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Ocugen Provides Business Update and Full Year 2019 Financial Results

Financial Results
Over 95% planned enrollment completed in Phase 3 oGVHD study; topline results anticipated by end of 2020

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat rare and underserved ophthalmic diseases, recently reported full year 2019 financial results along with a general business update.

“We are extremely pleased with the progress we have made in enrolling patients in our Phase 3 clinical trial for OCU300, an orphan drug candidate for ocular graft versus host disease (oGVHD). Based on current enrollment, we anticipate topline results by the end of the year,” commented Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-Founder of Ocugen.

“The publication of preclinical data on OCU400 in Nature Gene Therapy earlier this month is a key achievement for this program. We continue to advance IND-enabling studies toward bringing this potential breakthrough modifier gene therapy platform to patients in a Phase 1/2a clinical trial for OCU400 in 2021.

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“Similar to the situation with virtually all other biopharmaceutical companies, we are also assessing the potential impact of ongoing COVID-19 pandemic-related events on our programs and plans. We are grateful to healthcare professionals and others who are working hard to address and mitigate the challenges presented by the virus.”

Business Highlights:

  • OCU300 (oGVHD) – In December 2019, Ocugen announced 50% enrollment in its Phase 3 trial, and as of March 20, 2020, Ocugen has completed over 95% of the planned enrollment. Ocugen is anticipating topline results by the end of the year.
  • OCU400 (AAV-NR2E3) – On March 3, 2020, Nature Gene Therapy published preclinical data related to OCU400, supporting the use of nuclear hormone receptor gene NR2E3 as a genetic modifier and therapeutic agent to treat multiple retinal degenerative diseases and potentially serve as a broad-spectrum therapy for retinitis pigmentosa.
  • EB-5 Loan Agreement – On March 26, 2020, Ocugen drew down an additional $0.5 million under its loan agreement with EB5 Life Sciences, L.P.
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Full Year 2019 Financial Results:

  • Ocugen’s cash, cash equivalents and restricted cash totaled $7.6 million as of December 31, 2019, compared to $1.8 million as of December 31, 2018.
  • Research and development expenses for the year ended December 31, 2019 were $8.1 million compared to $10.3 million for the year ended December 31, 2018. General and administrative expenses for the year ended December 31, 2019 were $6.1 million compared to $5.8 million for the year ended December 31, 2018.
  • Ocugen reported a net loss of $20.2 million, or $1.46 loss per share, for the year ended December 31, 2019, compared to a net loss of $18.2 million, or $3.67 loss per share, for the year ended December 31, 2018.
  • The Company had 52,625,228 shares of common stock outstanding as of December 31, 2019.
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