Outlook Therapeutics, Inc. (OTLK) Earnings Call Transcript & Summary

Welcome back for another virtual investor "What this Means" segment featuring Outlook Therapeutics. My name is Jenene Thomas, and I am CEO of JTC IR and I will be moderating. I am very pleased to be joined by Dr. Jennifer Kissner. She is Senior Vice President of Clinical and Regulatory Affairs at Outlook Therapeutics. Welcome, Jennifer.

Thank you, Jenene. Happy to be here.

Before we get started, I just want to inform our audience that Outlook Therapeutics is publicly listed and trades on NASDAQ under the ticker OTLK. And during today's discussion, the company will be making forward-looking statements, and I encourage everyone to view the company's website at outlooktherapeutics.com for SEC filings and the latest information. For our audience, Outlook Therapeutics recently announced an analysis of the NORSE EIGHT data at week 12 showed ONS-5010 achieved a mean change in BCVA of 5.5 letters for ONS-5010 compared to 6.5 letters for ranibizumab. And this was statistically non-inferior with a p value of 0.0043. So with that in mind, Jennifer, can you help us understand these 12-week data and how they compare to the previous data released in December at week 8?

Thanks, Jenene. I appreciate the question. So you'll recall that the NORSE EIGHT study is a Phase III non-inferiority study that was requested by the FDA in order to provide a second adequate well-controlled trial of ONS-5010 to demonstrate safety and efficacy of the product. So our recent release was of a complete data set from this 12-week trial. It was designed as a 12-week trial with an 8-week primary endpoint for efficacy but the 12-week trial demonstrated that we had visual acuity improvements in both study arms across each study visit and improving greater at each visit. So the 2 study arms were also non-inferior at week 4 and week 12 and narrowly missed the non-inferiority margin at week 8. So what this means in context is that we have a trial that's demonstrating visual acuity games across multiple visits. And we know from the natural history of the disease and literature that the average patient who goes untreated for wet AMD would actually lose a letter of vision per month. So rather than losing 3 letters of vision, these patients have gained 3, 4 and 5 letters of vision. And this is also consistent with our NORSE TWO study where in the first 3 months, the 2 study arms were also dosed the same. And demonstrated visual acuity gains at each visit. So this gives us now 2 adequate well-controlled trials that are demonstrating a visual acuity improvement.

Jennifer, the company also announced for the first time the mean change in central retinal thickness data from NORSE EIGHT. Can you put these data into context for investors?

I can. Thank you. So central retinal thickness is an endpoint that is an anatomical measurement of the retinal thickness or the fluid in the back of the eye that is disturbing visual acuity. Physicians use this primarily as their means of determining how frequently a patient needs to be dosed with an anti-VEGF. And although the agency doesn't accept it as a primary endpoint, they certainly do look at it as additional evidence of activity of a product. So in the NORSE EIGHT study, we reported that both study arms rapidly decrease the retinal thickness, which means they're reducing the fluid in the back of the eye. And then that reduction was not only maintained across the study, but actually continue to improve at each visit. And the 2 study arms are not different. So again, this gives another layer of evidence to the totality of evidence that we will be presenting back to the FDA as the effect of ONS-5010 in these wet AMD patients.

And finally, Jennifer, the company has guided to refiling the BLA for ONS-5010 for first quarter calendar year of 2025. Can you provide any additional color on this time line and the subsequent milestones in 2025 for the U.S. market?

I can. Thank you. Yes, we are excited about this data and to be able to present this back to the agency. So we are targeting to refile our BLA before the end of this quarter. And then there will set a clock with the FDA. So the first thing that happens is the agency will provide us a letter within 30 days that acknowledges receipt of our filing, it will also provide us the confirmation of the classification, which this resubmission will be a Class II, which means a 6-month clock will be set for the review time line. And that clock actually starts upon our filing, not upon the letter. So 6 months from our filing, we will have then a review of the BLA. That means that if we file here before the end of the first quarter, then before the end of the third quarter, we will have responses back from the agency.

This concludes the virtual investor "What This Means" segment, featuring Outlook Therapeutics. I'd like to extend a huge thank you to Dr. Jennifer Kissner for joining us today. And as a reminder, Outlook Therapeutics trades on NASDAQ under the ticker OTLK. And if you like what you saw today, I encourage you to visit outlooktherapeutics.com for more information on the company and to sign up to follow the company to receive their alerts as well as follow their social channels to stay current on the latest information. You can also visit virtualinvestorco.com for a replay of today's event as well as our latest segment and event calendar want to thank everyone and wish you a great rest of your day.