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CEO Linda Marbán reiterated Capricor's belief that the original BLA submission was strong and that their primary goal is to address the FDA's interpretation of the existing data. For the Stealth X program, she highlighted its potential as a next-generation vaccine and a significant business development opportunity, separate from the company's core focus on deromyocel.

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Executive Anthony Bergmann addressed the facility, noting the original clean room was built for under $2 million and they anticipate a reasonable cost for the expansion. CEO Linda Marbán added that they expect to hear about a potential AdCom soon but do not believe the HOPE-3 data will be a focus. She also stated that while Capricor is evaluating in-licensing opportunities, the primary focus is on deramiocel's approval. Regarding Europe, negotiations with NS are ongoing, but the company is also working directly with the EMA to define the best path forward.

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CEO Thomas Schuetz clarified that the company had a formal FDA interaction on the trial design and plans a more robust interaction after the PFS/OS data readout in 2026. He downplayed the risk of the control arm overperforming, citing the 42.1% radiographic progression rate at week eight. For CTX-8371, he outlined a plan for a small, randomized expansion study of about 50 patients to explore two different doses in TNBC and NSCLC.

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The company had a formal FDA interaction on the tivesimig study design and plans a more robust meeting after the PFS/OS data readout. They are not concerned about the control arm overperforming, citing the high rate of early progressive disease (42.1% at week 8). The CTX-8371 expansion will be a small randomized study of about 50 patients exploring two different doses in NSCLC and TNBC, set to begin in Q4.

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CEO Thomas Schuetz clarified that the company had a formal FDA interaction on the Tivesimig study design and plans a more robust interaction after the PFS/OS data readout. He downplayed the risk of control arm overperformance, citing the high 42.1% progression rate at week eight. For CTX-8371, he outlined a plan for a small, randomized study of about 50 patients to explore two different doses in the expansion cohorts.

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President and CEO Robert Blum stated they are well-aligned with the FDA on the REMS and don't expect any preparations to be irrelevant. Stuart Kupfer, SVP & Chief Medical Officer, reported high investigator interest in COMET, driven by the high unmet need, positive GALACTIC subgroup data, and a streamlined trial design.

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President & CEO Robert I. Blum declined to comment on active FDA interactions but expressed confidence in their position ahead of the mid-cycle meeting. Regarding COMET-HF, EVP of R&D Fady Malik stated that enrollment is proceeding as estimated, leveraging learnings and investigators from the previous GALACTIC trial. He confirmed the plan is to complete enrollment in 2026, with the study proceeding according to plan.

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SVP & CFO Scott Coiante confirmed OpEx guidance includes stock-based comp. CEO Mike Exton stated the FDA meeting is not a rate-limiting step for partnering, as they are now re-engaging with a stronger data package. SVP & CMO Dr. Craig Granowitz described a 'golden opportunity' for HCM trial enrollment due to a lack of competing trials and noted a higher enrollment of non-obstructive patients in the U.S., where treatment options are scarce for that subgroup.

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CEO Dr. Mike Exton stated it would be difficult to justify further investment in another ZYNQUISTA study given the extensive existing evidence. Dr. Craig Granowitz, SVP & CMO, added there is no medical basis to rerun efficacy trials. On HCM, Dr. Granowitz noted strong investigator interest due to the pragmatic trial design. For LX9211, Dr. Exton explained that key benchmarks include both placebo-adjusted and baseline pain score reductions, highlighting the strategic value of demonstrating efficacy on top of standard-of-care therapies.

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EVP & Chief Commercial Officer David Santos attributed the growth to a record number of new patient starts, accelerated by improved patient affordability from the 2025 Inflation Reduction Act changes. President & CEO Raul Rodriguez added that the company was well-prepared for this dynamic, which led to strong results and better patient access.

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Chief Commercial Officer David Santos and Chief Financial Officer Dean Schorno responded. Mr. Santos stated that the company was pleased with the Q1 progress, noting that demand grew for all three brands and that the team successfully managed the impact of the Inflation Reduction Act. Mr. Schorno confirmed the strong demand and noted the expected seasonal drawdown in channel inventory, which was factored into their outlook.

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Chief Commercial Officer David Santos explained that for TAVALISSE, the majority of business is from carryover patients who remain on therapy, with growth driven by both this base and new patient starts. Regarding GAVRETO, Santos clarified that while a handful of top centers haven't placed direct orders, their patients may be serviced through the specialty pharmacy network. He noted the direct order business was already improving, growing from 45% to 50% by October.

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Chief Medical Officer Lisa Rojkjaer clarified that vorasidenib was approved for an earlier treatment setting (Grade 2 glioma post-surgery), whereas Rigel's olutasidenib study with CONNECT is for high-grade glioma in the maintenance setting post-radiotherapy. Chief Commercial Officer David Santos added that vorasidenib's approval is a positive development that validates the role of IDH inhibitors in glioma. President and CEO Raul Rodriguez noted that Rigel is exploring opportunities beyond the vorasidenib label, leveraging molecular differences.

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CFO Ben Halladay stated there are no anticipated rate-limiting steps for the PSC program, as its costs are incorporated into existing expense guidance. President & CEO Sheldon Koenig explained that prescriber growth will be driven by a combination of factors: targeted connected TV ads driving consumer demand, positive physician experiences leading to broader use, and the unique and compelling primary prevention indication, which he described as 'airspace' that Esperion owns.

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Chairman & CEO Krish Krishnan defined steady state as an average use of 26 vials per year, expected when the patient mix is 50/50 RDEB/DDEB. President of R&D Suma Krishnan explained the new scale will capture texture and quality improvements from elastin. Krish Krishnan added the goal is to spin out Jeune by 2026.

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CEO Jonathan Solomon explained that the company is preparing for discussions with regulatory agencies later in the year, exploring options for breakthrough and orphan designations. He noted that while the data opens up other indications, the primary focus remains on DFO. Solomon confirmed significant inbound interest from U.S. and European physicians, attributing the excitement to the trial data replicating positive outcomes previously seen in compassionate use cases.

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The company responded that while recruitment for the study has been challenging over its multi-year span, they have enrolled the majority of patients and remain on track to complete the study and report data in the first quarter of 2025. No specific enrollment numbers were provided.

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Jonathan Solomon, CEO, explained that the Phase IIb design for BX004 is well-developed in collaboration with the Cystic Fibrosis Foundation and is awaiting FDA feedback from a Type C meeting. He described the integration with APT as a complex but successful process that leverages APT's strengths in manufacturing and access to government agencies, stating the teams are now stabilized with clear work plans.

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Executive Frank Bedu-Addo and Chief Medical Officer Kirk Shepard confirmed strong investigator enthusiasm for VERSATILE-003, stating that experts understand the KEYNOTE-689 data does not apply to the HPV-positive population. Regarding the MUC1 program, Frank Bedu-Addo explained its differentiation lies in combining their proven Versamune technology with novel, more potent MUC1 agonist epitopes from the NCI, and adding their IL-12 fused antibody drug conjugate. He noted the initial trial is a single-site study run by the NCI.

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Matthew Foehr, President and CEO, and Bob Chen, VP of Discovery Systems, highlighted the platform's ease of use and efficiency. Chen emphasized its design lacks a fluidics system, a common failure point that causes clogs, making it simpler and more robust. On financials, Foehr and CFO Kurt Gustafson stated that tariffs have no significant impact, as the instrument is built in the U.S. from U.S.-sourced parts, and other lab supplies have multiple suppliers.

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President and CEO Matthew Foehr clarified that program attrition stems from normal strategic pipeline realignments by pharma partners, not technical issues. He noted that new technologies planned for 2025 will be scalable, enhance discovery efficiency, and likely be unveiled at key scientific conferences. Foehr also emphasized that OmniAb's flexible business model has proven resilient across various market cycles, a sentiment echoed by CFO Kurt Gustafson.

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Chief Commercial Officer Stephen Toor responded that while the IRA's impact on out-of-pocket expenses was beneficial, it was not a major factor in RUCONEST's growth, which was driven by the brand's underlying strength. For new prescribers, he noted that growth often comes from practices with few HAE patients, where the key factor is the timing of a patient review, creating an opportunity to position RUCONEST for those who have failed other therapies.

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CEO Fabrice Chouraqui and CCO Stephen Toor explained that new RUCONEST prescribers are often physicians outside major centers who are open to its unique profile for their severe HAE patients. Regarding future strategy, Mr. Chouraqui stated it was early but highlighted a focus on execution, P&L management, and pipeline expansion through both organic growth and value-accretive deals.

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CEO Brian Culley explained that the DOSED study will use a combination of new and experienced clinical sites, with UC San Diego being the first. He described surgeon and site training as a long continuum with multiple stage gates. A key logistical improvement highlighted was the development of an "immediate use" formulation for OPC1, which eliminates the hours-long, on-site dose preparation steps required in prior studies, easing the burden on the clinical sites.

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CEO Brian Culley pointed to Genentech's decision to fund an additional five years of follow-up for the original OpRegen study patients as a strong positive signal. Regarding OPC1, he emphasized a strategy of building value through de-risking key manufacturing and delivery elements to maximize future partnership economics rather than seeking a deal now. For ANP1, he differentiated it from gene therapies by highlighting its potential to treat a broader patient population by replacing lost cells, irrespective of the specific genetic mutation causing hearing loss.

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CFO Jill Howe confirmed that potential milestone payments are not factored into the current cash runway guidance. CEO Brian Culley added that while milestone triggers are confidential, the deal structure is not unusually back-loaded. Regarding OPC1, Culley stated that pre-patient activities like site training are underway, and they anticipate chronic SCI patients will be relatively straightforward to identify once the IND is cleared. He noted that CIRM grants can often cover about half of a study's cost, representing a very attractive form of capital.

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CEO Todd Davis explained that they syndicate deals when necessary to maintain portfolio diversification and adhere to their deal size discipline. CFO Tavo Espinoza noted that while an opportunistic buyback program exists, the primary use of capital is for royalty asset acquisition. He clarified the impairment charge was due to Takeda discontinuing the soticlestat program.

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CEO Todd Davis affirmed that the company is appropriately staffed, highlighting the business model's high operating leverage which allows for significant growth without substantial increases in headcount. He also clarified the buyback program is in place for 'corporate hygiene' with no immediate plans for use. CFO Tavo Espinoza explained that Captisol revenue follows an 80/20 rule, with most sales coming from a small number of commercial customers, though the pipeline of earlier-stage clients remains encouraging.

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Peter Altman, Ph.D., President and CEO, explained that the Heart Failure I data, particularly the 86% relative risk reduction in mortality for the target population, is a "huge selling point" for physicians and is expected to significantly boost enrollment. He noted that streamlining efforts, such as allowing phone-based follow-up visits, reduce costs for BioCardia and ease the burden on clinical sites. Dr. Altman acknowledged the historical gender imbalance in heart failure trials and stated that while achieving a 50/50 ratio is unlikely, the compelling safety and efficacy signals from Heart Failure I should encourage physicians to enroll more female patients in the second trial.

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Executive Lan Huang explained that partner Hengrui is an ideal and active partner in the China NMPA review, helping prepare responses and attending regulatory meetings. She stated the current rate-limiting step is answering reviewer questions. For the second U.S. CIN study, Huang said the company plans to conduct it themselves but remains open to a partnership.

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CEO Lan Huang stated that BeyondSpring's China team has been working daily with Hengrui since the agreement was signed on August 26. She mentioned they are focused on aligning medical science and messaging, but her full response was interrupted by a technical difficulty on the call.

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Co-Founder and CSO Tibor Keler explained that the spermatogenesis effect was an expected result of KIT inhibition at the very high doses used in toxicology studies and has been shown to be reversible. He noted it would be speculative to predict the effect at lower human doses. Regarding competition, he emphasized that Celldex's mechanism of depleting the mast cell is fundamentally different from others targeting mast cell receptors. For the oncology programs, the strategy is to complete enrollment in the current expansion cohorts before providing a meaningful update.

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Tibor Keler, EVP and Chief Scientific Officer, confirmed that CDX-1140 shows strong biological activity without reaching dose-limiting toxicity, even at high doses. Margo Heath-Chiozzi, SVP of Regulatory Affairs, noted that FAT1 and NOTCH mutations occur in roughly one-third and one-quarter of head and neck tumors, respectively, and that the company plans to collaborate with diagnostic firms if the biomarker strategy is validated.

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