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    Dingding Shi • Jefferies

    Dingding Shi's questions to Incyte Corp (INCY) leadership

    Dingding Shi's questions to Incyte Corp (INCY) leadership • Q4 2024

    Question

    Dingding Shi from Jefferies inquired about the KRAS G12D program, asking for details on expected proof-of-concept data, including sample size and tumor types, and its potential differentiation. She also asked if the povorcitinib HS data disclosure would include HiSCR75/90/100 results at both 12 and 16-week follow-ups.

    Answer

    Pablo Cagnoni, President, Head of R&D, said the KRAS program is focused on pancreatic and colorectal cancer and that Incyte believes its potent, selective inhibitor can compete, with data expected later in the year. Regarding the povorcitinib HS data, he stated that a final decision has not been made on which specific secondary endpoints and time points will be included in the top-line press release.

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    Dingding Shi's questions to PTC Therapeutics Inc (PTCT) leadership

    Dingding Shi's questions to PTC Therapeutics Inc (PTCT) leadership • Q4 2024

    Question

    Dingding Shi inquired about the expected clinical improvements in the PIVOT-HD trial from 12 to 24 months and asked for the patient split between Stage 2 and Stage 3 disease.

    Answer

    CEO Dr. Matthew Klein explained that they anticipate continued slowing of disease progression on key clinical scales like TMS, cUHDRS, and TFC with longer treatment. He clarified that the overall study population is balanced with about half Stage 2 and half Stage 3 patients.

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    Dingding Shi's questions to Beigene Ltd (ONC) leadership

    Dingding Shi's questions to Beigene Ltd (ONC) leadership • Q4 2024

    Question

    Dingding Shi of Jefferies asked for the key assumptions behind the 2025 revenue guidance of $4.9-$5.3 billion and inquired about the data disclosure timing for the B7-H4 ADC and CDK2 inhibitor.

    Answer

    CFO Aaron Rosenberg detailed that guidance is driven by continued BRUKINSA share gains in the U.S., the lapping of 2024 new patient starts, stable pricing, and global expansion. Global Head of R&D Lai Wang confirmed that initial data for the B7-H4 ADC and CDK2 inhibitor are expected at ASCO in the first half of 2025.

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    Dingding Shi's questions to Ascendis Pharma A/S (ASND) leadership

    Dingding Shi's questions to Ascendis Pharma A/S (ASND) leadership • Q3 2024

    Question

    Dingding Shi sought to confirm the implied Q4 SKYTROFA sales from the full-year guidance and asked if regulators had confirmed that 12-month data is sufficient for the TransCon CNP submission.

    Answer

    Scott Smith, EVP and CFO, confirmed the full-year guidance of €200-€220 million for SKYTROFA excludes prior-period sales deductions. Jan Mikkelsen, President and CEO, affirmed that the company has not been asked for more than 12 months of efficacy data for the TransCon CNP filing, aside from standard safety updates during the review process.

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    Dingding Shi's questions to Ascendis Pharma A/S (ASND) leadership • Q2 2024

    Question

    Dingding Shi (on behalf of Kelly Shi) asked for more detail on the ongoing discussions with regulators about using existing batches of YORVIPATH for an earlier U.S. launch.

    Answer

    President and CEO Jan Mikkelsen described the dialogue with the FDA as 'extremely constructive.' He emphasized that the discussions are driven by the urgent unmet medical need, particularly with the discontinuation of Natpar. He noted that patient organizations, physicians, and the FDA are all working collaboratively to find a solution to prevent a patient care crisis, suggesting a strong motivation to enable an earlier launch.

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    Dingding Shi's questions to Ocular Therapeutix Inc (OCUL) leadership

    Dingding Shi's questions to Ocular Therapeutix Inc (OCUL) leadership • Q3 2024

    Question

    Dingding Shi (Kelly Shi) asked about the progress of discussions with the European Medicines Agency (EMA) and inquired about the most suitable patient population for AXPAXLI in wet AMD based on trial enrollment experience.

    Answer

    President and CEO Dr. Pravin Dugel responded that while Ocular is engaged in discussions with ex-U.S. regulatory agencies, no formal guidance has been provided yet. Regarding patient population, he explained that for trials, they are derisking the population to be VEGF-responsive (SOL-1) or stable (SOL-R), but they believe AXPAXLI will be a drug of choice for all patients in the commercial market.

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    Dingding Shi's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2024

    Question

    Dingding Shi asked for expectations on the performance of the comparator arms in the SOL-R trial based on historical data and inquired about the next steps for AXPAXLI in diabetic retinopathy (DR) following the HELIOS study results.

    Answer

    Dr. Pravin Dugel, President and CEO, expressed high confidence in AXPAXLI's performance in SOL-R, referencing the U.S. study where 100% of patients were rescue-free at six months. For diabetic retinopathy, he clarified that the company's top priority remains the wet AMD trials (SOL-1 and SOL-R). While the HELIOS data in DR is 'remarkable' and provides a clear path forward, a formal FDA meeting for a DR study has not yet occurred. He noted the positive HELIOS data also increases confidence in the wet AMD program.

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    Dingding Shi's questions to Legend Biotech Corp (LEGN) leadership

    Dingding Shi's questions to Legend Biotech Corp (LEGN) leadership • Q3 2024

    Question

    Dingding Shi asked for details on the second-line launch ramp-up compared to the later-line launch and whether the majority of CARVYKTI use is expected to shift to earlier lines of therapy in the near future.

    Answer

    SVP of Commercial Development, Steven Gavel, confirmed that early-line adoption is ahead of internal expectations, driven by strong overall survival data. He projected that by the end of the following year, the patient mix would heavily favor the earlier-line (CARTITUDE-4) population, at a ratio of approximately two-thirds to one-third.

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    Dingding Shi's questions to Syndax Pharmaceuticals Inc (SNDX) leadership

    Dingding Shi's questions to Syndax Pharmaceuticals Inc (SNDX) leadership • Q3 2024

    Question

    Dingding Shi of Jefferies Financial Group Inc. inquired about the clinical bar for the CR/CRh rate in the pivotal NPM1 data, its correlation with overall survival (OS), and the expected OS benefit compared to the KMT2A subgroup.

    Answer

    CEO Michael Metzger stated that a CR/CRh rate of 20-30% is the historical precedent for approval in AML. CSO Dr. Anjali Ganguli added that while outcomes are poor for both groups in later lines, the expected median OS for third-line plus KMT2A patients is 2-3 months, compared to 4-5 months for NPM1 patients.

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    Dingding Shi's questions to Kymera Therapeutics Inc (KYMR) leadership

    Dingding Shi's questions to Kymera Therapeutics Inc (KYMR) leadership • Q3 2024

    Question

    Representing Kelly Shi, Dingding Shi of Jefferies asked about the biological differentiation of targeting STAT6 compared to upstream targets like IL-4/13 and the potential breadth of indications for the program.

    Answer

    CEO Nello Mainolfi and CMO Jared Gollob explained that both preclinical and human genetic data suggest STAT6 activity is almost entirely driven by IL-4/13 signaling, meaning its degradation should phenocopy drugs like dupilumab. Dr. Gollob added that the 24/7 pharmacology of a degrader could offer unique benefits in treating key symptoms like itch and pain.

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