Aldeyra Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Aldera Therapeutics second 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 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 June 30th, 2022 in recent corporate highlights. A copy of the press release is available on the investor 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 Eldera. 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 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 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 trials may be delayed. ELDIRA assumes no obligation to update these statements as 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 in our filings with the SEC. I will now turn the call over to Dr. Brady.

Thank you, Bruce, and good morning, everyone. In reflecting on our accomplishments so far in 2022, a couple of things stand out to me. The first is the exceptional progress our team has made in advancing our lead investigational new drug, Reproxilab, to a planned new drug application submission in the second half of 2022. We've amassed what we believe is the comprehensive regulatory package ever for a dry eye disease drug candidate. Based primarily on what we believe to be an unparalleled rapid onset of action, we're excited about Reproxilab's potential to change the treatment paradigm in what is one of the world's most prevalent ocular surface diseases. which today is suboptimally addressed with drugs that require at least weeks of administration for even modest improvement. With the recent completion of the crossover and phase three Tranquility II trials, we believe we put ourselves in a position to submit a thorough and extensive NDA based on robust symptomatic improvement and the achievement of three objective sign endpoints of dry eye disease, ocular redness, Shermer test, and the Shermer test greater than or equal to 10-millimeter responder analysis. As I previously stated, the key outcome of the crossover trial is affirmation of the potential rapid onset of activity of roproxilab which, based on the results of the trial, included observed improvement within minutes in ocular redness, tear production, and symptoms, including discomfort, dryness, burning, and stinging. For the primary endpoint of Shermer test on day one and ocular redness in the dry eye chamber on day two, the superiority of roproxilab was statistically significant with a p-value of 0.0004 for ocular redness and 0.0005 for Shermer test. I think the other important takeaway from our crossover trial results is the strength of Reproxilab's safety and tolerability profile. Our clinical experience with Reproxilab now encompasses more than 1,800 patients The drug has been well tolerated with no observed safety signals in any patient. Consistent with all of our prior trials and consistent with most topically administered ophthalmic drugs, the most common adverse event is transient and mild installation site irritation, which in Reproxilab's case has generally lasted less than one minute in duration. I think it's also worth reiterating that to our knowledge, Aldera is the first sponsor to evaluate an investigational dry disease drug in an adequate and well-controlled crossover trial. As I noted on our crossover data release call, a key learning from the trial is that the high degree of patient-to-patient variability that we've observed can be reduced with a crossover design. And we believe that the crossover design is feasible not only as it relates to dry eye disease, but also for other ocular surface disease trials involving therapies with potentially rapid activity. The effectiveness of the crossover trial design has also been demonstrated in the successful completion for Proxilapse Phase 2 and Invigorate Phase 3 allergic conjunctivitis trials. In addition, the ongoing Invigorate II Phase III trial is a crossover trial. Looking ahead, we expect to submit our NDA in dry eye disease in the second half of the year following our Type B pre-NDA meeting with the U.S. Food and Drug Administration later this quarter. The other accomplishment that stands out is the progress of ADX2191, our investigational new drug platform for rare but serious retinal diseases with no approved therapy. The development program of ADX2191 encompasses three such conditions. Number one, primary vitreoretinal lymphoma, which is a near universally fatal condition. cancer. Two, proliferative vitreoretinopathy, or PVR, a site-threatening condition that is the leading cause of failure of retinal reattachment surgery. And number three, retinitis pigmentosa, which is a rare group of genetic eye diseases. The FDA has granted orphan drug designation to ADX2191 for each of these indications, and ADX2191 is the first methotrexate formulation specifically designed to be compatible with the vitreous humor, the fluid in the back of the eye, and therefore represents what we believe to be a unique potential commercial opportunity for Alderaan. Results from our Phase III GARD trial in PVR are on schedule and are expected for the second half of this year. As a reminder, GARD is a multicenter, randomized, controlled, adaptive Phase III clinical trial of repeated intravitreal injections of ADX2191 for the prevention of PVR. The primary endpoint is retinal detachment over a period of 24 weeks. Relative to primary vitreoretinal lymphoma, we plan to have a pre-NDA meeting with the FDA in the second half of this year to discuss the regulatory path forward for ADX-2191. And finally, the third key milestone for 2191 is the top-line results from the Phase II trial in retinitis pigmentosa, which we anticipate to be reported in the first half of 2023, 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. Lastly, our oral RASP modulator platform, led by ADX629, continues to advance and represents a broad expansion of our pipeline from ocular inflammatory disease to systemic inflammatory disease, which, as many of you know, represents in aggregate one of the largest markets in pharmaceuticals. This year, we expect to report top-line results from a Phase II clinical trial in acute alcoholic hepatitis and to initiate Phase II trials in Sjogren-Larsen syndrome and minimal change disease. Top line results of the phase two trial of ADX629 in chronic cough are anticipated in the first half of 2023. I'd say in summary that we are full steam ahead on our programs in both anterior ocular and rare retinal diseases. With a busy and quite remarkable regulatory calendar plan for the balance of 2022 featuring two pre-NDA meetings and two planned NDA submissions. And with two late stage candidates in what we believe to be a clear strategic path to market, Aldera represents a real opportunity to positively affect patient care in both mass market and rare diseases. Now let me turn the call back over to Bruce for the financial review.