Evaxion(US:EVAX)2022-05-11 16:11Financial Data and Key Metrics Changes - In Q1 2022, cash and cash equivalents were US$31.4 million, a decrease from US$32.2 million as of December 31, 2021 [13] - Research and development expenses increased to US$4.8 million in Q1 2022 from US$3.9 million in Q1 2021, primarily due to higher employee-related costs [14] - General and administrative expenses rose to US$1.6 million in Q1 2022 from US$1.3 million in Q1 2021, attributed to increased external costs [14] - The net loss for Q1 2022 was US$5.8 million, or US$0.25 loss per share, compared to a net loss of US$4.1 million, or US$0.23 loss per share in Q1 2021 [15] Business Line Data and Key Metrics Changes - The company is advancing its lead cancer therapy, EVX-01, towards a Phase 2b clinical trial in combination with Merck's KEYTRUDA for metastatic melanoma [6][7] - Recruitment for the Phase 1/2a clinical trial of EVX-02 has been completed, and it is moving into a dedicated Phase 2b clinical trial for patients with resectable melanoma [8] Market Data and Key Metrics Changes - The company is actively discussing potential partnerships with pharmaceutical and biotech companies, aiming for solid progress in 2022 [7] Company Strategy and Development Direction - The company aims to improve the treatment landscape for melanoma and other cancers using its existing pipeline of cancer therapies [6] - Plans to select a second bacterial product candidate from the EDEN platform and the first viral candidate from the RAVEN platform in the second half of 2022 [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving significant progress in partnerships and clinical trials throughout 2022 [7] - The company is focused on validating its AI models to identify unique drug targets, which may enhance clinical success rates [10][22] Other Important Information - The company received regulatory clearance to initiate the Phase 2b trial of EVX-01 in January 2022, with the first patient visit expected in the first half of 2022 [8] - The manufacturing process for personalized medicine has been established, allowing for production timelines of 10 to 12 weeks for EVX-02 [20] Q&A Session Summary Question: Timing for an update on Phase 2a EVX-01 durability of response - Management expects to have data available within the next half to nine months, as they are continuously following up on patients [17] Question: Number of sites for EVX-01 Phase 2b study and enrollment pace - Initial recruitment will start in Australia with multiple sites, targeting to open 10 to 12 global sites [18] Question: Update on EVX-03 in light of EVX-02 advancement - Management is considering speeding up EVX-03 based on data from EVX-02, with ongoing data collection [19] Question: Production timeline for EVX-02 and update on EVX-03 - EVX-02 can be manufactured in 10 to 12 weeks, and this capability is crucial for future trials [20] Question: Data expectations from the ImmunoID NeXT Platform - The company is working to validate its AI system for selecting patients who will respond to immune therapy, with data expected to materialize during the year [23] Question: Timeline for data readout on EVX-02 - Management expects to share data in 2023, focusing on safety and immunological profiling [25] Question: Regulatory submissions for EVX-01 in the EU and U.S. - The process is moving according to plan, with expectations to start in EMA first, followed by FDA [26] Question: Legal proceedings with SSI around CAF09 - Management stated there is no material risk to the conduct of studies, as they already have a license for CAF09 [28]