OCUGEN : Management’s Discussion and Analysis of Financial Condition and Results of Operations. (form 10-K) – marketscreener.com

You should read the following discussion and analysis of our financial conditionand results of operations in conjunction with the financial statements and thenotes thereto included elsewhere in this Annual Report on Form 10-K. Some of theinformation contained in this discussion and analysis, including informationwith respect to our plans and strategy for our business and related financing,include forward-looking statements that involve risks, uncertainties andassumptions. These statements are based on our beliefs and expectations aboutfuture outcomes and are subject to risks and uncertainties that could cause ouractual results to differ materially from anticipated results. We undertake noobligation to publicly update these forward-looking statements, whether as aresult of new information, future events or otherwise. You should read the "RiskFactors" and "Special Note Regarding Forward-Looking Statements" sections ofthis Annual Report on Form 10-K for a discussion of important factors that couldcause actual results to differ materially from the results described in orimplied by the forward-looking statements contained in the following discussionand analysis.On September 27, 2019, Ocugen completed its reverse merger with Ocugen OpCo Inc.(formerly known as Ocugen, Inc. ("Former Ocugen")) in accordance with the termsof the Agreement and Plan of Merger and Reorganization, dated as of April 5,2019, by and among Histogenics, Former Ocugen and Restore Merger Sub, Inc., awholly owned subsidiary of Histogenics ("Merger Sub"), as amended (the "MergerAgreement"), pursuant to which Merger Sub merged with and into Former Ocugen,with Former Ocugen surviving as a wholly owned subsidiary of Histogenics (the"Merger"). Immediately after completion of the Merger, Histogenics changed itsname to Ocugen, Inc. For accounting purposes, the Merger is treated as a"reverse asset acquisition" under generally acceptable accounting principles inthe United States ("U.S. GAAP") and Former Ocugen is considered the accountingacquirer. Accordingly, Former Ocugen's historical results of operations replacedthe Company's historical results of operations for all periods prior to theMerger and, for all periods following the Merger, the results of operations ofthe combined company will be included in the Company's financial statements.OverviewWe are a clinical-stage biopharmaceutical company focused on discovering,developing and commercializing transformative therapies to treat the whole eye.Our lead product candidate, OCU300, is a small molecule therapeutic currently inPhase 3 clinical development for patients with ocular redness and discomfortstemming from ocular graft-versus-host disease ("oGVHD"). As of March 20, 2020,we had completed over 95% of planned enrollment of our Phase 3 clinical trialfor OCU300. OCU300 has received Orphan Drug Designation ("ODD") from the U.S.Food and Drug Administration (the "FDA"), and it is the first and only productcandidate to receive that designation for the treatment of symptoms associatedwith oGVHD. oGVHD, a severe chronic autoimmune disease that occurs in up to 60%of allogeneic hematopoietic stem cell transplantation ("HSCT") patients, canresult in light sensitivity, excessive ocular redness, severe ocular pain and,ultimately, vision impairment. We estimate the current prevalence of patientssuffering from oGVHD in the United States to be approximately 63,000. OCU300 isformulated using our proprietary nanoemulsion technology, OcuNanoE-Ocugen's ONEPlatform ("OcuNanoE"), which we believe represents an effective drug deliverymechanism to treat ocular surface disorders. We believe that OcuNanoE providesadditional protection to the ocular surface and the potential for enhancedefficacy compared to traditional formulations. We are the first company to usenanoemulsion technology in the ophthalmology space.We were developing OCU310 for patients with dry eye disease, which is alsoformulated using OcuNanoE. We have completed a Phase 3 clinical trial forOCU310 that was initiated in September 2018. Although the trial showed thatOCU310 is safe and well-tolerated, it did not meet its co-primary endpoints forsymptom and sign. We are no longer pursuing the development of this productcandidate.We are also developing a modifier gene therapy platform to generate therapiesdesigned to fulfill unmet medical needs in the area of retinal diseases,including inherited retinal diseases ("IRDs"). Our modifier gene therapyplatform is being designed to target nuclear hormone receptors ("NHRs"), whichhave the potential to restore homeostasis to the retina. Unlike single-genereplacement therapies, which only target one genetic mutation, we believe thatour gene therapy platform, through its use of NHRs, represents a novel approachin that it may address multiple retinal diseases with one product. Our firstgene therapy candidate, OCU400, received two ODDs from the FDA, one for thetreatment of nuclear receptor subfamily 2 group E member 3 ("NR2E3")mutation-associated retinal diseases and the other for the treatment ofcentrosomal protein 290 ("CEP290") mutation-associated retinal diseases. We areplanning to initiate a Phase 1/2a clinical trial for OCU400 in the next twoyears. Our second gene therapy candidate, OCU410, is being developed to utilizethe nuclear receptor genes RAR-related orphan receptor A ("RORA") for thetreatment of dry age-related macular degeneration ("AMD"). This candidate iscurrently in preclinical development. 85

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OCUGEN : Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-K) - marketscreener.com