A new dimension in addiction treatment - Entheon Biomedical
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A new dimension in addiction treatment
Corporate Presentation
Inverting the
expectations for
addiction therapy
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2
Corporate Presentation
Current Treatment Options
are not Sufficient
Core issues of addiction are not being adequately addressed.
Current models demonstrate low-efficacy, high unpredictability,
and a prohibitive cost structure.
Alcohol Opiates Smoking
§ 88,000 deaths/annually (3rd § Globally, 10% of people in § 480,000 deaths each year in America,
leading preventable cause need of treatment receive it linked to smoking
of death in the US) § 2.1 million Americans with § Success rate of current smoking
§ 2018: 14.4 million adults an opioid use disorder cessation interventions is less than 10%
with alcohol use disorder § Globally, 13.2 million suffer § 2018: 34.2 million adults in the United
§ 2015: only 4.4% with from opioid addiction States smoked cigarettes, while 16
alcoholism received million Americans live with a smoking-
treatment related disease
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Corporate Presentation
Substance-Use
Disorder, many
challenges
A complex diagnosis where the removal of the
harmful substance does not guarantee long term
abstinence.
The root of substance use disorder is thought to
be psychological and emotional in nature.
Solutions must be targeted at the psychological
and emotional causes.
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Corporate Presentation
DMN
Default Mode Network
Beliefs
Values
Ethics
Reactions Our responses
are controlled by
Habits engrained patterns
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What is DMT? Corporate Presentation
DMT is the Most Powerful of the Classic
Psychedelics
DMT is one of the classic
§ Safe in humans - Ideal molecular candidate for
medical use psychedelics, along with
§ Manufactured by the human body mescaline, LSD, and
§ Used therapeutically for hundreds of years psilocybin. All are serotonin
§ Short acting 5-HT2A receptor agonists
§ Present throughout the plant kingdom (serotonergic
§ Used therapeutically for hundreds of years hallucinogens) and share
§ Scientifically studied from at least the 1950s similar effects.
onward
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The Mechanism Corporate Presentation
of DMT
Well-positioned for Therapeutic
Advancement
Endogenous DMT is serotonergic modulator; its Modern DMT Research
biosynthesis and metabolism are well- Barker, S. A. N, N-dimethyltryptamine (DMT), an endogenous
understood, and multiple receptor targets hallucinogen: Past, present, and future research to determine its role and
have been identified. function. Front. Neurosci. 12, 1–17 (2018).
Frecska, E., Szabo, A., Winkelman, M. J., Luna, L. E. & Mckenna, D. J. A
Synaptic plasticity possibly sigma-1 receptor mediated role of dimethyltryptamine in tissue
protection , regeneration , and immunity. J Neural Transm 120, 1295–
1303 (2013).
Induction of unique brain activity
Timmermann, C. et al. Neural correlates of the DMT experience assessed
with multivariate EEG. Sci. Rep. 9, 1–13 (2019).
Disrupt the DMN
Carhart-Harris, R. L. et al. The entropic brain: A theory of conscious
states informed by neuroimaging research with psychedelic drugs. Front.
Hum. Neurosci. 8, 1–22 (2014).
Barker, S. A. N, N-dimethyltryptamine (DMT), an endogenous
hallucinogen: Past, present, and future research to determine its role and
function. Front. Neurosci. 12, 1–17 (2018).
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Corporate Presentation
DMT – Safe & Well-tolerated
Select studies demonstrating the safety
A long history of use
and efficacy of DMT & ayahuasca
§ The psychoactive in ayahuasca, a DMT safe in humans - Dose response and safety data – Dr. Rick Strassman
Strassman, R. J., Qualls, C. R. & Berg, L. M. Differential tolerance to biological and subjective
traditional hallucinogenic tea, used for effects of four closely spaced doses of N,N-Dimethyltryptamine in humans. Biol. Psychiatry 39,
hundreds of years by indigenous 784–795 (1996).
groups to treat “diseases of despair”.
Positive effect of Ayahuasca on treatment-resistant depression and substance-use disorders
Palhano-Fontes, F. et al. Rapid antidepressant effects of the psychedelic ayahuasca in treatment-
§ Uncontrolled and controlled studies in resistant depression: A randomized placebo-controlled trial. Psychol. Med. 49, 655–663 (2019).
healthy volunteers reported
administration of single ayahuasca Exploring ayahuasca assisted therapy for addiction: A qualitative analysis of preliminary
findings among an indigenous community in Canada. Argento, E., Capler, R., Thomas, G., Lucas,
doses were well tolerated, leading to P. & Tupper, K. W. Drug Alcohol Rev. 38, 781-789 (2019).
positive therapeutic effects.
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Corporate Presentation
DMT
The Default Mode Network disrupting molecule
Standard
Brain
Activity
DMT
Brain
Activity
N,N-Dimethyltryptamine (DMT)
an introspective psychedelic compound
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Corporate Presentation
DMT
The Psychedelic Experience
Although the DMT state is highly subjective many
experiencers report common phenomenon
§ Unusually vivid visual imagery and somatic effects
§ A sense of entering an entirely ‘other’ but no less
‘real’ world or dimension
§ Like a dream state but with full conscious
awareness
§ A wide and powerful range of emotions
§ Deep clarity and insight into one's life and
relationships
10DMT
Corporate Presentation
Perspectives
& possibilities
Trigger Response DMT
Dismantles deeply held
beliefs
Provides breakthrough
clarity
Gravitational pull to the
positive / constructive
Trigger Response
11Corporate Presentation
ENTHEON'S DMT
PROTOCOL
Control
Rapid onset
Dose modulation
Tailored experience
Off switch
Safety
12Therapeutic breakthrough Corporate Presentation
From realization to reality
1 Context and intent 2 DMT infusion 3 Integration
ED
ST
60-90
ES EW
SI
MINUTES ONGOING
IV N
AS
TRUST SUPPORT
CT EN
BELIEFS
N
PE TH
IA
MI
RS NG
IC
EX ND
PE TRE
YS
FEARS PE AL
RI TE
S
PH
EN RI
TRAUMA CE NG
CON
PAST ENV TROLL FUTURE
IRO E
VALUES NME D ORIENTED
NT
13Advancing our Corporate Presentation
DMT protocol
The Centre for Human Drug Research (CHDR) to carry out a data-intensive study to evaluate
the pharmacodynamics, pharmacokinetics and safety of a target-controlled intravenous
infusion of DMT in humans.
Clinical Trial - Estimated Milestones
2021 Q1 § Completion of Investigational Medicinal Product Dossier (IMPD)
§ Full clinical protocol completed in preparation for upcoming human trials at CHDR
§ Introductory meeting with Health Canada
Q2 § Introductory meeting with FDA
§ Drug formulation development; analytical method development; drug stability assays by CHDR
§ Finalize IMPD, Investigator’s Brochure
Q4 § First patient recruitment
§ Clinical study to begin at CHDR
2022 Q1 § End of study – last subject, last visit
§ First draft clinical report
14Corporate Presentation
Indications
Initial Target Indications Potential Indications
Nicotine cessation Behavioural addictions (e.g., food,
gambling, sex)
Opioid-use disorder
Additional substance-use disorders &
Alcoholism mental illnesses
15Clinical trial Corporate Presentation
timeline
Proof of Concept Human Study (Phase 1/2a equivalent) Alcohol and Opiate Addiction Pilot Studies
Location: Centre for Human Drug Research, Leiden, Netherlands (Phase 1/2a)
Timeline: 2020 Q4 – 2021 Q4 (projected) Location: Centre for Human Drug Research, Leiden, Netherlands
Objectives: Pharmacokinetic and pharmacodynamic assessment of DMT Timeline: 2022-2023
fumarate (GMP formulation) in otherwise healthy adult nicotine users. Objective: Translation of DMT therapeutic protocol to other forms of
Establish optimal dose range and duration for therapeutic efficacy, addiction.
including minimally effective and maximally tolerated doses.
Nicotine Addiction Multicenter Study (Phase 2b/3)
Nonclinical Studies (if required) Location: Worldwide clinics (under license)
Location: University of British Columbia or CRO Timeline: 2023-2024
Timeline: 2020 Q3 – 2021 Q4 (concurrent with proof-of-concept study) Objective: Expansion of pilot study to multiple clinics to assess
Objective: To obtain safety and toxicity data for DMT in various in vitro treatment outcomes in larger populations of nicotine users,
and animal models. including specific indications (e.g., COPD).
Nicotine Addiction Pilot Study in US (Phase 1/2a)
Location: Johns Hopkins University or similar US institution
Timeline: Projected start 2022
Objective: Demonstrate safety and efficacy of DMT (fumerate, GMP
formulation) administered via continuous intravenous infusion at doses
and duration determined in proof-of-concept study.
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16Corporate Presentation
Partnership,
acquisition
and Investment
Strategy
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17THE Psychedelic Corporate Presentation
Corporate Presentation
patient journey is
not an isolated
event
From physician assessment, to analysis of the psychedelic experience, as
well as post therapy tracking and support, Entheon is developing tools to
support all stages of the patient’s journey.
Increased safety
Precise dosing
Optimized outcomes
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18Corporate Presentation
DMT Drug Supplier
Contracted to manufacture GMP and non-GMP dimethyltryptamine (DMT) drug product for use
in upcoming clinical trials.
§ Psygen Labs Inc., a Calgary-based company specializing in the synthetic manufacture of psychedelic
medicines, with a focus on psilocybin, MDMA, DMT, LSD, 2C-B, and mescaline.
§ Construction is currently underway for Psygen's new 6000sq/ft lab capable of large-scale synthesis and
formulation.
19Corporate Presentation
Centre for Human Drug Research (CHDR)
Contract Research Organization (CRO)
§ The Centre for Human Drug Research (CHDR) is an independent, world-renowned, CRO that specializes in
cutting-edge technology & early-stage clinical drug research.
§ Entheon has contracted CHDR to carry out a study to evaluate the pharmacodynamics, pharmacokinetics
and safety of a target-controlled intravenous infusion of N,N-dimethyltryptamine (DMT) in humans. The
study is expected to take place in Q4 2021.
20Corporate Presentation
Investment into Heading Health, LLC
Participated in a Series A Preferred Stock Financing
§ Provides exposure to the ketamine-assisted therapy space and Heading’s full-suite of therapies and
diagnostic tools for the treatment of mental health disorders, including the fully regulated and
insurable Spravato® (esketamine) nasal spray for treatment-resistant depression.
§ Led by Dr. Steven Levine, experienced in operating and scaling psychiatric clinics, securing insurance
coverage and pioneering the most efficient and effective breakthroughs in clinical research and
technologies.
§ Provides guidance regarding clinical practice and, the permissioned use of data and biomarker capture
devices both in general psychiatric practice and Ketamine treatments.
21Corporate Presentation
Partnership & SOW with
Divergence Neuro Technologies Inc.
Co-development of technologically advanced predictive platform
that will be used to inform, modify, and optimize psychedelic-
assisted therapy.
§ Divergence is focused on the research and development of a data-driven,
cloud-based neuro platform based on EEG analysis, AI and machine
learning.
§ Research and develop a Biomarker Model and software platform to serve
as a predictive model to better inform and guide psychedelic therapies.
22Corporate Presentation
HaluGen Life Sciences Inc. Acquisition
A wholly owned subsidiary of Entheon, HaluGen is a biotech
company that is developing and commercializing a pre-screening test
to identify genetic markers in order to predict an individual's reaction
to hallucinogenic drugs.
§ Provides an essential and added layer of safety and predictability.
§ Genetic, personal and familial insights to better inform the psychedelic
experience, with the goal of improving patient care and reducing side
effects and risk of psychedelic assisted therapy.
23Corporate Presentation
A patient-centric &
Personalized system of
Psychedelic Medicine
Preparation Intra Experience Post-therapy
Analysis of experience
Clinical tools to optimize Alerts and feedback for and on-going change
prescriptive decisions physicians & clinicians over time
§ Genetic biomarkers based on real-time Long-term patient
§ EEG biomarkers analysis of EEG tracking and future
therapy optimization
24Our Team
Corporate Presentation
Andrew Hegle Brandon Schwabe Christopher Gondi Ruth Chun
Timothy Ko Yaron Eshel
Ph.D., M.Sc. CPA, CGA Ph.D., M.Sc. M.A., J.D.
CHIEF EXECUTIVE DIRECTOR OF
CHIEF FINANCIAL PROJECT MANAGER BOARD MEMBER BOARD MEMBER
OFFICER OPERATIONS, CSO
OFFICER
Broad background of Adjunct professor of A decade of professional Led clinical trials and Depts. Of Medicine, Surgery Corporate commercial
leading private Pharmacology at the experience in finance and worked with CRO’s all over and Pathology at the lawyer focused on
ventures in different University of British accounting the world University of Illinois advising regulated
sectors Columbia businesses
25Advised by a world-renowned Corporate Presentation
Scientific advisory board
Underscores the scientific enthusiasm for DMT
Matthew W. Robin-Carhart Dennis Christopher Malin Vedøy Kenneth Dr. Michael
Johnson Harris McKenna Timmerman Uthaug Tupper Walker
Ph.D., M.Sc. Ph.D. Ph.D. Ph.D. Ph.D. Ph.D.
Professor of Head, The Ethno- Lead Researcher, The Research Assist., Director, Substance Use Prof. Emeritus
Psychiatry and Psychedelic Research pharmacologist, Psychedelic Research Centre for Psychedelic Prevention & Harm Anesthesiology,
Behavioral Sciences, Group, Imperial research Group, Imperial College Research, Imperial Reduction, BC Ministry Pharmacology and
Johns Hopkins College London pharmacognosist, London College of London of Health Therapeutics, UBC
lecturer and author
26C A P I TA L S T R U C T U R E
Corporate Presentation
Financials
Nov. 12, 2020
Commenced trading
on the CSE
CSE: ENBI Outstanding Shares 52,320,271
FSE: 1XU1 Fully diluted 55,638,185
OTC: ENTBF Current Cash Position 5.7 M CAD
Average daily volume (as of 1/22/2021) 701,903
27Thank Connect with us
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