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Evaxion(EVAX) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:30
Financial Data and Key Metrics Changes - The cash runway has been extended to 2027, supported by a $7,500,000 exercise fee from MSD and additional capital market funding [5][18] - The company reported a quarterly income of $4,600,000, driven by the MSD deal and a net financial gain of $1,300,000 from a debt conversion [20][19] - Equity at the end of the quarter stands at $16,600,000, with a reduction in outstanding warrants to 2,800,000 [20][21] Business Line Data and Key Metrics Changes - The EVX-one program has shown a 75% objective overall response rate in a two-year clinical trial, with 11 out of 12 patients maintaining a sustained response [10][11] - The EVX-four program has been added to the pipeline, targeting acute myeloid leukemia with a novel AI-designed cancer vaccine [8][9] Market Data and Key Metrics Changes - The MSD deal represents the first in-licensing of an AI-discovered vaccine candidate by a major pharmaceutical company, indicating strong market validation [6][18] - The company is experiencing increased interest in its oncology and infectious disease programs, reflecting a growing market engagement [39] Company Strategy and Development Direction - The company aims to create value through partnerships, as evidenced by the MSD deal and ongoing discussions with other potential partners [6][22] - The focus remains on advancing R&D and business development, with multiple partnership discussions ongoing [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's operational momentum and the achievement of 2025 milestones, with expectations for further R&D updates [22] - The management noted that the questions from potential partners have shifted from data quality to applications of technology in other cancer indications, indicating a positive reception of clinical data [26] Other Important Information - The automated vaccine design module has been enhanced, significantly reducing design time and costs, positioning the company at the forefront of AI-driven vaccine innovation [12][14] - The evaluation period for the EVX-D2 program has been extended, allowing for further assessment [6] Q&A Session Summary Question: What are the key questions from potential partners regarding EVX-one? - The focus has shifted to how the technology can be applied to other cancer indications, with discussions ongoing about potential next steps for licensing [26] Question: Can you provide details on the EVX-four target in AML? - The company is targeting endogenous retroviral sequences from the dark genome, which are highly expressed in AML, allowing for a shared vaccine approach across patients [30] Question: How has the breadth of partnering conversations evolved? - There is increasing interest across the R&D pipeline, with dialogues centered on both target discovery and existing vaccine candidates [39] Question: Can the automated design module be used for partnerships? - The new module can support internal programs and has potential for monetization through partnerships, allowing other companies to utilize the technology [45] Question: What additional data is expected from the ongoing EVX-one trial? - Future presentations will include deeper analyses of immune profiles from patient samples collected during the trial [47] Question: What is the status of the MSD relationship regarding EVX-D2? - MSD is currently evaluating provided data and conducting confirmatory analyses, with an expected response in the first half of next year [49]
Evaxion Biotech A/S (NasdaqCM:EVAX) Update / Briefing Transcript
2025-10-22 15:32
Summary of Evaxion Biotech A/S Update / Briefing (October 22, 2025) Company Overview - **Company**: Evaxion Biotech A/S - **Founded**: 2008 in Copenhagen, Denmark - **Focus**: AI-first company leveraging proprietary AI-Immunology platform for vaccine discovery, design, and development [3][4] Industry Context - **Disease Focus**: Advanced melanoma, a highly aggressive skin cancer with high mortality rates, particularly in metastatic cases [14][15] - **Historical Context**: Prior to 2011, melanoma clinical trials had a high failure rate. Introduction of immunotherapy marked a significant shift in treatment efficacy [14][15] Core Points from the Call AI-Immunology Platform - **Functionality**: Decodes human systems for therapeutic target discovery by integrating genomic, transcriptomic, and proteomic data [3][4] - **Success Rate**: High success in selecting targets that induce potent T-cell responses against cancer cells [4] Clinical Trials - **Phase 1 Trial**: - Conducted on patients with Stage 3B and Stage 4 melanoma. - **Results**: 67% objective response rate (ORR) with 8 out of 12 patients showing response; however, 7 relapsed [8][9] - **Safety**: Well tolerated with mainly grade one and two adverse events [7][8] - **Key Learnings**: Recommended Phase 2 dose set at 200 micrograms; booster administrations included in Phase 2 to sustain T-cell levels [8][9] - **Phase 2 Trial**: - Included treatment-naive patients with Stage 3 unresectable or Stage 4 melanoma [18][19] - **Primary Endpoint**: Conversion from stable disease to partial or complete response [19][20] - **Secondary Endpoints**: Objective response rate, progression-free survival, overall survival, and neoantigen-specific T-cell response [20] - **Study Population**: 17 enrolled patients, predominantly Stage 4 melanoma [23] - **Safety Profile**: Consistent with Phase 1, primarily grade one adverse events [24][25] - **Results**: 75% best objective response rate; 54% conversion rate from stable disease to partial response [30][31] Efficacy and Safety - **T-cell Responses**: 81% of neoantigens induced T-cell responses, an increase from 65% in Phase 1 [31] - **Sustained Responses**: 92% of responders maintained responses at the 24-month mark [37] - **Manufacturing Success**: 100% success rate in vaccine manufacturing for all patients [38] Additional Insights - **Personalized Treatment**: Emphasis on the need for personalized therapies to improve efficacy and reduce toxicity compared to standard treatments [17][18] - **Future Directions**: Potential for further studies to explore the efficacy of personalized vaccines in previously treated melanoma patients and the role of booster doses [68][70] Conclusion - **Encouraging Data**: The results from the Phase 2 trial support the ongoing development of Evaxion's personalized cancer vaccine, EVX-01, in high-risk melanoma [38] - **Next Steps**: Continued evaluation of patient responses and potential adjustments to dosing schedules and treatment regimens based on emerging data [62][63]