graybug vision

© 2021 Graybug Vision

Graybug Vision

Cantor Global Healthcare Conference 2021

September 28, 2021


Legal Disclaimer

Any reproduction or distribution of this presentation, in whole or in part, without the prior consent of Graybug Vision, Inc. is prohibited.

These slides and the accompanying oral presentation contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding our clinical pipeline, our ability to advance GB-102 or any future product candidate through clinical development, our ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, our operating results and cash positions, and the timing and results of our clinical trials.

Any statements contained herein or provided orally that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by such terminology as ‘‘believe,’’ ‘‘may,’’ ‘‘will,’’ ‘‘potentially,’’ ‘‘estimate,’’ ‘‘continue,’’ ‘‘anticipate,’’ ‘‘intend,’’ ‘‘could,’’ ‘‘would,’’ ‘‘project,’’ ‘‘plan,’’ ‘‘expect’’ and similar expressions that convey uncertainty of future events or outcomes, although not all forward-looking statements contain these words.

You should not place undue reliance on forward-looking statements, as these statements are based upon our current expectations, forecasts, and assumptions and are subject to significant risks and uncertainties that may cause our actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading “Risk Factors” in our quarterly report on Form 10-Q for the three months ended June 30, 2021, and the other reports we file from time to time with the Securities and Exchange Commission.

We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations or circumstances, except as required by law. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements.

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Extensive experience in ophthalmology and healthcare

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✓ Novartis

Worldwide Head

Ophthalmology

✓ Alcon

Global Franchise Head

Pharmaceuticals

✓ Led extension of Novartis

ophthalmology pipeline:

Encore Vision, Lubricin®,

Luxturna®, Xiidra®

✓ Novartis

VP and Global Head, Clinical

Development and

Therapeutic Area Head,

Ophthalmology

✓ Ophthalmologist from

Moorfield’s Eye Hospital, UK

✓ Ocular immunologist from

Schepens Eye Research

Institute, a Harvard affiliated

institute

✓ Corium

CFO, IPO through PE sale

✓ Codexis

CFO, Private to IPO

✓ Aerogen

CFO, Public through Public

Sale

Fred Guerard

PharmD, CEO

Robert Breuil

CFO

Parisa Zamiri

MD, PhD, CMO

Bettina Maunz

Chief People Officer

✓ Novartis

Global Head Enterprise

Communications

✓ Alcon

VP and Global Head

Communications, President

Alcon Foundation

✓ Led teams and culture

change as part of significant

business transformations

across Pharma, Biotech and

Medical Device industry

Ming Yang

PhD, SVP R&D

✓ Genentech

Ocular drug delivery

✓ Wilmer Eye Institute at

Johns Hopkins

PhD Biomedical Engineering

✓ Developed technologies that

led to two FDA-approved

ophthalmic drugs


Our Scientific Advisory Board

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Dr. Rick Ferris

✓ Ophthalmic Research

Consultants

✓ National Eye Institute

(retired)

Dr. Jeff Heier

✓ Ophthalmic

Consultants of Boston

Dr. Arshad Khanani

✓ Sierra Eye Associates

✓ University of Nevada,

Reno School of

Medicine

Dr. Carl Regillo

✓ Retina Service Wills

Eye Hospital

✓ Thomas Jefferson

University School of

Medicine

Dr. David Boyer

✓ Retina-Vitreous

Associates Medical

Group, California

✓ USC/Keck School of

Medicine

Dr. Rishi Singh

✓ Cole Eye Institute,

Cleveland Clinic

✓ Lerner College of

Medicine


Graybug Investment Highlights

✓Potentially transformative, long-acting treatments for vision-threatening diseases

• Lead retina program GB-102 has demonstrated 12-month+ duration in 18-month Phase 2b trial

✓Differentiated clinical-stage candidates targeting $15B+ markets

• GB-102 for wet age-related macular degeneration (wet AMD)

• GB-401 for primary open-angle glaucoma (POAG)

✓Patent protection: GB-102 through 2039, GB-401 through 2041

✓Pursuing expansion of pipeline with focus on novel therapeutics addressing unmet needs

✓Cash and investments ($78.2M at June 30, 2021) support planned operations into 2023

• GB-102 partnering discussions active to support next clinical trial

• GB-401 ready for first-in-human clinical trial in 2H 2022

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Our TechnologyProprietary ocular technologies promote controlled, sustained drug delivery

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✓Extended durability & sustained drug delivery✓Differentiated mechanisms of action

✓Designed with safety in mind✓Versatile proprietary technologies


• Diagnosed wAMD within 18 months

• At least 3 prior anti-VEGF injections

• Anti-VEGF treatment within last 21 days

• Demonstrated response to prior anti-

VEGF treatments

• BCVA of 35-88 letters

18-month data of GB-102 Phase 2b Trial in wet AMD now available

1 6 patients withdrew for reasons unrelated to their treatment.2 Extension study eligibility criteria: patients who completed all study visits through Month 12 and did not require/receive supportive therapy treatment at the Month 12 final study visit.

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Extension Study provides information on GB-102 1 mg beyond Month 12

Monitoring Visit

12-Month Core Study 6-Month Extension

M13 M14 M15 M16 M17 M18

Population Criteria

Primary:

• Time to first rescue

Secondary:

• Change from baseline BCVA

• Change from baseline CST (OCT)

• Safety and tolerability

• 50 out of 56 patients completed 12-

month treatment phase1

• 58% of patients who completed

Month 12 visit were eligible2 and agreed

to continue clinical monitoring in six-

month trial extension

Trial Endpoints Extension Eligibility


ALTISSIMO 12-Month Core Study SummaryOverall, GB-102 1 mg was well tolerated and demonstrated best-in-class duration

• First IVT injection to demonstrate 6-month duration for half of patients in a randomized, controlled trial

✓GB-102 reduced annualized injection burden by 58% compared to pre-enrollment period

• Efficacy of GB-102 demonstrated by anatomical control (CST) similar to aflibercept

• GB-102 demonstrated favorable safety during the 12-month Core Study

✓No drug-related serious adverse events

✓No Treatment Emergent Adverse Events leading to drug discontinuation

✓No adverse event requiring surgical intervention

✓Medication was detected in the anterior chamber (AC) in 3 out of 37 injections (8.1%)

✓No vision-threatening inflammation or increase in intraocular pressure

✓Majority of drug-related adverse events were mild to moderate

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Median Time to First Rescue for GB-102 1 mg was 5 months (Core Study)61% of rescues either met no criteria or were not due to an increase in CST

129-001133-001

146-001

153-003

154-001

158-001

164-001

164-002

164-004

164-005

164-006

165-002

166-001

167-001169-001

186-003

191-002

192-001192-003

201-001

201-004

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Best On-study Duration GB-102 1 mg

≥3M ≥4M ≥5M ≥6M ≥8M

81% 62% 52% 48% 29% ≤ 3M

4-5 M

6-7 M≥ 8M

Duration

Scheduled dosing

Rescued solely due to BCVA

Rescued solely due to CST

Rescued due to BCVA and CST

Rescued, but no criteria met

Dosing

0 1M 2M 3M 4M 5M 6M 7M 8M 9M 10M 11M 12M

Early Exit

Patient 1

Patient 2

Patient 3

Patient 4

Patient 5

Patient 6

Patient 7

Patient 8

Patient 9

Patient 10

Patient 11

Patient 12

Patient 13

Patient 14

Patient 15

Patient 16

Patient 17

Patient 18

Patient 19

Patient 20

Patient 21

After 1st rescue


Control of CST with GB-102 1 mg given every 6 months was similar to that of bi-monthly aflibercept

100

150

200

250

300

350

400

450

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Me

an (

+/-S

D)

Core Study Month

GB-102 1mg/1mg q 6 Months Aflibercept 2mg q 2 Months

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Time Frame

GB-102 1 mg/1 mg

Mean (SD)

aflibercept

Mean (SD)

Change from Baseline at M6 44.3 (82.2) 19.3 (22.5)

Change from Baseline at M12 44.2 (79.6) 11.7 (21.1)

Aflibercept 2 mg q 2 MonthsGB-102 1 mg / 1 mg q 6 Months

Core Study Month


BCVA trended lower in GB-102 1 mg given every 6 months as compared with bi-monthly aflibercept — high standard deviation driven by 6 patients

30

40

50

60

70

80

90

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Me

an (

+/-S

D)

Core Study Month

GB-102 1mg/1mg q 6 Months Aflibercept 2mg q 2 Months

11

Aflibercept 2 mg q 2 Months

Time Frame

GB-102 1 mg/1 mg

Mean (SD)

aflibercept

Mean (SD)

Change from Baseline at M6 -5.7 (14.7) 2.3 (5.1)

Change from Baseline at M12 -11.5 (15.2) 1.1 (7.8)

GB-102 1 mg / 1 mg q 6 Months

Core Study Month


Opportunity to optimize clinical trial design and enhance formulation to deliver BCVA results similar to aflibercept

12

-60

-50

-40

-30

-20

-10

0

10

164-006 154-001 164-001 164-002 158-001 164-004 164-005 133-001

Ch

ange

fro

m B

ase

line

BC

VA

in C

ore

Stu

dy

Baseline to M6 Baseline to M12

Treatment-unrelated AEs & Hard-to-treat Patients

RPE Tear

@ D1

Retinal

Hemorrhage

@ M3

Subretinal

Fibrosis

@ M2

Progressive

Cataract

Patient 20 Patient 14 Patient 11 Patient 4 Patient 16 Patient 10 Patient 12 Patient 17

Particle Dispersion

Larger trial will distribute patients evenly across arms New formulation to reduce interference with vision


ALTISSIMO Extension Study Summary6M extension period validates duration of effect and control of disease with GB-102 1 mg

Duration

• GB-102 demonstrated a median duration of 12 months after the last treatment

• 55% of patients achieved at least 12-months of duration

Treatment Burden

• GB-102 reduced annualized injection burden by 73% compared to pre-enrollment period

Safety

• GB-102 continued to be well-tolerated and maintained a favorable safety profile up to 18 months

Efficacy

• Efficacy of GB-102 validated by anatomical control (CST) similar to aflibercept over 18 months

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Extension Period Duration from Last Dose* (N=11)

GB-102 1 mg Duration in Months

Mean (SD) 9.6 (5.3)

Median 12

Median Duration for GB-102 1 mg was 12 months (Extension Study)

*GB-102 or additional supportive therapy

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192-003192-001201-001164-002

169-001165-002153-003186-003164-004164-001164-005146-001154-001166-001158-001133-001129-001201-004164-006191-002

167-001

0 1M 2M 3M 4M 5M 6M 7M 8M 9M 10M 11M 12M 13M 14M 15M 16M 17M 18M

Early Exit

Patient 1

Patient 2

Patient 3

Patient 4

Patient 5

Patient 6

Patient 7

Patient 8

Patient 9

Patient 10

Patient 11

Patient 12

Patient 13

Patient 14

Patient 15

Patient 16

Patient 17

Patient 18

Patient 19

Patient 20

Patient 21

Exit at M13

≤ 3M

4-5 M

6-7 M≥ 8M

Duration

Scheduled dosing

Rescued solely due to BCVA

Rescued solely due to CST

Rescued due to BCVA and CST

Rescued, but no criteria met

Dosing

After 1st rescue


Clear Roadmap to SuccessCapitalize on good anatomical control and extended duration observed in ALTISSIMO

• 18-month ALTISSIMO data confirms:

✓ Improved and long-term safety profile

✓Unprecedented duration for an IVT injection

✓Pharmacological effect on CST similar to aflibercept

• Reduction in BCVA primarily driven by subgroup of patients

• Hard-to-treat patients, treatment-unrelated AEs, and events of particle dispersion

• Next steps include further optimization of formulation, entry criteria, and rescue criteria

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Optimization Safety Duration BCVA

Formulation

Entry criteria

Rescue criteria

Active partnership discussions ongoing to support next clinical trial


New GB-102 formulation designed to reduce interference with vision

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Benefits of new GB-102 formulation:

✓Instant aggregation upon injection

✓Aggregation is resistant to shear stress

✓Improved reconstitution reduces variability

✓Demonstrated safety in a GLP tox study

✓Same drug release profile

Aggregation Shear Stress Test (37oC)

Dispersed Depot

ALTISSIMO Formulation New Formulation

0

20

40

60

80

100

0 20 40 60 80 100

Dru

g R

elea

se %

Time (days)

In Vitro Release at 37o C

GB102-031219EB_HA

GB102-031219EB_0.9%BA

ALTISSIMO

New

Intact Depot


Graybug Programs in Active Development

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Program IndicationPhase of Development

Preclinical Phase 1 Phase 2a Phase 2b Phase 3

GB-1026-month dosing

Wet Age-Related Macular Degeneration

(wet AMD)

GB-4016-month dosing

Primary Open-Angle Glaucoma

(POAG)

Formulation optimization on-going; seeking partner

IND

2H22

Pursuing expansion of pipeline with focus on novel therapeutics addressing unmet needs


GB-401 implant development is underway toward clinical trial in 2H 2022

• GB-401 development updates:

✓Lead GB-401 implant formulation has been identified

✓Lead formulation lasts >4M in vitro

• Duration of 6M+ expected in humans

✓IND-enabling repeat-dose GLP tox study scheduled for Q4 2021

✓Scale-up manufacturing process has been developed

✓In-house GMP manufacturing capability has been established

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0

20

40

60

80

100

0 30 60 90 120 150

Cu

mu

lati

ve R

ele

ase

(%

)

Time (days)

In Vitro Release at 37oC

GB-401…GB-401 Implant

GB-401 IND planned in 2H 2022


GB-401 implant demonstrating durability in rabbit eyes

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Baseline Day 3 Day 7 Day 14

GB-401 implants are well tolerated in rabbit eyes

Day 28 Day 56 Day 84


Graybug Investment Highlights

✓Potentially transformative, long-acting treatments for vision-threatening diseases

• Lead retina program GB-102 has demonstrated 12-month+ duration in 18-month Phase 2b trial

✓Differentiated clinical-stage candidates targeting $15B+ markets

• GB-102 for wet age-related macular degeneration (wet AMD)

• GB-401 for primary open-angle glaucoma (POAG)

✓Patent protection: GB-102 through 2039, GB-401 through 2041

✓Pursuing expansion of pipeline with focus on novel therapeutics addressing unmet needs

✓Cash and investments ($78.2M at June 30, 2021) support planned operations into 2023

• GB-102 partnering discussions active to support next clinical trial

• GB-401 ready for first-in-human clinical trial in 2H 2022

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