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    Jason McCarthy

    Research Analyst at Maxim Group

    Jason McCarthy is Senior Managing Director and Head of Biotechnology Research at Maxim Group, specializing in equity research across the biotechnology sector. He covers 177 healthcare stocks with a focus on companies such as Capricor Therapeutics, Annovis Bio, and BrainStorm Cell Therapeutics, having issued 414 price targets and ratings on 66 stocks. Since joining Maxim Group in July 2014, McCarthy has established a notable presence in the field, highlighted by a best-performing recommendation that yielded a 93.3% return and an overall track record that includes a 28% success rate and an average return of -13.70% per rating. Holding a Ph.D., he is recognized for leading Maxim Group’s Biotechnology Research and actively participating in industry events, further solidifying his reputation as a credentialed sector specialist.

    Jason McCarthy's questions to Coherus Oncology (CHRS) leadership

    Jason McCarthy's questions to Coherus Oncology (CHRS) leadership • Q2 2025

    Question

    Jason Mccarthy of Maxim Group asked about the potential long-term risk of off-label competition to Loktorzi from KEYTRUDA biosimilars once the reference product loses patent protection.

    Answer

    Chief Medical Officer Rosh Dias, CEO Dennis Lanfear, and CSO Theresa Lavallee unequivocally stated they foresee no risk. They emphasized that Loktorzi is the only PD-1 approved for nasopharyngeal carcinoma (NPC), possesses superior data where competitors have failed, holds a Category 1 NCCN recommendation, and that KEYTRUDA biosimilars would not carry the NPC indication on their label.

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    Jason McCarthy's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership

    Jason McCarthy's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership • Q1 2025

    Question

    Jason Mccarthy of Maxim Group inquired about the potential to stratify the Phase IIIb trial by the UNC13A genotype, the use of hypoxic stress data to define NurOwn's mechanism of action for the BLA, and the current manufacturing capacity of the Tel Aviv facility.

    Answer

    Executive Chaim Lebovits and Chief Medical Officer Ibrahim Dagher explained that while the UNC13A findings are promising, the trial protocol is set under the Special Protocol Assessment (SPA), making stratification unlikely; it will be a post-hoc analysis. Executive Netta Blondheim-Shraga confirmed the hypoxic stress data supports a protective effect and was included in the IND. Chaim Lebovits added that the Tel Aviv facility will handle initial manufacturing before scaling with Pluri and a future U.S. site.

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    Jason McCarthy's questions to BRAINSTORM CELL THERAPEUTICS (BCLI) leadership • Q4 2024

    Question

    Jason Mccarthy of Maxim Group inquired about the evolving cell therapy landscape, the potential to use prior Phase III data to support the new trial, and details regarding the planned U.S. manufacturing facility.

    Answer

    Executive Chairman Chaim Lebovits acknowledged the more favorable regulatory environment but stressed the company's focus remains on executing its Special Protocol Assessment (SPA) with the FDA. Lebovits and Chief Medical Officer Ibrahim Dagher confirmed that data from the previous Phase III trial, particularly from the early-stage patient subgroup, will be used to support the new Phase IIIb trial. Lebovits also confirmed plans for a U.S. manufacturing site to be ready for potential commercialization, stating it is not a prerequisite for starting the current trial.

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    Jason McCarthy's questions to BioRestorative Therapies (BRTX) leadership

    Jason McCarthy's questions to BioRestorative Therapies (BRTX) leadership • Q1 2025

    Question

    Jason McCarthy of Maxim Group inquired about the pace of trial enrollment, whether the FDA is focused more on pain or function endpoints, the demographic characteristics of enrolled patients, and requested more detail on the observed morphological changes in MRI scans.

    Answer

    CEO Lance Alstodt stated that new recruitment strategies are accelerating enrollment, which he expects to counteract any typical summer slowdown. He noted that pain is a key endpoint, with more flexibility for discussion on function. VP of R&D Francisco Silva added that patient ages range from early 20s to late 50s and positive trends appear consistent across demographics. Silva also detailed encouraging morphological changes, citing a patient case with increased disc hydration and a nearly resolved annular tear at 52 weeks, suggesting this data could be a valuable part of the FDA submission.

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    Jason McCarthy's questions to Moleculin Biotech (MBRX) leadership

    Jason McCarthy's questions to Moleculin Biotech (MBRX) leadership • Q1 2025

    Question

    Jason McCarthy of Maxim Group asked whether durability data is required for approval, what the expected Complete Remission (CR) rate is for the cytarabine-only control arm, and if patient factors like age or mutations would impact the trial's results.

    Answer

    Executive Walter Klemp and Senior Chief Medical Officer Dr. John Waymack clarified that the 35-day CR rate is the primary endpoint for FDA approval, with durability being a secondary objective. Dr. Waymack expressed confidence that the control arm's CR rate would be in the teens, based on prior large-scale studies. Mr. Klemp added that the trial is designed to be agnostic to factors like age, prior therapies (including venetoclax failures), and genetic mutations, welcoming all such patients.

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    Jason McCarthy's questions to Moleculin Biotech (MBRX) leadership • Q1 2025

    Question

    Inquired about the MIRACLE trial's primary endpoint, asking if durability data is required for approval beyond the 35-day CR rate. Also asked about the expected performance of the control arm (cytarabine alone) and whether patient factors like age and mutations would be considered in the analysis.

    Answer

    Durability is a secondary objective and not required for approval; the primary endpoint is the 35-day CR rate. The control arm's CR rate is expected to be in the teens (around 17.5%), potentially lower since only one cycle is permitted. The trial will stratify by age and mutations, but the drug has shown to be effective across various patient subgroups, including elderly patients and those with prior venetoclax failures.

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    Jason McCarthy's questions to Moleculin Biotech (MBRX) leadership • Q3 2024

    Question

    Jason McCarthy from Maxim Group asked about the total expected cost for the Phase III MIRACLE trial and the company's strategic plans for its Soft Tissue Sarcoma (STS) program, specifically regarding internal development versus seeking a partner.

    Answer

    Executive John Waymack explained that the total trial cost is still being refined based on site selection, noting significant cost differences between US and international locations, but provided a rough run rate. Executive Walter Klemp stated that for the STS program, the company is committed to finding a partner to fund a pivotal trial, allowing Moleculin to focus its internal resources on the AML MIRACLE trial.

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    Jason McCarthy's questions to Moleculin Biotech (MBRX) leadership • Q3 2023

    Question

    The analyst asked for a comparison of annamycin's overall survival (OS) data with trabectedine's historical OS data, the mechanistic reason for different optimal dosing in STS versus AML, potential new indications for annamycin, and the associated risk of liver toxicity.

    Answer

    Executives stated that trabectedine's approval was based on Progression-Free Survival (PFS), not OS, making their own OS data particularly compelling. The different dosing is due to toxicity profiles; the dose-limiting toxicity in STS (low platelet counts) is the desired therapeutic effect in AML. Pancreatic cancer with liver metastases was highlighted as a highly promising future indication. They confirmed that no liver toxicity has been observed in patients to date despite accumulation in the liver.

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    Jason McCarthy's questions to Mind Medicine (MindMed) (MNMD) leadership

    Jason McCarthy's questions to Mind Medicine (MindMed) (MNMD) leadership • Q1 2025

    Question

    Michael Okunewitch, on behalf of Jason McCarthy, asked about the patient targeting strategy for MDD and GAD and whether having evidence in both indications provides a competitive benefit due to high comorbidity.

    Answer

    CCO Matthew Wiley stated that patient targeting strategy is in 'early days' with more clarity expected in H2 2025. CMO Dr. Dan Karlin explained that having a label covering both depression and anxiety would be a significant competitive advantage, making MM-120 a 'go-to' therapy that covers the 'entire waterfront' of these common conditions.

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    Jason McCarthy's questions to scPharmaceuticals (SCPH) leadership

    Jason McCarthy's questions to scPharmaceuticals (SCPH) leadership • Q4 2024

    Question

    Jason McCarthy inquired about the payer mix for CKD patients, specifically the split between commercial and government payers compared to heart failure, and asked about any anticipated disruptions in government payments.

    Answer

    SVP of Commercial Steve Parsons explained that the payer mix for CKD is very similar to heart failure, consisting predominantly of Medicare-aged patients, with a slightly higher proportion of Medicaid patients. Executive John Tucker confirmed that the company has not seen and does not expect any disruptions in government payments, citing the smooth FDA review process as evidence of normal operations.

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    Jason McCarthy's questions to Iterum Therapeutics (ITRM) leadership

    Jason McCarthy's questions to Iterum Therapeutics (ITRM) leadership • Q3 2024

    Question

    Jason McCarthy of Maxim Group asked about the regulatory requirements for ORLYNVAH approval outside the U.S., specifically if another trial would be needed for the EU, China, or Japan. He also questioned if the data from the previously unsuccessful complicated UTI trial could enhance the asset's attractiveness to potential partners.

    Answer

    CEO Corey Fishman clarified that the existing data package is sufficient for a regulatory filing in the EU, but an additional local study would likely be required for approval in China and Japan. He affirmed that the data from the complicated UTI trial is a point of interest for potential partners, suggesting that a single, well-designed follow-up study could secure an expanded indication and that this potential is part of ongoing strategic discussions.

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    Jason McCarthy's questions to Iterum Therapeutics (ITRM) leadership • Q3 2024

    Question

    The analyst inquired about the regulatory requirements for ex-U.S. approvals and whether the data from the previously unsuccessful complicated UTI trial could enhance the asset's attractiveness to potential partners.

    Answer

    The executive stated that the current data package is sufficient for a regulatory filing in the EU, but an additional local trial would be needed for China and Japan. They also confirmed that the data from the complicated UTI trial is considered valuable, as a single additional study could potentially secure an expanded indication, making the asset more attractive for a strategic transaction.

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    Jason McCarthy's questions to Inhibikase Therapeutics (IKT) leadership

    Jason McCarthy's questions to Inhibikase Therapeutics (IKT) leadership • Q2 2024

    Question

    Jason Mccarthy of Maxim Group inquired about Inhibikase's risvodetinib (risvo) Phase II trial, asking about the potential lag time for patients moving to the open-label extension (OLE) and the design of the subsequent Phase III program. He also requested details on the size and scope of the planned Phase IIb trial for IkT-001Pro in pulmonary arterial hypertension (PAH).

    Answer

    Executive Milton Werner confirmed a lag exists for the risvo OLE due to financial constraints, but expects a formal launch in the coming months, noting that few patients have started symptomatic therapies in the interim. For Phase III, he outlined a plan for two global trials of up to 12 months, enrolling a total of 300-400 patients. Regarding the IkT-001Pro trial for PAH, Werner described a derisking Phase IIb study of approximately 100 patients across two doses and a placebo, with a 24-week measurement duration, expressing confidence that the IND would be cleared by the FDA.

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    Jason McCarthy's questions to Inhibikase Therapeutics (IKT) leadership • Q2 2024

    Question

    Jason Mccarthy of Maxim Group inquired about the risvodetinib Phase II study, specifically asking about the potential lag time for patients moving to the 12-month open-label extension (OLE) and the risk of them starting symptomatic treatments. He also sought details on the planned Phase III program, including whether it would entail two studies and its duration. Finally, he asked for specifics on the size and scope of the Phase IIb trial for IkT-001Pro in pulmonary arterial hypertension (PAH).

    Answer

    Executive Milton Werner confirmed a lag has occurred with the OLE due to financial constraints but expects a formal launch within a couple of months, noting that few patients have started symptomatic meds so far. For Phase III, he stated the plan is for two global trials, dosing for up to 12 months, with a combined enrollment of 300-400 patients. For the PAH Phase IIb study, Werner described a derisking trial of roughly 100 patients across two doses plus placebo, with a 24-week measurement duration, designed to confirm efficacy and improve upon the safety profile of imatinib.

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    Jason McCarthy's questions to Sonoma Pharmaceuticals (SNOA) leadership

    Jason McCarthy's questions to Sonoma Pharmaceuticals (SNOA) leadership • Q4 2018

    Question

    Jason McCarthy of Maxim Group asked for more details on Sonoma's growth drivers for fiscal 2019, specifically regarding the recently launched Loyon product and the new partnership in Brazil.

    Answer

    CEO James Schutz explained that for Loyon, the company is working with the FDA to expand its label to include psoriasis, utilizing new clinical data from its German partner. CFO Robert Miller added that their Brazilian partner, NC Group, has already submitted purchase orders exceeding the first-year minimums. Miller highlighted that the partner's 70-person sales team covering 7,000 dermatologists is expected to significantly contribute to revenue and help Sonoma reach breakeven faster.

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    Jason McCarthy's questions to EOM Pharmaceutical Holdings (IMUC) leadership

    Jason McCarthy's questions to EOM Pharmaceutical Holdings (IMUC) leadership • Q4 2016

    Question

    Jason McCarthy from Maxim Group inquired about the remaining milestone-based funding from the California Institute of Regenerative Medicine (CIRM) for the ICT-107 trial. He also asked how the amended, shorter screening protocol for the Phase 3 study might affect the patient population, specifically regarding MGMT status and the rate of early progression.

    Answer

    David Fractor, VP Finance and Principal Accounting Officer, detailed that approximately $14.5 million remains from the $19.9 million CIRM award, with funds released based on patient randomization milestones, for which a specific timeline is not yet available. President and CEO Anthony Gringeri explained the protocol amendment was a logistical change to improve the accuracy of progression assessment, not to alter the MGMT patient ratio. He noted the trial size was increased to account for potential early progressors under the new, faster randomization timeline.

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    Jason McCarthy's questions to EOM Pharmaceutical Holdings (IMUC) leadership • Q3 2016

    Question

    Jason McCarthy of Maxim Group inquired about ImmunoCellular's financial runway, potential non-dilutive funding from CIRM, and the rationale for increasing the ICT-107 trial enrollment to over 500 patients, questioning its impact on statistical power.

    Answer

    CEO Andrew Gengos explained that the current cash runway is limited, with a burn rate of about $2 million per month against ~$15 million in cash. He noted that while significant CIRM funding remains, its timing is now uncertain due to protocol changes, likely necessitating financing beforehand. Gengos clarified the trial enrollment was increased to maintain statistical power after loosening screening criteria and moving randomization earlier, which introduces a risk of including early-progressing patients in the intent-to-treat analysis.

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    Jason McCarthy's questions to SBOT leadership

    Jason McCarthy's questions to SBOT leadership • Q4 2016

    Question

    Jason McCarthy of Maxim Group inquired about the required KLH supply for different clinical trial phases, such as a Phase 3 breast cancer study, and questioned the potential impact of recent Alzheimer's drug failures on partners developing KLH-based A-beta vaccines.

    Answer

    President and CEO Frank Oakes detailed that KLH demand varies by trial phase, moving from tens of grams in early stages to kilogram quantities for commercial launch. Regarding Alzheimer's research, Oakes stated that the failure of a competitor's monoclonal antibody has not dampened enthusiasm for the A-beta target, highlighting that KLH-based vaccines induce a different, potentially more effective, polyclonal response.

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    Jason McCarthy's questions to SBOT leadership • Q1 2016

    Question

    Jason McCarthy of Maxim Group inquired about the potential impact of partner OBI Pharma's upcoming pivotal trial results on KLH supply, the strategic options for the Neovacs joint venture to support Stellar's proprietary products, and the potential scale of KLH demand for a commercial breast cancer vaccine.

    Answer

    President and CEO Frank Oakes highlighted that the OBI Pharma trial is a critical inflection point for the industry and that Stellar is well-positioned through its manufacturing partner, Amaran Biotechnologies. He described the Neovacs joint venture as a strategic move to fill an industry gap for commercial-scale manufacturing, which would provide a clear pathway for Stellar's own products and other third parties. Regarding future demand, Oakes stated a commercial launch would require 'double-digit multiples' of KLH compared to clinical trial levels but did not provide specific forecasts.

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    Jason McCarthy's questions to Edesa Biotech (EDSA) leadership

    Jason McCarthy's questions to Edesa Biotech (EDSA) leadership • Q3 2016

    Question

    Jason McCarthy inquired about the status of partner OBI Pharma's breast cancer vaccine, the progress of partners in Alzheimer's disease research, and the company's projected cash runway following its recent financing.

    Answer

    President and CEO Frank Oakes responded that while he couldn't comment on specific customer plans, there is strong enthusiasm and interest in securing long-term KLH supply for oncology programs. He also noted positive early-stage data from partners in the Alzheimer's space, like Araclon, showing their KLH conjugate vaccines are well-tolerated and induce desired antibody responses. Regarding finances, Oakes confirmed at least a 12-month cash runway, which could be impacted by the need to scale production ahead of potential commercial launches by partners.

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    Jason McCarthy's questions to SELLAS Life Sciences Group (SLS) leadership

    Jason McCarthy's questions to SELLAS Life Sciences Group (SLS) leadership • Q2 2016

    Question

    Jason McCarthy of Maxim Group inquired about the planned trial for GALE-401, including its size, scope, and potential timeline. He also asked about the synergistic potential of combining NeuVax with Herceptin and requested an update on the company's cash burn forecast.

    Answer

    President and CEO Mark Schwartz outlined the GALE-401 plan, which involves a 505(b)(2) pathway for a trial of 100-120 patients with a roughly two-year timeline. Chief Medical Officer Dr. Bijan Nejadnik explained that preclinical data shows Herceptin may sensitize cancer cells to NeuVax's T-cell killing effects. VP of Finance John Burns confirmed cash burn guidance of $12-13 million for Q3 and $8-10 million for Q4, noting costs for closing the PRESENT trial.

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    Jason McCarthy's questions to STEM (STEM) leadership

    Jason McCarthy's questions to STEM (STEM) leadership • Q2 2015

    Question

    Jason McCarthy, on behalf of Jason Kolbert from Maxim Group, asked about the spinal cord injury trial, specifically questioning the importance of benchmarking tissue scarring in patient selection and whether multi-dosing could offer advantages over a single dose.

    Answer

    CEO Martin McGlynn explained that the company's clinical pathway is based on a one-time intervention due to the self-replicating nature of their proprietary cells. President and COO Dr. Ian Massey added that MRIs are used to evaluate lesion characteristics, including scarring, as part of the patient screening criteria. An Unidentified Company Representative also noted that in the first study, patients with less severe injuries showed greater benefit.

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