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    Roy Buchanan • Citizens JMP

    Roy Buchanan's questions to Dynavax Technologies Corp (DVAX) leadership

    Roy Buchanan's questions to Dynavax Technologies Corp (DVAX) leadership • Q2 2025

    Question

    Roy Buchanan from Citizens inquired about Dynavax's business development strategy, asking why a deal for a hospital antibiotic portfolio might not be a strategic fit and whether new internal programs like H5N1 and Lyme disease have altered the company's M&A focus.

    Answer

    CEO Ryan Spencer stated that Dynavax seeks to leverage its core strengths in vaccine development and institutional sales, making an inpatient hospital antibiotic portfolio a less strategic fit. He clarified that the early-stage H5N1 and Lyme programs require relatively small capital investments and do not diminish the company's focus on pursuing synergistic and accretive business development opportunities.

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    Roy Buchanan's questions to Dynavax Technologies Corp (DVAX) leadership • Q1 2025

    Question

    Roy Buchanan sought clarification on the upcoming shingles data, asking if the program would be halted if it fails to meet the previously discussed 75% median CD4 T-cell level versus Shingrix at the 1-month mark. He also asked for an explanation for the perceived slowdown in HEPLISAV-B's market share growth and inquired about the revenue contribution from Medicare.

    Answer

    CEO Ryan Spencer and CMO Robert Janssen clarified that the key immunogenicity endpoint for the 1-month shingles readout is now the vaccine response rate, not a specific T-cell frequency threshold. They explained that T-cell durability at 6 and 12 months is a more critical and informative measure. Regarding market share, CCO Donn Casale emphasized that year-over-year comparisons are more appropriate than sequential ones due to channel mix seasonality, and the company remains on track for its long-term goals. Casale also noted that Medicare is an important future growth driver, with broader access expected in the second half of the year.

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    Roy Buchanan's questions to Dynavax Technologies Corp (DVAX) leadership • Q4 2024

    Question

    Roy Buchanan inquired about how much can be inferred about the shingles vaccine's durability from the upcoming 1-month data, the rationale for the extension study in older adults, and the company's appetite for additional share buybacks.

    Answer

    CEO Ryan Spencer and Chief Medical Officer Rob Janssen explained that durability cannot be determined from the 1-month data alone, but 6- and 12-month follow-up data is being collected. Dr. Janssen added the extension study in adults over 70 is critical for assessing immunogenicity and collecting necessary safety data in the highest-risk population before a Phase III trial. CFO Kelly MacDonald stated that while buybacks are a useful tool, the primary focus remains on maximizing HEPLISAV-B and advancing the pipeline, though further buybacks could be considered later.

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    Roy Buchanan's questions to Dynavax Technologies Corp (DVAX) leadership • Q3 2024

    Question

    Roy Buchanan of Citizens JMP asked for details on the plague vaccine program, including the dose optimization plan submitted to the Department of Defense (DoD) and the expected timeline for a response. He also inquired about the sBLA for the HEPLISAV-B dialysis label, asking how long it might take to compile the required data and whether discussions with the FDA are ongoing.

    Answer

    CEO Ryan Spencer deferred specific comments on the plague program until the company receives a response from the DoD, which he anticipates in the near term, possibly by early next year. Regarding the dialysis sBLA, Spencer confirmed engagement with the FDA is ongoing. Chief Medical Officer Robert Janssen added that they are proposing a real-world evidence study and are optimistic about being able to resubmit by mid-May of the following year, despite the lack of a formal PDUFA timeline.

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    Roy Buchanan's questions to Arbutus Biopharma Corp (ABUS) leadership

    Roy Buchanan's questions to Arbutus Biopharma Corp (ABUS) leadership • Q3 2024

    Question

    Roy Buchanan of Citizens JMP asked for clarification on the denominator for calculating functional cure rates in Cohort A1, the strategy for imdusiran lead-in for future studies, and the expected scope of data from the AB-101 trial in the first half of next year.

    Answer

    Chief Medical Officer Dr. Karen Sims stated the functional cure rate would be assessed against the entire cohort but also analyzed in the subset of patients with low baseline surface antigen. Regarding trial design, she noted the lead-in strategy has been successful but all options are being considered. Interim President and CEO Mike McElhaugh added that HBV patient data for AB-101 is expected in H1 2025, but could not specify the exact dataset, and a forum would be found to release Part 1/2 data.

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    Roy Buchanan's questions to Arbutus Biopharma Corp (ABUS) leadership • Q2 2024

    Question

    Roy Buchanan sought to confirm if the planned Phase 2b trial would be the next and potentially only new trial initiated soon. He also asked about the company's strategic thinking on focusing on the patient sub-population with baseline HBsAg levels below 1,000 IU/mL.

    Answer

    Interim President and CEO Mike McElhaugh confirmed plans to advance imdusiran into a later-stage trial, likely a Phase 2b, but noted details are pending further data. He emphasized the strategic importance of the <1,000 IU/mL patient group, citing the dramatically higher response rate of 67% in the IM-PROVE I trial and the large size of this patient segment globally.

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    Roy Buchanan's questions to Arbutus Biopharma Corp (ABUS) leadership • Q1 2024

    Question

    Roy Buchanan sought confirmation on the imdusiran dosing schedule in the AB-729-203 trial, asked if durvalumab timing is the only variable between cohorts, inquired about AB-101's target engagement measurement, and requested an update on enrollment for the nivolumab combination cohort.

    Answer

    Chief Medical Officer Dr. Karen Sims confirmed the imdusiran dose is 60mg every 8 weeks and that the timing of the two durvalumab doses is the only variable between the trial's three arms. She explained that AB-101 target engagement is measured using peripheral blood mononuclear cells. Regarding enrollment, she noted that the nivolumab cohort enrolled 22 patients, slightly over the target of 20, due to screening logistics across global sites.

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