OIS@AAO Presentation

October 10th, 2019

Raul Trillo, MD, MBA

Chief Commercial Officer

2NON-CONFIDENTIAL

Nevakar Overview

Focus

We are a privately-held, late-stage specialty pharmaceutical

company focusing on drug repositioning and repurposing to

provide clinical benefits to patients while increasing compliance &

improving cost-benefit to the healthcare system.

Competitive

Advantage

Area of Expertise• Ophthalmology with focus on refractive errors

• Hospital-based products

Clinically beneficial and commercially differentiated products,

assuring market exclusivity and sustainability.

3NON-CONFIDENTIAL

Nevakar’s Evolution: Execution is Key for Management

(1) Does not include potential milestone payments from Endo partnership.

10

Employees

6

Product

Candidates

$55mm

Capital Raised

0

Partnered

Products

2

Patents Filed

65

Employees

$170mm(1)

Capital Raised to

Date

5

Partnered

Products

26 / 6

Patents Filed /

Granted

16

Product

Candidates

4 years

later

2015 /

2016

0

NDAs Filed

1 / 3NDAs Filed /

Expected in Next

12 months

How we started…

…and where we are today

4NON-CONFIDENTIAL

Current Product Pipeline -16 Projects in Active Development

Refractive

ErrorsResearch

Pre-

ClinicalPhase I Phase II Phase III

Clinical

Trials Future Milestones

Launch

YearPeak Sales

Ophthalmology

Products

Yes Phase III Readout 2022 2023 $1,400mm+

Yes TBD 2025 $1,000mm+

Yes Clinical POC Readout H1 ‘20 2024 $300mm+

Yes TBD TBD TBD

High Value ResearchPre-

ClinicalPhase I Phase II Phase III

Clinical

Trials Future Milestones

Launch

YearPeak Sales

Hospital

Products

Yes Phase I / IIa Readout H2 ‘20 2024 $400mm+

BE Study Only Yes Pilot BE H2 ‘20 2022 $225mm+

Yes Pre-clinical POC Readout Q4 ’19 2024 $800mm+

Partnering Research Technology Transfer ValidationClinical

Trials Future Milestones

Launch

YearPeak Sales

Hospital

Products -

Critical Care

No Various2020 -

2022$330mm+

No NDA 2021 2022 $30mm+

No NDA 2022 2023 $40mm+

No NDA 2022 2023 $30mm+

No NDA 2022 2023 $30mm+

No NDA H1 ‘20 2021 $35mm+

NVK-002 Atropine for Children with Myopia (US & Europe)

NVK-009

NVK-025

NVK-006

NVK-026

NVK-003, 014, 004, 019, 005 (Out-licensed to Endo)

NVK-017

NVK-002 Atropine for Children with Myopia (Japan)

NVK-027

NVK-028

NVK-029

NVK-016

EXP-019

NVK-002

Our Lead Asset in Ophthalmology - Low Dose Atropine

Slowing the Progression of Myopia in Children

NON-CONFIDENTIAL

The Myopia Epidemic: a Global Snapshot

6

Australia31%

Singapore

80%

China54%

Korea97%

Japan60%

Hong Kong

80%

54-90%

Sweden40%

Germany31%

Neth.

40%

UK50%

Spain

35%

31-50%

Chile19%

Mexico

25%

Brazil25%

Canada18%

US50%

18-50%

19-25%

WHO Report on Myopia and High Myopia:

The prevalence of myopia and high myopia are increasing globally at an alarming rate, with significant increases in the risks for vision impairment from pathologic conditions

associated with high myopia, including retinal damage, cataract and glaucoma

Source: World Health Organization: The Impact of myopia and high myopia; The Ophthalmologist: Myopia dystopia; Ipsos Multi-Country Ophthalmic Market Landscape Assessment, January 2018

7NON-CONFIDENTIAL

Global Prevalence of Myopia Almost Doubles by 2050

Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S, Global Prevalence of Myopia

and High Myopia and Temporal Trends from 2000 through 2050, Ophthalmology, May 2016 Volume 123, Issue 5, Pages 1036–1042.

22.9%

28.3%

34.0%

39.9%

45.2%

49.8%

2.7%4.0%

5.2% 6.1%7.7%

9.8%

2000 2010 2020 2030 2040 2050

Nu

mb

er o

f p

eo

ple

(in

mil

lio

ns

)

Myopia High Myopia

2.5bn people added

by 2050

Prevalence of high

myopia is growing

even faster

5,000

4,000

3,000

2,000

1,000

0

Consequences▪ Higher rates of debilitating

visual loss due to:• Glaucoma

• Retinal Detachment

• Cataracts

• Maculopathy

8NON-CONFIDENTIAL

Pivotal POC Studies have Shown Atropine Reduces Myopia Progression in Asian Populations

ATOM 1 & 2

• Provide compelling proof-of-concept data for the use of low dose atropine with less rebound than at higher doses

• Strong safety profile supports chronic administration in children

• Absence of placebo group in ATOM2 limits full understanding of the benefits of low dose atropine (0.01%) vs. placebo

• Studies were conducted in an Asian population limiting generalizability to non-Asian children

• However, a retrospective analysis in the US suggested similar benefits

Chia, A., Lu, Q., & Tan, D. (2016). Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2. Ophthalmology, 123(2), 391-399. ical Trial on Atropine for the Treatment of Myopia 2. Ophthalmology, 123(2), 391-399.

NON-CONFIDENTIAL

NVK-002: CHAMP Study Design / Status Details

9

36

mo

nth

s

12

mo

nth

s

ATROPINE

(Dose A)

ATROPINE

(Dose B)

Randomize 2:2:3 (N=576)

PRIMARY EFFICACY AND SAFETY ASSESSMENT

PLACEBO

Dose BDose ADose A Dose BDose APLACEBO

Re-Random Re-Random Re-Random

Evaluate the safety & efficacy of 2 concentrations

of low dose atropine sulfate ophthalmic solution

(dose A & dose B) compared to placebo (vehicle)

for the reduction of progression of myopia over a

3-year treatment period

Objective:

The between group difference in the proportion

of subjects who show < -0.5D progression at 36

months

Primary Endpoint:

✓ FPI – November 2017✓ Enrollment completed Q3 2019• Treatment is well tolerated with no new safety

findings• Last patient last visit (3-year endpoint) Q3

2022• NDA submission planned Q4 2022

Current Status:

Childhood Atropine for Myopia Progression (CHAMP)

A Single Phase III study

Dose B PLACEBO

NON-CONFIDENTIAL

NVK-002: Key Advantages

− Our US/ EU clinical program is furthest along in development

▪ Up to 2 years ahead of

other potential entrants

▪ Fully funded through NDA

submissions

▪ Expect robust patient

safety database

▪ Multiple concentrations

under investigation

▪ Commercial scale up

complete

Potential Issues with compounded, low-dose atropines

− Not approved by FDA or EMA

− Inconsistent formulation and preparation

▪ What is the actual concentration administered?

− Non-cGMP sterility assurance

− Short shelf-life

− Toxicity affects of long-term exposure to preservatives in children is not known

− Proprietary formulation

▪ Preservative-free

▪ Sterile, single use ampules

▪ Expect 24 months shelf-life

▪ Use of well-known,

established excipients

▪ US & Japanese patents

issued

− Additional patents

expected and under

various stages of

advancement

NVK-002 offers several distinct advantages

10

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