Yi Chen

Yi Chen of H.C. Wainwright & Co. requested clarification on the specific clinical milestones for MDX-2001 and MDX-2004 in 2026. He also questioned the BioReference margin expansion and expense bridge, seeking more color on why the total expense guidance of $725 million-$750 million seemed high following the divestiture.

Answer

Dr. Elias Zerhouni, Vice Chairman and President, outlined MDX-2001's milestone as completion of dose regimen and entry into Phase 1B, and MDX-2004's as Phase 1 escalation with Phase 1A completion this year. Adam Logal, SVP and CFO, explained that while BioReference expenses are declining, the overall expense expansion is driven by increased R&D investments, with other operating costs expected to stabilize or reduce.

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.

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.

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.

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.

Yi Chen inquired about the expected enrollment timeline for the Helios 2 trial (432 patients) and whether NPDR patients might be difficult to enroll due to initial reluctance for treatment.

Answer

Dr. Pravin Dugel (Executive Chairman, President and CEO) stated that the company anticipates efficient enrollment for Helios 2, despite initial reluctance often associated with NPDR patients. He noted strong demand from sites and patients for a sustainable treatment for advanced severe NPDR, expressing confidence in the de-risked study design and positive Helios 1 data.

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.

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.

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.

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.

Yi Chen asked for clarification on the eight systems that were brought back during the quarter, inquired about the expected return or attrition rate for newly placed systems, and sought details on how the new second Category I CPT code differs from the first and how it will facilitate reimbursement.

Answer

CEO Eric Holmlin clarified that the returned systems were primarily from reagent rental programs involving research-oriented labs, not from the core 'routine use' customer group. He stated it is premature to provide a return rate for the new cohort of customers under the current strategy but expects it to be very low. Dr. Holmlin explained that having two separate CPT codes for hematologic malignancies and constitutional genetic disorders is beneficial as they are distinct applications with different workflows and supporting literature, which could potentially lead to different reimbursement pricing.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Yi Chen asked if there would be another Data Safety Monitoring Committee (DSMC) meeting before the 2026 data readout and what the outlook is for top-line revenue in the coming quarters.

Answer

CMO Dr. Ramiro Ribeiro confirmed that DSMC meetings occur every six months, so at least two more are expected before top-line results. CFO George Elston stated that following the company's exit from the commercial business, future revenue will be 'de minimis' and not material, as EyePoint is now a clinical-stage company.

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.

Eduardo, on behalf of Yi Chen, asked for the rationale behind the 78-letter BCVA cutoff in the pivotal trials and for details on the patient attributes of the high-performing subgroup in the DME trial.

Answer

President and CEO Dr. Jay Duker explained the 78-letter cutoff is typical and ensures enrollment of patients with active wet AMD as required by the FDA. Regarding the DME subgroup, he noted they were un-rescued patients in the high-dose arm who showed strong, sustained improvement, but there is not yet enough data to prospectively identify these responders.

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.

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.

The analyst asked for the company's perspective on gene therapies in development for wet AMD, questioning if they could become a major competitor to sustained-release therapies and whether their use might be limited to the most severe patients.

Answer

The executive, Jay Duker, described gene therapy as an exciting advance but highlighted challenges for its application in wet AMD. He pointed to a potentially narrow therapeutic window between efficacy and safety. Furthermore, he questioned the cost-benefit justification, suggesting that gene therapy would need to demonstrate clear superiority over existing and developing treatments to warrant its higher price, which remains a significant hurdle.

Representing Yi Chen of H.C. Wainwright & Co., LLC, Eduardo Martinez-Montes asked for more details on the nature of the FDA's data requests for the Nico pulse oximeter and inquired about the strategic initiatives being discussed with the incoming CEO, Steven Dyson.

Answer

Donald Gregg, President of Zynex Monitoring Solutions, explained that the FDA's dialogue has focused on ensuring Nico's technology performs better than existing LED technology, particularly regarding accuracy, and on the product's claims positioning. CEO Thomas Sandgaard added that he and the leadership team are fully aligned with the incoming CEO on the current initiatives to refocus the pain management business and improve the company's valuation.

Yi Chen from H.C. Wainwright sought confirmation that Q1 2025 revenue and Q2 2025 guidance exclude TRICARE payments. He then asked about the mechanics of reimbursement if the TRICARE decision is positive, the company's contingency plans for a negative outcome, and the expected revenue timeline for the NiCO pulse oximeter post-approval.

Answer

CFO Daniel Moorhead confirmed that both Q1 revenue and Q2 guidance exclude TRICARE payments and that the company expects to be reimbursed for unpaid claims if the suspension is lifted. Executive Thomas Sandgaard added that claims have been adjudicated and are ready for payment upon a positive decision, and that the sales force is being refocused to grow other areas in a worst-case scenario. Donald Gregg, President of Zynex Monitoring, stated that the NiCO device will be launched immediately upon clearance and that 2026 is expected to be the year for meaningful revenue generation.

Yi Chen questioned the specific factors that triggered the TRICARE review and whether payment suspensions are a typical practice during such reviews. He also asked about the risk of other payers following TRICARE's lead, sought clarification on the potential 12-month resolution timeline, and inquired if TRICARE claims were national.

Answer

Executive Anna Lucsok responded that TRICARE has not clearly communicated the specific triggers. She noted that while payment suspensions are not the usual practice for payer reviews, they do occur. Executive Thomas Sandgaard asserted there is no connection or risk of contagion to other payers, as they operate independently and TRICARE is a distinct government entity. Anna Lucsok confirmed the 12-month maximum timeline was stated in TRICARE's letter but stressed the importance of the upcoming April appeal meeting. She also confirmed that TRICARE claims are national.

Yi Chen of H.C. Wainwright inquired about plans for hiring sales representatives through the end of 2024, the target sales force size needed to market the NiCO pulse oximeter post-clearance, and whether the monitoring division is expected to become independently profitable.

Answer

CEO Thomas Sandgaard stated a plan to add a net of 10 reps monthly for the next 18 months. Donald Gregg, President of Zynex Monitoring Solutions, explained the NiCO launch will begin with a small, focused sales team post-clearance in mid-2025. Both Sandgaard and CFO Daniel Moorhead affirmed the monitoring division is operated independently and is expected to be profitable in the long term.

Yi Chen of H.C. Wainwright & Co., LLC questioned the company's strategy regarding potential acquisitions of new high-growth MedTech products or further divestitures within the Med Device segment for fiscal year 2026.

Answer

President and CEO Jim Clemmer stated that the company is very pleased with its current portfolio and is focused on execution with its existing assets, which address large addressable markets. He emphasized that the team is busy with market development, clinical studies, and clearing regulatory hurdles, and therefore does not see a need to add another platform or pursue further divestitures at this time. The strategy is to drive growth from the current portfolio to deliver shareholder returns.

Eduardo, on behalf of Yi Chen from H.C. Wainwright, asked for an update on the AMBITION BTK study timeline for Auryon, its success metrics, the technology's specific advantages for below-the-knee applications, and related commercial team needs.

Answer

EVP & CFO Stephen Trowbridge explained that the AMBITION study, with enrollment expected next quarter, aims to prove Auryon plus balloon angioplasty is superior to angioplasty alone for below-the-knee procedures, potentially expanding the market. He stated that while the company will invest opportunistically in the Auryon sales force, a significant immediate expansion is not planned, with current investment focus on the thrombectomy and oncology teams.

Yi Chen from H.C. Wainwright & Co. requested feedback on the limited market release of Auryon in the European Union and asked about the timeline for a full market launch. He also inquired about the status of the RECOVER-AV trial for AlphaVac in the EU and whether U.S. sales would be limited until that trial's data is available.

Answer

Executive James Clemmer reported positive feedback on Auryon in the EU, driven by scientific symposiums that generated organic interest. He reiterated a targeted launch strategy, with a small revenue contribution expected in the second half of the fiscal year. CFO Stephen Trowbridge clarified that U.S. AlphaVac sales are not dependent on the RECOVER trial readout, as they are driven by the strong APEX trial data. He confirmed the RECOVER trial is ongoing as part of the company's commitment to data generation.

Yi Chen from H.C. Wainwright inquired about the expected launch trajectory for Auryon in Europe and the potential timeline for its sales to match U.S. levels. He also asked for clarification on whether the international order timing issue that affected Q1 results has been resolved and if it was exclusive to NanoKnife sales.

Answer

An executive, James Clemmer, stated that there is existing global demand for Auryon, and the company is proceeding with a conservative limited market release in Europe before a full launch later in the fiscal year. He noted the European PAD market is less mature than the U.S. market. Regarding international orders, Clemmer and CFO Stephen Trowbridge explained that choppiness is typical when onboarding new distributors who place large initial stock orders, which created a tough year-over-year comparison for NanoKnife in Q1. They expect this to smooth out over time as the business grows.

Yi Chen of H.C. Wainwright & Co., LLC inquired about Sensus Healthcare's outlook for the remainder of 2025 following a weaker Q1, the revenue contribution from the Fair Deal Agreement (FDA) program, and any impacts from U.S. tariff policies.

Answer

Chairman and CEO Joseph Sardano confirmed that while the Fair Deal Agreement program made a small contribution to Q1 revenue, its significant financial impact is expected in the second half of 2025. He stated that the company anticipates each subsequent quarter of 2025 to be profitable and has not witnessed any negative repercussions from U.S. tariff policies.

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.

Yi Chen of H.C. Wainwright asked about the potential impact of U.S. tariff policies or most favorable pricing regulations on future product sales.

Answer

CEO Jacqueline Shea responded that while it is a rapidly evolving situation the company is monitoring, it would not affect their initial launch years as their primary focus is a first launch in the U.S. market. She acknowledged the issue's importance for the broader biopharmaceutical sector.

Yi Chen asked about the dMAb technology, focusing on the durability of antibody production, the potential to switch off production for safety, and the specific location in the body where the antibodies are produced.

Answer

CEO Dr. Jacqueline Shea confirmed the antibody production is highly durable, holding steady for 72 weeks. She explained that while future versions could use inducible promoters to control expression, initial targets will likely not require this feature. Dr. Shea clarified that the dMAbs are produced within long-lived muscle cells (myocytes) in the arm following administration and are then secreted into the bloodstream.

An associate on behalf of Yi Chen requested more clarity on the timeline for initiating the INO-3107 confirmatory trial and how its start aligns with the planned BLA submission.

Answer

CEO Dr. Jacqueline Shea reiterated the target for a BLA submission in mid-2025 and clarified that the FDA requires the confirmatory trial to be initiated before the BLA is submitted. CMO Dr. Mike Sumner added that INOVIO is actively preparing for the trial start by identifying sites, contracting, and making IRB submissions to demonstrate commitment to the agency.

Yi Chen inquired about the potential for additional orders from international MCM customers this year, the expected revenue recognition schedule for the $65 million Ontario contract, whether Emergent could benefit from manufacturing onshoring, and if the company has been actively repurchasing shares under its new program.

Answer

CEO Joseph Papa highlighted the success of international diversification, noting $91 million in Q1 international revenue, and confirmed there is absolutely more opportunity for international MCM orders beyond what has been announced. CFO Rich Lindahl suggested that for modeling purposes, it is reasonable to assume the revenue from the 3-year Ontario contract will be recognized fairly evenly. Mr. Papa stated that while contract manufacturing is not a core focus, Emergent is well-positioned with its U.S. and Canadian footprint to opportunistically assist companies with onshoring. Regarding share repurchases, Mr. Lindahl said updates will be provided quarterly.

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.

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.

Yi Chen asked about the potential causes for a significant change in visual acuity (BCVA) without a corresponding change in retinal thickness (CST), and whether using this as an exclusion criterion would negatively affect trial enrollment or future market adoption.

Answer

Dr. Victor Chong, Chief Medical Officer, explained that BCVA can have high variability in elderly patients for non-disease reasons. He clarified that excluding patients with such unreliable vision changes before randomization is a scientifically justified method to reduce data variability. He estimated this would impact less than 10% of potential subjects, so it should not significantly slow enrollment or negatively affect the final product label.

An associate, speaking on behalf of Yi Chen, inquired about the market opportunity for the new Linea donor DNA product for CRISPR therapies, the source of the quarter's revenue increase, and the timeline and revenue expectations for the Phase I AML therapy trial.

Answer

Executives explained that the Linea donor DNA market for CRISPR applications has strong parallels to the IVT template market, utilizes existing manufacturing workflows, and is a large opportunity. The Q1 revenue increase was attributed to a DNA tagging shipment for cotton and increased isotopic testing services, not LineaRx. The AML trial is not seen as a major near-term revenue driver but is critically important for providing regulatory validation in Europe and demonstrating the platform's speed and effectiveness to the broader CAR T industry.

Yi Chen inquired about the future of clinical lab revenue, the timeline for the PGX assay approval, customer numbers and revenue growth potential for the Linea IVT platform, and the company's current cash position.

Answer

The company expects clinical lab revenue to decline. There is no firm timeline for the PGX assay approval but they are hopeful. They have a growing customer base for their IVT templates and the full Linea IVT platform, which they believe will drive sequential revenue growth due to better economics. The cash position was $4.5 million as of November 30th.

Yi Chen of H.C. Wainwright & Co., LLC questioned the reasoning behind the five "no" votes from the FDA advisory committee panelists for ProSense and asked if their concerns could be addressed to improve the product in the future.

Answer

Executive Shay Levav clarified that the panelists who voted "no" were not entirely against the device. He explained that three would have voted "maybe" if possible, and their main concern was encouraging the FDA to work with IceCure on special post-marketing controls. Another "no" vote came from a statistician who cited uncertainties in the ICE3 study, which could be addressed with more real-world data post-approval. Executive Ronen Tsimerman added that some panelists were also concerned about other companies using IceCure's de novo clearance as a predicate, reinforcing the need for special controls.

The analyst asked for details about the upcoming FDA advisory committee meeting, including its timing within Q4, the number of members on the panel, and whether the panel would review materials beyond what was formally submitted to the FDA.

Answer

The company expects to receive and announce the specific meeting date shortly, which will be webcast by the FDA. They do not know the exact number of members but anticipate a panel of breast surgeons, radiologists, oncologists, and regulatory experts. They confirmed that additional public clinical data will be used to support their case during the event.

Yi Chen of H.C. Wainwright & Co. asked about the timing and financial impact of the new Cardinal Health partnership, including whether it would shift instrument placements more toward the U.S. market. He also inquired about the expected revenue contribution timeline for the T2Lyme Panel as a Laboratory Developed Test (LDT).

Answer

CEO John Sperzel explained that marketing with Cardinal Health has commenced, with a significant impact anticipated in 2025, though some results may appear in Q4 2024. He emphasized that the partnership is expected to substantially increase U.S. instrument and consumable sales. Regarding the T2Lyme Panel, Sperzel confirmed the company is targeting a launch in the second quarter of 2025 to align with the start of the Lyme disease season.

Yi Chen from H.C. Wainwright & Co. inquired about the new Cardinal Health partnership, its expected impact on Q4 financials and U.S. instrument sales, and the revenue timeline for the T2Lyme LDT.

Answer

Executive John Sperzel confirmed that marketing with Cardinal Health has started and is expected to significantly impact 2025 results, with a potential effect in Q4 2024. He detailed the strategic rationale, highlighting Cardinal's extensive hospital network and credibility. Sperzel also stated that the T2Lyme LDT is planned to launch and contribute to revenue in the latter half of Q2 2025, aligning with the start of the Lyme disease season.

Yi Chen of H.C. Wainwright & Co. inquired about the new partnership with Cardinal Health, asking if marketing had begun, when financial impacts would be seen, and if it would shift instrument sales more towards the U.S. He also asked about the revenue timeline for the T2Lyme Panel LDT.

Answer

Executive John Sperzel confirmed that marketing with Cardinal Health has commenced and detailed the strategic benefits, including Cardinal's extensive hospital network. He anticipates a significant impact in 2025 with a possible contribution in late Q4 2024. Sperzel also stated the T2Lyme Panel LDT is planned to launch and contribute to revenue in the second quarter of 2025, aligning with the start of the Lyme disease season.

Yi Chen of H.C. Wainwright & Co. inquired about the new partnership with Cardinal Health, asking if marketing had commenced, when financial impacts might be seen, and if it would shift instrument sales more toward the U.S. market. He also asked about the revenue contribution timeline for the T2Lyme Panel LDT.

Answer

Executive John Sperzel confirmed that marketing with Cardinal Health has begun, with a potential minor impact in Q4 2024 but a significant impact expected in 2025. He affirmed the partnership is designed to substantially increase U.S. instrument and consumable sales by leveraging Cardinal's extensive hospital network. Regarding the T2Lyme Panel, Sperzel stated the company plans to launch it as a Laboratory Developed Test (LDT) in the second quarter of 2025, targeting the start of the Lyme disease season.

Yi Chen of H.C. Wainwright & Co. inquired about the new partnership with Cardinal Health, asking if marketing had commenced, when financial impacts would materialize, and if it would shift instrument sales more towards the U.S. market. He also asked about the expected revenue contribution timeline for the T2Lyme Panel as a Laboratory Developed Test (LDT).

Answer

John Sperzel, an executive at T2 Biosystems, confirmed that marketing with Cardinal Health has begun and could have a minor impact in Q4 2024, with a more significant impact expected in 2025. He affirmed the partnership's goal is to substantially increase U.S. instrument and consumable sales, leveraging Cardinal's extensive hospital network. Regarding the T2Lyme Panel, Sperzel stated the company plans to launch it as an LDT in the second quarter of 2025, with revenue contributions expected in the first half of the year.

Yi Chen from H.C. Wainwright & Co. inquired about the new partnership with Cardinal Health, asking about the timing of its financial impact and its potential to shift instrument sales towards the U.S. market. He also asked about the expected revenue contribution timeline for the T2Lyme Panel LDT.

Answer

John Sperzel, an executive at T2 Biosystems, confirmed that marketing with Cardinal Health has commenced, with a potential minor impact on Q4 2024 but a significant effect expected in 2025. He affirmed the partnership's goal is to boost U.S. sales, citing Cardinal's extensive hospital network and market credibility. Regarding the T2Lyme Panel, Sperzel stated the company plans for a revenue contribution in the second half of Q2 2025, aligning with the start of the Lyme disease season.

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.

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.

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.

Yi Chen of H.C. Wainwright & Co. asked about the expected timeline to advance enobosarm following the Phase IIb study results and whether the company plans to seek a partner for a potential registration study.

Answer

Dr. Mitchell Steiner, Chairman, CEO, and President, responded that with full enrollment complete, topline data from the 16-week portion of the study is expected in January 2025. He clarified this data is sufficient to begin discussions with the FDA and potential partners, and that the subsequent extension trial data is not a prerequisite for these next steps.

Chait, on behalf of Yi Chen, inquired about the preclinical progress for the LSCD and Sjogren's programs, whether data from the initial Phase II/III study of KPI-012 is required before starting a second pivotal trial, and the company's current cash runway.

Answer

Kim Brazzell, Head of R&D and Chief Medical Officer, explained that while development pathways for LSCD and Sjogren's are still being analyzed, they can leverage existing CMC work from the PCED program. She confirmed that results from the first Phase II/III trial are necessary to finalize the design of the second pivotal study. CFO Mary Reumuth stated that the company's cash runway extends into the second quarter of 2024, which is beyond the expected data readout for the KPI-012 trial.

Yi Chen from H.C. Wainwright asked if the upcoming Phase 2/3 trial for KPI-012 in PCED would need to recruit patients with similar underlying etiologies. He also inquired about the timing for reporting preclinical data from the TKI candidate.

Answer

Kim Brazzell, Head of R&D and Chief Medical Officer, clarified that the KPI-012 trial is designed for 'all comers,' meaning it will enroll patients with PCED from any underlying etiology, based on the hypothesis that its multi-factorial mechanism can address the condition broadly. Regarding the TKI candidate, he stated that data from ongoing studies would be reported throughout the year as substantial results become available.

Yi Chen of H.C. Wainwright questioned when the diagnostic business returned to pre-COVID levels and the potential impact of a COVID-19 resurgence. He also inquired about the average time to realize revenue from new, longer-term pharma contracts and the company's plan to regain NASDAQ listing compliance.

Answer

CFO Fred Knechtel stated that diagnostic testing volume has been above pre-COVID levels for the last four weeks of the quarter. Executive Jack Stover added that while they are cautious, they believe the company and its customers are better prepared to handle a resurgence without the complete shutdowns seen earlier. Knechtel explained that pharma contracts average a 3-year revenue realization timeline, with some new contracts extending to 5 years. Regarding NASDAQ, Stover confirmed they are proactively developing a plan to regain compliance with the minimum stockholders' equity requirement and will file it once notified.

Yi Chen of H.C. Wainwright questioned if the clinical testing and pharma services segments were recovering at different rates, whether potential revenue from new COVID-19 serology tests could offset diagnostic losses, if there were plans for PCR testing, and how the pandemic has impacted the BarreGEN study timeline.

Answer

President and CEO Jack Stover stated that both the diagnostic and pharma businesses are currently recovering at a similar pace. He clarified that they do not anticipate significant revenue from the new COVID-19 serology test in the short term and that it is secondary to rebuilding the core business. Stover confirmed they are exploring a partnership for PCR testing. He also noted that the COVID-19 impact on the BarreGEN study has been nominal, causing only a minor delay due to resource reallocation.

Yi Chen of H.C. Wainwright asked for clarification on whether the Q4 reserve was from clinical or pharma services, if it would be a recurring item, if revenue had been booked from the China partnership, and for details on the COVID-19 serology test's validation timeline and differentiation.

Answer

CFO Fred Knechtel clarified that the $5.2 million Q4 reserve was related to the diagnostics business for billings from Q1-Q3 2019 and is not expected to be a recurring issue due to improved tracking. Executive Jack Stover confirmed that while they have had bookings from the China partnership, he could not yet quantify the revenue. He stated the COVID-19 serology test should be validated and running in 2-3 weeks, emphasizing it's not a major commercial play but a response to partner needs.

Yi Chen from H.C. Wainwright & Co. asked for an update on the current number of outstanding common shares and warrants.

Answer

President and CEO Ian Massey deferred the question, stating he did not have the exact figures available during the call but would provide the information via email.