Bruce Jackson

Bruce Jackson asked about Humacyte's reconsideration of the NTAP submission strategy and any plans for resubmission, as well as anecdotal information regarding reorders in multi-hospital approvals and expansion beyond initial champion surgeons.

Answer

CEO Laura Niklason stated that Humacyte opted not to resubmit for NTAP in trauma, finding CMS's 'not novel' decision surprising and reductionist, and believing it's not an efficient use of resources, especially given that price reductions have already boosted market activity. CFO Dale Sander added that only about 4% of vascular trauma patients are covered by Medicare. Dr. Niklason confirmed observing Symvess usage expand beyond initial champion surgeons in a few trauma hospitals, and noted that while blanket VAC approvals for hospital systems are helpful, individual contracting with each hospital is still required and ongoing.

Bruce Jackson asked for an update on the NTAP submission strategy and whether there were plans to resubmit. He also inquired about anecdotal information regarding reorders, specifically if multi-hospital approvals led to additional hospital orders and if physician usage expanded beyond initial champions.

Answer

President and CEO Laura Niklason stated that Humacyte opted not to resubmit for NTAP in trauma, citing CMS's reductionist view on novelty and the company's decision that it was not a good use of resources. CFO Dale Sander added that only about 4% of vascular trauma patients are covered by Medicare. Dr. Niklason confirmed seeing usage expand beyond initial surgeon champions in several hospitals and noted that multi-hospital system VAC approvals still require individual contracting with each hospital.

Bruce Jackson of The Benchmark Company LLC requested an update on the progress of the coronary artery bypass graft (CABG) program.

Answer

CEO Laura Niklason provided an update, stating that a paper on the primate results for the CABG program has been accepted for publication. She confirmed that the company is on track to file the Investigational New Drug (IND) application with the FDA later in 2025. Following an anticipated review period, she expects the first human clinical trial to commence sometime in 2026, consistent with prior guidance.

Bruce Jackson asked for anecdotal information on surgeon adoption patterns within commercial accounts and requested an update on the BioVascular pancreas pipeline program, including any upcoming data releases.

Answer

CEO Dr. Laura Niklason shared an anecdote of a new surgeon having a positive experience, noting adoption typically starts with early adopters. CCO BJ Scheessele added that initial champions are a mix of vascular and trauma surgeons. Regarding the pipeline, Dr. Niklason stated that work on the BioVascular pancreas is continuing, with plans to publish preclinical results later in the year, but had no new explicit updates.

Bruce Jackson from The Benchmark Company requested a progress update on the biovascular pancreas project.

Answer

Executive Laura Niklason reported that ongoing primate studies have successfully demonstrated long-term islet survival and insulin production for months, even in a diabetic primate model. She stated that the company has proven the key technological hurdles of long-term engraftment and function. The current focus is on 'tweaking the design and the dosing' to optimize the therapeutic effect before moving forward.

Bruce Jackson asked about the regulatory pathway for the AV access supplemental BLA, its dependence on the trauma BLA, the anticipated timing, and also inquired about the current status and next steps for the CABG program.

Answer

Executive Laura Niklason explained that the AV access filing is largely independent of the trauma BLA's trajectory. The timing for a supplemental BLA submission in mid-2025 depends on whether the FDA requires one-year or full two-year follow-up data from the V007 trial. For the CABG program, she stated the FDA requested a third animal model (sheep), and Humacyte has a meeting scheduled to confirm this plan would be sufficient to support a future IND filing.

Inquired about the timeline for the AI feature submission and launch, the market's receptivity and need for physician education on AI, and the competitive advantages of having in-house AI development capabilities.

Answer

The company plans to submit its AI module in September for a launch next year. They believe no additional physician education will be needed as the AI detects recognizable abnormalities. The primary advantage of in-house AI is controlling their own development destiny, priorities, and resources, which is a significant advantage over competitors who may outsource this function.

Bruce Jackson from The Benchmark Company LLC focused on CapsoVision's AI module, asking about the submission and launch timeline, market receptivity and the potential need for physician education, and the specific competitive advantages gained from developing the AI capabilities in-house.

Answer

CEO Kang-Huai Wang confirmed the company plans to submit its AI module to the FDA in late September or early October for a launch next year. He stated that no special physician education would be required, as the AI identifies abnormalities that doctors are already trained to recognize. Wang emphasized that in-house AI development provides a 'tremendous' advantage, giving CapsoVision control over its own destiny, development timelines, and resource allocation without reliance on third-party priorities.

Bruce Jackson of The Benchmark Company LLC asked about the expected trajectory of gross margins following the new agreement with Biofrontera AG, the potential duration of high legal expenses, and the anticipated timing for the FDA submission for the superficial basal cell carcinoma (sBCC) indication.

Answer

CFO Fred Leffler explained that gross margins are expected to increase substantially, estimating a 12-13% improvement as the cost structure shifts from a transfer price to a royalty model. He also stated that the spike in Q2 legal costs was an anomaly and that SG&A should normalize in Q3 and Q4. CEO Hermann Luebbert added that the FDA submission for sBCC is being prepared and is planned for the second half of 2025.

Bruce Jackson from The Benchmark Company asked for an outlook on gross margins for the remainder of the year following a transfer pricing change and requested an update on the reimbursement status for the Ameluz 3-tube indication.

Answer

CFO Eugene Leffler stated that all inventory is now at the lower 25% transfer price, which should positively impact gross margins for the rest of the year, though lower-margin lamp sales could cause fluctuations. Executive Hermann Lubbert added that the company is not aware of any reimbursement denials for the 3-tube usage, indicating the issue appears resolved with payers.

Bruce Jackson from The Benchmark Company asked about the expected impact of new transfer pricing on 2025 gross margins, the size of the Q4 price increase, and the outlook for SG&A and R&D expenses.

Answer

CFO Eugene Leffler stated that the lower 25% transfer price will be in effect for nearly all of 2025, which should positively impact gross margins. He also confirmed a 5% price increase in Q4, which led to some customer buy-ins in Q3. Both Leffler and executive Hermann Lubbert indicated that SG&A and R&D expenses are expected to remain stable in 2025.

Bruce Jackson of Benchmark Company asked for a breakdown of Q2 sales to differentiate between the rebound from the Change Healthcare incident and organic growth. He also questioned the sales seasonality outlook, the future R&D expense run rate, and plans for releasing data from the basal cell carcinoma trial.

Answer

Executive Hermann Lubbert estimated that the rebound effect accounted for at most half of the Q2 sales strength, with May and June reflecting more typical organic growth. CFO Eugene Leffler projected R&D spending of approximately $2.4 million for the remainder of the year, or about $1 million per quarter, contingent on trial recruitment. Hermann Lubbert confirmed that clinical data from the BCC trial is expected by year-end, with follow-up data in H1 2025.

Bruce Jackson from The Benchmark Company LLC inquired if Belite Bio had discussed an accelerated approval pathway with the FDA following the breakthrough therapy designation. He also asked about any upcoming data presentations to educate the medical community.

Answer

Chairman & CEO Tom Lin confirmed a route for accelerated approval existed, but the FDA recommended completing the 24-month study for a potential single-study approval. Regarding data releases, Tom Lin noted the FDA prefers they keep efficacy data confidential until the submission. CFO Hao-Yuan Chuang added that the final 24-month data will be announced once available, prior to the formal filing.

Bruce Jackson from The Benchmark Company followed up on the rise in stock-based compensation, asking if it would remain high, and also inquired about the company's manufacturing supply chain geography.

Answer

CFO Hao-Yuan Chuang explained that future stock compensation expense is difficult to predict as it's tied to both time and development milestones, but he does not expect it to remain as high as it was in Q1. Chairman and CEO Dr. Tom Lin addressed manufacturing, stating that Tinlarebant is produced in the U.S. and other geographies, mitigating any potential tariff risks.

Bruce Jackson of The Benchmark Company asked a housekeeping question about whether the warrants from the recent $15 million capital raise had been exercised. He also requested an update on the progress their Contract Research Organization (CRO) has made in handling the regulatory submission process for the DRAGON trial data.

Answer

Chairman and CEO Dr. Tom Lin confirmed that the warrants from the February capital raise have not yet been exercised. Regarding the regulatory process, Dr. Lin stated that the company is using multiple CROs for different jurisdictions and that they are 'basically submitting as we speak,' indicating the process is actively underway.

Bruce Jackson from The Benchmark Company LLC asked if potential shifts in NIH funding could benefit specific product areas like neuroscience. He also inquired about other macro factors being monitored beyond China tariffs, such as in Europe, and sought an update on the MeSH MEA platform, specifically regarding upcoming academic publications.

Answer

President & CEO John Duke confirmed that an NIH focus on neuroscience would benefit their MeSH MEA organoid platform and pointed to the Society of Neuroscience show in November for new data. Interim CFO Mark Frost identified European tariffs as another key macro factor being watched, noting the company has operational flexibility in Europe to potentially mitigate impacts.

The analyst asked about the potential for the NIH budget to favor their neuroscience platform, other macro factors being monitored besides China tariffs, and upcoming developments for their MeSH MEA products.

Answer

The company stated that a neuroscience focus in the 2026 NIH budget would enhance their product portfolio. They are also monitoring European tariffs but have operational flexibility to mitigate impacts. New information and academic results for the MeSH MEA platform will be presented at the Society of Neuroscience show in November.

Bruce Jackson inquired about Harvard Bioscience's bioproduction business, specifically asking if a new CAR-T therapy opportunity was domestic or international. He also asked about the MeshMEA product line, seeking clarity on how the positive momentum from HHS's NAM initiative nets out against the unpredictable NIH funding environment and what the resulting inbound customer interest has been.

Answer

James Green, President and CEO, confirmed the CAR-T customer is a domestic biotech that used Harvard Bioscience's BTX AgilePulse system during development and is now adopting it for bioproduction. Regarding MeshMEA, Green acknowledged that academic purchasing has slowed due to NIH staffing issues but noted the overall interest and sales funnel are growing. He emphasized that the government's push for NAMs is driving significant new interest from biopharma companies and CROs, positioning it as a strong long-term growth driver.

Asked about expected efficiencies from the new ERP system, the outlook for the CAR-T therapy business, the funding stability of academic MeshMEA projects, and the inclusion of MeshMEA in new distributor agreements.

Answer

The new ERP system is expected to drive operational efficiencies and gross margin improvements in 2025 after an initial learning curve. The CAR-T business is a long-term opportunity tied to the drug development pipeline. MeshMEA projects are expanding from academia to pharma and CROs for applications like tox screening. The product will be included in expanded North American distribution agreements, which is expected to generate significant leads.

Inquired about the risk of the China market worsening despite signs of stabilization and asked for key market indicators. Also asked about the order-to-shipment lag time for the new Mesh MEA and organoid products to understand the potential revenue impact in 2025.

Answer

The executive stated that while uncertainty remains, their team in China sees stabilization, with the academic segment already recovering and the CRO/pharma segments expected to level off. For Mesh MEA, supply is currently limited during the beta phase, but production is being ramped up for Q2 2025, with the potential for $1-2 million in new quarterly growth plus significant recurring revenue. The focus is on scaling up the production of the consumable biochips.

Bruce Jackson of The Benchmark Company asked for more detail on the China market, questioning the basis for management's stabilization outlook and inquiring about the order-to-shipment timeline for the new Mesh MEA organoid platform to gauge its 2025 revenue impact.

Answer

President and CEO James Green explained that the outlook for China is based on stabilizing academic budgets and improving capital availability for CROs and pharma, leading to an expectation of stable to modest growth from a low base. Regarding the Mesh MEA platform, Green noted that after a controlled beta phase, the company is ramping up production of consumable biochips, with a tenfold increase planned by Q2 2025, positioning it as a major future growth driver.

Bruce Jackson inquired about the expected cadence for new product and booster launches and asked how the recent debt refinancing would impact net interest expense going forward.

Answer

CEO Marla Beck announced plans to launch Backbar and a hero skincare SKU in Q4 2025, with a broader rollout in 2026. She specified an optimal booster cadence of one to two launches per year to maximize adoption. CFO Michael Monahan confirmed the debt refinancing will increase interest expense, as $250 million of notes were refinanced at a 7.95% rate with a maturity extended to 2028.

Bruce Jackson of The Benchmark Company sought clarification on consumer demand dynamics, asking about the performance trends between the medical and health/beauty channels.

Answer

Executive Marla Beck clarified that demand has bifurcated: the med spa, dermatology, and wellness sectors are performing strongly. In contrast, day spas and plastic surgery practices, which are more discretionary, have not grown as well. She emphasized that the core signature Hydrafacial treatment remains healthy across all channels, with some trading away from luxury add-ons in the softer segments.

Bruce Jackson requested more details on the clinical study combining Hydrafacial with laser procedures and asked if this approach could be extended to other dermatology treatments. He also inquired about potential new features being considered for the Syndeo device.

Answer

CEO Marla Beck explained the laser combination study was prompted by existing use among dermatologists and that results would be published soon. She confirmed that exploring other treatment pairings is a key part of the go-forward strategy, aided by the new CMO's clinical background. Regarding the device, she stated the team is actively working on the innovation strategy for 2025.

Bruce Jackson, an analyst, inquired about the current geographic sales footprint of BioStem's partner, Venture Medical, and what percentage of the country is currently covered.

Answer

CEO Jason Matuszewski explained that their sales footprint is currently strongest west of the Mississippi River. He detailed that their partner, Venture Medical, is actively expanding to the East Coast by hiring 40 direct representatives and has appointed three area sales directors for the East, Central, and West regions to drive adoption where coverage is currently less significant.

Bruce Jackson inquired about the timeline for the Heska feline cancer testing program and its associated milestone payment, as well as the practical applications and potential implementation of the Lyon lung cancer study findings.

Answer

CEO Cameron Reynolds confirmed the feline cancer test adaptation is progressing well and is on track for completion later in the year, which would trigger the $5 million milestone payment from Antech. Regarding the Lyon study, Chief Medical Officer Dr. Andrew Retter and CEO Cameron Reynolds highlighted the study's exciting results, noting its potential for disease prognostication and its role in active discussions with national screening programs in France and other countries in Asia and Europe.

Bruce Jackson of The Benchmark Company inquired about the status of the feline cancer test, including whether the milestone had been met and if it was commercialized. He also asked about the timeline for upcoming data publications or presentations for the company's human cancer studies.

Answer

President and Group CEO Cameron Reynolds clarified that the feline milestone has not yet been achieved. He explained that the team successfully optimized the test for cats, which have lower nucleosome levels, and is now proceeding with a clinical utility study. Chief Medical Officer Dr. Andrew Retter added that two large publications on sepsis are nearing submission, and for oncology, papers related to lung cancer are drafted and in the submission process, supporting discussions around national screening programs.

Bruce Jackson of The Benchmark Company inquired about the expected revenue uptake curve for the Nu.Q Vet cancer test following recent partner launches and asked if the current level of operating expenses is sustainable going forward.

Answer

CFO Terig Hughes stated that while it's difficult to provide specific guidance on the revenue curve, they expect increases in the coming quarters due to recent launches by Antech and Fuji. President and CEO Cameron Reynolds added that revenue could be "lumpy" due to partner stocking cycles but the overall trend is positive. Regarding expenses, Hughes confirmed that costs are decreasing quarterly, with a target of a $10 million annualized reduction, and this trend will continue. Reynolds reinforced the commitment to cost control to extend the company's financial runway.

Bruce Jackson from The Benchmark Company asked about the strategy and process for securing reimbursement from additional Medicare Administrative Contractors (JMACs), whether distribution partners are ready for new JMAC regions, and if total Q4 revenue is expected to be up year-over-year.

Answer

CEO Jan Haverhals stated that Milestone is in 'advanced steps' with four additional JMACs, a process that involves educating the contractors on the technology's benefits. He confirmed they have a target list of specialized distributors for these regions but noted that these partners would likely engage formally only after reimbursement is approved. Regarding Q4 revenue, Haverhals avoided a direct forecast but said the goal is to reduce the year-to-date revenue gap compared to last year through various commercial efforts.

Bruce Jackson of The Benchmark Company inquired about several key initiatives, including the next steps and data timeline for the cuffless blood pressure monitor, the functionality and market potential of the upcoming Android app, the outlook for operating expenses in Q4 2024, and the specific nature of the final questions from the FDA regarding the EvieMed 510(k) submission.

Answer

CEO John Mastrototaro, CMO Tyla Bucher, and executive Jeremy Cogan addressed the questions. Mastrototaro expressed excitement about the cuffless blood pressure program, noting a new prototype was recently tested and that the company is on track for a market launch within two years. He and Bucher confirmed the Android app will have full feature parity with the iOS version, targeting the 40% of their audience on Android, which has been the most requested feature. Regarding financials, Cogan stated that while there will be incremental marketing spend for the holidays, the company will remain highly focused on managing its cash burn. Finally, Mastrototaro described the FDA process as being in the '11th hour,' with recent questions focusing on medical device aspects like labeling, and expressed strong confidence in their submitted responses and clinical data.

Bruce Jackson of The Benchmark Company asked about the development timeline for the cuffless blood pressure monitor, the feature parity and market size for the upcoming Android app, the outlook for Q4 operating expenses, and the final stages of the FDA 510(k) review process for the EvieMed ring.

Answer

CEO John Mastrototaro detailed progress on the cuffless blood pressure monitor, targeting a market launch within the next couple of years, and confirmed the Android app will have identical functionality to the iOS version. CMO Tyla Bucher added that Android users represent about 40% of the market. Executive Jeremy Cogan stated that while there will be some incremental Q4 marketing spend, the company will remain focused on managing its cash burn. Mastrototaro also expressed confidence in the final stages of the EvieMed 510(k) FDA review, noting recent questions were largely related to labeling and that the company's clinical data is exceptionally strong.

Bruce Jackson asked about the development timeline for the cuffless blood pressure device, the functionality of the upcoming Android app, the outlook for operating expenses in Q4, and the final stages of the FDA 510(k) submission for the EvieMed ring.

Answer

CEO John Mastrototaro and Executive Jeremy Cogan addressed the questions. Mr. Mastrototaro confirmed the blood pressure device is on track for market entry within a few years and that the Android app will mirror the iOS version's functionality. He also expressed high confidence in the FDA submission, noting they are in the '11th hour.' Mr. Cogan stated that while there will be incremental marketing spend, the company will remain judicious with capital and focused on managing its cash burn.

Bruce Jackson of The Benchmark Company inquired about the development timeline for the cuffless blood pressure monitor, the feature parity and market size for the upcoming Android app, the outlook for Q4 operating expenses, and the final stages of the FDA 510(k) clearance process for the EvieMed ring.

Answer

CEO John Mastrototaro explained that for the cuffless blood pressure monitor, they are analyzing data from a new prototype and expect to be on track for a market launch within a couple of years. He and CMO Tyla Bucher confirmed the upcoming Android app will have full feature parity with the iOS version, addressing a key customer request from their 40% Android user base. Regarding the FDA 510(k) process for EvieMed, Mastrototaro stated they are in the '11th hour' after responding to the FDA's final questions and feel confident in their strong clinical data. Executive Jeremy Cogan addressed financials, noting that while there will be some incremental Q4 marketing spend, the company will remain judicious with capital and focused on managing its burn rate.

Bruce Jackson of The Benchmark Company inquired about several key areas, including the next steps and data timeline for the cuffless blood pressure program, the functionality and market size for the upcoming Android app, the outlook for operating expenses in Q4, and the nature of the final questions from the FDA regarding the EvieMed 510(k) clearance.

Answer

CEO John Mastrototaro addressed the blood pressure program, noting a new prototype with more antennas yielded exceptionally clean signals in a recent trial, with plans for further studies and a market launch within a couple of years. For the Android app, Mastrototaro and CMO Tyla Bucher confirmed it will mirror iOS functionality and targets about 40% of the market, being their most requested feature. Executive Jeremy Cogan stated that while there will be incremental marketing spend for the holidays, the company will remain judicious with capital and focused on managing its cash burn. Finally, Mastrototaro expressed confidence in the FDA process, explaining they have responded to all questions, many related to labeling, and are in the final stages awaiting feedback.

Bruce Jackson of The Benchmark Company inquired about the technical differences between the new auto activity detection and the heart rate algorithm, the specifics of B2B engagements, and the status of the company's upcoming meeting with the FDA.

Answer

Chief Technology Officer Michael Leabman explained that the new heart rate algorithm is a deep learning-based fix for accuracy during motion, while auto activity detection is a separate feature to identify workouts automatically. Chief Commercial Officer Michael Soule stated that B2B engagements with providers, payers, and RPM channels are moving into agreement phases pending FDA clearance. CEO John Mastrototaro confirmed the FDA meeting is on schedule and expressed strong confidence in a positive outcome, citing their experienced regulatory team and the strength of the underlying clinical data for the pulse oximetry feature.

Bruce Jackson of The Benchmark Company inquired about the expansion of the University of California agreement, the international strategy for the Koligo subsidiary, and the recent revenue mix shift towards cell process development services.

Answer

Executive Vered Caplan clarified that the company is currently focused on validating the single UC Davis site in California before further expansion, noting that each site serves as a regional hub for multiple hospitals. She confirmed that international expansion for Koligo is still planned, supported by a Belgium grant for the European market. Regarding revenue, Caplan explained that the increase in cell process development services is due to onboarding new customers and represents a timing-related fluctuation, as process development builds the pipeline for future production.

Bruce Jackson of Benchmark Company inquired about the timeline for a formal agreement with the University of California, Davis, the specific processing capabilities of the OMPULs in the agreement, and the potential scale of the partnership. He also asked about Koligo's sales relative to its FDA inspection and the filing date for the 10-K.

Answer

CEO Vered Caplan explained that while they are pushing for a formal agreement with UC Davis, academic institutions have their own processes. She clarified that OMPULs are flexible and can be adapted for various therapies. The plan is to validate one location and then expand. Regarding Koligo, the FDA audit validated their process for duplication across a network of sites. CFO Neil Reithinger confirmed the 10-K would be filed the following day.

Bruce Jackson of Benchmark Company inquired about the impact of past capital constraints, how the new capital from Metalmark would accelerate the rollout of OMPULs, the current number of active OMPULs, and any notable progress within the therapeutic pipeline during the quarter.

Answer

CEO Vered Caplan explained that capital constraints were primarily CapEx-related, limiting the setup of new point-of-care sites. The new funding will enable expansion, especially in the U.S. Caplan declined to provide a specific number of active OMPULs, stating the focus is on full utilization of existing capacity rather than the quantity of units. Regarding the therapeutic pipeline, she noted that while there were no major clinical trial completions, programs are progressing well, and she is hopeful for more news and payment benefits in the coming year.

Bruce Jackson of The Benchmark Company inquired about the status of future revenue commitments for 2022 and 2023 and sought clarification on the asset composition of the new Orgenesis subsidiary.

Answer

CEO Vered Caplan confirmed the company remains on track with its revenue commitments, noting a minor positive adjustment of about $5 million from new contracts. Regarding the subsidiary, she clarified that it holds service-related assets like the 'on fields' and associated know-how, while intellectual property for the therapies themselves is held in separate entities.

Bruce Jackson from Benchmark inquired about the performance of the mail-order pharmacy program, the stability of the rebate situation, and the growth outlook for the new partnership in Brazil and Latin America.

Answer

CEO James Schutz and CFO Bob Miller responded, stating that mail-order now accounts for over 40% of unit volume, up from approximately 20% in the prior quarter. They confirmed the rebate situation has stabilized, aided by a mail-order program for cash-paying patients. Miller added that the initial shipment to Brazil was $248,000 and that they expect continued strong growth from the region as more products are launched.

Bruce Jackson of The Benchmark Group inquired about the progress with consultants on reimbursement rates, the duration of the Invekra agreement, and the anticipated timing for initial orders from the new partnership in Brazil.

Answer

CEO James Schutz confirmed they are providing financial arguments to an insurance consultant to detail the cost-effectiveness of their products. He and CFO Robert Miller stated the Invekra agreement was extended to late fall 2020. COO Marc Umscheid added that two significant orders from their new Brazilian partner have been received, with products expected to be on the market within 60 to 90 days.