Ocugen Secures $6 Million in Series A Funding to Advance Ophthalmic Drug Pipeline and Files Confidential IPO Prospectus

Ocugen, a company dedicated to developing therapies for ocular diseases, completed a $6 million Series A financing round on December 15 (local time). The round was led by several former executives from pharmaceutical companies, including Bernhard Hampl, former CEO of Sandoz Pharmaceuticals. Over $1 million of this financing came from life science projects under the U.S. EB-5 Immigrant Investor Program. This investment vehicle remains open and may secure an additional $9 million in financing with the assistance of Global City Regional Center LLC (GCRC).

Shankar Musunuri, Chairman and CEO of the Company, expressed strong satisfaction with the outcome of this financing round and stated that he was greatly encouraged by investors’ confidence in the Company’s and its projects’ prospects. He further noted that Ocugen would leverage these funds to fully advance the OCU300 program, aiming to submit an Investigational New Drug (IND) application within one year and deliver this therapeutic to the patients who need it most as soon as possible.

OCU300 is a repurposed drug with a well-established safety profile. Ocugen is investigating its potential for treating ocular graft-versus-host disease (oGVHD) and has submitted a 505(b)(2) application to the U.S. Food and Drug Administration (FDA) for review. oGVHD primarily affects patients who have undergone allogeneic hematopoietic stem cell transplantation or bone marrow transplantation, and there are currently no effective treatments available. In an observational study involving patients with this condition, treatment with OCU300 resulted in favorable outcomes in approximately 90% of cases, with no reported side effects.

On the same day, Ocugen also announced that it had received a Notice of Allowance from the United States Patent and Trademark Office for a patent related to OCU100. This patent, titled “Treatment of Degenerative Diseases with Lens Epithelium-Derived Growth Factor,” covers the drug composition, manufacturing methods, and methods of use for OCU100. OCU100 is a recombinant form of lens epithelium-derived growth factor (LEDGF) and has been demonstrated to effectively restore the function and morphology of retinal photoreceptors.

Ocugen’s product pipeline features a broad portfolio of drug candidates, encompassing both clinical-stage and preclinical-stage projects, aimed at addressing significant unmet medical needs. The company is dedicated to leveraging novel biological pathways to treat ocular inflammatory, degenerative, and neovascular diseases, maintaining a diverse mix of long-term and short-term development programs.

“Ocugen is committed to rapidly translating a highly effective therapeutic approach into a product to address the urgent unmet need in treating ocular graft-versus-host disease, which has imposed a significant burden on patients,” said Bernhard Hampl, the lead investor. “I am deeply impressed by the progress achieved with OCU300 to date and look forward to its potential demonstrated in late-stage clinical trials.”

Ahsan Nasratullah, CEO of the Global City Regional Center (GCRC), stated that attracting such a significant amount of overseas investment in the life sciences sector is unprecedented for an EB-5 project. He expressed strong hope that this initiative would help Ocugen raise additional capital and serve as a model to guide similar financing efforts, thereby providing momentum for the advancement of the life sciences industry.

Two novel biologics are currently under development, alongside a pharmaceutical product that has cleared the FDA 505(b)(2) review pathway and has already been launched on the market. The first-generation product, OCU100, is a therapy for retinitis pigmentosa, a rare disease, and received FDA Orphan Drug Designation in 2014. The second-generation product, OCU200, is an anti-angiogenic anti-tumor fusion protein indicated for the treatment of wet age-related macular degeneration. The third-generation product, OCU300 mentioned above, is indicated for the treatment of ocular graft-versus-host disease.

Global City Regional Center LLC (GCRC) is a multi-state “regional center” designated by U.S. Citizenship and Immigration Services (USCIS) in 2013, with branches across multiple states nationwide. It was established to promote economic development, enhance productivity, and create jobs in the Greater Philadelphia area (Pennsylvania and southern New Jersey). In 1990, the U.S. Congress created the EB-5 program to attract high-quality foreign investors. Since 2013, the EB-5 program has generated over $4 billion in investment annually in the United States, most of which has been directed toward real estate and service-sector projects. This investment in Ocugen marks a shift in U.S. foreign investment toward the life sciences sector.