11/5/2020

speaker
Todd Brady
CEO

that of standard of care antihistamines. In addition to durability, the rapid onset of response will be highlighted in a poster presentation next week at the American Academy of Ophthalmology 2020 virtual annual meeting. The poster features new data from responder analyses of our phase two allergen chamber trial, as well as new data on ocular tearing and post-chamber activity of drug after exposure to allergen has ceased. The data further support the clinical utility of Reproxilab, suggesting the possibility of rapid efficacy in reducing redness and itching in allergic conjunctivitis. For these reasons, we remain particularly excited about the potential of Reproxilab as the first novel mechanistic approach for late-stage allergic conjunctivitis in decades. Turning to the posterior segment of our ocular disease pipeline, we expect to complete enrollment in part one of the phase three GARD trial of ADX2191 for the prevention of recurrent retinal detachment due to proliferative vitreoretinopathy, or PVR, by the end of 2021. PVR is the leading cause of retinal detachment surgery failure, affecting roughly 4,000 patients per year in the United States and nearly twice as many in Europe and Japan combined. Recruitment for the GARD trial is underway at more than 20 clinical sites across the United States. And as I noted in our Q2 call, the pace of enrollment has been slower than anticipated, particularly due to delays caused by COVID-19. ADX2191 may also have the potential to treat primary vitreoretinal lymphoma, or PVRL, a rare aggressive high-grade cancer that affects approximately 2,900 people in the United States, with about 600 new cases diagnosed annually. There are no approved treatments for this severe type of ocular cancer. As for our systemic disease programs, in September, we received a study may proceed letter from the FDA clearing the way to start phase two testing of ADX629, our orally available RASP inhibitor, for the treatment of adult patients hospitalized for COVID-19. We continue to expect the trial to begin by year end. This quarter, we also plan to initiate Phase II clinical trials of ADX629 for the treatment of severe inflammation associated with Th2 type cytokine production represented by atopic asthma and Th1 type cytokine production represented by psoriasis. As I noted on our Q2 call, testing in an animal model of cytokine storm suggested that RASP inhibitors have the potential to act as immunological switches that may broadly modulate immune systems from pro-inflammatory states to anti-inflammatory states. Target engagement of ADX629 was confirmed in our Phase I clinical trial, in which reduction in the commonly described pro-inflammatory RAS malandialdehyde was observed in treated subjects. ADX629 was well tolerated, and no treatment-related adverse events were observed in the trial. We head into the final two months of the year in excellent financial condition. Based on current operating plans, we believe we are well capitalized and expect our cash runway to fund operations through 2022, including potential NDA submissions for reproxilab and dry disease and allergic conjunctivitis, assuming positive clinical trial results and regulatory review. Now I'll turn the call over to Joshua for the third quarter financial review.

speaker
Joshua
CFO

Thanks, Todd. For the quarter ended September 30, 2020, we reported a net loss of $8.9 million compared with a net loss of $18.7 million for the quarter ended September 30, 2019. Net loss per share was 23 cents for the quarter ended September 30, 2020, compared with 69 cents for the same period in 2019. Losses have resulted from the cost of clinical trials and research and development programs as well as from general and administrative expenses. Research and development expenses were $6.1 million for the quarter end of September 30, 2020, compared with $16.2 million for the same period in 2019. The decrease of $10.1 million is primarily related to a reduction in clinical research and development expenditures and lower personnel-related costs, partially offset by increases in manufacturing and preclinical development costs. General and administrative expenses were $2.3 million for the quarter ended September 30, 2020, compared with $2.8 million for the same period in 2019. The decrease of $500,000 is due to lower personnel-related costs and other miscellaneous administrative costs. For the quarter ended September 30, 2020, total operating expenses were $8.4 million, compared with total operating expenses of $19 million for the same period in 2019. Cash, cash equivalents, and marketable securities were $86.2 million as of September 30, 2020. Based on current operating plans, our cash, cash equivalents, and marketable securities as of September 30, 2020 are expected to be sufficient to fund operations through the end of 2022, including potential NDA submissions for raproxylapin, dry eye disease, and allergic conjunctivitis, pending clinical trial results, regulatory review, potential disruptions due to COVID-19, and other factors that may not be in our control. Use of cash, cash equivalents, and marketable securities are also expected to include part one of the phase three GAR trial in PVR, and Phase II clinical testing of ADX629, an orally administered RASP inhibitor in inflammatory diseases. Now I'll turn the call back to Todd for closing comments.

speaker
Todd Brady
CEO

Thanks, Joshua. As you can tell, we have a busy several quarters ahead, highlighted by significant clinical development milestones beginning this quarter and throughout 2021. We look forward to keeping you updated on our progress as we execute on our strategic plan to bring forward potential best-in-class immune-modulating therapies that improve the lives of patients with serious unmet medical needs. This month, we will be participating in the Jeff Reeds Virtual London Healthcare Conference and the Alliance Global Partners Virtual Healthcare Symposium. Please check the events and presentation section of our website for details. In addition, I would encourage you to register for tomorrow's Icelerator 2020 virtual conference. Icelerator is a new partnership between the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. Aldera is one of a number of companies participating in the event at Icelerator.com. With that, Josh, Dave, and I will be happy to take your questions. Operator?

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