2017 BIOPHARMX, INC. ALL RIGHTS RESERVED.
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1 SMARTER DRUG DELIVERY IN DERMATOLOGY Company Overview M a y
2 LEGAL DISCLOSURES Safe Harbor and Confidentiality This presentation may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are statements other than historical information or statements of current condition and relate to future events or future financial performance. These forward-looking statements relate to plans, objectives, and expectations for future operations. In light of risks and uncertainties, there can be no assurance that the forward-looking information contained in this presentation will in fact transpire or prove to be accurate. BioPharmX, Inc. undertakes no duty to update any forward-looking statement 1) to conform the statement to actual results, or 2) to reflect changes in the expectations of BioPharmX, Inc. All information in the following slide presentation is confidential and proprietary of BioPharmX, Inc. By your receipt of this information, you agree to hold such information confidential, unless required to disclose by law. All registration and trademarks herein are the property of BioPharmX, Inc. 2
3 BioPharmX Corporate Highlights Unique Drug Delivery Systems in Dermatology» Delivery to precise targets» Maximum efficacy» Fewer undesirable side effects» Applied to known APIs reduces regulatory time, cost and risk Phase 2 Product: BPX-01 (topical minocycline)» First non-lipophilic topical antibiotic formulation developed in-house» Acne: Phase 2b results in Q217» Rosacea: conducting Phase 2 feasibility study» Defined regulatory pathway via 505(b)2 Experienced Management Team» 28 employees» Commercialization & dermatology experience» Menlo Park, CA Strong Institutional Support» Franklin Templeton Advisors» Vivo Capital 3
4 BioPharmX Executive Team Anja Krammer President 20 years of commercialization experience; advisor for Fortune 100 companies & start-ups Kin Chan, PhD EVP Technology 15 years experience in biomedical sciences, dermatology, wound healing, biophotonics, optical-thermal interaction in biological tissue, medical device Greg Kitchener CFO 20 years experience in senior level finance and accounting roles AnnaMarie Daniels EVP Clinical and Regulatory Affairs 30 years of clinical, regulatory & quality experience for a number of large pharmaceutical companies Marie-Louise Bots SVP Corporate Development 30 years using licensing, partnerships and strategic acquisitions to boost the sales and profitability at several multinationals 4
5 Drug Delivery Pipeline in Dermatology Research Preclinical Phase 2 Phase 3 THERAPUETICS Anhydrous Hydrophilic Topical System 4 Patents Pending BPX-Retinoids BPX-Combinations BPX-Rosacea BPX-01-Acne COSMETICS AESTHETICS Injectable System BPX-02 Patents in Progress Encapsulation System 1 Patent Issued, 2 Pending 5
6 BioPharmX Unique Gel Delivery System Anhydrous Hydrophilic Topical Delivery System STABILIZES» Hydrophilic: non-occlusive, non-oily» Non-lipophilic (oil-based)» Suitable for APIs degraded in water SOLUBILIZES» Improves bioavailability» Not a suspension» Miscible w/ sebum Allows higher penetration and targeted delivery at lower concentration Optimizing Efficacy and Safety 6
7 Lead Product Candidate: BPX-01 is Differentiated Delivers leading antibiotic for acne, minocycline in unique topical gel formulation Improved Safety Profile» Low dose: 1% minocycline» Minimizes side effects» Low systemic exposure Strong Efficacy» Stabilizes & solubilizes minocycline» Delivered directly to sebaceous gland» Targeted penetration Positive Patient Experience» Rapidly absorbing» Non-staining» Non-oily» Non-fluorescing» 100% patient satisfaction in clinical trials Opportunity to DISRUPT moderate-to-severe acne market 7
8 BPX-01: Confirmed Delivery of Minocycline to Site Multiple Imaging Techniques Demonstrate Penetration Fluorescence Microscopy Fluorescence Microscopy» Shows penetration of minocycline (in pink) Untreated Control» BPX-01 1% achieves penetration to sebaceous gland with minimal epidermal residue» MALDI confirms spatial drug distribution of minocycline in sebaceous gland (target) Two-Photon Fluorescence BPX-01 (1%)» Provides evidence of rapid delivery of low concentration of minocycline to target» Developed in partnership with a leading university BPX-01 (4%) 8
9 BPX-01 Compared to Lipophilic Formulation Multiple doses of BPX-01 show quicker penetration and sustained effect:» BPX-01 1% has ~ 2-3 fold increased uptake compared to 1% lipophilic formulation» BPX-01 1% showed similar uptake to 4% lipophilic formulation at 4 hours Uptake (μg/cm2) Ex vivo Human Facial Skin Study 4% BPX-01 1% BPX-01 4% Lipophilic 1% Lipophilic Time (hrs) 9
10 Opportunity to Disrupt Global Acne Market* 2015 Global Acne Market Nears $10B» Moderate-to-severe acne market bifurcated and highly fragmented: Orals» High efficacy» Systemic side effects (dizziness, nausea, diarrhea) Topicals» Less effective» Non-systemic side effects (rashes, irritation, flaking) 2015 US Acne Market: $3.8B Revenue $1.6B Orals 4 leading products:» Valeant Solodyn» Almirall Acticlate» Galderma Oracea» Mayne Doryx» Significant physician and patient demand for innovation» BioPharmX topical gel formulation of minocycline is opportunity to become new standard of care $2.2B Topicals 6 leading products:» Galderma Epiduo» Allergan Aczone, Tazorac» Valeant Ziana, Retin-A-Micro» Bayer Finacea Source: SSR Health 2016 The holy grail in acne treatment is optimizing efficacy and tolerability. Dr. Ted Lain, Board certified dermatologist and BPX-01 investigator 10 * Source data on file
11 BPX-01 CLINICAL DEVELOPMENT 11
12 BPX-01: Phase 2a P. acnes Reduction Study» BPX-01 1% topical minocycline gel vs. vehicle control RESULTS STUDY DESIGN» 4-week, single-center US, randomized, double-blind study in 33 patients» Inclusion criteria: patients 18 to 40; >10,000 colonies/cm 2 of P. acnes» First-in-human study limited to measuring reduction in P. acnes and safety due to 4 week duration» Assessments at baseline, two, four and six weeks Primary Endpoint Achieved BPX-01 Minocycline (n=17) Log 10 mean change from Baseline at 4 weeks Log 10 mean change from Baseline % at 4 weeks % Secondary/Safety Endpoints» No drug-related adverse events» No detectable minocycline in plasma» No cutaneous toxicity» 100% patient satisfaction Vehicle (n=7) % 12
13 BPX-01: Phase 2a Safety Results Demonstrated Improved Safety Profile» No drug-related adverse events reported» No cases of cutaneous toxicity reported by investigators or patients at 2 and 4 weeks» No erythema, edema, peeling, hyperpigmentation» 100% patient satisfaction with usability and tolerability» No burning, stinging, tightness, or itching» No detectable levels of minocycline in plasma at 4 weeks Minocycline Plasma Concentrations (ng/ml) Study 1 Phase 2a Study 2 BPX-01 1% Vehicle Oral Minocycline Mean Mean Mean Baseline BLOQ BLOQ BLOQ Week 2 BLOQ BLOQ Week 4 BLOQ BLOQ BLOQ=Below Level of Quantification ( 50ng/mL) 13
14 BPX-01: Phase 2b Acne Vulgaris Study ENDPOINTS STUDY DESIGN» Randomized, double-blind, vehicle-controlled, dose-ranging study in 226 patients with moderate-to-severe acne» 12-week study evaluating 3 arms: 1% BPX-01, 2% BPX-01, vehicle» Conducted at 15 U.S. sites» Inclusion criteria: patients ages 9 to 40, IGA* moderate-to-severe, nonnodular inflammatory lesions Primary Endpoint» Absolute mean change in number of inflammatory lesions from baseline at week 12 Secondary Endpoint» Proportion of subjects with at least a two-grade reduction in IGA* (to clear 0 or almost clear 1 ) Safety/Exploratory Endpoints» Reduction in noninflammatory and nodular acne lesions» Cutaneous tolerance» Subject Global Assessment (SGA) TIMING» Topline results released May 2017» Comprehensive results provided June 1, * Investigator Global Assessment; based on scale of 0 (clear) to 4 (severe)
15 BPX-01: Phase 2b Topline Results BPX-01 2% (n=72) BPX-01 1% (n=73) Vehicle (n=74) RESULTS PRIMARY Mean change in inflammatory lesions SECONDARY Proportion with 2 grade reduction in IGA and clear to almost clear (p-value = 0.022) (p-value = 0.037) % 16.0% 17.1% Strong primary endpoint results: Statistically significant reduction in lesion count vs. vehicle at both 1% and 2% Clear numerical trend in IGA for 2% dose: Informs design and powering for phase 3 Phase 2b not powered to demonstrate statistical significance on IGA No serious drug-related adverse events; safety consistent with results of phase 2a Comprehensive data to be presented at June 1 event 15
16 BPX-01: Planned Phase 3 Acne Vulgaris Program ENDPOINTS STUDY DESIGN» Two randomized, double-blind, vehicle-controlled studies in patients with moderate-to-severe acne» 12-week study evaluating either BPX-01 1% or 2% minocycline» Trial size TBD after comprehensive Phase 2b data; conducted at U.S. sites» Inclusion criteria: patients ages 9 to 40, IGA moderate-to-severe, nonnodular inflammatory lesions Co-Primary Endpoint» Absolute mean change in number of inflammatory lesions from baseline at week 12» At least a two-point reduction in IGA to clear or almost clear TIMING» Request end of phase 2 meeting with FDA: 2Q 17» Phase 3 expected to begin in 3Q 17 16
17 Rosacea Clinical Development Overview PLANNED PHASE 2/3 FEASBILITY Feasibility Study» Open-label study: 20 patients with moderate-to-severe papulopustular rosacea» 12-week once-daily treatment with BPX-01 1% minocycline» Pending tolerability assessment at 4 weeks, initiate Phase 2/3» Assessment expected in Q1/Q2 Planned Phase 2/3» Multi-center, 12-week, randomized, double-blind study in 200 subjects with moderate-to-severe papulopustular rosacea» Inclusion criteria: patients ages >18, IGA of 3 or 4, minimum of inflammatory lesions at baseline» Co-Primary Endpoint:» Change in lesion count from baseline» Two-point improvement in IGA to clear or almost clear» Timing» Phase 2/3 expected to begin in 3Q 17 17
18 Market Development: Changing the Treatment Paradigm Established product profile supported by clinical evidence» Positive safety & efficacy data» 15 peer-reviewed publications/posters Renowned medical advisory board leading paradigm shift:» Ongoing stream of presentations at leading dermatology conferences» 9 presentations at AAD Strong network of KOLs/investigators engaged in peer-to-peer programs 18
19 2017 Anticipated Milestones Q1 Q2 Q3 Q4» AAD poster on BPX-01 acne development program» Society of Toxicology poster on BPX-01 safety profile» Rosacea feasibility assessment» BPX-01 Phase 2b topline data» Request end-of-phase 2 FDA meeting» Initiation of BPX-01 Phase 3 trial» DERM2017 Presentations» BPX-Rosacea Phase 2/3 begins» Advance one preclinical candidate into clinic (e.g. retinoids, combination) 19
20 Financial Information Capitalization» 74.1M shares outstanding» 131M fully-diluted shares» 40% institutional investors - Franklin Templeton Advisors and Vivo Capital Cash» $6.5 million as of January 31, 2017» + $4.5M raised in April (not included above) in offering to existing institutional investors» Sufficient cash to fund BPX-01 phase 2b clinical trial & advance R&D pipeline NYSE MKT: BPMX 1 On a pro-forma basis. Reported Fiscal Q316 cash of $0.5M plus $11.2M in net proceeds of secondary offering 20
21 Summary» Experienced management team» Significant opportunity to disrupt standard of care in the $3.8B acne market» Demonstrated therapeutic dose using 1% minocycline» Positive Phase 2a and Phase 2b study results; established path toward commercialization» Women s health asset, Violet, positioned for license and/or divestiture» Novel delivery system with potential for targeting multiple indications as well as incorporating additional APIs» Extensive R&D pipeline of other delivery platforms; biologics & encapsulation 21
22 THANK YOU
23 APPENDIX 23
24 2015 US Acne Market: $3.8B Revenue Branded prescription TOPICAL acne products WAC market share: Brand Name Active Pharmaceutical Ingredient(s) Manufacturer Sales ($mm) Epiduo Adapalene / BPO Galderma $452 Aczone Dapsone Allergan 369 Tazorac Tazarotene Allergan 211 Ziana Clindamycin / Tretinoin Valeant 197 Retin-A-Micro Tretinion Valeant 157 Finacea Azelaic Acid Bayer 148 Acanya Clindamycin / BPO Valeant 129 Onexton Clindamycin / BPO Valeant 123 Benzaclin Clindamycin / BPO Valeant % 5.6% 5.6% 5.9% 6.8% 7.2% 9.0% 20.7% 9.7% 16.9% Epiduo Aczone Tazorac Ziana Retin-A-Micro Finacea Acanya Onexton Benzaclin Other Other 294 Total: $2,181 Branded prescription ORAL acne products WAC market share: Brand Name Active Pharmaceutical Ingredient(s) Manufacturer Sales ($mm) Solodyn Minocycline Valeant $ % 24.0% Acticlate Oracea Acticlate Doxycycline Hyclate Almirall 389 Doryx Oracea Doxycycline Galderma 378 Doryx Doxycycline Actavis (now Mayne) 265 Zithromax Azithromycin Pfizer 15 Total: $1, % 16.4% 23.3% Zithromax Solodyn 24
25 BPX-01: >$1B Annual Market Opportunity (US & EU5) PATIENTS 75M 15M 4.5M 450K The US & EU5 Acne Market: 75 Million» Approximately 75M in US and EU5 Suffer from Acne Moderate to Severe: 15 Million» Approximately 20% of acne market suffers from moderate-to-severe acne Treated Population: 4.5 Million» Assuming only 30% of moderate-to-severe cases are being treated by a physician BPX-01 Market Share: 450K» Assuming a 10% market share capture Price / Patient / Year: $1,300 - $2,600» ~$500 per month US / ~$300 per month EU5 assuming week treatment regimen per patient per year $600M $1.2B BPX-01 US & EU5 Market Opportunity» Gross revenue 25
26 Prominent Medical Advisory Board Hilary Baldwin, MD Co-Chair Neal Bhatia, MD Co-Chair Diane S. Berson, MD» Past President, American Acne and Rosacea Society» Medical Director of the Acne Cure Alliance» Vice-Chair, Dept. of Derm., SUNY Downstate» Board of Directors, AAD » Editorial Boards: Practical Dermatology; The Dermatologist; J Clinical and Aesthetic Dermatology» Past President and Current Director, Women s Dermatologic Society» Director, American Society for Dermatologic Surgery» Director, Medical Council of the Skin Cancer Foundation» Founder, American Society of Cosmetic Dermatology and Aesthetic Surgery» Founder, the American Acne and Rosacea Society James Del Rosso, DO Julie Harper. MD Diane Thiboutot, MD Guy Webster, MD, PhD» Past President, American Acne and Rosacea Society» Past President, American Osteopathic College of Derm.» Past President, American Society for Mohs Surgery» Editor-in-Chief, J Clinical and Aesthetic Dermatology» Founding Director & current President- Elect of the American Acne and Rosacea Society» Currently serves on AAD s Acne Work Group» Past President, Alabama Dermatological Society» Past President, American Acne and Rosacea Society» Professor of Dermatology, Vice-Chair for Research for Dermatology, Hershey Medical Center» Founding President of the American Acne and Rosacea Society» Editorial Board for Dermatology Online Journal» Editorial Board for Clinics in Dermatology 26
27 BPX-01: Rigorous, Robust Phase 2 Program Option B Multiple phase 2 studies designed to mitigate phase 3 risk» Phase 2b powered to evaluate primary endpoint of lesion reduction» Provides insight on IGA endpoint to inform phase 3 size and scope» Experienced sites with dermatology specialists enable consistent IGA reporting» Inclusion of multiple patient-reported outcomes measures:» Cutaneous tolerance» SGA of severity and improvement» Evaluation of systemic exposure (plasma drug levels) 27
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