Core Insights - The U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Opus Genetics' investigational gene therapy OPGx-LCA5 for treating Leber Congenital Amaurosis (LCA) due to mutations in the LCA5 gene, marking a significant milestone for the company and the patient community [1][3][4] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on developing gene therapies for inherited retinal diseases (IRDs) and other ophthalmic disorders [6] - The company's pipeline includes AAV-based investigational gene therapies targeting mutations in various genes associated with retinal diseases, including LCA and retinitis pigmentosa [6] Product Details - OPGx-LCA5 is designed to treat LCA caused by biallelic mutations in the LCA5 gene, which encodes the lebercilin protein, and is currently in a Phase 1/2 clinical trial [5][6] - The therapy utilizes an adeno-associated virus 8 (AAV8) vector to deliver a functional LCA5 gene to the outer retina, aiming to address severe vision loss in affected patients [5] Regulatory Milestones - The RMAT designation allows for expedited development and review of OPGx-LCA5, providing early interactions with the FDA and guidance on efficient development and manufacturing [4] - Opus Genetics has been invited to participate in the FDA's Initial Comprehensive Multidisciplinary RMAT Meeting and the Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) program [3]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) Delaware 86-1889525 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 1510 West Loop South, Houston, Texas ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 1510 West Loop South, Houston, Texas 77027 (Address of principal executive offices, including zip code) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) Delaware 86-1889525 (State or other jurisdiction of inc ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023 Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) Delaware 86-1889525 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 1510 West Loop South, Houston, Texas 7702 ...

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 Or Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, o ...

Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022 (IRS Employer Identification No.) 1510 West Loop South, Houston, Texas 77027 (Address of principal executive offices, including zip code) Registrant's tel ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022 Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) Delaware 86-1889525 (State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.) 1510 West Loop South, Houston, Texas 77027 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022 Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) (State or other jurisdiction of incorporation or organization) Delaware 86-1889525 (IRS Employer Identification No.) 1510 West Loop South, Houston, Texas 7702 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-40283 (Commission File Number) Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) | Delaware | | 86-1889525 | | --- | ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2021 Landcadia Holdings IV, Inc. (Exact name of registrant as specified in its charter) 001-40283 (Commission File Number) (State or other jurisdiction of incorporation or organization) Delaware 86-1889525 (IRS Employer Identification No.) 1510 West Loop South, Houston, Texas ...