EVAX Evaxion Biotech A/S

8.2
+0.09  (+1%)
Previous Close 8.11
Open 8.24
52 Week Low 5.155
52 Week High 10.34
Market Cap $157,430,997
Shares 19,198,668
Float 19,198,668
Enterprise Value $134,556,437
Volume 3,951
Av. Daily Volume 104,683
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Drug Pipeline

Drug Stage Notes
EVX-02
Adjuvant melanoma
Phase 1/2
Phase 1/2
Phase 2 trial to be initiated 2Q 2022.
EVX-01 and KEYTRUDA (pembrolizumab) / OPDIVO (nivolumab)
Melanoma/NSCLC/Bladder cancer
Phase 2b
Phase 2b
Phase 1/2 data released July 8, 2021. Objective Response Rate (ORR) of 67%. 22% Complete Response (CR) and 44% Partial Response (PR). Phase 2b trial to be initiated December 2021.

Latest News

    • Dr. Rønø has developed Evaxion's pre-clinical and early clinical oncology pipeline
    • Newly-created Chief Scientific Officer role strengthens Evaxion's leadership team

    COPENHAGEN, Denmark, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, announced today it has promoted its Senior Director, Immuno-Oncology, Birgitte Rønø, Ph.D, to the newly-created position of Chief Scientific Officer, effective immediately.

    Lars Wegner, CEO of Evaxion, said: "As Senior Director of Evaxion's Cancer Immunotherapy, Birgitte Rønø…

    • Dr. Rønø has developed Evaxion's pre-clinical and early clinical oncology pipeline

    • Newly-created Chief Scientific Officer role strengthens Evaxion's leadership team

    COPENHAGEN, Denmark, Sept. 21, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, announced today it has promoted its Senior Director, Immuno-Oncology, Birgitte Rønø, Ph.D, to the newly-created position of Chief Scientific Officer, effective immediately.

    Lars Wegner, CEO of Evaxion, said: "As Senior Director of Evaxion's Cancer Immunotherapy, Birgitte Rønø played a critical role in the development of Evaxion's pre-clinical and early clinical oncology pipeline. Her appointment as CSO is a well-deserved recognition of her achievements, and she will now take on additional responsibilities to further expand the scientific foundations of Evaxion to advance the development of our pipeline. The CSO position is a new one within Evaxion's leadership team and comes at a key time for the Company, as we continue to make encouraging progress in the clinic, with two of our lead product candidates expected to advance into Phase 2b trials, one in late 2021 and the other in the first half of 2022."

    Dr. Rønø has more than 15 years' experience in biopharmaceutical drug discovery, both in academia and industry. Prior to joining Evaxion, Dr. Rønø served as a specialist, team leader and project manager at Novo Nordisk A/S, where she led early drug discovery projects, evaluated in-licensing opportunities, and supported drug development projects with pre-clinical and biomarker expertise.

    Birgitte Rønø, CSO of Evaxion, said: "I am very excited to take up my new role as CSO at Evaxion. Having already worked at the company for more than four years, I am intimately familiar with Evaxion's AI-driven immunotherapies and I am looking forward to taking on a leadership role, as we continue to develop these innovative drug discovery processes to improve the lives of patients."

    Dr. Rønø holds a Bachelor's Degree in Medicine and a Master's Degree in Human Biology, both from the University of Copenhagen, Denmark. She received her Ph.D in Experimental Oncology and Immunology from the National Institutes of Health, Bethesda, USA and Copenhagen University Hospital, Denmark.

    About Evaxion

    Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development, both of which are expected to advance into Phase 2b trials, one in late 2021 and the other in the first half of 2022. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.

    For more information 
    EvaxionLifeSci Advisors LLC
    Glenn S. VraniakCorey Davis, Ph.D.
    Chief Financial OfficerManaging Director
    gvr@evaxion-biotech.comcdavis@lifesciadvisors.com
    +1 (513) 476-2669212-915-2577

    Source: Evaxion Biotech

    Forward-looking statement

    This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company's future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "hope," "aim," "intend," "may," "might," "anticipate," "contemplate," "continue," "estimate," "plan," "potential," "predict," "project," "will," "can have," "likely," "should," "would," "could," and other words and terms of similar meaning or the negative thereof. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company's financial condition and need for additional capital; risks associated with the Company's development work; cost and success of the Company's product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company's AI platform technology, including the rate and degree of market acceptance of the Company's product candidates; risks related to the Company's dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company's inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company's intellectual property rights; risks related to employee matters and managing growth; risks related to the Company's ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company's business operations and financial condition.

    Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, see the risks described in the "Risk Factors" section included in the Company's Form 20-F for the year ended December 31, 2020 and the Company's other reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.



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    • Data reported in early July from EVX-01 clinical program showed a robust anti-tumor effect in combination with anti-PD-1 treatment for patients with metastatic melanoma, supporting advancement into a Phase 2b clinical trial
    • Data also reported in early July from the EVX-02 clinical program in adjuvant melanoma support advancing into a Phase 2b clinical trial
    • Product candidate EVX-B1 is progressing through preclinical development as planned
    • Reported preclinical proof of concept for the Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses (AICoV) program
    • Cash reserves of $18.8 million as of June 30, 2021 are expected to provide funding of key programs into 2022

    COPENHAGEN, Denmark, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Evaxion…

    • Data reported in early July from EVX-01 clinical program showed a robust anti-tumor effect in combination with anti-PD-1 treatment for patients with metastatic melanoma, supporting advancement into a Phase 2b clinical trial
    • Data also reported in early July from the EVX-02 clinical program in adjuvant melanoma support advancing into a Phase 2b clinical trial
    • Product candidate EVX-B1 is progressing through preclinical development as planned
    • Reported preclinical proof of concept for the Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses (AICoV) program
    • Cash reserves of $18.8 million as of June 30, 2021 are expected to provide funding of key programs into 2022

    COPENHAGEN, Denmark, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, announced today the second quarter 2021 financial results and provided an operational update.

    Lars Wegner, CEO of Evaxion, said: "Evaxion has made very encouraging clinical progress in the second quarter of 2021, reporting data in July which we believe support advancing both of our lead programs into Phase 2b trials. Phase 1/2a data on our lead program EVX-01 showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b trial for EVX-01 in melanoma in December 2021 and initiate a Phase 2b trial of EVX-02, in conjunction with our third program, EVX-03, in Q2 2022. We also reported preclinical proof of concept data for our RAVEN AI platform for vaccine design and development for viral infections, which we believe has the potential to make a significant contribution in addressing coronavirus infections and other viral diseases. Our cash reserves of $18.8 million provide a solid financial foundation and will facilitate the continued development of these four lead programs."

    Operational and Business Highlights in Q2 2021

    • Reported preclinical proof of concept data in June for the Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses (AICoV) program, supporting next-generation coronavirus vaccine technology. First-generation SARS-COV-2 vaccines are focused on the generation of neutralizing antibodies by B cells that bind to the spike protein of the virus and inhibit infection. Activation of T cells may help broaden the immune system's response to coronavirus and protect against mutations on the spike protein that have been shown to circumvent immunity. Early data demonstrate our RAVEN platform identifies novel immunogenic T-cell epitopes beyond just the spike protein. The proof-of-concept data show RAVEN's potential to rapidly support the design of novel SARS-COV-2 vaccines capable of tackling newly emerging coronavirus variants.
    • EVX-03, a novel patient-specific therapy for multiple cancer indications and EVX-B1, a vaccine for the prevention of Staphylococcus aureus including MRSA, continue to progress as expected through preclinical and Chemistry, Manufacturing and Controls (CMC) development.
    • Presentation in April at the 4th Neoantigen Summit Europe, described Evaxion's recent improvement in determining cancer neoepitopes through measurement and prediction of peptide-MHC (pMHC) complex stability. We believe this is a significant improvement over AI models trained on traditional mass spectrometry ligand data and the data have already proven valuable in improving our discovery and design of patient-specific neoepitopes used to derive our cancer therapies.
    • Acceptance of a scientific paper by the International Conference on Machine Learning describing a novel predictive system based on deep probabilistic programming that enables the rapid conversion of sequence data into structural information on protein fragments, which we believe may be useful for drug and vaccine design.

    Events after the Reporting Period

    • Reported new clinical data in early July from Phase 1/2a trials of EVX-01 and EVX-02.
      • EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, a checkpoint inhibitor anticancer drug, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b trial of EVX-01 is planned to start in December 2021.
      • Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. A Phase 2b trial of EVX-02, in combination with EVX-03, our novel patient-specific therapy for multiple cancer indications, is planned to start in Q2 2022 as a combination therapy with anti-PD-1 in adjuvant melanoma.

    Expected milestones in 2021 & 2022

    • Phase 2b trial initiation of EVX-01 in metastatic melanoma – Q4 2021.
    • Phase 2b trial regulatory filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – Q2 2022.
    • Phase 1a trial regulatory filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
    • First viral candidate selected from RAVEN platform – Q1 2022.

    Second Quarter 2021 Financial Results

    • Cash position: As of June 30, 2021, cash and cash equivalents were $18.8 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after underwriting discounts and commissions, but before offering expenses.
    • Research and Development expenses were $5.1 million for the quarter ended June 30, 2021, compared to $2.6 million for the same period in 2020. The increase of $2.5 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
    • General and Administrative expenses were $1.9 million for the quarter ended June 30, 2021, compared to $1.4 million for the same period in 2020. The increase of $0.5 million was primarily related to increases in overhead and professional fees related to the expansion of our corporate function.
    • Net loss was $6.8 million for the quarter ended June 30, 2021 or ($0.36) loss per basic and diluted share, compared to $3.6 million, or ($0.24) loss per basic and diluted share, for the same period in 2020.

    Guidance

    • Evaxion's current cash position of $18.8 million is expected to be sufficient to fund key clinical programs into 2022.

    Webcast and Conference Call

    Evaxion will host a webcast and conference call today, August 12, at 8:30 a.m. EDT.

    To dial-in for the conference call, please use the following details:

    US: 877-407-0792

    International: +1-201-689-8263

    Conference ID: 13722183

    Alternatively to access the audio webcast, please visit the events page of Evaxion's website at:

    https://evaxion-biotech.com/news-and-events/events/default.aspx

    About Evaxion

    Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.

    For more information

    EvaxionLifeSci Advisors LLC
    Glenn S. VraniakCorey Davis, Ph.D.
    Chief Financial OfficerManaging Director
    gvr@evaxion-biotech.comcdavis@lifesciadvisors.com
    +1 (513) 476-2669212-915-2577

    Source: Evaxion Biotech

    Forward-looking statement

    This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company's future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "hope," "aim," "intend," "may," "might," "anticipate," "contemplate," "continue," "estimate," "plan," "potential," "predict," "project," "will," "can have," "likely," "should," "would," "could," and other words and terms of similar meaning or the negative thereof. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company's financial condition and need for additional capital; risks associated with the Company's development work; cost and success of the Company's product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company's AI platform technology, including the rate and degree of market acceptance of the Company's product candidates; risks related to the Company's dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company's inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company's intellectual property rights; risks related to employee matters and managing growth; risks related to the Company's ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company's business operations and financial condition.

    Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, see the risks described in the "Risk Factors" section included in the Company's Form 20-F for the year ended December 31, 2020 and the Company's other reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.



    Evaxion Biotech A/S
    Consolidated Statements of Financial Position Data (Unaudited)
    (USD in thousands)
      June 30,   Dec 31, 
      2021   2020 
       
    Cash and cash equivalents$18,799  $5,834 
    Total assets 27,657   11,965 
    Total liabilities 5,828   4,927 
    Share capital 3,132   2,648 
    Other reserves 56,168   31,669 
    Accumulated deficit (37,471)  (27,279)
    Total equity 21,829   7,038 
    Total liabilities and equity$27,657  $11,965 





    Evaxion Biotech A/S
    Consolidated Statements of Comprehensive Loss Data (Unaudited)
    (USD in thousands, except per share data)
     Three Months Six months

     Ended June 30 Ended June 30

      2021   2020   2021   2020 
                    
    Research and development expenses$5,111  $2,570  $9,004   5,080 
    General and administrative expenses 1,915   1,372   3,197   2,153 
    Operating loss (7,026)  (3,942)  (12,201)  (7,233)
    Finance income 33   6   1,005   22 
    Finance expenses (495)  --   (792)  (4)
    Net loss before tax (7,488)  (3,936)  (11,988)  (7,215)
    Income tax benefit 669   296   1,076   476 
    Net loss for the period$(6,819) $(3,640) $(10,912) $(6,739)
    Net loss attributable to equity holders of Evaxion Biotech A/S$(6,819) $(3,640) $(10,912) $(6,739)
    Loss per share – basic and diluted$(0.36) $(0.24) $(0.59) $(0.44)
    Number of shares used for calculation (basic and diluted) 19,198,668   15,184,152   18,535,685   15,184,152 
                    

     



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    • New clinical data demonstrates antitumor effect of EVX-01 in combination with anti-PD1 treatment
    • Objective Response Rate (ORR) of 67% with EVX-01 + anti-PD1 treatment in nine metastatic melanoma patients, including 22% Complete Response (CR) and 44% Partial Response (PR)
    • Clinical trial data supports the proprietary AI-Immunology platform, PIONEER, with regard to: neoepitope prediction, de novo T-cell activation and clinical response in cancer patients 
    • Phase 2 trial of EVX-01 in melanoma, planned to start in December 2021
    • First patients in Phase 1/2a trial of EVX-02 showed T-cell activation, with further data to be generated with aim of initiating Phase 2 trial in Q2 2022
    • Conference call and webcast this morning July 8, 2021 at 8:00 AM EDT

    COPENHAGEN…

    • New clinical data demonstrates antitumor effect of EVX-01 in combination with anti-PD1 treatment

    • Objective Response Rate (ORR) of 67% with EVX-01 + anti-PD1 treatment in nine metastatic melanoma patients, including 22% Complete Response (CR) and 44% Partial Response (PR)
    • Clinical trial data supports the proprietary AI-Immunology platform, PIONEER, with regard to: neoepitope prediction, de novo T-cell activation and clinical response in cancer patients 
    • Phase 2 trial of EVX-01 in melanoma, planned to start in December 2021
    • First patients in Phase 1/2a trial of EVX-02 showed T-cell activation, with further data to be generated with aim of initiating Phase 2 trial in Q2 2022
    • Conference call and webcast this morning July 8, 2021 at 8:00 AM EDT

    COPENHAGEN, Denmark, July 08, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX), a clinical-stage biotech company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today results from both its Phase 1/2a trial of cancer immunotherapy EVX-01 in metastatic melanoma and interim Phase 1/2a trial of cancer immunotherapy EVX-02 in adjuvant melanoma.

    Data from the trial of EVX-01, a novel patient-specific cancer neoepitope immunotherapy based on Evaxion's PIONEER AI technology in combination with a PD-1 checkpoint inhibitor, showed a safety profile with only Grade 1 and 2 adverse events observed.

    Combined therapy with EVX-01 demonstrated an objective response rate of 67% across all nine patients compared with historical data of 40% with anti-PD1 treatment alone1. The study also demonstrated a complete response rate of 22%, compared with a historical 7%1 with anti-PD1 treatment alone, and a partial response rate of 44%, versus 33% compared with anti-PD1 treatment alone1. Among the four patients on the highest two doses, there was an objective response rate of 75%. Three patients with Stable Disease for 10, 8 and 9 months on anti-PD1 treatment alone, achieved CR, CR and PR respectively following EVX-01 administration and subsequent activation of a neoepitope specific de novo T-cell response.

    Lars Wegner, CEO of Evaxion, said: "We are very excited about the Phase 1/2a data for EVX-01, which shows encouraging results for our AI-developed immunotherapy in metastatic melanoma and appears to be well tolerated with only Grade 1 and 2 adverse events such as fatigue and fever all of which were resolved with treatment. The complete elimination of all tumors we see in the two patients stable for 8-10 months on checkpoint inhibitor treatment has further increased our belief in the benefit our neoepitope-based therapies can bring to patients. In addition, the tumor reduction in patients correlates with neoepitope specific T-cell activation and PIONEER predictions. The data demonstrate the potential of our PIONEER platform and its ability to identify patient specific cancer neoeptiopes. Importantly, the objective response rate demonstrates that EVX-01 may be able to improve the treatment landscape in melanoma and potentially other cancers. Furthermore, the first results from our Phase 1/2a trial with EVX-02 demonstrate its potential for treatment of melanoma. Based on the data from these two studies, we expect to initiate a Phase 2 trial with EVX-01 by the end of the year and a Phase 2 trial with EVX-02 in Q2 2022."

    Professor Inge Marie Svane, Head of the Danish Centre for Cancer Immunotherapy and Principal Investigator of the EVX-01 study, said: "These Phase 1/2a data demonstrate the feasibility of the combination of EVX-01 with anti-PD1 therapy with substantial reduction of tumor burden in some patients. It is particularly interesting to see that two patients improved their response to anti-PD1 therapy further to complete response following addition of EVX-01. This could be good news for patients and I look forward to contributing to the further development of this novel therapy."

    About the EVX-01 Phase 1/2a clinical trial in metastatic melanoma

    In the Phase 1/2a trial, nine patients with metastatic melanoma were injected biweekly with EVX-01, three times intraperitoneal and three times intramuscular plus, with pembrolizumab every three weeks or nivolumab every four weeks. Patients were dosed at three different levels of EVX-01, 500 μg, 1,000 μg and 2,000 μg.

    The study also revealed encouraging biomarker information supporting EVX-01's mechanism of action. There was broad T-cell activation in all patients, with 76.2% of the administered neoepitopes inducing reactive T cells, while 84.8% of EVX-01 induced reactive T cells were de novo responses. Patient cases established a direct link between EVX-01 activated T cells and antitumor effect and duration of response. The data further demonstrated a link between neoepitopes identified by the PIONEER platform and clinical response.

    The results also showed that Evaxion's novel proprietary AI-Immunogenetic Drug Response Platform (AI-DeeP™), which provides immuno-genetic profiling of individual patients based on biological rational for drug response, can predict the response to therapy with precision and sensitivity.

    We believe that the data support progressing the development of EVX-01 into a subsequent randomized Phase 2b trial, which we expect to initiate in December 2021. We also intend to present the data at a upcoming medical society meeting in first half of 2022.

    Phase 1/2a results with EVX-02 in adjuvant melanoma

    This is an open label, multi-center study assessing the safety, tolerability, pharmacodynamics, and potential efficacy of EVX-02 in combination with checkpoint inhibitor in patients who have had a complete resection of Stage IIIB/IIIC/IIID or Stage IV melanoma and are at high risk of recurrence. The study is taking place at five clinical centers in Australia.

    Data from the first patients in the trial showed T-cell activation, even in assays which had not been prestimulated. Based on this readout, Evaxion will continue to generate more data from the trial with the aim of initiating a Phase 2 trial with EVX-02 in an adjuvant setting in the second quarter of 2022.

          1)   Robert et al. 2015. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N. Engl. J. Med. 372: 2521–32.

    Webcast and Conference Call

    To discuss today's data announcement Evaxion will host a webcast and conference call today, July 8, 2021 at 8:00 a.m. EDT.

    To dial-in for the conference call, please use the following details:

    US: 877-407-0792

    International: +1-201-689-8263

    Conference ID: 13720456

    Webcast: http://public.viavid.com/index.php?id=145224

    The webcast recording will be available from 8th of July 2021 at: Webcast Archive

    About Evaxion

    Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, and vaccines against bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.

    For more information
    EvaxionLifeSci Advisors, LLC
    Glenn S. VraniakCorey Davis
    Chief Financial Officer 
    gvr@evaxion-biotech.comcdavis@lifesciadvisors.com
    +1 (513) 476-2669+1 (212) 915 2577

    Source: Evaxion Biotech

    Forward-looking statement

    This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company's future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "hope," "aim," "intend," "may," "might," "anticipate," "contemplate," "continue," "estimate," "plan," "potential," "predict," "project," "will," "can have," "likely," "should," "would," "could," and other words and terms of similar meaning or the negative thereof. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company's financial condition and need for additional capital; risks associated with the Company's development work; cost and success of the Company's product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company's AI platform technology, including the rate and degree of market acceptance of the Company's product candidates; risks related to the Company's dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company's inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company's intellectual property rights; risks related to employee matters and managing growth; risks related to the Company's ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company's business operations and financial condition.

    Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, see the risks described in the "Risk Factors" section included in the Company's Form 20-F for the year end December 31, 2020 and the Company's current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.



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  1. COPENHAGEN, Denmark, July 07, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, announced today that it will hold a conference call to discuss Phase 1/2a data on EVX-01 and EVX-02 on Thursday, July 8, 2021.

    Lars Wegner, CEO of Evaxion, Glenn Vraniak, CFO, and Niels Iversen Moller, co-founder and CBO, will host the call, at 8:00 a.m. EDT.

    To dial in for the conference call, please use the following details:

    Date: July 8, 2021
    Time: 8:00 AM EDT
    US Dial-in: 877-407-0792
    International Dial-in: + 1-201-689-8263
    Conference ID: 13720456
    Webcast: http://public.viavid.com/index.php?id=145224

    COPENHAGEN, Denmark, July 07, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, announced today that it will hold a conference call to discuss Phase 1/2a data on EVX-01 and EVX-02 on Thursday, July 8, 2021.

    Lars Wegner, CEO of Evaxion, Glenn Vraniak, CFO, and Niels Iversen Moller, co-founder and CBO, will host the call, at 8:00 a.m. EDT.

    To dial in for the conference call, please use the following details:

    Date: July 8, 2021

    Time: 8:00 AM EDT

    US Dial-in: 877-407-0792

    International Dial-in: + 1-201-689-8263

    Conference ID: 13720456

    Webcast: http://public.viavid.com/index.php?id=145224

    Slides will accompany the event and a live webcast of the call will also be available via the Investor Relations page of Evaxion website, available here, and will be archived for one year.

    About Evaxion

    Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, and vaccines against bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.

    For more information  
    Evaxion LifeSci Advisors LLC
    Glenn S. Vraniak Corey Davis
    Chief Financial Officer  
    gvr@evaxion-biotech.com cdavis@lifesciadvisors.com
    +1 (513) 476-2669 +1 (212) 915-2577

    Forward-looking statements

    This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company's future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "hope," "aim," "intend," "may," "might," "anticipate," "contemplate," "continue," "estimate," "plan," "potential," "predict," "project," "will," "can have," "likely," "should," "would," "could", and other words and terms of similar meaning or the negative thereof. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company's financial condition and need for additional capital; risks associated with the Company's development work; cost and success of the Company's product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company's AI platform technology, including the rate and degree of market acceptance of the Company's product candidates; risks related to the Company's dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company's inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company's intellectual property rights; risks related to employee matters and managing growth; risks related to the Company's ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company's business operations and financial condition.

    Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, see the risks described in the "Risk Factors" section included in the Company's Form 20-F for the year end December 31, 2020 and the Company's current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.



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  2. COPENHAGEN, Denmark, June 25, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today the acceptance of a new scientific paper by the International Conference on Machine Learning (ICML 2021). A draft of the article is available on the open-access scientific server bioRxiv.org.

    The paper is entitled "Efficient Generative Modelling of Protein Structure Fragments using a Deep Markov Model", and was written and developed by Evaxion personnel in collaboration with Assoc. Prof. Thomas Hamelryck's probabilistic programming group at the University of Copenhagen…

    COPENHAGEN, Denmark, June 25, 2021 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today the acceptance of a new scientific paper by the International Conference on Machine Learning (ICML 2021). A draft of the article is available on the open-access scientific server bioRxiv.org.

    The paper is entitled "Efficient Generative Modelling of Protein Structure Fragments using a Deep Markov Model", and was written and developed by Evaxion personnel in collaboration with Assoc. Prof. Thomas Hamelryck's probabilistic programming group at the University of Copenhagen. The paper describes BIFROST, a novel predictive system based on deep probabilistic programming that enables the rapid conversion of sequence data into structural information on protein fragments, which we believe may be useful for drug or vaccine design. Deep probabilistic programming is a new development in machine learning that combines the principled treatment of uncertainty provided by Bayesian statistics with the capabilities of deep learning. Compared to existing protein structure prediction approaches, BIFROST appears to be computationally more efficient, only requires sequence information and, importantly, incorporates an assessment of the reliability of its own predictions.

    Lars Wegner, CEO of Evaxion, said: "This work is an exciting development by the collaborative team that we believe has the potential to make vaccine development more efficient. We intend to apply our expertise to further the development of Bayesian machine learning and to integrate these methods fully into Evaxion's AI platforms, including both our EDEN and RAVEN platforms for vaccine development."

    Protein structure prediction methods such as BIFROST have the potential to facilitate AI-driven pharmaceutical design by indicating the likely conformation that components of immunotherapies or vaccines and their target might adopt. Existing methods for predicting the conformation of protein fragments do not explicitly evaluate the probability of conformations given the sequence which can make it difficult to dissect the reliability of subsequent calculations. By including estimates of uncertainty in predictions, BIFROST's Bayesian approach may be particularly useful in drug development datasets that, typically, are incomplete and relatively small.

    Anders B. Sørensen, Evaxion Director, Research and Discovery, said: "We are excited to share this first-time application of Deep Markov Models within the field of protein structure prediction. This has significant potential to improve how we develop medicines and showcases the power harnessed when we combine academic research with industrial application."

    About Evaxion

    Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, and vaccines against bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.

    For more information   
    Evaxion   LifeSci Advisors LLC
    Glenn S. Vraniak   Mary-Ann Chang
    Chief Financial Officer   Managing Director
    gvr@evaxion-biotech.com   mchang@lifesciadvisors.com
    +1 (513) 476-2669   +44 7483 284 853

    Source: Evaxion Biotech

    Forward-looking statement

    This announcement contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this announcement regarding the Company's future operations, plans and objectives are forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this announcement about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "hope," "aim," "intend," "may," "might," "anticipate," "contemplate," "continue," "estimate," "plan," "potential," "predict," "project," "will," "can have," "likely," "should," "would," "could", and other words and terms of similar meaning or the negative thereof. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including but not limited to: risks associated with the Company's financial condition and need for additional capital; risks associated with the Company's development work; cost and success of the Company's product development activities and preclinical and clinical trials; risks related to commercializing any approved pharmaceutical product developed using the Company's AI platform technology, including the rate and degree of market acceptance of the Company's product candidates; risks related to the Company's dependence on third parties including for conduct of clinical testing and product manufacture; risks associated with the Company's inability to enter into partnerships; risks related to government regulation; risks associated with protection of the Company's intellectual property rights; risks related to employee matters and managing growth; risks related to the Company's ADSs and ordinary shares, risks associated with the pandemic caused by the coronavirus known as COVID-19 and other risks and uncertainties affecting the Company's business operations and financial condition.

    Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company's business in general, see the risks described in the "Risk Factors" section included in the Company's Form 20-F for the year end December 31, 2020 and the Company's current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this announcement speak only as of the date hereof, and except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.



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