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    Faisal KhurshidLeerink Partners

    Faisal Khurshid's questions to Kymera Therapeutics Inc (KYMR) leadership

    Faisal Khurshid's questions to Kymera Therapeutics Inc (KYMR) leadership • Q2 2025

    Question

    Faisal Khurshid from Leerink Partners sought clarification on whether the second dose added to the Phase 1b study was higher or lower than the first, if these doses would be used in Phase 2b, the patient count, and if a dose-response was expected.

    Answer

    CEO Nello Mainolfi declined to specify if the added dose was higher or lower to avoid speculation, but confirmed both were tested in healthy volunteers. He also withheld the Phase 2b doses for competitive reasons. He affirmed the trial size remains approximately 20 patients and deferred comment on observing a dose-response until the full data is presented.

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    Faisal Khurshid's questions to Kymera Therapeutics Inc (KYMR) leadership • Q4 2024

    Question

    Faisal Khurshid of Leerink Partners questioned the sufficiency of the 28-day dosing period in the KT-621 Phase Ib trial for atopic dermatitis to show robust biomarker activity, and asked about the rationale for the study's inclusion criteria and lack of a placebo arm.

    Answer

    Chief Medical Officer Jared Gollob stated that 28 days is sufficient based on prior dupilumab trial data showing clear impacts at 4 weeks. He also highlighted the importance of stringent eligibility criteria. CEO Nello Mainolfi added that the study is designed to expedite the move to a pivotal Phase IIb trial and that a placebo arm is unnecessary for the primary biomarker endpoints.

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    Faisal Khurshid's questions to Kymera Therapeutics Inc (KYMR) leadership • Q3 2024

    Question

    Faisal Khurshid of Leerink Partners asked about Kymera's strategy regarding potential partnerships for the KT-621 program and the ideal timing for such a transaction.

    Answer

    CEO Nello Mainolfi described any near-term partnership for KT-621 as 'exceptionally premature.' He stated that Kymera is best positioned to develop the asset through key inflection points, likely Phase 2b studies. While a deal might be considered closer to commercialization, he emphasized the bar for partnering would be 'extremely high.'

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    Faisal Khurshid's questions to Kymera Therapeutics Inc (KYMR) leadership • Q1 2024

    Question

    Faisal Khurshid noted another disclosed IRF5 program using an allosteric modulator and asked about the potential benefits of Kymera's degrader approach over such a mechanism.

    Answer

    President and CEO Nello Mainolfi responded that while there is no public data from the competitor, he believes the key challenges for any IRF5 drug are achieving selectivity and blocking all protein functions, including splicing variants. He argued that a degrader is uniquely suited to accomplish this, which is extremely difficult for a traditional inhibitor, and also offers a PK/PD advantage for maintaining continuous target suppression.

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    Faisal Khurshid's questions to ANI Pharmaceuticals Inc (ANIP) leadership

    Faisal Khurshid's questions to ANI Pharmaceuticals Inc (ANIP) leadership • Q2 2025

    Question

    Faisal Khurshid asked for more specific details on what is driving the significant inflection and expansion of the overall ACTH drug class. He also inquired about the economics of the new Cortrophin prefilled syringe and whether they differ from the traditional vial and syringe format.

    Answer

    President, Director & CEO Nikhil Lalwani attributed the strong growth to multiple factors: the faster-than-expected impact of the expanded sales force, acceleration in newer indications like gout and ophthalmology, the rapid uptake of the new prefilled syringe (accounting for 70% of new cases initiated), and the addition of new prescribers who were previously naive to ACTH therapy. He noted a modest upward pricing advantage for the prefilled syringe but declined to provide further economic details.

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    Faisal Khurshid's questions to ANI Pharmaceuticals Inc (ANIP) leadership • Q1 2025

    Question

    Faisal Khurshid requested more detail on the commercial and market access challenges for ILUVIEN, specifically asking how the company plans to work around them using specialty pharmacy and Medicare Part D. He also asked about opportunities to replicate Cortrophin Gel's success in acute gouty arthritis in other indications.

    Answer

    President and CEO Nikhil Lalwani clarified that the ILUVIEN challenge stems from a lack of foundation co-pay support for Medicare Part B patients. He explained the strategy to mitigate this involves exploring access for patients with a Part D pharmacy benefit, which offers co-pay caps, via a specialty pharmacy channel. Regarding Cortrophin, he confirmed that opportunities exist to apply focused commercial efforts to other therapeutic areas, citing the fact that 40% of its prescribers were new to the ACTH category as evidence of their ability to expand the market.

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    Faisal Khurshid's questions to ANI Pharmaceuticals Inc (ANIP) leadership • Q4 2024

    Question

    Faisal Khurshid of Leerink Partners requested more clarification on the Medicare reimbursement changes, asking if it was related to the Part D redesign and whether the impact was specific to ILUVIEN and YUTIQ or if it also affected Cortrophin.

    Answer

    Executive Nikhil Lalwani explained the issue is not a redesign but rather a lack of 2025 funding for certain third-party programs that assist Medicare patients with co-pays. He confirmed this dynamic does not impact Cortrophin, which is primarily a Part B drug and sees some tailwinds in Part D from IRA changes. He noted the funding issue could affect other products beyond ANI's portfolio.

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    Faisal Khurshid's questions to Abcellera Biologics Inc (ABCL) leadership

    Faisal Khurshid's questions to Abcellera Biologics Inc (ABCL) leadership • Q2 2025

    Question

    Faisal Khurshid from Leerink Partners asked whether the higher-than-usual partnership and licensing revenue recorded in the quarter should be considered a new baseline for future quarters.

    Answer

    CFO Andrew Booth clarified that the $10 million in licensing revenue was a one-off payment related to an earn-out from the Trianni acquisition. He explicitly stated that this level of revenue is not expected to be recurring.

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    Faisal Khurshid's questions to Trevi Therapeutics Inc (TRVI) leadership

    Faisal Khurshid's questions to Trevi Therapeutics Inc (TRVI) leadership • Q2 2025

    Question

    Faisal Khurshid of Leerink Partners inquired about the progress and potential risks of the ongoing respiratory depression study (TITLE) and the rationale for conducting a drug-drug interaction (DDI) study given prior background use of anti-fibrotics.

    Answer

    James Cassella, Chief Development Officer, explained the respiratory safety study is an FDA-requested assessment to characterize Haduvio's effects in IPF patients and is on track for the end-of-Phase 2 meeting. He described the DDI study as a standard, pre-Phase 3 "check the box" activity to formally characterize any potential pharmacokinetic interactions with common anti-fibrotics, thereby de-risking the Phase 3 program.

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    Faisal Khurshid's questions to Trevi Therapeutics Inc (TRVI) leadership • Q1 2025

    Question

    Faisal Khurshid inquired about the criteria for a positive readout from the CORAL trial for both efficacy and safety, and asked about the company's next major catalysts following the CORAL data release.

    Answer

    Executive Jennifer Good stated that for the CORAL trial, a statistically significant positive result is the primary bar for success to continue development, especially given the high unmet need in IPF chronic cough. She confirmed the safety profile has shown no unusual adverse events and that the company will provide a clearer catalyst path after the CORAL data is analyzed.

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    Faisal Khurshid's questions to Trevi Therapeutics Inc (TRVI) leadership • Q4 2024

    Question

    Faisal Khurshid of Leerink Partners asked about the patient characteristics in the CORAL study, inquiring if there were differences between the first and second halves of enrollment, and also requested an update on the study's discontinuation rate.

    Answer

    Executive Jennifer Good stated that no changes were made to the CORAL study protocol, sites, or enrollment criteria following the sample size reestimation, ensuring population consistency. She also confirmed that the blinded discontinuation rate remained low and consistent in the single digits throughout the entire study.

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    Faisal Khurshid's questions to Trevi Therapeutics Inc (TRVI) leadership • Q3 2024

    Question

    Faisal Khurshid from Leerink Partners inquired about the expected drug liking results for the comparator butorphanol in the Human Abuse Potential (HAP) study and what specific outcomes for nalbuphine would support an unscheduled designation.

    Answer

    Dr. James Cassella, Chief Development Officer, explained that butorphanol is a scheduled drug and is expected to show a clear differentiation from placebo to validate the study. For nalbuphine to support an unscheduled label, it would need to show no significant difference from placebo within a prespecified equivalence margin of 11 points on the drug liking scale. This is one of several factors in the overall scheduling decision.

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    Faisal Khurshid's questions to MannKind Corp (MNKD) leadership

    Faisal Khurshid's questions to MannKind Corp (MNKD) leadership • Q2 2025

    Question

    Faisal Khurshid from Leerink Partners asked about the company's confidence in the safety and efficacy of using inhaled nintedanib (MANNKIND-201) on top of background pirfenidone therapy, and questioned what would be required to bring the development program into the U.S.

    Answer

    SVP, Therapeutic Area Head - Rare Lung Diseases, Wassim Fares stated that due to the low systemic exposure of inhaled nintedanib, drug-drug interaction with pirfenidone is expected to be minimal, and the future of IPF is combination therapy. CEO Michael Castagna added that while the Phase 2 trial is ex-US due to enrollment challenges with a placebo arm in the US, a successful outcome would lead to a global Phase 3 trial that includes the U.S.

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    Faisal Khurshid's questions to MannKind Corp (MNKD) leadership • Q4 2024

    Question

    Faisal Khurshid from Leerink Partners asked about the balance between maintaining operational profitability and funding the Afrezza pediatric launch, and also questioned the priority of pipeline expansion.

    Answer

    Executive Michael Castagna explained that after prioritizing debt reduction, the company's focus is now on deploying capital for growth drivers, including the Afrezza pediatric launch and advancing the clofazimine and nintedanib trials. He also confirmed that pipeline expansion is a key priority, with several non-public product opportunities and life cycle management programs for existing assets currently in development.

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    Faisal Khurshid's questions to MannKind Corp (MNKD) leadership • Q3 2024

    Question

    Faisal Khurshid of Leerink Partners requested more information on the adverse event profile from the MNKD-201 Phase I study, specifically asking about the cause and time course of FEV1 drop and cough events.

    Answer

    Executive Michael Castagna clarified that there were no significant concerns regarding the FEV1 drop, as it was not progressive and led to no discontinuations. He hypothesized the events were likely caused by lung irritation from the frequent, protocol-mandated FEV1 tests rather than the drug itself, noting similar occurrences in the placebo (excipient-only) arm.

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