Tara Bancroft

Tara Bancroft inquired about the various factors and partner feedback contributing to the observed pricing stabilization in the PSMA market, and whether management believes it will remain a three-player market into 2026 given expected pass-through dynamics.

Answer

Brian Markison, CEO, expects the PSMA market to remain a three-player market in the near term. He attributed pricing stabilization to disciplined pricing, top-notch service, and Polarify's clinical differentiation, particularly its sensitivity and specificity in low-volume disease.

Tara Bancroft sought clarification on the factors and partner feedback contributing to PYLARIFY's pricing stabilization and whether the PSMA imaging market is expected to remain a three-player market into 2026, considering pass-through dynamics.

Answer

CEO Brian Markison anticipates a three-player market in the near term, attributing pricing stabilization to disciplined pricing, unparalleled service, and PYLARIFY's distinct clinical differentiation. He highlighted the team's execution and the product's sensitivity and specificity.

Francis, on behalf of Tara Bancroft, asked for the specific impact of MUC-based pricing on revenue compared to other factors and sought confirmation on the percentage of patients affected by MUC.

Answer

President Paul Blanchfield clarified that MUC pricing impacts approximately 20% of patients, not 10%. He explained that it is difficult to isolate the MUC impact from competitive pricing and product availability, as they are all interconnected. He characterized the MUC impact as likely transitory as imaging sites grow accustomed to the new payment mechanics.

Tara Bancroft shifted focus to the Alzheimer's diagnostic pipeline, asking how the assets differentiate from current options and emerging blood tests, what the company's market outlook is, and if more details would be shared in 2025.

Answer

Chief Medical Officer Jeff Humphrey highlighted the assets' differentiation as second-generation agents with high sensitivity and low off-target binding, allowing for anatomical visualization that correlates with symptom severity. President Paul Blanchfield added that the U.S. market could reach $1.5 billion by the end of the decade, viewing blood tests as complementary and noting the pipeline leverages existing F-18 infrastructure.

Tara Bancroft inquired about the expected percentage of non-center-involved DME patients in the Helios trials and the company's confidence in achieving a broad DME-inclusive label without separate DME trials, also asking if successful DME trials could encompass NPDR.

Answer

Pravin U. Dugel, Executive Chairman, President and CEO, indicated that the specific percentage of non-center-involved DME patients would be disclosed later. He expressed high confidence in a broad DME-inclusive label, citing strong Helios 1 data where all non-center-involved DME patients improved with a single XPAXLY injection, and historical FDA labeling precedents. He clarified that DME trials cannot encompass NPDR due to the disease continuum.

Tara Bancroft inquired about the expected percentage of non-center-involved DME patients in Helios trials, the confidence in a broad DME-inclusive label, and whether successful DME trials could encompass NPDR.

Answer

Dr. Pravin Dugel (Executive Chairman, President and CEO) expressed strong confidence in a broad DME-inclusive label based on positive Helios 1 data, where all non-center-involved DME patients improved with a single XPAXLY injection. He cited historical FDA labeling precedents for broad labels despite specific trial populations, noting that DME always includes DR, but not vice-versa.

Tara Bancroft of TD Cowen asked for clarification on how the FDA might view the updated rescue criteria for the SOLAR trial when evaluating the primary endpoint, and how this differs from the previous criteria.

Answer

Pravin Dugel, Executive Chairman, President & CEO, reiterated that the modification to the rescue criteria was a strategic decision to better align the trial with real-world clinical practice and enhance adoptability. He stated there would be no change in how the FDA evaluates the primary endpoint, as the change was not an FDA requirement.

Tara Bancroft questioned whether Ocular would provide regular updates on SOL-R enrollment progress now that it can accelerate and asked about the general expectations for how long enrollment might take.

Answer

President and CEO Dr. Pravin Dugel stated that updates on SOL-R enrollment will be provided 'as appropriate.' He emphasized the trial's momentum, noting a seamless transition and a large bolus of patients from SOL-1, and expressed confidence in the recruitment pace due to the trial's more familiar non-inferiority design.

Tara Bancroft sought clarification on the term 'generally acceptable' from the FDA's written response as mentioned in the press release. She also asked if management perceives any remaining risk to the two studies satisfying NDA requirements and what proactive measures are being taken to mitigate such risks.

Answer

Dr. Pravin Dugel, President and CEO, clarified that 'generally acceptable' is standard FDA terminology and the key message is the company's complete alignment with the agency, now confirmed in writing. He highlighted that this written response explicitly noted that a sham control is not recommended, which de-risks Ocular's studies as they do not use a sham, thereby validating their clinical development strategy.

Tara Bancroft of TD Cowen asked for expectations regarding the upcoming second-half 2025 data for EMILY, inquiring about the minimum follow-up period, the number of patients to be included, and the efficacy benchmarks Mersana aims to meet or exceed.

Answer

President and CEO Dr. Martin Huber explained that the data will be based on the 45+ patients enrolled across Dose A and Dose B cohorts. He noted that Dose A will have a longer follow-up duration, but Dose B will have sufficient data to assess efficacy and safety. Dr. Huber reiterated that an objective response rate (ORR) in the 20s and a progression-free survival (PFS) of 16 weeks would be considered a strong result compared to the standard of care's 5% ORR and 6-7 week PFS.

Tara Bancroft inquired about the higher dose of Emi-Le, seeking more details on its safety profile, the updated proteinuria management protocol, and its distinct pharmacokinetic (PK) profile, and asked if this data would be part of the ASCO update.

Answer

CEO Dr. Martin Huber clarified that the ASCO update will only cover escalation and backfill data, not the new expansion cohort data. He explained the rationale for the new dose (44.5mg Day 1/8 followed by 80mg Q4W), stating it provides a meaningfully higher drug exposure than the 67mg dose, which is important for Project Optimus. While this dose was highly effective, it caused proteinuria-related interruptions, which the company now believes can be managed with new mitigation strategies. The switch to 80mg Q4W after the first cycle was based on investigator feedback for a more manageable long-term schedule.

Tara Bancroft of TD Cowen asked for perspective on how to benchmark the upcoming XMT-1660 data, given that most enrolled patients have prior TOPO1 ADC exposure, a key difference from competitor trial populations.

Answer

CEO Martin Huber explained that Mersana is not providing specific guidance on Overall Response Rate (ORR). He noted that benchmarks from competitors like Pfizer and AstraZeneca involved patient populations with little to no prior TOPO1 ADC treatment, making direct comparisons challenging. Dr. Huber emphasized that these are non-trivial differences and that predicting the right benchmark is difficult at this stage.

Tara Bancroft of TD Cowen inquired about early launch metrics for Zestory in July, asking for details on script rates, active accounts, or qualitative feedback on pent-up patient demand.

Answer

President & CEO Liz Barrett and CCO David Lin explained that while specific metrics would not be shared this early, they are encouraged by the positive receptivity from healthcare providers. Barrett noted that patient enrollment forms are coming in and site-of-care setups are on track. She emphasized that reimbursement is the primary hurdle, with many physicians waiting for the permanent J-code in 2026, but confirmed the company is aligned with consensus estimates for the year.

Tara Bancroft inquired about the anticipated Medicare and Medicaid exposure for UGN-102 and the current mix for JELMYTO, as well as the potential pricing dynamics.

Answer

CEO Liz Barrett clarified that as a U.S.-only company, UroGen has no international pricing risks. Chief Commercial Officer David Lin added that they anticipate the Medicare population will constitute approximately 70% of the business for UGN-102, which is consistent with the patient demographic for low-grade intermediate risk NMIBC.

Tara Bancroft inquired about the FDA's rationale for granting a standard review instead of a priority review for UGN-102, seeking details from the 72-day letter or other communications.

Answer

President and CEO Liz Barrett explained that the FDA's letter did not comment on the review type but focused on standard review questions regarding the ENVISION and ATLAS trial data. She speculated that the standard timeline better accommodates the expected ODAC meeting and gives the agency more time, as they had not yet reviewed the clinical data when the application was accepted.

Tara Bancroft inquired about the current number of active patients receiving Rytello and sought to quantify how much of the 17% Q2 demand growth was driven by new patient starts in the first and second lines of therapy.

Answer

Jim Ziegler, EVP & Chief Commercial Officer, explained that precise patient counts are difficult in a buy-and-bill market but estimated a minimum of over 600 patients based on reordering accounts. He confirmed that while market research indicates about 30% of new starts are in earlier lines, he could not attribute a specific portion of the 17% demand increase directly to that segment due to data limitations.

Tara Bancroft asked for Geron's outlook on Q2 and the rest of the year, questioning when the increased commercial investment and improving demand might lead to a sales inflection point for RYTELO.

Answer

Jim Ziegler, Chief Commercial Officer, explained that while the newly hired sales reps' impact will be felt later in the year after their Q3 start, the company is already seeing positive indicators. He cited a 10% demand increase in April over March and the addition of 300 new ordering sites in Q1. Ziegler stated that Geron anticipates momentum will continue to build in Q2 and be sustained throughout 2025.

Tara Bancroft from TD Cowen asked for details on market seasonality affecting Rytelo and the broader MDS space, noting similar trends with other products. She also inquired about the expected cadence of revenue growth for the year following the implementation of new commercial strategies.

Answer

Jim Ziegler, Chief Commercial Officer, acknowledged a seasonal slowdown beginning around the Thanksgiving holiday, attributing it to physician hesitancy in starting new therapies requiring monitoring during that period. He noted a high correlation with other products in the space, suggesting a market-wide trend. Regarding growth, he stated it depends on driving new patient starts in earlier lines of therapy, a process that will take time as it involves changing prescribing behaviors.

Tara Bancroft of TD Cowen inquired about the expected growth cadence for RYTELO in the coming year and how Geron's growth assumptions influenced the terms of its recent royalty financing deal.

Answer

EVP & CCO Jim Ziegler stated that Geron expects 'steady, consistent growth' across all patient segments but is not providing specific guidance. EVP & CFO Michelle Robertson added that the royalty deal resulted from a competitive process and its terms were negotiated using the company's internal forecasts.

Tara Bancroft from TD Cowen asked for the proportion of new versus continuing scripts in Q2 and questioned the extent to which recent ASCO data on rash management and growth velocity contributed to new patient starts.

Answer

CEO Jeremy Bender confirmed the positive impact of the two-year data. CCO Lauren Merendino added that the data was well-received by physicians, as it confirmed Ogenda's efficacy and provided reassuring evidence of catch-up growth post-treatment, which directly contributed to an uptick in new patient starts in the latter half of Q2.

Tara Bancroft from TD Cowen asked for a breakdown of revenue from new versus ongoing patients and inquired about any Q1 headwinds related to gross-to-net adjustments and reimbursement.

Answer

CEO Jeremy Bender stated that new versus ongoing patient dynamics are similar to the prior quarter and that total scripts and revenue are the key metrics. CCO Lauren Merendino attributed Q1 seasonality to holiday-related delays in scans, noting a strong rebound in new patient starts in April. COO & CFO Charles York confirmed the gross-to-net percentage remained in the 12-15% range, slightly higher due to a January price increase and typical Q1 co-pay assistance needs.

Tara Bancroft inquired about the expected cadence of new patient starts for OJEMDA in the coming year, asking whether to anticipate an inflection point or more linear growth.

Answer

Chief Commercial Officer Lauren Merendino, prompted by CEO Jeremy Bender, stated that due to the slow-moving nature of pLGG, she anticipates continued steady growth in new patient starts rather than a single, dramatic inflection point. She emphasized that even after a physician decides to use OJEMDA, it can take time for a treatment decision to arise.

Tara Bancroft inquired about the full-year 2025 revenue guidance for BRIUMVI, noting that it implies a moderation in growth during the second half of the year, and asked for details on expected headwinds and tailwinds for Q3 and Q4.

Answer

Chief Commercial Officer Adam Waldman confirmed the company raised its full-year guidance. He explained that while summer seasonality is expected in Q3, stronger growth is anticipated from Q3 to Q4. Waldman attributed the overall guidance increase to better-than-expected new patient enrollments and strong patient persistence.

Tara Bancroft inquired about the competitive landscape for Briumvi, particularly regarding new patient market share against OCREVUS and any signs of preferential uptake.

Answer

Chief Commercialization Officer Adam Waldman responded, stating that TG Therapeutics has seen 'zero impact' on Briumvi from competitors in the de novo patient segment. He highlighted that the first three months of the year were the highest ever for new patient enrollments and that the company continues to gain market share in the IV anti-CD20 segment, which is now believed to be above the 25% previously cited.

Tara Bancroft from TD Cowen questioned if future growth would be steady or follow a seasonal cadence, and asked about the ideal volume and dosing interval being targeted for the subcutaneous BRIUMVI formulation.

Answer

Chief Commercialization Officer Adam Waldman acknowledged seasonal dynamics in the MS market but stated the company is poised for more growth, fueled by new investments. CEO Michael Weiss added that for the subcutaneous version, the minimum target for dosing frequency is every other month, with a goal of being as infrequent as possible.

Tara Bancroft of TD Cowen asked for Celcuity's updated perspective on what would constitute a 'good' minimum hazard ratio (HR) for the VIKTORIA-1 wild-type data, considering statistical significance, competitor data, and KOL expectations.

Answer

CEO Brian Sullivan declined to provide specific projections on a target hazard ratio, citing the imminent data readout. He reiterated that an incremental three-month improvement in Progression-Free Survival (PFS) is generally considered clinically meaningful, and a statistically significant hazard ratio consistent with that benchmark would also be viewed favorably. The direct comparison to other regimens will depend on the final data.

Tara Bancroft of TD Cowen asked for specific median Progression-Free Survival (mPFS) expectations for the VIKTORIA-1 wild-type arms that would instill confidence for the mutant cohort. She also requested Celcuity's view on the control arm's expected performance, especially with the upcoming Ember-3 data.

Answer

Executive Brian Sullivan avoided giving a specific mPFS forecast but highlighted that the Phase III population has a more favorable prognosis than the Phase Ib study, which reported a 12.9-month median PFS. He reiterated that key opinion leaders consider a three-month mPFS delta over the control arm to be clinically meaningful. For the control arm, Sullivan cited historical data from four similar studies showing fulvestrant's mPFS ranges from 2 to 3.5 months, suggesting results are unlikely to deviate from this range.

Tara Bancroft requested more color on the refill rates for patients who started Ohtuvayre six or more months ago and how this is expected to evolve. She also asked if Verona Pharma has the option or interest to repurchase the China rights from Nuance Pharma.

Answer

Chief Commercial Officer Christopher Martin explained that while it's early and the number of long-term patients is still growing, the company is very encouraged by persistency and refill rates. He noted that while typical COPD patients refill about six times a year, there is potential upside for Ohtuvayre due to its benefits and the company's 'white glove' distribution service. CEO David Zaccardelli stated that while an opportunity to repurchase China rights exists under certain conditions, it is not part of the current plan, and the collaboration with Nuance Pharma remains strong.

Tara Bancroft from TD Cowen asked for more details on refill rates for patients on Ohtuvayre for six months or more, the expected steady-state refill rate, and whether Verona has the option or interest in repurchasing the rights for China.

Answer

Christopher Martin, Chief Commercial Officer, noted that while it's early for long-term data, persistency and refill rates are very encouraging, with potential upside to the typical six fills per year in COPD. CEO David Zaccardelli stated that repurchasing China rights is not part of the current plan and is contingent on other factors, highlighting the strong ongoing collaboration with Nuance Pharma.

Tara Bancroft asked for clarification on the improved safety profile of vobramitamab duocarmazine (vobra duo) in the TAMARACK study compared to Phase I, questioning the perceived improvement given the additional treatment cycles.

Answer

Dr. Scott Koenig, President and CEO, explained that a direct comparison at the 16-week mark showed TAMARACK had half the Grade 3 adverse events, fewer discontinuations, and fewer drug interruptions than the Phase I prostate cohort. He emphasized that side effects are overwhelmingly Grade 1/2 and manageable, and discontinuation rates compare favorably to other approved prostate cancer therapies.

Representing Tara Bancroft of TD Cowen, an analyst asked for a specific timeline on when to expect clinical data for FT819 in lupus.

Answer

CEO Scott Wolchko reiterated the company's guidance, stating that an update on the first 3 to 5 patients treated with FT819 for systemic lupus erythematosus (SLE) is expected by the end of 2024.

Inquired about potential sub-populations where the drug might have shown more effectiveness and whether the FDA might be open to a filing based on a more limited patient group.

Answer

It is too early to identify specific subgroups, but the comprehensive data set, which includes multiple stratification factors, is being reviewed. The company will not speculate on the FDA's reaction but noted the agency's awareness of the high unmet need in relapsed/refractory AML and plans to engage with them after the data analysis is complete.

Asked about potential future combination partners for vudalimab beyond chemotherapy and requested an update on the safety profile of the ongoing chemo-combo study.

Answer

Future combinations could include sequencing after PLUVICTO or pairing with their CD28 or CD3 bispecifics. In the current chemo-combo study, the protocol was amended to focus on docetaxel, which investigators report has improved tolerability.

Tara Bancroft from Piper Sandler asked for commentary on the recent safety signals with Beovu, including potential causes for the observed vasculitis, and whether this has any read-through for intravitreal gene therapies or sentiment towards long-acting treatments like ADVM-022.

Answer

President and CEO Leone Patterson stated that the inflammation seen with ADVM-022 is low-grade and manageable, differing significantly from the posterior inflammation and vasculitis reported with Beovu. Chief Medical Officer Aaron Osborne elaborated that the Beovu-related events involve sight-threatening vasculitis in the back of the eye. He contrasted this by stating ADVM-022 has shown no evidence of retinal vasculitis, retinitis, or choroiditis. The inflammation with ADVM-022 is an expected, low-grade immune response in the front of the eye that is manageable with topical steroids.