Evaxion Biotech A/S (EVAX) , along with its undisclosed partner, announced the successful completion of a series of large non-rodent animal infection studies, testing antigens from its investigational EVX-B1 vaccine candidate, which is being developed to treat Staphylococcus aureus (S. aureus) infection.Per the companies, in the completed pre-clinical studies, treatment with EVX-B1 antigens significantly reduced the disease burden. Based on such positive results, Evaxion and its partner are currently discus ...

Financial Data and Key Metrics Changes - The net loss for 2023 amounted to $22.1 million, compared to a net loss of $23.2 million in the previous year, indicating a slight improvement in financial performance [47] - Research and development expenses for 2023 totaled $11.9 million, while administrative expenses were $20.4 million, reflecting a focus on optimizing cash burn without compromising long-term growth [46][61] - Cash and cash equivalents as of December 31, 2023, were $5.6 million, with expectations that existing funds will be sufficient to cover operations into February 2025 following a public offering [67] Business Line Data and Key Metrics Changes - The company reported strong progress in its R&D pipeline, particularly with the EVX-01 personalized cancer vaccine, which is set to provide one-year clinical readout in Q3 2024 [41][54] - The EVX-B1 project against Staphylococcus aureus showed promising results in large animal models, marking a significant milestone in vaccine development [42][44] - The precision vaccine project is on track, with encouraging initial Phase 2 data from EVX-01 and ongoing discussions for further development [68] Market Data and Key Metrics Changes - The company is experiencing interest in both its infectious disease and oncology pipelines, indicating a balanced market demand for its products [83] - The collaboration with MSD Global Health Innovation Fund has positioned the company favorably in the market, with MSD being the largest shareholder [51] Company Strategy and Development Direction - The company has refined its strategy to focus on a three-pronged business model based on its AI immunology platform, which includes targets, pipeline, and responder models [34][35] - A multi-partner approach is emphasized for value realization, with ongoing discussions for partnerships to fund operational cash burn [52][53] - The company aims to progress its precision vaccine project and capitalize on the unmet needs in both cancer and infectious disease markets [60][68] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in the past six months, highlighting strong execution of the refined strategy and successful collaborations [49] - The focus remains on advancing various partnership discussions to support operational funding and growth [52][60] - Management anticipates significant milestones in 2024, including the conclusion of key collaborations and clinical trials [68] Other Important Information - The company has reduced its organization by 30% during 2023 to optimize cash burn and align with its focused strategy [60] - The upcoming AI model version 5.0 is expected to enhance predictive capabilities, further supporting vaccine discovery efforts [80][81] Q&A Session All Questions and Answers Question: Can you provide more details on the collaboration and data for EVX-B1? - The company is currently in discussions with the collaborator, and the data is supportive of the compound, indicating a promising outlook for clinical efficacy [70][72] Question: What are the next steps for EVX-B3 with MSD? - The next steps involve final IND-enabling activities, which are expected to take 1 to 1.5 years before clinical trials can be initiated [79] Question: What is unique about the new AI model version? - The new version incorporates additional building blocks to enhance predictive capabilities and expand the training dataset, increasing the model's precision [80][81] Question: Is there a greater interest in infectious disease candidates compared to cancer? - The company has seen balanced interest in both infectious disease and oncology candidates, with no significant tilt towards one over the other [83] Question: What is the status of outstanding prefunded warrants? - Approximately $4 million remains outstanding related to prefunded warrants, which will be released as they are exercised [89] Question: Does the company have a policy for takeover bids? - The company cannot comment on potential takeover bids but will communicate any relevant information if necessary [101]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ OR ☐ SHELL COMPANY REP ...

The proprietary AI-Immunology™ platform brings the potential for a new era in vaccine discovery, design and development using advanced AI and machine learning technologiesAI-Immunology™ outcompetes standard vaccine target discovery approaches and holds the promise of addressing serious unmet needsWith a unique modular architecture, AI-Immunology™ is scalable and adaptable towards partner needsThe potential of AI-Immunology™ is validated by established partnerships, including an ongoing vaccine collaboration ...

COPENHAGEN, Denmark, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announces that it will host a Research & Development (R&D) Day focusing on its core AI-Immunology™ platform on March 19, 2024, at 14:00 - 18:00 CET / 8:00 a.m. - 12:00 a.m. EST. The R&D Day will feature a series of talks from Evaxion's scientists and bioinformaticians, providing insights into ...

COPENHAGEN, Denmark, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announced that on February 05, 2024, it received a Notification Letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") stating that the Company had regained compliance with the minimum bid price requirement set forth under Nasdaq Listing Rule 5550(a)(2). Th ...

COPENHAGEN, Denmark, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announced the closing on February 5, 2024 of its previously announced public offering of 3,750,000 of its American Depositary Shares ("ADSs") (or pre-funded warrants in lieu thereof) and warrants to purchase up to 3,750,000 ADSs at a combined public offering price of $4.00 per ADS (or pre-fund ...

COPENHAGEN, Denmark, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ:EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today announced the pricing of a public offering of an aggregate of 3,750,000 of its American Depositary Shares ("ADSs") (or pre-funded warrants in lieu thereof) and warrants to purchase up to 3,750,000 ADSs at a combined public offering price of $4.00 per ADS (or pre-funded warrant in lieu thereof) ...

Financial Performance - For the three months ended June 30, 2023, total operating expenses were $5,677,000, a decrease of 9.3% compared to $6,259,000 for the same period in 2022[5]. - The net loss for the period was $5,683,000, compared to a net loss of $4,768,000 for the same period in 2022, reflecting an increase of 19.2%[5]. - The total comprehensive loss for the six months ended June 30, 2023, was $11,891,000, compared to $12,764,000 for the same period in 2022, showing a slight improvement of 6.9%[5]. - Research and development expenses for the six months ended June 30, 2023, were $6,788,000, down 24% from $8,916,000 in the same period of 2022[5]. - The company reported finance income of $47,000 for the three months ended June 30, 2023, a significant decrease from $1,539,000 in the same period of 2022[5]. Cash and Assets - Cash and cash equivalents decreased to $7,118,000 as of June 30, 2023, down from $13,184,000 at the beginning of the year, representing a decline of 46%[8]. - Total assets decreased to $16,754,000 as of June 30, 2023, from $22,025,000 as of December 31, 2022, a reduction of 24%[8]. - The accumulated deficit increased to $84,257,000 as of June 30, 2023, compared to $72,659,000 at the end of 2022, indicating a rise of 15.9%[8]. Financing and Capital Needs - The company plans to finance cash needs through equity offerings or other capital sources, requiring additional financing by December 2023[18]. - The company raised $5,973,000 from the issuance of shares and exercise of warrants during the six months ended June 30, 2023[12]. - The company entered into a Purchase Agreement to sell up to $40 million of its ordinary shares over a 36-month period, with no sales made as of June 30, 2023[24]. - The company has a financing agreement of up to $20 million with Global Growth Holding Limited as of July 31, 2023[26]. - The company’s current cash position and forecasted cash requirements indicate a need for additional financing to continue operations and product development[17]. Legal Proceedings - As of June 30, 2023, the Company and SSI have agreed to pause ongoing court proceedings and begin out-of-court negotiations[71]. - The Company believes ongoing legal proceedings will not materially impact future financial results[71]. - The Company believes it has strong defenses against SSI's claim regarding the Invention[70]. - The Company does not expect a material impact on its rights to use the Invention for developing and commercializing EVX-01[70]. - The Company intends to vigorously defend against SSI's claim, which it believes is without merit[70]. Going Concern - The company has significant doubt about its ability to continue as a going concern for at least one year from the balance sheet date due to ongoing losses and funding needs[19]. Shareholder Information - The carrying amount of the warrant liability decreased from $573,000 at January 1, 2023, to $402,000 at June 30, 2023, due to remeasurement[46]. - As of June 30, 2023, the number of warrants as a percentage of outstanding ordinary shares was 8.6%, down from 11.0% in 2022[47]. - The company granted 10,000 warrants to an employee on March 15, 2023, which vest over 36 months[50]. - The company sold 3,160,208 ordinary shares represented by ADSs from January 1, 2023, to June 30, 2023, at a volume weighted average price of $1.84 per ADS, generating approximately $6.0 million in gross proceeds[64]. - The company issued 428,572 ordinary shares as a commitment fee of $1.2 million for Lincoln Park's commitment under the Purchase Agreement[24].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ OR ☐ SHELL COMPANY REP ...