Jonathan Aschoff

Jonathan Aschoff from Roth Capital Partners asked about the current status of the Clover-WM study's progression-free survival (PFS) data, specifically seeking an update beyond the previously reported 11.4 months with 8 months of follow-up, and how this compares to the standard of care for Waldenstrom's macroglobulinemia. He also sought clarification on the sequential steps for initiating the CLR 225 pancreatic cancer trial.

Answer

President and CEO Jim Caruso emphasized that global thought leaders considered 4-6 months of PFS an excellent outcome for heavily pre-treated WM patients, making iopofosine's initial PFS of approximately one year significantly robust. COO Jarrod Longcor confirmed that while 12 months of follow-up data for all Clover-WM patients is now available, the company is not publicly updating PFS data at this time to avoid pre-submission promotional concerns with the FDA. Mr. Longcor also clarified that the ex-U.S. filing for the CLR 225 pancreatic cancer study has been accepted, and the trial is ready to initiate pending capital.

Jonathan Aschoff sought clarification on the sequence of steps for the CLR 225 pancreatic cancer program, specifically regarding filing, securing funding, and initiating the trial.

Answer

COO Jarrod Longcor clarified that the company has already filed ex-U.S. with the appropriate authority and received acceptance for the CLR 225 study. Therefore, the current sequence is to await the necessary capital and then initiate the trial.

Jonathan Aschoff of H.C. Wainwright & Co. requested clarification on Q2 2024 net income, share count, the release timing for HGG data, and the initiation of the Phase I trial for the actinium alpha emitter.

Answer

CFO Chad Kolean stated that net income could not be provided due to the ongoing financial restatement but confirmed an 8-K with the full cap table was forthcoming. SVP, Medical, Dr. Andrei Shustov, projected initial HGG study results by year-end. COO Jarrod Longcor added that IND-enabling studies for the actinium program are expected to conclude in Q4 2024, with a Phase I study to begin late 2024 or early 2025.

Jonathan Aschoff of Roth Capital Partners, LLC inquired about several key operating metrics, including the number of RhodoLED lamps placed in Q2, data release timelines for acne and peripheral actinic keratosis (AK) trials, future pricing strategy, the dynamics of converting Levulan users, and the predictability of future SG&A expenses.

Answer

CFO Fred Leffler and CEO Hermann Luebbert confirmed 18 XL lamps were placed in Q2, totaling 40 for the first half of 2025, with over 700 total lamps now in the field. Luebbert stated that data for both the acne and peripheral AK trials are expected in Q4 2025 and that no price hikes are planned for the current year. He also noted that Levulan users typically adopt Ameluz alongside their existing treatment. Leffler clarified that the Q2 spike in SG&A was due to non-recurring legal costs and is not indicative of a new run rate.

Jonathan Aschoff of Roth MKM inquired about potential sales force attrition, asking for the current headcount compared to year-end and whether turnover explained the noted decrease in personnel expenses.

Answer

CFO Eugene Leffler explained that the company is restructuring its commercial team by hiring more junior representatives at lower salaries and reorganizing territories for efficiency. He acknowledged some turnover but affirmed the company's commitment to replacing those roles to finish the year strong.

Jonathan Aschoff of ROTH MKM inquired about the current patient enrollment number for the Phase II acne study and sought confirmation on the expected data release timeline.

Answer

Hermann Lubbert, an executive, confirmed the enrollment stood at 116 patients. He noted that the trial might conclude earlier than anticipated, potentially with a slightly larger cohort, and affirmed that the data timing remains on track.

Jonathan Aschoff of Benchmark Company inquired about specific lamp placement figures for Q2 and Q3-to-date, the planned Ameluz price increase, timelines for clinical trial data, the point at which LSA savings will exceed trial costs, and the status of the low-cost portable lamp.

Answer

Executive Hermann Lubbert provided Q2 lamp placement figures (57 original, 4 XL) but noted Q3 data was not yet public. CFO Eugene Leffler confirmed a 5% price increase for Ameluz effective October 1. Hermann Lubbert stated that data for the acne and AK extremity trials are expected in H2 2025. Eugene Leffler projected LSA savings would surpass trial costs by late Q1 or early Q2 2025. Hermann Lubbert added that a prototype for the low-cost portable lamp is nearing completion.

Jonathan Aschoff of Roth Capital Partners, LLC inquired about the timeline for the cervical disc disease trial, the revenue growth trajectory for the cosmeceutical business, the expected trend for SG&A expenses, and the sustainability of low Cost of Goods Sold (COGS).

Answer

Chairman and CEO Lance Alstodt stated the company is laser-focused on advancing the lumbar trial (BRTX-100) to a BLA before initiating other trials. He noted it's too early to provide specific revenue guidance but expects increased visibility and high margins from the cosmeceutical business. CFO Robert Kristal confirmed the expected SG&A trend and attributed low COGS to improved manufacturing efficiencies and better pricing on packaging.

The analyst inquired about the timeline for the cervical trial, the revenue growth outlook for the Cosmoceutical business, the expected trend for SG&A expenses, and the sustainability of the low cost of goods sold (COGS).

Answer

The company stated they are prioritizing the lumbar trial over the cervical trial for now. Revenue growth is expected, but it's too early for specific guidance. The historical SG&A trend is expected to continue, with a potential decrease in 2026. The low COGS is attributed to high product margins and improved operational efficiencies.

Jonathan Aschoff of Roth Capital Partners questioned the use of the term 'preliminary endpoint' for efficacy, asked why mentions of a potential interim analysis were removed from a recent presentation, and sought clarity on the source of the 45 patients for an upcoming data release.

Answer

Francisco Silva, VP of Research and Development, clarified that 'preliminary' is used because the trial's primary endpoint is safety, while efficacy is a secondary endpoint. He and CEO Lance Alstodt explained that an interim analysis remains an option but was de-emphasized as they explore leveraging current data with the FDA to potentially shorten the regulatory timeline, which an unblinding could compromise. They also confirmed the 45 patients are from the current Phase II study, indicating enrollment is significantly more advanced than the 15-patient cohort previously discussed.

Jonathan Aschoff inquired about the timeline for the BRTX-100 data, asking when the current 10-patient data was cut, when to expect the first unblinded results, and the potential timing for a 26-week interim analysis. He also questioned the cash runway and sought clarification on the placebo protocol (saline vs. sham) for patients in the trial.

Answer

Francisco Silva, VP of Research and Development, clarified that the data is several months old and that future data releases at academic conferences will remain blinded to maintain trial integrity. CEO Lance Alstodt projected a potential unblinded interim analysis in the first half of 2025. Alstodt also confirmed that only one patient received saline, with subsequent placebo patients receiving a sham injection, and stated the company's $13.1 million cash position is sufficient to reach key trial milestones without an imminent need for financing.

Jonathan Aschoff of Roth Capital Partners, LLC inquired about the administration method for the GEO-MVA vaccine's pivotal trial, the reasons for its second-half 2026 start date, and sought clarification on the reported R&D expense figure.

Answer

Chairman & CEO David Dodd and VP of Business Development John W. Sharkey clarified that the trial will use standard vaccine delivery, not a patch. Dr. Sharkey explained the 2H 2026 start is due to the comprehensive process of statistical planning, dossier preparation, and regulatory approvals, not solely vaccine availability. CFO Mark Reynolds clarified that the $10 million R&D expense was for the six-month period, not a single quarter.

Jonathan Aschoff inquired about the possibility of selling the GEO-MVA Mpox vaccine for emergency use without full clinical testing, the company's strategy for ensuring equitable global vaccine access, and the specific requirements and timeline for initiating the next Gedeptin trial.

Answer

Executive David Dodd explained that while typically not possible, selling GEO-MVA under an emergency use license with the WHO is a potential avenue given the critical global need, noting Africa's stated requirement for 20-25 million doses. He confirmed ongoing discussions with Africa CDC, UNICEF, and European agencies to ensure equitable access. Regarding the Gedeptin trial, Dodd stated that manufacturing issues with a cell line have caused delays, pushing the anticipated trial start to the mid-to-latter part of the following year.

Jonathan Aschoff of H.C. Wainwright & Co. inquired about potential timeline delays for the MIRACLE trial in the EU, the development progress for an optimal WP1066 formulation, and the expected R&D expense run rate.

Answer

Executive Walter Klemp stated that the company does not anticipate a delay in the EU trial timeline due to the EMA's request for additional GLP data, but it is a possibility they are managing. He also indicated a year-end target for the new WP1066 formulation is reasonable but not guaranteed. CFO Jonathan Foster confirmed that R&D expenses will increase, particularly in 2026, to support GLP studies and drug manufacturing for Part B of the trial.

Jonathan Aschoff of H.C. Wainwright & Co. inquired about several topics, including an update on the median Overall Survival (OS) for second-line patients, the rationale behind increasing patient numbers in the MIRACLE trial's various stages, whether the recent R&D spending represents a new run rate, and clarification on the number of shares from prepaid warrants.

Answer

Executive John Waymack reported that the median OS has improved to over 7 months. Executive Walter Klemp clarified that the trial size for Part B was not doubled but rather rephrased to 240 total patients (120 per arm) for clarity. He added that the Part A patient count was adjusted based on ongoing statistical optimization to accelerate trial startup. John Waymack also confirmed that the Q3 R&D expense was not a new run rate due to a one-time 'slug' for annamycin production and sponsored research, and that roughly 2 million shares are from prepaid warrants.

Jonathan Aschoff of H.C. Wainwright & Co. inquired about any new allergic reactions, the timeline for the pivotal trial start, a potential typo in the press release regarding timelines, and the impact of recent positive data on patient recruitment.

Answer

Executive Paul Waymack confirmed there has only been one allergic reaction to annamycin in over 80 patients, which was a rare event. Executive Walter Klemp clarified that the H1 2025 trial start date is a conservative estimate and could potentially begin by the end of 2024. Executive Jonathan Foster acknowledged a likely typo in the press release regarding a 2026 date. Walter Klemp also confirmed that the strong efficacy data, particularly the 60% CRc rate, has significantly accelerated patient recruitment for their trial.

Jonathan Aschoff of Roth Capital Partners questioned the cause of the decline in adult revenue given the strong pediatric growth, asking if it was due to international sales or a seasonal trend. He also sought specific details on the progress of the outpatient Aquadex strategy since the January 1 reimbursement change and requested updates on the enrollment status of the REVERSE-HF trial and the start timeline for the Vivian clinical trial.

Answer

Executive John Erb clarified that the drop in Critical Care revenue was not seasonal but a one-time event caused by a large customer building inventory in Q4 2024, with purchasing expected to normalize in Q2. Regarding the outpatient strategy, Erb stated Nuwellis is actively working with four hospitals on logistical setups and expects revenue to begin in Q2, accelerating in Q3 and Q4. He also reported that the REVERSE-HF trial is approximately halfway to its enrollment goal and that the Vivian clinical trial is anticipated to commence late in the current year or early next year.

Jonathan Aschoff inquired about the cause of the decline in adult revenue, the specific progress being made in the outpatient setting following new reimbursement rules, and the current enrollment status and timelines for the REVERSE-HF and Vivian clinical trials.

Answer

Executive John Erb clarified that the revenue dip was isolated to the Critical Care segment due to a single large customer building inventory in Q4 2024, and was not a seasonal trend. He stated that four hospitals are actively working on the logistics to launch outpatient clinics, with revenue expected to begin in Q2 and accelerate. Regarding trials, Erb noted the REVERSE-HF study is nearly halfway to its enrollment goal, and the Vivian clinical trial is anticipated to commence in late 2025 or early 2026.

Jonathan Aschoff inquired about the initial market traction for Aquadex in the outpatient setting following the new reimbursement change, the number of console units placed in Q3 and Q4 2024, and the expected timeline for completing enrollment in the REVERSE-HF and Vivian clinical trials.

Answer

Executive John Erb stated that outpatient traction is building with existing accounts, but it will likely take another month to see new facilities come online. CFO Robert Scott reported that Nuwellis sold 3 console units in Q4 2024 and 11 units in Q3 2024. John Erb added that it is premature to provide a definitive timeline for the completion of the REVERSE-HF and Vivian trial enrollments.

Jonathan Aschoff of Roth Capital Partners inquired about the economic comparison of using Aquadex in an outpatient setting versus other methods under the new reimbursement rates, its potential to replace inpatient treatment, the reasons for the DaVita partnership's outcome, and development timelines for the REVERSE-HF trial and the Vivian product.

Answer

Executive Nestor Jaramillo explained that the new outpatient reimbursement of $1,639 per day makes Aquadex profitable for hospitals, contrasting with the financial losses incurred from inpatient DRGs. He affirmed the goal is to replace inpatient admissions, which also improves patient outcomes. Jaramillo attributed the stalled DaVita partnership to losing an internal champion and initial strategic missteps. He projected the REVERSE-HF trial data would be ready for submission by late 2026 and the Vivian in-human trial would begin by the end of 2025.

Jonathan Aschoff of B. Riley Securities inquired about the future trend of R&D expenses, the performance and growth drivers of the pediatric business, potential guidance for the QUELimmune product, and the status of the pilot program with DaVita.

Answer

CFO Robert Scott indicated that R&D spending would likely remain consistent with Q2 in the near term before ramping up for the Vivian pediatric device development. Executive Nestor Jaramillo explained that the pediatric business, representing 30% of revenue, was impacted by a lower patient census this quarter despite new console sales. He stated it's too early for QUELimmune guidance due to hospital-by-hospital IRB approval requirements and noted the DaVita pilot has been slower than expected due to administrative and contractual complexities between DaVita and the hospitals, not training issues.

Jonathan Aschoff of Roth Capital Partners inquired about the outlook for quarter-over-quarter revenue growth in Q4, details on the Keep Well financing facility, pro forma debt and cash, the number of outstanding warrants, the current size of the prospective client pipeline, and the status of the Community Care Plan (CCP) rollout.

Answer

CFO James Park confirmed that while the new customer will contribute to Q4 revenue, a more significant impact is expected in early 2025. He clarified the Keep Well agreement details, stating $4.5 million was drawn down, leaving $10.5 million available. President and Chief Commercial Officer Mary Louise Osborne noted the active prospect pipeline remains strong at 26, with new prospects replacing the newly signed customer. She also confirmed the successful launch with CCP in one Florida region, with an expansion to five regions planned for January 2025. CEO Brandon LaVerne added that enrollment for both WholeHealth+ and Engage with CCP is on forecast.

Jonathan Aschoff inquired about the market size for prexigebersen in AML patients who cannot tolerate intensive chemotherapy and whether its clinical development is paused pending Fast Track designation. He also asked about the starting dose for the BP1002 combination therapy trial and which cohorts of BP1001-A and BP1003 might see progress in 2024.

Answer

Executive Peter Nielsen estimated the market for fragile AML patients is around 10,000 and confirmed a temporary pause in new enrollment for prexigebersen Cohorts 1 and 2. He projected the BP1002 combination therapy would likely start at a 60 to 90 mg/m² dose after monotherapy testing. Nielsen also clarified that the potential 2024 data readout for BP1001-A would be from the solid tumor trial's second dose cohort, which is currently enrolling at 90 mg/m².

Inquired about the strategic options and level of interest for fadraciclib, the final dose level for the Phase I fadra trial, and whether there were any indications that a different dosing schedule might be needed.

Answer

The company confirmed strategic interest in fadraciclib from multiple parties, noting that the upcoming biomarker data disclosure is expected to be a significant catalyst for these discussions. They are close to completing dose level 6A for the Phase I fadra trial and are hopeful it will be the recommended Phase II dose. They also expressed satisfaction with the current dosing schedule.

Inquired about the details of the Pacific Blue Cross (PBC) study, including the calculation of the $1.6 million savings, the exact number of patients who returned to work, the reasons for discrepancies in patient outcomes, and whether the company used its ATM facility during the quarter.

Answer

The company explained the $1.6 million savings was a conservative estimate based on remaining long-term disability claims. They clarified that 5 patients returned to work, closing their claims, and that the discrepancy between the 8 with improved gait and the 5 who returned to work was not due to factors PoNS treats. They also confirmed raising $284,000 from their ATM during the quarter.