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    Mayank Mamtani • B. Riley Securities

    Mayank Mamtani's questions to Harrow Inc (HROW) leadership

    Mayank Mamtani's questions to Harrow Inc (HROW) leadership • Q2 2025

    Question

    Mayank Mamtani sought confirmation that VEVYE's Q2 Average Selling Price (ASP) has reset to a new sustainable level and asked about the end-of-quarter stocking dynamics for IHEZO compared to Q4 2024.

    Answer

    CEO Mark Baum confirmed they are comfortable with VEVYE's current ASP levels and see a bias for improvement, noting the current average is well ahead of pre-launch plans. He stated there were no significant stocking dynamics for IHEZO or other products in Q2, and highlighted that IHEZO adoption is accelerating in retina practices, with Q3 new account starts already surpassing the entire second quarter.

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    Mayank Mamtani's questions to Harrow Inc (HROW) leadership • Q1 2025

    Question

    Mayank Mamtani questioned the IHEEZO revenue decline despite stable unit demand, asking about account dynamics. For VEVYE, he asked about the progress of transitioning Klarity-C patients and its market share. He also requested an update on debt refinancing.

    Answer

    CEO Mark L. Baum attributed IHEEZO's revenue variance to ASP management for buy-and-bill products but noted positive demand trends from retina accounts. For VEVYE, he expressed high confidence in winning the cyclosporine market due to its superior clinical profile and competitive pricing, without giving specific transition numbers. CFO Andrew Boll confirmed that Harrow is in active, positive discussions with lenders and expects to complete a debt refinancing by late summer or early fall 2025.

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    Mayank Mamtani's questions to Harrow Inc (HROW) leadership • Q4 2024

    Question

    Mayank Mamtani asked about Q1 trends versus seasonality, the net price and profitability impact of the 'VEVYE Access For All' program, and for an update on the company's 5-year plan in light of its debt maturity and acquisition strategy.

    Answer

    CEO Mark L. Baum suggested viewing the business in two halves, with Q1 typically being lighter due to deductible resets. He boldly predicted the VEVYE access program would increase both unit volume and average selling price (ASP) within six months. CFO Andrew Boll stated the company has great options to refinance its debt. Baum confirmed the 5-year plan is intact without needing acquisitions, though the company remains open to intelligent, value-creating deals like Melt.

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    Mayank Mamtani's questions to Harrow Inc (HROW) leadership • Q3 2024

    Question

    Mayank Mamtani questioned the strategy for improving VEVYE's gross-to-net margin and asked about potential DTC advertising. He also inquired about the procedural overlap between IHEEZO and TRIESENCE, the expected net price for TRIESENCE, and the potential value creation from the upcoming MELT-300 data.

    Answer

    CEO Mark Baum stated Harrow will not pursue DTC advertising for VEVYE but will improve gross-to-net through payer contracting, driven by strong clinical data, with the goal of meaningfully improving ASP. CFO Andrew Boll added the focus is shifting from volume to margin improvement. Baum noted IHEEZO and TRIESENCE are bundled for GPOs but declined to comment on TRIESENCE's net price. Regarding MELT-300, he said positive data, expected next week, could create a nearly $100 million annual revenue opportunity for Harrow.

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    Mayank Mamtani's questions to Kymera Therapeutics Inc (KYMR) leadership

    Mayank Mamtani's questions to Kymera Therapeutics Inc (KYMR) leadership • Q2 2025

    Question

    Mayank Mamtani of B. Riley Securities asked about the baseline EASI scores of enrolled patients, screen failure rates, the method for measuring skin degradation, and any learnings from the 4-month toxicology studies.

    Answer

    CEO Nello Mainolfi and CMO Jared Gollob stated the entry criterion is an EASI score of 16 or higher but did not comment on the baseline of enrolled patients or screen failure rates. They confirmed skin degradation is measured by mass spectrometry on biopsies. From the toxicology studies, Nello Mainolfi confirmed that STAT6 degradation was complete and sustained throughout the study period.

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    Mayank Mamtani's questions to Trevi Therapeutics Inc (TRVI) leadership

    Mayank Mamtani's questions to Trevi Therapeutics Inc (TRVI) leadership • Q2 2025

    Question

    Mayank Mamtani from B. Riley Securities asked about the dose levels in the two ongoing Phase 1 studies, how dose-finding work informs the company's IP strategy, and whether FVC data from the CORAL trial would be presented at CHEST.

    Answer

    CEO Jennifer Good confirmed that FVC data will not be presented, as the study was too short for it to be meaningful, and that all study data is reviewed for new IP opportunities. Chief Development Officer James Cassella specified that the TITLE study is a dose-escalation trial, while the DDI study uses a single strength of Haduvio.

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    Mayank Mamtani's questions to Trevi Therapeutics Inc (TRVI) leadership • Q1 2025

    Question

    Mayank Mamtani asked about plans for further dose exploration for RCC, the potential trial design for a broader interstitial lung disease (ILD) study, and details regarding the recent FDA Type C meeting.

    Answer

    Executive Jennifer Good stated that decisions on RCC dose exploration will follow the IPF data readout. Chief Development Officer Dr. James Cassella and Chief Commercial Officer Farrell Simon indicated a future ILD trial would likely use a crossover design and target a broad population with both ILD and chronic cough. Regarding the FDA, management confirmed the Type C meeting was a technical query on validating the cough count endpoint, and the agency provided clear, timely guidance.

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    Mayank Mamtani's questions to Trevi Therapeutics Inc (TRVI) leadership • Q4 2024

    Question

    Mayank Mamtani from B. Riley Securities inquired about the placebo response expectations for the IPF chronic cough study, the nature of the two-week run-in period, and how baseline cough counts might differ from the prior CANAL study. He also asked about the potential market positioning of Haduvio versus P2X3 antagonists for RCC.

    Answer

    Executive Jennifer Good clarified the two-week period is for dose titration, not a placebo run-in, and noted the study's powering assumption of a 30% placebo effect is conservative compared to the 15-23% seen in prior IPF cough studies. For market positioning, she explained Haduvio would target RCC patients who have failed other therapies, including potential P2X3 antagonists, thereby addressing a significant unmet need.

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    Mayank Mamtani's questions to Zymeworks Inc (ZYME) leadership

    Mayank Mamtani's questions to Zymeworks Inc (ZYME) leadership • Q2 2025

    Question

    On behalf of Mayank Mamtani from B. Riley Securities, an analyst inquired about the potential for ZW191 data at upcoming fall conferences like ESMO and asked for an estimate of how many dose escalation cohorts would be completed by that time.

    Answer

    CEO Kenneth Galbraith reiterated that while the company is eager to share initial ZW191 data, it will only do so at a peer-reviewed medical meeting once an abstract is accepted. He declined to provide a specific timeline or commit to a particular conference, stating a data release is possible in 2025 or early 2026.

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    Mayank Mamtani's questions to Novavax Inc (NVAX) leadership

    Mayank Mamtani's questions to Novavax Inc (NVAX) leadership • Q2 2025

    Question

    Mayank Mamtani from B. Riley Securities asked if comparable CD4 T-cell superiority data could be expected from Sanofi's study and questioned the importance of B-strain immunogenicity. He also inquired about the process of converting Material Transfer Agreements (MTAs) into financial transactions and Novavax's understanding of the evolving BARDA framework.

    Answer

    EVP, Head of Research & Development Ruxandra Draghia-Akli stated she could not comment on Sanofi's data but noted their own T-cell data is encouraging, while strain-specific performance is variable year-to-year. President, CEO & Director John Jacobs explained that MTAs allow potential partners to validate Novavax's technology, which can lead to licensing deals. EVP, Chief Corporate Affairs & Advocacy Officer Silvia Taylor added that Novavax continues to engage with BARDA on potential funding for its pandemic influenza asset, emphasizing the value of its technology platform.

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    Mayank Mamtani's questions to Novavax Inc (NVAX) leadership • Q1 2025

    Question

    Mayank Mamtani from B. Riley Securities asked about the regulatory weight of real-world quality-of-life data, the potential design of a pivotal trial for the CIC/Flu vaccine, the timeline for IND filings for early-stage programs, and whether potential new partnerships are included in financial guidance.

    Answer

    Head of R&D Dr. Ruxandra Draghia-Akli noted that real-world data like the SHIELD study primarily informs consumers, as regulators focus on controlled trial data. CEO John Jacobs added that any pivotal trial for CIC/Flu would be designed with a future partner. CFO James Kelly confirmed the current revenue framework excludes any yet-to-be-signed partnership agreements.

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    Mayank Mamtani's questions to Novavax Inc (NVAX) leadership • Q4 2024

    Question

    Mayank Mamtani asked for an update on BLA-related interactions with the FDA, plans for the CDC ACIP meeting, visibility on H5N1 pandemic preparedness funding, and a preview of the second-half 2025 R&D Day.

    Answer

    President and COO John Trizzino described FDA interactions as 'positive and productive' ahead of the April PDUFA date. Head of R&D Ruxandra Draghia-Akli highlighted positive non-human primate data for its H5N1 vaccine. President and CEO John Jacobs added that the company is seeking government funding for H5N1 and that it's too early to preview the R&D day, but the goal is a comprehensive update on all new programs.

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    Mayank Mamtani's questions to Novavax Inc (NVAX) leadership • Q3 2024

    Question

    Mayank Mamtani from B. Riley Securities asked about the expected trends for net pricing and distribution channels once Sanofi takes over commercialization in 2025. He also inquired about the company's steady-state operating expense structure for 2026-2027 and sought clarity on the next IND filing and any insight into Sanofi's pipeline prioritization.

    Answer

    President and COO John Trizzino expressed confidence that Sanofi's global marketing strength would have a 'dramatic impact' on demand and confirmed Novavax's strategy is to partner late-stage assets rather than build a commercial team. CEO John Jacobs highlighted that approximately $30 million in quarterly commercial spend will be eliminated, supporting cost reduction goals. Chief Medical Officer Dr. Robert Walker identified the RSV combination and pandemic influenza programs as the next candidates moving toward IND-enabling activities.

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    Mayank Mamtani's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership

    Mayank Mamtani's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q2 2025

    Question

    Mayank Mamtani of B. Riley Securities requested more detail on the claims of the newly issued patent extending to 2045, specifically its basis in weight-based dosing, and asked about plans to further build IP with emerging F4C outcomes data.

    Answer

    CEO Bill Sibold clarified that the strong new patent is based on the clear finding from the MAESTRO-NASH trial that weight-based dosing optimizes ResDiffera's efficacy and safety, a regimen adopted in the FDA label. He confirmed that 2045 is now the company's base case for all strategic planning. While they will look for future IP opportunities with the F4C indication, it is premature to detail those plans.

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    Mayank Mamtani's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q1 2025

    Question

    Mayank Mamtani asked for commentary on patient segmentation in light of new semaglutide data and the implications of upcoming F4 data for European pricing and launch strategy.

    Answer

    CEO William Sibold stated the new competitor data doesn't change their view, citing real-world adherence challenges for GLP-1s. He noted Rezdiffra is used across F2 and F3 stages and aims to be the foundational therapy from F2 to F4c. For Europe, he believes Rezdiffra's innovation will be recognized in pricing and that the two drug classes can coexist, as many patients still have MASH despite prior GLP-1 exposure.

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    Mayank Mamtani's questions to Syndax Pharmaceuticals Inc (SNDX) leadership

    Mayank Mamtani's questions to Syndax Pharmaceuticals Inc (SNDX) leadership • Q2 2025

    Question

    Mayank Mamtani asked about plans to generate real-world evidence for Revuforge as a post-transplant maintenance therapy and the expected duration in that setting. He also inquired about development milestones for moving Nyktymbo into earlier lines of GVHD.

    Answer

    CMO Dr. Nick Botwood confirmed that preliminary real-world data, including post-transplant use, will be presented later this year. CEO Michael Metzger reiterated that physicians anticipate a maintenance duration of one to two years. For Nyktymbo, Dr. Botwood highlighted ongoing trials in earlier-line GVHD, including a Phase 3 combo with steroids and a Phase 2 with ruxolitinib, as key to future expansion.

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    Mayank Mamtani's questions to TG Therapeutics Inc (TGTX) leadership

    Mayank Mamtani's questions to TG Therapeutics Inc (TGTX) leadership • Q2 2025

    Question

    Mayank Mamtani asked about the company's assumptions for the overall IV anti-CD20 market trends and new patient starts for competitors. He also inquired about how upcoming competitor data in CD19 CAR-T for MS might influence TG's development strategy for its own azacel program.

    Answer

    Chief Commercial Officer Adam Waldman stated that BRIUMVI continues to see strong growth in new patient enrollments with limited impact from competitors, and that the IV market has stabilized at around 60% of the total CD20 market. CEO Michael Weiss added that upcoming competitor CAR-T data is expected to be very early and is unlikely to alter their well-defined development plan for azacel.

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    Mayank Mamtani's questions to TG Therapeutics Inc (TGTX) leadership • Q1 2025

    Question

    Mayank Mamtani asked a series of questions regarding physician feedback on the 30-minute infusion, the scope of upcoming Phase III trials, drivers of R&D and SG&A spend, future profitability, and the status of the North Carolina manufacturing plant.

    Answer

    CEO Michael Weiss and CCO Adam Waldman responded. Waldman noted positive feedback on the 30-minute infusion's convenience. Weiss clarified plans for two pivotal trials (simplified dosing and 30-min infusion), explained that higher R&D spend was due to subcu manufacturing materials, and stated the focus is not on profitability targets this year. He also confirmed the North Carolina plant is a long-term, multi-year project for manufacturing backup.

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    Mayank Mamtani's questions to TG Therapeutics Inc (TGTX) leadership • Q4 2024

    Question

    Mayank Mamtani asked for the revenue split between new and maintenance BRIUMVI patients, details on dynamic market share, and an update on the size and objectives of the allogeneic CD19 (azer-cel) study.

    Answer

    Chief Commercialization Officer Adam Waldman did not provide a specific revenue split but expects maintenance prescriptions to become the majority in early 2025, and noted BRIUMVI is capturing about 1 in 4 new IV anti-CD20 patients. CEO Michael Weiss stated the azer-cel study is ready to enroll and is focused on dose-finding and establishing the right conditioning regimen, with the ultimate goal of slowing or stopping MS progression.

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    Mayank Mamtani's questions to TG Therapeutics Inc (TGTX) leadership • Q3 2024

    Question

    Mayank Mamtani from B. Riley Securities asked about the revenue split between new and maintenance patients, market share in newly diagnosed patients, the size of the intra-CD20 switch market, and the long-term supply goals for the dual-facility manufacturing setup.

    Answer

    Chief Commercialization Officer Adam Waldman noted that new patients still drive most revenue but expects repeat prescriptions to become the majority in the next few quarters. He confirmed a sizable portion of business comes from OCREVUS and KESIMPTA switches. CEO Michael Weiss stated that long-term supply goals between the two manufacturing sites are not yet defined but are being secured for long-term needs.

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    Mayank Mamtani's questions to Viking Therapeutics Inc (VKTX) leadership

    Mayank Mamtani's questions to Viking Therapeutics Inc (VKTX) leadership • Q2 2025

    Question

    Mayank Mamtani of B. Riley Securities questioned the rationale for selecting a 17.5mg top dose in the Phase III VANQUISH trial, up from 15mg in Phase II, and the reasoning behind the slower titration schedule. He also asked if a scenario exists where the oral formulation could be developed as a frontline therapy.

    Answer

    President & CEO Brian Lian explained that the excellent tolerability at 15mg in Phase II suggested room to go higher. The titration was slowed to a four-week cadence to potentially improve tolerability further, aligning with current commercial standards. Regarding the oral formulation, he noted it's premature to map out next steps, but a frontline therapy scenario is possible pending the data.

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    Mayank Mamtani's questions to Viking Therapeutics Inc (VKTX) leadership • Q1 2025

    Question

    Mayank Mamtani asked about the targeted cost of goods sold (COGS) under the CordenPharma manufacturing agreement and the objective of the 30mg maintenance dose arm in the VENTURE-Oral study.

    Answer

    Brian Lian, President and CEO, explained that while specific COGS figures are confidential, he expects margins to be consistent with other peptide products, benefiting from favorable tiered pricing at scale. He described the 30mg maintenance arm as a test to see if stepping down from a higher dose can prevent weight regain, exploring the viability of a low-dose oral maintenance therapy.

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    Mayank Mamtani's questions to Viking Therapeutics Inc (VKTX) leadership • Q4 2024

    Question

    Mayank Mamtani asked about the 13-week weight loss expectations for the oral Phase II study, potential cost of goods, and plans to study lean muscle mass preservation. He also sought an update on partnering discussions for the NASH program, VK2809.

    Answer

    CEO Brian Lian stated it was too early to predict 13-week weight loss or discuss COGS. He confirmed that while DEXA scans for lean muscle mass will be part of Phase III, a specific muscle preservation study is not planned. For VK2809, he acknowledged ongoing partnering discussions but noted the Phase III biopsy requirement remains a complicating factor.

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    Mayank Mamtani's questions to Altimmune Inc (ALT) leadership

    Mayank Mamtani's questions to Altimmune Inc (ALT) leadership • Q1 2025

    Question

    Mayank Mamtani of B. Riley Securities asked about the expected placebo response range, baseline demographics, which secondary endpoints will be in the top-line release, and pemvidutide's potential impact on bone and muscle health.

    Answer

    An Altimmune executive projected a placebo response for fibrosis between 7% and 13% due to their biopsy rereading method but deferred on specific demographics until final data. The top-line release will include weight loss, liver fat reduction, NITs like FibroScan and ELF, and safety data. The executive also highlighted pemvidutide's class-leading lean mass preservation (21.9% of weight loss) as a key differentiator against other metabolic drugs.

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    Mayank Mamtani's questions to Altimmune Inc (ALT) leadership • Q3 2024

    Question

    William, on behalf of Mayank Mamtani from B. Riley Securities, asked what specific details Altimmune is looking for in the full ESSENCE trial data presentation and how discussions with potential strategic partners have evolved recently.

    Answer

    CMO Dr. Scott Harris responded that while they will review the full ESSENCE data, the modest top-line results were predictable and reinforce their confidence in pemvidutide's potential for a superior profile. CBO Ray Jordt noted that partners are still defining their obesity strategies, and Altimmune's continued data generation on differentiating factors like lean mass preservation and MASH efficacy strengthens their position. CEO Dr. Vipin Garg added that the recent FDA alignment provides crucial clarity for these ongoing discussions.

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    Mayank Mamtani's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership

    Mayank Mamtani's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q2 2025

    Question

    Mayank Mamtani from B. Riley Securities asked for learnings from the obesity study's SAD data, whether MAD and combo cohorts are parallel, and which milestones are in the 2028 cash runway guidance.

    Answer

    An executive confirmed the multi-dose cohorts are enrolling in parallel and deferred sharing SAD data until later in the year. Outgoing CFO Ken Myszkowski stated that the cash runway guidance into 2028 includes near-term milestones expected from Sarepta and other milestones deemed probable, without providing specifics.

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    Mayank Mamtani's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q1 2025

    Question

    Mayank Mamtani sought clarification on the timing of data disclosures for the Sarepta-partnered programs, ARO-DM1 and ARO-DUX4. He also asked for a comparison of the target patient population for zodasiran in HoFH versus evinacumab.

    Answer

    An executive stated that they could not provide guidance on data readouts for the Sarepta-partnered programs, as the timing of disclosure is Sarepta's decision. Regarding zodasiran, another executive explained the target HoFH population is very similar to evinacumab's but highlighted potential advantages for zodasiran, including quarterly subcutaneous dosing versus monthly IV infusion and a different safety profile.

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    Mayank Mamtani's questions to Arrowhead Pharmaceuticals Inc (ARWR) leadership • Q3 2024

    Question

    An analyst on behalf of Mayank Mamtani asked about key factors being monitored in the neuromuscular landscape that could influence ARO-DM1 and DUX4 development, the clinical timeline for dimer candidates, and the timeline for the adipose tissue targeting program.

    Answer

    Dr. James Hamilton, Chief of Discovery and Translational Medicine, stated they follow all competitor programs closely. President and CEO Dr. Christopher Anzalone added that they aim to be best-in-class by learning from others' regulatory paths. He expects the first dimer (PCSK9/APOC3) in the clinic next year and guided for a CTA filing for the first adipose-targeted candidate this year, with more details at the August 14 webinar.

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    Mayank Mamtani's questions to Cytokinetics Inc (CYTK) leadership

    Mayank Mamtani's questions to Cytokinetics Inc (CYTK) leadership • Q1 2025

    Question

    Mayank Mamtani of B. Riley Securities asked about the confidence in the submitted REMS being accepted, what to expect after the June late-cycle meeting, and the potential value of an Adcom.

    Answer

    Robert I. Blum, President and CEO, noted that REMS negotiations are iterative, which is likely why the FDA designated the submission a major amendment, allowing sufficient time for discussion. He confirmed the late-cycle meeting is expected in June and dismissed the idea of an Adcom, as the FDA has not planned one and such meetings rarely focus on REMS implementation.

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    Mayank Mamtani's questions to Cytokinetics Inc (CYTK) leadership • Q4 2024

    Question

    Mayank Mamtani from B. Riley Securities asked about the CK-586 study in HFpEF, inquiring if the high-dose cohort is contingent on results from the first two, and what the company aims to learn about tolerability and biomarkers.

    Answer

    SVP & CMO Stuart Kupfer confirmed the study has a flexible design, and the decision to proceed with the third cohort will be based on data from the first two, which are expected to complete enrollment by year-end. He stated the trial's primary focus is on safety and tolerability, but it will also collect data on cardiac biomarkers like NT-proBNP, pharmacokinetics, and ejection fraction to inform future development in this dose-finding study.

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    Mayank Mamtani's questions to Cytokinetics Inc (CYTK) leadership • Q3 2024

    Question

    Mayank Mamtani of B. Riley Securities inquired about the CK-586 Phase II trial, asking about expectations for functional improvement and how the drug compares to GLP-1s in the HFpEF space.

    Answer

    Fady Malik, EVP of R&D, and Stuart Kupfer, SVP & CMO, responded. They noted the 12-week trial is sufficient for dose-finding and observing signals, similar to the nHCM cohort in REDWOOD. They positioned CK-586 as complementary to GLP-1s, which target obesity-related HFpEF, whereas CK-586 is aimed at a hypercontractile phenotype that may not be obesity-driven.

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    Mayank Mamtani's questions to Mink Therapeutics Inc (INKT) leadership

    Mayank Mamtani's questions to Mink Therapeutics Inc (INKT) leadership • Q4 2024

    Question

    Mayank Mamtani asked for investigator feedback on the recent ACR IO presentation, the potential for a registrational path for AGENT-797 based on current data, and how the PRAME TCR iNKT approach differentiates from competitors. He also asked for the IND timeline for next-gen programs.

    Answer

    President and CEO Dr. Jennifer Buell noted that the lead investigator is highly motivated and will present future data. Regarding a registrational path, she said the company will accumulate more data before advancing regulatory discussions. Dr. Buell explained that the PRAME TCR iNKT platform is differentiated by its ability to recruit T cells and NK cells and its favorable tolerability profile. She also confirmed the IND filing for program 215 is planned for 2025.

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