Aldeyra Therapeutics, Inc.

Standing by, and welcome to the Aldera Therapeutics First 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 the conference over to the company's Chief Financial Officer, 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 March 31, 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 runaway, our possible or assumed future results of operations, expenses and financial position, 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 with respect to future events and 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 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 would now like to turn the call over to Dr. Brady.

Thank you, Joshua. The remarkable top line results we reported last week from our phase three invigorate trial and allergic conjunctivitis set up what we expect to be a catalyst rich year for Aldera in 2021. Reproxilab achieved statistically significant improvement over vehicle for the primary endpoint. of patient-reported ocular itching, the key secondary endpoint of investigator-assessed ocular redness, and the secondary endpoints of patient-reported ocular tearing and total ocular severity score. The clarity of the p-values achieved in the invigorate allergen chamber further suggests Reproxilab's clinical utility in reducing ocular itching, redness, and tearing which are the hallmark symptoms and signs of allergic conjunctivitis. To our knowledge, Reproxilab is the first allergic conjunctivitis compound that has been observed to show activity versus vehicle across symptoms and signs in a large, well-controlled allergen chamber trial. Invigorate achieved the primary endpoint of improvement over vehicle in patient reported ocular itching score at all 11 pre-specified time points, each with a p-value of less than 0.0001. Over the duration of the allergen chamber, improvement over vehicle for the key secondary endpoint of ocular redness was achieved, as were the secondary endpoints of patient reported ocular tearing score and total ocular severity score. Consistent with the primary endpoint, p-values for all secondary endpoints were less than 0.0001, indicating superiority of a proxlap over vehicle and potential clinical utility across symptoms and signs of allergic conjunctivitis in a setting of continuous moderate to high pollen exposure. Consistent with the prior clinical experience of Reproxilab and other prescription ophthalmic solutions, mild and transient installation site discomfort was observed. But importantly, there were no observed safety or tolerability concerns in the trial and no discontinuations due to adverse events. Reproxilab has now been tested in over 1,200 patients with no clinically significant safety signals. With the Invigorate trial completed, we look forward to meeting with the FDA in the second half of this year to discuss the results and the potential submission of a new drug application. Based on the results of Invigorate, we're very encouraged about the potential of our Phase III Tranquility and Tranquility II trials of Raproxilab in dry eye disease. Similar to the key secondary endpoint of Invigorate, the primary endpoint of the two-day Tranquility trials is ocular redness, which, in the case of Tranquility, is assessed over 90 minutes in a dry eye chamber with tear rasp levels, Shermer's test, and dry eye symptoms as secondary endpoints. There is substantial documented clinical overlap between allergic conjunctivitis and dry eye disease. Approximately half the patients who complain of ocular dryness also complain of ocular itching and vice versa. In addition, ocular redness may be the only objective sign of allergic conjunctivitis and dry eye disease that is of considerable importance to patients. Patient enrollment in the Tranquility Trial is underway. Both Tranquility and Tranquility II, which are identical and are expected to enroll approximately 100 patients per arm, remain on track to read out top-line results in the second half of this year. Turning to our systemic disease programs, initial Phase II clinical trial results from ADX629 are expected in the second half of this year in asthma, psoriasis, and COVID-19. ADX629 is a first-in-class, orally available, and irreversible covalent inhibitor of pro-inflammatory RASP and potentially represent a new paradigm in the understanding and treatment of immune-mediated disease that could be broadly applicable across a myriad of clinical indications with unmet clinical need. As I noted in our Q4 call, we are also evaluating new and potentially more important, more potent RASP-inhibiting compounds for retinal and systemic disease, the lead molecules of which could be in clinical development as early as next year. We remain excited about the potential first-line commercial prospects for aproxilab for the treatment of anterior segment inflammation, but we remain equally excited about the possible therapeutic potential for RASP inhibition broadly, especially as Aldera advances programs in inflammatory retinal and systemic diseases, the number and scope of which are far greater than that of anterior ocular disease. Our pipeline and clinical development plans are supported by a strong and well-capitalized balance sheet. Since the beginning of the year, we have generated combined net proceeds of more than $187 million through two underwritten public offerings, including last month's offering that raised $125 million in gross proceeds. We are extremely appreciative of the support from both the current and new institutional investors who have participated in these offerings. With that, I'll turn the call back over to Joshua to review our first quarter financial results.