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    Jonathan Chang • Morgan Stanley

    Jonathan Chang's questions to Kura Oncology Inc (KURA) leadership

    Jonathan Chang's questions to Kura Oncology Inc (KURA) leadership • Q2 2025

    Question

    Jonathan Chang inquired about the progress of regulatory interactions for Zifdomenib ahead of its PDUFA date and the strategic scope of the farnesyltransferase inhibitor (FTI) opportunity, including which programs Kura might develop alone versus with a partner.

    Answer

    Chief Medical Officer Dr. Mollie Leoni confirmed that FDA interactions for Zifdomenib have been collaborative and constructive, aligning with the priority review timeline. CEO Dr. Troy Wilson and Dr. Leoni added that the FTI program aims to reshape the field by using combinations to overcome resistance in areas like RCC, PI3 kinase, and KRAS, with potential for broad applicability.

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    Jonathan Chang's questions to Kura Oncology Inc (KURA) leadership • Q1 2025

    Question

    Jonathan Chang of Leerink Partners inquired about any impact from regulatory agency changes on ziftomenib's approval timeline and asked for expectations regarding the upcoming ASCO presentation of KOMET-001 data, specifically the difference between the abstract and the full presentation.

    Answer

    CEO Troy Wilson stated that Kura has not experienced any disruptions from FDA changes, highlighting the drug's Breakthrough Therapy Designation. He confirmed the ASCO abstract and presentation will use the same data cutoff, but the oral presentation will offer a more comprehensive dataset, with the CR/CRh rate expected between 20% and 30%.

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    Jonathan Chang's questions to Kura Oncology Inc (KURA) leadership • Q3 2024

    Question

    Jonathan Chang from Leerink Partners inquired about how emerging long-term data for ziftomenib and other menin inhibitors is shaping the company's view on the class's potential and the key factors determining patient treatment duration.

    Answer

    CEO Dr. Troy Wilson emphasized the significance of the frontline setting, highlighting that in the 7+3 adverse risk cohort, a high percentage of patients remained on therapy after a year. He stated the major commercial opportunity is in treating patients early and keeping them in response for extended periods (12-18+ months), a potential suggested by the emerging data.

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    Jonathan Chang's questions to Genmab A/S (GMAB) leadership

    Jonathan Chang's questions to Genmab A/S (GMAB) leadership • Q2 2025

    Question

    Jonathan Chang of Leerink Partners asked about Epkinley's competitive positioning against other CD20 bispecifics following the positive Phase III EPCORE FL1 results.

    Answer

    Chief Medical Officer Tahamtan Ahmadi highlighted Epkinley's broad development plan, head start in second-line follicular lymphoma, and strong data generation. Chief Commercial Officer Brad Bailey noted its leading sales position and dual-indication approval. CEO Jan van de Winkel added that numerous abstracts have been submitted for the upcoming ASH meeting.

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    Jonathan Chang's questions to Zai Lab Ltd (ZLAB) leadership

    Jonathan Chang's questions to Zai Lab Ltd (ZLAB) leadership • Q2 2025

    Question

    Jonathan Chang of Leerink Partners inquired about the commercial opportunity for bemarituzumab in frontline gastric cancer, including necessary biomarker status and the observed safety profile. He also asked about Zai Lab's confidence in achieving its 2025 revenue guidance and year-end profitability goal, specifically questioning the role of VIVGART in reaching these targets.

    Answer

    Josh Smiley, President & COO, outlined a potential billion-dollar sales opportunity for bemarituzumab in China, targeting the one-third of gastric cancer patients overexpressing FGFR2b. Rafael Amado, President and Head of Global R&D, specified the biomarker cutoff and described the expected ocular toxicity as manageable. Regarding guidance, Josh Smiley reaffirmed the full-year revenue target of $560-$590 million and the goal of Q4 non-GAAP profitability, attributing confidence to accelerating VIVGART growth and the stabilization of ZEJULA sales.

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    Jonathan Chang's questions to Zai Lab Ltd (ZLAB) leadership • Q1 2025

    Question

    Yen-Der Li, on behalf of Jonathan Chang, asked about the potential impact of recent FDA changes and U.S. tariffs on Zai Lab's business, and requested details on the pivotal trial design for ZL-1310 in small cell lung cancer.

    Answer

    Joshua Smiley, President and COO, stated no anticipated impact from tariffs due to local manufacturing strategies. Dr. Rafael Amado, President and Head of Global R&D, noted no changes in their interactions with the FDA. Jonathan Wang, CBO, described the ZL-1310 trial as a randomized study designed for accelerated approval based on response rate, with overall survival as the final endpoint.

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    Jonathan Chang's questions to Zai Lab Ltd (ZLAB) leadership • Q4 2024

    Question

    Yen-Der Li, on behalf of Jonathan Chang, asked for clarification on the regulatory strategy for ZL-1310, specifically whether the pivotal study for accelerated approval would be single-arm or randomized, and how the timeline compares to competitors like tarlatamab.

    Answer

    Dr. Rafael Amado, President and Head of Global R&D, stated that while he could not disclose details of FDA discussions, both single-arm and randomized trial pathways exist for accelerated approval. He reiterated confidence in a potential 2027 approval, noting ZL-1310's higher response rate (70% vs 40%) gives them a strong position relative to tarlatamab.

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    Jonathan Chang's questions to Zai Lab Ltd (ZLAB) leadership • Q1 2024

    Question

    Jonathan Chang of Leerink Partners asked for expectations on the upcoming clinical data for the DLL3 ADC, ZL-1310, and questioned the company's broader strategy for expanding its global portfolio beyond in-licensing.

    Answer

    Dr. Rafael Amado, President and Head of Global Oncology R&D, stated that the ZL-1310 dose-escalation trial is progressing well, with initial data expected in late 2024 or early 2025. He also highlighted the company's internal discovery efforts, which aim to generate at least one global IND per year, complementing their business development strategy.

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    Jonathan Chang's questions to Revolution Medicines Inc (RVMD) leadership

    Jonathan Chang's questions to Revolution Medicines Inc (RVMD) leadership • Q2 2025

    Question

    Jonathan Chang of Leerink Partners requested more detail on the type and amount of doraxonerasib combination data expected later this year to inform the frontline PDAC study design. He also asked about the key considerations for selecting the specific chemotherapy regimen for that registrational study.

    Answer

    CEO Mark Goldsmith explained that the company will share a data set sufficient to justify their decision-making for the trial. President of R&D Steve Kelsey reiterated that the primary consideration is minimizing dose interruptions and maximizing the dose intensity of the RAS inhibitor, while using standard, globally accepted chemotherapy drugs and schedules.

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    Jonathan Chang's questions to Revolution Medicines Inc (RVMD) leadership • Q1 2025

    Question

    Jonathan Chang of Leerink Partners asked about the company's perspective on the potential duration of clinical benefit for the multi-selective inhibitor daraxonrasib versus mutant-selective inhibitors like zoldonrasib and elironrasib, and how this comparison influences development strategy.

    Answer

    Dr. Stephen Kelsey, President of R&D, explained that duration of benefit is the primary consideration. He noted that the mechanisms of escape from multi-selective and mutant-selective inhibitors are different, which is the core rationale for combining them. The combination is expected to cover these different escape pathways, leading to a longer PFS than either agent alone, with the high response rate being a positive early indicator. Dr. Mark Goldsmith, CEO, added that this is consistent with preclinical findings.

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    Jonathan Chang's questions to Revolution Medicines Inc (RVMD) leadership • Q3 2024

    Question

    Jonathan Chang requested more color on what is included in the company's cash runway guidance, particularly concerning the various potential development paths in pancreatic and lung cancer.

    Answer

    Jack Anders, CFO, explained that the cash runway guidance, which extends into 2027, fully incorporates the costs for the two disclosed Phase III second-line studies in pancreatic and lung cancer. For other potential programs and future pivotal trials, the company uses a probability-adjusted model, so specific additional programs are not explicitly detailed in the forecast.

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    Jonathan Chang's questions to Novocure Ltd (NVCR) leadership

    Jonathan Chang's questions to Novocure Ltd (NVCR) leadership • Q2 2025

    Question

    Jonathan Chang from Leerink Partners questioned the company's path to profitability, including key levers and potential timing. He also asked about plans to study Tumor Treating Fields in pancreatic cancer with other chemotherapy regimens.

    Answer

    CFO Christoph Brackmann reiterated that the company has a path to profitability, anchoring expectations to an approximate $750 million revenue level for adjusted EBITDA breakeven, and confirmed they are on track with internal plans. He also stated they are actively exploring new combinations for pancreatic cancer. CEO Ashley Cordova added that the upcoming PANOVA-4 data will help inform future directions.

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    Jonathan Chang's questions to Novocure Ltd (NVCR) leadership • Q1 2025

    Question

    Jonathan Chang's team inquired about the potential read-through from the positive PANOVA-3 results to the PANOVA-4 trial in metastatic pancreatic cancer and sought commentary on the local versus systemic effects of Tumor Treating Fields.

    Answer

    CEO Ashley Cordova cautioned against direct read-throughs but suggested the LUNAR trial's combination of TTFields and an immune checkpoint inhibitor (ICI) was a more interesting parallel. Executive Nicolas Leupin emphasized the significance of a positive Phase III trial in pancreatic cancer, noting PANOVA-4's combination with an ICI in metastatic disease could build on indications of systemic impact.

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    Jonathan Chang's questions to Novocure Ltd (NVCR) leadership • Q4 2024

    Question

    Jonathan Chang inquired about the specific timing and venue for the full PANOVA-3 data presentation and what additional details might be revealed compared to the top-line results.

    Answer

    CEO Ashley Cordova stated that while she could not yet confirm a specific conference, Novocure is targeting major medical conferences in the spring and will announce details upon acceptance. Executive Nicolas Leupin added that the company is thrilled to present these important data soon.

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    Jonathan Chang's questions to Novocure Ltd (NVCR) leadership • Q3 2024

    Question

    Jonathan Chang of Leerink Partners questioned how the upcoming executive leadership transitions might impact Novocure's overall corporate strategy. He also requested an update on the regulatory review status for Optune in lung cancer in Germany and the anticipated breadth of the label.

    Answer

    Incoming CEO Ashley Cordova asserted that the company's core strategy will not change, maintaining a focus on growing the GBM business, executing a successful lung cancer launch, and advancing the clinical pipeline. Retiring CEO Asaf Danziger added that there were no new updates on the German regulatory process since the prior quarter but confirmed the company still anticipates receiving a broad label similar to the one granted by the FDA.

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    Jonathan Chang's questions to Replimune Group Inc (REPL) leadership

    Jonathan Chang's questions to Replimune Group Inc (REPL) leadership • Q4 2025

    Question

    Jonathan Chang of Leerink Partners questioned the impact of recent regulatory changes, the status of FDA interactions, and how IGNYTE's response rates translate to PFS and OS compared to benchmarks.

    Answer

    CFO Emily Hill confirmed that the late-cycle meeting and manufacturing inspections with the FDA are complete with no impediments to the July 22 PDUFA date. CEO Sushil Patel addressed efficacy, noting IGNYTE's ~33% durable response rate, ~4-month PFS, and an impressive OS with over 55% of patients alive at 3 years, which compares favorably to benchmarks where median OS is typically under 12 months.

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    Jonathan Chang's questions to Immunocore Holdings PLC (IMCR) leadership

    Jonathan Chang's questions to Immunocore Holdings PLC (IMCR) leadership • Q4 2024

    Question

    Jonathan Chang from Leerink Partners asked about the company's perspective on business development opportunities for 2025.

    Answer

    Travis Coy, CFO and Head of Corporate Development, responded that while the company is very excited about its internal pipeline, it continuously evaluates external opportunities that offer a good strategic fit and leverage its expertise. He emphasized that Immunocore's strong position provides the optionality to pursue partnerships.

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    Jonathan Chang's questions to Immunocore Holdings PLC (IMCR) leadership • Q2 2024

    Question

    Jonathan Chang of Leerink Partners asked about the evolving competitive landscape for uveal melanoma and requested more details on how the company's AI-enabled patient finder tool works.

    Answer

    David Berman, Head of R&D, expressed confidence in KIMMTRAK's 3-year survival data and its well-designed adjuvant trial. Ralph Torbay, Head of Commercial, explained the AI tool uses predictive models to identify patients in low-density community centers, enabling a 'just-in-time' commercial approach without increasing the sales force.

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    Jonathan Chang's questions to Immunocore Holdings PLC (IMCR) leadership • Q2 2024

    Question

    Jonathan Chang of Leerink Securities asked about the evolving competitive landscape in uveal melanoma and requested more details on the company's AI-enabled patient finder tool.

    Answer

    David Berman, Head of R&D, addressed competition by highlighting KIMMTRAK's 3-year survival data and the well-designed ATOM trial in the adjuvant setting. Ralph Torbay, Head of Commercial, explained the AI tool uses predictive models to identify patients in low-density community practices, enabling 'just-in-time' rep deployment without increasing the field force footprint.

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    Jonathan Chang's questions to Solvay SA (SLVYY) leadership

    Jonathan Chang's questions to Solvay SA (SLVYY) leadership • Q1 2024

    Question

    Jonathan Chang from Morgan Stanley sought an explanation for a EUR 10 million gain on net indebtedness, details on decarbonization CapEx, and a recap of the Q2 free cash flow outlook.

    Answer

    CFO Alexandre Blum explained the gain was mainly from a revaluation of shares for long-term incentives. CEO Philippe Kehren stated that about EUR 30 million in decarbonization CapEx is planned for the year within the essential CapEx budget. Blum reiterated that Q2 free cash flow is expected to be slightly positive, impacted by variable remuneration and tax payments.

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