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    Tony Butler

    Senior Analyst at Rodman & Renshaw

    Tony Butler, Ph.D., is a Senior Analyst at Rodman & Renshaw specializing in biotechnology and oncology sector research, with a focus on companies developing advanced therapeutics. He has covered and issued performance-driven calls on firms including Intellia Therapeutics, CRISPR Therapeutics, Telesis Bio, GT Biopharma, Atara Biotherapeutics, TCR2 Therapeutics, and Ayala Pharmaceuticals, with notable ratings such as a 184.85% return on CRISPR Therapeutics and multiple triple-digit returns across biotech stocks. Butler began his analyst career over a decade ago, has held senior equity analyst roles at firms including Rodman & Renshaw since at least 2020, and is recognized for quantitative results on platforms tracking analyst performance. He holds a Ph.D., is FINRA-registered, and maintains industry-standard securities licenses, underlining his expertise and credentials in equity research.

    Tony Butler's questions to Adaptimmune Therapeutics (ADAP) leadership

    Tony Butler's questions to Adaptimmune Therapeutics (ADAP) leadership • Q4 2024

    Question

    Tony Butler of Rodman & Renshaw asked about the future geographic rollout of Authorized Treatment Centers (ATCs), particularly in the Midwest, and whether the company anticipates needing more salespeople to support this expansion.

    Answer

    Executive Cintia Piccina confirmed that while more ATCs are planned for the middle of the country, the current distribution is based on patient population density. She stated that the existing commercial team of five regional leads is considered sufficient for now, though the company remains open to future expansion if needed.

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    Tony Butler's questions to Adaptimmune Therapeutics (ADAP) leadership • Q3 2024

    Question

    Tony Butler asked about the potential need for bridging studies for lete-cel, its CMC (Chemistry, Manufacturing, and Controls) status, its cost of goods relative to Tecelra, and the possibility of licensing uza-cel ovarian cancer data to Galapagos.

    Answer

    CEO Adrian Rawcliffe stated that they plan to use the existing commercial process for lete-cel manufactured by Miltenyi Biotech, mitigating the need for major bridging work. He indicated the cost of goods would be similar to Tecelra, aligning with the previously guided 70% gross margin at peak sales for the franchise. Regarding uza-cel, he noted that while Galapagos has options for other indications on their platform, he would not prejudge any future discussions about the ovarian cancer data.

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    Tony Butler's questions to Adaptimmune Therapeutics (ADAP) leadership • Q2 2024

    Question

    Tony Butler asked about the SURPASS-3 trial's site distribution, noting a majority are ex-U.S., and questioned whether the company's operating expense guidance of roughly $230 million annually is sufficient given the trial's ramp-up.

    Answer

    CEO Adrian Rawcliffe confirmed the ex-U.S. site strategy is intentional and that enrollment is progressing well. He affirmed the cost guidance is appropriate because while SURPASS-3 costs are ongoing, costs from the now-completed SPEARHEAD-1 trial are decreasing, and the guidance already accounts for the commercial team build-out in H1 2024.

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    Tony Butler's questions to COMPUGEN (CGEN) leadership

    Tony Butler's questions to COMPUGEN (CGEN) leadership • Q4 2024

    Question

    Tony Butler asked about the expected enrollment rate for the COM701 ovarian cancer study and the real-world percentage of platinum-sensitive patients who are not treated with bevacizumab or PARP inhibitors.

    Answer

    Chief Medical Officer Dr. Michelle Mahler expressed confidence in a rapid enrollment rate due to high investigator interest and few competing trials. She explained that PARP inhibitor eligibility is genetically determined, while bevacizumab use varies, with some physicians reserving it for later lines, creating the target patient pool for the study.

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    Tony Butler's questions to COMPUGEN (CGEN) leadership • Q3 2024

    Question

    Tony Butler of Rodman & Renshaw questioned what progression-free survival (PFS) improvement would be considered clinically relevant in the platinum-sensitive maintenance setting and asked about the necessity of engaging the GOG for trial enrollment.

    Answer

    Chief Medical Officer Dr. Michelle Mahler stated that a three-month improvement in PFS over the placebo arm is the target. She also noted that while they have engaged with key opinion leaders involved in the GOG, the organization typically supports later-stage studies. Guest investigator Dr. Oladapo Yeku added that achieving a PFS of 8-9 months would be clinically meaningful as it would maintain a patient's platinum-sensitive status, which is correlated with better long-term outcomes.

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    Tony Butler's questions to Rain Enhancement Technologies Holdco (RAIN) leadership

    Tony Butler's questions to Rain Enhancement Technologies Holdco (RAIN) leadership • Q1 2023

    Question

    Tony Butler from EF Hutton asked about tumor heterogeneity in DDLPS, specifically whether varying tumor growth kinetics within a single tumor could impact the efficacy of milademetan's 'growth arrest' mechanism.

    Answer

    CSO Robert Doebele acknowledged that heterogeneity exists, including different components like well-differentiated liposarcoma, which could respond differently. He explained that DDLPS tumors contain significant non-cancerous tissue that may not shrink, and that p53 reactivation can induce both growth arrest and apoptosis, with milademetan showing tumor shrinkage in other tumor types.

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    Tony Butler's questions to Rain Enhancement Technologies Holdco (RAIN) leadership • Q4 2022

    Question

    Tony Butler of EF Hutton questioned the rationale for using a PD-L1 antibody (atezolizumab) over a PD-1 antibody in the MANTRA-4 trial, referencing nonclinical data. He also asked about the biological mechanism of progression for patients who initially respond to milademetan.

    Answer

    CSO Robert Doebele explained that the company sees no meaningful clinical or preclinical difference between targeting PD-1 and PD-L1, as they affect the same interaction. He also stated that the expected resistance mechanism to milademetan is the emergence of p53 mutations, which can be monitored, rather than second-site mutations in the MDM2 drug-binding pocket.

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    Tony Butler's questions to GT Biopharma (GTBP) leadership

    Tony Butler's questions to GT Biopharma (GTBP) leadership • Q2 2021

    Question

    Tony Butler of ROTH Capital asked for clarification on the status of the Wisconsin clinical trial site for the GTB-3550 study, which is listed but not recruiting. He also requested more details on the second-generation TriKEs, their enhanced potency and cytotoxicity, and how the B7H3 TriKE exemplifies these advancements.

    Answer

    CEO Tony Cataldo clarified that the Wisconsin site, along with another in Oregon, was put on hold but is ready to be activated for Phase II, with plans to expand to 8-10 sites total. CTO Martin Schroeder explained that second-generation TriKEs, like the B7H3 candidate, use nanobodies instead of single-chain fragments to improve steric interaction, resulting in dramatic potency improvements, sometimes up to tenfold.

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    Tony Butler's questions to Marker Therapeutics (MRKR) leadership

    Tony Butler's questions to Marker Therapeutics (MRKR) leadership • Q1 2021

    Question

    Tony Butler from ROTH Capital Partners asked for clarification on the biological data required by the FDA to demonstrate comparability between the two different reagents being used in the six-patient safety lead-in portion of the AML study.

    Answer

    CEO Peter Hoang and CMO Dr. Mythili Koneru clarified that the issue of product comparability between reagents has already been settled with the FDA. The safety lead-in's primary purpose is solely to monitor for dose-limiting toxicities (DLTs), and no additional biological comparability data is required to be submitted to the agency before proceeding to the main Phase II trial.

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    Tony Butler's questions to Marker Therapeutics (MRKR) leadership • Q1 2020

    Question

    Tony Butler of ROTH Capital Partners asked about the process following the completion of the six-patient safety lead-in for the AML trial. He specifically questioned what data needs to be reported to the FDA and whether the company must wait for FDA feedback before proceeding to the larger portion of the study.

    Answer

    Chief Medical Officer Dr. Mythili Koneru explained that the company will monitor for dose-limiting toxicities (DLTs) as outlined in the protocol. She clarified that if no DLTs are identified, Marker can proceed directly into the main Phase 2 portion of the study without waiting for a response from the FDA, although the safety data will be reported to the agency.

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    Tony Butler's questions to Marker Therapeutics (MRKR) leadership • Q3 2019

    Question

    Tony Butler of Roth Capital inquired about the key endpoints and design of the upcoming AML trial, the process for enrolling patients with active disease post-transplant, and the planned total enrollment size.

    Answer

    SVP of Clinical Development, Dr. Mythili Koneru, detailed the Phase 2 study design, which includes a 120-patient randomized adjuvant arm (60 receiving MultiTAA, 60 observation) and a 40-patient single-arm active disease arm. President and CEO Peter Hoang clarified the patient enrollment pathway post-transplant and confirmed the total planned enrollment is 160 patients.

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