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    Hartaj Singh

    Managing Director and Senior Equity Research Analyst at Oppenheimer

    Hartaj Singh is a Managing Director and Senior Equity Research Analyst at Oppenheimer, specializing in biotechnology and pharmaceuticals. He covers a range of publicly traded biopharma companies, including notable names such as Moderna, BioNTech, Amgen, and Regeneron, and is recognized for generating strong investment returns and achieving high accuracy in his recommendations, with TipRanks indicating a success rate above 60% and average returns well above peer benchmarks. Singh began his career in the late 1990s, holding roles at Lehman Brothers, Dresdner Kleinwort, and BTIG before joining Oppenheimer, where he has been a senior analyst for over a decade. He holds multiple FINRA registrations including Series 7, 63, 86, and 87, reflecting his deep expertise and regulatory credentials in equity research analysis.

    Hartaj Singh's questions to ONCT leadership

    Hartaj Singh's questions to ONCT leadership • Q4 2023

    Question

    Inquired about the market potential for ONCT-534, the timeline for patient recruitment in the amended ONCT-808 trial, and the reasons for lower-than-expected Q4 operating expenses and future cash burn rate.

    Answer

    The company sees a potential $1B+ market for ONCT-534, which could expand to multi-billions in earlier therapy lines. Patient recruitment for ONCT-808 is expected to resume soon as investigators are eager. The lower Q4 OpEx was due to efficient wind-down of the ZILO-301 program, and the actual cash burn is closer to $7.5M-$9M per quarter after excluding non-cash expenses.

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    Hartaj Singh's questions to ONCT leadership • Q3 2023

    Question

    Inquired about the minimum efficacy and durability criteria for advancing ONCT-808, the signals for moving ONCT-534 to dose expansion, the potential therapeutic dose for ONCT-534, and the rationale for testing two dose levels in the expansion phase.

    Answer

    For ONCT-808, the company expects to see objective and durable responses, noting that for patients who have failed prior CAR-T, even a few months of progression-free survival would be significant. For ONCT-534, a therapeutic dose might start from 300mg and above. The two-dose level strategy is aligned with the FDA's Project Optimus, which encourages finding the optimal balance between efficacy and safety by exploring doses below the maximum tolerated dose.

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    Hartaj Singh's questions to Astria Therapeutics (ATXS) leadership

    Hartaj Singh's questions to Astria Therapeutics (ATXS) leadership • Q3 2023

    Question

    Asked about feedback from payers in a competitive market, the strategy to increase physician awareness of STAR-0215, and whether biomarkers could be used to accelerate the Phase III trial design.

    Answer

    Payers currently allow access to prescribed HAE treatments but the class will be managed more actively in the future; efficacy is a key factor for them. Awareness will be built through data presentations, publications, and a growing medical affairs function. Biomarkers are useful for showing target engagement but are not considered surrogates for clinical endpoints; PK data is a stronger supporter of potential effectiveness but won't replace the primary endpoint.

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    Hartaj Singh's questions to Cellectis (CLLS) leadership

    Hartaj Singh's questions to Cellectis (CLLS) leadership • Q3 2023

    Question

    Inquired about the definition of durable response for the complete responses seen in the BALLI and NAtHaLI trials and asked whether the UCART123 program has switched to the in-house manufactured commercial product.

    Answer

    A 3- to 6-month duration of response would be considered good for this heavily pretreated patient population. The UCART123 program is still using the product manufactured by the CDMO.

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    Hartaj Singh's questions to SELLAS Life Sciences Group (SLS) leadership

    Hartaj Singh's questions to SELLAS Life Sciences Group (SLS) leadership • Q3 2018

    Question

    Hartaj Singh of Oppenheimer & Co. inquired about SELLAS's nelipepimut-S (NPS) program, asking about upcoming data presentations, potential outcomes from FDA discussions regarding an accelerated approval path for triple-negative breast cancer (TNBC), and the impact on partnering discussions. He also asked about the galinpepimut-S (GPS) program, specifically if a single Phase III trial in acute myeloid leukemia (AML) could be sufficient for approval, the potential for a trial in multiple myeloma, and the expected data flow from the GPS basket trial in 2019.

    Answer

    President and CEO Angelos Stergiou confirmed that new, undisclosed data for NPS would be presented at the upcoming San Antonio Breast Cancer Symposium. While declining to speculate on FDA meeting outcomes, he highlighted the Data Safety Monitoring Board's strong recommendation to seek regulatory guidance. He affirmed that one positive pivotal trial for GPS in AML would likely suffice for approval and that the first patient would be enrolled in Q1 2019. Regarding the basket trial, he noted its adaptive design would allow for a rigorous news flow in 2019. He also acknowledged strong past data in multiple myeloma but stated the company's current focus is on AML and the PD-1 combination trial.

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