Aldeyra Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Aldira Therapeutics Third Quarter 2021 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 Chief Financial Officer, Mr. Joshua Reed. Please go ahead, sir.

Good morning, everyone. With me is Dr. Todd Brady, President and Chief Executive Officer of Aldera. This morning we issued a press release reporting our financial results for the quarter-ended September 30, 2021. 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 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 positions, and potential growth opportunities, among other things. These statements are based upon the information available to the company today. These statements reflect ALDERA's 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 results from clinical trials or portions of clinical trials may not accurately predict the results of future trials for the same or different indications. and 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 as circumstances change. Future events and actual results could differ materially from those projected in the company's 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 the company's press release issued this morning and our filings with the SEC. I will now turn the call over to Dr. Brady.

Thank you, Joshua. This morning I'm excited to share with you important progress we've made in the development of our novel therapeutic approaches for ocular and systemic immunological diseases as we continue to strive to improve the lives of patients with significant unmet medical needs. Let me begin by updating you on our anterior segment ocular programs. This quarter, we expect to report top line results from the Tranquility and Tranquility II clinical trials of Reproxilab in dry eye disease. The primary endpoint of these trials is ocular redness, which is arguably the only objective sign of dry eye disease that matters to patients. Secondary endpoints are tear rasp levels, Shermer's test, and dry eye symptoms. Additionally, enrollment has completed in a multi-center, double-masked, randomized, vehicle-controlled parallel group Phase II clinical trial of roproxilap and dry eye disease. The purpose of the Phase II trial is to optimize the tear collection process to measure rasp. Pending ongoing discussions with the FDA and the timing of clinical results, including our 12-month safety trial of roproxilab, and consistent with prior guidance, we expect to be in a position to file a new drug application, or NDA, early next year for dry eye disease. In addition, we remain in discussions with the FDA regarding NDA requirements for allergic conjunctivitis, and expect to be able to provide an NDA update for Reproxilab by the end of this year. During the year, several peer-reviewed journals have published articles highlighting the safety and efficacy profile of Reproxilab in dry eye disease and allergic conjunctivitis. Most recently, the journal Clinical Ophthalmology reported results of the clinical trial evaluating the subjective eyedrop experience of two formulations of Reproxilab versus Lefitograst in patients with dry eye disease. The paper, entitled A Post-Acute Ocular Tolerability Comparison of Reproxilab and Lefitograst, is open access and available on PubMed. Turning to our retina programs, as many of you know, ADX2191 has been granted orphan drug designation for three distinct clinical indications that affect the retina. Retinitis pigmentosa, proliferative vitreoretinopathy, or PVR, and primary vitreoretinal lymphoma. Retinitis pigmentosa is a group of rare genetic eye diseases that affects an estimated 80 to 100,000 individuals in the United States, and approximately one in 4,000 people worldwide. Last quarter, we announced our plan to initiate a phase two clinical trial of ADX2191 in patients with retinitis pigmentosa, and we remain on track to do so by the end of this year. The primary endpoint of the trial will be safety and tolerability of ADX2191. Secondary endpoints include visual acuity, central retinal sensitivity, dark adapted retinal sensitivity, and retinal morphology. PVR is a sight-threatening condition and the leading cause of failure of retinal detachment surgery. We remain on track to conclude enrollment at the end of this year for Part 1 of our ongoing Phase 3 GARD trial in PVR, and we expect results from GARD next year. We continue to be excited about the broad ADX2191 platform and the potential of ADX2191 to treat rare immune-mediated retinal diseases that today have no currently approved therapies. Turning to our systemic disease program, we remain on track to report Phase II proof-of-concept clinical results from ADX629 in asthma, psoriasis, and COVID-19 patients. in the fourth quarter of 2021 or the first quarter of 2022. ADX629 is our orally available RASP inhibitor. It represents a first-in-class systems-based therapeutic approach for the potential treatment of many immune-mediated diseases that are currently treated with single-target drugs that can lead to toxicity. We've also continued to evaluate the possibility of expanding clinical testing for ADX629 and other indications where RASP may mediate pathology and where current therapy is either inadequately effective or toxic. We expect to update you on our progress later this year. With that, I'll turn the call back over to Joshua to review our third quarter financial results.