This week Ocugen, Inc. ($OCGN) entered into an agreement with Kemwell Biopharma for the cGMP production of OCU200. This is the new biologic product candidate in preclinical development for the treatment of severe vision-threatening diseases, such as: diabetic macular edema (DME), diabetic retinopathy (DR) and wet age-related macular degeneration (Wet-AMD).
What is the power of Kemwell and OCU200?
Kemwell intends to manage all CMC and clinical manufacturing operations and provide OCU200 supplies for IND-enabling toxicology studies and Phase 1/2a clinical studies. This makes biological production indispensable and speed-limiting for Phase 1/2a clinical studies.
The agreement makes it possible for Ocugen to enter the clinic by 1H2022. A CMO with commercial capabilities has been chosen, with its main goals being to ensure product consistency during development and minimize regulatory issues, while the team directs the development of OCU200.
The plan is for Ocugen to start IND-enabling studies in 2021, including GLP toxicology studies. DME is the first targeted indication for OCU200, and the company plans to advance to Phase 1/2a studies in 1H2022. Following its success at DME, the company will conduct an evaluation of broader indications such as DR and Wet-AMD. This is desperately needed, as 9.5 million patients in the United States alone are affected by these retinal diseases. Approximately 50% of those patients do not respond to current therapies, further demonstrating the importance of Ocugen’s studies.
Graphs and numbers don’t lie
In the past quarter, Ocugen reported a remarkable profit of $3.41 million. With that, the company saw sales increase to $430.000. It also has free cash flow of -$7.81 million as of June 2020. The company’s EBITDA is noted at -$3.35 million, which is favorable in comparison to the direct competition. Shareholders will also note that earnings per share amounted to -$3.50. Ocugen posted assets of $23.76 million at the end of the last quarter. Finally, it now has a market cap of $44.84 million and a float of $121.38 million. This increases the credibility of Ocugen in the sector, which in addition to the developments of the company, can also contribute to the remarkable increase of today.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. The breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and the novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. For more information, visit www.ocugen.com.
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