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    Chris Howerton

    Research Analyst at Jefferies

    Chris Howerton's questions to Alaunos Therapeutics (TCRT) leadership

    Chris Howerton's questions to Alaunos Therapeutics (TCRT) leadership • Q3 2022

    Question

    On behalf of Chris Howerton, an analyst asked about any differences in purity and viability of TCR-T cells from the cryopreserved process, the expected tumor type for the next patient, and the timing of the next data release.

    Answer

    VP of Technical Operations, Abhi Srivastava, stated that qualification runs show no significant differences in viability, purity, or TCR positivity between fresh and cryopreserved products. CEO Kevin Boyle Senior said the indication for the next patient has not been disclosed but that more comprehensive data, including translational data, will be presented at a major medical conference in 2023.

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    Chris Howerton's questions to KALA BIO (KALA) leadership

    Chris Howerton's questions to KALA BIO (KALA) leadership • Q4 2021

    Question

    Chris Howerton from Jefferies asked about the typical duration a patient remains on the co-pay assistance program and the success rate of converting them to paying customers. He also inquired about the specific pre-IND activities for KPI-012 and whether high script rejection rates were negatively impacting physician prescribing behavior.

    Answer

    Todd Bazemore, President and COO, explained that since EYSUVIS is an acute therapy, conversion happens upon refill after coverage is secured. He noted the sales force uses targeted messaging to physicians in practices with high coverage to mitigate prescribing hesitation. Kim Brazzell, Head of R&D and Chief Medical Officer, detailed that pre-IND work for KPI-012 involves manufacturing process optimization, analytical technique development, a GLP toxicology study, and protocol finalization.

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    Chris Howerton's questions to KALA BIO (KALA) leadership • Q3 2021

    Question

    Chris Howerton of Jefferies asked how the company plans to prioritize the development of KPI-012 relative to its existing new chemical entity assets. He also requested examples of successful direct-to-consumer (DTC) marketing campaigns in the ophthalmology space and any related return-on-investment metrics.

    Answer

    Chairman, President and CEO Mark Iwicki stated that the company's cash resources are sufficient to advance both the late-stage KPI-012 program and the earlier-stage TKI program concurrently. COO Todd Bazemore cited Restasis and Xiidra as highly successful examples of DTC marketing in ophthalmology. He explained that while it's too early for ROI metrics, the company sees digital DTC as the next key lever to pull for growth, with the sales force now at an optimal size of 105 representatives.

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    Chris Howerton's questions to Celldex Therapeutics (CLDX) leadership

    Chris Howerton's questions to Celldex Therapeutics (CLDX) leadership • Q4 2021

    Question

    Chris Howerton from Jefferies asked if the Phase 1b CSU data readout is a gating item for starting the Phase 2 study. He also questioned if there were any findings related to female gamete production in the non-human primate toxicology studies and the expected timeline for spermatogenesis normalization. In a follow-up, he asked about the status of the manufacturing tech transfer and if the subcutaneous formulation volume would permit self-administration.

    Answer

    SVP and CMO Diane Young clarified that the Phase 1b data is not a gating item for the Phase 2 trial initiation. CEO Anthony Marucci and SVP of Regulatory Affairs Margo Heath-Chiozzi reported no adverse effects on female reproductive organs. Executive Director of Research Diego Alvarado and Margo Heath-Chiozzi explained that spermatogenesis recovery will follow drug clearance, which will take time due to the high doses used, with more data expected late in the year. Anthony Marucci confirmed the tech transfer has started, and Diane Young added that the planned 0.5 to 2 mL injection volumes are within the range for potential future self-administration.

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    Chris Howerton's questions to Lyra Therapeutics (LYRA) leadership

    Chris Howerton's questions to Lyra Therapeutics (LYRA) leadership • Q3 2021

    Question

    Chris Howerton from Jefferies inquired about the expected enrollment timeline for the Phase 3 ENLIGHTEN program for LYR-210, the potential scientific mechanism behind the durable effects observed six months after device removal, and the enrollment expectations for the Phase 2 BEACON study for LYR-220.

    Answer

    President and CEO Maria Palasis stated that enrollment for the ENLIGHTEN and BEACON studies is expected to take approximately 12 months, running through 2022. Chief Medical Officer Dr. Robert Kern speculated that the broad anti-inflammatory effect of the steroid, unlike targeted biologics, may lead to tissue remodeling and a 'walking back the clock' effect on the disease, though he cautioned these are early findings.

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    Chris Howerton's questions to Lyra Therapeutics (LYRA) leadership • Q1 2021

    Question

    Chris Howerton from Jefferies posed several questions, asking about the specific learnings from the US-based PK study and their impact on the Phase 3 trial design, whether the design for LYR-220 has been finalized, and what clinical activities are included in the company's financial guidance.

    Answer

    President and CEO Maria Palasis clarified that for LYR-220, two designs with the 7,500 microgram dose will be advanced into the Phase 2 trial. Chief Medical Officer Rob Kern noted that the PK study demonstrated ease of patient recruitment and acceptance in the US, which bodes well for the Phase 3 trial. CFO Don Elsey confirmed that the financial guidance, which provides cash runway into 2023, includes the costs for the LYR-210 Phase 3 trial and the LYR-220 Phase 2 trial.

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    Chris Howerton's questions to Lyra Therapeutics (LYRA) leadership • Q4 2020

    Question

    Chris Howerton from Jefferies inquired about the new data to be presented at the upcoming COSM conference, the company's evolving reimbursement strategy, and Dr. Kern's perspective on LYR-210's potential to halt disease progression in chronic rhinosinusitis (CRS).

    Answer

    President & CEO Maria Palasis detailed that the COSM presentation would include data on each of the four cardinal symptoms, MRI results, and outcomes for patients with and without polyps. SVP of Commercial Strategy Corinne Noyes confirmed plans for a hybrid reimbursement model incorporating both buy-and-bill and specialty pharmacy. CMO Dr. Rob Kern and CEO Maria Palasis discussed how early intervention with LYR-210 could potentially prevent disease progression and the need for surgery, noting this will be an endpoint in the Phase 3 trial.

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    Chris Howerton's questions to Protagonist Therapeutics (PTGX) leadership

    Chris Howerton's questions to Protagonist Therapeutics (PTGX) leadership • Q4 2020

    Question

    Chris Howerton of Jefferies asked about the key features for FDA alignment on the primary endpoint for the polycythemia vera (PV) registrational study and requested a comparison of systemic versus local gut-restricted activity for PN-943 in IBD.

    Answer

    Chief Medical Officer Samuel Saks stated that for the PV study, the backbone of the primary endpoint will involve maintaining hematocrit levels below 45% over a significant period. Regarding PN-943, CEO Dinesh Patel and Chief Scientific Officer David Liu explained that their unique gut-restricted approach has already shown clinical proof-of-concept with a prior drug. They detailed that high local target engagement blocks both immune cell trafficking and local T-cell activation, with a 74% blood receptor occupancy being their established benchmark for efficacy, unlike systemic drugs that target 100%.

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