the company describes as first-in-class and intended to "reset neural networks" in the brain. The underlying intellectual property was licensed on an exclusive worldwide basis from NYU Langone Health (announced July 2021), built on the clinical research of Stephen Ross, MD; the clinical study drug for the Phase 2b trial is supplied under a license from Filament Health Corp. of Canada. The company received FDA Safe to Proceed for the RSTP1000 IND in November 2023 and is conducting a multicenter, randomized, dose-ranging, double-blind Phase 2b study evaluating a single oral dose in cancer patients with demoralization syndrome.

The business is pre-revenue with no commercialized product. The intended revenue model is pharmaceutical product sales upon regulatory approval, distributed through direct enterprise sales to oncology centers, cancer treatment facilities, and hospital psychiatric departments, with specialty pharmacy distribution for controlled-substance handling. Target end users are patients with cancer and clinically relevant demoralization — an estimated 250,000+ per year in the U.S. — for whom no approved treatments currently exist and who respond poorly to conventional antidepressants. The company is incorporated in Delaware, headquartered in Great Neck, New York, employs 11–50 people, and has raised approximately $12.7 million through an SEC exempt offering in February 2022 from investors including Ayuh Ventures, Negev Capital, and PsyMed Ventures.

The team is composed of senior pharma executives with CNS drug development backgrounds at Eli Lilly, GlaxoSmithKline, Pfizer, Bayer, Genentech, Novartis, and Merck, supported by Scientific and Strategic Advisory Boards anchored by Stephen Ross, MD and William Breitbart, MD (Memorial Sloan Kettering). Future commercial expansion depends entirely on successful execution of the Phase 2b program, subsequent Phase 3 trials, regulatory approval, and the build-out of an oncology-focused specialty sales channel.

Name

Reset Pharmaceuticals

Legal name

Reset Pharmaceuticals, Inc.

Website

https://resetpharma.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Psychedelic Pharmaceuticals

NAICS

Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)

akta.pro secondary industry

Clinical Trial Pharmacy & IMP Management at Site (HLAGACAK)

Keywords

• Psychedelic pharmaceuticals
• Psilocybin therapy
• Oncology mental health
• Demoralization syndrome treatment
• CNS drug development

Headquarters

HQ city

Great Neck

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

Revenue model

1. Future Pharmaceutical Product Revenue: Pre-revenue clinical stage biotech company. Planned revenue stream will come from commercialization of psilocybin-based therapeutic RSTP1000 upon successful clinical development and regulatory approval for treatment of demoralization syndrome in cancer patients.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Reset Pharma is a clinical-stage biotechnology company developing RSTP1000, an oral psilocybin product candidate for the treatment of demoralization syndrome in cancer patients. The drug is currently in a multicenter, randomized, dose-ranging, double-blind, parallel-group Phase 2b trial after receiving FDA Safe to Proceed notification. The company holds an exclusive worldwide license from NYU Langone Health for the underlying intellectual property.

Product overview

Reset Pharma is a neuro-biotechnology company developing a single core product: RSTP1000, an oral psilocybin therapy for treating demoralization syndrome in cancer patients. The company operates with a focused pipeline approach, initially concentrating on this lead program while exploring related psychedelic therapies for mental illness in patients with life-threatening diseases.

Differentiator

Problem solved

Functional benefit

Products and services

• RSTP1000 Oral psilocybin product candidate being developed for the treatment of demoralization syndrome in patients with cancer. The study drug for Phase 2b trial was licensed from Filament Health Corp., Canada. RSTP1000 is in Phase 2b clinical development and is intended for use as a treatment for cancer patients with clinically relevant demoralization characterized by loss of hope, purpose, and meaning.

Quantifiable outcome

• Fast (24 hours) and sustained clinical benefit (4.5 years) observed in NYU Langone Health study for patients with cancer and demoralization syndrome
• +2 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Two partnerships are on record, tiered core.

• Filament Health Corp.coreOEM/ Whitelabel/ Licensing Partner · 1 November 2023Reset Pharma licensed its study drug for the Phase 2b trial from Filament Health Corp., Canada. The company is conducting a multicenter, randomized, dose-ranging, double-blind, parallel-group Phase 2b study to investigate preliminary efficacy, safety, and tolerability of orally administered RSTP1000 for up to 6 months.
• NYU Langone HealthcoreOEM/ Whitelabel/ Licensing Partner · 7 July 2021Reset Pharma acquired an exclusive worldwide license from NYU Langone Health for intellectual property associated with the use of psilocybin and related psychedelics for the treatment of mental illness in patients with life-threatening diseases, including cancer. This agreement is based on the seminal work of Stephen Ross, MD, a world leader in psychedelic medicine and prominent addiction psychiatrist at NYU Langone. NYU Langone will receive milestone and royalty compensation. Reset Pharma obtained exclusive global rights to develop and commercialize the intellectual property.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Sage Therapeutics: Commercial CNS biopharma with ZURZUVAE (zuranolone) approved for postpartum depression. Comparable as a CNS-focused developer that has executed FDA approvals in psychiatric indications, providing a relevant development and commercialization benchmark.
• Janssen (Johnson & Johnson): Approved SPRAVATO (esketamine) for treatment-resistant depression, establishing a regulatory and commercial precedent for psychedelic-adjacent CNS therapies. Comparable as a broad incumbent that has navigated FDA approval and REMS for a controlled-substance psychiatric therapy.

Direct peers

• Compass Pathways: Clinical-stage psychedelic biotech developing COMP360 psilocybin therapy in treatment-resistant depression and other psychiatric indications. Most directly comparable to Reset as a psilocybin-focused developer in CNS, though with a much larger capital base and different primary indication.
• Atai Life Sciences: Clinical-stage biopharma platform developing multiple psychedelic and non-psychedelic compounds for mental health indications including depression and anxiety in oncology-adjacent settings. Closest platform analog to Reset given psychedelic focus and CNS oncology overlap.
• MindMed: Clinical-stage psychedelic medicine company developing LSD (MM-120) for anxiety disorders and other CNS indications. Comparable as a publicly listed psychedelic clinical developer with overlapping CNS regulatory pathway.
• GH Research: Clinical-stage company developing mebufotenin (5-MeO-DMT, GH001) for treatment-resistant depression. Highly comparable as a small-cap psychedelic clinical developer with a single lead asset in CNS psychiatry.

Emerging players

• Filament Health: Botanical psilocybin drug developer and the licensor of RSTP1000's drug substance to Reset. Directly comparable technology platform and also advancing its own psilocybin candidates in depression, with overlap in supply chain and clinical-stage psychedelic development.
• Cybin Inc. Clinical-stage developer of deuterated psilocybin analogs (CYB003) for major depressive disorder. Comparable as a small psychedelic clinical developer focused on optimized psilocybin derivatives for psychiatric indications.
• Seelos Therapeutics: Clinical-stage company that has investigated psilocybin (SLS-002) for suicidal ideation in PTSD/depression. Comparable given the suicide-risk and oncology-psychiatric overlap with Reset's target indication of demoralization syndrome.
• Journey Life Sciences: Psychedelic-medicine company founded/led by Greg McKee, who sits on Reset's board. Comparable given overlapping psychedelic drug development focus and shared leadership links in the psilocybin development ecosystem.

Market position

Strengths4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/resetpharma
• LinkedInlinkedin.com/company/resetpharma

Revenue estimate

Valuation estimate

Number of profiles

Profiles22 records

Funding overview

Funding rounds1 record

Investors3 records

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 Reset Pharmaceuticals