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    Soumit Roy • Jones Trading

    Soumit Roy's questions to Anavex Life Sciences Corp (AVXL) leadership

    Soumit Roy's questions to Anavex Life Sciences Corp (AVXL) leadership • Q3 2025

    Question

    Soumit Roy from Jones Trading inquired about the four-year open-label extension data for blarcamesine, specifically asking for clarification on the delayed-start patient group, the differing trajectories of the ADAS-cog and ADL endpoints, and whether patients were restaged. He also asked about the drug's applicability to moderate-stage Alzheimer's, the timeline for the EMA review, the commercialization strategy, and the status of a UK regulatory filing.

    Answer

    President & CEO Dr. Christopher Missling explained that the data shows patients starting blarcamesine later do not catch up to the benefit seen in the early-start group, emphasizing the importance of early and continuous treatment. He attributed the endpoint differences to ADAS-cog's higher sensitivity and trial interruptions from COVID. Dr. Missling confirmed patients were not restaged but noted the drug has shown benefit in mild-to-moderate patients. He guided for EMA feedback in Q1 of the following year but would not comment on the process. On commercialization, he stated that while all options are open, partnering post-approval often maximizes shareholder value, and a UK filing is being planned.

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    Soumit Roy's questions to Anavex Life Sciences Corp (AVXL) leadership • Q2 2025

    Question

    Soumit Roy of JonesTrading inquired about the expected timeline for a decision from the European Medicines Agency (EMA) on blarcamesine and asked about the key inflection points for 2025, focusing on the Phase II schizophrenia trial for ANAVEX 3-71.

    Answer

    President and CEO Dr. Christopher Missling stated that Anavex Life Sciences anticipates feedback from the EMA by the end of the current year or early in the next quarter, approximately 12 months after the submission was accepted. He clarified that the company will only report the final decision. Dr. Missling also identified the top-line data from the ANAVEX 3-71 schizophrenia study, expected in the second half of the year, as a key inflection point, emphasizing the trial's focus on safety and biomarker effects (EEG/ERP) in a hard-to-treat patient population.

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    Soumit Roy's questions to Nuvation Bio Inc (NUVB) leadership

    Soumit Roy's questions to Nuvation Bio Inc (NUVB) leadership • Q2 2025

    Question

    Soumit Roy of Jones Trading asked about the real-world impact of Iptrozy's NCCN preferred status, the adoption trend of RNA-based testing for ROS1, and the strategic rationale behind the updated study design for the pipeline asset sacrocitinib.

    Answer

    CEO David Hung confirmed that the rapid NCCN designation is having a positive impact, with the sentiment echoed by physicians and thought leaders. He noted growing awareness of RNA testing's benefits but could not predict an adoption timeline. Regarding sacrocitinib, Hung clarified the study design change to a maintenance setting was a company decision and that the drug targets all IDH1 mutations.

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    Soumit Roy's questions to Day One Biopharmaceuticals Inc (DAWN) leadership

    Soumit Roy's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q1 2025

    Question

    Soumit Roy from Jones Research requested details on the DAY301 development pipeline, including tumor types being studied, dose levels completed, expected data timing, and the criteria for go-forward decisions.

    Answer

    CEO Dr. Jeremy Bender explained that DAY301, a PTK7-targeted ADC, is in Phase I dose escalation for adult solid tumors like endometrial, non-small cell lung, and triple-negative breast cancer. The first dose cohort has been cleared, but data timing is not yet guided. The plan is to establish a safe and tolerable dose with evidence of antitumor activity before moving to dose expansion cohorts, which will likely use a diagnostic to select for PTK7 expression.

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    Soumit Roy's questions to Day One Biopharmaceuticals Inc (DAWN) leadership • Q3 2024

    Question

    Soumit Roy of Jones Research asked about OJEMDA's adoption in the community physician setting and inquired about patient eligibility for the front-line FIREFLY-2 trial, specifically regarding prior MEK inhibitor use.

    Answer

    CCO Lauren Merendino confirmed strong uptake in both academic and community settings, with no notable resistance. Dr. Samuel Blackman, Head of R&D, clarified that the FIREFLY-2 trial enrolls patients for their first systemic therapy, precluding any prior MEK inhibitor treatment.

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