Aldeyra Therapeutics, Inc. Q2 FY2022 earnings call

Todd Brady highlighted progress on several programs. Reproxalap is on track for a new drug application submission in the second half of 2022, with strong Phase III trial results showing rapid onset of action, statistical significance in endpoints like ocular redness and Schirmer test, and a favorable safety profile. ADX-2191's development includes Phase 2 GUARD trial for PVR expected in the second half of 2022, orphan drug designations, and ongoing trials for primary vitreoretinal lymphoma and retinitis pigmentosa. The systemic RASP platform led by ADX-629 is advancing, with plans for Phase 2 trials in acute alcoholic hepatitis, Sjögren-Larsson syndrome, minimal change disease, and top-line results expected in 2023 for chronic cough.

Bruce Greenberg stated cash, cash equivalents, and marketable securities as of June 30, 2022 were $196.7 million, sufficient to cover operating expenses through end of 2023 including potential NDA submissions. Todd Brady mentioned a busy regulatory calendar with two pre-NDA meetings and two planned NDA submissions in 2022.

Risks include those from clinical trials like variability in trial results, potential delays due to COVID-19 affecting clinical site availability, staffing, and patient recruitment. Also, regulatory uncertainties regarding the approval processes for product candidates.

Q: Catherine Novack asked about the 629-ethanol toxicity study, its initiation, and registrational path.

A: Todd Brady discussed the systemic RASP platform, including the acute alcoholic hepatitis trial as a crossover trial to study ADX-629's interaction with acetaldehyde, and options for go-forward signals.

Q: Yigal Nochomovitz inquired about the pre-NDA meeting for dry eye, how much is administrative and outstanding questions.

A: Todd Brady said the pre-NDA meeting is to discuss submission details and FDA's view on the breadth of data submitted for efficacy requirements.

Q: Kelly Shi asked about 2191 in PVR Phase III GUARD trial dosing, discontinuation, and regulatory bar.

A: Todd Brady mentioned the GUARD trial's dosing for various severities, acceptable discontinuation rate, and regulatory bar to be determined from Type C meeting after trial results.

Q: Tom Shrader asked about 2191 formulation, dosing, and pricing.

A: Todd Brady said formulation is the same, dosing regimen may evolve, and pricing to be determined based on approved indication.

Q: Justin Kim asked about 629 clinical trial initiation and steroid-sparing in MCD.

A: Todd Brady discussed 629's four-pronged Phase II approach, safety advantages, and steroid-sparing as a goal in MCD.

Q: Unidentified Analyst asked about reproxalap allergic conjunctivitis regulatory pathway and 2191 PVR filing.

A: Todd Brady said reproxalap allergic conjunctivitis could be a supplemental NDA post-dry eye approval, and PVR NDA would combine real-world data, literature, and GUARD trial results.

Q: Yale Jen asked about SLS study centers.

A: Todd Brady said previous SLS study was single center, current study with Dr. Rizzo may involve similar or multicenter, but Dr. Rizzo has a large SLS cohort.

Q: Yale Jen also asked about 2191 PVL regulatory pathway focus.

A: Todd Brady said FDA will focus on confirming safety of the novel vitreous-mimicking formulation of methotrexate in 2191.

Q: Yale Jen asked about sales overlap if 2191 and reproxalap approved and marketed by Aldeyra.

A: Todd Brady said some sales synergies but front offices are separate, with retinal surgeons focusing on retinal diseases and ophthalmologists on anterior segment.