Sign in

    Kumar Raja

    Research Analyst at Roth Capital Partners

    Kumar Raja's questions to Rain Enhancement Technologies Holdco (RAIN) leadership

    Kumar Raja's questions to Rain Enhancement Technologies Holdco (RAIN) leadership • Q4 2022

    Question

    Kumar Raja from Roth Capital Partners asked how the company might pursue a development path focused on one or two specific cancer types for MANTRA-2, given the diverse activity seen in early data. He also inquired about the most common tumor types with high MDM2 copy numbers.

    Answer

    CEO Avanish Vellanki clarified that such a path would be considered if confirmed responses with meaningful durability are observed in only a few tumor types, but not broadly across many. CSO Robert Doebele reiterated that breast, lung, and bladder cancer account for approximately 75% of all MDM2 amplified patients.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to SCYNEXIS (SCYX) leadership

    Kumar Raja's questions to SCYNEXIS (SCYX) leadership • Q2 2022

    Question

    Kumar Raja questioned the timeline for initiating a trial with the liposomal IV formulation post-FDA interaction, the expected payer negotiation timeline and copays for the label expansion, future SG&A spending, and the outlook for Cost of Goods Sold (COGS).

    Answer

    Chief Medical Officer Dr. David Angulo stated that a trial for the IV formulation could start 'soon' after FDA discussions, as manufacturing is ready. Chief Commercial Officer Christine Coyne confirmed that payer negotiations for the new indication began months ago, with copays expected to be similar to current levels, and that SG&A will remain flat as marketing materials are already in development. Dr. Angulo also addressed COGS, explaining that costs are expected to improve with increased manufacturing volume and market expansion.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to SCYNEXIS (SCYX) leadership • Q1 2022

    Question

    A representative for Kumar Raja of Brookline Capital Markets asked for details on the Phase 3 MARIO study, including the number of planned sites and their activation timeline. They also inquired about the clinical development path for mucormycosis following recent preclinical data.

    Answer

    Chief Medical Officer Dr. David Angulo explained that the MARIO study is a global trial planned for 70-80 sites, with some already open for enrollment. Regarding mucormycosis, Dr. Angulo noted that following promising preclinical combination therapy data, investigators for the FURI study are now being notified that they can enroll patients with mucor infections, as the existing protocol allows for it.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to SCYNEXIS (SCYX) leadership • Q4 2021

    Question

    Kumar Raja of Brookline Capital Markets asked about SCYNEXIS's plans to educate physicians on recurrent VVC ahead of the sNDA approval, including presentations at medical meetings. He also inquired about the status of regulatory interactions for potential geographic expansion into Europe, Japan, and Latin America.

    Answer

    Chief Medical Officer Dr. David Angulo detailed a strong educational campaign planned by the medical affairs team, including a significant presence at OB-GYN and nurse practitioner meetings, CME programs, and publications. Regarding expansion, Dr. Angulo explained that European programs were designed with EMA feedback to be submission-ready, while a potential partner for Japan would need to conduct specific bridging studies.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to Forte Biosciences (FBRX) leadership

    Kumar Raja's questions to Forte Biosciences (FBRX) leadership • Q1 2021

    Question

    Kumar Raja from Brookline Capital Markets asked about plans for an open-label extension study, the strategy for development in Europe and other ex-U.S. regions, and for more detail on the age distribution of trial patients and its potential impact on compliance.

    Answer

    CMO Dan Birch confirmed that an open-label extension for the Phase 2 subjects has been initiated, which will include placebo patients and focus on safety over one year. CEO Paul Wagner and CMO Dan Birch stated they are developing an integrated global plan for Europe and Asia and are engaging consultants to navigate the process. Paul Wagner detailed that approximately 75% of subjects are under 18 and that compliance is not an issue due to the simple, infrequent spray application. Dan Birch added that parental enthusiasm for a non-chemical therapy has driven strong enrollment and compliance.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to XBiotech (XBIT) leadership

    Kumar Raja's questions to XBiotech (XBIT) leadership • Q1 2017

    Question

    Kumar Raja of Noble Capital inquired about leveraging the ongoing US colorectal trial for the EMA re-examination process and asked about the planned size and design of the Phase 3 staph aureus trial to address imbalances seen in Phase 2.

    Answer

    CEO John Simard explained that while there is precedent for using ongoing trial data in an EMA re-examination, he believes their case is strong enough without it since they met the primary endpoint. Medical Director Mike Stecher added that the staph aureus Phase 3 trial will use a larger patient population and one-to-one randomization to mitigate the imbalances observed in the smaller Phase 2 study.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to XBiotech (XBIT) leadership • Q4 2016

    Question

    Kumar Raja of Noble Capital Markets inquired about the timeline for the 75% event milestone in the Phase 3 oncology trial, its potential to halt the study, and its impact on the European approval process. He also asked about the market opportunity for hidradenitis suppurativa.

    Answer

    Medical Director Mike Stecher stated the 75% event milestone was achieved, with an interim analysis set for June. He noted it's uncertain if the trial will stop then, and this data will not factor into the immediate EMA decision. Regarding hidradenitis, he explained that market strategy is still under review. CEO John Simard added that the survival signals from the first interim analysis are positive for the European application, as the study was not stopped for futility.

    Ask Fintool Equity Research AI

    Kumar Raja's questions to SELLAS Life Sciences Group (SLS) leadership

    Kumar Raja's questions to SELLAS Life Sciences Group (SLS) leadership • Q3 2016

    Question

    Kumar Raja from Noble Financial Group inquired about the timeline and variability of pseudo-progression observed in the NeuVax trial, and also asked for details on the planned Phase III trial design for GALE-401 (Anagrelide).

    Answer

    EVP & Chief Medical Officer Bijan Nejadnik explained that pseudo-progression timing varies based on the cancer type and immunotherapy agent, with active vaccines like NeuVax inducing a slower response than passive therapies. He attributed the variability among patients to the presence or absence of micrometastases and individual immune responses. Regarding GALE-401, Dr. Nejadnik confirmed the company is actively designing the Phase III trial in consultation with experts and the FDA, with a face-to-face meeting scheduled.

    Ask Fintool Equity Research AI