EX-99.1 2 neot-ex991_6.htm EX-99.1 neot-ex991_6.pptx.htm

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March 2016 Corporate Overview Exhibit 99.1

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Safe Harbor Statement This presentation, including the accompanying oral presentation, may contain forward-looking statements concerning our business, operations and financial condition as well as our future plans, objectives and expectations.  All forward-looking statements are subject to a number of risks, uncertainties and assumptions, and you should not rely upon forward-looking statements as predictions of future events.  All forward-looking statements will be based upon current estimates and expectations about future events and financial and other trends. There is no guarantee that future results, performance or events reflected in the forward-looking statements will be achieved or occur.  No person assumes responsibility for the accuracy and completeness of the forward-looking statements, and, except as required by law, no person undertakes any obligation to update any forward-looking statements for any reason after the date of this presentation. This presentation does not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offering of securities will only be made by means of a registration statement (including a prospectus) filed with the SEC and only after such registration statement becomes effective.  No such registration statement has become effective as of the date of this presentation.  Before you decide whether to buy securities, you should read when available the registration statement (including the prospectus and risk factors set forth therein), for more complete information about the company and any proposed offering. Please note that these materials contain proprietary and confidential information.  By accepting these materials, you agree that no part of this document may be reproduced, disseminated, shared with other parties, transmitted, or used in any way except for the purpose of evaluation, without the express written permission of Neothetics, Inc.

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LIPO-202: Key Highlights Source: Company Data, ASAPS 2015 Potential best-in-class non-surgical procedure to reduce fat in the central abdomen 505(b)(2), reference safety profile of ADVAIR® Commercially efficient and cash pay LIPO-202 (Salmeterol) Liposuction was the #1 cosmetic procedure in 2015 ~$2.8B was spent on cosmetic injectables in 2015 (20% growth YOY) Injectable drug option appeals to current aesthetic patients and new patients Low barrier to adoption, more physicians can do body contouring Expandable and Transformative Market Opportunity Clinically meaningful results in Phase 2 <1% of patients discontinue due to adverse events No damage to nearby tissues (nerves, hair follicles) No pain management before or after treatment Significant Results and Favorable Safety Profile

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Neothetics: Path Forward for LIPO-202 Develop modified formulation of LIPO-202, based on the drug product formulation used in the RESET trial Initiate Phase 2 trial of LIPO-202 in 3Q2016 for central abdominal bulging, top-line data in 1Q2017 Initiate Phase 2 proof of concept study of LIPO-202 in 3Q2016 for reduction of localized fat deposits under the chin (submental fat), top-line data in YE2016 Phase 3 studies demonstrated near identical results to each other with no bias in sites or subgroups Results inconsistent with Phase 2 program Expert consultants engaged to review LIPO-202 formulation used in Phase 3 trials Expert consultants concluded that modifications to make LIPO-202 commercially ready may have affected the drug product December 2015 Neothetics reported negative results for Phase 3 Trials, AbCONTOUR1 and AbCONTOUR2 LIPO-202 demonstrated no difference from placebo in co-primary or secondary endpoints Safety profile of LIPO-202 was similar to placebo Path Forward What We Learned What Happened

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Smooth Results LIPO-202: Changing the Landscape of Body Contouring Meaningful change in central abdomen Measurable results as early as Week 4 No post-treatment divots or irregularities reported Volume reduction limited volume liposuction   Safety Profile Extremely Favorable No treatment-related serious adverse events No pain management necessary before or after procedure < 1% of subjects discontinue due to adverse events Simplicity of a Syringe Easy to administer; incremental to the practice No capital equipment required Low risk, low barrier to entry

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Current Cosmetic Patients are Asking Their Doctor About Body Contouring of the Abdomen “On what part(s) of your body would you like to reduce the amount of fat?” >80% Mention Abdominal Area Source: Company Market Research conducted in 2014

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LIPO-202: Expanding Body Contouring Options, Right Balance of Benefits Reduction in line with limited volume liposuction Results in as early as 4 weeks Visible Results AE’s in line with placebo NO damage to nearby tissues (nerves, hair follicles) NO paresthesia Favorable Safety Profile No capital equipment investment Simple ~15 minute procedure Incremental to practice Low Barriers To Entry No visible signs that procedure was done Truly a lunch time procedure No Recovery Time Volume reduction similar to limited volume liposuction Clinically Meaningful Results Clinical Efficacy

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LIPO-202: Potential Best-in-Class Non-Surgical Procedure TRIGGERS BODY’S OWN PROCESS OF TRIGLYCERIDE METABLISM LOCALIZED Affects only fat cells; does not affect other structures in the tissue GENTLE No necrosis; No need for pain medication; No downtime Baseline

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LIPO-202: Well Understood, Targeted Mechanism of Action Triggers the natural process of burning fat – “spot reduction” Reduces size/volume of fat cells in treatment area Selectively targets fat cells; no damage to nearby tissues Mimicking The Body’s Natural Metabolic Process Fat (trigylceride) is stored in adipocytes, which expand in size until fat is used for fuel LIPO-202 stimulates fat metabolism, reducing adipocyte size

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LIPO-202: Phase 2 Clinical Program Phase 2 Clinical Program Highlights Consistent results across trials No treatment related adverse events Volume reduction similar to limited volume liposuction Defined dose-response curve Single agent SX formulation chosen Weekly 0.4 microgram dose chosen Post treatment area uniform, smooth and flat; no divots or irregularities Endpoint tools selected Achieved Phase 2 Primary and Secondary Endpoints in RESET

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Phase 2 RESET Trial: Protocol Inclusion Criteria Male or non-pregnant female Good general health Active & on a stable diet Good skin elasticity BMI < 30 Bulging that fits treatment grid (~400 cm2) P-GAPS & C-GAPS of “Slight Bulge, Not Flat” or greater Dissatisfaction with abdominal contour History of stable weight in past 3 months Exclusion Criteria Pannus or excess skin Bulging due to visceral fat Known hypersensitivity to study drugs Treatment with an investigational agent within 30 days of first dose Strong CYP3A inhibitors Any prior treatment of abdominal contour defect RANDOMI ZAT I ON LIPO-202 DOSE = 4.0 µg SX N = 125 LIPO-202 DOSE = 1.0 µg SX N = 125 Placebo N = 125 Endpoints SAFETY assessments  Vital signs, injection site assessment, clinical laboratory tests (hematology, and serum chemistry) and adverse events Subjective EFFICACY assessments  Patient and Clinician Global Abdominal Perception Scale at baseline and at Days 29 and 57 (P-GAPS & C-GAPS) Patient and Clinician Photo-numeric Scale at baseline and at Days 29 and 57 (PPnS & CPnS) Abdominal Contour Questionnaire (ACQ) at baseline and at Days 29 and 57 Patient Global Treatment Assessment Question at Day 57 Objective EFFICACY assessments  MRI assessments of abdominal volume and circumference at baseline and at Days 29 and 57 Manual tape abdominal circumference at baseline and at Days 29 and 57 Caliper assessment of abdominal skin-fold thickness at baseline and at Days 29 and 57 20 Weekly Injections for 8 Weeks LIPO-202 DOSE = 0.4 µg SX N = 125

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Phase 2 RESET Trial: Primary Endpoint Tools Validated CLINICIAN Photonumeric Rating Scale (CPnS) Validated PATIENT Global Assessment Rating Scale (P-GAPs) Male Female Responders demonstrate > 2-Point P-GAPS + > 2-Point CPnS How Does Your Belly Look Today? ¨ Flat ¨ Almost Flat ¨ Slight Bulge, Not Flat ¨ Bulge ¨ Big Bulge

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Phase 2 RESET Trial: Secondary, Objective, Confirmatory Endpoint Tool QUANTITATIVE: Highly Standardized, Precise and Reproducable Laser-Guided Tape Measure

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% 1-Point P-GAPS / 2-Point CPnS Composite Responders at Day 57 Phase 2 RESET Trial: Results Statistically Significant and “Clinically Meaningful” % 2-Point P-GAPS / 2-Point CPnS Composite Responders at Day 57 p=0.043 p=0.024 Placebo LIPO-202 0.4 µg Placebo LIPO-202 0.4 µg Source: Krochmal LM, et al. (2015) Aesthetic Treatment of Central Abdominal Bulging (CAB) with LIPO-202 (Salmeterol Xinafoate for Injection). J Dermatology and Clin Res 3(3): 1050

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Statistically Significant Reductions in Treatment Area Circumference and Volume RESET: Change in Treatment Area Volume* (+35 to -70 mm) Phase 2 RESET Trial: Results RESET: Change in Umbilical Circumference* p=0.001 p=0.001 Placebo LIPO-202 0.4 µg Day 57 Day 57 Placebo LIPO-202 0.4 µg *Calculated from tape circumference Source: Krochmal LM, et al. (2015) Aesthetic Treatment of Central Abdominal Bulging (CAB) with LIPO-202 (Salmeterol Xinafoate for Injection). J Dermatology and Clin Res 3(3): 1050

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Volume Reduction Consistent With Limited Volume Liposuction VAL-CL-10: Change in Treatment Area Volume with Limited Volume Liposuction Phase 2 RESET Trial: Results RESET: Change in Treatment Area Volume* p=0.001 p=0.001 Day 57 Week 10 Canfield 3D Calc from Tape Placebo LIPO-202 0.4 µg *Calculated from tape circumference Source: Cohen et al., Aesthetic Surg J 32(5):593-600, 2012

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RESET Results: Favorable Safety and Tolerability Profile Treatment-Related Adverse Effects Similar to Placebo* Adverse Effect Placebo (n=130) 0.4 µg SX (n=132) 1.0 µg SX (n=124) 4.0 µg SX (n=127) Any adverse event definitely or possibly related to study drug 10% 11% 12% 12% Injection site reactions 5% 8% 10% 9% Injection site hematoma 2% 5% 6% 6% Injection site pain 2% 2% 2% 2% Injection site erythema 2% 2% <1% 0% Injection site hemorrhage 2% 0% 0% 0% *Primarily mild injection site reactions due to needle sticks.

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LIPO-202: Shrinking Unwanted Bulge Post-treatment area flatter without divots or irregularities Photos reflect ONLY treatment of central bulge (NOT flanks or back) Results seen as early as week 4 Safety similar to placebo injections Baseline Week 8

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LIPO-202: Shrinking Unwanted Bulge Post-treatment area flatter without divots or irregularities Photos reflect ONLY treatment of central bulge (NOT flanks or back) Results seen as early as week 4 Safety similar to placebo injections Baseline Week 8

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LIPO-202: Shrinking Unwanted Bulge Male patients accounted for ~17% of nonsurgical fat reduction in 2015 Male patients want options that are quick and discrete Photos reflect ONLY treatment of central bulge (NOT flanks or back) Baseline Week 8 Source: Company data, ASAPS 2015

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LIPO-202: Meeting the Needs of Doctors and Consumers My patients are satisfied! Clinical efficacy Consistent results No side effects to explain and justify Easy to incorporate into the practice What Doctors Want I look better in my clothes! Visible results…Quickly No downtime No discomfort Discreet What Consumers Want Smooth, consistent results…in as early as 4 weeks No downtime; go straight back to work Short procedure time No capital equipment purchase – Low risk investment for physicians LIPO-202

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LIPO-202: Initial Target, Current Injectable Consumers Core target finds LIPO-202 appealing (90%) 80% of these consumers are interested in contouring their abdomen These consumers are very valuable to the practice 33% of these consumers have already had a body contouring procedure And they will have more…on average 4.7 procedures ~2.8M Interested in LIPO-202 ~3.8M Injectable Users ~3M Want to Contour Their Abdomen Source: Company Research, ASAPS 2015, Plastic Surgery Statistics Report 2014, US Market 2018E

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LIPO-202: Broader Target, New Body Contouring Patients There is a large and growing patient population 50% of US consumers are considering an aesthetic treatment LIPO-202 is highly appealing 66% of consumers are interested Key consumer attributes No recovery time Minimal side effects Reduction is in the range of what I want to lose Sources: US Census Data; ASDS Annual Consumer Procedures Survey 2015, Company Research 2014 160M People 18-55 83M HHI>$50K US Market 2018E 32M Interested in LIPO-202 49M BMI >18.5 but <30

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LIPO-202: Tiered Approach to Physician Targeting Sources: Company research, ASDS, IMS, Industry Data Focus on High Current and Future Utilizers High Volume Aesthetic Doctors (3,000) Cosmetic Dermatologists (5,000) Cosmetic procedures are concentrated among ~3,000 doctors Early adopters of new treatment options Easily combined with other body contouring procedures ~65% are not performing body contouring~3,000 Capital investment is a deterrent LIPO-202 is a low risk entry to the category

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Capitalization $37.7M Cash 4Q2015 13.7M Basic Shares 17M Diluted Shares $10M Debt4Q2015

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Key Milestones 2016 and Beyond Q3 2016: Initiate Phase 2 study of LIPO-202 for central abdominal bulging Q3 2016: Initiate Phase 2 proof of concept study of LIPO-202 for submental fat YE 2016: Top-line Phase 2 proof of concept data for LIPO-202 in submental fat Q1 2017: Top-line Phase 2 data for LIPO-202 in central abdominal bulging

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Intellectual Property 801 / 802 Combination and single-agent treatment method and composition patents Protection at least until 2026 803 Treatment method and composition patents Protection to 2030 Issued 804 Compositions and formulations Potential protection to 2031 805 Treatment method and composition claims Potential protection to 2031 Pending

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Leadership Team and Board Kim Kamdar Domain Associates Martha Demski Independent, CFO-Ajinomoto Althea Maxim Gorbachev RusnanoMedInvest Jeffrey Nugent Chairman and Chief Executive Officer Sientra Operating Committee (Martha Demski , Kim Kamdar, Jeffrey Nugent) Fara Berkowitz, RPh , PharmD Senior Director Investor Relations and Corporate Development Susan Knudson Chief Financial Officer Ken Locke, PhD . Chief Scientific Officer Maria Feldman VP, Clinical Research and Operations, Regulatory Affairs and Quality Assurance

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www.neothetics.com