Evaxion(EVAX)

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80% of the EVX-01 vaccine targets trigger a tumor-reactive immune response - Evaxion presents striking EVX-01 data at the AACR Annual meeting
Globenewswire· 2025-04-28 12:00
Core Insights - Evaxion Biotech A/S has announced new data highlighting the effectiveness of its personalized cancer vaccine EVX-01 in generating a targeted immune response against advanced melanoma [1][4] - The ongoing phase 2 trial of EVX-01 shows an 80% tumor-specific immune response rate, an improvement from previous rates of 71% and 79% reported at earlier conferences [2][3][9] - The trial is set to provide two-year clinical data in the second half of 2025, with an extension allowing for a more comprehensive evaluation of EVX-01's potential [5] Company Overview - Evaxion Biotech A/S specializes in AI-Immunology™ powered vaccines, focusing on personalized treatments for cancer and other diseases [1][12] - The company’s lead clinical asset, EVX-01, is designed to target the unique tumor profiles of individual patients, enhancing the immune system's ability to combat cancer [10][8] Clinical Trial Details - The phase 2 trial investigates EVX-01 in combination with Merck's KEYTRUDA® (pembrolizumab) for patients with advanced melanoma [6] - The trial has demonstrated overall response rates of 69% and 67% in previous analyses, indicating a strong correlation between clinical responses and AI-Immunology™ predictions [11] Presentation Information - New immune data will be presented at the AACR Annual Meeting, with details including the abstract title and session information [7]
Evaxion to present at World Vaccine Congress
Newsfilter· 2025-04-10 12:00
Core Insights - Evaxion Biotech A/S will participate in the World Vaccine Congress from April 21-24, 2025, in Washington, D.C., showcasing its AI-Immunology™ powered vaccine development [1][3] - The company will present two key topics: the application of its AI-Immunology™ platform for cancer vaccine target discovery and for infectious disease vaccine target discovery [2][4] Company Overview - Evaxion is a clinical-stage TechBio company that utilizes its proprietary AI-Immunology™ platform to develop innovative immunotherapies for cancer and infectious diseases [5] - The company has a clinical-stage oncology pipeline focused on personalized vaccines and a preclinical pipeline addressing bacterial and viral diseases with significant unmet medical needs [5] Event Details - Birgitte Rønø, Chief Scientific Officer, will present on April 23, 2025, at 11:40 ET regarding AI-powered antigen target discovery for cancer vaccines [4] - Pär Comstedt, Vice President of Infectious Disease Vaccine Development, will present on the same day at 15:10 ET about AI-powered target discovery for infectious disease vaccines [4]
Evaxion(EVAX) - 2024 Q4 - Earnings Call Transcript
2025-04-01 22:30
Financial Data and Key Metrics Changes - In 2024, the company recorded revenue of $3.3 million from an optional license agreement with MSD, with expectations for future income from this agreement [44] - The net loss for 2024 was $10.6 million, an improvement from a loss of $22 million in 2023, driven by increased revenue and reduced R&D and G&A expenses [48][49] - Cash and cash equivalents at the end of December 2024 were $6 million, up from $5.6 million at the end of 2023, with sufficient funds projected to last into mid-2026 [46][51] Business Line Data and Key Metrics Changes - The ongoing EBX01 Phase II trial showed a 69% overall response rate at the one-year readout, with 15 out of 16 patients showing a reduction in tumor target lesions [8][33] - The company has established a new precision cancer vaccine concept targeting non-conventional endogenous retroviruses, broadening the potential of cancer vaccines [9][35] Market Data and Key Metrics Changes - The partnership with MSD, established in September 2024, is expected to generate significant future income, with a potential option exercise in the second half of 2025 [6][15] - The company aims to generate at least two new agreements in 2025, focusing on a multi-partner approach to build its pipeline [17][19] Company Strategy and Development Direction - The company is focused on deriving value from both its platform and pipeline, emphasizing a dual focus on platform and pipeline development [18][20] - The strategy includes entering into high-value, low-risk partnerships around target discovery and the development of novel vaccine candidates [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong position, highlighting the successful execution of the pipeline and the transformative agreement with MSD [55][56] - The company is well-positioned for strong execution in 2025, with key milestones and value triggers identified [56] Other Important Information - The company extended the EVX01 trial from two to three years to collect three-year outcome data, which will provide a strong data package [27][34] - The company has raised $17 million through public offerings and other capital market activities, extending its cash runway to mid-2026 [12][21] Q&A Session Summary Question: How does the company ensure new pipeline candidates are partnerable assets? - The company emphasizes unmet medical needs and commercial potential as primary criteria, engaging in early dialogues with potential partners to shape preclinical programs accordingly [62][64] Question: What is the status of the CMV vaccine program after Expression Biotech returned rights? - The decision was made by Expression Biotech, and the company is confident in its plan to drive the program forward independently, exploring alternative solutions for antigen production [68][70] Question: What data should be expected at the upcoming AACR meeting regarding EBX01? - The company will present biomarker data and additional T cell data from patients, providing a more in-depth analysis than previously shared [80] Question: What types of cancers could the ERV vaccines target? - The company has identified specific cancer indications with a high burden where ERV sequences are shared across patients, with plans to share more information by the end of the year [85][86] Question: Will any data be released ahead of submitting to MSD for their decision on exercising the option for EVX B2 and B3? - No additional data will be released for B2, as MSD is conducting confirmatory work, while B3 is finalizing the current work plan [88][89]
Evaxion(EVAX) - 2024 Q4 - Earnings Call Transcript
2025-04-01 19:16
Financial Data and Key Metrics Changes - In 2024, the company recorded revenue of $3.3 million from an optional license agreement with MSD, with expectations for future income from this agreement [44] - The net loss for 2024 was $10.6 million, an improvement from a loss of $22 million in 2023, driven by increased revenue and reduced R&D and G&A expenses [48][49] - Cash and cash equivalents at the end of December 2024 were $6 million, up from $5.6 million at the end of 2023, with sufficient funds projected to last into mid-2026 [46][51] Business Line Data and Key Metrics Changes - The ongoing EBX01 Phase II trial showed a 69% overall response rate at the one-year readout, with 15 out of 16 patients showing a reduction in tumor target lesions [8] - The company has established a new precision cancer vaccine concept targeting non-conventional endogenous retroviruses, broadening the potential of cancer vaccines [9][10] Market Data and Key Metrics Changes - The partnership with MSD, established in September 2024, is expected to lead to potential option exercises in the second half of 2025, which could generate up to $10 million in income [6][15] - The company aims to generate at least two new agreements in 2025, focusing on a multi-partner approach to expand its pipeline [17][18] Company Strategy and Development Direction - The company is focused on deriving value from both its platform and pipeline, emphasizing the complementarity of its AI immunology capabilities [18][20] - The strategy includes entering into high-value, low-risk partnerships for target discovery and the development of novel vaccine candidates [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong position, highlighting the successful execution of the pipeline and the transformative agreement with MSD [55][56] - The company is well-positioned for strong execution in 2025, with key milestones and value triggers locked in [56] Other Important Information - The company extended the EVX01 trial from two to three years to collect three-year outcome data, which is expected to enhance the data package for the personalized cancer vaccine [27] - The company has raised $17 million through public offerings and other capital market activities, extending its cash runway to mid-2026 [12][21] Q&A Session Summary Question: How does the company ensure new pipeline candidates are partnerable assets? - The company emphasizes unmet medical needs and commercial potential as primary criteria, engaging in early dialogues with potential partners to shape preclinical programs accordingly [62][64] Question: What data should be expected at the AACR regarding EBX01? - The company will present biomarker data and additional T cell data, providing a more in-depth analysis of the ongoing trial [80] Question: What types of cancers could the ERV vaccines target? - The company has identified specific cancer indications with a high burden where ERV sequences are shared across patients, with further information expected by the end of the year [86] Question: Will any data be released ahead of submitting to MSD for EVX B2 and B3? - No additional data will be released for B2, as MSD is conducting confirmatory work on existing data, while B3 is in the finalization stage of the work plan [89]
Evaxion(EVAX) - 2024 Q4 - Earnings Call Presentation
2025-04-01 14:28
C O R P O R A T E P R E S E N T A T I O N – A P R I L 2 0 2 5 DE C ODI N G T HE H UM A N I M MUN E SY ST EM T O DE VEL OP NO VEL V A CC I N ES FOR C A NC E R A N D I N FEC T I OUS DI SEA SE S WI T H OUR A I - I MM UN OL OGY P LA T FO RM EVAX EVAX A black and Forward-looking statement This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "target," "believe ...
Evaxion(EVAX) - 2024 Q4 - Annual Report
2025-04-01 13:33
Foreign Exchange Gains - For the years ended December 31, 2024, 2023, and 2022, the net foreign exchange gains were $0.3 million, $0.2 million, and $2.4 million, respectively[1101]. Interest Rate Risk - The company does not currently have any loans or holdings with variable interest rates, indicating no material exposure to interest rate risk[1102]. License Agreement and Payments - The company entered into a license agreement in June 2020, which triggered a milestone payment of $35,000, with potential future payments ranging from $70,000 to $250,000[1104]. Financial Instruments and Liabilities - The company issued warrants as part of a loan agreement with EIB, with the liability initially recognized at fair value and subsequently measured at amortized cost[1114][1115]. - The 2023 SPA Investor Warrants and 2024 Public Offering Investor Warrants were classified as derivative financial instruments due to their exercise price being in USD, not the company's functional currency[1116]. - The exercise price for the 2023 SPA Warrants was amended from $7.07 to DKK 47.99, and for the 2024 Investor Warrants from $4.00 to DKK 27.52, resulting in a change from liability to equity classification[1118]. Lease Agreement - The lease contract for premises customization has a repayment period of 8 years and an interest rate of 6% per annum[1120].
Evaxion(EVAX) - 2024 Q4 - Annual Report
2025-04-01 11:45
Financial Performance - Revenue for the full year 2024 was $3.3 million, a significant increase from $0.1 million in 2023, primarily due to a signed option and license agreement with MSD[25] - The net loss for 2024 was $10.6 million, or $(0.20) per share, compared to a net loss of $22.1 million, or $(0.81) per share in 2023[27] - Evaxion's total liabilities decreased to $14.1 million in 2024 from $17.6 million in 2023, reflecting improved financial health[29] - Cash and cash equivalents as of December 31, 2024, were $6.0 million, up from $5.6 million at the end of 2023, with expectations to fund operations until mid-2026[24] Expenses - Research and development expenses decreased to $10.5 million in 2024 from $11.9 million in 2023, attributed to reduced headcount and cost efficiencies[25] - General and administrative expenses were $7.6 million in 2024, down from $10.4 million in 2023, driven by management changes and cost reductions[26] - The company anticipates an operational cash burn of approximately $14 million in 2025, maintaining strict cost control[6] Clinical Trials and Development - The company completed dosing in the EVX-01 phase 2 trial in January 2025, with a one-year interim data showing a 69% overall response rate[11][12] - Evaxion expects to identify a lead vaccine candidate for its ERV-based precision cancer vaccine concept in the second half of 2025[13] - The partnership with MSD is progressing towards potential option exercise in the second half of 2025, with an option exercise fee of up to $10 million[8][9] Risks and Uncertainties - Key risks include financial condition, need for additional capital, and product development costs[34] - The company emphasizes dependence on third parties for clinical testing and product manufacturing[34] - There are uncertainties related to government regulation and protection of intellectual property rights[34] - The impact of international economic and geopolitical factors, including inflation, is highlighted as a risk[34] - The announcement includes forward-looking statements that may differ materially from actual results due to various risks[34] - The company does not assume any obligation to update forward-looking statements except as required by law[34]
Evaxion announces business update and full year 2024 financial results
Newsfilter· 2025-04-01 11:30
Core Insights - Evaxion Biotech A/S has made significant advancements in business development, research, and financing, achieving key milestones in 2024 and early 2025 [2][3] - The company is focused on executing its business development strategy, continuing the EVX-01 phase 2 trial, and enhancing its AI-Immunology™ platform [5][6] - Financially, Evaxion reported a revenue increase to $3.3 million in 2024, compared to $0.1 million in 2023, primarily due to a licensing agreement with MSD [25] Business Highlights - Evaxion completed dosing in the EVX-01 phase 2 trial in January 2025, marking a significant milestone [3] - The company aims to launch an automated lead vaccine candidate design module and secure at least two new business agreements in 2025 [7][19] - A partnership with MSD on two vaccine candidates is progressing towards potential option exercise in the second half of 2025 [8][14] Research & Development Update - The EVX-01 trial is on track for a two-year clinical efficacy readout, with one-year data showing a 69% overall response rate [12][11] - Evaxion is advancing a novel precision cancer vaccine concept targeting ERV tumor antigens, with a lead candidate expected in the second half of 2025 [13] - The AI-Immunology™ platform has been enhanced to predict toxin antigens, improving the development of bacterial vaccines [17][18] Financial Overview - As of December 31, 2024, cash and cash equivalents were $6.0 million, up from $5.6 million in 2023, with a net loss of $10.6 million for the year [24][27] - Research and development expenses decreased to $10.5 million in 2024 from $11.9 million in 2023, reflecting cost efficiencies [25] - The company expects operational cash burn of approximately $14 million in 2025, maintaining cost control while increasing activity levels [6]
Evaxion to announce business update and full year 2024 financial results on April 1, 2025
Newsfilter· 2025-03-27 12:00
Company Overview - Evaxion Biotech A/S is a clinical-stage TechBio company that specializes in developing AI-Immunology™ powered vaccines [4] - The company utilizes proprietary AI prediction models to decode the human immune system and create novel immunotherapies for cancer, bacterial diseases, and viral infections [4] - Evaxion has developed a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with high unmet medical needs [4] Upcoming Events - Evaxion will provide a business update and report its full year 2024 financial results on April 1, 2025, before the opening of the Nasdaq CM [1] - The Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST to present the update and results, as well as to take questions from the public [2] - The conference call is free and open to the public, with registration required to receive dial-in information [2] Contact Information - For inquiries, Mads Kronborg, Vice President of Investor Relations & Communication, can be contacted at +45 53 54 82 96 or via email at mak@evaxion.ai [4]
Evaxion to present new phase 2 data for AI-designed personalized cancer vaccine EVX-01 at AACR Annual Meeting
Globenewswire· 2025-03-25 20:30
Core Insights - Evaxion Biotech A/S is set to present new data for its personalized cancer vaccine EVX-01 at the AACR Annual Meeting in April 2025, highlighting its ongoing commitment to advancing cancer treatment through AI-Immunology™ technology [1][2][3] Group 1: Clinical Trial and Data Presentation - The ongoing phase 2 trial of EVX-01 has produced strong interim one-year clinical data, with a two-year data readout expected in the second half of 2025 [4][8] - New biomarker and immune data from the trial will be presented, further enhancing the clinical data package for EVX-01 [2][8] - The trial investigates EVX-01 in combination with Merck's KEYTRUDA® (pembrolizumab) for advanced melanoma patients, with each vaccine tailored to individual patient biology [5][6] Group 2: Product Overview and Efficacy - EVX-01 is a personalized peptide-based cancer vaccine designed for first-line treatment of multiple advanced solid cancers, leveraging AI-Immunology™ to target unique tumor profiles [6][9] - Clinical trials have shown overall response rates of 69% and 67% in patients with advanced melanoma, indicating strong efficacy and predictive power of the AI platform [7]