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The Emergence of New Chemical Cannabinoid Treatments piketx.com

The Emergence of New Chemical Cannabinoid Treatments · 2020-02-11 · Global CINV Market: 2015 $2.7B Estimated Global CINV Market: 2022 $150M Dronabinol sales in the U.S 2015 $79.5B

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Page 1: The Emergence of New Chemical Cannabinoid Treatments · 2020-02-11 · Global CINV Market: 2015 $2.7B Estimated Global CINV Market: 2022 $150M Dronabinol sales in the U.S 2015 $79.5B

The Emergence of New Chemical Cannabinoid Treatments

piketx.com

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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).

CONFIDENTIAL 5

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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.

CONFIDENTIAL 7

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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

CONFIDENTIAL 11

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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.

CONFIDENTIAL 18

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Appendix

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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.

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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.

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Thank You.

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