Sean Lee

Sean Lee asked if Novavax expects to disclose any milestones or preclinical data for its three early pipeline products this year, specifically targeting any conferences for such disclosures.

Answer

President and CEO John Jacobs stated that while Novavax is excited about its progress, it will be cautious about sharing too much for competitive reasons. He confirmed the intent to ready one or more assets for IND with regulatory authorities this year, potentially leading to human trials as early as 2027. He added that Novavax will continue to unveil progress, as demonstrated with the C. diff example, while remaining strategically guarded.

Sean Lee asked if any milestones regarding data disclosures for the three preclinical pipeline products (C. diff, shingles, RSV) can be expected this year, specifically if Novavax is targeting any conferences to present preclinical data.

Answer

CEO John Jacobs stated that while they are excited about progress, they will be cautious about sharing too much for competitive reasons, especially if a potential pathway forward is unlocked. He noted that as preclinical work wraps up, one or more assets could be ready for IND submission this year, with the potential to be in human trials as early as 2027. He confirmed that Novavax will continue to unveil information, as done today for C. diff, but will remain guarded on some details for competitive reasons.

Sean Lee inquired if there were noticeable differences between the commercial patients receiving AvmapKefaxin Jakobak and those in the clinical study, and asked about the expected speed of the VS7375 study's progression into specific indications.

Answer

President and CEO Dan Paterson stated that the commercial patient profile aligns well with the RAMP 201 study, with a mix of heavily pre-treated patients and those at first relapse. He also explained that the VS7375 trial is moving very quickly, having started at a high dose due to including Chinese data in the IND, which saved 6-9 months.

Sean Lee asked for anecdotal evidence on the rate at which new surgeons, after training, are adopting ATEC's more advanced procedures like PTP or complex deformity.

Answer

Chairman & CEO Pat Miles provided an anecdotal view, explaining that the PTP procedure often reinvigorates interest from surgeons who had previously dismissed lateral surgery because it solves key challenges with alignment and access. He believes that integrating navigation will further "democratize" the technique, making more surgeons comfortable and expanding the user base for these advanced procedures.

Sean Lee asked for more color on the key drivers and obstacles within the O&P channel and whether its current growth pace is expected to continue through the second half of the year.

Answer

CEO Paul Gudonis characterized the MyoPro as a significant 'white space' growth opportunity for O&P clinics, which operate in a traditionally slow-growth industry. He identified the main 'pull' or challenge as the time commitment required from busy clinicians to complete the necessary certification training. However, he emphasized that the clinics view it as a worthwhile investment for their practice and patients, suggesting continued growth.

Sean Lee inquired about the growth drivers for CytoSorb sales outside of Germany, the reasons for Germany's flat performance, and the specific metrics needed to achieve the core business's near-breakeven goal.

Answer

CFO Peter Mariani attributed international growth to strong adoption in specific applications with reimbursement wins and maturing distributor markets. He cited post-COVID issues and hospital reforms for Germany's flatness but highlighted the company's sales force reorganization. Regarding breakeven, Mariani indicated that 'good solid revenue growth' and 70%+ gross margins were the key drivers, without providing specific revenue targets.

Sean Lee of H.C. Wainwright posed several questions regarding the Leptomeningeal Metastases (LM) program and the CNSide diagnostic. He asked if the 44 millicurie dose expansion is part of Phase I or a new Phase II, questioned the timing of the multi-dose study relative to a potential Phase II trial, and inquired about the market opportunity for CNSide.

Answer

President and CEO Marc Hedrick clarified his aspiration is for the dose expansion to be a Phase II trial focused on breast cancer patients, subject to FDA agreement, which could potentially roll directly into an approval trial. He confirmed they will proceed with a single-dose trial (Phase Ib or II) without waiting for multi-dose data, as the single-dose data is already very promising. Regarding CNSide, Hedrick estimated a U.S. market opportunity of up to 500,000 tests per year and expects the tumor cell enumeration test to be commercially rolled out geographically over the next year.

Sean Lee questioned the qualitative differences in the ReSPECT-LM data planned for presentation at various upcoming medical conferences and inquired about the specific dosing regimen for the pediatric study.

Answer

Executive Marc Hedrick clarified that the June SNMMI presentation will largely be a recap of existing data for a new audience, while the August SNO/ASCO update will focus on enrollment and safety. A more comprehensive efficacy update is planned for the SNO annual meeting in November. Chief Medical Officer Dr. Norman LaFrance explained that the pediatric trial's dosing regimen has been agreed upon in principle with the FDA and will involve a dose escalation based on tumor volume, similar to the GBM trial.

Sean Lee from H.C. Wainwright inquired about the necessary steps before launching CNCT19, specifically regarding manufacturing capacity and commercial structure expansion, and also asked for timelines on data for BI-1206 and development updates for Thiotepa.

Answer

Chairman and CEO Wei-Wu He confirmed that current manufacturing capacity is sufficient for the first year's launch, estimated at 500 to 1,000 patients. Executive VP and CMO Alex Zukiwski added that for Thiotepa, they are responding to CDE questions and expect feedback within four to six months. For BI-1206, the goal is to dose the first patient in China in H2 2022 and eventually join the global registration study.

Sean Lee of H.C. Wainwright & Co. asked for the expected timing of initial results from the CID-103 study and inquired about other clinical milestones anticipated in the next 12 months.

Answer

Alexander Zukiwski, EVP and Chief Medical Officer, stated the CID-103 study is in a high-level dose escalation phase and data will be released at a future scientific meeting. He outlined other milestones, including the BI-1206 study initiation in Q2 with the first patient expected in Q4, progress on the CB-5339 regulatory application, and ongoing regulatory discussions for Thiotepa.

Sean Lee of H.C. Wainwright asked about the potential disruption to sales from recent COVID-19 lockdowns in China, plans for sales force expansion beyond the current 100 individuals, and the expected timing for clinical data on CID-103.

Answer

Chairman and CEO Wei-Wu He acknowledged some communication difficulties with physicians in March due to lockdowns but noted the first two months of the year were normal. He also stated the sales force will expand to over 200 people in the next 18 months in preparation for the CAR-T launch. Chief Medical Officer Alex Zukiwski indicated that CID-103 data might be presented at the upcoming ASH meeting, though it is not a guarantee.

Sean Lee of H.C. Wainwright & Co. asked for an update on the number of patients treated with EVOMELA in the first nine months of 2021 and its total market potential. He also inquired about the enrollment status for the CNCT19 trials, commercial preparations, and the next steps for BI-1206 development.

Answer

Wei-Wu He (Chairman & CEO) and Wong Hu (Former COO) confirmed that nearly 4,000 patients were treated with EVOMELA in the first nine months, with a long-term goal of over 10,000 patients annually. He stated the CNCT19 B-ALL trial is on track to complete enrollment by year-end for an NDA submission in 2022. Alexander Zukiwski (Chief Medical Officer) added that for BI-1206, an IND equivalent is filed in China, and CASI will conduct a local PK/PD study before joining global registration programs.