Ocular Therapeutix 2026 Q3 Earnings Call

Good morning, everyone, and thank you for joining us today. Earlier this morning, we issued a press release and filed our quarterly report on Form 10-Q, outlining our financial results and business updates for the third quarter of 2026. We will begin today's call with prepared remarks summarizing recent business highlights from Dr. Pravin Dugel, Ocular's Executive Chairman, President, and CEO, Dr. Nadia Waheed, Ocular's Chief Medical Officer, and David Robinson, Ocular's Global Chief Commercial Officer. Donald Notman, Ocular's Chief Operating Officer, will join for the question-and-answer session. We refer everyone to this morning's press release and our Form 10-Q for a comprehensive update of third quarter 2026 financial and business results. During today's call, certain statements we will be making constitute forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Actual results may differ materially as a result of a variety of factors, including risks and uncertainties identified in the risk factors section of our annual report on Form 10-K and our other SEC filings. On today's call, we will discuss our investigational product candidate, AXPAXLI, also known as OTX-TKI, which is in development for wet age-related macular degeneration and non-proliferative diabetic retinopathy. As a reminder, the safety and efficacy of AXPAXLI have not been established by the FDA or any other regulatory authority, and AXPAXLI has not been approved for marketing. With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates.

Pravin. Thanks, Bill, and good morning, everyone. 2026 has been an extraordinary and truly transformational year for Ocular Therapeutix.

We've achieved landmark phase III superiority results in SOL-1, established a clear regulatory path forward toward our first potential approval for AXPAXLI in wet AMD, and continue to generate compelling clinical evidence showing AXPAXLI's durability and disease control. As we approach the end of the year, I believe we are in the strongest position in our company's 20-year history, with an extraordinary opportunity to fundamentally transform the treatment paradigm for retinal diseases. Today, while several bolus treatment agents are either approved or in development, AXPAXLI stands alone as the only intravitreal sustained-release maintenance agent with positive phase III data in wet AMD. With a competitive landscape evolving significantly in recent months, we believe our opportunity has never been greater.

I want to begin by addressing recent competitive developments, because they reinforce the importance of the fundamental principles that have guided our AXPAXLI development strategy from the outset. These include the importance of TKI potency, drug delivery vehicle, and thoughtful clinical trial design, including rigorous patient selection. In drug development, molecular potency matters. The drug's delivery vehicle matters. Rigorous clinical trial design matters, and patient selection matters. First, on potency. We have seen potency make a huge difference in wet AMD studies before. For example, Lucentis was considerably more potent than Macugen. Similarly, axitinib, the TKI used in AXPAXLI, has demonstrated the greatest potency of the TKIs currently in development for retinal diseases. Axitinib has approximately a 100-fold greater potency against VEGF receptor two when compared to vorolanib, as well as greater potency in the other VEGF receptors.

We believe this distinction is critical to achieving sustained VEGF suppression over extended treatment intervals. Next, delivery matters. As we know from preclinical studies, our bioresorbable hydrogel is capable of delivering consistent daily release of axitinib. The 9 to 12-month durability observed in SOL-1 provides compelling evidence that the hydrogel performs similarly in humans to what we saw preclinically. Equally important as TKI potency and the bioresorbable hydrogel selected to deliver VEGF suppression is the clinical trial design and patient selection of each trial being evaluated. SOL-1 and SOL-R randomized different groups of treatment-naive patients, since the trials were deliberately designed to answer very distinct clinical questions. In SOL-1, our objective was to demonstrate superiority in vision maintenance over a single administration of aflibercept two milligrams. Accordingly, we prioritized a challenging population specifically selected to lose vision.

Nonetheless, approximately 75% of patients receiving AXPAXLI maintained vision at week 36 primary endpoint, and approximately two-thirds through week 52 following a single injection. In SOL-R, our objective is non-inferiority in BCVA to aflibercept two milligrams administered every eight weeks. Accordingly, we incorporated a differentiating six-month screening and loading period to exclude from randomization patients with early persistent fluid or significant fluid variability. These patients are known to have negatively impacted historical non-inferiority trials. Contrast this with recent developments from a peer that utilized a TKI that is less potent against VEGF receptor two in trials that combined previously treated and treatment-naive patients and randomized patients before the loading phase. We believe our peers' results do not reflect a limitation of the TKI class, but rather they underscore the importance of getting all three elements right: the TKI and the delivery vehicle, the trial design, and the patient population.

These principles were critical to our success in SOL-1, and we believe they provide a compelling foundation for success in SOL-R. Turning to our regulatory process, our highest near-term priority remains the planned submission of our NDA for AXPAXLI in wet AMD in the fourth quarter of this year. Following our positive pre-NDA meeting in September, we remain aligned with the FDA on our planned submission package. Our NDA will be supported by SOL-1 week 52 efficacy data, SOL-1 and interim SOL-R week 52 safety data, and a comprehensive body of confirmatory evidence. Importantly, we also plan to submit repeat dosing safety data from patients who have received multiple AXPAXLI injections in both phase III trials as part of the NDA review process.

Together, our safety database at the time of submission will include more than 300 patients with at least one year follow-up after AXPAXLI treatment, consistent with FDA requirements. We remain on track to conduct the interim SOL-R safety analysis this quarter, with these results to be incorporated into our planned NDA submission. Throughout this process, we have maintained consistent engagement with the FDA, including our special protocol assessment agreement for SOL-1, our Type C meeting earlier this year, and most recently, our positive pre-NDA meeting in September. We also remained aligned with the agency on pursuing approval through the 505(b)(two) regulatory pathway, which has the potential to shorten the review timeline by up to 60 days compared with the traditional 505(b)(one) pathway for a new molecular entity.

This will be an incredibly important milestone for our organization and one that reflects years of disciplined clinical development, rigorous execution, and extensive collaboration with the FDA. The incredible progress that we've achieved only occurs when you have a tremendous team in place. Today, you will hear from some of those team members, starting with Dr. Nadia Waheed, Ocular's Chief Medical Officer, who will speak to recent updates regarding our clinical programs. David Robinson, Ocular's Global Chief Commercial Officer, who will then review the transformative commercial opportunity ahead. Nadia, please go ahead. Thanks, Pravin.

Let's start with SOL-R, our second phase III trial in wet AMD. I want to emphasize that our confidence in this important trial remains very strong and continues to grow. While SOL-R efficacy data are not required for our planned NDA submission, we believe positive results could provide additional commercial advantages in the U.S. and support regulatory approvals internationally. At the recent American Academy of Ophthalmology meeting, we presented a post-hoc analysis using an AI-based assessment of retinal fluid. This analysis demonstrated that approximately 71% of AXPAXLI-treated subjects were quantitatively dry at week eight, meaning they had less than or equal to 10 nanoliters of total fluid volume in the six by 6 millimeter scan. Under this stringent definition of dryness, remarkably, approximately 70% of these subjects remained quantitatively dry through week 36 following a single AXPAXLI injection.

We believe these findings provide more than just another illustration of AXPAXLI's potential durability. They offer clinicians a potential roadmap for treatment: achieve initial disease control with a couple of bolus anti-VEGF injections, then transition to AXPAXLI for long-term maintenance treatment. Importantly, recent SOL-1 post-hoc analyses have also provided compelling insights into the relationship between early retinal fluid control durability, and long-term outcomes, reinforcing our confidence in the SOL-R study design. At last week's Empire Forum in New York City, we presented a separate post-hoc analysis reporting that approximately 28% of AXPAXLI-treated subjects in SOL-1 experienced early persistent retinal fluid or fluid variability, defined as a greater than 30-micron increase in central subfield thickness at week eight. These patients had worse visual outcomes, a 32-week earlier time to supplemental injection, and an increased frequency of needing supplemental injections compared to subjects without early persistent fluid in the same period.

This was consistent across both AXPAXLI and aflibercept-treated patients, reinforcing the importance of early disease stability independent of treatment assignment. This is precisely where the design of SOL-R becomes so important. SOL-R incorporates a six-month pre-randomization period specifically designed to screen out patients with early persistent retinal fluid or significant fluid variability. Our preliminary analysis indicates approximately 20% of patients otherwise eligible for SOL-R were excluded from randomization because of these characteristics. This is also consistent with historical expectations and closely aligns with the findings from SOL-1. In short, SOL-R is designed to randomize the very population in which we observed the strongest durability profile for AXPAXLI in SOL-1. As it relates to SOL-R, I would also like to address an important refinement to the primary endpoint, which reflects our priority to protect the integrity of our primary analysis.