Justin Zelin

Justin Zelin asked for an update on CARVYKTI's outpatient administration, specifically the percentage of patients dosed in an outpatient setting, and the contribution of revenue from earlier versus later lines.

Answer

Alan Bash, President of CARVYKTI, reiterated that about 50% of patients are treated outpatient, expecting growth, though new site onboarding can temporarily slow the overall mix. He confirmed 60% of scripts come from second through fourth-line populations, with third-line showing the most pronounced growth.

Justin Zelin asked for an update on the percentage of CARVYKTI patients receiving outpatient administration and the contribution of revenue from earlier lines versus later lines of therapy.

Answer

Alan Bash, President of CARVYKTI, reported that approximately 50% of patients are currently treated in an outpatient setting, with expectations for this percentage to grow. He also noted that about 60% of CARVYKTI scripts originate from the second through fourth line patient population, with the third line showing the fastest growth.

Justin Zelin asked about the company's strategy for reinvesting capital once it reaches profitability and whether recent U.S. tariff changes are expected to have a material impact on manufacturing costs or the supply chain.

Answer

Interim CFO Jessie Yeung stated that while the company is disciplined with spending, it is committed to reinvesting in next-generation cell therapies. Regarding tariffs, she explained that because U.S. products are predominantly made and sourced in the U.S., the company does not anticipate any material exposure based on current evaluations.

On behalf of Justin Zelin, an analyst asked about the ultimate potential percentage of patients that could be treated in the outpatient setting and how to model capital expenditures going forward.

Answer

Executive Alan Bash stated that they see continued growth in outpatient use and have not modeled a specific cap or ceiling, as centers that start with inpatient use tend to quickly adopt outpatient protocols. Executive Jessie Yeung commented on CapEx, stating that while investment continues worldwide, the bulk of it will be completed in 2025.

On behalf of Justin Zelin, Jed asked if clinician hesitancy due to neurotoxicity concerns remains a factor in the second-line setting. He also inquired about the launch trajectory for CARVYKTI in China.

Answer

SVP Steven Gavel acknowledged that toxicity is a key consideration in earlier lines, which is why educational efforts have been increased, but noted the strong OS data helps ease concerns. CEO Ying Huang explained that due to supply priorities, the U.S. and European markets are being prioritized over China for now. He also confirmed that U.S./EU production uses no raw materials from China, mitigating any potential tariff impact.

Justin Zelin asked about Viking's latest thinking on partnership versus going alone for commercialization in the obesity field, given increasing strategic interest.

Answer

Brian Lian (President and CEO, Viking Therapeutics) reiterated that Viking is receptive to outside interest and prefers a larger partner for commercialization, but it is not mandatory. He stated that Viking is prepared to go alone if necessary, and the focus remains on executing phase three trials and commercial preparation.

Justin Zelin asked about Viking's latest thinking on partnership versus going alone for commercialization in the obesity field, given increasing strategic interest.

Answer

Brian Lian (President and CEO, Viking Therapeutics) reiterated that Viking is receptive to outside interest and believes a larger partner would be very helpful for commercialization, though it's not mandatory. He stated that Viking is prepared to go alone but also to engage with interested parties, focusing on executing Phase 3 trials and continuing commercial preparation.

Justin Zelin of BTIG inquired about the plan for using auto-injectors in the Phase III VANQUISH studies and whether a bridging study would be required for their implementation.

Answer

President & CEO Brian Lian confirmed that the company plans to transition patients to auto-injectors early next year. He also stated that a bioequivalence study will be conducted in the interim to assess the auto-injector relative to the current vial and syringe format.

Justin Zelin asked for commentary on upcoming data from oral small molecule obesity competitors and the relative scalability of peptide API compared to small molecules.

Answer

CEO Brian Lian declined to speculate on competitor data. He addressed what he called a 'misperception' about manufacturing, stating that while peptide chemistry is simple, scalability is the main challenge. He expressed confidence in Viking's ability to produce at a scale that supports a multi-billion dollar franchise.

Justin Zelin inquired whether the Phase III study for subcutaneous VK2735 would use an auto-injector and asked for clarification on the clinical development path for VK0214 in X-ALD, specifically if the next step would be a registrational trial.

Answer

Brian Lian, an executive, confirmed that an auto-injector will be used in the Phase III study, either from the start or by transitioning patients during the trial. For the X-ALD program, he affirmed the expectation that the next step would be a registrational study focused on a functional or quality-of-life endpoint, moving beyond biomarkers.

Justin Zelin from BTIG requested an update on the enrollment progress for the IPH4502 Phase 1 study, including expectations for initial data release in H1 2026, the number of patients, and anticipated safety/efficacy insights.

Answer

CMO Sonia Quaratino reported that IPH4502 enrollment is progressing very well, with a continuous list of patients for different dose levels and parallel enrollment in backfill cohorts. She expects enrollment to complete by Q1 2026, with preliminary efficacy data from approximately 50-60 patients available about a quarter after the last cohort is recruited.

Justin Zelin asked for an update on the enrollment progress for IPH4502's Phase I study, including expectations for initial data release, the number of patients, and anticipated safety and efficacy profiles.

Answer

Sonia Quaratino, CMO, reported that IPH4502 enrollment is progressing 'extremely well' with a steady list of patients and parallel enrollment in backfill cohorts due to the Bayesian design. She expects enrollment to complete in Q1 2026, with preliminary efficacy data (first CT scan) available approximately eight weeks after the last dosing, leading to a pool of 50-60 patients by then.

Justin Zelin from BTIG sought an update on the enrollment progress for the IPH4502 Phase 1 study, including the expected timeline for initial data, the number of patients whose data would be available, and any preliminary safety or efficacy expectations.

Answer

Sonia Quaratino, EVP & Chief Medical Officer, reported that IPH4502 enrollment is progressing very well, utilizing an adaptive Bayesian design allowing parallel enrollment. She anticipates enrollment completion by Q1 2026, with preliminary safety and efficacy data (including first CT scans) expected in H1 2026 from a pool of approximately 50-60 patients.

Justin Zelin asked if the Q2 revenue of $2.1 million for AvmapKefaxin Jakobak reflects true patient demand with minimal channel stocking, and inquired about future inventory expectations, gross-to-net dynamics, and the payer mix.

Answer

President and CEO Dan Paterson confirmed that due to the use of only two specialty pharmacies and tight inventory controls, the revenue reflects true demand with minimal stocking. CFO Dan Calkins added that while specific guidance isn't provided, a gross-to-net in the 15% to 20% range, typical for oral oncology drugs, is a reasonable expectation.

Justin Zelin from BTIG inquired about specific new markets for ChemTrak launches and the company's strategy for them, as well as the most effective tactics for driving growth in the U.S. community setting.

Answer

Ralph Torbay, EVP of Commercial, highlighted ongoing launches in the UK, Poland, and the Netherlands, and a new partnership with Air Chem for Turkey and the MENA region. For U.S. community growth, he mentioned leveraging data-driven triggers and AI to smartly predict where patients are and deploy resources efficiently, rather than expanding operations.

Justin Zelin of BTIG inquired about the expected safety and tolerability profile for Immunocore's pipeline candidates outside of oncology, specifically in infectious and autoimmune diseases. He also asked about the minimum commercially successful TPP regarding adverse events like cytokine release syndrome (CRS) in these settings.

Answer

David Berman, Head of R&D, explained that for infectious diseases, only mild CRS is expected, whereas for autoimmune diseases, no CRS is anticipated because the mechanism turns the immune system off rather than on. He highlighted that the tissue-specific platform is designed to avoid systemic immunosuppression. CEO Bahija Jallal added that the ongoing dose escalation in the HIV trial beyond 300 micrograms suggests a very good safety profile.

Justin Zelin from BTIG inquired about the timeline for the autoimmune disease programs to enter the clinic, noting that CMC manufacturing has commenced.

Answer

CEO Bahija Jallal responded that with CMC manufacturing going well, the company is hopeful that the autoimmune programs will enter the clinic by next year.

Justin Zelin from BTIG inquired about the timeline for the company's autoimmune disease programs to enter the clinic, noting that CMC manufacturing for candidates is underway.

Answer

CEO Bahija Jallal responded that CMC manufacturing is progressing well and that the company is 'hoping by next year' for the autoimmune programs to enter the clinic.

Justin Zelin asked about the commercial preparations for the anticipated NPM1 label expansion for Revuforge and whether the uptake is expected to be immediate and meaningful or more gradual.

Answer

CCO Steve Closter explained that the commercial team is well-prepared as they are already targeting the same physicians who are now experienced with Revuforge. He anticipates a significant 'bump' in uptake upon approval, not a gradual one, given the strong data and low off-label use. CEO Michael Metzger emphasized that the expansion triples the addressable patient population, making it a major growth driver.

Justin Zelin of BTIG questioned the company's confidence in receiving a broad NCCN recommendation for NPM1, asked about payer discussions for this indication ahead of FDA approval, and inquired about the strategic importance of being first-to-market.

Answer

CEO Michael Metzger expressed high confidence in NCCN inclusion due to the practice-changing data. CCO Steven Closter explained that payer discussions for NPM1 will begin after the sNDA is filed, but noted payers are currently reimbursing based on unmet need. He emphasized that the first-mover advantage is critical for building "competitive immunity" through superior customer experience.

Justin Zelin from BTIG, LLC inquired whether a companion diagnostic would be required for the approval of Revumenib for the KMT2A indication.

Answer

CEO Michael Metzger responded that while there is precedent for a companion diagnostic to be required post-approval, the company is confident in its path to approval given the availability of existing and robust testing methods for KMT2A. He indicated more details would be provided after the regulatory decision.

Justin Zelin asked about the desired target product profile for ZW251 to ensure differentiation and inquired about the linker stability and expected toxicity profile of ZW191 compared to other technologies.

Answer

CSO Dr. Paul Moore explained that for ZW251, the goal is to meet or exceed current benchmarks in HCC, leveraging the broad expression of the GPC3 target. For ZW191, he described the linker as having traditional stability, not a highly stable one, which is part of a design philosophy focused on creating a tolerable profile to enable higher dosing and future combination strategies, a concept supported by preclinical data.

An associate for Justin Zelin asked why the 115 mg dose of Emi-Le was discontinued, if the next data update will include a meaningful number of patients with proteinuria mitigation, and about any KOL feedback comparing Emi-Le to Pfizer's discontinued program.

Answer

An executive explained that the 115 mg dose was stopped after observing reversible Grade 3 AST in two of three patients and because target exposures were achieved at 95 mg and below. Regarding KOL feedback, the executive noted that investigators were already seeking to join Mersana's trial for post-topo-1 TNBC patients because Pfizer was not pursuing that indication, making Emi-Le 'the only game in town'.

Justin Zelin from BTIG asked what would be a meaningful safety delta to differentiate XMT-1660 and how that profile could enable future combination therapies.

Answer

CEO Martin Huber identified avoiding dose-limiting toxicities like severe neutropenia, peripheral neuropathy, and ocular toxicity as the key differentiator, referencing prior experience with the payload. Chief Development Officer Mohan Bala elaborated with data from the UPGRADE study, where a previous ADC (UpRi) was successfully combined with carboplatin without exacerbating toxicities and showed a 70%+ response rate, serving as a proof-of-concept for the payload's combination potential.

Justin Zelin of BTIG asked about the wholly-owned farnesyl transferase inhibitor (FTI) programs, specifically if Kura has preclinical data with pan-KRAS inhibitors. He also inquired about the company's business development strategy for the remainder of the year.

Answer

CEO Troy Wilson confirmed they have non-clinical data showing synergistic activity with both mutant-selective and pan-RAS inhibitors. Regarding business development, he stated the bar for in-licensing is very high, and the focus is on clinical collaborations rather than out-licensing, with the notable exception of the diabetes program, which may be partnered.

Justin Zelin from BTIG inquired if Kura plans to analyze for resistance mutations in its combination and earlier-line studies and what their expectations are for those findings.

Answer

EVP of Clinical Development, Dr. Mollie Leoni, stated they do not expect baseline resistance in frontline settings. She explained that the risk of developing resistance decreases enormously in combination therapy because it 'hits it harder and faster,' preventing resistant colonies from growing. Therefore, she anticipates fewer issues with mutations in combination settings.

A representative for Justin Zelin of BTIG requested more details on the FDA feedback for the ROR2 and CTLA-4 programs, specifically asking about the investigator treatment choice options for ROR2 and the potential dose and control arm for the frontline melanoma study.

Answer

Executive Jay Short stated that pivotal trials for both programs are planned for 2025, with ROR2 being further along. Executive Eric Sievers specified the ROR2 investigator choice options are cetuximab, docetaxel, or methotrexate. For the CTLA-4 program, Sievers confirmed the control arm would allow for a doublet checkpoint inhibitor and that the company is evaluating 350 mg and 700 mg doses, highlighting the observed dose-response relationship.

Inquired about the durability of the treatment effect, the potential need for redosing, and the characteristics of the patient subgroup that showed eGFR preservation.

Answer

The Phase II data suggests a potential tail-off of benefit, but the Phase III program will provide more definitive insights on durability. Redosing around 18-24 months is considered a possibility. A majority (56%) of the patients with preserved eGFR were in stage 4.

Justin Zelin from BTIG inquired about the potential for COVID-19 disruptions to delay the CNCT-19 NDA filing and impact future EVOMELA sales.

Answer

Alexander Zukiwski, EVP and Chief Medical Officer, acknowledged a potential slight delay for the CNCT-19 filing but remained confident it would be completed within 12 months, barring new disruptions. Larry Zhang, President, noted strong Q1 EVOMELA sales but highlighted uncertainty from lockdowns in key revenue centers like Shanghai. Chairman and CEO Wei-Wu He reinforced this uncertainty, noting sales teams are currently unable to visit doctors in Beijing and Shanghai.

Justin Zelin from BTIG inquired about the impact of COVID-19 lockdowns on clinical trial activities in China and asked about the company's strategy for future business development and pipeline expansion.

Answer

Chairman and CEO Wei-Wu He reported no significant disruptions to clinical trials, although sales force access to physicians is restricted. He and SVP of Business Development Jim Goldschmidt reiterated their strategy of acquiring innovative hematology/oncology assets for the China market, leveraging their commercial expertise and forging strategic partnerships to strengthen their pipeline.

Justin Zelin from BTIG asked about the key drivers for growing EVOMELA patient numbers towards the 10,000 target, questioning if it would come from new geographies, sites, or indications. He also inquired about market uptake trends and potential price pushback for currently available CAR-T therapies in China.

Answer

Wei-Wu He, Chairman & CEO, identified the primary bottleneck for EVOMELA growth as the limited number of hospital transplant units, not a lack of demand. The strategy focuses on re-educating doctors about the benefits of transplant therapy. Regarding CAR-T, He noted that the two approved competitor therapies are priced high (over ~$200,000 USD), resulting in very slow uptake with fewer than 50 patients treated. He stated that CASI's CNCT19 is expected to be priced significantly lower.

Justin Zelin of BTIG requested context on how Aramchol's fibrosis improvement results compare to other available data sets in the competitive NASH landscape.

Answer

Professor Vlad Ratziu explained that while direct head-to-head comparisons are difficult, very few drugs have demonstrated a clear antifibrotic effect. He positioned Aramchol favorably, noting that its 60% fibrosis improvement rate is very high compared to historical placebo rates of 15-30%. He suggested its magnitude of effect appears higher than what has been shown with other agents like obeticholic acid (OCA), though he cautioned this was not from a direct comparison and emphasized the need for Phase 3 data.