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    Yale Jen • Laidlaw & Company

    Yale Jen's questions to Soleno Therapeutics Inc (SLNO) leadership

    Yale Jen's questions to Soleno Therapeutics Inc (SLNO) leadership • Q2 2025

    Question

    Yale Jen from Laidlaw & Company asked for a breakdown of revenue between patients in the initial titration phase versus the maintenance phase, and also requested details on the current payer mix between government and commercial.

    Answer

    CEO Anish Bhatnagar clarified that with only about 60 former US trial patients, the vast majority of the 646 start forms were new patients, many of whom were still in the titration phase during Q2. He stated it was too early to provide a precise payer mix but reiterated the expected population split is roughly one-third each for commercial, Medicare, and Medicaid.

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    Yale Jen's questions to Soleno Therapeutics Inc (SLNO) leadership • Q1 2025

    Question

    Yale Jen asked about the procedural steps for a new patient to obtain a Vykat XR prescription and sought an update on the company's European commercialization strategy, specifically regarding a potential partnership.

    Answer

    Executive James MacKaness outlined the process: a physician fills out a start form, which is sent to a specialty pharmacy to initiate patient access. Executive Anish Bhatnagar stated that Soleno is still evaluating both a partnership and a self-commercialization strategy for Europe, with a decision to be made following the planned MAA submission to the EMA this quarter.

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    Yale Jen's questions to Delcath Systems Inc (DCTH) leadership

    Yale Jen's questions to Delcath Systems Inc (DCTH) leadership • Q2 2025

    Question

    Yale Jen of Laidlaw & Company asked for specifics on the data to be presented from the CHOPEN trial at ESMO and sought more color on the reasons for lowering the site activation forecast.

    Answer

    CMO Vojislav Vukovic confirmed the CHOPEN presentation will include the primary endpoint of one-year progression-free survival, plus safety and secondary efficacy data. GM Kevin Muir and CEO Gerard Michel explained the activation slowdown is due to complexities at large institutions, citing perfusion services as a key hurdle that the team is now addressing earlier in the process.

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    Yale Jen's questions to Delcath Systems Inc (DCTH) leadership • Q1 2025

    Question

    Yale Jen asked about the number of sites for the CRC trial, the number of HEPZATO units sold, details on a recent price increase, the breakdown of patient referrals, and the meaning behind the consistent quarterly revenue growth.

    Answer

    CMO Vojo Vukovic stated over 20 sites are planned for the CRC trial. CFO Sandra Pennell detailed a price increase from $182.5k to $187.5k on February 1. General Manager Kevin Muir estimated 30-40% of patients are organic to treatment sites, with the rest referred in. CEO Gerard Michel explained the steady ~$4M quarterly revenue increase is a function of the consistent pace of new center activations, which is typical for this type of product ramp, but declined to extrapolate the trend.

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    Yale Jen's questions to Delcath Systems Inc (DCTH) leadership • Q4 2024

    Question

    Yale Jen of Laidlaw & Company inquired about the trial design for the upcoming metastatic colorectal cancer (CRC) study, including treatment cycles and sequencing. He also asked about revenue expectations and reimbursement strategy for European markets.

    Answer

    CMO Vojo Vukovic detailed the CRC trial design: two initial cycles of HEPZATO followed by standard of care, sequenced this way to address the liver-dominant disease first. CEO Gerard Michel projected "modest growth" for Europe in 2025, emphasizing its strategic importance for data generation over near-term revenue. He added that reimbursement efforts involve creating country-specific pharmacoeconomic models.

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    Yale Jen's questions to Delcath Systems Inc (DCTH) leadership • Q3 2024

    Question

    Yale Jen of Laidlaw & Company asked about the company's progress in engaging medical oncologists to build a referral network and inquired about the clinical data supporting the decision to pursue trials in colorectal and breast cancer.

    Answer

    CEO Gerard Michel confirmed that the commercial team is actively building a referral network, which is a key priority for success in 2025. He explained the colorectal cancer indication is supported by strong historical data from a similar surgical procedure that showed high response rates with melphalan. The breast cancer indication is based on promising results, including complete responses, observed in about a dozen patients treated with CHEMOSAT in Europe.

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    Yale Jen's questions to OPKO Health Inc (OPK) leadership

    Yale Jen's questions to OPKO Health Inc (OPK) leadership • Q2 2025

    Question

    Yale Jen of Laidlaw & Company asked for the estimated patient size for the Phase 1 study targeting both obesity and NASH. He also sought clarification on the differences between the GLP-1/glucagon agonist (OPK-88006) and the GLP-2 candidate for short bowel syndrome, as well as the clinical timeline for the latter.

    Answer

    President & Vice Chairman Dr. Elias Zerhouni estimated the Phase 1 study would enroll between 100 and 170 patients with biomarker evidence of F2-F4 stage NASH. He clarified that the GLP-2 agonist is a completely different molecule targeting intestinal absorption for the distinct unmet need of short bowel syndrome. He stated the short bowel syndrome program is expected to enter clinical studies next year, pending regulatory feedback.

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    Yale Jen's questions to OPKO Health Inc (OPK) leadership • Q1 2025

    Question

    Yale Jen of Laidlaw & Company inquired about the potential impact of government tariffs on operations and R&D, and also asked whether the MASH development program would target early-stage or later-stage fibrosis patients.

    Answer

    Executive Adam Logal assessed the tariff risk as manageable for the supply chain, while Executive Elias Zerhouni noted no significant impact is expected on R&D. Regarding the MASH program, Zerhouni specified that the focus is on later-stage patients with F3 and early F4 (pre-cirrhotic) NASH, where the unmet medical need is greatest.

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    Yale Jen's questions to OPKO Health Inc (OPK) leadership • Q4 2024

    Question

    Yale Jen of Laidlaw and Company asked a macro-level question regarding potential concerns about the impact of recent government changes on the future prospects for vaccine development and related government funding.

    Answer

    Executive Elias Zerhouni acknowledged the uncertainty but stated that OPKO has not received any indication of a slowdown from its partner Merck on the EBV vaccine or from BARDA on its antibody programs. He emphasized the continued importance of these programs for public health and pandemic preparedness, expressing no immediate worry about the current funding or program progression.

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    Yale Jen's questions to Viking Therapeutics Inc (VKTX) leadership

    Yale Jen's questions to Viking Therapeutics Inc (VKTX) leadership • Q2 2025

    Question

    Yale Jen from Laidlaw & Company asked about the potential impact of upcoming Phase III data from Lilly's oral GLP-1 on Viking's oral program. He also inquired about the status of the calcitonin receptor aspect of Viking's amylin program.

    Answer

    President & CEO Brian Lian expressed that the obesity market is large enough to accommodate multiple agents, so they are not overly concerned about a single competitor's data. Regarding the amylin program, he clarified that their compounds are balanced agonists of both the amylin and calcitonin receptors, as their preclinical work showed this balanced approach yielded the best results for weight and food consumption.

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    Yale Jen's questions to Viking Therapeutics Inc (VKTX) leadership • Q1 2025

    Question

    Yale Jen asked about the number of clinical sites prepared for the upcoming Phase III study and requested a status update on potential partnerships for the VK0214 and VK2809 programs.

    Answer

    Brian Lian, President and CEO, did not disclose the specific number of sites for the large Phase III program. Regarding the VK0214 (X-ALD) and VK2809 (NASH) programs, he confirmed both are available for licensing and are attracting interest, but he could not provide details on any ongoing discussions.

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    Yale Jen's questions to Viking Therapeutics Inc (VKTX) leadership • Q4 2024

    Question

    Yale Jen asked if the Phase III study in type 2 diabetes patients could support a standalone diabetes indication. He also inquired about preparations for an auto-injector and whether a bridging study would be necessary.

    Answer

    CEO Brian Lian clarified that the study is intended to support an obesity label for patients with type 2 diabetes, not a separate diabetes treatment indication. He confirmed that Viking plans to introduce an auto-injector during the Phase III program and would likely conduct a bioequivalence bridging study to support it.

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    Yale Jen's questions to Viking Therapeutics Inc (VKTX) leadership • Q3 2024

    Question

    Yale Jen asked if there were any surprises in the recent FDA feedback for VK2809 and its potential impact on partnering, and also inquired about how recent competitor data on amylin agonists might influence Viking's own program strategy.

    Answer

    Brian Lian, an executive, reported that while the company was still reviewing the FDA feedback for VK2809, there were no surprises so far. Regarding the competitive landscape, he stated that exciting data from other amylin programs is viewed positively, as it validates the mechanism and bodes well for Viking's own combination strategy with VK2735.

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    Yale Jen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Yale Jen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q1 2025

    Question

    Yale Jen of Laidlaw & Company followed up on the data release plan for 2026, asking if the top-line results for the two Phase III trials would be released approximately two months apart.

    Answer

    President and CEO Dr. Jay Duker confirmed that a roughly two-month separation between the data releases for the LUGANO and LUCIA trials is a likely scenario. He stated that the company plans to release the data for each trial as it becomes available, and the approximate two-month gap is based on the staggered trial start times and similar enrollment patterns.

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    Yale Jen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q4 2024

    Question

    Yale Jen asked for a comment on EyePoint's first-to-market potential given a competitor's timeline and whether the company had analyzed patient characteristics from earlier studies to predict which patients might not need supplemental treatment.

    Answer

    President and CEO Dr. Jay Duker reiterated confidence in being first-to-market, noting the critical factor is the last patient in the second trial, LUCIA, which is recruiting rapidly. Chief Medical Officer Ramiro Ribeiro explained that due to the small size of earlier studies, it is difficult to predict supplement-free patients, but it's something they may analyze with the larger Phase III database.

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