Joseph Pantginis • H.C. Wainwright & Co.

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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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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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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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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 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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