Harrow, Inc. · NASDAQ:HROW
Harrow — Imprimis Pharmaceuticals — Corporate Update (October 2017)
36 slides from Harrow's corporate update, Oct 24, 2017
Slide 1: October 2017
October 2017
Slide 2: Shareholder Harbor
SHA geF RE HARBOR
Slide 3: Abstract
A BS | R A CL Surface, a subsidiary of Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), will be financed and managed as a separate entity Led by an experienced and proven management and board of directors team Focus is development of branded 505(b)(2) patent-pending drug candidates for the ocular surf
Slide 4: Problem
PROBLEM Ahigh percentage of patients suffering from DED do not respond to current therapies! = Drug idates int segments of the multi-billion dollar DRY EYE DISEASE (DED) ma M+ blepharitis market* Topical formulatio livery vehic nabilitate th rface dr
Slide 5: Surface Drug Candidates
SURFACE DRUG = = Three proprietary,drug candidates C AN DIDATES For up to five indieations: — =< BETAMETHASONE + LOW DOSE DOXYCYCLINE + OMEGA-3 CAPSULE MYCOPHENOLIC ACID SURF- + KLARITY 200 (drug incumbents: Restasis/Xiidra) [drug incumbents: Lotemax-off label) = Recalcitrant dry eye = end Gneimsed
Slide 6: Dry Eye Disease Market Dynamics
DRYEYE DED is ubiquitous, complex, and not a single | disease of the ocular surface and tears DISEASE MARKET DED affects patient populations differently and DYNAMICS au depending 30 million patien r from DED? of irritation, including blurred anc sion accompanied by increased o inflammation of 30+ MI
Slide 7: Dry Eye Disease Market Dynamics
DRYEYE DISEASE MARKET DED is categorized and treated based ona iD) Y N A M | Cc S change in physiology and pathology: = Surface’s drug candidates have been formulated to target patients who do not respondto current therapies Non-responders are the largest group of DED patients for each category
Slide 8: Formulation Real World Use as 505(b)(2) Development
FORMULATION REAL WORLD USE AS 505(B)(2) DEVELOPMENT DEVELOPMENT COMPOUNDED DRUG CANDIDATE APPROACH TO DRUG DEVELOPMENT: UTILIZING THE 505(B)(2) PATHWAY + Surface drug candidates are born from the experience of patients and their clinicians * They have demonstrated real world human value as. compound
Slide 9: Klarity Delivery Vehicle
KLARITY DELIVERY VEHICLE * Developed by Richard L. Lindstrom, MD, inventor of Optisol GS (an advanced corneal preservation solution) + Patented Klarity delivery vehicle is designed to protect and rehabilitate the ocular surface pathology for patients with moderate to severe dry eye disease + Precede
Slide 10: SURF-100
SURF-100 PaMgiaaidstet eeu
Slide 11: Chronic Dry Eye Disease
conjunctivitis sicca is le with dry eyes CHRONIC DRY EYE DISEASE or burning
Slide 12: Approved Therapies for Chronic DED: Restasis
APPROVED Restasis (0.05% cyclosporine ophthalmic emulsion) THERAPIES FOR + 2016 drug sales $1.5 billion CHRONIC DED * Owned by Allergan * Approved in 2002; no generic equivalents + Current price $480 - $560 (30 days)? >: * Cyclosporine is an immunosuppressive drug; oral ‘Restasis form can be used to
Slide 13: Approved Therapies for Chronic DED: Xiidra
surfac APPROVED THERAPIES FOR CHRONIC DED a. X\id ra lifitegrast ophthalmic solution) 5% Xiidra (5% lifitegrast ophthalmic solution) 2020 sales estimate $1 billion’? Acquired by Shire for up to $525M as Phase Ill asset (SARcode Bioscience) Approved in July 2016; covered under patent until 2033; no g
Slide 14: SURF-100 Mycophenolic Acid + Klarity
SURF-100 MYCOPHENOLIC ACID +KLARITY CHRONIC DRY EYE DISEASE SURF-100 chronic, light to moderate dry eye disease (9M patients) Patent-pending formulation utilizes Klarity base as its delivery vehicle and mycophenolic acid as its active pharmaceutical ingredient Immunosuppressive drug, oral form used
Slide 15: Mechanism of Action
“= SMECHANISM OF ACTION (MOA) Restasis and Xiidra MOAs lower T- cell activations associated with the inflammation in DED Mycophenolic acid uses a different pathway than Restasis and Xiidra to lower T and B cell activations to address the inflammation in DED. SONG NJ
Slide 16: SURF-200 Betamethasone + Klarity
SURF-200 BETAMETHASONE + KLARITY EPISODIC DRY EYE DISEASE 201 PAIN AND INFLAMMATION
Slide 17: Episodic Dry Eye Disease
EPISODIC DRY EYE DISEASE
Slide 18: Therapies Used for Episodic DED
THERAPIES Sereonsaise and steroids Including: prednisolone, dexamethasone, USED FOR fluorometholone, betamethasone ‘+ Clinical evidence indicates that anti-inflammatory therapies ERISODIG DEI) aitintioit iatlemmatory medistors cedure the stgis-and symptoms of DED? * Topical corticosteroids are appro
Slide 19: SURF-200
SURF-200 Patent-pending formulation, utilizing Klarity delivery vehicle and low concentration of betamethasone Practitioners often begin dry eye treatment by prescribing both topical steroids and cyclosporine®; no steroid has a label with indication for dry eye Betamethasone listed as one of the mos
Slide 20: SURF-201
SURF-201 BETAMETHASONE + KLARITY PAIN AND INFLAMMATION SURF-201: Label expansion —Pain and inflammation post ocular surgery * 7.7 million ocular surgeries including nearly 4 million cataract surgeries annual in US? * Unique offering; first betamethasone based offering for ophthalmic use in the US ma
Slide 21: Doxycycline + Omega-3
DOXYCYCLINE + OMEGA-3 DRY EYE DISEASE & BLEPHARITIS ORAL THERAPIES ww ( suRF-300
Slide 22: Dry Eye Disease - Oral Therapies
DR Y EYE DISEASE - ORAL THERAPIES
Slide 23: Therapies for DED (Oral)
THERAPIES FOR DED (ORAL) Oral Antibiotics Can decrease the number of bacteria that break down the lipid layer of the tear film'* + Certain antibiotics (particularly tetracycline and doxycycline) have been found to stimulate oil production in the glands around the eyes + Certain antibiotics have been
Slide 24: SURF-300
SURF-300 SURF-300: Recalcitrant DED patients Contains 10mg Doxycycline + powderized, triglyceride Omega-3: Low dose doxycycline may minimize Gl distress and dysbiosis No current indication for dry eye or ocular surface disorder Patent-pending formulation includes acid resistant capsule technology *
Slide 25: SURF-301 Blepharitis
S U R F a 3 0 ig DOXYCYCLINE +OMEGA-3 CAPSULE BLEPHARITIS ‘SURF-301: Label expansion — Blepharitis Clinical Program through Phase II* * Effects up 25 million patients in US}, believed tobe an. * May only require one Phase Il study, if any underdiagnosed condition * Complete Phase ll program 1H 2020
Slide 26: Compounded Doxy + Omega-3 Patient Observations
S U R F a 3 0 (6) DOXWGY CL +OMEGA-3 CAPSULE Two sites administering compounded Doxy + Omega -3 Additional Observations Included: Sat bles to adniate So severe DD NaUe its + Patients established a significantimprovement based on validated questionnaire (SPEED and OSDI) ‘outcomes after 30 to 60 days
Slide 27: Key Team Members and Summary
\ KEY TEAM MEMBERS AND SUMMARY
Slide 28: Key Team Members
KEY TEAM MEMBERS = — CEO & President*: Kamran Hosseini, MD, PhD 20 years experience in ophthalmology drug and device development. Site Lead & CMO at Insite Vision (a Sun Pharma company), oversaw clinical, pre-clinical, CMC, manufacturing, regulatory affairs, and drug development programs. He led the
Slide 29: Review of Surface Drug Candidates
REVIEW OF SURFACE.D'RUG CANDIDATES —s SURF-200/201: KLARITY + BETAMETHASONE ‘Plans and studies are dependent upon FDA reviews, recommendations and determinaiions. Scenarios Isted are what webelieve are likely, howeverother scenarios ~ forbetier_ or worse ~ are possible and may require al_capital and
Slide 30: Estimated Timelines and Costs
ESTIMATED TIMELINES AND COSTS* [Human Data (compounded) BLIND Filing Bi Phase it Complete “ans and studies are dependent upon a numberof factorsinclading FDA review. Scenarios stad are what we baieve are probable and assume: 3 Phase study wil only be required for SURF> 300 and not the other programs
Slide 31: Current Therapy Options Summary
CURRENT THERAPY OPTIONS SUMMARY KE xidra Restasis ites Mild Steroids Oral Antibiotics (ocospame Conteh Emesoy 0085 ‘ophthalmic Solutons 2015 U.S. PRICE (wac) N ~$430 PER MONTH Bee + Physicians have high = pasa familiarity and comfort bacterial-a ADVANTAGES . Given. strong compliance, atio a inflamma
Slide 32: Summary
SUMMARY Imprimis Pharmaceuticals, Inc. (NAS Surface will be fin: and man; by an exp d and prov board of directors team n mile and other human data ndin
Slide 33: References
R EPR ERE NBE ES Norby ne investor resentation (hay 47,201) Reviews september 22 2017 {0g Meg “eae Pete opt ere Mae. Aa ari. Wee Farge Secure “ninting wt Outpertrm on New Payer in Opttnaincog ‘tp Immo ater cm/news/ ewe Tmeon-esterergu-Reprong 246 i-th pel funn serge com/ sees paresis ppt ‘Soa (2017)
Slide 34: Appendix
\ APPENDIX
Slide 35: Mycophenolic Acid Mechanism of Action
MYCOPHENOLIC ACID MECHANISM OF-ACTION INHIBITS THE SE PROLIFERATION OF er ad ES B - AND ' y T-LYMPHOCYTES a : Gin J Guanes sanine / Salvage pathway _/ monephe: i S:phosphoriboiyk ~~, ‘monophosphate 1-phosphate- Ss
Slide 36: Thank You
THANK YOU
Imprimis Pharmaceuticals — Corporate Update (October 2017) on 6ix