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    Mark Breidenbach

    Research Analyst at Oppenheimer & Co. Inc.

    Mark Breidenbach's questions to Immuneering (IMRX) leadership

    Mark Breidenbach's questions to Immuneering (IMRX) leadership • Q4 2022

    Question

    Mark Breidenbach from Oppenheimer & Co. Inc. questioned why IMM-1-104's broad RAS-agnostic activity is unique for a MEK inhibitor and confirmed whether establishing the Recommended Phase 2 Dose (RP2D) is required before starting expansion cohorts.

    Answer

    President and CEO Benjamin Zeskind and CSO Brett Hall explained that unlike older MEK inhibitors limited by toxicity and adaptive resistance (like CRAF-bypass), IMM-1-104's "deep cyclic inhibition" mechanism and novel engagement avoids these issues, unlocking MEK's potential. Chief Medical Officer Scott Barrett confirmed that the RP2D must be determined before starting Phase 2a expansion cohorts, noting a specific dose evaluation phase is planned to select the optimal dose.

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    Mark Breidenbach's questions to SYNLOGIC (SYBX) leadership

    Mark Breidenbach's questions to SYNLOGIC (SYBX) leadership • Q2 2022

    Question

    Mark Breidenbach from Oppenheimer & Co. Inc. inquired about the timeline for finalizing the PKU Phase III protocol, its potential for global registration, the manufacturing plan for the study, and the mechanism of action for the new gout candidate, SYNB 2081.

    Answer

    CEO Aoife Brennan stated that Phase III design details will be shared after the end-of-Phase II FDA meeting, noting a focus on US BLA speed despite global ambitions. COO Tony Awad confirmed that Phase III materials will be supplied by their in-house, expanded manufacturing facility. CSO Dave Hava explained that SYNB 2081 is expected to target uric acid from both dietary sources and systemic recirculation.

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    Mark Breidenbach's questions to SYNLOGIC (SYBX) leadership • Q1 2022

    Question

    Mark Breidenbach from Oppenheimer inquired if baseline plasma Phenylalanine (Phe) levels could skew the treatment effect in PKU patients and asked about the company's plans for engaging with the EMA for a regulatory path in Europe, including the potential for ex-U.S. sites in the Phase III trial.

    Answer

    CEO Aoife Brennan explained that current modeling and clinical data suggest the absolute Phe reduction is independent of baseline levels for patients above the 600 micromole/liter threshold. She also confirmed that Synlogic is actively engaging with ex-U.S. regulators due to the significant global commercial opportunity. While the intent is to include ex-U.S. sites to accelerate the Phase III trial, a firm commitment awaits clarification of the regulatory pathway to avoid potential delays.

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