a clinical-stage psychedelics biotech company
TRANSCRIPT
PharmaTher Holdings Ltd.
OTCQB: PHRRF | CSE: PHRM
Corporate Presentation
April 2022
This presentation of PharmaTher Holdings Ltd. (“PharmaTher”) contains "forward-looking information", which may include, but is not limitedto, statements with respect to anticipated business plans or strategies of PharmaTher, the anticipated date of completion of researchstudies, the timing of any drug trials, the success of its clinical trials, the ability to enter into licenses, acquisitions or collaborations to enhanceits drug development platform, the success of any such licenses, acquisitions or collaborations and the ability to use the information relatingto, or obtain patents or other intellectual property protection on, data and clinical trials generated directly by PharmaTher or through suchlicenses, acquisitions or collaborations, and the success or stage of development of discoveries or medicines. Often, but not always,forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates","forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certainactions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements involve knownand unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of PharmaTher to bematerially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factorsthat could cause actual results to differ materially from those anticipated in these forward-looking statements are described under thecaption “Risk Factors” in PharmaTher’s management’s discussion and analysis for the period of November 30, 2021 (“MD&A”), dated January27, 2022, which is available on PharmaTher’s profile at www.sedar.com. Forward-looking statements contained herein are made as of thedate of this presentation and PharmaTher disclaims, other than as required by law, any obligation to update any forward-lookingstatements whether as a result of new information, results, future events, circumstances, or if management's estimates or opinions shouldchange, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and futureevents could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place undue reliance onforward-looking statements.
Forward Looking Statements
COMMERCIALIZE novelKETAMINE solutions
Focus
UNLOCK potential ofKETAMINE
Purpose
EXPAND adoption ofKETAMINE
Grow
KetamineMicroneedle PatchKetamine
IV / Injection
Repurpose
Delivery
Formulations
Mental Health
Neurological
Pain
Surgery
About Us
KETARX™
Procedures
Partnerships
About Ketamine
50 years of clincal use
FDA approved for anesthesia andprocedural sedation
Commonly delivered by intravenous,intramuscular injection, intranasal
NMDA receptor antagonistresponsible for anesthetic, analgesicand anti-depressant activity
Global Opportunity
Anesthesia / SedationSurgeries - General, Emergency, Pediatric
Procedures - MRI, Dental, Endoscopy, Biopsies, Cosmetic
Mental HealthDepression, Suicidal ideation,
Substance abuse, PTSD, Bipolar, OCD
PainNeuropathic, CRPS, Fibromyalgia, Cancer,
various chronic/acute conditions
Neurological DisordersParkinson's disease, ALS, Seizures
500 M
1.5 B 700 M
10 M
- Various dosage/delivery forms- Partner with pharma, clinics, hospitals, HCPs
Commercialize KETARX™
- Depression, Pain, Parkinson's disease, ALS, Seizures, Procedures
Expand clinical uses
- ANDA and FDA 505(b)(2)- Patent protection, FDA orphan drug designation
Obtain regulatory approvals
- Microneedle patch for all type of drugsCollaborations
KetamineMicroneedle Patch
KetamineIV / Injection
KETARX™
Strategy
Not FDA approved. Not for sale.
Additional Expected Milestones Clinical and product development updates Patents and exclusive regulatory designations Collaborations and commercial licensing
Expected Q2-2022Follow-on study results with ketamine forParkinson's disease
Study results - microneedle patch Ketamine
MDMA
DMT
MilestonesExpected H2-2022
Submit FDA application of KETARX™ IV /Injection via ANDA regulatory pathway
FDA acceptance for Phase 3 study withKETARX™ IV for Parkinson’s disease
FDA/EU acceptance for Phase 2 studywith KETARX™ Patch for depression/pain
Study results - KETABET™ (ketamine+betaine) Pain
Depression
KETARX™ IV
KETARX™ IV
Indication Pre-Clinical Phase 1 Phase 2 Phase 3Product
This is our plan to make our food delivery service exclusive and top-notch.
AmyotrophicLateral Sclerosis
Anesthesia &Sedation
Parkinson'sDisease
Current 12 Months
KETARX™ IV
KETARX™ MN Patch Depression
KETARX™ MN Patch
*Complex Regional Pain Syndrome; FDA ODD for ketamine only, not with MN patch
PHARMAPATCH™ Partnerships
Seek ANDA Approval
Granted FDA OrphanDrug Designation
Granted FDA OrphanDrug Designation
IV – Intravenous / InjectionMN - Microneedle
Pain*
Product Pipeline
KETARX™ IV / Injection
- Obtain FDA approval via ANDA pathway in 2022 - Off-label use for mental illness and pain
Initial target is anesthesia/sedation
- Clinical studies in Parkinson's disease, ALS- Seek FDA approval via 505(b)(2) regulatory pathway
Expand to neurological disorders
- Ketamine IV is regularly on the FDA drug shortages list- Near-term revenue and partnerships opportunities- Establishes footprint for new ketamine products
Position for growth
Not FDA approved. Not for sale.
KETARX™ Patch
- Offers a safe and improved efficacy over other dosage forms - Pain-free, easy administration and improves compliance- Deliver ketamine from 10 minutes up to 30 days- Tamper-proof: avoid patient misuse, abuse, diversion
Next generation ketamine product
- Mental health, neurological and pain disorders- FDA approvals via 505(b)(2) regulatory pathway
Unlocks new indications
- Ketamine clinics and hospitals use (alternative to IV/injection)- Out-patient / Home use becomes a possibility
Significantly expands utilizationKetamine'Hydrogel'
Microneedle PatchNot FDA approved. Not for sale.
How KETARX™ Patch Works?
Ketamine inreservoir
Ketamine diffusesthrough the swollen
microneedles
Ketamine-loadedreservoir is
completely dissolved
Insterstitial fluidsoaks into
microneedle
Ketamine diffuses through theswollen microneedles and
facilitates permeation into thedermal microcirculation
PHARMAPATCH™ Technology
- Drug combinations, controlled and rapid delivery- Control PK profile & drug load (high/low)- Avoid first-pass metabolism, higher bioavailability
Different dosing / delivery options
- Pain-free, patient compliance, safety and usability- Allow for treatment at home
Patient improvement
- Controlled-substances (psychedelics), small and large molecule drugs, biologics, etc
Partnering opportunities
Relationships Collaborations
Licenses
Granted Patents, PCTs, Provisional PatentsDeliveryMicroneedle patchand hydrogelcomposites fordrugs/APIs
RepurposeCompositions andmethods for ketaminein Parkinson’s Disease,Amyotrophic lateralsclerosis
FormulationMethod andcomposition fordecreasing sideeffects and addictivedisorder of ketamine
Regulatory and Patent Portfolio
Ketamine- Amyotrophic lateral sclerosis- Complex Regional Pain Syndrome - Status Epilepticus (Seizures)
3 Granted
20 ProcessManufacturing processfor ketamine solution
Team
Fabio Chianelli
Founder, CEO, President atRevive Therapeutics Ltd.
Founder, Chairman, CEO
Carmelo Marrelli
CFO of TSX, CSE, OTCQBlisted companies
Chief Financial Officer
Dr. Owen Van Cauwenberghe
Director, Research at Eli Lilly CADDirector, Pharma R&D at Accucaps
VP, Pharmaceutical Development
Dr. Maurizio Fava, MD
Psychiatrist-in-Chief, MGHDirector Clinical , MGH
Clinical Advisor, Depression
Professor Ryan Donnelly
Chair of PharmaceuticalTechnology, QU Belfast
Technical Advisor, MN patch
Dr. Robert A. Hauser, MD
Director, USF Parkinson'sDisease and MD Center
Clinical Advisor, Parkinson's
Fabio Chianelli
Founder, CEO, President atRevive Therapeutics Ltd.
Founder, Chairman, CEO
Dr. Bev Incledon
EVP, CSO, Ironshore Pharma25 years drug development
Director
Entrepreneur and investor
Christian ScovennaDirector
Investor, Biotech/Real estate
Carlo SansaloneDirector
Management Advisors Board of Directors
88,169,065**Issued & Outstanding Common Shares
4,749,000**Stock options outstanding
16,908,000**Warrants outstanding
Financial Snapshot
* As at November 30, 2021** As of March 31, 2022
~ $14 million* Cash and investments
~ 19%* Insiders Ownership
PHRRF
3,499,000 @ $0.10 (expires July 2025)1,000,000 @ $0.18 (expires March 2027)250,000 @ $0.91 (expires Sept 2026)
16,875,000 @ $0.80 (expires Sept 2026)33,000 @ $0.10 (expires July 2022)