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1 CORPORATE OVERVIEW Products to Diagnose and Treat Gastrointestinal Diseases Today

CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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Page 1: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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CORPORATE OVERVIEW

Products to Diagnose and Treat Gastrointestinal Diseases Today

Page 2: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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WHO WE ARE

Page 3: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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OUR COMPANYAries Pharmaceuticals

Aries Pharmaceuticals Inc., a San Diego-based,

specialty pharmaceutical and medical device company,

is focused on developing and commercializing best in

class products in endoscopy and to treat

gastrointestinal diseases. We are a wholly owned

subsidiary of Aries Pharmaceuticals, Ltd., which is a

wholly owned Subsidiary of Cosmo Pharmaceuticals,

NV. Aries is in charge of the US distribution of the

Cosmo products.

Page 4: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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MEET OUR MANAGEMENT TEAM

Teri ChuppeVice President,

Controller

Mike WaltherVice President of Marketing

Blake BolandSenior Vice President of

Sales

Jon HeeChief

Commercial Officer

Tom JoycePresident and C.E.O

David KrieselExecutive

Director of Medical Affairs

Page 5: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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OUR PRODUCTSImproving healthcare with better endoscopy/gastrointestinal focused products

Eleview™, Aries’ anticipated first product

to market, is an injectable composition

intended for use in gastrointestinal

endoscopic procedures for submucosal lift

of polyps, adenomas, early stage cancers

or other mucosal lesions prior to excision.

Remimazolam is currently in phase III

development for procedural sedation with

recently announced positive phase III data

in patients undergoing colonoscopy. The

completion of the 2nd pivotal study in

Bronchoscopy patients is expected to be

completed in Q2 2017. In-licensed by

Cosmo Pharmaceuticals from PAION.

Rifamycin SV MMX is a pharmaceutical

product employing MMX® technology.

Aries recently announced positive phase III

data in travelers’ diarrhea and phase II

trials underway for IBS-D and

uncomplicated diverticulitis.

Methylene Blue MMX, also called

LumeBlue, is a novel application of

methylene blue, a coloring agent that is

used to stain the mucosa to discover

pre-cancerous lesions and polyps in the

colon. Aries recently announced phase III

data in the increase of adenoma

detection rate in colonoscopies

compared to standard of care.

LumeBlue®

Page 6: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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COSMO PHARMACEUTICALS, NVOur parent company

Cosmo (COPN:SW), a Dutch pharmaceutical and

medical device company founded in Italy, aims to

become a global leader in the market of optimized

therapies for selected gastrointestinal diseases

including Inflammatory Bowel Diseases (IBD), colon

infections and colon diagnosis. Cosmo’s proprietary

MMX® technology is at the core of the company’s

product pipeline.

Page 7: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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COSMO PHARMACEUTICALS, NV

• COPN:SW (SIX SWISS EX)

• Shares : 14,419 M

• Market Cap: 2.568B

• Revenue (ttm): 76.22M

• EBITDA: 32.25M

• Headquarters: Dublin, Ireland

• Employees: 201-500

• Founded: 1996

Page 8: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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TECHNOLOGY

Page 9: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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MMX® MULTI MATRIX TECHNOLOGY

• Allows the delivery of active pharmaceutical ingredients into the lumen of the colon through tablets in a delayed and controlled extent with the effect that the active pharmaceutical ingredients can be applied to the full length of the colon

• The tablets manufactured according to the MMX technology are coated with pH-resistant acrylic copolymers which delay the release until the tablet reaches the indicated intestinal location where the programmed dissolution begins

• That allows for protection of the active substances from adverse pH conditions and enzymatic presence in the upper digestive tracts

• The controlled release over the length of the colon not only simplifies the application for the patients but allows for the topical application of the active pharmaceutical ingredients to the whole bowel surface that is affected by inflammations

• This technology may also be used for other diseases affecting the colon and can be used as a platform for applications outside the colon where a controlled release is of importance

Cosmo develops a range of pharmaceutical product projects that are based on MMX® technology

Page 10: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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PRODUCT DEVELOPMENT

Page 11: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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OUR PRODUCTSImproving healthcare with better endoscopy/gastrointestinal focused products

LumeBlue®

Page 12: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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PRODUCT / CANDIDATE PHASE 1 PHASE 2 PHASE 3 APPROVED NEXT MILESTONE

Launch May 2017

NDA FilingJune 2017

NDA FilingSeptember 2017

Bronchoscopy Trial Completion 1H 2017

OUR PRODUCT PIPELINEImproving healthcare with better endoscopy/gastrointestinal-focused products

LumeBlue®

ZEMCOLO®

Page 13: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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METHYLENE BLUE MMX TO IMPROVE ADENOMA DETECTION RATE DURING COLONOSCOPY

LuMeBlue®

• Adenoma detection rates are a primary quality indicator for colonoscopy

• Methylene blue MMX is a locally-acting vital dye indicated for enhanced visualization of adenoma in patients undergoing colonoscopy

• Oral tablets with MMX technology allows targeted delivery to the colon

• Studied in a ‘one of a kind’ multicenter, placebo controlled trial with 1270 patients

– Endoscopy charter required HDWL

– Colonoscopies all recorded and centrally reviewed

– Lesions all rated by central histologist

• NDA submission anticipated June 2017

47.81%

56.29%

42%

44%

46%

48%

50%

52%

54%

56%

58%Proportion of Patients ≥1 Proven Adenoma / Carcinoma*

HDWL+PBO HDWL+MB 200 mg*Full Analysis SetHDWL = high definition white light; PBO = placebo; MB = methylene blue

P=0.0099

+18% Gain with MB

Phase 3 Data Highlights

Page 14: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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RIFAMYCIN SV MMX TO ADDRESS GI-TRACT INFECTIONSZEMCOLO®

• Systemic antibiotics may be associated with greater drug interactions, side effects, and bacterial resistance

• Rifamycin SV MMX is a broad-spectrum non-absorbed antibiotic with strong eradicating effect across a variety of common GI pathogens

• Oral tablets with MMX technology allows targeted delivery to the colon

• Studied in two phase 3 trials for the treatment of traveler’s diarrhea

• Rifamycin SV MMX vs. Placebo • Rifamycin SV MMX vs. Ciprofloxacin

• NDA submission anticipated September 2017

• Additional potential indications are under investigation

Phase 3 Data Highlights

Time to last unformed stoolRifamycin SV MMX vs. Placebo

Time to last unformed stoolRifamycin SV MMX vs. Ciprofloxacin

P=0.0018for non-inferiority

P=0.0008for superiority

ITT Population

Page 15: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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REMIMAZOLAM TO ADDRESS GI-TRACT INFECTIONS

• Current sedatives attempt to balance onset, duration of action, reversal potential, and potential adverse events

• Bundling for colonoscopy services creates an incentive for GI-directed procedural anesthesia

• Remimazolam is an IV benzodiazepine with more rapid onset/reversal than midazolam while not requiring anesthesiologist-monitoring like propofol

• Large phase 3 trial for colonoscopy sedation completed

• Remimazolam vs. placebo vs. midazolam• Safety study in ASA III/IV patients ongoing

• Additional phase 3 trial for bronchoscopy sedation underway

Phase 3 Data Highlights

Chi-squared test for dependency

25.2%

1.7%

91.3%

0%

20%

40%

60%

80%

100%

Success of Procedure*

Midazolam Placebo Remimazolam

*Requires all: completion of colonoscopy, no requirement for rescue sedative medication, no more than 5 doses of study medication with 15 minute window for placebo and remimazolam,

no more than 3 doses within 12 minute window for midazolam

P<0.0001 P<0.001

Page 16: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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MANUFACTURING

Page 17: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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MANUFACTURING

• Solid and liquid forms for oral administration (tablets, capsules, granules, powders, syrups, solutions and suspensions)

• Topical dosage form (solutions, emulsions, gels, creams, ointments and suppositories)

• Injectable forms by final sterilization (cartridge ampoules for local nerve anesthesia)

• A significant portion of the company’s production is focused on pharmaceuticals in solid forms. The manufacturing process is controlled with respect to the raw materials and process parameters as well as final product quality. The controls are conducted according to procedures which comply with the provisions of Good Manufacturing Practices (GMP).

• Furthermore, the FDA has certified Cosmo for the production of Lialda®/ Mezavant® and Uceris® / Cortiment® tablets for the US market

Cosmo produces Aries’ pharmaceuticals at the company's facilities in Lainate, Milan

Page 18: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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OVERVIEW

Page 19: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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ELEVIEW™ OVERVIEW

• Colored clear emulsion submucosal injectable composition

• Delivers an immediate and long-lasting submucosal cushion of optimal height and duration

• Methylene Blue contrast agent offers greater margin visibility and submucosal layer staining

• Potentially reduces risk of perforations, adverse events, and post-op complications

• Used with standard, commercially available endoscopic injection needle – no special apparatus or equipment

Designed to allow the endoscopist an easy and safe endoscopic procedure

Page 20: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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ELEVIEW™ OFFERS GREATER VISIBILITY OF MARGINS FOR IMPROVED PROCEDURAL VISIONImproved margin visualization decreases the risk of damaging the external muscular layer, which could lead to perforation

Inject to form a submucosal cushion of optimal height and duration

Cushions last up to 45 minutes facilitating an easy and safe resection procedure

Methylene blue provides detailed delineation of the lesion edges and stains the submucosa, facilitating identification of muscle injury and enhancing the postresection view.

Reconfigures to form a colored cushion that pushes the mucosa away from the submucosa

Page 21: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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THE COMPONENTS OF ELEVIEW™ ARE DESIGNED TO CREATE A BETTER CUSHION1,2

Transforms upon injection to occupy the interstitial space, for a cushion of optimal height

EleviewTM Instructions for Use. Aries Pharmaceuticals, Inc. September 2016. Data on file.

Material Function

Water for injection Solvent

Medium chain triglycerides Oil component

Poloxamer 188 Bulking-cushioning agent

Polyoxyl-15-hydrostearate Emulsifier

Sodium chloride Osmotic agent

Methylene blue Dye enhances visibility

Page 22: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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ELEVIEW™ HAS A LONG-LASTING CUSHION DURATION OF UP TO 45 MINUTESEleviewTM demonstrated better cushion forming ability and duration when compared to saline*

*In an ex vivo porcine gastric mucosa model

Cushion Height As a Function of Time for Eleview™ versus Normal Saline

-52.9

-2.4

-60

-50

-40

-30

-20

-10

0Normal Saline Eleview

Perc

enta

ge D

ecre

ase

50 10 15 20 25 30 35 40 450

2000400060008000

10,00012,00014,00016,00018,000

Time (minutes)

Cush

ion

Heig

ht (m

m)

Percentage Reduction in Cushion Height After 45 Minutes for Eleview™ versus Normal Saline

Eleview™

Saline

Page 23: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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MARKETING & SALES

Page 24: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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ELEVIEW™ BRAND GOAL

Establish Eleview™ as thesuperior submucosal

injection standard when performing GI endoscopic

resection procedures

Page 25: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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ELEVIEW™ LAUNCHING MAY 2017 IN THE USFDA approved in September 2015

Page 26: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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INTEGRATED LAUNCH PLATFORM

Advertising & Communication Strategy

Medical Conference & Events

Medical /Scientific Education

Access and Distribution

Multi-Channel, Multi-Customer Resourcing

Advocacy and Early Experience

Page 27: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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KEY STUDY FIND ELEVIEW™ EFFECTIVE AND SAFE

Page 28: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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NEXT STEPS

Page 29: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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WHAT’S NEXT

• List

Measurable Goals and Outcomes

Page 30: CORPORATE OVERVIEW€¦ · Improving healthcare with better endoscopy/gastrointestinal focused products. Eleview™, Aries’ anticipated first product to market, is an injectable

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THANK YOU!