Aldeyra Therapeutics, Inc.

ladies and gentlemen thank you for standing by and welcome to the aldera therapeutics third quarter 2022 financial results conference call at this time all participants are in listen only mode after the speaker's presentations there will be a question and answer session i would now like to hand over the conference to the company's interim chief financial officer mr bruce greenberg please go ahead sir good morning everyone

With me today is Dr. Todd Brady, our President and Chief Executive Officer. This morning, we issued a press release reporting our financial results for the quarter ended September 30th, 2022 and recent corporate highlights. A copy of the press release is available on the investors and media section of our website at www.aldera.com. Please note that this morning's conference call contains forward-looking statements regarding future events in the future performance of Aldera. Forward-looking statements include, but are not limited to, statements regarding submission of potential new drug applications, potential commercialization, the anticipated timing of results from our clinical trials, our projected cash runway, our possible or assumed future results of operations, expenses, and financial position, and potential growth opportunities. These statements are based on the information available to us today and reflect our current views concerning future events. They are based on assumptions and subject to risks and uncertainties, including the development, clinical regulatory plans, or expectations for Aldera's product candidates and systems-based approaches. The risks that result from clinical trials or portions of clinical trials may not accurately predict the results of future trials for the same or different indications in El Dera's continuing review and quality control analysis of clinical data. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected, and the timelines to complete our trials may be delayed. El Dera assumes no obligation to update these statements as circumstances change. Future and events, Future events and actual results could differ materially from those projected in our forward-looking statements, including the current and potential future impact of the COVID-19 pandemic on our business, results of operations, and financial position. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in our press release issued this morning and in our filings with the SEC. I will now turn the call over to Dr. Brady.

Thank you, Bruce, and good morning, everyone. Today I'd like to share with you the progress we've made in advancing our lead pre-commercial product candidates, Reproxilab and ADX2191, toward regulatory approval. Individually, these products have the potential to provide us with unique revenue streams while together They represent an opportunity to build a formidable ocular franchise encompassing both large and rare retinal diseases that are significantly underserved by currently available treatments. The success to date in developing Reproxilab and ADX2191 and the commercial potential of both product candidates serve as evidence of Aldera's position as a leader. and the developments of systems-based therapies for diseases characterized by inflammation. Leading off with Reproxilab, in September, we had a successful pre-NDA meeting with the U.S. Food and Drug Administration, gaining alignment on the key aspects of the planned NDA submissions. In the fourth quarter of 2022, we plan to submit what we believe will be the most comprehensive regulatory package ever for a dry eye disease drug candidate. With results based on five adequate and well-controlled completed clinical trials, we intend to submit the NDA with data for ocular dryness symptom score, ocular redness, Shermer test, and Shermer tests greater than or equal to 10 millimeter responder analysis. The NDA efficacy package is expected to include activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings. The NDA package will also include up to 12 months of Reproxilab safety data. As a reminder, Reproxilab has been studied in more than 2,000 patients with no observed clinically significant safety concerns, with the most commonly reported adverse event being mild and transient installation site irritation. Complementing our dry eye disease program, we're also advancing Reproxilab toward a potential supplemental, NDA submission in allergic conjunctivitis. Results from the Invigorate II allergen chamber trial, which could represent our final clinical trial of roproxilab in allergic conjunctivitis, are expected in 2023. In October, the previously completed Phase III Invigorate trial was the subject of a presentation, the American Academy of Optometry 2022 annual meeting. Moving to our clinical development programs targeting diseases in the back of the eye, several planned milestones are approaching for ADX2191, our pre-commercial product candidate for rare retinal disease. ADX2191 is the first sterile non-compounded formulation of methotrexate designed to meet the unique requirements of intravitreal administration. It is intended to be vitreous compatible and optimized for excipient composition, viscosity, density, tonicity, pH, active ingredient concentration, and volume of administration. Importantly, the volume of administration is less than that of compounded methotrexate, potentially resulting in an improved safety profile. Although compounded methotrexate is injected into the vitreous today, ADX2191, if approved, would represent the first GMP-manufactured methotrexate drug product for intravitreal administration. Our ADX2191 platform is targeting three indications, all of which have received US FDA orphan drug designation. Primary vitreoretinal lymphoma is a rare, aggressive, and fatal cancer that is diagnosed in approximately 300 to 600 patients in the United States per year. Proliferative vitreoretinopathy, or PVR, is a sight-threatening condition and a leading cause of failure of retinal reattachment surgery that affects approximately 4,000 patients in the U.S. per year. And retinitis pigmentosa is a group of rare genetic eye diseases characterized by cell death and loss of vision affecting an estimated 82,000 individuals in the United States and approximately 1 in 4,000 people worldwide. We scheduled a pre-NDA meeting with the FDA in the fourth quarter of 2022 to discuss ADX2191 for the treatment of primary vitreoretinal lymphoma. Pending the results of the pre-NDA meeting, NDA submission may occur as soon as the end of 2022. For PVR, this quarter, we announced that ADX 2191 met the primary endpoint in part one of the phase three GARD trial. ADX 2191 was statistically superior to historical control for the prevention of retinal detachment due to PVR over six months. with a p-value of 0.024. Although not statistically powered for secondary or exploratory endpoints, the results of the GARD trial demonstrated numerical superiority of ADX2191 over routine surgical care in reducing every assessed dichotomous endpoint of ocular disease with an overall p-value of 0.047. The most common adverse event associated with ADX2191 treatment was punctate keratitis, a well-known side effect of intravitreal methotrexate that was most commonly mild in severity. Across all other treatment emergent adverse events occurring in at least 10% of patients in either treatment arm, relative to patients treated with routine surgical care, ADX2191-treated patients had numerically fewer side effects with an overall p-value of 0.0002. We plan to discuss the completion of clinical development for PVR in a Type C meeting with the FDA in the first half of 2023. We also expect to announce Phase II clinical trial results of ADX2191 and retinitis pigmentosa in the first half of next year. Eight patients are expected to be enrolled in the trial with half receiving monthly intravitreal injections and the other half receiving twice monthly intravitreal injections over a period of three months. Turning to ADX629, our oral RAS modulator platform targeting systemic inflammatory disease, we remain on track to report top line results this year from a phase two clinical trial in acute alcoholic hepatitis. In addition, by year end, we also plan to initiate phase two clinical trials in Sjogren-Larsen syndrome and minimal change disease. Top line results of the Phase II clinical trial and chronic cough are anticipated in the first half of 2023. Now I'll turn the call over to Bruce for the financial review. Bruce?