Workflow
Evaxion(EVAX)
icon
Search documents
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]
Evaxion to present at numerous upcoming conferences
Globenewswire· 2025-03-04 13:00
Core Insights - Evaxion Biotech A/S is actively participating in various investor and scientific conferences in the US and Europe to provide updates and engage with stakeholders, which is a key part of its strategy to identify potential partnerships and collaborations [1][2] Conference Participation - Evaxion's upcoming conference schedule includes: - Immunotherapy and Immuno-Oncology Congress, March 12-14 in London - HC Wainwright AI Based Drug Discovery & Development Conference, April 2 (Virtual) - Jones Healthcare and Technology Innovation Conference, April 8-9 in Las Vegas - World Vaccine Congress, April 21-25 in Washington - AACR Annual Meeting, April 25-30 in Chicago - Sidoti Micro-Cap Conference, May 20-21 (Virtual) - Dark Genome Target Discovery & Development Summit, June 16-18 in Boston - BIO International Convention, June 16-19 in Boston - World Conference on Infectious Diseases, June 18-20 in Stockholm - International Neoantigen Summit, June 24-26 in Amsterdam - Additional conferences for stakeholder engagement where Evaxion will participate but not present [3] Company Overview - Evaxion is a pioneering TechBio company utilizing its AI platform, AI-Immunology™, to develop innovative immunotherapies for cancer, bacterial diseases, and viral infections. The company has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with significant unmet medical needs [4]
Evaxion extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package
Globenewswire· 2025-02-25 13:00
Core Viewpoint - Evaxion Biotech A/S is extending its phase 2 trial of the personalized cancer vaccine EVX-01 from two to three years to enhance the data package and potentially document better treatment effects for advanced melanoma [1][4][9]. Group 1: Trial Details - The trial will allow active participants to enter a one-year extension after completing the initial two-year protocol, receiving additional doses of EVX-01 as monotherapy [2]. - The trial is progressing as planned, with a two-year data readout expected in the second half of 2025, and all active patients have shown a reduction in tumor target lesions [3][9]. - The extension aims to collect more data on clinical response duration and immune activation, which may provide insights into the durability of the immune response [9]. Group 2: Treatment Efficacy - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% overall response rate, with tumor target lesions reduced in 15 out of 16 patients [7]. - A positive correlation was observed between the AI-Immunology™ platform predictions and immune responses, with 79% of vaccine targets triggering a targeted immune response [7][10]. - In a completed phase 1/2a trial, 67% of metastatic melanoma patients had objective clinical responses, indicating the potential effectiveness of EVX-01 [9][10]. Group 3: Technology and Innovation - EVX-01 is developed using Evaxion's AI-Immunology™ platform, which tailors the vaccine to each patient's unique tumor profile and immune characteristics [5][8]. - The vaccine engages the patient's immune system to mount a targeted response against tumors, representing a novel approach in cancer treatment [5][8].
Nasdaq confirms Evaxion is fully compliant, withdraws delisting determination
Globenewswire· 2025-02-14 13:00
Core Points - Evaxion Biotech A/S has re-established compliance with Nasdaq's minimum stockholders' equity requirement and will remain listed on the exchange [1][8] - The company has significantly strengthened its equity and cash position, focusing on executing its strategy and pursuing 2025 milestones [2][8] - Evaxion completed a public offering of $10.8 million and raised an additional $7.6 million through other capital market activities, totaling approximately $17 million in cash and equity [5][8] Compliance and Financial Position - On January 28, 2025, Evaxion was given until May 12, 2025, to demonstrate compliance with Nasdaq listing rule 5550(b)(1), which requires stockholders' equity of at least $2.5 million [3] - The company has successfully executed its plan to restore equity and has re-established compliance with Nasdaq [3][4] - Nasdaq has imposed a "Mandatory Panel Monitor" for one year, during which Evaxion must maintain compliance to avoid delisting [4] Future Prospects - Evaxion is in discussions with the European Investment Bank regarding the conversion of €3.5 million of its €7 million loan, which is expected to increase equity by $3.7 million upon completion [6] - The agreement with the EIB is anticipated to be finalized in the first quarter of 2025 [6][8] - The company's cash runway has been extended to mid-2026 due to recent capital market activities [5][8]
Evaxion announces closing of $10.8 million public offering
Globenewswire· 2025-01-31 21:05
Core Viewpoint - Evaxion Biotech A/S has successfully closed a public offering of 3,997,361 American Depositary Shares (ADSs) and warrants, raising gross proceeds of $10.8 million to advance its clinical pipeline and support operational expenses [1][4]. Group 1: Offering Details - The public offering price was set at $2.71 per ADS, with one warrant for every two ADSs purchased [1]. - The warrants have an exercise price of $2.71 per ADS, are immediately exercisable, and will expire five years after issuance [3]. - The offering was facilitated by Lake Street Capital Markets and Jones as exclusive placement agents [4]. Group 2: Participation and Use of Proceeds - MSD Global Health Innovation Fund, along with other healthcare-focused investment funds and members of Evaxion's Board of Directors and Management, participated in the offering [2]. - The net proceeds from the offering will be utilized to advance the company's preclinical and clinical pipeline, as well as for ongoing operating expenses and working capital [4]. Group 3: Company Overview - Evaxion Biotech A/S is a clinical-stage TechBio company that leverages its AI-Immunology™ platform to develop innovative vaccines targeting cancer, bacterial diseases, and viral infections [8]. - The company is focused on creating personalized vaccines and addressing high unmet medical needs in infectious diseases [8].