Ani Pharmaceuticals, Inc. · NASDAQ:ANIP
Ani Pharmaceuticals — Technical Presentation (July 2025)
27 slides from Ani Pharmaceuticals's technical presentation, Jul 23, 2025
Slide 1: NEW DAY Clinical Trial Results
NEW DAY Clinical Trial Results July 23, 2025 1
Slide 2: Disclaimers: Forward-Looking Statements
Disclaimers 2 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Act, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements about our expectations, beliefs, plans, objectives, assumptions or future ev
Slide 3: Speakers and Agenda
Speakers and Agenda 3 NIKHIL LALWANI President and Chief Executive Officer CHRISTOPER MUTZ Senior Vice President, Head of Rare Disease MARY PAO, MD, PhD Chief Medical Officer of Rare Disease MICHAEL A. SINGER, MD Medical Center Ophthalmology Associates and University of Texas Health Science Center,
Slide 4: ILUVIEN Overview
ILUVIEN Overview 4 DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure Chronic non-infectious uveitis affecting the posterior segment of the eye Provides constant and controlled drug release with sta
Slide 5: Most Commonly Used Pharmacologic Treatments for DME Include Anti-VEGF Agents and Corticosteroids
The Most Commonly Used Pharmacologic Treatments for DME Include Anti-VEGF Agents and Corticosteroids 5 Diagnosis Anti-VEGF Patients not well served by anti- VEGF Steroids Laser Therapy Regular monitoring, ongoing treatment and/or treatment adjustments MOA: anti- inflammatory MOA: block formation and
Slide 6: Steroids are the Treatment of Choice for DME Patients Not Well Served by Anti-VEGF Therapy
Steroids are the Treatment of Choice for DME Patients Not Well Served by Anti-VEGF Therapy 1. Ciulla TA, et al. Br J Ophthalmol. 2021;105(2):216-221. 2. Nakao S, et al. Graefes Arch Clin Exp Ophthalmol. 2024;262(12):3749-3759.3. Sorour OA, et al. Surv Ophthalmol. 2023;68(2):147-174. 4. Usui-Ouchi A,
Slide 7: NEW DAY Study Overview
NEW DAY Study Overview 1. A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME) (NEW DAY). ClinicalTrials.gov identifier: NCT04469595. Accessed November 1, 2024. https://clinicaltrials.gov/study/NCT04469595 2. Data on File, ANI Pharmaceutica
Slide 8: NEW DAY Inclusion and Exclusion Criteria
NEW DAY Inclusion and Exclusion Criteria 8 • Patients ≥18 years old with a diagnosis of Type 1 or Type 2 diabetes • Center-involving DME confirmed by SD-OCT and CST of ≥350 µm • BCVA of ≥35 and ≤80 ETDRS letters in study eye at screening visit Proliferative Diabetic Retinopathy • Glaucoma or ocular
Slide 9: NEW DAY: Patient Disposition, ITT
NEW DAY: Patient Disposition, ITT 9 Intent to Treat Discontinued Early ILUVIEN Implant N = 154 Aflibercept (2 mg) N = 152 N = 30 N = 34 Lost to follow-up: 14 Withdrawal of consent: 7 Death: 3 Noncompliance: 2 Adverse event: 1 Sponsor request: 1 Investigator decision: 0 Other: 2 Lost to follow-up: 10
Slide 10: Patient Demographics, ITT
Patient Demographics, ITT 10 ILUVIEN N = 154 Aflibercept N = 152 Overall N = 306 Age (Years) n Mean (SD) Median Min, max 154 61.0 (8.08) 61.0 38, 84 152 61.8 (9.10) 61.5 36, 86 306 61.4 (8.60) 61.0 36, 86 Gender, n (%) Female Male 54 (35.1) 100 (64.9) 60 (39.5) 92 (60.5) 114 (37.3) 192 (62.7) Race,
Slide 11: Baseline Characteristics, ITT
Baseline Characteristics, ITT 11 ILUVIEN N = 154 Aflibercept N = 152 Overall N = 306 Baseline visual acuity n Mean (SD) Median Min, max 153 66.2 (11.19) 69.0 30, 86 152 65.7 (11.33) 68.0 28, 92 305 66.0 (11.24) 68.0 28, 92 Baseline median IOP n Mean (SD) Median Min, max 154 17.2 (3.11) 17.0 9, 26 15
Slide 12: Post Hoc Analysis: Per Protocol (PP) Population
Post Hoc Analysis: Per Protocol (PP) Population 12 Subset of the randomized patients who did not have major study deviation: • Randomized/enrolled without meeting eligibility criteria • Administered incorrect treatment • Received prohibited concomitant medication/therapy A total of 44 patients exper
Slide 13: Patient Demographics, PP
Patient Demographics, PP PP, post hoc per protocol; SD, standard deviation. 1. Data on File, ANI Pharmaceuticals, Inc. 13 ILUVIEN N = 128 Aflibercept N = 134 Overall N = 262 Age (Years) n Mean (SD) Median Min, max 128 60.8 (7.93) 61.0 38, 84 134 61.9 (9.35) 62.0 36, 86 262 61.4 (8.69) 61.0 36, 86 Ge
Slide 14: Baseline Characteristics, PP
Baseline Characteristics, PP *The difference between ILUVIEN and aflibercept was assessed using a two-sided independent pooled t-test DR, diabetic retinopathy; DRSS, diabetic retinopathy severity scale; ETDRS, Early Treatment Diabetic Retinopathy Study; IOP, intraocular pressure; PP, modified protoc
Slide 15: Results in ITT Population
Results in ITT Population Primary Endpoint ILUVIEN N = 154 Aflibercept N = 152 P-value* Mean # of supplemental aflibercept injections 2.4 2.5 0.756 *The difference between FAc and aflibercept was assessed using a two-sided independent pooled t-test. 15 Secondary Endpoints ILUVIEN Aflibercept P-value
Slide 16: Results in PP Population
Results in PP Population Primary Endpoint ILUVIEN N = 128 Aflibercept N = 134 P-value* Mean # of supplemental aflibercept injections 1.8 2.5 0.029 *The difference between FAc and aflibercept was assessed using a two-sided independent pooled t-test. 16 Secondary Endpoint ILUVIEN Aflibercept P-value*
Slide 17: Secondary Visual Acuity Endpoint Results, ITT
Secondary Visual Acuity Endpoint Results, ITT *P-value based on difference in means at Month 18. 17 Mean Change From Baseline in BCVA Score Over 18 Months in Patients Who Did Not Meet the Prespecified Non- Inferiority Margin of 4 ETDRS Letters, ITT P = 0.080 at month 18* Mean Change From Baseline i
Slide 18: Proportion of Patients With 5, 10, and 15 Letter ETDRS Gains from Baseline, ITT
Proportion of Patients With 5, 10, and 15 Letter ETDRS Gains from Baseline, ITT *P-value was assessed using the likelihood ratio chi-square test. 18 ILUVIEN N = 122 Aflibercept N = 117 P-value* Patients With 5 Letter ETDRS Gain from Baseline at 18 Months 41.0% 49.6% 0.182 Patients With 10 Letter ETD
Slide 19: Central Subfield Thickness Results
Central Subfield Thickness Results *P-value based on difference in means at Month 18. 19 Mean CST Over 18 Months, ITT P = 0.278 at month 18* Mean Change from Baseline in CST Over 18 Months, ITT P = 0.709 at month 18* Mean Change from Baseline in CST Over 18 Months in Non-Rescued Patients, ITT P = 0.
Slide 20: Overall Safety Summary
Overall Safety Summary 20 ILUVIEN N = 154 Aflibercept N = 152 Overall N = 306 Any TEAE, n (%) 136 (88.3) 115 (75.7) 251 (82.0) Treatment-related TEAEs, n (%) 63 (40.9) 5 (3.3) 68 (22.2) Serious TEAEs, n (%) 38 (24.7) 46 (30.3) 84 (27.5) Serious treatment-related TEAEs, n (%) 0 (0) 0 (0) 0 (0)
Slide 21: Serious TEAEs With an Incidence ≥1% by System Organ Class
Serious TEAEs With an Incidence ≥1% by System Organ Class Only specific TEAEs with an incidence ≥1% are shown in the above table. 21 ILUVIEN N = 154 Aflibercept N = 152 Overall N = 306 Patients with ≥1 TEAE, n (%) 38 (24.7) 46 (30.3) 84 (27.5) Blood and lymphatic system disorders (overall) 1 (0.6) 1
Slide 22: Ocular TEAEs by System Organ Class
Ocular TEAEs by System Organ Class ILUVIEN N = 154 Aflibercept N = 152 Overall N = 306 Patients with one or more treatment-emergent adverse events related to study treatment, n (%) 63 (40.9%) 5 (3.3%) 68 (22.2%) Eye disorders Borderline glaucoma Cataract Cataract subcapsular Conjunctival hemorrhage
Slide 23: Safety: Patients With an IOP Increase
Safety: Patients With an IOP Increase 23 ILUVIEN N = 154 Aflibercept N = 152 Patients that experienced any IOP increase event, n (%) 24 (15.6) 5 (3.3) IOP increase event description, n (%) Change in IOP ≥10 mmHg from baseline IOP ≥25 mmHg IOP ≥35 mmHg 4 (2.6) 17 (11.0) 3 (1.9) 1 (0.7) 4 (2.6) 0 (0.0
Slide 24: Safety: Patients Who Underwent IOP Lowering Laser Therapy and Surgery
Safety: Patients Who Underwent IOP Lowering Laser Therapy and Surgery 24 ILUVIEN N = 154 Aflibercept N = 152 Overall N = 306 Any laser and incisional IOP-lowering interventions during study, n (%) 7 (4.5) 2 (1.3) 9 (2.9) Laser (SLT and PI) 4 (2.6) 2 (1.3) 6 (2.0) Incisional surgery 3 (1.9) 0 3 (1.0)
Slide 25: NEW DAY Clinical Trial Summary
• Results demonstrated a statistically significant difference in mean number of supplemental aflibercept injections in favor of the ILUVIEN arm (1.8 vs. 2.5 injections, p=0.029, N=128 in ILUVIEN arm, N=134 in aflibercept arm) o Lower total number of aflibercept injections needed (2.8 vs. 7.5 injecti
Slide 26: Closing Remarks
Closing Remarks Thank You to All the NEW DAY Study Sites and Patients 306 eyes across 42 sites in the United States 26
Slide 27: Questions and Answers
Questions and Answers 27
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