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Cartesian Therapeutics(RNAC) - 2022 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q2 2022, Selecta reported collaboration and license revenue of $39.3 million, up from $19.7 million in Q2 2021, primarily driven by clinical supply shipments and reimbursements related to the Phase III DISSOLVE program [32] - Net cash used in operating activities was $24.1 million for the six months ended June 30, 2022, compared to $18.2 million for the same period in 2021 [32] - Selecta reported a net income of $8.6 million or basic net income per share of $0.06 for Q2 2022, compared to a net income of $4.6 million or basic net income per share of $0.04 for Q2 2021 [33] Business Line Data and Key Metrics Changes - The company completed enrollment of the DISSOLVE II trial, triggering a $10 million milestone payment from Sobi [5] - Sarepta extended their option and license agreement, resulting in anticipated payments of $6 million in Q3 2022 [6] - The company raised approximately $38.7 million through an underwritten offering, ending Q2 2022 with approximately $143.4 million in cash and equivalents [7][31] Market Data and Key Metrics Changes - Over 24 million Americans suffer from autoimmune diseases, with current treatments often leaving patients vulnerable to serious infections [10] - The company aims to address the unmet medical need in autoimmune diseases, particularly in primary biliary cholangitis (PBC), where existing treatments have limited efficacy [13][91] Company Strategy and Development Direction - Selecta is focused on advancing its proprietary pipeline, including the ImmTOR platform and gene therapy candidates [5][9] - The company plans to commence Phase I clinical trials for SEL-302 in Q4 2022 and expects to complete the Phase III DISSOLVE trial in collaboration with Sobi [7][8] - Selecta aims to leverage its precision immune tolerance platform to transform treatment paradigms in autoimmune diseases and enhance the efficacy of gene therapies [9][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial opportunity for SEL-212, highlighting the differentiation of monthly dosing compared to competitors [40] - The company remains committed to addressing the challenges in autoimmune diseases and believes its technology could represent a generational leap forward [35] - Management anticipates multiple clinical readouts within its cash runway, including results from the Phase III DISSOLVE trials in Q1 2023 [31] Other Important Information - Selecta's proprietary IgG protease candidate, Xork, is being developed to enable repeat dosing of gene therapies by addressing preexisting antibodies [22][23] - The company is working with external partners to identify an IgA protease candidate for the treatment of IgA nephropathy [30] Q&A Session Summary Question: What could be driving the low uptake of KRYSTEXXA in the refractory gout market? - Management noted that compliance is a key driver, as SEL-212 would offer a monthly treatment compared to KRYSTEXXA's bi-monthly regimen, which could enhance patient adherence [40] Question: What is the total amount of milestone payments remaining for the Sobi partnership? - Management indicated that Selecta is eligible to receive $630 million in milestones, with $10 million already received for full enrollment in DISSOLVE II [43][46] Question: Are there plans to include IL-2 in the MMA study? - Management confirmed that IL-2 will not be included in the initial MMA trial but may be added in the future once safety studies are completed [52][54] Question: What are the biomarkers for PBC? - Management highlighted alkaline phosphatase levels as a validated biomarker for PBC, which will be monitored during trials [65] Question: What is the market opportunity for PBC? - Management emphasized the unmet medical need in PBC, as current therapies do not address the underlying immunologic causes of the disease [91]