Exhibit 99.1
Histogenics and Ocugen Enter into Definitive Merger Agreement to Create Nasdaq-Listed Clinical-Stage
Company Developing Novel Ocular Gene Therapies and Biotherapeutics
— Conference call to be held today at 8:30 a.m. Eastern Time —
BOSTON, Mass. and MALVERN, Penn. — April 8, 2019 — Histogenics Corporation (Nasdaq: HSGX) and Ocugen, Inc., a privately held clinical-stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases, today jointly announced that they have entered into a definitive merger agreement under which the stockholders of Ocugen will become the majority owners of Histogenics’ outstanding common stock upon the close of the merger. The proposed merger will result in a combined publicly-traded, clinical-stage biopharmaceutical company operating under the Ocugen name.
“Since Ocugen’s founding, we have sought to develop innovative therapies to treat rare and underserved eye diseases through a combination of therapeutic approaches that utilize small molecules, biologics, and gene therapies,” said Shankar Musunuri, Ph.D., M.B.A., Chairman, Chief Executive Officer andCo-Founder of Ocugen. “We have developed a broad pipeline which includes OCU300, an orphan drug candidate for ocular graft versus host disease, and OCU310 for dry eye disease; our modifier gene therapy platform, and OCU400, a gene augmentation therapy for patients with inherited retinal diseases caused by mutations in the NR2E3 gene, which recently received orphan drug designation from the FDA. We’ve also madepre-clinical progress toward our retinal disease programs which includes novel biologic therapies for wet-age-related macular degeneration, diabetic macular edema and diabetic retinopathy, as well as for retinitis pigmentosa.”
“This transaction with Ocugen reflects the continued commitment of our management team and Board of Directors to deliver value to stockholders and make a difference in patients’ lives,” said Adam Gridley, President of Histogenics. “Following a thorough review of strategic alternatives for Histogenics and the NeoCart program, we have determined that a merger with Ocugen will enable Histogenics investors to participate in Ocugen’s broader pipeline of ocular disease and gene therapy opportunities, including several late-stage clinical candidates, and a robust preclinical platform. In addition, we plan to continue to evaluate opportunities to realize additional value from the discontinued NeoCart program over the coming weeks.”
Ocugen’s broad pipeline of promising ophthalmology programs in development include:
Modifier Gene Therapy Platform
Ocugen’s modifier gene therapy platform is licensed from the Schepens Eye Research Institute of Massachusetts Eye and Ear (Harvard Medical School) and involves targeted delivery and expression of one or more nuclear hormone receptor (NHR) genes in the disease tissues. NHRs are believed to play a vital role in regulating retinal cell development, maturation, metabolism, visual cycle function, survival, and maintaining the cellular and molecular homeostasis of various tissues, including the retina. Multiple animal models have shown that expression of NHRs within the retina can stabilize retinal cells and suppress/prevent the development of inherited diseases, demonstrating their modifier function. Many degenerative retinal conditions are caused by genetic mutations that are passed down within families and lead to progressive disease, severe visual impairment and blindness.
OCU400 (NR2E3-AAV) for the treatment ofNR2E3 mutation-associated retinal degenerative diseases consists of a functional copy of the NHR gene, NR2E3, delivered to target cells in the retina using an adeno-associated viral (AAV) vector. OCU400 is a novel gene therapy currently in development as a gene augmentation therapy product for the treatment of NR2E3-mutation associated retinal degenerative diseases, and in February 2019, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (the FDA). In a mouse model of Nr2e3 mutation, Nr2e3 delivery to retinal cells reversed disease progression and restored retinal histology. Based on preclinical studies, Ocugen plans to initiate a Phase 1/2a clinical study of OCU400. Unlike single-gene replacement approaches, which have shown tremendous promise in rare retinal diseases despite being highly specific for a single condition, OCU400 represents a powerful and remarkably broadened means of potentially treating a variety of IRDs (inherited retinal diseases) with a single therapy.