Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — IPO Roadshow (March 2014)
28 slides from Aldeyra Therapeutics's IPO roadshow presentation, Mar 21, 2014
Slide 1: A Pharmaceutical Platform Focused on Trapping Aldehydes
Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333-193204 March 21, 2014 A Pharmaceutical Platform Focused on Trapping Aldehydes
Slide 2: Forward-Looking Statements
Forward-Looking This “objective,” intended you sufficiency which labeling ability expectations product Forward-looking performances by in Although our result Registration financial developments You 2inherent the law, actual should should presentation of, future. we towe candidates; for in to conditi
Slide 3: Free Writing Prospectus notice
Freebecome This We yet information website Alternatively, 10019, have Writing presentation telephone: atfiled http://www.sec.gov. effective. about Prospectus we a registration or highlights 212-813-1010, usany and Before underwriter Statement thestatement basic offering. you invest, e-mail: informat
Slide 4: Offering Summary
Offering Issuer Clinical Use 4Sole of Book-Runner Aldeyra Proceeds development Summary Therapeutics, and Aegis other of NS2, Capital general Inc. working Corp. Exchange/Ticker corporate capital, purposes NASDAQ Capital Market / ALDX Shares Offered 2,275,000 (100% primary) Over-Allotment 15% or 341,2
Slide 5: Management and Board of Directors
Management business Domain Xanthus/Antisoma), Pharmaceuticals –Scott Oxigene, 5Todd overYoung Genetics Brady, Brady 15Associates, 25and Repligen years Institute, ––M.D., clinical and CEO Chief of(acquired Directors pharmaceutical Ph.D. Aldeyra Phenome Genzyme, Aderis Operating development –by Presid
Slide 6: Investment Highlights
Investment Unique, Rare Modest $10M Initiate Lead Large Markets Strong Extend Marquee 6Johnson and compound Markets for Patent four to Funding Innovative for & Investors mass-market currently late Johnson Highlights orphan Phase Portfolio 2020s with in Required II Validate 4planned indications Platf
Slide 7: NS2 Product Portfolio
NS2Ocular Sjögren- Discoid Rare No Formulation Topical Issued DATA Sjögren-Larsson Ocular 7(1) FDA-Market Product Disease EXPECTED Issued Rosacea Ocular Acute Rosacea Dermatologic Portfolio Rare Issued Larsson (1) Syndrome with Disease with IN Issued No SECOND Anterior Meibomian FDA- Topical Rare (D
Slide 8: Aldehydes Are Toxic and Implicated in Disease
Aldehydes Toxic Modify Dehydrogenases Modification High 8Cytokine levels mediators cellular Release Are are eliminate Mediators implicated constituents, of attempt NF-KB numerous free toActivation of inMetabolism aldehydes Disease Free autoimmune, diseases Aldehydes inflammatory, lead to indigestibl
Slide 9: Aldeyra's Novel Therapeutic Approach: Aldehyde Traps
Aldehyde Adduct Cellular 9Aldeyra’s ••Trapped Drug Traps: •lead Aldeyra’s aldehyde and Aaldehydes Novel aldehydes compounds trap, Therapeutic are NS2, are Transport rapidly Disposal appears Approach trap transported metabolized to Binding have minimal to free within thealdehydes pharmacology; lysoso
Slide 10: Trapping Aldehydes Generates Broad Anti-Inflammatory Response
Trapping Mice endotoxin 0% Levels hours Cytokine *** In 10 an-80% endotoxin treated after -20% Aldehydes ** Reduction exposure; endotoxin Vehicle with model NS2 Generates TNF-a in ** exposure of or -60% -100% cytokine vehicle IL-1b **a-40% ** vs. Broad 30 IL-5 p<0.01 generation minutes IL-17 Anti-In
Slide 11: NS2 Decreases Inflammation in Animal Models
NS2 0)150 Vehicle Murine Single 11 )0* 150 p<0.05 Decreases dose Model NS2of (mm Vehicle NS2 of Dermal (mm Contact has NS2 ** Inflammation early Dermatitis p<0.01 and potent * Thickness (PMA) in Animal anti-inflammatory Murine 100Models **Model Thickness effect of Allergic 100 thatEar reduces Dermat
Slide 12: NS2 Reduces Scarring and Mucositis in Animal Models
Hamster 3V 026Severe NS Day NS2 12 ehicle 21 None 36 Speeds Minimal speeds Moderate cheek lesion Healing pouch p=0.1 healing and radiation-induced Score Reduces and 2reduces Score Scarring Marked scarring oralofmucositis Lesions mucositis in a model in Animal p=0.01 of skinModels Fibrosis and eye1di
Slide 13: NS2 Protects Human Skin and Eye Cells
Aldehyde- p<0.01 Normal NS2 13 Protects prevents SLSAldehyde SLS aaldehyde-mediated KeyMutants Lipid Damaged Relevant + Human Aldehyde- damage toSkin SkinCells of Lipid and lipid Eye Cells Damaged that Disease Mutants is critical Control inNS2 Cell to dermal Lipid Systems NS2+Aldehyde moisture barri
Slide 14: NS2 Reduces Malondialdehyde Levels in Human Tissue
NS2 Malondialdehyde Human 25 Levels Aldehyde Normal Potential (Including 14 )MTraps 10 20 Skin Tissue toLevels Sjögren-Larsson Aldehydes reduce Tissue Dry (Malondialdehyde concentration aldehyde-mediated Tissue Human Generated Dry Syndrome Ocular Tissue inbyhuman Tissue Dry mM) +damage and NS2 Condi
Slide 15: Summary of NS2 Mechanisms of Action
Decreased NS2 Anti-inflammatory Lesion The 15 same Summary Healing biological Aldehyde of Anti-fibrotic Efficacy: Load mechanisms Lipid Multiple Protection mayMechanisms apply to many of Action rare and prevalent diseases.
Slide 16: Phase I Eye Drop Results
-oPositive 16 Single Seven Two 48 healthy Double treatment day day NS2 masked 0.25% 0.25% volunteers Eyestages and Drop & & 0.5% placebo 0.5% for Phase two qid bidIcontrolled drug oResults &Eye qidconcentrations: drops were well tolerated in all treatment groups o No plasma exposure detected by LC-M
Slide 17: Acute Anterior Uveitis and Ocular Rosacea
Acuteexceed Rosacea Uveitis Ocular Pain, May Estimated 10M Aldehydes 17 patients Burning/itching, Anterior anterior are 25,000 patients/year Ocular inflammatory Uveitis USocular photophobia, and Ocular mediators inflammation Rosacea eyelid of both swelling, inflammation withocular Meibomian loss dis
Slide 18: Anticipated Ocular Clinical Trial Designs
Anticipated Acute Uveitis Formulation Treatment Endpoints (1) 18 Ocular Anterior Ocular Cell Time Rosacea Clinical EyeRosacea Counts, 8Drop weeks with Trial Eye Symptoms (1) Meibomian 12 Designs Drop weeksControl for Ocular Gland Ocular Active Signs, Dysfunction Disease 1:1 Symptoms Placebo 1:1 Tota
Slide 19: Sjögren-Larsson Syndrome: A Rare Disease
Sjögren-Larsson Rare Symptoms Diagnosed 50s (1) 19 Extrapolating Europe diseaseat include (1) caused birth, would Syndrome from by butbe mutation aEstimated Swedish analogous (SLS): in estimate, no Fatty Atoapproved Rare ansevere enzyme Disease it istherapy skin generally replacement with thickening
Slide 20: Discoid Lupus: A Rare Disease of the Skin
Discoid Rare Steroids reduce 20 disease inflammation, Lupus: commonly Symptoms A Rare Estimated promote Disease associated prevalence healing, of Skin withand high isdiminish prescribed characterized scarring but toxicity by lesions 100,000 aldehyde patients levelsinand the that Therapeutic are infl
Slide 21: Anticipated Dermatologic Clinical Trial Designs
Anticipated Discoid Sjögren-Larsson Formulation Syndrome Treatment Endpoints 21 Lupus Visual Time Clinical Dermal 8Rating weeks Trial Topical CLASI 12 Designs weeks DermalForTopical Dermatologic Control Disease Placebo 1:1 Placebo 1:1 Total Patients 12 Patients 20 Patients
Slide 22: Unmet Medical Need for Our Clinical Indications
Unmet We There Therapies 22 believe isMedical nofor market FDA-approved discoid Need demand lupus for Our therapy is andsubstantial Clinical acute foranterior Indications Sjögren-Larsson Ocular for a uveitis Rosacea novel therapy arewith Syndrome associated Meibomian that is safe withand Gland signi
Slide 23: Orphan Drug Pricing Is Attractive
Orphan Twice Payer >$200,000 *Total 23NS2US research per has Topical SLS day not permarket: received surface year Estimated Drug: Pricing higher Attractive area ~$200M orphan forconfirms pricing treatment Cutaneous designation Pricing, for similar treated aLymphoma topical Large or SLS Market 25% th
Slide 24: Intellectual Property Portfolio
Intellectual Formulation Method NS2 *Pending 24 to 2033 Uses inProperty Brazil, Topical in forUS, aldehyde India assuming dosing Portfolio: traps Hatch-Composition Composition in diseases of Matter Waxman into the extension; 2030s Issued or allowed worldwide*
Slide 25: Rare Disease Valuation Comparables
Diseases Company Aldeyra (midpoint Bluebird Sarepta Intercept Rare (1) 25 Anticipated $77M Disease disease-focused Therapeutics Therapeutics in Bio Pharmaceuticals Stage post-money) (BLUE) Company by Phase end(SRPT) biotechnology (ALDX) Phase II ofValuation or 2014, (ICPT) III IIPhase Valuation 2Pha
Slide 26: Pre-IPO Capitalization
Pre-IPO Capitalization Common (1) (3) 26 Includes Common Capital Stock Preferred Stock Shares (1) Structure 3,970,164 to Outstanding be Stock issued to85% be upon converted %Stock Outstanding net exercise Options to Common of (2)outstanding 609,842 Stock13% atwarrants IPO Warrants (2) Does at IPO (3
Slide 27: Use of Proceeds
Use –Research Working Data 27Orphan Phase of from Proceeds II/III III capital and for designations, for allNS2 for trials Development: discoid acute ocular and and Sjögren-Larsson oral expected anterior other rosacea News lupus administration INDgeneral Flow uveitis $10M filings, in 2015 Syndrome co
Slide 28: Investment Highlights
Investment Rare, Orphan Modest $10M Initiate Lead Large Markets Strong Extend Marquee Johnson 28 compound Innovative Markets for Patent four to and Funding for &Investors currently late Johnson Highlights mass-market orphan Phase Portfolio 2020s with in Required Platform II Validate 4planned indicat