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    Vernon Bernardino

    Research Analyst at H.C. Wainwright & Co.

    Vernon Bernardino is Managing Director and Senior Biotechnology Analyst at H.C. Wainwright & Co., specializing in equity research for biotechnology and biopharmaceutical companies focused on cancer, infectious diseases, immunotherapy, and cell-based therapies. He covers firms such as Miragen Therapeutics, Cassava Sciences, ENDRA Life Sciences, vTv Therapeutics, Pluristem Therapeutics, and Novavax, with a track record that includes notable call returns exceeding 35% on Cassava Sciences and 29% on ENDRA Life Sciences, alongside a quantitative success rate shown on platforms like Benzinga. Bernardino began his career as a buy-side analyst at Nicholas Applegate Capital Management and has held senior analyst positions at Rodman & Renshaw, UBS Securities, FBR & Co., MLV & Co., Seaport Global Securities, and Brinson Patrick Securities Corporation, joining H.C. Wainwright in December 2018. He holds a bachelor's degree from Rutgers University and an MBA in finance from the University of San Diego, supported by over a decade of industry experience and recognized professional credentials.

    Vernon Bernardino's questions to Humacyte (HUMA) leadership

    Vernon Bernardino's questions to Humacyte (HUMA) leadership • Q4 2024

    Question

    Vernon Bernardino of H.C. Wainwright asked about the sales force's educational process for new institutions, whether the ATEV supplemental BLA review would be faster than the original, and if the smaller CABG vessel would have a lower manufacturing cost.

    Answer

    Executive Laura Niklason described a 'two-pronged' educational strategy combining the sales team (teaching to the label) and medical affairs specialists (discussing published data and biology). She also noted the use of a new budget impact model for VAC committees. While hoping for a shorter review for the supplemental BLA, she declined to predict FDA timelines. She confirmed that the smaller, shorter CABG vessel will be less costly to produce as costs scale roughly with the mass of the tissue.

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    Vernon Bernardino's questions to Humacyte (HUMA) leadership • Q3 2024

    Question

    Vernon Bernardino asked for an update on the BioVascular Pancreas (BVP) program, including next steps toward a human clinical study and the timeline for seeing early primate data, referencing recent successes in islet cell implantation by other institutions.

    Answer

    Executive Laura Niklason detailed that the BVP program is focused on optimizing islet dosing in primates to fully reverse the diabetic state. She highlighted the platform's key advantages: it is islet-source agnostic and allows for the retrieval of transplanted cells, unlike liver injections. While confident in the technology, she indicated that proving the principle in large animals is the priority before selecting an islet source for a first-in-man study. She advised to 'stay tuned' for primate data, suggesting it would be a 'few more months'.

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    Vernon Bernardino's questions to NRX Pharmaceuticals (NRXP) leadership

    Vernon Bernardino's questions to NRX Pharmaceuticals (NRXP) leadership • Q4 2024

    Question

    Vernon Bernardino questioned the expected timing for finalizing the NRX-100 commercial deal, the competitive barrier for others to create single-use ketamine, the revenue run-rate of target clinics, and details about the TMS device manufacturer partnership.

    Answer

    CEO Jonathan Javitt expressed hope for a deal finalization in the second quarter but stated the company is not dependent on it. He noted that any competitor would face a multi-year delay to establish stability data for a preservative-free formulation, creating a significant head start for NRx. He confirmed target clinics have run rates of $5 million or larger and declined to provide further details on the TMS manufacturer term sheet at this time.

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    Vernon Bernardino's questions to NRX Pharmaceuticals (NRXP) leadership • Q4 2024

    Question

    Asked about the timeline for the NRX-100 commercial deal, the competitive landscape for single-use ketamine, the revenue profile of acquisition targets, and details about the TMS partnership.

    Answer

    A deal for NRX-100 could potentially be finalized in Q2, but it is not certain. Competitors would face a multi-year delay to replicate the company's preservative-free formulation. Acquired clinics are expected to have revenues of $5 million or more. The previously mentioned '3 acquisitions' figure includes Kadima. No further details were provided on the TMS partner.

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    Vernon Bernardino's questions to NRX Pharmaceuticals (NRXP) leadership • Q3 2024

    Question

    Asked for details on the company's revenue recognition policy for the planned clinic acquisitions and whether future guidance would include performance metrics for these acquired entities.

    Answer

    The CEO clarified his forward-looking statement was about aggregating revenue-generating entities, not the specifics of GAAP accounting. The new CFO stated that the exact revenue recognition policy is complex and will be finalized with auditors to ensure compliance, and that future disclosures will be complete.

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    Vernon Bernardino's questions to NOVAVAX (NVAX) leadership

    Vernon Bernardino's questions to NOVAVAX (NVAX) leadership • Q4 2024

    Question

    Vernon Bernardino inquired about potential changes to the 2025-2026 seasonal flu vaccine composition and asked how long manufacturers can wait for strain selection before needing to produce doses at risk.

    Answer

    Chief Medical Officer Robert Walker clarified there are no plans to extend the current Phase III cohort and that strain selection for a future vaccine would be aligned with public health authorities after a partner is secured. President and CEO John Jacobs declined to speculate on at-risk manufacturing timelines.

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    Vernon Bernardino's questions to NOVAVAX (NVAX) leadership • Q3 2024

    Question

    Vernon Bernardino from H.C. Wainwright & Co. asked how the CIC vaccine's flu component is designed to handle seasons with lower flu vaccine efficacy. He also requested insight into how the company's gross margins are expected to change in the future.

    Answer

    Chief Medical Officer Dr. Robert Walker explained that the CIC trial is a comparative immunogenicity study, not a clinical efficacy trial. Its primary endpoint is to show the immune response is non-inferior to a competitor vaccine, a metric independent of a given flu season's real-world effectiveness. CEO John Jacobs clarified that from 2025, traditional gross margin will not be a relevant metric, as product supplied to Sanofi will be on a cost-plus basis.

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    Vernon Bernardino's questions to GeoVax Labs (GOVX) leadership

    Vernon Bernardino's questions to GeoVax Labs (GOVX) leadership • Q3 2024

    Question

    Asked about future R&D expenses for manufacturing, the payment structure with Oxford Biomedica, and the timing of BARDA reimbursements.

    Answer

    Most heavy manufacturing costs for 2024 are complete. BARDA-related costs are fully reimbursed, with a roughly 30-60 day lag. The Oxford Biomedica contract is milestone-based.

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    Vernon Bernardino's questions to Moleculin Biotech (MBRX) leadership

    Vernon Bernardino's questions to Moleculin Biotech (MBRX) leadership • Q3 2024

    Question

    Vernon Bernardino of H.C. Wainwright & Co. questioned whether Moleculin has pursued or intends to pursue a Special Protocol Assessment (SPA) with the FDA for the MIRACLE trial.

    Answer

    Executive John Waymack revealed that the company had discussed an SPA with the FDA, but the agency advised against it to avoid the months-long delay, given that both parties were already in full agreement on the trial design. Executive Walter Klemp added that an SPA can also restrict flexibility, as any future deviation from the agreed-upon protocol would negate the assessment, making it less practical when minor tweaks might be needed.

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    Vernon Bernardino's questions to Moleculin Biotech (MBRX) leadership • Q1 2024

    Question

    Vernon Bernardino of H.C. Wainwright & Co. asked about the expected timing of additional MB-106 trial results and what specific details would be announced regarding the upcoming End of Phase II meeting with the FDA.

    Answer

    CFO Jonathan Foster stated that Moleculin will not announce the specific date of the End of Phase II meeting but confirmed it will occur by the end of June, with feedback to be shared publicly in early Q3. CEO Walter Klemp added that it is unlikely any new data from the MB-106 trial will be released before the meeting. Jonathan Foster further clarified that an update on the MB-106 first-line patients will likely be provided in August with the next quarterly earnings report.

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    Vernon Bernardino's questions to Moleculin Biotech (MBRX) leadership • Q1 2024

    Question

    Asked about the timing and content of upcoming announcements, specifically regarding additional MB-106 trial results and the details that will be shared about the End of Phase II FDA meeting.

    Answer

    The company will not pre-announce the FDA meeting date but will hold it by the end of June and share feedback in early Q3. They do not expect to release new MB-106 data before the meeting, with the next update on first-line patients likely coming in August with quarterly results.

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    Vernon Bernardino's questions to Senseonics Holdings (SENS) leadership

    Vernon Bernardino's questions to Senseonics Holdings (SENS) leadership • Q3 2024

    Question

    Vernon Bernardino of H.C. Wainwright & Co. inquired about the gross margin projections for 2025 following the Eversense 365 launch and the expected pace of patient transitions to the new product.

    Answer

    CFO Frederick Sullivan stated that with the improved unit economics of the 365-day product, gross profit margins are expected to approach 30% by the end of 2025 and could eventually reach 50% under the current Ascensia partnership. CEO Tim Goodnow explained that the U.S. transition to the 365-day sensor is immediate for patients needing a new device, describing it as a 'light switch' change, while the European transition will take longer pending regulatory approval.

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    Vernon Bernardino's questions to CASSAVA SCIENCES (SAVA) leadership

    Vernon Bernardino's questions to CASSAVA SCIENCES (SAVA) leadership • Q3 2024

    Question

    Vernon Bernardino asked for an update on the status of Cassava Dx and inquired about the specific details of the biomarker data to be released with the top-line results, including which biomarkers would be reported and their measurement time points.

    Answer

    Executive Richard Barry explained that with the advancement of other diagnostic tools like pTau 217, the company is re-evaluating the allocation of resources to Cassava Dx versus pursuing other indications for simufilam. He confirmed the upcoming top-line results will include plasma biomarker data for pTau 217, NFL, GFAP, and total tau, measured from baseline to the patient's last visit.

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    Vernon Bernardino's questions to CASSAVA SCIENCES (SAVA) leadership • Q2 2024

    Question

    Inquired about the specifics of the SEC investigation and the $40M reserve, the inclusion of biomarker data in the upcoming top-line results, whether biomarkers will address past controversies, and the statistical plan for patient analysis.

    Answer

    The SEC investigation, which began after the 2021 citizen petition, is primarily focused on a capital raise from late 2020 or early 2021. The company hopes to release plasma biomarker data from the RETHINK study along with the cognitive data at year-end. These biomarkers will assess cell function and may augment earlier findings. The primary statistical analysis will be a modified intent-to-treat (mITT) analysis on the full study population, with subgroup analyses also planned.

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    Vernon Bernardino's questions to CASSAVA SCIENCES (SAVA) leadership • Q2 2024

    Question

    Vernon Bernardino of H.C. Wainwright & Co. asked for more details on the SEC investigation and the basis for the $40 million settlement reserve. He also questioned if Phase III biomarker data would be included in the top-line RETHINK results and if these biomarkers could address historical controversies, and followed up on the statistical plan for patient targeting.

    Answer

    Executive Chair Richard Barry explained the SEC investigation stemmed from a 2021 citizen's petition and that the commission's focus appears to be on a capital raise from that period. Chief Medical Officer Dr. James Kupiec stated they hope to release plasma biomarker data with the top-line RETHINK results by year-end. He added that the analysis will use contemporary biomarkers to assess cell function and inflammation, aiming to confirm and expand on earlier findings. Dr. Kupiec also confirmed the primary analysis will be a modified intent-to-treat (mITT) for the entire study population.

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    Vernon Bernardino's questions to Eledon Pharmaceuticals (ELDN) leadership

    Vernon Bernardino's questions to Eledon Pharmaceuticals (ELDN) leadership • Q1 2023

    Question

    Vernon Bernardino from H.C. Wainwright & Co. asked if the data from kidney transplant and the deprioritized IgAN program are providing evidence that targeting anti-CD40 ligand is working as expected. He also asked if the company plans to present further preclinical data to validate the approach.

    Answer

    President and Chief Scientific Officer Steve Perrin responded that data across all indications has been very informative, showing robust target engagement and functional decreases in pro-inflammatory markers in the ALS study, alongside an encouraging safety profile. He stated this supports the hypothesis that blocking the pathway has potential in multiple autoimmune and transplant indications. Perrin also confirmed plans to present data from ongoing preclinical allograft and xenograft transplant collaborations at future scientific conferences.

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    Vernon Bernardino's questions to Can-Fite BioPharma (CANF) leadership

    Vernon Bernardino's questions to Can-Fite BioPharma (CANF) leadership • Q2 2020

    Question

    Vernon Bernardino inquired about the expected data from the upcoming interim analysis for Piclidenoson in rheumatoid arthritis and psoriasis. He also asked for insights on regulators' views of the Phase III trial design for Namodenoson in liver cancer, particularly for Child Pugh B7 patients, and requested an update on the compassionate use program. In a follow-up, he asked about intra-trial monitoring of oxygen status in the COVID-19 study and the mechanics of the new cannabis compound assay.

    Answer

    CEO Pnina Fishman stated the Piclidenoson interim analysis, expected in Q4, will assess non-inferiority against methotrexate (for RA) and Otezla (for psoriasis). She confirmed that both the FDA and EMA encouraged targeting the Child Pugh B population for the liver cancer trial. Regarding the COVID-19 study, she affirmed that oxygen status would be monitored throughout the trial as an early indicator of efficacy. She also explained the cannabis assay is a cell-based platform used to screen compounds for activity against various diseases by observing effects on cell proliferation and function.

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    Vernon Bernardino's questions to Can-Fite BioPharma (CANF) leadership • Q1 2020

    Question

    Vernon Bernardino of H.C. Wainwright & Co. asked for details on the planned Piclidenoson study in COVID-19, including which drugs it would be studied alongside, the expected nature of the FDA's response to the pre-IND filing, and if there were further plans for the NASH program based on any additional data or FDA guidance.

    Answer

    CEO Pnina Fishman explained that Piclidenoson would be studied in moderate-to-severe COVID-19 patients as an add-on to the standard-of-care, which is typically Remdesivir or supportive care, and not alongside other investigational drugs. She stated that the company is awaiting instructions from the FDA on the pre-IND submission and cannot predict the timing or format of the response. Regarding NASH, Dr. Fishman confirmed the company is finalizing data analysis, which will guide the design of the next clinical study.

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    Vernon Bernardino's questions to GALECTIN THERAPEUTICS (GALT) leadership

    Vernon Bernardino's questions to GALECTIN THERAPEUTICS (GALT) leadership • Q4 2015

    Question

    Vernon Bernardino inquired about the GR-MD-02 melanoma studies, asking for confirmation of the drug dosage in the Yervoy combination trial and the expected endpoints and timing for the data release.

    Answer

    Peter Traber (President, CEO & CMO) explained the dose-escalation design for the Yervoy combination trial, starting at 1 mg/kg and ascending in cohorts up to 8 mg/kg. He confirmed that data, including both RECIST criteria and immune marker data, is expected by the end of the year. Traber highlighted that immune markers are a crucial endpoint for determining immunological effect and that they hope to replicate positive results seen in animal studies.

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