Aldeyra Therapeutics, Inc. Q3 FY2022 earnings call

• Progress on reproxalap: Successful pre-NDA meeting with FDA, plan to submit NDA in Q4 2022 with data on ocular dryness, redness, Schirmer test, etc. Also advancing toward supplemental NDA for allergic conjunctivitis with INVIGORATE-2 data expected in 2023.
• Progress on ADX-2191: Scheduled pre-NDA meeting with FDA for primary Vitreoretinal Lymphoma in Q4 2022, NDA submission possible by end of 2022. ADX-2191 met primary endpoint in Phase 3 GUARD Trial for PVR. Plans to discuss completion of clinical development for PVR and Type C meeting with FDA in H1 2023, and announce Phase 2 results in retinitis pigmentosa in H1 2023.
• Progress on ADX-629: On track to report top line results in 2022 for Phase 2 clinical trial in acute alcoholic hepatitis. Plan to initiate Phase 2 trials in Sjogren-Larsson syndrome and minimal change disease by year-end.

No product segments with revenue contribution percentages provided. Cash, cash equivalents, and marketable securities as of September 30, 2022, were $185.3 million. Net loss for the three months ended September 30, 2022 was $14.6 million or $0.25 per share. Research and development expenses were $11.5 million, down from $12.9 million in 2021. General and administrative expenses were $3.2 million, up from $2.5 million in 2021.

• Plan to submit reproxalap NDA in Q4 2022.
• Scheduled pre-NDA meeting with FDA for ADX-2191 in PVR in Q4 2022, NDA submission possible by end of 2022.
• ADX-629 on track to report top line results in 2022 for acute alcoholic hepatitis. Plan to initiate Phase 2 trials in Sjogren-Larsson syndrome and minimal change disease by year-end.

• Clinical trial risks: Results of clinical trials may not predict future trials, COVID-19 pandemic affecting site availability, staffing, patient recruitment, and delaying trial timelines.
• Regulatory risks: Uncertainties in regulatory approval processes for NDA submissions.

Q: Elaborate on what still needs to happen before submitting the reproxalap NDA by the end of the year and if rolling NDA was considered.

A: Todd Brady said the NDA submission process is well underway, very little left to complete. Rolling NDA typically not for dry eye disease as it's not a rare/fatal disease with lack of therapy.

Q: Talk about what to see in ADX-629 data in acute alcoholic hepatitis to establish proof of concept.

A: Todd Brady said they need to see the data first. Alcoholic hepatitis is underaddressed, RASP modulator mechanism is appropriate. Criteria for advancement involve achieving symptom or sign to study in larger trial.

Q: Elaborate on upcoming pre-NDA meeting for PBR and safety study for reproxalap.

A: Pre-NDA meeting main objective is to avoid misunderstandings on efficacy and safety data. Safety trial for reproxalap is practically complete as they're guiding submission in Q4.

Q: Color on new candidates for RASP modulation, improvements on reproxalap and 629, and indications.

A: ADX-629 is part of RASP modulation platform. RASP is novel target, ADX-629 in trials for alcoholic hepatitis, etc. Systemic treatment for Sjögren-Larsson Syndrome with ADX-629 as it can affect skin and neurological aspects.

Q: Clarity on when INVIGORATE 2 data is expected and steps for supplemental NDA for allergic conjunctivitis.

A: INVIGORATE 2 data expected after winter as allergic conjunctivitis trial seasonality. Supplemental NDA for allergic conjunctivitis likely towards end of 2023 after dry eye NDA approval.

Q: Prioritizing multiple development programs and use of alcoholic hepatitis data for other indications.

A: Alcoholic hepatitis data shows target engagement. Program prioritization is systematic. Activity in alcoholic hepatitis can inform other indications by showing target engagement.