Aldeyra Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Eldera Therapeutics First Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. I would now like to hand over the conference to Company's Chief Financial Officer, Mr. Joshua Reed. Please go ahead, sir.

Good morning, everyone. With me today are Dr. Todd Brady, President and Chief Executive Officer, and Bruce Greenberg, incoming interim CFO. This morning we issued a press release reporting our financial results for the quarter end at March 31, 2022. A copy of the press release is available on the investors and media section of our website, www.aldera.com. Please note that this morning's conference call contains forward-looking statements regarding future events and 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 upon 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, and 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 Aldera'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 clinical trials may be delayed. Aldera assumes no obligation to update these statements if circumstances change. 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 our filings with the SEC. As many of you know, next week I will be leaving Aldera to take a position as CFO of another publicly traded company in a life sciences space. Though the timing was less than ideal, It was an opportunity I could not let pass. While transitions are a natural part of this business, you always relish the friendships you make and the skills you gain along the way. Aldera's provided both. It has been gratifying to work with Todd, the board of directors, and our entire team over the past three and a half years. I'm exceedingly proud of what we accomplished and look forward to seeing the company's continued success. Bruce Greenberg, Aldera's incoming CFO, It's highly qualified for the post. I've taken particular pride in helping build a strong finance team at Aldera. With more than 25 years of science and operating experience, much of it at public companies, Bruce exemplifies that depth of knowledge. Having hired Bruce as our controller in 2019 and working closely with him since, I know that he'll do an outstanding job. I will now turn the call over to Dr. Brady.

Thank you, Joshua. Good morning, everyone. Thank you for joining us as we review the recent progress of our clinical programs and discuss our first quarter financial results. But before we do that, let me convey my sincere appreciation to Joshua for his work and dedication over the past three and a half years. All of us at Aldera wish him much success as he begins the next chapter of his career. I also want to congratulate Bruce on his appointment as Vice President, Finance, Interim CFO, and Treasurer. I expect that Bruce's knowledge of our business over the past several years, coupled with deep industry and financial experience, will make this a truly seamless transition. Turning to our recent research and development highlights, between our clinical accomplishments and our R&D day, Q1 was an exciting quarter for Aldera. It marked the start of what we believe will be a catalyst-rich year for our company, one in which we plan to continue executing on the key strategic milestones in our ocular, systemic, and retinal disease programs. We're continuing to advance Reproxilab toward an expected mid-year NDA submission in dry eye disease. Reproxilab is the lead asset in our drug discovery and development platform targeting RASP, which represent a novel pharmaceutical target comprised of pro-inflammatory small molecules that are implicated in a wide range of immunological diseases. Dry eye disease affects an estimated 39 million adults in the U.S., a large percentage of whom are dissatisfied with current standard of care treatments. It's been nearly 20 years since the first approval of the prescription drug for dry eye disease. Currently available topical therapies often require months to demonstrate even modest efficacy. As a result, the dry disease market remains significantly underserved. We envision introducing a new therapy that changes that pattern. We took another step toward that vision in first quarter, completing enrollment in the Phase III Tranquility II trial of Raproxilab in dry eye disease. We've received many questions from investors on Tranquility II, and I want to spend some time describing the precise nature of the trial, the criteria for success, the potential implications for our product label if approved, and the timing of planned FDA interactions regarding our dry eye disease NDA submission. The primary endpoints of Tranquility 2 are Shermer test on the first day of dosing and ocular redness on the second day of dosing during a dry eye chamber. Because we've implemented an alpha sharing mechanism per FDA multiplicity guidance that distributes alpha roughly equally across both endpoints, If either redness or Shermer test is achieved, the primary endpoint of Tranquility 2 will have been met. Based on the results of the previously completed Phase 2 and Tranquility trials, simulations of Tranquility 2 indicate that in at least 90 percent of the potential outcomes, the simulated trial was positive. statistical significance of drug over vehicle for either ocular redness or Shermer test was achieved. We're continuing to review the Tranquility data to confirm the analytical plans for Tranquility 2, and we remain on schedule to report results of Tranquility 2 in the second quarter. Our next major interaction with the FDA is expected to be the Type B pre-NDA meeting, following the results of Tranquility 2. We may submit two pivotal trials for either ocular redness or Shermer test, or two trials for both signs if ocular redness and Shermer test are achieved in Tranquility 2. Pending the outcome of Tranquility 2, Raproxilab could represent the first time a dry disease drug will have qualified for the demonstration of activity for two objective signs in addition to symptoms. Two additional trials are ongoing, a crossover chamber trial and a one-day Shermer test trial. Either of these trials could also serve as pivotal trials in support of an NDA submission. Both trials are designed to generate results soon after Tranquility II so as not to significantly impact NDA submission timing. In addition to dry eye disease, ReproxLap is also in a Phase III clinical trial in allergic conjunctivitis, a condition that affects at least 66 million adults in the U.S. alone. We initiated the Phase III Invigorate II Allergen Chamber Trial earlier this year and expect results in 2023. Enrollment criteria endpoints, trial design, and study conduct are substantially similar to our previously completed Invigorate Trial, which demonstrated statistically significant improvement in the primary endpoint of ocular itching and the key secondary endpoint of ocular redness. Based on data from Invigorate, simulation modeling of Invigorate 2 indicates that more than 90% of outcomes achieved the primary endpoint of patient-reported ocular itching. At our R&D day in March, we announced top line data from our proof of concept trials of ADX629, our first in class oral RASP modulator, in psoriasis, asthma, and COVID-19 infection. In those trials, ADX629 demonstrated signs of pharmacodynamic and clinical activity consistent with broad-based reduction in pathologic inflammation. As we announced at R&D day, we have advanced ADX 629 to phase two clinical trials in four new clinical indications. Our phase two clinical trials in ethanol toxicity and chronic cough have already initiated. Phase two clinical trials in Sjogren-Larsen syndrome and minimal change disease are expected to be initiated later this year. Positioning our systemic program for multiple clinical milestones over the remainder of 2022 and 2023. We also continue to advance ADX 2191, our vitreous-compatible formulation of methotrexate for orphan retinal diseases. An investigator-sponsored Phase II clinical trial in retinitis pigmentosa conducted at Duke University Medical Center has been initiated. In addition, in the first quarter, we completed enrollment in part one of the phase three GARD trial in proliferative vitreoretinopathy. Results from both of these trials are expected in the second half of this year. Now I'll turn the call over to Joshua, after which I will summarize our recent clinical progress and our future potential in developing novel platforms for the treatment of immune-mediated diseases.