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The Emergence of New Chemical Cannabinoid Treatments
piketx.com
This presentation, any supplemental information or documents provided herewith and any attendant oral commentary (collectively, this “Presentation”) (i) have been prepared for discussion purposes by Pike Therapeutics (“Pike”), (ii) are intended solely for use by Pike in connection with the Company’s financial presentation dated as of the date hereof and (iii) should not be used, considered or relied upon for any other purpose or in connection with any other matter. With respect to any investment in the Company you should only rely on the materials presented in connection with such investment (the “Definitive Agreement”) and not on this Presentation. This Presentation will not be deemed to constitute financial advice or an offering of securities. This Presentation is confidential and proprietary and, without the prior written consent of Pike, may not be reproduced, disseminated, quoted from or referred to, in whole or in part, at any time, in any manner or for any purpose. If you are not the intended recipient of this Presentation, please immediately delete and destroy all copies in your possession.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and
potential opportunities for Pike, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Pike. Any forward-looking statements which we make in this Presentation, represent our views only as of today. We disclaim any duty to update any such information. In addition, market data, such as but not limited to, our revenue potential or the size of a generic drug market is derived from third-party sources, and we have not verified the accuracy of such data.
DisclaimerCONFIDENTIAL 2
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PHYTO CANNABINOIDS: Found in cannabis and hemp plants
ENDOCANNABINOIDS: Cannabinoids that are body produced
SYNTHETIC CANNABINOIDS: Pharmaceutically manufactured or biosynthesized
THC (TETRAHYDROCANNABINOL): THC is the main psychoactive compound in marijuana that gives the high sensation. It is known to modulate the brain’s response to pain (block pain).
CINV: Chemotherapy-induced nausea and vomiting (CINV) is a common (and most feared) side-effect of many cancer treatments.
DRONABINOL: Dronabinol (synthetic THC) is one of the only two synthetic, pharmaceutical grade, THC products approved by the United States food and Drug Administration (FDA). It is orally delivered (capsule & liquid).
HEC: Chemotherapy regimens that are linked to a high incidence (90%or higher) of CINV are referred to as Highly Emetogenic Chemotherapy (HEC).
PIKE’S TRANSDERMAL DELIVERY: Combining sophisticated drug reformulation and a PROVEN transdermal delivery technology to develop a unique path delivery system that is modern, has well controlled efficacy and is safe to use.
Terms to KnowCONFIDENTIAL 3
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Pike Therapeutics is a biotechnology company focused on developing FDA approved treatments for unmet medical needs, by formulating SYNTHETIC cannabinoids in combination with a superior, proprietary delivery platform (patch).
» Synthetic cannabinoids are the exact same molecules as the cannabinoids obtained from plants, BUT, are chemically produced to ensure a lower cost, consistent and scalable pharma strategy compared to using plants.
» Our superior patch technology delivers synthetic cannabinoids through the skin to improve efficacy and/or reduce side effects compared to oral routes.
Our goal is to develop a robust delivery platform of synthetic cannabinoid treatments designed to address significant unmet medical needs.
Pike was initially formed as a spinout from Starton Therapeutics. Pike is using the same underlying platform strategy as Starton, but specific to synthetic, reformulated cannabinoids.
Pike Therapeutics: Who We Are
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Pike Therapeutics: Who We Are
Pike Uses Synthetic Versus Plant Based Cannabinoids
» Pike focuses on chemically synthetic cannabinoids for drug development
» Use of chemical cannabinoids is cost effective, scalable for manufacturing, and provides consistency, and, allows us to boost their efficacy through reformulation.
» The FDA has approved TWO pharmaceutical grade THC products. Pike will use one of those, Dronabinol.
Delivery Advantages
» reformulating chemical cannabinoids for transdermal versus oral (capsule and liquid) delivery can improve efficacy, offer fewer side effects, increase tolerability, higher patient compliance, and provides a consistent delivery into bloodstream.
» Our enhanced patch delivery system targets quick onset and avoids high CMAX and periods of subtherapeutic blood levels (see chart on the following slide, note Optimal Effectiveness).
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Benefits of Enhanced Transdermal Delivery
Higher and improved blood level control for use in chronic
conditions
Ability to achieve high initial blood level to treat acute conditions
Unique ability to treat conditions requiring acute and chronic
treatment
OptimalE�ectiveness
MinimalE�ectiveness
SideE�ects
BreakthroughSymptoms
Up to 7 Days24 Hours
Pike Transdermal Delivery Classic Transdermal Delivery IV or Oral Delivery
OptimalE�ectiveness
MinimalE�ectiveness
SideE�ects
BreakthroughSymptoms
Up to 7 Days24 Hours
Pike Transdermal Delivery Classic Transdermal Delivery IV or Oral Delivery
Blood Concentration with Optimal Delivery
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Pike Therapeutics: Our Difference
FDA Approval Focus
» The FDA has stated medical claims for CBD cannot be made unless approved via clinical trials. They also have concerns about liver toxicity, and extreme lethargy side effects.
» Our synthetic CBD indications address these FDA concerns, as our delivery approach bypasses first pass metabolism, the GI tract and liver.
» An FDA approved transdermal treatment for a medical need would allow for medical claims, patient reimbursement, and physician supervision.
Clinical Pathway
» we are using a 505 (b)2 pathway for our anchor Dronabinol CINV treatment
» this pathway offers a low risk, fast to market, and limited capital needs strategy. It allows for accelerated development by referencing work done on an already approved drug (Dronabinol, aka synthetic THC).
» Our target is to achieve a Phase 3 registered trial in twenty-four months.
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Transdermally Reformulated Dronabinol for CINV
» Dronabinol has been approved by the FDA since 1985 and is used to reduce chemo induced nausea/vomiting (CINV), chemotherapy’s most feared and debillitating side effects.
» Dronabinol is approved as a “rescue drug” for CINV patients with breakthrough symptoms. Breakthrough means, the standard of care drugs are not working. There are approximately 1.6 million patients undergoing chemotherapy in the United States annually, and approximately 50% are estimated to experience breakthrough symptoms.
» Thus 800,000 potential patients and a significant unmet medical need.
Pike Therapeutics: Our Pipeline
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Pike’s transdermal dronabinol is designed to greatly improve the patient’s quality of life.
% of patients with Complete Response (CR)(based on current National Comprehensive Cancer Network
recommended standard of care)
13%
37%
87%
63%
Acute Phase (Day 1)
Delayed Phase(Day 2)
Lack of CompleteResponse
Complete Response(no vomiting, no rescue medication)
Patients undergochemotherapy
each year
1.6mChemotherapy patients
treated withHEC regimens1
35%HEC prescribers
adherent toNCCN guidelines2
<34%
1. Symphony Health 2017 2. Daniel and Waddell. J Oncol Pharm Practice.
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2.High
Absorption Variability
150-200% Variability2
For the same dosage, patients experience zero to unpredictable
psychotropic effects3
3.Slowtime To Onset
<25% Detectable Plasma Concentration 1
(after 15 minutes)
1 – 12 hours to Cmax (peak blood concentration)
(in healthy individuals)
1.Poor
Bioavailability
80-90% Waste(still contributes to side effects)
10-20% Bioavailable1
1. Parikh et al. Clin Pharmacol. 2016 2. Klumpers et al. Br J Clin Pharmacol. 2012 3. Issa et al. 2014 Clin J Pain
THE PROBLEM: The currently available oral Dronabinol treatment (oral) has significant drawbacks which can limit effectiveness, tolerability, and use.
ORAL DRONABINOL IS AN INEFFICIENT DELIVERY METHOD.
Pike Therapeutics: Our Pipeline
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THE SOLUTION: Pike’s unique transdermal Dronabinol formulation and delivery is designed to eliminate these drawbacks and offer a superior treatment that could obtain significant market share in the breakthrough population and could potentially expand beyond breakthrough use into broader CINV standard of care.
We will improve Dronabinol through proprietary reformulation and transdermal delivery
Pike Therapeutics: Our Pipeline
Oral Dronabinol Pike Reformulated Transdermal Dronabinol
• Increased compliance and convenience
3-4 DAILYDOSAGES
MULTI-DAY (5 DAY)*PATCH
• Proprietary techniques to accelerate time to onset
• Provides rapid relief to patients suffering from nausea and vomiting
SLOWTIME TO ONSET
ACCELERATEDTIME TO ONSET
HIGHVARIABILITY
STEADY STATEDELIVERY
* Being developed
• Direct to blood stream = 4-5x more bioavailable
• Avoids gastrointestinal tract (bypasses first-pass metabolism)
• Increased and consistent efficacy
• Improve side effect profile
10 -20%BIOAVAILABILITY
40-100%BIOAVAILABILITY
• Eliminates peak-trough variability, high Cmax, and periods below the minimum efficacious dose
• Avoids side effects related to over absorption of oral dose
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Our Road Map: Low Risk, Low Cost, Fast to Market
» Pike is pursing the FDA 505 (b)2 pathway for the approval of our lead treatment.
» Pike would leverage an FDA approval for transdermal Dronabinol CINV for additional EU and FDA approvals
» Quickly apply for approval in EU countries where Dronabinol is already approved
» Pursue another FDA approved indication via a supplemental NDA (sNDA)
Pike Therapeutics: Our Pipeline
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Transdermal Dronabinol has high potential in the therapeutics market – CINV will be the initial market we target
Other potential Indications
$650MUS market size for enhanced
transdermal dronabinol opportunity*
$1.7BGlobal CINV Market: 2015
$2.7BEstimated Global CINV
Market: 2022
$150MDronabinol sales in
the U.S 2015
$79.5BEstimated global pain
manage-ment therapeutics market revenue: 20241
100MAmericans suffering from
chronic pain2
20M+Patients prescribed opioid
painkillers3
* Source: Top Tier Pharma Consultant 1. Zion Market Research, Sep 2018 2. Study by the Institute of Medicine of the National Academies 3. Skolnick; Ann Rev Pharm Tox2018
Pike Therapeutics: Market Opportunity
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Transdermal Synthetic CBD for Treatment Resistant Epilepsy
» Condition where seizures persist despite multiple anti-epileptic drugs (AEDs)
» Orally delivered, plant derived CBD has been given FDA approval as an epileptic seizure treatment associated with Dravet Syndrome and Lennox-Gastaut Syndrome.
» A significant unmet need in Treatment Resistant Epilepsy exists.
» There are approximately 15-20 thousand patients with Dravet Syndrome, 30-50 thousand with Lennox-Gastaut syndrome, 40-50 thousand with Tuberous sclerosis complex, 160 thousand with Treatment Resistance Pediatric Epilepsy, and 1 million patients with Treatment Resistant Epilepsy.
Pike Therapeutics: Our Pipeline Treatment 2
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The Solution
» Pike’s unique transdermal synthetic CBD formulation and delivery is designed to eliminate these potential side effects and offer a superior treatment.
» Our transdermal delivery will bypass first pass metabolism, GI tract, and liver, and in addition, with a consistent and constant transdermal CBD delivery, could avoid high CBD blood concentrations which could assist in avoid lethargy and extreme sleepiness.
Pike Therapeutics: Our Pipeline Treatment 2
The Problem:
The Problem: The current FDA approved oral CBD treatment is effective however, it is prescribed along with potential side effects and warnings.
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Pike Therapeutics: Our Pipeline Treatment 2
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Indication Pre-Clinical & Formulation Phase I Phase II
CommencePhase III
Q2/22NDA FDA Approval
Pike – CINV* 505 (b)2 Pathway
Pike – TRE ** Pre-clinical Investigation
Pike – UDC***
*Breakthrough Chemo Induced Nausea and Vomiting **Dravet’s Syndrome and Lennox-Gastaut (Epileptic Indications) ***Undisclosed
Pike Therapeutics: Our Pipeline
TARGET
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Our PartnersPike has an experienced R & D partner in both reformulation and transdermal delivery
Transdermal Research Pharm Laboratories, LLC (TRPL)
State of the art research & development facility in Long
Island City, NY.
Schedule-1 licensed by FDA, DEA, and NY State to work with controlled substances.
Focused on developing Transdermal Drug Delivery
Systems (TDDS) for new chemical entities and
approved drug products.
Scientific staff of 70+ years of experience in developing
formulations for TDDS.
Advanced 3 TDDS into Phase 1 clinical trials and GMP manufacturing in past
4 years.
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Appendix
CONFIDENTIAL 19
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Pike Therapeutics: News of Note “The all cash-acquisition for €225.9 million (CDN $342.9 million) furthers Canopy Growth’s expansion
into European markets with prescription medicines and gives the Company immediate access to a wealth of knowledge and intellectual property that C3 has developed in its nearly 20 years of research and development into synthetic and natural cannabis medical products.”
“C3’s primary medicinal offering is dronabinol, a pure chemical compound with standardized concentrations of tetrahydrocannabinol (THC), one of the active ingredients found in cannabis plants that is responsible for various pharmacological effects. Dronabinol is available in Austria, Denmark, and Germany for nausea and vomiting refractory to conventional treatment in oncology and palliative care, and for cancer pain. In Germany, dronabinol can be prescribed for any type of chronic pain and for any condition in palliative care. C3 has a total of five medicines in the market and its commercial operations generated €27.1 million (CDN $41.5 million) in 2018.”
“We are committed to changing the conversation around cannabis-based therapeutics in Canada and around the world,” said Dr. Mark Ware, Chief Medical Officer, Canopy Growth. “To do that, we need a diverse toolbox of therapies that can be used by physicians who see the potential of the complete spectrum of cannabinoid-based medicines. Welcoming C3 into our portfolio will help us put those tools in the hands of physicians and their patients in Germany and elsewhere across Europe.”
Canopy Growth Corp. strategically acquires a German dronabinol manufacturing facility. The $343M move helps the company excel into the the European pharmaceutical cannabinoid space.
Canopy Growth Corporation, May 02, 2019
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Pike Therapeutics: News of Note
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Brad MilesChairman and CEO
Twenty-five years plus in capital markets and investment management, and senior advisory roles in the biotech and
cannabinoid sectors, with companies including Scotia Capital Markets and Opiant Pharmaceuticals, where he played a key
role bringing NARCAN Nasal Spray to market. He is currently President of LYL Holdings, where he leads investment analysis
and drug royalties and special situations.
Ian Fodie - CAChief Financial Officer
Mr. Fodie graduated from the University of Otago, New Zealand, with a Bachelor of Commerce degree, obtained his
professional designation from the New Zealand Institute of Chartered Accountants and has resided in Canada for
thirty years. Most recently, he was appointed CFO of Rapid Dose Therapeutics Corp., a Canadian leader in drug delivery solutions. Prior, Mr Fodie acted as the CFO of Green Growth
Brands Limited. His experience also includes CFO of First Bauxite Corporation and Lithium Americas Corp., C-Suite at Oriental Metals (now Almonty Industries) and CFO of
Longview Capital Partners Inc (now Resinco Capital Partners Inc.).
Pike Therapeutics: Our Team
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Pike Therapeutics: Board of Directors
Brad MilesTwenty-five years plus in cap-ital markets and investment management, and senior ad-
visory roles in the biotech and cannabinoid sectors, with com-panies including Scotia Capital Markets and Opiant Pharma-
ceuticals, where he played a key role bringing NARCAN Nasal
Spray to market. He is current-ly President of LYL Holdings,
where he leads investment analysis and drug royalties and
special situations.
Zach Stadnyk Independent Director
Mr. Stadnyk is the CEO and founder of DC Acquisition
Corp., a Capital Pool Company. Mr. Stadnyk is a corporate fi-
nance and advisory profession-al. He has held various senior
positions in companies, includ-ing Supreme Cannabis Com-pany, Code Cannabis Invest-
ments, FSD Pharma, Eupraxia Pharmaceuticals, and Guerrero
Exploration
Ian Fodie - CATwenty-five years plus expe-rience in CFO positions with companies including, Most recently, Rapid Dose Thera-
peutics Corp., Green Growth Brands Limited. First Baux-ite Corporation and Lithium
Americas Corp., Oriental Met-als (now Woulfe Mining Cor-poration) and Longview Capi-tal Partners Inc (now Resinco
Capital Partners Inc.).
Mark Purdy - CFA Independent Director
Mr. Purdy is Managing Director, CIO, and Chair of the Investment Committee at Arrow Capital Management. With over
20 years of related experience, Mr. Purdy shares responsibility for hedge fund
manager selection and asset allocation process. He has served on Arrow
Capital’s Investment Committee since its inception. Mr. Purdy held senior roles
at BPI Financial Corporation and IBM Canada Ltd. Mr. Purdy graduated from
the University of Toronto with a Bachelor of Commerce and Economics degree.
CONFIDENTIAL 23
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Pedro LichtingerCEO Starton Therapeutics
Starton is a clinical-stage biotechnology company focused on transforming standard of care therapeutics. Mr. Lichtinger is the former President of Pfizer Global Primary Care,
and President Pfizer Europe, having held responsibility for 52% of Pfizer Inc. revenues, management of pipeline, and $800 million plus clinical budget. He has experience managing
two biotechnology companies as the former President and CEO of Optimer Inc. and Asterias Biotherapeutics.
Mr. Lichtinger serves on the Board of Directors for Gemphire Therapeutics and Sanfer de Mexico and sits on the Advisory Board of Zero Gravity. He holds an MBA degree from Wharton
School of Business and an engineering degree from the National University of Mexico.
Roy WaldronCEO Starton Therapeutics
Dr. Roy Waldron, Ph.D, J.D, served as the Senior Vice President, Associate General Counsel and Chief Intellectual Property Counsel at Pfizer (Retired June, 2018).
There, he led global teams of Pfizer attorneys and professionals in procuring patents, and worked closely with R&D, Business Development and Pfizer Business Units to develop and
strengthen intellectual property strategies for development and acquisition targets. Dr. Waldron has been published numerous times, and often serves as a panelist and keynote
speaker at events. He has participated in many industry related committees, including International Federation of Pharmaceutical Manufacturers and Associations (IFPMA),
Pharmaceutical Research and Manufacturers of America (PhRMA). INTERPAT, Intellectual Property Owners Association (IPO), Hoover IP 2, Association of Corporate Counsel (ACPC)
and Gibbons Institute of Law Science and Technology. Dr. Waldron holds a JD from New York University Law School, a PhD from Yale and a BA from Dartmouth College.
“We are extremely pleased to have both Pedro and Roy on the Pike Advisory Board. The combination of Pedro’s proven track record
of successful drug development at Pfizer, and Roy’s success in developing intellectual property strategies for Pfizer will be invaluable as we build out our synthetic cannabinoid
delivery platform.” —Brad Miles, CEO Pike Therapeutics
Pike Therapeutics: Advisory Board
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Pike Therapeutics: Capitalization Table
Pike Valuation (in USD)
Total Value ($) Per Share ($) # of Shares Outstanding % of Total
Pre-Money Valuation $32 M 0.258 96,830,953 72.6%
New Equity Raised $12 M $0.33 36,363,636 27.4%
Post-Money Valuation $43 M $0.33 133,194,586 100%
IPO issued half warrants are not included - 18,181,818
Pike Ownership Cap Table: Post-Raise
Shareholders % ownership
Management 9.6
Founders 34.8
Starton Therapeutics shareholders 21
RTO CPC (DC Acquisitions) 7.3
IPO investors 27.3
IPO issued half warrants are not included - 18,181,818 * Options will be limited and TBD
Total Post Money IPO raise will provide for a projected 30 month burn rate.* (Undisclosed) An additional indication based on detailed Pharma Consulting analysis.
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Pike Therapeutics: Capital Raises and Use of Proceeds
Capital Raise and Use of Proceeds (all in USD) Capital Raise
1. Founders and Management $2.2 M
2. Amalgamation with DC Acquisitions $1.5 M
3. IPO $12 M
TOTAL FUNDING: $14.7 M
IPO issued half warrants are not included - 18,181,818 * Options will be limited and TBD
Post-Money IPO Use of Proceeds » Concludes platform ownership agreement with Starton Therapeutics
» Target Phase 3 FDA Registered Trial acceptance in approx. 24 months
» Investigate Clinical Proof of Concept for a Treatment Resistance Epilepsy indication
» Pre-formulation Studies, Formulation Development & Optimization, Clinical Proof of Concept for another attractive transdermal indication may be persued*
» Engagement of Top Tier Pharma Consulting Company to assist in the identification of compelling dronabinol and synthetic CBD indications for proprietary transdermal delivery
Total Post Money IPO raise will provide for a 30 month burn rate. * (Undisclosed) An additional indication based on detailed Pharma Consulting analysis.
CONFIDENTIAL 26
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Thank You.
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