ALTISSIMO Full-Data Analysis 12-Month Treatment Phase
Conference Call
May 12, 2021
Forward-Looking Statements
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Today’s Presenters
✓ 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
Fred Guerard PharmD, CEO
Parisa Zamiri MD, PhD, CMO
GB-102 Phase 2b trial in wet AMD (ALTISSIMO)
*6 patients withdrew for reasons unrelated to their treatment
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Extension study to provide information on GB-102 1mg beyond month 12 Primary endpoint: time to first use of additional supportive therapy
Monitoring Visit
Population
• nAMD ≤ 18 months
• ≥ 3 prior anti-VEGF injections
• Response to treatment
• Anti-VEGF ≤ 21 days
• 20/20 - 20/200 Endpoints
• Time to first rescue
• BCVA
• CST (OCT)
• Adverse events
Overall, GB-102 1 mg was safe and well tolerated
✓No drug-related serious adverse events
✓No Treatment Emergent Adverse Events (study eye or non-ocular) leading to drug discontinuation
✓No adverse event requiring surgical intervention
✓No vision-threatening inflammation or increase in intraocular pressure
✓Majority of drug-related adverse events were mild to moderate
✓Medication was detected in the anterior chamber (AC) in 7.8% of GB-102 1 mg injections, a 79% reduction from ADAGIO
Optimization of manufacturing process led to 79% reduction in frequency of presence of medication in anterior chamber compared to ADAGIO
Drug-related TEAE (Study Eye) aflibercept (N = 13)
GB-102 1mg/1mg (N = 21) [BL-6/6-12]*
Product residue present in AC 0 3 [2/1]
Vitreous floaters 0** 5 [5/1]
Product residue in the vitreous 0 1 [1/0]
Iritis 0 4 [2/3]
Uveitis 0 1 [0/1]
Vitritis 0 1 [0/1]
Vision blurred 0 1 [0/1]
Visual acuity reduced 0 2 [0/2]
Visual impairment 0 1 [1/0]
Retinal haemorrhage 0 1 [1/0]
*Some patients experienced the same AE during both 6 months period
**There were 2 cases of floaters in aflibercept group that were deemed not related
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Median Time to Additional Supportive Therapy for GB-102 1 mg: 5 months
Time to additional supportive therapy
GB-102 1mg 1M 2M ≥3M ≥4M ≥5M ≥6M
Dose 1 10% 10% 81% 57% 48% 43%
Dose 2 25% 31% 44% 44% 38% 31%
129-001 133-001 146-001 153-003
154-001 158-001 164-001 164-002
164-004 164-005
164-006 165-002
166-001 167-001 169-001
186-003
191-002 192-001 192-003 201-001
201-004
≤ 3MD
4-5 M 6-7 M
≥ 8M
After 1strescue Duration:
D
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
Treatment burden reduced by 58% while CST and BCVA was maintained
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0 10 20 30 40 50 60 70 80 90 100
Mean BCVA (+/-SD)
Study Month 0
50 100 150 200 250 300 350 400 450 500
Mean CST (+/-SD)
Injections per Year (GB-102 Arm) Mean prior anti-VEGF: 10.2 Mean on-trial anti-VEGF: 4.2
Pre-enrollment 0 2 4 6 8 10 12
Mean pre-enrollment CST: 281.9 ± 53.1 Mean Month 12 CST: 250.4 ± 95.9
Mean pre-enrollment BCVA: 59.90 ± 16.73 Mean Month 12 BCVA: 59.2 ± 19.65
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
Mean (+/-SD)
Trial Month
GB-102 1mg/1mg q 6 Months Aflibercept 2mg q 2 Months
Time Frame GB-102 1mg/1mg 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)
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
Mean (+/-SD)
Study Month
GB-102 1mg/1mg q 6 Months Aflibercept 2mg q 2 Months
10
Time Frame GB-102 1mg/1mg 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)
Mean BCVA Letter Changes
@Baseline M1-12 @M12*
Aflibercept 0.0 1.8 1.1
All GB-102 1mg 0.0 (7.4) (11.5)
Subgroup of 6 0.0 (18.8) (24.2)
Subgroup of 14 0.0 (2.7) (6.0)
All GB-102 vs. aflibercept 0.0 (9.3) (12.5)
Best 14 vs. aflibercept 0.0 (4.5) (7.1)
Median BCVA Letter Changes
@Baseline M1-12 @M12
Aflibercept 0.0 1.0 1.0
All GB-102 1mg 0.0 (5.5) (8.5)
Subgroup of 6 0.0 (12.5) (21.0)
Subgroup of 14 0.0 (1.0) (1.5)
All GB-102 vs. aflibercept 0.0 (6.5) (9.5)
Best 14 vs. aflibercept 0.0 (2.0) (2.5)
*M1-12 is the median of the medians BCVA loss across those visits
Opportunity to optimize clinical trial design and using enhanced formulation to deliver similar BCVA results to aflibercept
6 patients adversely impacted mean BCVA
192-003 192-001 201-001 164-002
169-001 165-002 153-003 186-003 146-001 167-001
GB-102 1 mg reduced injection frequency of the top 10 patients by 72%
Average # of injection/year prior to BL = 9.1 Average # of injection/year on trial = 2.5
-22M -20M -18M -16M -14M -12M -10M -8M -6M -4M -2M 0 2M 4M 6M 8M 10M 12M
≤ 3MD
4-5 M 6-7 M
≥ 8M
After 1strescue Duration:
Scheduled dosingD
Rescued solely due to BCVA Rescued solely due to CST
Rescued, but no criteria met Dosing:
Pre-enrollment anti-VEGF injections
12
Pre-enrollment 0 2 4 6 8 10 12
GB-102 1 mg controlled CST of top 10 patients whilst reducing magnitude of fluctuations over 12 months by 33%
100 200 300 400
Mean (+/-SD)
Study Month
GB-102 1mg pre-enrollment Aflibercept pre-enrollment GB-102 1mg/1mg Aflibercept 2 mg
Time Frame GB-102 1mg/1mg Mean (SD)
aflibercept Mean (SD) Change from Baseline at M6 12.6 (20.0) 19.3 (22.5) Change from Baseline at M12 38.9 (45.1) 11.7 (21.1)
GB-102 1mg provided top 10 patients with BCVA control within non- inferiority margin* to aflibercept
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30 40 50 60 70 80 90 100
Mean (+/-SD)
Study Month
GB-102 1mg pre-enrollment Aflibercept pre-enrollment GB-102 1mg/1mg Aflibercept 2 mg
Pre-enrollment 0 2 4 6 8 10 12
Time Frame GB-102 1mg/1mg Mean (SD)
aflibercept Mean (SD)
Change from Baseline at M6 2.1 (5.6) 2.3 (5.1) Change from Baseline at M12 -1.4 (6.5) 1.1 (7.8)
*ALTISSIMO not powered to demonstrate non-inferiority
Subject ID: XXX-XXX Demographic: 66/F/W Lesion type: Minimally classic, CNV Treatment/Study Eye: 1.0 mg GB-
102/OS Prior Injections: 7 Relevant Medical History: nAMD (OS),Cataract (OU), Dry AMD (OU), PVD (OU)
M 7 M 8 M 9 M 10M 10 M 11 M 12
M 11 M 12
M1
Baseline W 2 M 1 M 2M 2 M 4M 3 M 5M 4 M 5M 5
Screening Baseline W 2 M 1 M 2 M 3 M 4
M 9
Screening Baseline W 2 M 1 M 2 M 3 M 4 M 5
M 6 M 7 M 8 M 9 M 10 M 11
Screening Baseline W 2 M 1 M 2 M 3 M 4 M 5
M 7 M 8 M 9 M 10 M 11 M 12
Baseline W 2 M 1 M 2 M 3 M 5
M 6 M 8 M 9 M 11
Screening Baseline
0 10 20 30 40 50 60 70 80 90
50 100 150 200 250 300 350 400 450 500 550
-9.0 -8.0 -7.0 -6.0 -5.0 -4.0 -3.0 -2.0 -1.0 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0
BCVA
CST
IOP
Iritis (start at M 9 and End at M 10)
*
Screening Baseline W 2 M 1 M 2 M 3 M 4 M 5
M 6 M 7 M 8 M 9 M 10 M 11 M 12
Actionable Findings from ALTISSIMO
Capitalize on good anatomical control and increase probability of success
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Variable ALTISSIMO Action
Duration 48% of patients reached 6 Months Refining criteria could reduce rescues by >50%
Reduction in BCVA primarily driven by subgroup of six patients
Two hard-to-treat patients Tighten inclusion criteria
Two treatment-unrelated AEs Larger study will distribute these patients evenly
Two events of particle dispersion Optimized formulations should improve behavior
Reconstitution /
Injection Procedure Inconsistent aggregation Faster aggregating microparticles or implants will reduce injection technique variability
ALTISSIMO Summary
• First IVT treatment to demonstrate 6-month duration for half of patients in controlled trial
• Safety and tolerability of GB-102 1 mg established
• Efficacy of sunitinib demonstrated by anatomical control similar to Eylea
• Lower trend in visual outcome is understood and can be addressed
• Work on optimized formulations of GB-102 initiated in 2020
• Prioritization of capital towards projects with potential for near-term catalysts
Thank You
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