Aldeyra Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Algea therapeutic full year 2022 financial results conference call. At this time, all participants are in a listen only mode. After the speaker's presentations, there will be a question and answer session. I would now like to hand the conference call over to Mr. Bruce Greenberg, the company's interim chief financial officer. Please go ahead, Bruce Greenberg.

Thank you, and good morning, everyone. With me today is Dr. Todd Brady, our President and Chief Executive Officer. This morning, we issued a press release reporting recent corporate highlights and our financial results for the year ended December 31st, 2022. A copy of the press release is available on the Investors in Media section of our website at www.aldera.com. Please note that this morning's conference call contains forward-looking statements regarding future events and the future performance of LDR. Forward-looking statements include, but are not limited to, statements regarding FDA review of our new drug applications, potential commercialization, the anticipated timing of initiation of results from our clinical trials, a projected cash runway, are 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 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 LDR's continuing review and quality control analysis of clinical data. LDR 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. 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, and thank you for joining us. Let me begin by recognizing the entire ALDERA team. as well as the clinical investigators and researchers and patients who have worked with us over the past year. The time and dedication you've invested to advance our strategic priorities in 2022 have resulted in two FDA-accepted new drug applications, Reproxilab for dry eye disease and ADX2191, which was recently designated priority review for primary vitreoretinal lymphoma. a rare, aggressive, high-grade retinal cancer with no approved therapy. We deeply appreciate your support in achieving a milestone that few companies of any size achieved this quarter and are proud to be actively working with the FDA to potentially bring two new therapies to patients as quickly as possible. These NDAs are catalysts for Aldera's future. They validate the novel platforms we've developed to treat both common and rare immune-mediated diseases characterized by inflammation. And they speak to the power of our drug discovery and development engine. Building on this strong foundation, we're focused on advancing the next generation of our RAS modulation platform ADX629, ADX246, and ADX248 in 2023. For those of you that are new to Aldera, RASP are pro-inflammatory mediators that are elevated in ocular and systemic inflammatory disease and thus represent therapeutic targets for immune modulation. Because RASP affects many proteins simultaneously, The RASP modulator platform represents a unique and novel pharmacologic approach. Unlike almost all drugs in use today, the platform is not designed to directly inhibit or activate a particular protein, but instead selectively target a family of small molecules that in turn modulate the activity and structure of many proteins simultaneously. ADX629, our first-in-class orally administered RAS modulator product candidate, is being evaluated in Phase II clinical trials in multiple systemic indications, including idiopathic nephrotic syndrome, which encompasses a broad group of renal inflammatory diseases, including minimal change disease, and is characterized by edema, proteinuria, and hypoalbuminemia. Sjogren-Larsen syndrome, an autosomal recessive neurocutaneous inborn error metabolism that prevents degradation of specific rasp, and atopic dermatitis, a chronic hypersensitivity condition that is characterized by dry, itchy, and inflamed skin. The ADX629 clinical trials encompass a variety of clinical designs and are intended to develop to demonstrate activity across a range of diseases where RASP are implicated. Top line results from Sjogren-Larsen syndrome as well as part one of the atopic dermatitis and idiopathic nephrotic syndrome trials are expected in the second half of 2023. Our strategic approach is to identify multiple opportunities to establish the clinical relevance of ADX629 in both common and rare diseases where the unmet medical need is significant. Toward this end, we also are conducting a multicenter randomized crossover phase two clinical trial in approximately 50 patients with refractory or unexplained chronic cough. We expect to announce top line results from the trial in the first half of this year. Additionally, in 2023, we plan to initiate a phase two trial in moderate alcohol associated hepatitis The decision to pursue this indication stems from the positive results reported in December of a placebo-controlled Phase II alcohol challenge clinical trial in which ADX629 improved signs of alcohol intoxication. ADX629 was superior to placebo in reducing dermal flushing, increasing Romberg test balance time, and lowering levels of the ethanol RAS metabolite acetaldehyde following acute exposure to alcohol. We believe these results support the potential role of RAS modulation in treating alcohol-associated liver diseases, an indication for which there are few treatment options. ADF629 has been administered to approximately 110 patients across multiple Phase I and Phase II clinical trials for up to 90 days. The drug has been observed to be generally well tolerated and has not resulted in any serious adverse events. We have invested thoughtfully and strategically to expand our RAS modulator pipeline. The newest product candidates powered by our systems-based drug discovery and development engine are ADX246 and ADX248. In the second half of 2023, early 2024, we plan to initiate a Phase I-II clinical trial of orally administered ADX246 for the treatment of systemic immune-mediated diseases and intravitrally injected ADX248 for the treatment of geographic atrophy, a severe form of macular degeneration. With regard to ADX2191, Last week, we were thrilled to announce that the FDA accepted for priority review our NDA for the treatment of primary vitreal retinal lymphoma, also known as ocular lymphoma. The FDA defined a PDUFA date of June 21st, 2023, four months from the acceptance of the NDA for review. The NDA is supported by a combination of more than 30 years of published literature on the safety and efficacy of methotrexate the active ingredient of ADX2191, for the treatment of ocular lymphoma. The submission is further supported by safety data from the recently completed Phase III GARD trial of ADX2191 in patients with proliferative vitreoretinopathy. An estimated 300 to 600 patients in the United States are diagnosed with ocular lymphoma each year, and the median survival for newly diagnosed patients is less than five years. If approved, we expect to launch ADX2191 in the United States in the second half of this year, which would make ADX2191 the first FDA-approved drug available for patients suffering from ocular lymphoma. ADX2191 is also in development for two other retinal diseases without FDA-approved therapies. proliferative vitreoretinopathy, a rare condition that is the leading cause of failure of retinal reattachment surgery, and retinitis pigmentosa, a group of rare genetic eye diseases characterized by retinal cell death and loss of vision. We plan to conduct a Type C meeting mid-2023 with the FDA to discuss the completion of clinical development of ADX2191 for the prevention of proliferative vitreoretinopathy. In addition, we plan to report top-line results from the Phase II clinical trial of ADX2191 in patients with retinitis pigmentosa in the first half of this year. With respect to Reproxilab, the PDUFA date is November 23, 2023. We continue to engage in potential partnering discussions with multiple parties for Reproxilab and are also preparing for commercialization internally. Our commercial preparations are designed to exploit the unparalleled rapid onset and breadth of activity observed in clinical trials of proproxilab in patients with dry eye disease. Last week, we reported top line results of the vehicle controlled 12 month safety clinical trial for proproxilab in dry disease patients. Ocular safety was similar across Reproxilab and vehicle treatment groups, and no treatment emergent serious adverse events deemed at least possibly related to treatment were identified. What we believe to be particularly significant about the results is the potentially landmark evidence that visual acuity in patients treated with Reproxilab was statistically superior to that in patients treated with vehicle. Visual acuity in the Reproxilab group improved by approximately 37%, resulting in a p-value of less than 0.0001. Coupled with demonstrated broad activity and rapid onset of action, if positive visual acuity data observed in the safety trial potentially further differentiate Reproxilab in what we estimate is a $23 billion addressable market in the U.S. Now I'll turn the call back over to Bruce for the financial review.