Delcath(US:DCTH)2020-11-11 18:29Financial Data and Key Metrics Changes - Product revenue for Q3 2020 was approximately $340,000, an increase from $216,000 in the prior year period [42] - Selling, general and administrative expenses decreased to approximately $2 million from $4 million in the prior year quarter [43] - Research and development expenses increased to $3.3 million from $1.8 million in the prior year quarter [43] - Net loss for Q3 2020 was $5 million, compared to a net loss of $7.5 million for the same period in 2019 [44] - Cash, cash equivalents, and restricted cash totaled $11.1 million at September 30, 2020, compared to $10.2 million at December 31, 2019, and $15.5 million at the end of September 30, 2019 [44] Business Line Data and Key Metrics Changes - The company is focused on the Melphalan/HDS product, which is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure [9][10] - The lead indication is metastatic ocular melanoma, with an estimated 1,200 to 1,500 patients in the U.S. and no standard-of-care currently available [10] Market Data and Key Metrics Changes - The company believes Melphalan/HDS will eventually have a role in treating other solid tumors of the liver in the U.S., as it already does in the EU [15] - The liver is often the life-limiting organ for cancer patients, with overall survival usually under 12 months [16] Company Strategy and Development Direction - The company aims to complete the FOCUS trial and submit an approvable NDA, prepare for commercialization of Melphalan/HDS, raise awareness in the investor community, and prioritize additional indications for Melphalan/HDS [29] - The FDA conditionally accepted the trade name HEPZATO kit for use in the U.S. [36] - The company is focusing on expanding into larger markets over time, with plans to investigate the efficacy of Melphalan/HDS in a broader set of tumor types [17][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of the Melphalan/HDS device, noting improvements over the previous generation [18][22] - The company is navigating challenges related to COVID-19, which has impacted site access for data monitoring [31][34] - Management is optimistic about the upcoming top-line data release in early 2021 and NDA submission projected for Q1 2022 [30][31] Other Important Information - The company has not recorded any treatment-related deaths in over 1,000 treatments in Europe, and the FOCUS trial has not experienced any safety concerns requiring a pause [24][25][80] - The management team is committed to transparency and open communication with investors to raise awareness of the company's progress [37] Q&A Session Summary Question: Interpretation of treatment cycles per patient - Management noted that on average, patients are receiving about four treatments, which is an encouraging sign [46][47] Question: Gating factors for data release and NDA filing - The gating factor is monitoring, particularly at sites with a backlog due to COVID-19 [48][49] Question: Concerns about the 21% response rate bar - Management is not concerned that the bar has shifted significantly since the last meeting with the FDA [51][52] Question: Completion timeline for ongoing treatments - Management indicated that the completion of treatments for the nine patients depends on the number of cycles they receive [55][56] Question: Commercial viability based on response rates - Management believes that even a modest response rate above the bar would still be commercially viable due to the lack of available treatments [61][62] Question: Learnings from previous roles - Management emphasized the importance of transparency, trusting the team, and balancing specific goals with flexibility [64][66] Question: Novelty and learning curve of the technology - The technology's novelty lies in isolation, saturation, and filtration, and while there is a learning curve, training programs are in place to facilitate this [69][72] Question: Future indications for Melphalan/HDS - Management is considering multiple indications, including neuroendocrine tumors, breast cancer, and colorectal cancer, based on unmet needs and available data [76][79]