Justin Walsh

Justin Walsh asked about the potential market dynamics with the entry of other clinically differentiated products, specifically a copper-64-based agent, and how Lantheus plans to maintain its competitive edge in the PSMA imaging space.

Answer

CEO Brian Markison stated that Lantheus is monitoring copper-64 agents but remains confident in PYLARIFY's sensitivity, specificity, and network. CFO Bob Marshall added that any new entries would likely launch into a growing market opportunity, with a rising tide lifting all boats.

Justin Walsh asked about the potential dynamics that could emerge in the PSMA imaging market as other clinically differentiated products, such as a copper-64-based agent, enter, and how Lantheus plans to maintain its edge.

Answer

Brian Markison, CEO, stated that Lantheus is monitoring the copper-64 agent's progression but remains highly confident in Polarify's sensitivity, specificity, and network. Bob Marshall, CFO, added that a rising tide lifts all boats in a market projected to reach $3.5 billion by the end of the decade.

Justin Walsh of Jones Trading asked about the Transitional Pass-Through (TPT) payment timelines for key competitors and Lantheus's confidence in securing TPT status for its new formulation.

Answer

CEO Brian Markison expressed high confidence in obtaining TPT status. President Paul Blanchfield detailed that a key gallium competitor lost TPT on July 1, while a primary F-18 competitor will lose it on October 1, 2026. He noted Lantheus's new formulation could gain TPT status around the same time the competitor's expires, leveling the reimbursement field.

Justin Walsh asked about the long-term opportunity for the GRPR-targeting theranostic in prostate cancer, including the diagnostic's value outside the therapeutic and the therapeutic's potential positioning relative to PSMA treatments.

Answer

CEO Brian Markison detailed the strategic value of the GRPR target, noting its expression can be negatively correlated with PSMA, creating an opportunity in patients with low PSMA expression. He sees a distinct role for the imaging agent alone and envisions the therapeutic being used in combination with other modalities across all stages of prostate cancer, not just as a single agent.

Justin Walsh asked about the company's broader ex-U.S. commercial plans for its pipeline assets and its long-term focus on the U.S. market.

Answer

CEO Brian Markison stated that the company's focus is currently U.S.-based. The pending acquisition of Life Molecular Imaging will provide a stronger international footprint, and the company will carefully evaluate expanding into other markets like the EU on an opportunity basis, rather than through a greenfield approach. The goal is to reduce reliance on out-licensing assets.

Justin Walsh asked for commentary on the planned subset analyses for PNT2002 and what potential outcomes would determine whether Lantheus continues its agreement with Eli Lilly or steps away.

Answer

Executive Mark Kinarney highlighted Dr. Sartor's recent ESMO presentation, which showed positive findings from post-hoc analyses that adjusted for the high patient crossover rate confounding the OS data. Chief Medical Officer Jeff Humphrey added that the trial clearly met its primary endpoint and showed quality-of-life benefits. Management indicated they will continue to analyze the data with their partner before determining the final path forward.

Justin Walsh of Jones Trading inquired about the market's reception to the pancreatic cancer data presented at ASCO, asking specifically about feedback from physicians or potential partners.

Answer

CFO Mali Zeevi responded that there was excitement around the ASCO data, particularly regarding the promising results on liver metastases, which she noted is an unusual finding and received very positive feedback.

Justin Walsh from Jones Trading asked for management's perspective on the long-term opportunity for Effexxa now that its commercialization is handled by Aramid. He also inquired about BioLineRx's high-level thoughts on the current trajectory and potential headwinds in the broader cell and gene therapy fields.

Answer

CEO Philip Serlin stated that while he cannot speak for Aramid, BioLineRx has consistently viewed the total market as approximately $300 million, with Effexxa having the potential to become a $100+ million product. This would generate significant value through the 18-23% tiered royalty agreement. Regarding cell and gene therapy, Mr. Serlin acknowledged initial headwinds but emphasized it's a long-term play. He believes motixafortide (Effexxa) is positioned as a superior mobilization agent that can reduce costs and improve cell collection for these potentially curative therapies, representing significant future upside.

Inquired about the long-term market opportunity for Effexxa now that it is licensed to Aramid, and asked for the company's high-level view on the trajectory of the cell and gene therapy sector.

Answer

The company estimates the long-term opportunity for Effexxa to be in the $100+ million range within a total addressable market of about $300 million. They view the cell and gene therapy space as a long-term play where Effexxa has significant upside as a superior mobilization agent, despite current headwinds in the field.

Justin Walsh asked for more detail on how the new agreement with the Premier GPO facilitates customer engagement and helps overcome market entry barriers for hospitals.

Answer

CEO Steve Lisi responded that the Premier agreement is significant because it removes a major initial barrier to entry. He explained that it allows for direct and serious discussions with member hospitals and streamlines the sales process by having pricing and terms pre-negotiated, which saves time.

Justin Walsh from Jones Trading questioned how the strategic partnership with Omnicom might affect potential discussions with more traditional pharmaceutical partners.

Answer

CEO Rick Stewart described the Omnicom partnership as complementary to other potential routes, emphasizing the need for flexibility. CCO Jaime Xinos added that Omnicom is a well-known entity that has launched over 100 products for major pharma companies, suggesting the relationship adds credibility and demonstrates that Achieve will have a complete and valuable launch package.

Justin Walsh asked if there have been any noticeable changes in the company's interactions with the FDA and whether the current administration's focus on chronic diseases presents a philosophical opportunity for a product like cytisinicline.

Answer

Dr. Cindy Jacobs, President and Chief Medical Officer, responded that there have been no changes in interactions with the FDA, which remains as responsive as usual. Regarding the broader regulatory environment, she expressed hope that cytisinicline's strong efficacy and safety data will be viewed favorably, especially given its potential to address chronic diseases like COPD and cardiovascular conditions caused by smoking.

Justin Walsh asked what specific narrative and data points would be most effective in converting high-volume varenicline prescribers to cytisinicline. He also inquired about potential barriers to entry for future generics beyond intellectual property, such as the complexity of the plant-based extraction manufacturing process.

Answer

Chief Commercial Officer Jaime Xinos explained that physicians are eager for new options and that cytisinicline's compelling profile of superior efficacy, tolerability, and compliance will be key differentiators. CEO Richard A. Stewart added that the positive patient experience from clinical trials creates a strong reputational advantage. Regarding generics, Stewart highlighted that the difficulty in sourcing and extracting the raw material from plants, which take time to mature, serves as a significant manufacturing barrier in addition to the company's robust IP estate extending beyond 2040.

Justin Walsh from JonesTrading inquired about the company's plans for disclosing data from the ORCA-OL trial and whether any commercial groundwork was being laid for a potential future vaping cessation indication.

Answer

Dr. Cindy Jacobs, President and Chief Medical Officer, explained that full ORCA-OL data would likely be presented at a meeting after the NDA submission, not before, and pointed to the positive DSMC safety reviews as the current focus. CEO Rick Stewart added that while the vaping opportunity is significant, the immediate commercial focus is on smoking cessation, with plans to expand the commercial structure to vaping later.

Justin Walsh inquired about the key success metrics for the upcoming PERIO-03 data readout for nelitolimod that would attract pharmaceutical partners. He also asked about the nature of potential partnerships, specifically whether interest is in nelitolimod alone or in conjunction with the TriNav delivery system, and how TriSalus envisions the structure of such a deal.

Answer

CEO Mary Szela explained that for the PERIO-03 Phase I trial, key outcomes are the device's performance and the drug's ability to stimulate the pancreatic tumor's innate immune environment. She noted that about 50% of the 12 patients are still alive, a positive sign. Szela clarified that nelitolimod's optimal performance is achieved through the TriNav delivery system. She stated that partnership interest is high, particularly because nelitolimod has shown efficacy in checkpoint-refractory patients, and the ideal partnership would involve TriSalus managing the procedural aspect while potentially participating in the drug's upside.

Justin Walsh of JonesTrading requested details on what to expect from the PERIO-03 trial data in pancreatic cancer, including appropriate benchmarks, and asked about the level of interest from potential partners for the nelitolimod program in UMLM.

Answer

CEO Mary Szela clarified that PERIO-03 is a Phase I monotherapy study in very sick patients, so it will not be compared to chemotherapy. The primary goals were to assess the safety and success of the new venous delivery technology, which she confirmed was successful. Final patient progression data is expected mid-year. Szela also reported surprisingly strong interest from pharmaceutical companies in partnering on nelitolimod, citing its mechanism of reducing myeloid-derived suppressor cells.

Justin Walsh from JonesTrading asked about the market dynamics between TriNav and TriNav Large, questioning how physicians would choose between the two devices. He also inquired about the competitive landscape and whether any other novel delivery catheters are emerging as potential competitors.

Answer

President and CEO Mary Szela explained that most interventional radiologists will use both TriNav and TriNav Large, as the choice is determined by the patient's vessel size, which is often unknown until the procedure begins. She noted that lacking TriNav Large previously excluded them from about 30% of the market. Regarding competition, she stated there are no direct competitors with similar pressure modulation technology for the liver or a venous approach for the pancreas, and highlighted the company's strong IP portfolio.

Justin Walsh asked about the company's current plans for developing naxitamab (DANYELZA) for the treatment of osteosarcoma.

Answer

CEO Michael Rossi confirmed that Y-mAbs continues to support investigator-sponsored studies (ISS) in osteosarcoma. He added that the company is leveraging learnings from its GD2-SADA trial to potentially develop a better diagnostic for GD2 expression, which could improve patient selection and accelerate future development in this indication.

Justin Walsh from JonesTrading asked about the unmet need in the CD38 SADA target indication and what level of clinical benefit would be required for the asset to be considered commercially viable.

Answer

CEO Michael Rossi acknowledged that while there is an unmet need in non-Hodgkin's lymphoma, it is a very competitive space. He explained that the CD38 program was advanced primarily to validate a second SADA target in the clinic, test the platform in a circulating tumor, and compare data against the solid tumor program. The long-term commitment to the program will be determined by future data and the strategic target roadmap to be unveiled in Q2.

Justin Walsh asked for Y-mAbs' perspective on the growing number of companies testing pretargeting radioimmunotherapy approaches and whether this trend provides additional validation for the SADA platform.

Answer

President and CEO Michael Rossi responded that increased activity from other companies validates the pretargeting concept, which aims to maximize tumor dose while minimizing off-target effects and improving logistics. He welcomed the intellectual contributions from others, stating that it increases the likelihood of getting more pretargeting products to patients and allows Y-mAbs to focus on its own strengths. He noted that time will tell which methods are optimal.

Justin Walsh of Jones Trading asked for management's view on the relative market opportunity for DANYELZA in potential new indications like frontline high-risk neuroblastoma and osteosarcoma, compared to its current approved use in relapsed/refractory neuroblastoma.

Answer

Chief Commercial Officer Sue Smith responded that while the bulk of current use is in the relapsed setting, a new commercial campaign is effectively increasing awareness and physician use in the refractory setting. She emphasized the drug's specific data for patients with an incomplete response and residual disease in the bone or bone marrow, which is where the company is seeing increased adoption.

Justin Walsh from JonesTrading asked for more details on the planned transition from the EGRIFTA SV to the new EGRIFTA WR formulation, and also requested commentary on the medium- to long-term growth expectations for the EGRIFTA franchise.

Answer

President and CEO Paul Lévesque and Global Commercial Officer John Leasure explained the transition process, noting it will be carefully orchestrated over approximately six months to manage payer readiness and system updates, starting with manufacturing and packaging. Regarding growth, they highlighted strong demand indicators, including a 15% year-over-year increase in new enrollments and a full patient base recovery post-shortage, driven by the growing medical recognition of EVAF's link to cardiovascular risk.

Inquired about the transition plan from EGRIFTA SV to the new EGRIFTA WR formulation and the company's medium- to long-term growth expectations for the EGRIFTA franchise.

Answer

The transition to EGRIFTA WR is planned as a well-orchestrated process over approximately 6 months, starting in July, to manage payer system updates. The company has experience from a previous formulation change. Long-term growth for the EGRIFTA franchise is expected to be strong, driven by increasing recognition of EVAF as a serious condition, a 15% year-over-year growth in new enrollments, and a patient base that has already recovered from the recent supply disruption.

Justin Walsh inquired about the specifics of the remediation efforts at the EGRIFTA SV manufacturer, the company's contingency plans for potential manufacturing delays, and the expected timing for business development activities and accretive asset acquisitions.

Answer

CEO Paul Lévesque stated the company is in daily contact with the manufacturer and is confident the PAS filing will be comprehensive enough for an expedited FDA review, noting there is sufficient patient-level supply until mid-January. Global Commercial Officer John Leasure added that inventory is being managed closely and multiple future manufacturing slots are reserved. Regarding business development, Mr. Lévesque highlighted the company's strong financial position and commercial capabilities, which have attracted interest from potential partners, and advised to 'stay tuned' for announcements.

Justin Walsh of JonesTrading inquired about updates on Theratechnologies' efforts to find accretive assets for its portfolio and asked for feedback from the ASCO presentation regarding potential partnership interest in sudocetaxel zendusortide.

Answer

President and CEO Paul Lévesque and Global Commercial Officer John Leasure addressed the asset acquisition question, stating they are actively engaged in discussions following over 45 meetings at BIO, are focused on finding the right asset without overpaying, and have advanced several opportunities. On the ASCO feedback, SVP and Chief Medical Officer Dr. Christian Marsolais noted the poster was well-attended and highlighted the clinical benefit seen in 44% of patients, which he attributed to a unique mechanism of action that is generating significant interest.

Justin Walsh of JonesTrading asked for more context on the types of clinical decisions informed by the CNSide diagnostic and inquired about the expected timeline and enrollment pace for the upcoming multi-dose trial for leptomeningeal metastases (LM).

Answer

Executive Marc Hedrick explained that CNSide informs critical decisions beyond therapy selection, such as initial diagnosis of LM, assessing for genetic drift in tumors, and determining when to potentially stop treatment. Regarding the multi-dose trial, Hedrick stated that they anticipate a faster data accumulation rate compared to the single-dose study due to a more streamlined protocol without the previous trial's built-in delays for DSMB reviews. He expects the trial to begin enrolling later in 2024, pending final FDA feedback.

Justin Walsh inquired about the comparative development timelines for rhenium obisbemeda in GBM versus LM, the expected patient data updates at upcoming conferences, and the key remaining clinical questions for the asset.

Answer

Executive Marc Hedrick stated that the Leptomeningeal Metastases (LM) program could achieve approval before the Glioblastoma (GBM) program due to a potentially more streamlined pivotal trial design and faster enrollment. Chief Medical Officer Dr. Norman LaFrance added that surprisingly positive Phase I efficacy signals for LM have accelerated its development. Hedrick also outlined patient enrollment goals for both trials and clarified that key clinical questions involve optimizing delivery for GBM and determining the optimal multi-dosing regimen for LM.

The analyst inquired about the specific efficacy and safety expectations for the upcoming data release, particularly any concerns related to the inhaled formulation that the FDA might focus on. He also asked for an update on other applications of the Thin Film Freezing technology beyond the main clinical programs.

Answer

The company stated they will be monitoring for a reduction in known oral voriconazole toxicities (liver, visual, rashes) as well as any potential inhaled-specific adverse events like bronchospasm. The year-end data will be a preliminary, directionally informative subset. Regarding other applications, the company mentioned ongoing collaborations with pharma partners on molecules like monoclonal antibodies and vaccines, citing a recent publication with Aptar Pharma, but emphasized these are currently viewed as upside potential to the core VORI and TAC programs.

Justin Walsh of B. Riley Securities inquired about the expected data presentation at the upcoming ESMO conference, including patient numbers and follow-up details. He also asked for more specifics on the previously reported Grade 1 CRS case and sought clarification on Dr. Jeffrey Miller's evolving role following the new Sponsored Research Agreement.

Answer

Chief Medical Officer Dr. Greg Berk stated that updated safety data for up to 12 patients would be presented at ESMO, noting that data for the 13th patient would not be ready. He clarified the CRS case was a non-dose-limiting fever. Chief Technology Officer Martin Schroeder added that Dr. Miller's involvement remains strong, focusing on advancing the TriKE platform and developing new candidates like dual-targeting TriKEs.