Exxel Pharma Presentation...to 26.9-30.9% for the Vietnam war, 12.1% for the Gulf war, and 13.8% for the Operation Iraqi Freedom (Iraqi/Afghan wars). Current treatments only provide

“The need has never been more urgent. More than 50 million adults in the U.S. are living with chronic pain at an estimated annual cost of $560 billion in medical care, lost productivity and disability programs, according to federal data. Unlike acute pain—the sharp, instantaneous sensation that alerts the body to injury or trauma—chronic pain can persist long after normal healing, lasting for months or years….”

- A New Prognosis for Pain Care -WSJ, February 6, 2019

Exxel Pharma Presentation

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Exxel Pharma at a Glance

• Advancing two FAAH inhibitor programs licensed from the laboratory of Professor Daniele Piomelli and the University of California, Irvine.

• URB937 program

o A first-in-class, peripherally restricted FAAH inhibitor

o Broad application in pain indications; Lead indication is pain associated with CIPN

o IND enabling studies completed

o Pre-IND FDA meeting completed in May of 2019

• ARN program

o Global FAAH inhibitors with application in diseases of the CNS

o Lead indication is PTSD

o Based on well-characterized parent molecule URB597

Development stage pharmaceutical company preparing for phase I clinical testing and human proof of concept

Exxel Pharma is pioneering therapeutics that boost the endocannabinoid system

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The Endocannabinoid System

Human Body

Endocannabinoid System (ECS)

Two receptors: CB1 and CB2

Endocannabinoid signaling molecules

Cannabis

Phytocannabinoids

Cannabis derived THC and CBD

Difficult to develop as Rx

No patent protection

Pharmaceuticals

Rationally designed FAAH inhibitors

New class of medicines targeting the ECS

FDA approved Rx drug

Patent protection

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Drug target: FAAH

FAAH inhibitors boost Anandamide’stherapeutic effects

Anandamide

Ethanolamine

FAAH

FAAH inhibitor

Ana

Arachidonic acid

Ana

Inhibition of FAAH results in elevated Anandamide levels, which produces multiple therapeutic effects.

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Exxel Pipeline

Two distinct FAAH inhibitor programs which work by boosting the natural therapeutic effects of the human endocannabinoid system.

PRECLINICAL DEVELOPMENT CLINICAL DEVELOPMENT

ExploratoryResearch

Preclinical Development

Safety pharmacology /

toxicologyIND Phase I Phase II POC

URB937 Program

2020 2021

URB597 Analogs

Neuropathic Pain

Migraine headache

Hyperactive bladder

Opioid sparing

ARN14663 & ARN14280

URB937: A first-in-class, peripherally restricted FAAH inhibitor

Lead indication: Peripheral neuropathic pain

Status: IND enabling studies completed

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Chronic Pain: Challenge and Opportunity

Neuropathic Pain

Neuropathic Pain is a chronic pain condition associated with diabetes, chemotherapy, HIV and herpes.

It affects 7-10% of the general population.

Only one in four of neuropathic pain patients achieves over 50% pain relief with current first line therapies.

Opioid type drugs are not typically recommended, but are used as second line therapies.

There is an urgent, unmet medical need for novel, safe and effective pain medications.

Current Drugs

Lyrica, Pfizer: $5B/year Patent expiration: 2018Type: Anti-epileptic

Cymbalta, Lilly: $940M/yearPatent expiration: 2013Type: Anti-depressant

Neurontin, Pfizer: $123M/year Patent expiration: 2000Type: Anti-epileptic

Nucytna, Grunenthal: $375M/yearPatent expiration: 2022Type: Opioid analgesic

Lidoderm, Grunenthal: $330M/yearPatent expiration: 2014Type: Topical anesthetic

The Opportunity

An urgent, unmet medical need exists as current treatments fail to provide pain relief in the majority of patients.

Strong sales of current neuropathic pain drugs document a multi billion-dollar pain market opportunity.

Current pain drugs have limited patent coverage which amplifies the opportunity for new and innovative pain products.

Competing pipeline drugs mirror current drugs and lack innovative mechanisms of action.

Source: GlobalData and EvaluatePharma

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URB937: A first-in-class peripheral FAAH inhibitor

• Developed by Professor Daniele Piomelli at the University of California, Irvine.

• Protected by issued and pending patents, covering composition of matter and use.

• Therapeutic and commercial potential:

• Chronic pain (neuropathy), hyperactive bladder, migraine headache, wound healing.

• URB937 exhibits unexpected efficacy and remarkable safety by being entirely excluded from the CNS:

• The peripheral restriction distinguishes the drug’s MOA from all other FAAH inhibitors.

• Supported by non-dilutive grant funding:

• A $1.4mm NIH STTR grant was awarded to prepare the drug for a phase I trial.

• A $225k NIH grant was recently awarded to test URB937 as an opioid sparing therapy.

The combination of published animal data, patent protection and non-dilutive grant funding makes URB937 a significantly derisked drug with high commercial potential.

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MOA: URB937 suppresses pain through peripheral FAAH inhibition

URB937 strongly inhibits FAAH, preventing anandamide

metabolism.

URB937 does not enter the brain or the fetus

(Left) URB937 suppresses pain behavior elicited by neural injury in mice. (a-c) Effects of single administration of vehicle (shaded bars) or URB937 (1 mg-kg−1, i.p.; closed bars) on (a) mechanical hyperalgesia, (b) thermal hyperalgesia, and (c) mechanical allodynia produced by sciatic nerve ligation. BL, baseline (measured before nerve ligation); IL, ipsilateral (ligated) paw; CL, contralateral (non-ligated) paw. Results are expressed as mean±s.e.m.; n = 6 in each panel. *P<0.05, **P<0.01 and ***P<0.001 vs baseline; #P<0.05, # # P<0.01 and # # # P<0.001 vs vehicle.

Effects of URB937 on anandamidelevels in liver of wild-type C57Bl/6

mice (+/+) and FAAH-deficient littermates (−/−).

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URB937: IND-enabling studies completed

Outsourced and cost-effective development strategy using top-tier CROs to rapidly advance URB937.

Regulatory and clinical development

Pre-IND meeting

Phase I trial design

IND prep/submission

Clinical trial site selection and management

IND-enabling safety/pharmacology

In vitro drug metabolism

GLP Genetox

MTD/DRF, rat & dog GLP 28-day tox, rat & dog GLP FOV/Respiratory/CV Drug Product Manufacturing

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URB937: Early Clinical Development Plan (ECDP)

Exxel Pharma targets a 505(b)(1) NDA application for URB937 in the treatment of chemotherapy induced peripheral neuropathic pain.

Late Q2 2020: Phase I MADMultiple Ascending Dose (MAD) study to determine Safety Toleration, PK and PD and preliminary food-effect in Normal Healthy Volunteers• Design: A Single-Center, Randomized, Placebo Controlled, Low, Medium, and High

dose (determined from SAD) sequential in four dose rising cohorts plus one additional cohort to assess preliminary food-effect PK at the highest dose level.

• Treatment Duration: QD oral AM dosing X 7 days (TBD) with 14 day safety review interval between dose levels

• N= 6 active and 2 placebo per cohort. Approximately 32 total subjects• Objectives: Safety/tolerability, identify maximum tolerated dose (MTD), PK and PD,

variability, linearity, steady-state parameters (accumulation, time-dependency) and Preliminary exploration of drug elimination (urine PK, metabolite identification) and assess preliminary food effect data.

Early Q2 2020: Phase I SADFirst-in-Human, Single Ascending Dose (SAD), Safety, Toleration, PK and PD Study in Fasting Normal Healthy Volunteers• Design: A Single-Center, Two-part, Sentinel (2 sequentially dosed subjects) followed

by 4-5 Dose-Rising Randomized Placebo-controlled cohorts• N = 2 (Sentinel) followed by approximately 4-5 additional cohorts, each with 6 active

and 2 placebo subjects) Approximately 34-42 total subjects • Objectives: identify safe and tolerable dose(s),

o Measure Safety/Tolerability endpoints (exploring MTD)o Characterize PK and PD of URB 937 and active metabolite following escalating

single fasting orally administered doseso Characterize relationship to PD markers

• Dose Escalation and Safety Monitoring Committee (DESMC) : Chartered to assure subject safety (14 day Safety and PD assessments between each dosing cohort)

FDA IND: Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) and The Division of Oncology Products 1 (DOP1)

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URB937: Human Proof of Concept

Q2 of 2021: Phase IIa (PoC)

A Phase IIa Proof of Concept (PoC) Study to assess the Safety, Efficacy and PK/PD of URB937 in patients with chemotherapy-induced neuropathic pain • Design: A Multi-Center, Randomized (in a 1:1:1 manner) , Parallel, Double Blind, Placebo Controlled 12-week

superiority study to assess the effect of a low and high dose of URB937 in patients compared to placebo with Chemotherapy Induced Peripheral Neuropathic Pain

• Primary outcome: Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) [ Time Frame: Baseline, End of Treatment ]

• Secondary Outcomes: Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale, Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form and Pain Interference Index Scores, Pain Treatment Satisfaction Scale (PTSS), Pain Treatment Satisfaction Scale (PTSS), Visual Analogue Scale for Pain, Mean Daily Sleep Interference Score (DSIS), Patient Global Impression of Change (PGIC) [Clinical Global Impression of Change (CGIC).

• Anticipated trial size: N of patients to be based on a minimum of 80% power to detect a TBD effect size

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URB937 Intellectual Property

Patent family 1 (US 9,187,413):• Composition of matter for URB937.• Methods of use including pain including chronic neuropathic pain associated with neuropathy. • Basic patent expiry: July 2031.

Patent family 2 (US 9,745,255 B2):• Composition of matter for URB937.• Methods of use including pain including chronic neuropathic pain associated with neuropathy

plus additional indications.• Basic patent expiry: July 2032.

Exxel Pharma has an exclusive, world-wide license to the URB937 patent portfolios.

U.S. Provisional Application No. 62/938,847• Composition of matter for URB937 polymorph.• Filing date: Nov 21, 2019. Expected basic patent expiry: Nov 21, 2040.

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Time Line for URB937

Advanced Pivotal Studies

2023

Phase ITesting of oral delivery on

healthy volunteers for safety; including testing multiple

doses

2020

Phase IIa

2021

Human Proof-of-ConceptAt this stage, Exxel aims to enter a

JV with a strategic partner.

GLP Safety/ToxCompleted formal IND-

enabling toxicology studies

2019

URB937 License executed with

University of California, Irvine

2017 2020

IND submissionDrug product

manufacturing completed, Phase I

ready

Pre-IND meeting

2019

In-person pre-IND meeting with the Division of Anesthesia, Analgesia, and Addiction Products

FDA approval

2024

Exxel Pharma has a focused strategy with clear, near-term, regulatory and clinical milestones.

ARN Program

Lead indication: PTSD

Status: Molecules in preclinical development

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PTSD: Problem and Opportunity

PTSD

PTSD develops in some people who experience a shocking, scary or dangerous event.

An estimated 8 million Americans, or 3.5% of the US population, suffer from PTSD at any given time.

For veterans, the prevalence was estimated to 26.9-30.9% for the Vietnam war, 12.1% for the Gulf war, and 13.8% for the Operation Iraqi Freedom (Iraqi/Afghan wars).

Current treatments only provide relief from symptoms in some patients, leaving a significant unmet medical need for new therapeutics.

Approved Drugs

Zoloft, Pfizer: $469M/year Patent expiration: 2006Type: Anti-depressant

Paxil/Paroxetine: ~$1.5B/yearPatent expiration: GenericsType: Anti-depressant

Prozac (Lilly), Effexor XR (Pfizer), Seroquel (AstraZeneca), Risperdal (Janssen) and other anti-psychotics are used off-label to treat PTSD.

The PTSD market is estimated to reach $1.2B by 2028.

The Opportunity

A large unmet medical need exists as current treatments only provide relief in some patients.

Strong sales and off label use of current drugs indicate a multi billion-dollar pain market opportunity.

There are only two FDA approved PTSD drugs, which are both off patent, creating an opportunity for new and innovative pain products.

Source: GlobalData

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The ARN FAAH inhibitors enter the Central Nervous System (CNS), enabling treatment of neurological disorders such as PTSD, substance addiction, MS, anxiety and insomnia.

ARN: A Potential Therapeutic for PTSD, anxiety and Substance Use Disorders

PTSD-focused R&D in Professor Piomelli’s laboratory is sponsored by the US Department of Defense.

Preclinical safety and efficacy for URB597 supported by >400 peer-reviewed publications.

The ARN parent molecule, URB597, was previously approved for a phase I clinical trial by Health Canada.

The combination of research data, patent protection and non-dilutive grant funding supports the commercial potential of the ARN global FAAH inhibitors.

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Patent family 1 (US 7,176,201):• Composition of matter for URB597• Methods of use including treatment of PTSD & Substance use disorders• Basic patent expiry: February 2024; 5-year extension (PTE) potentially possible

Intellectual Property

Patent family 2 (US 9,822,068 B2):• Composition of matter for newer global FAAH inhibitors (ARN14280 and ARN14663)• Methods of use including treatment of reduced appetite, smoking, substance abuse, PTSD • Basic patent expiry: July 2035

Exxel Pharma has an exclusive, world-wide license to the two families of global FAAH inhibitors.

Two patent families cover the composition of matter and methods of use for Exxel Pharma’s global FAAH inhibitors

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Time Line for the ARN therapeutics

Exxel Pharma has a focused strategy with clear, near-term, regulatory and clinical milestones.

2021

IND submissionDrug product

manufacturing completed, Phase I

ready

Advanced Pivotal Studies

2025

Phase ITesting of oral delivery on

healthy volunteers for safety; including testing multiple

doses

2022

Phase IIa

2023

Human Proof-of-ConceptAt this stage, Exxel aims to enter a

JV with a strategic partner.

2020

URB597 & ARNs License executed with

University of California, Irvine

2017

Pre-IND meeting

2021

In-person pre-IND meeting targeted for development at PTSD therapeutic

FDA approval

2026

GLP Safety/ToxComplete formal IND-enabling

toxicology studies

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M&A activities and potential

Exxel Pharma: Time to exit & exit size are favorable

Trends in Healthcare Investments and Exits 2018

50% of recent of recent M&A deals were transactions at the pre-clinical or phase I stage.The M&A activities underscore big pharma’s appetite for innovative technologies and companies.

Example: 2015 BIOGEN acquisition of Convergence.

• Deal was centered around the neuropathic pain drug CNV1014802.

• CNV1014802 is a sodium channel blocker in development for neuropathic pain.

• CNV1014802 was in Phase II clinical testing at the time of acquisition.

• Deal size: $200M upfront plus $475M in milestone payments.

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Management Team

Richard Paul, MDCMODr. Paul is a licensed MD with more than two decades of experience in drug development, regulatory affairs and clinical research. His career started with post graduate work at Albert Einstein College of Medicine, Rutgers University’s Internal Medicine Residency program and a Fellowship tenure at Harvard Medical School/Joslin Diabetes Center. After 9 years of clinical practice, he transitioning into pharmaceutical research with Pfizer and subsequently held executive leadership positions in clinical research, regulatory and medical safety departments with Ergo Science, Grünenthal USA, Shionogi USA and Schering Plough Corporation. Notably, Dr. Paul was the founding Managing Director of Grünenthal USA, establishing the subsidiary for Grünenthal GmbH of Germany. Rich’s experience spans medical safety, clinical research, and regulatory strategy. He has multi-divisional FDA experience having supported a number of Investigational and New Drug Applications with the US FDA and other international regulatory agencies.

Soren Mogelsvang, PhDPresident and CEO, DirectorDr. Mogelsvang is a biotech executive and entrepreneur with over 15 years of experience. He is the co-founder of several biotech companies and brings a track record in building and leading privately funded and publicly traded companies. Recent positions he has held include President and CEO of Peak Pharmaceuticals, which he built from concept to a profitable veterinary health company; Co-founder and VP of R&D at Serpin Pharma, a clinical stage biotech company; Co-founder and Head of R&D at Caerus Discovery, an immunology company launched with support from BioWa – Kyowa Hakko Kirin and ImmunoCellular Therapeutics; and Head of Cell Biology at ATCC. Soren has PhD in Cell Biology from the University of Cambridge (UK), an MSc in Plant Molecular Biology from the University of Copenhagen (Denmark), and did postdoctoral research at the University of Colorado School of Medicine.

Daniele Piomelli, PhD, MD (h.c.) CSODaniele is an Italian-born American scientist. He studied neuroscience in New York City, with James H. Schwartz and Eric R. Kandel at Columbia University College of Physicians and Surgeons (PhD, 1983-1988) and later with Paul Greengard at the Rockefeller University (Post-doc, 1988-1990). Two of his mentors (ERK and PG) received the Nobel Prize for their contributions to medicine in 2000. After working at the INSERM in Paris (1990-1995) and at the Neurosciences Institute in La Jolla (1995-1998) with Nobel Laureate Gerald Edelman, he joined the University of California Irvine School of Medicine, where he is now Louise Turner Arnold Chair in Neurosciences and Professor of Anatomy and Neurobiology, Pharmacology and Biological Chemistry. Daniele is scientific cofounder of Kadmus Pharmaceuticals, Thesan Pharmaceuticals and NeoKera.

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Summary

Led by an experienced management team Industry data and comparables suggest ExxelPharma has significant near-term upside

URB937: First-in-class peripheral FAAH inhibitor ARN: Non-addictive global FAAH inhibitors

Completed in-person pre-IND meeting for URB937 on May 1, 2019.• Strong chance of Fast Track designation

The company aims to begin clinical testing with URB937 in Q2 of 2020• IND submission on track for Q2 2020• Drug Product (DP) manufacturing on-going

Global FAAH inhibitor family• The ARN parent molecule, URB597 is backed by

100s of peer-reviewed research publications• IND enabling studies previously completed for

URB597 showing no toxicity

Broad application in diseases with significant unmet medical needs • First clinical proof-of-concept for a global FAAH

inhibitor published over the past year

For more informationSoren Mogelsvang, PhDPresident and CEO Exxel Pharma, IncPhone: 720.261.1109Email: [email protected]