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    David Bautz

    Senior Analyst at Zacks Small Cap Research

    David Bautz, PhD, is a Senior Analyst at Zacks Small Cap Research specializing in healthcare equities, with a particular focus on biotechnology and pharmaceutical companies. He has covered firms such as Imunon, MediciNova, and Oncotelic, consistently providing detailed, science-driven coverage; his reports highlight clinical trial progress and company valuations, but platform-verified performance metrics such as success rates or returns are not publicly disclosed. Bautz began his career as a research associate at Human Genome Sciences before earning his PhD in Biochemistry and Biophysics and later served as an NRSA postdoctoral fellow studying cancer immunotherapies prior to joining Zacks in 2014. He holds BS and MS degrees in Biochemistry from Virginia Tech and earned his PhD from UNC Chapel Hill; no evidence of FINRA registration or traditional securities licenses is available, but he is well recognized for translating complex scientific information into actionable investment research.

    David Bautz's questions to Imunon (IMNN) leadership

    David Bautz's questions to Imunon (IMNN) leadership • Q2 2025

    Question

    David Bautz of Zacks Small Cap Research questioned what is needed to open remaining clinical trial sites for OVATION III, specifically if financing was a holdup, and whether the EU would require European sites for a potential regulatory filing.

    Answer

    Chief Medical Officer Dr. Douglas Faller explained that enrolling patients in the EU is not an absolute requirement for approval, especially with a strong Overall Survival (OS) endpoint, though they are considering European sites. He also stated there are no barriers to opening more US and Canadian sites, noting they are receiving unsolicited requests to participate. President and CEO Dr. Stacy Lindborg added that site activation is a naturally staged and ordered process.

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    David Bautz's questions to Imunon (IMNN) leadership • Q3 2024

    Question

    David Bautz of Zacks Investment Research inquired about the design of the upcoming Phase III trial for IMNN-001, specifically regarding the inclusion of patients on PARP inhibitors and other combination therapies. He also asked about the company's financing strategy for the study.

    Answer

    CEO Stacy Lindborg explained that the Phase III trial design will account for PARP inhibitor use, which was around 40% in Phase II, and will be discussed with the FDA to ensure balance. She confirmed that the current cash runway covers the trial's launch, and the company is actively seeking long-term investors to fully fund the study through the most investor-friendly means.

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    David Bautz's questions to Imunon (IMNN) leadership • Q2 2024

    Question

    Asked about key design factors for the Phase 3 trial to be discussed with the FDA, the enrollment progress of the MRD study, and whether a potential partnership for the vaccine program would cover just COVID or the entire platform.

    Answer

    Key Phase 3 design factors include ensuring balance for patients likely to receive PARP inhibitors and using overall survival as the primary endpoint. Enrollment in the MRD study is competitive and will be accelerated by adding two new sites (MSK, Johns Hopkins). The company confirmed they would seek to partner the entire vaccine platform, not just the COVID program.

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    David Bautz's questions to Imunon (IMNN) leadership • Q2 2024

    Question

    David Bautz asked about the key design factors for the Phase 3 trial being discussed with the FDA, the enrollment progress of the MRD study, and whether a potential partnership for IMNN-101 would cover just the COVID program or the entire vaccine platform.

    Answer

    CEO Stacy Lindborg explained that a key Phase 3 design consideration is ensuring balance for patients with genetic mutations (e.g., BRCA) who are likely to receive PARP inhibitors, with overall survival as the primary endpoint. She noted the MRD study enrollment is competitive and will accelerate as more sites come online, with data expected by year-end. Finally, she confirmed that the company intends to partner the entire PlaCCine vaccine platform, not just the COVID-19 asset.

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    David Bautz's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership

    David Bautz's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership • Q1 2025

    Question

    David Bautz of Zacks Small-Cap Research asked for confirmation on the plan for 15 clinical trial sites, the steps needed to activate them beyond funding, and the estimated monthly patient enrollment rate.

    Answer

    Executive Chaim Lebovits confirmed a list of potential sites is public on clinicaltrials.gov but Clinical Trial Agreements (CTAs) are still being finalized and will be announced upon signing. He did not provide a specific monthly enrollment number but noted the 200-patient trial is expected to take three years to fully enroll, with a BLA filing possible after Part A is complete.

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    David Bautz's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership • Q1 2025

    Question

    The analyst asked for confirmation on the number of planned clinical trial sites, the necessary steps to get those sites operational for patient enrollment, and an estimate of monthly enrollment capacity based on manufacturing capabilities.

    Answer

    The company confirmed that a list of potential sites is available on clinicaltrials.gov, but they are still in the process of signing Clinical Trial Agreements (CTAs) and will announce them as they are finalized. The enrollment will be gradual and will scale alongside manufacturing capacity. The entire 200-patient trial is expected to take three years to enroll and treat, with a BLA filing possible after the first part of the trial if results are statistically significant.

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    David Bautz's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership • Q4 2024

    Question

    David Bautz of Zacks Small-Cap Research asked about the company's financial runway, specifically what percentage of trial funding is needed to begin enrollment and the subsequent timeline to enroll the first patient.

    Answer

    Executive Chairman Chaim Lebovits explained that while a specific funding percentage isn't required to start, the company's partners are providing significant leeway. He highlighted the recent $1.64 million warrant inducement and other funding efforts, including a potential non-dilutive grant in the fall, as key to their strategy. He did not provide a specific timeline for first patient enrollment post-funding.

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    David Bautz's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership • Q2 2024

    Question

    David Bautz asked if a Biologics License Application (BLA) could be filed immediately after the 24-week double-blind portion of the Phase III trial, or if data from the open-label extension would be required. He also inquired about the level of enthusiasm for NurOwn among patient advocacy groups and whether they might be a source of grant funding.

    Answer

    Executive Chaim Lebovits confirmed that the company could file the BLA based on positive results from the 24-week double-blind period alone. He also stated that enthusiasm from patient advocacy groups is even stronger than for the previous trial, as they are supportive of getting a clear answer on NurOwn in the targeted patient population, and the company hopes this support will translate into grants.

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    David Bautz's questions to X4 Pharmaceuticals (XFOR) leadership

    David Bautz's questions to X4 Pharmaceuticals (XFOR) leadership • Q4 2024

    Question

    David Bautz of Zacks Small-Cap Research asked about 2025 sales goals for XOLREMDI, data on patient prescription refill rates, and whether the revised primary outcome for the 4WARD trial could affect the potential label for chronic neutropenia.

    Answer

    Mark Baldry (Executive) and Paula Ragan (Executive) explained that no formal sales guidance is being provided, as the focus is on building a new market through education. They noted patient adherence is high. Christophe Arbet-Engels (Executive) stated the trial's endpoint change is not expected to impact the potential label, as the full data package will be submitted.

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    David Bautz's questions to X4 Pharmaceuticals (XFOR) leadership • Q3 2024

    Question

    David Bautz of Zacks Investment Research asked if the company would provide 2025 sales guidance for XOLREMDI and whether any infection data was collected in the Phase II study, particularly for patients with reduced G-CSF.

    Answer

    CEO Paula Ragan stated that the company is not providing 2025 sales guidance at this time but will offer more commercial details heading into the new year. She explained that the Phase II study was not designed to assess infection rates, but highlighted that the observed robust increase in functional neutrophils is a proven correlate for infection risk reduction, giving them high confidence for the Phase III trial.

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    David Bautz's questions to X4 Pharmaceuticals (XFOR) leadership • Q2 2024

    Question

    David Bautz inquired about the mechanics of how XOLREMDI prescriptions are filled, such as on a monthly basis, and how the company recognizes revenue in relation to those prescription fills.

    Answer

    President and CEO Dr. Paula Ragan explained that it was too early to disclose the specific play-by-play of patient prescriptions. She noted that the current revenue figure reflects a blend of both inventory stocking at the specialty pharmacy and revenue from individual patients on therapy. Dr. Ragan indicated that more detailed metrics to help with forecasting may be provided later in the year or in 2025.

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    David Bautz's questions to Armata Pharmaceuticals (ARMP) leadership

    David Bautz's questions to Armata Pharmaceuticals (ARMP) leadership • Q1 2018

    Question

    David Bautz of Zacks Investment Research asked if another patient outcome update would be provided before the FDA meeting, what percentage of treatment inquiries result in actual treatment, and what dosing data is being gathered from the expanded access program.

    Answer

    COO Igor Bilinsky stated that while two new case studies will be presented at upcoming conferences, a cumulative update before the FDA meeting is uncertain. CFO Steve Martin explained that not all inquiries lead to treatment, as many requests are for patients who do not meet the strict regulatory criteria for life-threatening disease. CEO Paul Grint added that they are gaining insights on dosing, with a regimen of twice-daily intravenous administration emerging as a consistent approach, which has yielded positive responses.

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    David Bautz's questions to Armata Pharmaceuticals (ARMP) leadership • Q3 2017

    Question

    David Bautz from Zacks Investment Research asked for clarification on the timing of discussions with the FDA, inquiring if the company would wait for data from more than the initial 10 patients. He also questioned what specific data types the FDA would require and if the FDA only allows phage therapy from GMP-certified facilities under expanded access programs.

    Answer

    CEO Paul Grint confirmed that AmpliPhi will wait until it has data from a larger cohort of approximately 30 patients before engaging the FDA to help refine study designs. Grint explained the FDA would want comprehensive data, including clinical chemistries, safety markers, microbiological results, and mortality data. Regarding GMP facilities, he noted that AmpliPhi is likely the only company currently treating U.S. patients under single-patient expanded access and referenced an FDA NIH workshop for more details on the agency's quality expectations.

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    David Bautz's questions to Armata Pharmaceuticals (ARMP) leadership • Q2 2017

    Question

    David Bautz from Zacks Investment Research asked about the patient identification process for the expanded access program, whether the company is selective in the cases it accepts, and if the recently treated patient with a Pseudomonas lung infection had cystic fibrosis.

    Answer

    CEO Paul Grint explained that the company is establishing a network of infectious disease physicians in the U.S. and Australia who identify appropriate patients. He clarified that while they are not 'choosy,' they are focusing on specific, difficult-to-treat infections with high unmet medical need, such as prosthetic joint infections and resistant endocarditis. Dr. Grint declined to comment on the specific medical history of the recently treated patient, citing patient confidentiality.

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    David Bautz's questions to Nuo Therapeutics (AURX) leadership

    David Bautz's questions to Nuo Therapeutics (AURX) leadership • Q2 2015

    Question

    David Bautz of Zacks Investment Research inquired about the ongoing CMS reimbursement rate discussions for Aurix, the payment and coverage structure within the VA system, and the timeline for any interim analysis of the Gold Study.

    Answer

    CEO Dean Tozer explained that the current $430 Aurix reimbursement rate is under its annual review by CMS, with final 2016 rates expected in November. CFO (Acting) David Jorden clarified that in the VA system, Aurix has national coverage at a $340 price point via the Federal Supply System (FSS), with adoption focused on clinical trials at individual facilities rather than reimbursement hurdles. Regarding the Gold Study, Tozer stated no guidance on an interim analysis is available yet, pending the launch of an automated data collection system.

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