COMMERCIAL-FOCUSED SPECIALTY PHARMA - PHARMATHER HOLDINGS LTD. PHARMATHER.COM OTCQB: PHRRF | CSE: PHRM
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Commercial-Focused
Specialty Pharma
Corporate Presentation PharmaTher Holdings Ltd.
June 2023 PharmaTher.com
OTCQB: PHRRF | CSE: PHRM
Forward Looking Statements
This presentation of PharmaTher Holdings Ltd. (“PharmaTher”) contains "forward-looking information", which may include, but is not limited
to, statements with respect to anticipated business plans or strategies of PharmaTher, the anticipated date of completion of research
studies, the timing of any drug trials, the success of its clinical trials, the ability to enter into licenses, acquisitions or collaborations to enhance
its drug development platform, the success of any such licenses, acquisitions or collaborations and the ability to use the information relating
to, or obtain patents or other intellectual property protection on, data and clinical trials generated directly by PharmaTher or through such
licenses, 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 certain
actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements involve known
and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of PharmaTher to be
materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Factors
that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the
caption “Risk Factors” in PharmaTher’s management’s discussion and analysis for the three and nine months ended February 28, 2023
("MD&A"), dated April 28, 2023, which is available on the Company's profile at www.sedar.com. Forward-looking statements contained herein
are made as of the date of this presentation and PharmaTher disclaims, other than as required by law, any obligation to update any
forward-looking statements whether as a result of new information, results, future events, circumstances, or if management's estimates or
opinions should change, or otherwise. There can be no assurance that forward-looking statements will prove to be accurate, as actual
results and future events could differ materially from those anticipated in such statements. Accordingly, the reader is cautioned not to place
undue reliance on forward-looking statements.
Commercial Focused
Specialty Pharma
KETARX™ PharmaPatch™
Ketamine Transdermal Delivery
Prefilled
Microneedle Patch
Vial, IV bag, Syringe
Target Markets
+2 Billion
Infectious Diseases
1.5 Billon 700 Million
Pain Mental Health
500 Million 10 Millon
Surgeries / Procedures Neurological
Strategy
KETARX™ Commercialize KETARX™
- FDA and international approvals
- Expand product dosages/concentrations
Commercialize PharmaPatch™
- Partner with Pharma co's and receive equity, licensing,
R&D, milestones, royalties, manufacturing fees
Prefilled Vial, IV bag, Syringe
Not FDA approved. Not for sale.
Pursue favorable regulatory options
PharmaPatch™
- ANDA and 505(b)(2) pathways
- Fast-track and orphan drug designations
Research Partnerhships
- Investigate novel clinical uses in Depression,
PTSD, Pain, Parkinson's, ALS, Rett Syndrome,
Infectious diseases
Microneedle Patch
Expected Milestones Next 12 months FDA approval of KETARX™ via ANDA pathway Commercial sales & global distribution agreements for KETARX™ Revenue-generating partnerships with PharmaPatch™ Study results of KETARX™ Patch Study results of PharmaPatch™ with various drugs Phase 2 study top-line results for Rett Syndrome
About Ketamine 50 years of clinical use with known safety and efficacy FDA approved for anesthesia and procedural sedation NMDA receptor antagonist responsible for anesthetic, analgesic and anti-depressant activity FDA approved delivery methods: IV, injection and intranasal Growing use in mental health, neurological, pain and abuse disorders
Ketamine Portfolio
This is our plan to make our food delivery service exclusive and top-notch.
Dosage Indication Pre-clinical Phase 1 Phase 2 Phase 3 Status
Anesthesia &
IV Sedation
Filing for FDA ANDA Approval
Ketamine
Parkinson's
IV Disease
Preparing for Phase 3 study
Granted FDA Orphan Status
IV Rett Syndrome Awaiting for Phase 2 top-line results
Amyotrophic Granted FDA Orphan Status
IV Lateral Sclerosis FDA IND accepted for Phase 1/2
Patch Mental Health Preparing Phase 1/2 study
Patch Pain Preparing Phase 1/2 study
Current 12 Months
KETARX™ Opportunity
Initial target is anesthesia and sedation
- Expected FDA approval via ANDA pathway in Q1-2024
Target rare indications under 505(b)(2)
regulatory pathway
- Parkinson's disease, Rett Syndrome, ALS, and CRPS
Favorable market dynamics
- Increasing demand (Ketamine on FDA drug shortages list)
- Growing adoption in mental health and pain
- Offering new dosage forms (RTA Prefills, patch, pump)
Not FDA approved. Not for sale. - Expanding pharma interestPharmaPatch™
Microneedle Delivery
Next generation delivery
- Pain-free, easy administration and improves compliance
- Tamper-proof potential to avoid patient misuse, abuse, diversion
Unlocks new indications
- Mental health and pain disorders, infectious diseases
- FDA approvals under 505(b)(2) regulatory pathway
Expands utilization
- Clinics and hospitals use
- Out-patient / Home use becomes a possibilityPharmaPatch™ Portfolio
This is our plan to make our food delivery service exclusive and top-notch.
Drug Indication Pre-clinical Phase 1 Phase 2 Phase 3 Status
Collaboration with Revive
Psilocybin Depression
Therapeutics
Collaboration with Revive
MDMA TBD
Therapeutics
DMT TBD Collaboration with
PharmaDrug
LSD TBD Seeking partner
Undisclosed
PH-010 Infectious Disease
Preclinical studies ongoing
Undisclosed
PH-020 Medical Preclinical studies ongoing
Countermeasure
Current 12 MonthsRegulatory and Patent Portfolio
5
Ketamine
Granted -
-
Amyotrophic lateral sclerosis
Rett Syndrome
- Complex Regional Pain Syndrome
- Status Epilepticus (Seizures)
10
- Ischemia/Reperfusion Injury
Granted Patents, PCTs, Provisional Patents
Delivery Method
Microneedle patch and hydrogel Compositions and methods for
composites for drugs/APIs ketamine in Parkinson’s Disease,
Amyotrophic lateral sclerosis,Strategic Partners
USA Commercializatioin
Rett SyndromeManagement Team and Board
Fabio Chianelli Carmelo Marrelli Dr. Owen Van Cauwenberghe
Founder, Chairman, CEO Chief Financial Officer VP, Pharmaceutical Development
Founder, CEO, President at CFO of TSX, CSE, OTCQB Director, Research, Eli Lilly CAD
Revive Therapeutics Ltd. listed companies Director, Pharma R&D, Accucaps
Dr. Bev Incledon Christian Scovenna Carlo Sansalone
Director Director
Director
Entrepreneur and investor Investor, Biotech. Real estate
EVP, CSO, Ironshore Pharma
25 years drug developmentFinancial Snapshot
PHRRF 88,169,065
Issued & Outstanding Common Shares
~ $7.5 million 5,749,000
Cash and investment Stock options outstanding
~ 19% 16,875,000
Insiders Ownership Warrants outstanding
16,875,000 @ $0.80 (expires Sept 2026)
* As of latest financials posted on April 28, 2023 at SedarYou can also read
