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Evaxion Biotech A/S (symbol: EVAX) is a clinical-stage biotechnology company founded in 2008 with the mission to address some of the most significant global health challenges using artificial intelligence (AI). The company has developed robust platforms for creating novel vaccines and therapies. Evaxion's primary AI platforms, PIONEER and EDEN, utilize advanced in silico tools including big data, AI, and supercomputing to predict, rank, and optimize epitopes and antigens that stimulate highly protective immune responses against cancers and infectious diseases.
Evaxion's EDEN platform focuses on the rapid discovery of new antigens eliciting cross-protective immune responses against bacterial pathogens. On the other hand, the PIONEER platform identifies epitopes of mutated proteins to activate the body's natural immune responses. Additionally, the company has developed two more AI platforms, RAVEN and ObsERV, to further enhance its drug development pipeline.
The company's leading product candidates include EVX-01 and EVX-02, which are under development for cancer treatment, as well as EVX-03, a pre-clinical candidate for non-small-cell lung cancer (NSCLC). With a strong focus on AI-driven drug discovery and development, Evaxion aims to create innovative immunotherapies with improved efficacy for patients with unmet medical needs.
Recent news highlights key company activities, such as:
- A replay of the R&D Day presentations is available on the company's website.
- Information about the EVX-01 Phase 2 clinical trial.
- The company resolved a Nasdaq equity deficiency issue stemming from the IFRS accounting treatment of investor warrants.
To learn more about Evaxion Biotech A/S and its innovative AI-driven approaches, please visit Evaxion Biotech.
Evaxion Biotech (NASDAQ: EVAX) has completed dosing all 16 patients in its phase 2 trial of EVX-01, a personalized cancer vaccine for advanced melanoma treatment. The trial, which combines EVX-01 with MSD's KEYTRUDA®, remains on track for completion and data readout in H2 2025.
The company's AI-Immunology™ platform-designed vaccine has shown promising interim results presented at ESMO Congress in September 2024, including a 69% Overall Response Rate and tumor reduction in 15 out of 16 patients. The data demonstrated a positive correlation between AI-platform predictions and immune responses, with 79% of vaccine targets triggering targeted immune responses.
EVX-01 is tailored to each patient's unique tumor profile and immune characteristics, targeting a market of over 300,000 new melanoma cases annually.
Evaxion Biotech (NASDAQ: EVAX) has completed its previously announced ADS ratio change effective January 14, 2025. The ratio has been modified from 1 ADS representing 10 ordinary shares to 1 ADS representing 50 ordinary shares, equivalent to a one-for-five reverse ADS split.
The change was automatically implemented, with existing ADSs being cancelled and new ones issued by The Bank of New York Mellon. Holders of certificated ADSs were required to surrender their certificates for exchange, while uncertificated ADSs in DRS and DTC were automatically converted. No fractional ADSs were issued; instead, fractional entitlements will be sold and proceeds distributed to affected holders.
The company continues trading on Nasdaq under 'EVAX'. While the ADS trading price is expected to increase proportionally, Evaxion provided no assurance regarding the post-change trading price or liquidity effects.
Evaxion Biotech (NASDAQ: EVAX) has announced an extension to its planned American Depositary Shares (ADS) ratio change. The effective date has been moved to January 14, 2025, one day later than initially planned, due to Nasdaq Capital Markets' closure on January 9 in observance of President Jimmy Carter's passing.
The ADS ratio will change from 1:10 (one ADS representing ten ordinary shares) to 1:50 (one ADS representing fifty ordinary shares). This change will function similarly to a one-for-five reverse ADS split and aims to enhance ADS liquidity. Holders of uncertificated ADSs will have their shares automatically exchanged, while those with certificated ADSs must surrender them for cancellation and replacement. The stock will continue trading under 'EVAX' on Nasdaq, with fractional ADSs being sold and proceeds distributed to holders.
Evaxion Biotech (NASDAQ: EVAX) announced plans to change its American Depositary Shares (ADS) ratio from 1 ADS representing 10 ordinary shares to 1 ADS representing 50 ordinary shares, effective January 13, 2025. This change will function like a 1-for-5 reverse ADS split.
Holders of uncertificated ADSs in DRS and DTC will have their shares automatically exchanged, while certificated ADS holders must surrender their certificates for cancellation to receive 1 new ADS for every 5 existing ADSs. The company will continue trading on Nasdaq under 'EVAX'. Fractional ADSs will be sold, with net proceeds distributed to affected holders.
Evaxion Biotech (NASDAQ: EVAX) is in advanced discussions with the European Investment Bank (EIB) to convert €3.5 million of its €7 million loan into an equity-type instrument. The conversion is expected to increase Evaxion's equity by $3.7 million upon completion in Q1 2025. This strategic move aims to ensure compliance with Nasdaq listing requirements and strengthen the company's financial position.
As Evaxion's only debt is the EIB loan, the conversion would significantly reduce overall liabilities, simplify the balance sheet, and improve financial flexibility and cash flow. The terms under discussion are reported to be favorable for both the company and its shareholders.
Evaxion Biotech (NASDAQ: EVAX), a clinical-stage TechBio company, has achieved preclinical Proof-of-Concept (PoC) for its AI-Immunology™ platform, which designs precision cancer vaccines targeting non-conventional ERV tumor antigens. The new data, presented at the ESMO Immuno-Oncology Congress, confirm the approach's effectiveness by inducing strong T-cell responses and inhibiting tumor growth in mice.
The AI-Immunology™ platform identifies ERV fragments, or hotspots, that match diverse immune system profiles, potentially broadening the applicability of cancer vaccines to patients unresponsive to conventional immunotherapies. Evaxion plans to select a lead ERV precision vaccine candidate by the second half of 2025.
CEO Christian Kanstrup highlighted the milestone achievement, emphasizing the potential for improved treatment options leveraging AI-Immunology™ to design broadly applicable precision vaccines. The data from human cell and mouse model studies demonstrate the platform's capability to induce functional, antigen-specific T-cells and inhibit tumor growth.
Evaxion Biotech (NASDAQ: EVAX) has announced its strategic milestones for 2025 following the successful achievement of most 2024 goals. The company's key priorities include executing business development strategy, continuing the EVX-01 phase 2 trial, strengthening their AI-Immunology™ platform, and advancing research activities.
The 2025 milestones include: launching an automated lead vaccine candidate design module in H2, securing at least two new partnership agreements, completing EVX-01 patient dosing in H1, obtaining phase 2 clinical efficacy readout in H2, selecting a lead vaccine candidate for precision ERV cancer vaccines, potential MSD option exercise worth up to $10 million, selecting lead antigens for CMV vaccine candidate, and introducing two new pipeline candidates in infectious diseases.
Evaxion Biotech A/S (NASDAQ: EVAX), a clinical-stage TechBio company, will present preclinical Proof-of-Concept for its precision cancer vaccine concept at the ESMO Immuno-Oncology Congress from December 11-13, 2024, in Geneva, Switzerland.
The data, derived from studies in human cells and mouse tumor models, highlight human T-cell responses and mouse tumor growth inhibition induced by the precision ERV (endogenous retrovirus) vaccine targets identified using Evaxion's AI-Immunology™ platform.
ERV antigens can be selected for precision therapeutic cancer vaccines, offering new treatments for various cancer types, including those unresponsive to conventional immunotherapy. This approach allows for designing vaccines effective across diverse immune system characteristics, suitable for a wide range of patients.
Evaxion will use this preclinically validated concept to design new precision vaccine candidates to enhance its existing pipeline.
Conference Details:
Abstract title: AI-designed cancer vaccines: antigens from the dark genome are promising cancer vaccine targets
Poster#: 124P
Location: Foyer Mezzanine
Date/Time: December 12, 2024, at 12.30 CET/06.30 EST
Presenter: Daniela Kleine-Kohlbrecher, Senior Project Manager at Evaxion
Evaxion Biotech (NASDAQ: EVAX) has received a delisting determination from Nasdaq due to failure to maintain stockholders' equity of at least $2.5 million. The company has appealed the decision and requested a hearing, seeking another 180-day extension to comply with Nasdaq's equity requirements. The appeal will suspend any trading suspension until the hearing process concludes. This follows a previous deficiency letter received on May 7, 2024, after which Evaxion was granted a 180-day extension that expired on November 4, 2024. The company plans to increase stockholder's equity through business development income and capital markets activities, though compliance cannot be guaranteed.
Evaxion reported positive preclinical data for its cytomegalovirus (CMV) vaccine program EVX-V1. The study demonstrated that CMV antigens identified using their proprietary AI-Immunology™ platform successfully triggered targeted immune responses. The results also validated their proprietary prefusion glycoprotein B (gB) antigen design, showing virus neutralization capabilities. Based on these findings, Evaxion is proceeding with the development of a multi-component CMV vaccine candidate.
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