Ocugen, Inc. Announces Binding Term Sheet with Roots Pharmaceutical to License OCU400Modifier Gene Therapy for Retinitis Pigmentosa in the Middle East and North Africa

Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced the signing of a binding term sheet to negotiate and enter into a license agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, for the exclusive rights to OCU400, Ocugen's novel modifier gene therapy for Retinitis Pigmentosa (RP), in the Middle East and North Africa (MENA) region.

Pursuant to the term sheet, under the license agreement, Ocugen is expected to receive upfront license fees and near-term development milestone payments totaling up to $4 million. The Company would be entitled to sales milestone payments up to $255 million, in addition to a 22% royalty on net sales of OCU400 generated by Ocugen's partner. Additionally, Ocugen would manufacture commercial supply of OCU400 under the terms of a related supply agreement.

RP is a leading cause of inherited vision loss globally, with notable prevalence across the MENA region, underscoring the significant unmet need OCU400 is positioned to address through this partnership.

"This step forward represents an important milestone in our effort to advance OCU400 regional partnership strategy," said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. "By partnering with an established leader with strong reach across the Middle East and North Africa, we are expanding our ability to bring this one-time potential treatment for life to a region where RP is highly prevalent with a significant unmet medical need where patients are desperately looking for rescue from blindness. This agreement underscores the momentum behind OCU400 and our continued commitment to patients."

“Bringing innovative gene therapies to patients across the MENA region is a strategic imperative for Roots Pharmaceutical and its strategic partner Al-Dhow International Holding,” said Dr. Islam Zayed, CEO & Co-founder of Roots Pharmaceutical. Dr. Zayed emphasized that “OCU400 built on our legacy of bringing Rare Disease therapies to patients in MENA and enables our combined teams to decrease disease burden in the region. Importantly, Roots is dedicated to bringing OCU400 to patients with Retinitis Pigmentosa and creating a new treatment paradigm. We are excited to partner with the Ocugen team.”

Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 90 days.

Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical development with a topline readout expected in 1Q 2027 and BLA submission to follow.