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    Kyuwon Choi • Goldman Sachs Group Inc.

    Kyuwon Choi's questions to Gossamer Bio Inc (GOSS) leadership

    Kyuwon Choi's questions to Gossamer Bio Inc (GOSS) leadership • Q1 2025

    Question

    Kyuwon Choi (on behalf of Paul Choi) asked about the baseline usage of sotatercept in the PROSERA study, what is now considered a clinically meaningful improvement in the 6-minute walk test, and which financial milestones related to the Chiesi partnership are included in the cash runway guidance.

    Answer

    COO Bryan Giraudo reported that only 3-4 patients have been enrolled on background sotatercept due to strict stability requirements. CEO Faheem Hasnain argued that a 20-plus meter improvement would be clinically meaningful, given seralutinib's safety profile and unique potential for continued improvement over time. Bryan Giraudo clarified the cash runway guidance to H1 2027 includes cost-sharing benefits but excludes potential large regulatory milestone payments from Chiesi.

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    Kyuwon Choi's questions to Regenxbio Inc (RGNX) leadership

    Kyuwon Choi's questions to Regenxbio Inc (RGNX) leadership • Q1 2025

    Question

    Speaking for Paul Choi, Kyuwon Choi from Goldman Sachs asked if an AdCom is anticipated for the RGX-121 BLA and requested details on the number of patients and follow-up duration for the upcoming RGX-202 functional data update.

    Answer

    President and CEO Curran Simpson said the company is preparing for a potential AdCom for RGX-121, though one has not been confirmed by the FDA. For the RGX-202 update, he expects to report on 4 to 5 patients from dose level 2, with follow-up of at least 9 months and some out to 12 months.

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    Kyuwon Choi's questions to Regenxbio Inc (RGNX) leadership • Q4 2024

    Question

    Kyuwon Choi, on behalf of Paul Choi at Goldman Sachs, asked about the anticipated post-approval requirements for the AFFINITY DMD study, such as a confirmatory trial. He also inquired about the company's interest in exploring RGX-202 for the non-ambulatory Duchenne population.

    Answer

    CEO Curran Simpson explained that while detailed discussions with the FDA are pending, they plan to continue enrolling to complete a confirmatory study as quickly as possible and have already prepared the necessary drug supply. Regarding the non-ambulatory population, he stated they are 'strongly considering' it but are prioritizing the completion of the current pivotal trial for ambulatory patients to maintain momentum toward a BLA filing.

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    Kyuwon Choi's questions to Regenxbio Inc (RGNX) leadership • Q3 2024

    Question

    Kyuwon Choi of Goldman Sachs inquired about the likelihood of an Advisory Committee (AdCom) meeting for the RGX-121 BLA filing and asked for the latest feedback on its competitive positioning against Denali Therapeutics' asset for MPS II.

    Answer

    CEO Curran Simpson stated that while they have no specific information, they are preparing as if an AdCom will be required. He differentiated RGX-121 from Denali's approach by highlighting its value as a one-time gene therapy versus a weekly IV infusion. He also noted that data shows most patients on RGX-121 were able to discontinue prior enzyme replacement therapy, positioning it as a strong first-choice option.

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    Kyuwon Choi's questions to Cytokinetics Inc (CYTK) leadership

    Kyuwon Choi's questions to Cytokinetics Inc (CYTK) leadership • Q1 2025

    Question

    Paul Choi of Goldman Sachs questioned what differentiation remains for aficamten following recent updates to the Camzyos label.

    Answer

    Robert I. Blum, President and CEO, asserted that significant differentiation opportunities remain. He corrected the premise that Camzyos's limitations were fully removed, noting that restrictions related to drug-drug interactions and echo monitoring persist, particularly during the titration phase. He expressed confidence that the submitted REMS for aficamten will support a distinct profile.

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    Kyuwon Choi's questions to Cytokinetics Inc (CYTK) leadership • Q3 2024

    Question

    Kyuwon Choi of Goldman Sachs asked about payer discussions regarding the MAPLE-HCM trial and what clinical efficacy bar would be considered meaningful to drive guideline changes.

    Answer

    Robert I. Blum, President and CEO, stated it was premature to discuss MAPLE with payers. Andrew Callos, EVP and CCO, elaborated that current payer talks focus on SEQUOIA data. He explained MAPLE's primary value is expanding the prescriber market by providing head-to-head evidence against standard of care, which enhances the overall value argument rather than setting a specific payer bar.

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    Kyuwon Choi's questions to Vir Biotechnology Inc (VIR) leadership

    Kyuwon Choi's questions to Vir Biotechnology Inc (VIR) leadership • Q4 2024

    Question

    Kyuwon Choi from Goldman Sachs asked about the envisioned patient population for the Phase I study of the EGFR T-cell engager, VIR-5525, particularly regarding prior treatments. He also requested a refresher on the go/no-go criteria for the hepatitis B program and what would be attractive to a potential partner.

    Answer

    CEO Dr. Marianne De Backer clarified that the VIR-5525 study is a standard first-in-human trial for patients who have exhausted all standard of care, but it will allow patients who have received prior experimental drugs. Dr. Mark Eisner, Chief Medical Officer, reiterated the go/no-go criteria for the hepatitis B program, targeting a 30% functional cure rate in the triplet therapy and 20% in the doublet, noting this is based on KOL feedback and would be attractive for a partnership.

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    Kyuwon Choi's questions to Vir Biotechnology Inc (VIR) leadership • Q3 2024

    Question

    Kyuwon Choi inquired about the status of Vir's end-of-Phase II meeting with the FDA for its hepatitis delta (HDV) program and the key metrics being evaluated for the VIR-5818 T-cell engager program, both as a monotherapy and in combination with pembrolizumab.

    Answer

    Dr. Mark Eisner, Chief Medical Officer, confirmed that Vir has engaged with the FDA on its HDV program and will provide a detailed update at the hepatitis-focused investor event on November 19. Regarding the VIR-5818 T-cell engager, he stated that preliminary monotherapy data will be shared in Q1 2025, at which point more perspective on the program's progress will be available.

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    Kyuwon Choi's questions to Lantheus Holdings Inc (LNTH) leadership

    Kyuwon Choi's questions to Lantheus Holdings Inc (LNTH) leadership • Q4 2024

    Question

    Kyuwon Choi inquired about the decision-making process and potential rate-limiting steps regarding the option to co-promote Flyrcado in partnership with GE HealthCare.

    Answer

    CEO Brian Markison stated that Lantheus is not anticipating entering into the co-promote option with GE HealthCare at this time, expressing confidence in GE's ability to achieve its goals independently while noting Lantheus is available to support them if needed.

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    Kyuwon Choi's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership

    Kyuwon Choi's questions to Kiniksa Pharmaceuticals International PLC (KNSA) leadership • Q4 2024

    Question

    Kyuwon Choi of Goldman Sachs asked for details on the clinical development plan for KPL-387 and for clarification on the terms of the Regeneron arrangement for ARCALYST, particularly regarding a potential future focus on KPL-387.

    Answer

    Dr. John Paolini, Chief Medical Officer, noted that the Phase II/III trial design was discussed with the FDA and will begin mid-year, with specifics to be released later. Sanj K. Patel, Chief Executive Officer, affirmed Kiniksa's commitment to ARCALYST's growth, stated there is no non-compete clause with Regeneron, and expressed excitement for both products.

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    Kyuwon Choi's questions to Ascendis Pharma A/S (ASND) leadership

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

    Question

    Kyuwon Choi asked if management agreed that a 505(b)(2) pathway for a monthly GLP-1 agonist is likely, potentially shortening development, and inquired about the timeline for recognizing royalty revenue.

    Answer

    Jan Mikkelsen, President and CEO, fully agreed that a 505(b)(2) pathway is a likely and advantageous route that could shorten development timelines and secure a broad label. However, he deferred to their partner, Novo Nordisk, for any specific timelines regarding development or potential revenue recognition.

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    Kyuwon Choi's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Kyuwon Choi's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q3 2024

    Question

    Kyuwon Choi noted the close proximity of the projected completion dates for the X-TOLE2 and X-TOLE3 studies and asked how X-TOLE3 fits into the overall regulatory filing strategy for the U.S. and Europe.

    Answer

    CEO Ian Mortimer clarified that X-TOLE2 has been prioritized and is on the critical path for the U.S. NDA submission. X-TOLE3 is important for filings in ex-U.S. jurisdictions and for strengthening the overall safety database. CMO Dr. Christopher Kenney emphatically stated that the NDA will be submitted based on X-TOLE and X-TOLE2 data, without waiting for X-TOLE3 results.

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    Kyuwon Choi's questions to Dynavax Technologies Corp (DVAX) leadership

    Kyuwon Choi's questions to Dynavax Technologies Corp (DVAX) leadership • Q3 2024

    Question

    Kyuwon Choi of Goldman Sachs, asking as Paul Choi, inquired about the shingles vaccine program (Z-1018), specifically asking about the potential for a single-dose candidate. He questioned if a one-dose option could be viable if it met non-inferiority margins on immunogenicity versus Shingrix, even if it came with a higher rate of adverse events.

    Answer

    Chief Medical Officer Robert Janssen stated that achieving success with a single dose is challenging, noting that while their candidate has a better tolerability profile, previous data showed Shingrix's immunogenicity improved more significantly after the second dose. CEO Ryan Spencer added that developing a vaccine with higher reactogenicity than Shingrix, which is already known for being highly reactogenic, would likely not be a successful commercial strategy.

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    Kyuwon Choi's questions to Amarin Corporation PLC (AMRN) leadership

    Kyuwon Choi's questions to Amarin Corporation PLC (AMRN) leadership • Q3 2024

    Question

    Kyuwon Choi of Goldman Sachs inquired about the company's capital prioritization, specifically asking for an update on the share repurchase program and its capacity and strategy for business development to acquire pipeline assets.

    Answer

    VP and Global Controller Peter Fishman confirmed the share repurchase program is approved but has not been initiated, as the company continues to monitor market dynamics and prioritize prudent cash management. President and CEO Aaron Berg stated that the company's primary focus is on executing the growth of VAZKEPA/VASCEPA, particularly in Europe where there is significant runway. He indicated that considering new assets is a possibility for the future, but the immediate priority is maximizing the value of their current product.

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