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    Yi Chen • H.C. Wainwright & Co.

    Yi Chen's questions to Neuropace Inc (NPCE) leadership

    Yi Chen's questions to Neuropace Inc (NPCE) leadership • Q2 2025

    Question

    Yi Chen of H.C. Wainwright & Co., LLC asked about the likelihood of the FDA requiring an additional clinical trial for the IGE indication, given the plan to submit based on the full NAUTILUS study population. He also inquired about the size of the pediatric market opportunity and the expected timeline for a potential submission.

    Answer

    CEO Joel Becker stated that the company believes the existing NAUTILUS data is compelling and sufficient for a benefit-risk determination, making an additional trial unnecessary. He described the pediatric market as a significant opportunity with strong adoption dynamics due to the high unmet need and urgency in treating developmental epilepsy. Becker reiterated that the company is targeting a submission for the pediatric indication in 2025.

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    Yi Chen's questions to Harrow Inc (HROW) leadership

    Yi Chen's questions to Harrow Inc (HROW) leadership • Q2 2025

    Question

    Yi Chen asked about any timing difference between VEVYE's quarterly prescription growth and its recognized revenue, and also inquired about the estimated timeline for VEVYE to become the leading cyclosporine-based product.

    Answer

    CFO Andrew Boll stated that there were no significant stocking dynamics in the quarter, so prescription demand and revenue recognition were tightly correlated. CEO Mark Baum outlined the strategy for VEVYE, stating the primary goal is to become the number one cyclosporine product, followed by becoming the number one anti-inflammatory, and ultimately the number one overall prescribed dry eye product.

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    Yi Chen's questions to Harrow Inc (HROW) leadership • Q1 2025

    Question

    Yi Chen noted that VEVYE revenue grew despite lower quarterly prescription numbers and asked about the collection cycle. He also inquired if any Harrow products are affected by current tariff policies.

    Answer

    CFO Andrew Boll and CEO Mark L. Baum explained that revenue recognition is not perfectly aligned with prescription volume and that Q1 revenue benefited from a higher ASP due to new business rules. They highlighted that the VEVYE Access for All program, launched late Q1, is now driving rapid volume growth, which will create immense value through compounding refills in Q3 and Q4. Regarding tariffs, Baum stated the impact is negligible, estimating it at only 50 basis points on 2024 gross margins.

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    Yi Chen's questions to Harrow Inc (HROW) leadership • Q4 2024

    Question

    Yi Chen asked about the percentage of IHEEZO volume used for anti-VEGF injections, the regulatory timeline for MELT-300, and whether quarterly revenue reflects end-user demand or distributor stocking.

    Answer

    CEO Mark L. Baum did not provide a specific percentage for IHEEZO but confirmed that growth is being driven by the 'retina pivot' for anti-VEGF injections. Speaking as Melt's Board Chair, he estimated a potential NDA filing for MELT-300 around early 2026. CFO Andrew Boll clarified that revenue is recognized on sale to distributors, and while some light Q4 stocking may have occurred, the primary driver was strong end-user demand for key products.

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    Yi Chen's questions to Belite Bio Inc (BLTE) leadership

    Yi Chen's questions to Belite Bio Inc (BLTE) leadership • Q2 2025

    Question

    Yi Chen from H.C. Wainwright & Co., LLC inquired about the timeline for reaching full enrollment in the DRAGON-2 trial and whether the current pace met expectations. He also asked about the drivers behind rising operating expenses and their sustainability.

    Answer

    Chairman & CEO Tom Lin stated that DRAGON-2 enrollment was intentionally staggered but is now accelerating, with completion expected by year-end. CFO & Director Hao-Yuan Chuang clarified that the OpEx increase was driven by $7.6M in non-cash share-based compensation. He projected a cash burn of $40-45M for the current and next year, supporting the company's four-year cash runway.

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    Yi Chen's questions to Belite Bio Inc (BLTE) leadership • Q1 2025

    Question

    Yi Chen of H.C. Wainwright & Co. asked about Belite Bio's strategy for ex-U.S. drug approval in light of potential U.S. pricing policies and questioned if operating expenses would continue to increase through 2025.

    Answer

    Chairman and CEO Dr. Tom Lin responded that since Tinlarebant is not yet launched, potential pricing policies have no immediate impact, and the company is monitoring the situation. CFO Hao-Yuan Chuang confirmed that operating expenses are expected to be slightly higher for the remainder of 2025 and the following year due to key clinical trial milestones, after which they should decrease.

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    Yi Chen's questions to Belite Bio Inc (BLTE) leadership • Q4 2024

    Question

    Yi Chen from H.C. Wainwright & Co. asked what percentage of the real-world Stargardt disease population is represented by the adolescent patients in the DRAGON trial. He also sought clarification on whether a potential approval would cover a broader age range and inquired about potential reimbursement limitations from payers if the label is broader than the trial population.

    Answer

    Chief Medical Officer Dr. Hendrik Scholl estimated that the trial's population (ages 12-20) represents about two-thirds of patients seen in a typical clinic, as the disease commonly onsets in the second decade of life. Dr. Scholl stated there would be no reason not to prescribe the drug to an adult patient. Chairman and CEO Dr. Tom Lin added that the company will seek a broad label for adults, which they believe is achievable, potentially supported by a future PK study.

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    Yi Chen's questions to Belite Bio Inc (BLTE) leadership • Q3 2024

    Question

    Yi Chen questioned the baseline characteristics of PHOENIX trial subjects compared to those in trials for approved GA therapies, whether smaller lesions make efficacy easier to observe, and if the PHOENIX interim analysis would include an efficacy readout.

    Answer

    Chief Medical Officer Dr. Hendrik Scholl and Chief Scientific Officer Dr. Nathan L. Mata clarified that the PHOENIX trial targets patients with smaller lesions and consequently less inflammation than the cohorts in competitor trials. Dr. Scholl noted that while patients may not easily perceive the slowing of progression, it is clearly measurable by physicians. Executive Tom Lin confirmed the interim analysis is for the DSMB and is not expected to include a public efficacy readout.

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    Yi Chen's questions to BioLife Solutions Inc (BLFS) leadership

    Yi Chen's questions to BioLife Solutions Inc (BLFS) leadership • Q2 2025

    Question

    Yi Chen of H.C. Wainwright & Co., LLC inquired about the rationale for structuring the Pluristics investment as a convertible note and the likelihood of an eventual acquisition. He also asked for an overview of the company's broader M&A strategy going forward.

    Answer

    Chairman & CEO Roderick de Greef explained that the Pluristics investment structure, similar to past deals, provides rights for a potential future acquisition. He noted that a decision to acquire would depend on BioLife's strategic conclusion to enter the assays market and on Pluristics demonstrating sufficient revenue growth. De Greef described the overall M&A strategy as a disciplined approach focused on strategically adjacent products within cell manufacturing that can either solidify or create market leadership positions for BioLife.

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    Yi Chen's questions to BioLife Solutions Inc (BLFS) leadership • Q1 2025

    Question

    Yi Chen asked if BioLife could potentially benefit from the onshoring of pharmaceutical and biotechnology manufacturing as a result of tariffs.

    Answer

    CEO Roderick de Greef stated that it is too early to quantify any potential benefit. He explained that because BioLife's products represent a very small fraction (less than 1%) of a cell and gene therapy manufacturer's cost of goods, it is unlikely to be a deciding factor in their manufacturing location decisions, making it a de minimis issue for now.

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    Yi Chen's questions to BioLife Solutions Inc (BLFS) leadership • Q3 2024

    Question

    An analyst from H.C. Wainwright asked for the approximate number of customers represented by BioLife's top three distributors. They also inquired about the current number of approved therapies using the company's media and the outlook for new approvals in the near term.

    Answer

    CEO Roderick de Greef estimated that the top distributors collectively represent 4,000 to 5,000 customers globally. He confirmed that 17 unique approved therapies currently incorporate BioLife's biopreservation media and that the company anticipates six additional approvals, geographic expansions, or new indications within the next 9 to 12 months.

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    Yi Chen's questions to Regenxbio Inc (RGNX) leadership

    Yi Chen's questions to Regenxbio Inc (RGNX) leadership • Q2 2025

    Question

    Yi Chen asked for a comparison of the dosing levels for Suravec between the subretinal delivery for wet AMD and the suprachoroidal delivery, and whether the difference is related to the delivery route's impact on efficacy.

    Answer

    CMO Dr. Steve Pakola confirmed that the subretinal doses are lower. He explained that for the newer suprachoroidal route, the company conducted new dose-ranging studies and had the flexibility based on preclinical data to use higher doses to meet the target product profile while maintaining the safety benefits of targeted, compartmentalized delivery.

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    Yi Chen's questions to Regenxbio Inc (RGNX) leadership • Q4 2024

    Question

    Yi Chen of H.C. Wainwright inquired about the U.S. sales presence of partner Nippon Shinyaku for the commercialization of RGX-121. He asked about the size of the promotional team and whether sales-related milestones could be triggered within the first year of launch.

    Answer

    CEO Curran Simpson explained that Nippon Shinyaku has a significant U.S. rare disease commercial team already in place for its Duchenne product, and this existing infrastructure is expected to support the RGX-121 launch. He projected a launch in late 2025 or early 2026 following a potential Q4 2025 PDUFA date. He also confirmed that some of the potential $700 million in sales milestones are structured to be achievable within the first or second year of commercialization.

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    Yi Chen's questions to Regenxbio Inc (RGNX) leadership • Q3 2024

    Question

    Yi Chen of H.C. Wainwright & Co. asked if the pivotal trial for RGX-314 in diabetic retinopathy (DR) will enroll asymptomatic patients and what the primary efficacy endpoint would be for that population.

    Answer

    Dr. Steve Pakola, CMO, confirmed the trial would include asymptomatic patients, as this is a key population that could benefit from a one-time preventative treatment. He explained the primary efficacy endpoint would involve monitoring for the worsening of DR severity and the occurrence of vision-threatening complications, noting the Phase II study already showed a nearly 90% reduction in such events.

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    Yi Chen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership

    Yi Chen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q2 2025

    Question

    Yi Chen from H.C. Wainwright & Co. asked if there would be another Data Safety Monitoring Committee (DSMC) meeting before the 2026 data readout and about the outlook for top-line revenue in coming quarters.

    Answer

    CMO Ramiro Ribeiro confirmed that DSMC meetings occur every six months, so at least two more are expected before top-line results. CFO George Elston addressed revenue, stating that with the exit from the commercial business, revenue recognition from the YUTIQ license agreement was completed in Q2. He clarified that future revenue will be 'de minimis,' primarily from supplying a partner in China, as the company is now a clinical-stage entity.

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    Yi Chen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q1 2025

    Question

    Eduardo, on behalf of Yi Chen at H.C. Wainwright, asked about the rationale for the 78-letter BCVA cutoff in the Phase III trials and for details on the attributes of the high-performing patient subgroup in the DME trial.

    Answer

    CEO Dr. Jay Duker explained the 78-letter cutoff is typical and required by the FDA to ensure patients have active wet AMD with decreased vision. Regarding the DME subgroup, he noted that in the high-dose arm, un-rescued patients showed a strong, sustained 10-letter vision improvement. He stated that while it would be great to identify these patients beforehand, the trial size was too small to determine predictive attributes, which they hope to elucidate in future pivotal trials.

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    Yi Chen's questions to EyePoint Pharmaceuticals Inc (EYPT) leadership • Q4 2024

    Question

    Yi Chen asked about the timeline for initiating a Phase III trial in DME, the potential for a partnership for that indication, and the likely target enrollment for such a trial.

    Answer

    President and CEO Dr. Jay Duker stated there are no plans to start the DME trial in 2025, targeting it as a 2026 event. He noted that while a partner would be welcome, it would need to be part of a larger, strategic partnership, not just for the DME indication. Chief Medical Officer Ramiro Ribeiro added that they would be optimistic about enrollment rates, leveraging the same sites as the wet AMD trials.

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    Yi Chen's questions to Ocular Therapeutix Inc (OCUL) leadership

    Yi Chen's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2025

    Question

    Yi Chen of H.C. Wainwright & Co., LLC asked about the previous rescue criteria for the SOLAR trial, the expected impact of the change on the number of rescues, and whether real-world rescue practices have evolved recently.

    Answer

    Pravin Dugel, Executive Chairman, President & CEO, responded that the change was made for strategic reasons to align with current clinical practice and reflect the company's confidence in the drug. By making the criteria more liberal, they aim to ensure the trial's results are directly relevant to physicians, which should support adoption. This decision was based on investigator feedback and observations from the masked SOUL-one data.

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    Yi Chen's questions to Ocular Therapeutix Inc (OCUL) leadership • Q4 2024

    Question

    Yi Chen asked how quickly Ocular anticipates advancing its NPDR and DME programs into clinical trials after receiving FDA feedback and whether the company intends to pursue both indications concurrently.

    Answer

    President and CEO Dr. Pravin Dugel confirmed the goal is to pursue both NPDR and DME, citing strong data from the HELIOS study. He stated that the specific trial design and implementation speed depend on the outcome of the formal FDA meeting, planned for the first half of the year. He emphasized that the company is well-financed into 2028 and does not plan to raise additional capital this year, even with the potential for these new trials.

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    Yi Chen's questions to Ocular Therapeutix Inc (OCUL) leadership • Q3 2024

    Question

    Yi Chen asked about the diabetic retinopathy program, specifically whether the next trial would be Phase 2 or Phase 3 and what efficacy endpoint (DRSS improvement vs. disease progression) would be appropriate for a pivotal study.

    Answer

    President and CEO Dr. Pravin Dugel explained that while the HELIOS study data was remarkable—showing zero vision-threatening complications at 48 weeks—the company's current priority is the SOL program. He stated that Ocular will pursue the diabetic retinopathy indication after receiving FDA feedback, but the timing is dependent on progress with the wet AMD trials.

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    Yi Chen's questions to Ocular Therapeutix Inc (OCUL) leadership • Q2 2024

    Question

    Yi Chen asked for an estimated enrollment completion timeline for the SOL-R trial. He also sought clarification on whether the initial enrollment for SOL-R is exclusively for patients who screen-failed the SOL-1 trial.

    Answer

    Dr. Pravin Dugel, President and CEO, stated that no official guidance has been provided for the SOL-R enrollment timeline. He confirmed that the trial is strategically designed to initially enroll only patients who screen-fail in SOL-1, which helps accelerate SOL-1 recruitment without cannibalizing it. Dr. Dugel noted that Ocular controls a 'switch' to allow direct, external enrollment into SOL-R once SOL-1 is sufficiently recruited, a design that is highly attractive to clinical trial sites.

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    Yi Chen's questions to OPKO Health Inc (OPK) leadership

    Yi Chen's questions to OPKO Health Inc (OPK) leadership • Q2 2025

    Question

    Yi Chen of H.C. Wainwright & Co., LLC questioned whether OpCo Health's long-acting GLP-1/glucagon dual agonist could potentially improve upon the common GI side effects and lean muscle mass loss seen with current GLP-1 drugs.

    Answer

    President & Vice Chairman Dr. Elias Zerhouni responded that while he is hopeful proper titration could mitigate GI side effects based on a good preclinical profile, it remains an open question. Regarding lean muscle mass, he noted that while glucagon enhances metabolism, he would not definitively claim a better profile, though he is hopeful due to the drug's different metabolic action.

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    Yi Chen's questions to OPKO Health Inc (OPK) leadership • Q1 2025

    Question

    Yi Chen of H.C. Wainwright asked for the development timeline for the oral GLP-1/Glucagon tablet, including expected clinical results and dosing frequency, and questioned its key differentiating factors compared to existing treatments.

    Answer

    Executive Adam Logal projected an IND filing by late 2025 or early 2026, with potential Phase 1 results by the end of 2026. Executive Elias Zerhouni added that the oral tablet is planned for once-daily dosing, while the injectable is once-weekly. Zerhouni emphasized that the primary differentiator is its focus on MASH (fatty liver disease), where the dual-agonist mechanism is expected to be superior.

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    Yi Chen's questions to OPKO Health Inc (OPK) leadership • Q4 2024

    Question

    Speaking for Yi Chen of H.C. Wainwright, an associate asked if current BARDA funding is sufficient for 2025 clinical plans, requested an update on the HIV monoclonal antibody program, and inquired about the patient selection criteria for the MDX-2001 solid tumor trial, specifically regarding c-MET and TROP2 expression levels.

    Answer

    Executive Phillip Frost confirmed that the $110 million in committed BARDA funding is secure and sufficient to advance the lead COVID antibody through Phase 1. Executive Gary Nabel reported that a second-generation HIV antibody has been optimized for potency and partnership discussions are underway. Regarding MDX-2001, Phillip Frost and Gary Nabel explained that while expression levels are measured, the trial is currently enrolling all comers, as preclinical data showed efficacy even at low expression levels.

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    Yi Chen's questions to OPKO Health Inc (OPK) leadership • Q3 2024

    Question

    Yi Chen asked about the competitive positioning of the OPK-88006 dual-agonist peptide, inquiring about its expected efficacy compared to marketed GLP-1 drugs and which formulation—weekly subcutaneous or daily oral—might see better market adoption. He also followed up with a question about its potential safety profile.

    Answer

    Executive Elias Zerhouni responded that the drug's differentiation lies in its potential benefit for patients with liver disease like NASH, as glucagon receptors are present in the liver while GLP-1 receptors are not. He suggested the daily oral version could have a better side-effect profile due to its dosing regimen, which avoids the high peak concentration seen in weekly injectables, but he refrained from speculating on the injectable's safety relative to competitors.

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    Yi Chen's questions to Sanara Medtech Inc (SMTI) leadership

    Yi Chen's questions to Sanara Medtech Inc (SMTI) leadership • Q1 2025

    Question

    Yi Chen inquired about Sanara MedTech's strategy for increasing penetration within existing healthcare facilities and asked for data on product reorder rates.

    Answer

    Seth Yon, an executive at Sanara MedTech, explained that deeper penetration is achieved through a combined effort of their direct sales team and an expanded network of distributor partners. Regarding reorder rates, Yon stated that while specific numbers are not disclosed, products like CellerateRX and BIASURGE have high user retention once surgeons gain experience with them on high-risk cases.

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    Yi Chen's questions to CareDx Inc (CDNA) leadership

    Yi Chen's questions to CareDx Inc (CDNA) leadership • Q1 2025

    Question

    An analyst on behalf of Yi Chen from H.C. Wainwright & Co. asked about competitive developments, specifically mentioning OncoCyte's VitaGraft and its potential for Medicare expansion, and whether this could affect CareDx's guidance.

    Answer

    CEO John Hanna stated he did not foresee any impact on guidance from the OncoCyte announcement, noting it appeared to be for a study that is several years from potential approval. He reinforced CareDx's market leadership, built over 25 years, and said that while competition is healthy, this specific development is not a near-term concern.

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    Yi Chen's questions to CareDx Inc (CDNA) leadership • Q3 2024

    Question

    Yi Chen asked for the company's outlook on the number of transplantation procedures in 2025 and the key factors driving that trend.

    Answer

    CEO John Hanna stated that the company's plan is based on a mid-single-digit secular growth rate for the transplant market. He credited perfusion technologies for recent growth and noted that significant future acceleration would likely depend on government programs, mentioning the announced delay of the IOTA model for kidney transplants.

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    Yi Chen's questions to LifeMD Inc (LFMD) leadership

    Yi Chen's questions to LifeMD Inc (LFMD) leadership • Q3 2024

    Question

    Speaking for Yi Chen, Eduardo Martinez-Montes questioned if GLP-1 therapies will continue to be the primary growth driver and what other offerings the company is excited about for 2025. He also asked how these new services would be structured, such as add-ons or standalone product lines.

    Answer

    Executive Justin Schreiber confirmed that GLP-1s will be a significant growth driver but stressed that the underlying business will also see strong growth. He expressed excitement for the RexMD hormone therapy program, women's wellness programs, and potential expansion into behavioral health, type 2 diabetes, and cardiovascular health. He clarified that nearly all new offerings will be driven by the core LifeMD technology and care platform.

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    Yi Chen's questions to LifeMD Inc (LFMD) leadership • Q1 2024

    Question

    Yi Chen asked how a patient chooses between Wegovy and Zepbound on the platform and if that choice affects LifeMD's financials. He also inquired about a competitor's higher pricing for similar services and whether LifeMD plans to continue offering compounded GLP-1s.

    Answer

    CEO Justin Schreiber explained that a patient's choice of medication does not impact LifeMD's revenue. The decision is based on patient preference, price, delivery mechanism, and a provider's clinical recommendation. He declined to comment on competitor pricing but stated LifeMD's care pricing will be similar to its current programs. He clarified that LifeMD does not compound drugs but will prescribe to a compounding pharmacy only when branded and other generic options are not clinically or financially appropriate for a patient.

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    Yi Chen's questions to Evaxion Biotech A/S (EVAX) leadership

    Yi Chen's questions to Evaxion Biotech A/S (EVAX) leadership • Q2 2024

    Question

    Yi Chen of H.C. Wainwright & Co. inquired about the data release timeline for the EVX-01 program, the development and partnership strategy for the EVX-B2 vaccine, and the status and upcoming data for the ERV platform.

    Answer

    CSO Birgitte Rono stated that additional EVX-01 biomarker data is expected in early 2025. CEO Christian Kanstrup explained that EVX-B2's next steps involve securing partnerships and presenting preclinical proof of concept for the Afrigen collaboration in September. Rono and Kanstrup also confirmed that preclinical data for the ERV-based precision vaccine is on track for release in the second half of 2024.

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