Short Seller Dives into Ocugen CEO’s Claims of Bold Progress with Vaccines and Gene Therapies
platform for the delivery of COVID-19, influenza, and combination COVID-19+influenza vaccines with an intent to initially manufacture for pre-clinical studies in the near future.
Tim Berners Lee: “Dr. Musunuri, how confident are you in the accuracy of the information disclosed in your most recent SEC filing? It appears that the company is reporting considerable advances on multiple fronts - from NeoCart to OCU400 - and I’m skeptical that the business is progressing as quickly as you are suggesting. Can you tell me more about the evidence that you have to back up these ambitious developments?”
Dr. Musunuri: “Tim, I absolutely stand by the information included in our recent SEC disclosure. We have made materials advances in both NeoCart and OCU400, as evidenced by our recent submissions and milestones. With NeoCart, the FDA has concurred on the confirmatory Phase 3 clinical trial design and we intend to initiate the Phase 3 clinical trial in the first half of 2024. As for OCU400, we have established the high dose as the maximum tolerable dose and completed retinitis pigmentosa patient enrollment. We are also continuing to enroll patients with LCA to receive the high dose and intend to initiate a Phase 3 clinical trial near the end of 2023.”
Tim Berners Lee: “But what about the flu and combination COVID-19+flu vaccine development? Your filing implies several advances in the past quarter.”
Dr. Musunuri: “We are indeed making great progress in the development of our vaccine portfolio. We are developing a novel mucosal vaccine platform for the delivery of COVID-19, influenza, and combination COVID-19+influenza vaccines through the OCU500 series. In addition, we have our eyes set on manufacturing for pre-clinical studies in the near future, which is a very important step in the process. We believe that our efforts will ultimately help to increase the effectiveness and reduce the time of vaccine development.”
Tim Berners Lee: “So then what is the most realistic timeline for progress in this area?”
Dr. Musunuri: “We’re still in the early days of developing our OCU500 series. Despite this, we remain very encouraged by the progress that has been made thus far. We anticipate that pre-clinical studies could begin within the next twelve months, and the results of those studies should help to inform a more definitive timeline for the rest of the development process.”
Tim Berners Lee: “I see. Well, thank you for your time, Dr. Musunuri.”
Original Release: https://www.globenewswire.com/news-release/2023/02/28/2616886/0/en/Ocugen-Provides-Business-Update-with-Fourth-Quarter-and-Full-Year-2022-Financial-Results.html