Rezolute, Inc. · NASDAQ:RZLT
Rezolute — AntriaBio — Investor Presentation (September 2015)
31 slides from Rezolute's investor presentation, Sep 30, 2015
Slide 1: AntriaBio
antriabio www.antriabio.com (OTCQB: ANTB)
Slide 2: Forward-looking Statements
Forward-looking Statements Statements in this presentation that are not descriptions of historical facts are forward- looking statements relating to future events, and as such all forward-looking statements are made pursuant to the Securities Litigation Reform Act of 1995. Statements may contain cer
Slide 3: Forward-looking Statements
Forward-looking Statements Statements in this presentation that are not descriptions of historical facts are forward- looking statements relating to future events, and as such all forward-looking statements are made pursuant to the Securities Litigation Reform Act of 1995. Statements may contain cer
Slide 4: AntriaBio is a biopharmaceutical company
AntriaBio is a biopharmaceutical company that develops novel, sustained release injectable therapies We apply our proprietary formulation and manufacturing capabilities to known, well-characterized molecules to create differentiated, patent-protected products that have the potential to significantly
Slide 5: Product Pipeline
Product Pipeline Compound | Discovery | Preclinical PhaseI Phase IL ABIO1 Injectable once- weekly basal insulin for type 1 and type2 diabetes AB301 Injectable once- wookly GLP-1 agonist/basal insulin combination for type2 diabetes > Fe
Slide 6: Superior Microsphere Technology
Superior Microsphere Technology + Our products are formulated using proprietary PLGA microsphere technology + Amylin/Astrazeneca’s Bydureon (exenatide), a currently marketed GLP-1 agonist for type 2 diabetes, is also formulated using PLGA microspheres + Light microscopy and particle size comparisons
Slide 7: AB101
AB101
Slide 8: Insulin: Role & Function
Insulin: Role & Function * Insulin is a hormone that keeps blood sugar in a normal range by moving glucose into the liver, fat and muscle * Bolus: insulin released by pancreas when food is consumed. * Basal: background insulin continually released by pancreas to control blood sugar levels between me
Slide 9: Benefits of Long-Acting Insulin
Benefits of Long-Acting Insulin * The benefits of long-acting insulin are well recognized, including: + Less fasting blood glucose variability, + Lower risk of hypoglycemia, and + Less weight gain. + Recent studies suggest the beneficial effects of early insulin initiation - Early insulin initiation
Slide 10: Current Insulin Market: >$22B
Current Insulin Market: >$22B * Basal insulin market is ~50% of the total insulin market at ~$11B * There is no commercially available insulin in the US with a duration beyond 24 hours Insulin Brand/Generic Name Duration | Market Share 2014 Sales + Lantus (insulin glargine) ~80% + Levemir (insulin d
Slide 11: Emerging Basal Insulin Market
Emerging Basal Insulin Market Many companies are validating the need for a basal insulin therapy with duration beyond 24 hours, but their products are complex insulin analogs Ate ual Dosing Stage Formulation LAAT QON1436) Woeksy Phase 1 Ineuin Analog horeanis pee Weekly Phase 1 rene eo Weensy Phase2
Slide 12: The Solution: AB101
The Solution: AB101 * The Goal: Develop a human recombinant insulin formulation that can be administered in a single, small volume injection to cover approximately one week of basal insulin requirements * The Challenge: Insulin is a notoriously difficult molecule to formulate + The Solution: A unifo
Slide 13: AB101 Addresses Unmet Clinical Need
AB101 Addresses Unmet Clinical Need + Barriers to adequate insulin utilization may include: - Insulin/needle-averse patients - Safety concerns, including hypoglycemia - Weight gain + Alonger-acting basal insulin represents a convenient, effective, and safe treatment option - AB101 is being developed
Slide 14: AB101 Formulation Step 1: PEGylation
AB101 Formulation Step 1: PEGylation * Using site-specific amine PEGylation, attach a low molecular weight PEG to the N terminus of human insulin’s B peptide chain so that insulin dissolves uniformly in oil or water-based solutions Chain B @) 30 amino acids Chain A Q_21 amino acias (Fre rn ‘emrvecti
Slide 15: AB101 Formulation Step 2: Dissolution
AB101 Formulation Step 2: Dissolution + PEGylated insulin is co-dissolved with a polymer (poly-lactic co-glycolic acid, or PLGA), in a solvent [oil phase] + PLGA is critical for determining the rate at which PEGylated insulin is released into the body by hydrolysis PEG-Insulin PLGA PEG fe) ae HO = o
Slide 16: AB101 Formulation Step 3: Emulsion
AB101 Formulation Step 3: Emulsion + Generate an oil-in-water emulsion by passing both the oil and water phases through a packed glass bead bed emulsifier to form uniform microspheres comprised of PEG-insulin and PLGA ‘Water Phase Mix Tank oil Phase Mix Tank Emulsifier > Fe Reconstitution: Prior to
Slide 17: AB101: in Vitro Pharmacology
AB101: in Vitro Pharmacology The following preclinical results were presented in June at the American Diabetes Association 75" Scientific Sessions® in Boston + inVitro Characterization of PEGylated Insulin (drug substance): - Displayed an affinity for the IGF-1 receptor that is similar to native ins
Slide 18: AB101: in Vivo Pharmacology
AB101: in Vivo Pharmacology The following preclinical results were presented in June at the American Diabetes Association 75" Scientific Sessions® in Boston + inVivo Pharmacokinetics and Pharmacodynamics of 4ABIO1: - Slow onset, sustained insulin increases and corresponding glucose reductions over t
Slide 19: AB101: Clinical Development Plan
AB101: Clinical Development Plan + Completed: Pharmacology and toxicology studies in dogs and rats + H1 2016: File Investigational New Drug (IND) application with FDA + H2 2016: Single and repeat ascending dose safety and efficacy studies (PK-PD) to establish once-weekly dosing regimen in type 1 and
Slide 20: Phase 1 First-in-Human Study Design
Phase 1 First-in-Human Study Design Single center Randomized, Open-Label, Single Ascending Dose Population: type 1 & type 2 diabetes patients and standard inclusion/exclusion criteria comparable to other insulin programs Sample size of 36-48 subjects per population in sequential ascending dose cohor
Slide 21: AB301
AB301
Slide 22: Incretin-Based Therapies
Incretin-Based Therapies + DPP-4 inhibitors and GLP-1 agonists are now well- established treatments for type 2 diabetes + No validation needed for GLP-1 therapies - Numerous marketed daily and weekly GLP-1 agonists * Therefore, focus of differentiation and advancement is on a combination therapy wit
Slide 23: Emerging GLP-1/Basal Insulin Combinations
Emerging GLP-1/Basal Insulin Combinations The world’s leading diabetes care companies are validating the need for a GLP-1 agonist and basal insulin combination therapy, but their products are targeting daily dosing Company Compound Stage Xultophy (IDegLira) NovoNoraisx Tesiba(insulindegiudec)and Lor
Slide 24: AB301
AB301 + Potential once-weekly injectable combination of a PEGylated GLP-1 agonist + AB101 * Combination therapy has potential to complement glycemic control while attenuating weight gain and hypoglycemic risk + Preclinical studies are ongoing > Fe 8
Slide 25: Key Intellectual Property
Key Intellectual Property + Existing issued patent, which expires in April 2024: - Site-specific modification of selected proteins l, PEG attached to insulin at residue PheB1 - Methods to formulate a mixture of a PEGylated protein with a biodegradable polymer |, PEG-insulin with PLGA * Pending paten
Slide 26: 2015 Milestones
2015 Milestones M Raised >$20M to date M Presented results of in vitro and multi-species PK/PD studies for AB101 at the American Diabetes Association 75" Scientific Sessions® M Completed IND-enabling toxicology studies for ABI101 M Announced additional pipeline candidate supported by in vitro and vi
Slide 27: Upcoming Milestones
Upcoming Milestones OFile AB101 IND application with FDA UO Initiate AB101 phase 1 first-in-human clinical study O Continue preclinical studies of AB301 > Fe 26
Slide 28: Financials
Financials As of June 30, 201 Shares Outstanding 24,338,219 $2.78 CHRGHO SERIE) | os tegi cae EEE) $2.33, Warrants Outstanding (weighted average exercise price) Fully Diluted 52,057,028 Cash $5,278,706 Exchange OTCOB: ANTB > Fe 8,702,418 19,016,391 at
Slide 29: Senior Management Team
Senior Management Team Nevan Elam, J.D., Chairman and Chief Executive Officer - Former Head of Nektar Therapeutics’ Pulmonary Business Unit, which was acquired by Novartis in 2008 + Spun out Nektar's asthma and COPD assets to form Pearl Therapeutics, which was acquired by AstraZeneca in2013 for $1 b
Slide 30: Scientific Advisory Board
Scientific Advisory Board + Hoyoung Huh, M.D., Ph.D. (Chair), former CEO of BiPar Sciences, Inc., former COO of Nektar Therapeutics, successful pharmaceutical entrepreneur + Andrew R. Hoffman, M.D., Professor of Medicine in the Division of Endocrinology, Gerontology and Metabolism at Stanford Univer
Slide 31: AntriaBio
antriabio 1450 Infinite Drive Louisville, CO 80027 (303) 222-2128 info@antriabio.com. ‘www.antriabio.com (OTCQB: ANTB)