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Savant HWP • Privately Held Biopharmaceutical Focused on Developing Novel Treatments for Rare Diseases and Addiction Disorders

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Savant HWP • Privately Held Biopharmaceutical Focused on Developing Novel Treatments for Rare Diseases and Addiction Disorders Corporate Presentation Ferdinand Belga CONFIDENTIAL AND PROPRIETARY | 1 Overview and Investment Objective Savant HWP • Privately held biopharmaceutical Focused on developinG novel treatments For rare diseases and addiction disorders. Primary Goal to address the opioid crisis. • Lead asset developed From research at Albany medical research trianGle • Completed Phase I (First-In-Human studies). Phase II in process. • World-wide LicensinG and StronG IP Investment Objective • SeekinG capital raise to: 1. Expedite ReGulatory/Quality resources towards NDA submission For two separate NDAs 2. Drive clinical resources and clinical trial plan For opioid addiction relieF 3. Advance critical speciFic contractual manuFacturinG processes 4. Execute leGal strateGy and Further IP FilinGs 5. Conduct Phase II clinical studies [opioid] Exit Options • Early Exit. Priority Review Voucher (PRV) Value awarded at FDA clearance. $70- $350M commercial value potential. Lowers investor risk. • Acquisition Exit. Latest Benchmark: $735M- EmerGent buys Narcan. AuG 28, 2018 • Other benchmark exits are multi-billion • Expertise to launch/commercialize, iF necessary. Blockbuster potential. CONFIDENTIAL AND PROPRIETARY | 2 Business Model and Strategy Business Model § Target highest potential rare/disease modifying assets; opioid addiction is the initial indication with follow-on addiction pipeline indications: § Nicotine § Alcohol § Sucrose cravings (obesity) § Cocaine [No Pharma Treatment available, High, unmet need] § Methamphetamine [No Pharma Treatment available, High, unmet need] § Strong Team with world-class expertise and efficient use of capital 2018 FDA Incentives § Faster FDA Review and Potential Approval. Accelerated Approval/Breakthrough Designation for development of treatments for opioid use disorders. (April 2018). § FDA lowered threshold for approval. New draft guidance issued (August 2018) to encourage development of novel medicines. Addressed some barriers of clinical endpoints. CONFIDENTIAL AND PROPRIETARY | 3 Market Challenge and Product Solution Market Challenge § Opioid addiction and dependence is the greatest healthcare challenge in the US today: 150 daily deaths, 650,000 daily RXs filled1, Addiction Market:$35B+ in treatment expense2 with ~9% CAGR3 § Current medicines do not treat the cause of the disease and are basically substitute therapies that do not break the cycle of craving e.g. methadone, naltrexone, nicotine patches) § ~25% effective 12 months post treatment4 § Overdose deaths rising ~10%. >72,000 in 20176 5 Product Solution § 18-MC is a novel, first-in-class anti-addictive molecule to target the rewards center of the brain (dopaminergic pathway). § Specifically, pre-clinical studies show it: § Controls cravings § Reduces relapse rate § Significantly reduces § Is not habit-forming withdrawal symptoms 1HHS.gov 2016 and 2017. 2Forbes April 27, 2015. CONFIDENTIAL AND PROPRIETARY | 4 3SAMHSA.gov. SAMHSA. 4 NEJM 1999. 5New York Times June 6, 2017. 6NY Times Aug 15, 2018 18-MC’s Novel Mechanism of Action in Addiction Habenulo- Mesolimbic interpeduncular Dopaminergic Pathway Pathway 18-MC l Parallel reward pathway l Normalizes dopamine levels l Rich in α3β4 nicotinic Negative Allosteric Modulator cholinergic receptors l Does not directly block dopaminergic receptors 1) Controls cravings 2) Controls withdrawals 3) Controls relapses UNIQUE UNIQUE BENEFITS: 4) Non-habit forming CONFIDENTIAL AND PROPRIETARY | 5 18-MC Reverses the Disease Process REPEATED TRADITIONAL OPIATE ADDICTION OPIATE USE TREATMENT Pleasure Methadone Dopamine Dopamine Baseline Distress Time 18-MC Many current drug treatments, such as methadone, are simply Keeps Dopamine a substitute for opioids on neural pathways. This approach Level in Normal Range Without does not break the cravings that a person might experience. Ongoing Addiction • 18-MC works differently, reversing the disease process in the brain and modulating the rewarding effects and cravings caused by opiates and other drugs of abuse. CONFIDENTIAL AND PROPRIETARY | 6 1 18-MC Efficacy: Reverses Opioid Cravings 120 100 • Effective and ideal treatment 80 – No impact for non-drug reinforcers (eg, food and 60 water) 40 Percent of Baseline of Percent Water Morphine • Reverses the brain’s 20 * reward center and reduces cravings 0 0 10 20 30 40 18-MC (mg/kg) IP 18-MC reduces drug self-administration in rats *Denotes Statistical Significance. Link to Pipeline Slide Glick et al. See Scientific References. CONFIDENTIAL AND PROPRIETARY | 7 18-MC Pipeline Indications: Broad Applicability^ 120 100 Blockbuster potential 80 No approved drug works 60 * for all substances Percent of Percent Baseline 40 Water Morphine * Potential to treat Cocaine 20 Methamphetamine * compulsive behaviors e.g., Nicotine * obesity Sucrose 0 * (Obesity treatment market to 2 0 10 20 30 40 reach $15.6B by 2024 ) 18-MC (mg/kg) IP US drug & alcohol treatment market: ~$35B1 (CAGR 9%) *Denotes Statistical Significance. 1 2 ^Glick et al. See Scientific References. Forbes April 27, 2015 Grandview Research 2016. CONFIDENTIAL AND PROPRIETARY | 8 2 18-MC Reduces the Intensity of Withdrawals Less Weight Less Teeth Less Intestinal Less Impulsive Loss Chattering Impact Behavior 15 30 3 10 10 20 2 * Burying 5 * Diarrhea * Weight Loss 5 10 * 1 Teeth Chattering * 0 0 0 0 Control 10 20 40 Control 10 20 40 Control 10 20 40 Control 10 20 40 18-MC (mg/kg, i.p.) 18-MC (mg/kg, i.p.) 18-MC (mg/kg, i.p.) 18-MC (mg/kg, i.p.) Benefits: Greater compliance, patient safety *Denotes Statistical Significance. Glick et al. See Scientific References. CONFIDENTIAL AND PROPRIETARY | 9 3 18-MC Is Not Habit-Forming 18-MC behaves the same as control (saline). Non-addictive. Cocaine treatment arm shows rapid and Cocaine, Saline, 18-MC constant demand for more (Addictive). Glick et al. See Scientific References. CONFIDENTIAL AND PROPRIETARY | 10 4 18-MC Prevents Cue-Induced Relapse 35 18-MC (n=7) 35 Saline (n=7) * 30 30 Indicates no stimulus 25 25 SEM) triggers - (visual/auditory) 20 20 15 15 18-MC blocks musical cue-induced 10 10 reinstatement in rats Active Lever Presses (+/ Presses Lever Active Cocaine Infusions (0.4 mg/kg/inf) (0.4 Infusions Cocaine 5 5 0 0 DAY DAY DAY DAY DAY DAY DAY DAYDAY DAY DAY DAY DAY DAY DAY EXT EXT EXT EXT EXT TEST 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1 2 3 4 5 *Denotes Statistical Significance. Glick et al. See Scientific References. CONFIDENTIAL AND PROPRIETARY | 11 5 Successful Human Clinical Trial (Phase I) No CV risks Primary goals of SAD achieved QD oral dosing Ready for Phase II Safe in human trials This was the first in human study for 18-MC 18-MC No serious adverse was safe event occurred Data on File. CONFIDENTIAL AND PROPRIETARY | 12 18-MC: Strong IP Position Exclusive, Worldwide License From Albany Medical College Coronaridine Congeners l U.S. Patent 6,211,360 B1 SAVANT HWP – Composition of Matter Claims for Congener Family and 18-MC Specifically, Including Salts There of: FOCUS – Method of Treating Addiction Using Such Compounds Developing New IP from – Issued Canada, Great Britain and France trade secrets: • Human DMPK l U.S. Patent Application 12/360,434 • Pharmaceutical formulations – Use of Coronaridine Congeners for Treating Obesity • Proprietary Manufacturing – PCT/US09/32093 Pending Ex-U.S. l U.S. Patent Application 14/387,339 – Blocking Cue-induced Drug Reinstatement – PCT Pending Ex-U.S. Additional IP Licensed CONFIDENTIAL AND PROPRIETARY | 13 Milestones and Source of Funds Preclinical Phase I-A Phase I-B Phase II Phase III Clinical Trials NDA Friends & Sources NIDA - $6.8M Series A Series B Family-$1M Uses Generated pre- Completed Ø Multiple Dose clinical data on single dose Study several clinical study Ø Additional Ø Proof of ² FDA indications: (Brazil - 2015) formulation, concept: breakthrough § Opiates IP, and drug Opiates (US) designation/ac § Cocaine production celerated § Methampheta- approval mine § Nicotine Ø Clinical study: ² PRV received § Alcohol Leishmaniasis with NDA § Sugar (Brazil/FDA approval Registered) Ø Proof of principle: Nicotine (US) Timing ü COMPLETE ü COMPLETE 2019 2019 2020 CONFIDENTIAL AND PROPRIETARY | 14 Regulatory Plan and IP Regulatory Plan § Seek indication for treatment of opioid addiction as first indication § Has IND: undergoing human safety trials and dose range § Have reviewed development, trial plans with FDA § Received $6.8M in National Institute for Drug Abuse (NIDA) grant, likely increasing its appeal to regulators § Seek new FDA meeting to update, review plan § Strategy: submit NDA under accelerated review status with most minimally sufficient human trial data while maintaining rigorous post-market surveillance given public health crisis Intellectual Property (IP) § Significant IP protection (filed and issued) for molecule, manufacturing, and method of action § Savant: exclusive world-wide license for commercialization § Both domestic and limited international filings to date § Future: PK (Pharmacokinetic), manufacturing process, and potential additional method of action applications CONFIDENTIAL AND PROPRIETARY | 15 Competition and Competitive Advantage Competition § Opioid treatment market (US): $5B, 9% CAGR § Options today: substitutionary treatments, and habit forming, too o $3B: Methadone (various generic; injection) o $1.8B: Suboxone (buprenorphine naloxone – opiates) o $400M: Vivitrol (Naltrexone injection) o $300M: Naltrexone (alcohol and opiates) o $200M: Buprenorphine (generic) § Outside of US: Ibogaine (side effects potentially fatal) § Clinical studies: Cochrane (2011): no better
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