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    Justin Kim

    Research Analyst at Oppenheimer & Co.

    Justin Kim's questions to Aldeyra Therapeutics (ALDX) leadership

    Justin Kim's questions to Aldeyra Therapeutics (ALDX) leadership • Q4 2022

    Question

    Justin Kim of Oppenheimer & Co. asked about the differing commercialization strategies and investment timelines for Reproxalap and ADX-2191, and also inquired about the differentiation of ADX-246 compared to ADX-629.

    Answer

    President and CEO Dr. Todd Brady explained that while back-office synergies exist, the sales efforts are distinct: Reproxalap targets optometrists and anterior segment ophthalmologists, while ADX-2191 targets a small, specialized group of retinal surgeons, making its launch more of a market access effort. He noted the company is capitalized for initial launches of both. Regarding the pipeline, Dr. Brady stated that ADX-246 is more potent than ADX-629 and has the potential for once-daily dosing.

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    Justin Kim's questions to Aldeyra Therapeutics (ALDX) leadership • Q3 2022

    Question

    Justin Kim inquired about the key topics for the upcoming pre-NDA meeting for ADX-2191 in PVR and asked for confirmation that the safety study requirements for the reproxalap NDA have been met.

    Answer

    President and CEO Dr. Todd Brady stated that the PVR pre-NDA meeting aims to align with the FDA on submission requirements for efficacy, safety, and timing, with a focus on process rather than the utility of methotrexate. Regarding the reproxalap safety trial, Dr. Brady confirmed it is 'practically complete' and meets FDA guidance (300 subjects for six weeks, ~100 for 12 months), supporting the planned Q4 NDA submission.

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    Justin Kim's questions to Aldeyra Therapeutics (ALDX) leadership • Q2 2022

    Question

    Justin Kim asked about the preparatory work for the ADX-629 trials in Sjögren-Larsson syndrome and minimal change disease, the clinical meaningfulness of steroid-sparing in MCD, and the status of the reproxalap long-term safety study.

    Answer

    President & CEO Dr. Todd Brady explained that for ADX-629, each new indication requires an IND submission; the SLS trial is under an investigator IND, while Aldeyra will sponsor the MCD IND. He affirmed that steroid-sparing is a highly meaningful benefit for children with MCD due to the significant toxicities of long-term steroid use. Regarding the reproxalap safety trial, he confirmed it remains on track and that strong patient retention over 12 months is a very positive sign.

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    Justin Kim's questions to Aldeyra Therapeutics (ALDX) leadership • Q1 2022

    Question

    Justin Kim of Oppenheimer & Co. Inc. asked about Aldeyra's confidence in its NDA data package for reproxalap, the rationale for conducting two additional trials, and whether the long-term safety study remains on the critical path for a midyear filing.

    Answer

    CEO Dr. Todd Brady expressed high confidence in the NDA submission, stating it will be one of the most comprehensive ever submitted for dry eye disease. He explained that both Schirmer test and ocular redness have FDA precedent as approvable signs. The additional trials serve as backups to strengthen the submission package. Dr. Brady confirmed the safety trial is the gating factor for the NDA submission and the company remains on track for a midyear filing.

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    Justin Kim's questions to XBiotech (XBIT) leadership

    Justin Kim's questions to XBiotech (XBIT) leadership • Q3 2016

    Question

    Justin Kim of Cantor Fitzgerald inquired about the company's manufacturing readiness, the potential timing for a product launch upon EMA approval, and whether the company envisions using partners for the launch.

    Answer

    Founder, President & CEO John Simard confirmed that the company is ready to launch very quickly following a potential EMA approval, targeting a launch in the EU5 market shortly after a mid-February ratification. He stated that while XBiotech is building its own commercial team to launch independently, the company remains open to potential partnerships.

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