zunibergene rocparvovec (4D-150) / 4D Molecular Therap, Otsuka - LARVOL DELTA

4D-150 for Diabetic Macular Edema (DME) (GlobeNewswire) - "Global Phase 3 trial design and initiation expected in Q3 2026; SPECTRA clinical trial 2-year data expected in Q4 2026."

Clinical protocol • New P3 trial • P2 data • Diabetic Macular Edema

4FRONT Global Phase 3 Program (GlobeNewswire) - "4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in Q2 2027; 4FRONT-2, Global Clinical Trial: Enrollment completed in June 2026 with N>500 expected to be randomized; topline data expected in H2 2027."

Enrollment closed • P3 data: top line • Wet Age-related Macular Degeneration

Company to host an Investor Day in New York City on October 21, 2026 (GlobeNewswire) - "Investor Day will provide an overview of the commercial potential of 4D-150 and include participation from senior leadership and leading retinal disease key opinion leaders. Additional details will be provided in advance of the event."

Clinical • Diabetic Macular Edema • Wet Age-related Macular Degeneration

4D-150: "4D-150 demonstrated consistent, durable, and predictable clinical activity and was tolerated"; Wet age-related macular degeneration (4D Molecular Therapeutics) - ASRS 2026

P2 data • Wet Age-related Macular Degeneration

4DMT Announces Positive 2-Year Data from PRISM Phase 2b Clinical Trial in a Broad Wet AMD Population (GlobeNewswire) - "The Phase 2b trial enrolled 45 patients at two dose levels of a single intravitreal dose of 4D-150 (3E10 and 1E10 vg/eye); 3E10 vg/eye was chosen as the dose for the 4FRONT Phase 3 clinical trials...Consistent, durable and clinically meaningful reduction in treatment burden: Overall cohort: 78% overall treatment burden reduction (2.7 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W); Recently diagnosed subgroup: 87% overall treatment burden reduction (1.6 mean supplemental injections per patient vs. 12.0 injections projected with on-label aflibercept 2 mg Q8W)....As previously reported, within approximately the first 6 months (28 weeks) post-4D-150 dosing, 2.8% (2 of 71) of patients had 4D-150-related 1+ (mild) intraocular inflammation (IOI) (SUN/NEI scales), which were transient 1+ vitreous cells noted at a single timepoint."

P2b data • Wet Age-related Macular Degeneration

4DMT Completes Enrollment for 4FRONT-2 Global Phase 3 Clinical Trial of 4D-150 in Wet AMD (GlobeNewswire) - "4FRONT-2 global enrollment completed approximately 4 months ahead of initial projections. 4FRONT-2 over-enrolled (anticipated N>500), with final patient randomization expected in Q3 2026, reflecting strong interest from investigators and patients. 4FRONT-2 52-week topline data is expected in H2 2027."

P3 data: top line • Trial status • Wet Age-related Macular Degeneration

4D-150 for Wet Age-related Macular Degeneration (GlobeNewswire) - "4FRONT Global Phase 3 Program: 4FRONT-1, North American Clinical Trial: Enrollment completed in February 2026 and randomization completed (N=523) in March 2026; topline data expected in H1 2027; 4FRONT-2, Global Clinical Trial: Enrollment completion expected in H2 2026; topline data expected in H2 2027....PRISM Phase 1/2 Clinical Trial: Phase 2b 2-year data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in Q3 2026."

Enrollment status • P2b data • P3 data: top line • Wet Age-related Macular Degeneration

4D-150 for Diabetic Macular Edema (GlobeNewswire) - "SPECTRA clinical trial 2-year data expected in H2 2026; Global Phase 3 trial design expected in mid-2026 and initiation expected in Q3 2026."

Clinical protocol • New P3 trial • P2 data • Diabetic Macular Edema

4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=480 | Active, not recruiting | Sponsor: 4D Molecular Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

4D-150 for Diabetic Macular Edema (GlobeNewswire) - "2-year SPECTRA Phase 1/2 clinical trial data expected in H2 2026. Phase 3 trial design expected mid-2026. Global Phase 3 trial initiation expected in Q3 2026."

Clinical protocol • New P3 trial • P1/2 data • Diabetic Macular Edema

4D-150 for Wet Age-related Macular Degeneration (GlobeNewswire) - "(i) 4FRONT-1, North American Clinical Trial:...topline data expected in H1 2027; (ii) 4FRONT-2, Global Clinical Trial: Ex-U.S. site activation and patient screening accelerating across Europe and Asia-Pacific; enrollment remains on track to be completed in H2 2026, with topline data expected in H2 2027...; (iii) PRISM Phase 1/2 Clinical Trial:...2-year Phase 2b data in a broad patient population, including the recently diagnosed subgroup population most comparable to the 4FRONT Phase 3 population, expected to be presented at a scientific conference in mid-2026."

P2 data • P3 data: top line • Trial status • Wet Age-related Macular Degeneration

4D-150-C004: A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2) (clinicaltrialsregister.eu) - P2/3 | N=298 | Recruiting | Sponsor: 4d Molecular Therapeutics Inc.

New P2/3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

4DMT Completes Enrollment for 4FRONT-1 Phase 3 Clinical Trial of 4D-150 in Wet AMD (GlobeNewswire) - "Enrollment for 4FRONT-1...was completed within an approximately 11-month period, ahead of initial projections. 4FRONT-1 overenrolled and expected to exceed 500 patients randomized, reflecting strong interest from investigators and patients. Topline data from 4FRONT-1 expected in H1 2027. 4FRONT-2 global site activation momentum continues, with enrollment completion on track for H2 2026 and topline data expected in H2 2027."

Enrollment status • P3 data: top line • Wet Age-related Macular Degeneration

4DMT Announces Positive Interim Data from 4D-150 SPECTRA Clinical Trial in DME and Alignment with FDA on Registrational Path (GlobeNewswire) - P2 | N=72 | NCT05930561 | "Efficacy Results Through 32 Weeks: i) 3E10 vg/eye arm: Sustained gain of best corrected visual acuity (BCVA) of +8.4 letters; Sustained reduction of CST, as measured by optical coherence tomography (OCT), of -194 µm; ii) Supplemental injections: Post-aflibercept loading doses (3), 3E10 vg/eye achieved substantially fewer supplemental injections compared to 1E10 vg/eye and projected on-label aflibercept 2mg Q8W...Results to be presented in a corporate webcast on February 10, 2025; 52-week interim data update expected at a scientific conference in mid-2025...Next steps for DME development to be presented in a corporate webcast on February 10, 2025."

P2 data • Diabetic Macular Edema

4DMT Presents Positive 52-Week Results from Phase 2b Cohort of PRISM Wet AMD Study and Long-term Durability Data Supporting 4D-150 4FRONT Global Registration Program (GlobeNewswire) - P1/2 | N=215 | PRISM (NCT05197270) | Sponsor: 4D Molecular Therapeutics | "Topline 52-Week Efficacy Results for 4D-150 3E10 vg/eye (Planned Phase 3 Dose) from Phase 2b Population Extension Cohort of PRISM (Data Cut-Off January 15, 2025): Phase 2b (n=30): Broad Wet AMD Disease Activity...Supplemental aflibercept injections: 83% reduction, representing 0.97 mean supplemental injections per patient over 52-weeks vs. 6.0 injections projected with on-label aflibercept 2 mg Q8W; 70% 0-1 injection; 57% injection-free...Phase 2b (n=15): Recently Diagnosed Subgroup...Supplemental aflibercept injections: 94% reduction, representing 0.33 mean supplemental injections per patient over 52-weeks vs. 6.0 injections; projected with on-label aflibercept 2 mg Q8W; 87% 0-1 injection; 80% injection-free....4D-150 Safety Update from PRISM (Data Cut-Off January 15, 2025)...2.8% (2 of 71) had 4D-150–related 1+ intraocular inflammation (IOI) (SUN/NEI scales)..."

P2b data • Wet Age-related Macular Degeneration

4DMT Announces RMAT Designation Granted by FDA for 4D-150 for DME (GlobeNewswire) - "4D Molecular Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME)....'The RMAT designation is based on the review of our results to-date from our ongoing 4D-150 SPECTRA DME study...'"

FDA event • Diabetic Macular Edema

4DMT Announces Corporate Webcast to Review Interim 52-week Results from the Phase 2b Cohort of PRISM in a Broad Wet AMD Population (GlobeNewswire) - P1/2 | N=215 | NCT05197270 | Sponsor: 4D Molecular Therapeutics | "4D Molecular Therapeutics...announced that the Company will present the initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad wet age-related macular degeneration (wet AMD) patient population at Angiogenesis, Exudation, and Degeneration 2025 being held virtually on February 8, 2025. The Company will host a webcast to discuss the PRISM interim data and additional analyses from the 4D-150 program in wet AMD and diabetic macular edema (DME) on Monday, February 10, 2025 at 8:00 a.m. ET."

P2b data • Diabetic Macular Edema

4D Molecular Therapeutics…announced a strategic partnership with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to develop and commercialize 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific (APAC) region including Japan (GlobeNewswire) - "4DMT to receive $85 million upfront cash payment and expect to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration. Up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties depending on net sales in Otsuka’s territories. Proceeds and cost sharing expected to support global Phase 3 clinical trial in DME and pre-commercial activities."

Licensing / partnership • Diabetic Macular Edema • Wet Age-related Macular Degeneration

4D-150 in Patients With Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=72 | Active, not recruiting | Sponsor: 4D Molecular Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2028 ➔ Feb 2029 | Trial primary completion date: Feb 2028 ➔ Feb 2029

Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Diabetic Retinopathy • Gene Therapies • Ophthalmology • Retinal Disorders

4FRONT-2: Single Intravitreal Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: 4D Molecular Therapeutics

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

PRISM: 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration (clinicaltrials.gov) - P1/2 | N=215 | Recruiting | Sponsor: 4D Molecular Therapeutics | Trial completion date: Nov 2026 ➔ Jan 2031 | Trial primary completion date: Nov 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Interim results from the phase 2b population extension cohort in the PRISM clinical trial evaluating 4D-150 in adults with neovascular (wet) age-related macular degeneration (ARVO 2025) - P1/2 | "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P2b data • Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC

4DMT Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD (GlobeNewswire) - "4D Molecular Therapeutics...today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AMD)."

Trial status • Wet Age-related Macular Degeneration

4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: 4D Molecular Therapeutics

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

4D-150 Program Milestones (GlobeNewswire) - "4FRONT-1 and 4FRONT-2 expected to initiate in Q1 and Q3 2025, respectively; Two-year Phase 1/2a and 18-month Phase 2b PRISM data expected in Q4 2025; Primary endpoint 52-week topline data from both 4FRONT-1 and 4FRONT-2 expected in H2 2027."

Clinical data • New P3 trial • Wet Age-related Macular Degeneration