Tillkännagivande • Jun 11
Evaxion A/S Presents New Preclinical Data For EVX-04, An Off-The-Shelf Therapeutic Vaccine For Acute Myeloid Leukemia Evaxion A/S announced new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML). EVX-04 is successfully expressed and secreted in human cells enabling immune recognition and activation. The vaccine antigens drive specific immune responses across different human immune profiles and induce targeted cell-killing. Poster presentation at the European Hematology Association (EHA) 2026 Congress, taking place in Stockholm, Sweden. Developed with AI-Immunology, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome. The new data demonstrates EVX-04's complete expression in human cells, including correct transcription and translation. Further, EVX-04 is secreted in human cells, enabling immune recognition and activation. The data also shows that all ERV antigens included in EVX-04 drive specific immune responses both in mice (in vivo) and human cells (in vitro) across different human immune profiles. These vaccine-induced immune cells mediate targeted cell-killing, highlighting EVX-04's potential as a new effective therapeutic cancer vaccine. Data will be presented at a poster presentation at the European Hematology Association (EHA) 2026 Congress taking place in Stockholm, Sweden, on June 13, 2026. Developed with AI-Immunology platform, EVX-04 targets non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome. These antigens are selectively expressed in specific tumors but absent in normal tissue, making them highly attractive therapeutic cancer targets. Using sequencing data from AML patients, AI-Immunology platform first identified ERV tumor antigens and then mined these to determine smaller fragments with the potential for immune recognition. From the five million ERV antigen fragments discovered, AI-Immunology combined and selected 16 optimal sets of ERV fragments based on their cross-patient relevance and immunogenic potential. All 16 ERV fragments included in EVX-04 elicit a specific immune response and EVX-04 prevents tumor growth in preclinical tumor models. The data-driven target selection ensures that EVX-04 provides broad tumor coverage regardless of immune and tumor ERV antigen differences across patients. Thus, EVX-04 is developed as an off-the-shelf vaccine pre-produced and ready for immediate administration after diagnosis. The same concept is broadly applicable across cancers where immunotherapies remain inadequate and conserved immunogenic antigens can be identified. AML is an aggressive hematologic malignancy characterized by clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. It has poor outcomes for patients ineligible for intensive chemotherapy or stem cell transplantation, highlighting the need for novel and less toxic treatment strategies. AML is the most frequent leukemia, occurring across all age groups, however, predominantly observed in older adults (median age at diagnosis of 68 years). Approximately 50% of patients, typically the elderly, are not fit for intensive treatment, so the standard of care is low-intensity chemotherapy. Remissions are, however, short lived with a 3 year overall survival rate at only 25% reported (Kantarjian et al. 2025). Tillkännagivande • Apr 29
Evaxion A/S Promotes Birgitte Rønø as Chief Scientific and Chief Operating Officer Evaxion A/S announced that Birgitte Rønø, its Chief Scientific Officer (CSO), will take on the dual responsibilities of CSO and Chief Operating Officer (COO). The promotion follows an internal management review of the optimal way of working to continue to deliver Evaxion’s strategy through broader external visibility of the power of the AI-Immunology platform with partners and investors. It also reflects the recognition of Dr Rønø’s long and extensive contribution to the internal operation of Evaxion over many years. Following the promotion, Evaxion’s management team remains composed of the following members: Helen Tayton-Martin, CEO; Birgitte Rønø, CSO and COO; Thomas Schmidt, CFO; and Andreas Mattsson, Chief AI Officer. Tillkännagivande • Apr 18
Evaxion A/S Demonstrates Scalability of Ai-Immunology Platform in Glioblastoma Evaxion A/S announced new data demonstrating the platform’s ability to also potentially develop vaccines for glioblastoma (brain cancer). The data, which will be presented at the AACR Annual Meeting in San Diego, California, on April 22, 2026, is another confirmation of how AI-Immunology™ can be applied across a range of different cancers as well as other diseases. Evaxion has collaborated with researchers at Duke University School of Medicine to identify endogenous retrovirus (ERV)-derived antigens in tumor samples from multiple glioblastoma patients to include in vaccines to treat the deadly brain cancer, for which limited therapeutic options exist. ERVs are tumor antigens from the dark genome. These antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines. AI-Immunology™ has unique capabilities in identifying ERVs and this opens a whole new source of antigens, which can potentially greatly improve the efficacy of cancer vaccines for glioblastoma patients, who generally have few neoantigens to target due to low mutational burden. In addition to the ERV-derived antigens, the company also identified neoantigens of sufficient quality to include in a vaccine in the majority of patients. The new findings include bioinformatic analysis profiling ERV expression in patient tumor samples and vaccine design feasibility assessment as well as experimental data demonstrating immunologic responses of the discovered ERV antigens. They show that ERVs constitute a relevant antigen source that may overcome limitations imposed by low mutational burden, providing a strong Proof-of-Concept for personalized vaccines incorporating ERV-derived antigens. Tillkännagivande • Apr 17
Evaxion A/S Elects Jens Bitsch Nørhave to the Board of Directors Evaxion A/S held its Annual General Meeting ON April 16, 2026 at the company’s offices. The 2025 Annual Report was approved and the Board of Directors’ proposals passed. Jens Bitsch Nørhave was elected to the Board of Directors. Tillkännagivande • Apr 09
Evaxion A/S Announces Last Patient Visit in One-Year Extension of Phase 2 Trial with Personalized Cancer Vaccine Evx-01 Evaxion A/S had successfully completed the one-year extension of its phase 2 trial with personalized cancer vaccine EVX-01 with the last patient having now had last physician visit. Patients in the trial will continue to be monitored and data prepared for expected presentation in the second half of 2026. Designed with AI-Immunology™, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). In the first two years of the phase 2 trial, patients were treated with EVX-01 in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, Keytruda® (pembrolizumab). In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect both as stand-alone and combination treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of induced immune response. Data from the first two years of the trial demonstrated an Objective Response Rate of 75%, as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed. 54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial. In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology™ platform in accurately identifying neoantigens, which leads to detectable signals in patients. Data also confirmed EVX-01 to be a well-tolerated treatment. Tillkännagivande • Mar 30
Evaxion A S Presents Novel AI Based Polio Vaccine Design Concepts and Evx V1 Cmv Vaccine Program Evaxion A/S has in collaboration with the Gates Foundation developed novel and potentially superior concepts for design of vaccines to combat polio. These concepts, and the underlying research, will be presented at the World Vaccine Congress taking place in Washington D.C. from March 31 to April 2, 2026. Current polio vaccines are based on inactivated or attenuated versions of the virus. While these vaccines are effective, they each have shortcomings in certain settings. Thus, it has been a long-standing - but so far unreachable - goal to create a novel polio vaccine that combines the strongest aspects of the existing vaccines. To achieve this, Evaxion has deployed AI-Immunology to develop novel vaccine design concepts for a next-generation polio vaccine, which may enhance the chances of completing and sustaining polio eradication once and for all. Evaxion will also present data from its EVX-V1 program at the World Vaccine Congress. EVX-V1 targets Cytomegalovirus (CMV). AI-Immunology has discovered novel CMV antigens and EVX-V1 is a next-generation, multi-component vaccine program combining these novel AI-discovered antigens with AI-optimized versions of established CMV vaccine antigens. This broader multi-targeted strategy is expected to strengthen the protective potential of the future vaccine. Tillkännagivande • Mar 20
Evaxion A/S, Annual General Meeting, Apr 16, 2026 Evaxion A/S, Annual General Meeting, Apr 16, 2026, at 14:00 Romance Standard Time. Location: dr neergaards vej 5f 2970, horsholm, Denmark Tillkännagivande • Jan 13
Evaxion A/S Expands AI-Immunology Platform Into Autoimmune Diseases Evaxion A/S announced it will expand the use of its proprietary AI-Immunology™ platform to also discover and develop new treatments for autoimmune diseases. Evaxion will in the future work within cancers, infectious and autoimmune diseases as its core disease areas. The expansion leverages the unique scalability of AI-Immunology™ and will increase the pool of diseases for which the company can decode the immune system and potentially discover and develop new treatments. In turn, this will improve the quantity and quality of new programs within pipeline, potentially available for partnership. Autoimmune diseases are characterized by high unmet medical need and offer significant partnership potential across all stages of drug development. Evaxion plans to expand and train AI-Immunology™ to be applicable to autoimmune diseases during the second half of 2026. Specifically, the AI-Immunology™ platform potentially allows for development of precision treatments targeting underlying disease mechanisms, in contrast to current treatment approaches that primarily address symptoms. The related work on the autoimmune disease application development is already included in Evaxion’s cashflow outlook and does not impact our cash runway, which still extends to the second half of 2027. The expansion to autoimmune diseases represents a new strategic milestone for Evaxion in addition to other milestones for 2026 as outlined below. These reflect continued execution of strategy of creating value from both platform and pipeline assets through partnerships. Milestone Target: EVX-01 Additional biomarker and immunogenicity data First Half; AI-Immunology™ New application for autoimmune diseases Second Half; EVX-01 Three-year phase 2 clinical efficacy data Second Half; EVX-04 Regulatory filing for phase 1 trial Second Half; EVX-B4 Design and preclinical validation of antigens Second Half. Tillkännagivande • Oct 31
Evaxion A/S to Report Q3, 2025 Results on Nov 06, 2025 Evaxion A/S announced that they will report Q3, 2025 results Pre-Market on Nov 06, 2025 Tillkännagivande • Oct 20
Evaxion A/S Announces New Two-Year Unprecedented Clinical Efficacy Data of Its Personalized Cancer Vaccine EVX-01 in Patients with Advanced Melanoma Evaxion A/S announced new two-year unprecedented clinical efficacy data of its personalized cancer vaccine EVX-01 in patients with advanced melanoma. The two-year phase 2 data demonstrates an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. The ORR is even higher than the 69% observed after one year of treatment. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at 24 months follow-up and no relapses were observed. 54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial. EVX-01, developed with Evaxion's AI-Immunology platform, is designed to target multiple neoantigens; cancer unique proteins arising from mutations. In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology platform in accurately identifying neoantigens, which leads to detectable signals in patients. Data also confirmed EVX-01 to be a well-tolerated treatment. The company present these two-year phase 2 data for EVX-01 demonstrating high response rates and an impressive durability of responses, whilst confirming the favorable safety profile observed in phase 1 study. A 75% ORR is unprecedented in this hard-to-treat patient population and underscores the significant potential of EVX-01 as well as the first-year trial with AI-Immunology powered vaccines. The two-year phase2 data demonstrates an Objective Response Rate ("ORR") of 75% as 12 out the targeted neoantigens generate potential specific T-cell responses. The ORR is even highest than the 69% observed after One year of treatment. Additionally, an durable clinical benefit was observed as92% of patients were still respond at 24 months follow-up. Immune activation observed in all patients with 81% of EVX-01's vaccine targets triggering a specific response. Treatment was well tolerated. Data is presented at the ESMO Congress and will be discussed at a webinar with key opinion leader Professor Muhammad Adnan Khattak on October 22, 2025. Data is presented at theESMO Congress and will be discussed in October 22, 2025. Tillkännagivande • Oct 03
Evaxion A/S to Present New Biomarker Data for AI- Designed Personalized Cancer Vaccine EVX-01 At the SITC 2025 Annual Meeting Evaxion A/S will present new data for its lead asset EVX-01 at a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor November 5-9, 2025. Designed with Evaxion's AI-Immunology™? platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). Evaxion will present new biomarker and immune data stemming from the ongoing phase 2 trial with EVX-01. The two-year clinical efficacy data from the trial will, as earlier announced, be presented in an oral presentation at the ESMO 2025 congress on October 17, 2025. KeyTRUDA®? is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc., Rahway, NJ, USA. SITC presentation details: Abstract title: Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients. Abstract#: 605; Poster#: 605; Session (category): Clinical trials in progress (subcategory: Skin cancers); Location: Lower Level Atrium - Prince George's ABC; Date/Time: Friday, November 7, 2025, 5:10-6:35 p.m. ET/23.10-00.35 CET; Presenter: Michail Angelos Pavlidis, Research Associate at Evaxion. EVX-01 is a personal peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion's lead clinical asset. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology™, the. Tillkännagivande • Aug 11
Evaxion A/S to Report Q2, 2025 Results on Aug 14, 2025 Evaxion A/S announced that they will report Q2, 2025 results Pre-Market on Aug 14, 2025 Tillkännagivande • Jul 25
Evaxion A/S to Present Two-Year Clinical Efficacy Data from Phase 2 Trial with AI- Designed Personalized Cancer Vaccine EVX-01 at the ESMO Congress 2025 Evaxion A/S will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025. Designed with Evaxion's AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). The phase 2 trial investigates EVX-01 in combination with MSD's (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA®? (pembrolizumab) in patients with advanced melanoma (skin cancer). It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination With a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses. In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™? predictions was observed, underlining the predictive power of the platform. Tillkännagivande • Jun 25
Evaxion Expands R&D Pipeline with New Vaccine Program Targeting Group A Streptococcus Evaxion A/S initiates work to develop a new preventive vaccine against Group A Streptococcus (GAS), a bacteria causing hundreds of millions of infections globally each year. Infection carries the risk of several complications including life threatening conditions like rheumatic heart disease and necrotizing fasciitis ("flesh eating bacteria") and less severe yet serious diseases like strepthroat and scarlet fever. The new vaccine program, named EVX-B4, has been added to Evaxion's research & development (R&D) pipeline of cancer and infectious disease vaccine candidates. Initial computational analysis demonstrated that AI-Immunology™? can identify novel vaccine targets to combat GAS, which could pave the way for a new approach to fight the bacteria. Deploying AI-Immunology™®? allows for fast and effective target discovery, design and validation, accelerating preclinical development of EVX-B4. This work will create a comprehensive preclinical data package to facilitate partnership discussions. Adding EVX-B4 to the pipeline achieves another of Evaxion’s milestones for 2025. Evaxion’s R&D pipeline now comprises five specified vaccine candidates for infectious diseases and three for cancer. The build-up of the pipeline supports Evaxion’s partnership strategy as the company increases the number of assets for out-licensing. Tillkännagivande • May 23
Evaxion A/S to Report Q1, 2025 Results on May 27, 2025 Evaxion A/S announced that they will report Q1, 2025 results Pre-Market on May 27, 2025 Tillkännagivande • May 22
Evaxion Doses First Patient in Extension of Phase 2 Trial Exploring the Full Potential of Ai- Designed Personalized Cancer Vaccine Evx-01 Evaxion A/S announced that it has dosed the first patient in its one-year extension of the ongoing phase 2 trial with its lead asset EVX-01. Designed with Evaxion's AI-Immunology™? platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The extension will further explore the full potential of EVX-01 as a possible new and innovative treatment of advanced melanoma, particularly its long-term clinical and immune benefits. The trial extension involves minimal cost as trial sites are running and the vaccine product has already been produced. Having completed the initial two-year treatment, the first patient in the extension of the trial has now received the first additional dose of EVX-01. Patients entering the one-year extension of the trial will in total receive two additional EVX-01 doses as monotherapy. Initially planned to run for two years, the trial remains on track to yield two-year data for presentation in the second half of 2025. Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses. In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™®? predictions was observed, underlining the predictive power of the platform. Tillkännagivande • Apr 28
Evaxion Biotech A/S Presents striking EVX-01 Data at the AACR Annual Meeting Evaxion Biotech A/S announced new data underscoring the ability of cancer vaccine EVX-01 to drive a targeted and robust immune response. Designed with Evaxion's AI-Immunology™? platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). New immune data from the ongoing phase 2 trial with EVX-01 will be presented at a poster session on April 29, 2025 at the American Association for Cancer Research (AACR) Annual Meeting taking place in Chicago. In earlier interim analyses presented at the ASCO and ESMO 2024 meetings, a vaccine target hit rate of 71% and 79%, respectively, was demonstrated. Now, with more long-term patient samples analyzed, the company's improved this hit rate to 80%, reinforcing the potential of EVX-01 as a new and effective treatment for a broad range of solid tumors. Tillkännagivande • Apr 08
Evaxion Biotech A/S, Annual General Meeting, Apr 30, 2025 Evaxion Biotech A/S, Annual General Meeting, Apr 30, 2025, at 14:00 Romance Standard Time. Location: at evaxion biotech a/s, dr. neergaards vej 5f, 2970 horsholm, denmark, Denmark Tillkännagivande • Feb 25
Evaxion Biotech A/S Extends Phase 2 Trial with AI-Immunology™? Evaxion Biotech A/S will further enhance the data package from its ongoing phase 2 trial with the company's lead asset EVX-01 by extending the trial from two to three years. Designed with Evaxion's AI-Immunology™? platform, EVX-01 is a personalized cancer vaccine being developed as a treatment for advanced melanoma (skin cancer). Active participants in the trial will be given the opportunity to enter the one-year extension after completing the two-year protocol. They will receive additional EVX-01 doses as monotherapy, with close monitoring to assess clinical response duration and immune activation. In the first two years of the trial, patients received EVX-01 in combination with standard anti-PD-1 therapy. The trial is progressing according to plan, with two-year data readout expected in the second half of 2025. All trial active patients have achieved reduction in tumor target lesions and are faring well, which should allow for a seamless transition into the extension of the trial. EVX-01 is designed with Evaxion’s AI-Immunology™ platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. Tillkännagivande • Feb 15
Nasdaq Confirms Evaxion Is Fully Compliant, Withdraws Delisting Determination Evaxion Biotech A/S (“Evaxion”) has received confirmation from the Nasdaq Stock Market LLC (“Nasdaq”) that it has re-established compliance with Nasdaq’s minimum stockholders’ equity requirement. Nasdaq has withdrawn its determination to delist Evaxion, and the company will remain listed as fully compliant with Nasdaq’s rules.“We are very pleased to have received formal confirmation that we are again fully compliant with Nasdaq’s rules and will remain listed as we always planned for. We thank Nasdaq for a constructive dialogue on the matter. Having significantly strengthened our equity and cash position, full focus is now on executing upon our strategy and pursuing our 2025 milestones”, says Christian Kanstrup, CEO of Evaxion.On January 28, 2025, Evaxion was given until May 12, 2025, to formally evidence compliance with Nasdaq listing rule 5550(b)(1) requiring stockholders’ equity of at least $2.5 million. The company has already successfully executed its plan to restore its equity and has re-established compliance. In line with the applicable Nasdaq rules in such circumstances, the notice also indicated that Nasdaq had imposed a “Mandatory Panel Monitor,” as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the compliance determination, pursuant to which in the event Evaxion fails to timely satisfy the minimum stockholders’ equity requirement during the one-year monitor period, Evaxion will not have the opportunity to provide a compliance plan for Nasdaq Staff’s review; rather, Nasdaq would instead issue a delist determination pursuant to which Evaxion could request a hearing and stay of the delist determination pending another hearing before the Panel. Tillkännagivande • Jan 15
Evaxion Completes Dosing in Phase 2 Trial with Personalized Cancer Vaccine EVX-01 Evaxion Biotech A/S has now completed the dosing of all 16 patients in its phase 2 trial with the company's lead asset EVX-01. Designed with Evaxion's AI-Immunology™? platform, EVX-01 is a personalized cancer vaccine being developed as a treatment of advanced melanoma (skin cancer). Dosing has been completed according to trial protocol and timelines, meaning the trial remains on track for completion and data readout in the second half of 2025. Coincidently, the first patient has now completed the trial and has had last visit according to the protocol. Patients will continue to be monitored and data collected. Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology™, platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Further, 79% of EVX-01’s vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches. EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.EVX-01 is a personalized therapy designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors. In the completed Phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses with two complete and six partial responses. In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions was observed, underlining the predictive power of the platform. Tillkännagivande • Dec 14
Evaxion Biotech A/S Establishes New AI-Derived Precision Cancer Vaccine Concept Evaxion Biotech A/S obtains preclinical Proof-of-Concept (PoC) for its precision cancer vaccine concept targeting non-conventional ERV (endogenous retrovirus) tumor antigens shared across patients. New data confirming the preclinical PoC is presented at the ESMO Immuno-Oncology Congress, currently taking place in Geneva, Switzerland. Evaxion’s AI-Immunology™ platform can identify and select vaccine targets from ERVs expressed in the cancer cells, enabling the design of precision cancer vaccines for multiple specific cancer types. This precision vaccine concept leverages unique data insights and expertise in identifying vaccine targets compatible with the diversity of the immune system. By selecting ERV fragments, so-called hotspots, that match a broad spectrum of immune system profiles, these vaccines have the potential to be effective across a wide range of patients. The new data prove that the AI-Immunology™ platform can identify functional and potent ERV antigenic hotspots. This warrants further development towards clinical application. The new data stems from studies in human cell and mouse models. Stimulation with ERV precision vaccine targets induced ERV-specific T-cell responses in human immune cells from several donors. Further, AI-Immunology™ designed mouse ERV precision vaccines induced functional antigen-specific T-cells and inhibited tumor growth in mice. Tillkännagivande • Nov 19
Evaxion Biotech A/S has filed a Follow-on Equity Offering in the amount of $12.5 million. Evaxion Biotech A/S has filed a Follow-on Equity Offering in the amount of $12.5 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 5,252,100
Security Name: Pre Funded Warrants
Security Type: Equity Warrant
Securities Offered: 5,252,100 Tillkännagivande • Nov 01
Evaxion Update on Nasdaq Notification Regarding Minimum Stockholders’ Equity Requirement As communicated earlier, on May 7, 2024, Evaxion Biotech A/S received a deficiency letter from Nasdaq Stock Market LLC (“Nasdaq”) for failure to maintain stockholders’ equity of at least $2.5 million, following which we presented a plan to Nasdaq to regain compliance. Nasdaq provided us until November 4, 2024, to evidence compliance based upon the plan submitted. We remain committed to ensuring compliance with the Nasdaq minimum stockholder’s equity requirement and maintain our Nasdaq listing. This is to be pursued through increasing shareholder’s equity via a combination of business development income and capital markets activities. However, current equity market environment, the geopolitical uncertainties and timing of business development activities have to date impacted timing for the full required increase in shareholder’s equity. We do not expect to have regained compliance by November 4, 2024, and therefore expect Nasdaq to send us a delisting notification after such date. We then plan to appeal the delisting determination and request a hearing on the matter, following which a new 180-day extension could be granted based on our plan to regain compliance. We are in constructive dialogue with Nasdaq around this process, though we will not receive any guarantee that another 180-day extension will be granted before the anticipated hearing. Tillkännagivande • Oct 28
Evaxion Biotech A/S to Report Q3, 2024 Results on Oct 31, 2024 Evaxion Biotech A/S announced that they will report Q3, 2024 results Pre-Market on Oct 31, 2024 Tillkännagivande • Oct 10
Evaxion Biotech A/S Announces Strong Validation of Ai-Immunology Platform in Multiple Clinical Trials Evaxion Biotech A/S has now evidence from three different clinical trials validating the vaccine target predictions of its AI platform. Evaxion has developed three personalized cancer vaccine candidates with the use of its AI-Immunology platform. Two of these EVX-01 and EVX-02 have completed clinical phase 1 testing and EVX-01 is currently in phase 2, while the third EVX-03 is an IND-ready vaccine candidate. The AI-Immunology platform identifies cancer vaccine targets, so called neoantigens, and assigns a prediction score reflecting the likelihood of each vaccine target to elicit a specific immune response against the tumor. In all three clinical trials, a statistically significant correlation was observed between the AI-Immunology prediction scores and the immunological responses measured in the patients, with the most robust responses being generated by vaccine targets with the highest AI-Immunology prediction scores. Further, in the one trial where it was assessed, a statistically significant correlation was demonstrated between AI-Immunology™ prediction scores and Progression Free Survival in patients, underscoring the platform's ability to identify vaccine targets with meaningful clinical impact. Tillkännagivande • Sep 16
Evaxion Biotech A/S Reports Convincing One-Year Data from Phase 2 Trial on AI-Designed Personalized Cancer Vaccine EVX-01 Evaxion Biotech A/S announced positive one-year data from the ongoing phase 2 trial with its lead asset EVX-01, an AI-designed personalized cancer vaccine. The data stems from a one-year interim analysis of the ongoing phase 2 trial investigating EVX-01 in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). The data was presented during the weekend at a poster session at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Unique profile of EVX-01 supported by both clinical efficacy and immune data. The data demonstrates 69% ORR, reduction in tumor target lesions in 15 out of 16 patients, an immunogenicity rate of 79%, and a positive correlation between Evaxion’s AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Neoantigens are newly formed antigens generated from cancer-specific mutations. As a neoantigen vaccine, EVX-01 aims at triggering the patient’s immune system to target these specific antigens and thereby eradicate the cancer cells. The 69% ORR is calculated based on 11 out of 16 patients in the trial having objective clinical responses. This rate may increase as more data are collected but will not decrease. Final results are expected in the third quarter of 2025. Further to the encouraging clinical data, the immunogenicity data from the trial are also impressive, demonstrating that 79% of EVX-01’s neoantigens triggered a targeted immune response. This immunogenicity rate stands out as unprecedented compared to historical observations and compares very favorably to what is seen with other approaches. It also underlines and validates the precision of the AI-Immunology platform in identifying neoantigens which leads to detectable signals in patients. The new data also confirms the strong predictive capabilities of AI-Immunology™ with a positive correlation between its predictions and the neoantigen immune response detected in the patients with a p-value of p=0.00013. In other words, the data confirms that the neoantigens identified by the platform as the most relevant vaccine targets are also the ones that trigger specific immune responses in patients. Tillkännagivande • Sep 11
Evaxion Biotech A/S Reports 69% Overall Response Rate in its Phase 2 Trial on Lead Cancer Vaccine Candidate EVX-01 Evaxion Biotech A/S announced new exciting clinical phase 2 data for its lead compound EVX-01. The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate (ORR). 15 out of the 16 patients had reduction of their tumors (target lesions). This topline data is part of a one-year interim analysis of the ongoing phase 2 trial assessing EVX-01 in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). The complete one-year clinical data will be presented at a poster session at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024. Major Estimate Revision • Aug 21
Consensus revenue estimates increase by 331% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$290.0k to US$1.25m. Forecast losses expected to reduce from -US$0.89 to -US$0.233 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$10.85 unchanged from last update. Share price rose 19% to US$3.23 over the past week. Tillkännagivande • Aug 12
Evaxion Biotech A/S to Report Q2, 2024 Results on Aug 14, 2024 Evaxion Biotech A/S announced that they will report Q2, 2024 results Pre-Market on Aug 14, 2024 Tillkännagivande • Jun 20
Evaxion Biotech A/S Announces Publication of Data from Its Phase 1 Dose Escalation Study of Its Lead Personalized Cancer Vaccine, EVX-01 Evaxion Biotech A/S announced publication of data from its Phase 1 dose escalation study of its lead personalized cancer vaccine candidate, EVX-01, for metastatic melanoma. The study results, published in the Journal for ImmunoTherapy of Cancer, demonstrated that eight out of 12 patients (67%) experienced objective clinical responses (ORR) with six partial and two complete responses. Further, EVX-01 immunization did not induce vaccine-related serious adverse events in patients co-administered with anti-PD1 therapy. This represents a novel treatment paradigm with potential broad application in cancer therapy. At this year's ASCO annual meeting, the Company presented comprehensive immune data from its ongoing EVX-01 Phase 2 study, with 71% of the administered neoantigens inducing a specific T-cell response. Furthermore, a positive correlation between the neoantigen prediction score assigned by AI-Immunology™? and the reported induced immune response confirmed the Phase 1 study findings and further substantiated the predictive power of Evaxion's AI platform. Major Estimate Revision • Jun 06
Consensus revenue estimates decrease by 97%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$6.27m to US$160.0k. EPS estimate increased from -US$1.39 to -US$0.965 per share. Biotechs industry in the US expected to see average net income decline 9.5% next year. Consensus price target of US$11.75 unchanged from last update. Share price fell 2.1% to US$3.53 over the past week. Major Estimate Revision • Jun 04
Consensus revenue estimates decrease by 24%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$6.27m to US$4.76m. EPS estimate increased from -US$1.39 to -US$1.33 per share. Biotechs industry in the US expected to see average net income decline 10% next year. Consensus price target of US$11.75 unchanged from last update. Share price fell 13% to US$3.52 over the past week. New Risk • May 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$18m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Shareholders have been substantially diluted in the past year (105% increase in shares outstanding). Revenue is less than US$1m (US$124k revenue). Minor Risk Market cap is less than US$100m (US$20.7m market cap). Tillkännagivande • May 24
Evaxion Biotech A/S to Present New Positive Data from Ongoing Phase 2 Study on Lead Vaccine Candidate EVX-01 at the American Society of Clinical Oncology Annual Meeting 2024 Evaxion Biotech A/S announced its participation in the American Society of Clinical Oncology (ASCO) Annual Meeting, where it will present positive immune data form its ongoing EVX-01 Phase 2 study. The study assesses the personalized cancer vaccine EVX-01 in combination with anti-PD1 therapy in patients with advanced melanoma. The conference will take place in Chicago, IL, from May 31 – June 4, 2024. This ongoing Phase 2 study currently confirms findings from the previous Phase 1 study, reaffirming the ability of Evaxion’s AI-Immunology™ platform to precisely select therapeutically relevant vaccine targets and generate new valuable insights. Key highlights from the Phase 2 study are: Analyses of patient samples demonstrated EVX-01 vaccine-induced specific and robust immune responses, mediated by both CD4+ and CD8+ T-cells; Booster immunizations tended to increase the immune response and did not impose any safety concerns; The EVX-01 vaccine candidate was found to be well-tolerated with only grade 1 and 2 adverse events. EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab (more commonly known as KEYTRUDA®) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. Tillkännagivande • Apr 18
Evaxion Announces Phase 2 Clinical Trial Update Evaxion Biotech A/S announced that the first patient in its EVX-01 Phase 2 trial in metastatic melanoma received the last vaccine dose in combination with KEYTRUDA (NCT05309421). The Company initiated its Phase 2 clinical study in September 2022 to assess the efficacy, safety and ability to reduce a tumor-specific immune response of the EVX-01 cancer vaccine in metastatic melanoma patients. At the end of 2023, Evaxion reported initial EVX-01 Phase 2 data confirming the favorable safety profile and promising immunological data as observed in the previously successful Phase 1 clinical trial. EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC that, together with leading principal investigators and research centers from Italy and Australia, aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421. Evaxion's proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. 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 related to: financial condition and need for additional capital; development work; cost and success of product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using AI platform technology, including the rate and degree of market acceptance of product candidates; dependence on third parties including for conduct of clinical testing and product manufacture; inability to enter into partnerships; government regulation; protection of intellectual property rights; employee matters and managing growth; ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and business factors, including inflation and other factors. Tillkännagivande • Apr 03
Evaxion and Undisclosed Collaborator Announce Encouraging Results for Evx-B1 Vaccine Antigens Against Staphylococcus Aureus Infection Evaxion Biotech A/S announce the successful conclusion of a series of large non-rodent animal infection studies, testing antigens from Evaxion’s preclinical EVX-B1 vaccine candidate against Staphylococcus aureus (S. aureus). In the animal studies, the EVX-B1 antigens significantly reduced disease burden. Currently, the two companies are engaged in discussions regarding the path forward. There is no S. aureus vaccine available for human use. This pathogen can cause infections of multiple organs and tissues, which can be profoundly severe or even fatal. Most at risk are individuals with chronic conditions and patients undergoing surgeries. Also, the presence of antibiotic-resistant S. aureus is limiting available treatment options. The Centers for Disease Control and Prevention (CDC) has reported 120,000 bloodstream infections associated with S. aureus in the US annually. Three separate studies in large, non-rodent animals were conducted with the following conclusions: The EVX-B1 vaccine antigens significantly reduced S. aureus bacterial burden in a surgical site infection model; Induction of meaningful antigen-specific antibody titers in all vaccinated animals; The ability of the antigens to induce a protective immune response in the animals when being colonized with S. aureus mimicking the human situation; Ability of the immune blood to neutralize clinically relevant S. aureus in a whole blood killing assay, holding promise for translational assay readout in early clinical development. Major Estimate Revision • Apr 03
Consensus revenue estimates increase by 33%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$4.50m to US$6.00m. EPS estimate fell from -US$2.50 to -US$3.80 per share. Biotechs industry in the US expected to see average net income decline 9.8% next year. Consensus price target down from US$18.00 to US$12.25. Share price rose 29% to US$3.88 over the past week. Tillkännagivande • Mar 27
Evaxion Biotech A/S, Annual General Meeting, Apr 16, 2024 Evaxion Biotech A/S, Annual General Meeting, Apr 16, 2024, at 15:00 Central European Standard Time. Location: Evaxion Biotech A/S, Dr Neergaards Vej 5F, 2970 Hørsholm Hørsholm Denmark Agenda: Election of the chairman of the meeting; to consider the board of directors' report on activities of the Company in the past year; to consider Presentation of the audited annual report for adoption; to consider Resolution on the appropriation of the loss recorded in the adopted annual report; to consider Election of members to the board of directors; to consider Election of auditor; to consider Any motion from the board of directors and/or the shareholders; to consider Proposal to authorize the chairman of the meeting; to consider Miscellaneous. Breakeven Date Change • Feb 14
Forecast to breakeven in 2025 The 4 analysts covering Evaxion Biotech expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 34% per year to 2024. The company is expected to make a profit of US$25.9m in 2025. Average annual earnings growth of 52% is required to achieve expected profit on schedule. Tillkännagivande • Feb 07
Evaxion Biotech A/S has completed a Follow-on Equity Offering in the amount of $15 million. Evaxion Biotech A/S has completed a Follow-on Equity Offering in the amount of $15 million.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 757,500
Price\Range: $4
Discount Per Security: $0.3
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 2,992,500
Price\Range: $4
Discount Per Security: $0.3
Security Name: Series A Warrants
Security Type: Equity Warrant
Securities Offered: 3,750,000 New Risk • Feb 04
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$2.7m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Negative equity (-US$2.7m). Shareholders have been substantially diluted in the past year (209% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$3.3m net loss in 2 years). Market cap is less than US$100m (US$34.2m market cap). Tillkännagivande • Jan 25
Evaxion Biotech A/S to Develop Tailored Novel Cancer Vaccines Based Upon A New Untapped Source of Ai-Discovered Targets Evaxion Biotech A/S announced an expanded commitment to developing tailored cancer vaccines by targeting a novel category of AI-identified tumor antigens, named Endogenous Retroviruses (ERVs). The new treatment opportunity may broaden the applicability of cancer vaccines. Through the new vaccine targets, ERVs, treating patients unresponsive to conventional cancer immunotherapy may become possible. With the elevated focus on this therapeutic concept, Evaxion has initiated preclinical activities with a goal of generating Proof-of-Concept data by the second half of 2024. Tillkännagivande • Dec 21
Evaxion Biotech A/S announced that it expects to receive $5.291433 million in funding from Merck Global Health Innovation Fund, LLC Evaxion Biotech A/S entered into definitive agreements with MSD Global Health Innovation Fund, new investor and existing shareholders for the issuance and sale of 9,726,898 American Depositary Shares being represented by ordinary shares and accompanying warrants (the “Warrants”) to purchase up to 9,726,898 Ordinary Shares represented by ADSs at a purchase price of $0.544 per ADS for aggregate gross proceeds of $5,291,432.512 on December 19, 2023. Each Ordinary Share is represented by one American Depositary Share. The Warrants are exercisable immediately upon issuance, have a term of three years, and an exercise price equal to $0.707 per Ordinary Share. The Private Placement is expected to close on or about December 21, 2023, subject to the satisfaction of customary closing conditions. No brokerage, finder’s fees, or commissions were payable by the Company in connection with the Private Placement. The transaction will include participation from MSD Global Health Innovation Fund for approximately 2,431,725 ADS, existing shareholders, members of the Company’s management and the Company’s board of directors. Tillkännagivande • Nov 01
Evaxion Biotech A/S Announces Encouraging Initial Phase 2 Clinical Data on its Personalised Cancer Vaccine EVX-01 Evaxion Biotech A/S announced initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings. A comprehensive clinical update will be presented at the Society for Immunotherapy of Cancer (SITC) 38th annual meeting, taking place in San Diego, California, from November 1-5, 2023. Key highlights of the initial Phase 2 results for the first five metastatic melanoma patients treated with EVX-01 include: Phase 2 data confirm the favorable safety profile of EVX-01 observed in the Phase 1 trial, Promising immunological and clinical outcomes align with the Phase 1 outcomes, Upon EVX-01 treatment, a pronounced and ongoing tumor reduction was observed in a patient with progressive disease, Phase 2 data confirms Evaxion’s AI-Immunology™ platform’s ability to identify therapeutically relevant cancer vaccine targets. Earlier this year, Evaxion reported a successful Phase 1 clinical trial for EVX-01 in combination with a checkpoint inhibitor. The trial demonstrated a 67% clinical response rate while meeting safety standards and reporting only mild adverse events. Further, high-quality neoantigens predicted by AI-Immunology™ were associated with longer progression-free survival. To EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalised cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, and together with leading principal investigators and research centers from Italy and Australia aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. Tillkännagivande • Oct 28
New and Exciting Clinical Data on Evaxion's Ai-Immunology™?-Based Personalized Cancer Vaccines to Be Presented Evaxion Biotech A/S announced that it will be presenting clinical readouts on its two personalized cancer vaccine trials at SITC's 38th annual meeting, taking place in San Diego, California from November 1-5, 2023. The results will be presented in two posters: " effects of an AI-generated personalized neopeptide-based immunotherapy, EVX-01, in combination with pembrolizumab in patients with metastatic melanoma. A clinical trial update" poster #: 782-H Location: Exhibit Hall B - San Diego Convention Center Time: Saturday, November 4, 9 a.m. - 8:30 p.m. PDT. This poster will be presented by principal investigator Professor Adnan Khattak from the Hollywood Private Hospital in Nedlands, Australia. EVX-01 is Evaxion's lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, together with leading principal investigators and research centers from Italy and Australia, and aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421. The EVX-02 Phase 1/2a represents Evaxion's first-in-human DNA-based personalized cancer vaccine study. This open-label, multi-center study aims at assessing the safety, tolerability, pharmacodynamic responses, and efficacy of EVX-02 neoantigen vaccine and anti-PD-1 treatment (nivolumab) in patients who have had a complete resection of a Stage IIIB/IIIC/IIID or Stage IV melanoma with risk of recurrence. More information can be accessed over clinical trial ID NCT04455503. Evaxion's proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-immunology™?, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. 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 related to: financial condition and need for additional capital; development work; cost and success of product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using AI platform technology, including the rate and degree of market acceptance of product candidates; dependence on third parties including for conduct of clinical testing and product candidates; dependence on third party including for conduct of clinical testing, and product candidates; dependence on Third parties including for conduct of clinical tests and product candidates; and product candidates. Tillkännagivande • Oct 06
Evaxion Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency Evaxion Biotech A/S announced the Company received a letter on September 29, 2023 from the Listings Qualifications Department of the Nasdaq Stock Market LLC indicating that, for the last thirty consecutive business days, the bid price for the Company’s American Depositary Shares had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until March 27, 2024, to regain compliance. The letter states that the Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 5550(a)(2) if at any time before March 27, 2024, the bid price of the Company’s ADSs closes at $1.00 per share or more for a minimum of ten consecutive business days. The Nasdaq letter is only a notification of deficiency and has no immediate effect on the listing or trading of the Company’s ADSs and the ADSs will continue to trade on the Nasdaq Global Market under the symbol “EVAX.” The Company’s business operations are not affected by the receipt of the Notification Letter. The Company intends to monitor the bid price of its ADSs between now and March 27, 2024, and to evaluate its available options to regain compliance with Nasdaq’s minimum bid price rule within the compliance period, including, but not limited to, implementing a reverse share split of its outstanding ordinary shares. If the Company does not regain compliance with Rule 5550(a)(2) by March 27, 2024, the Company may be eligible for an additional 180 calendar day compliance period. To qualify, the Company would be required meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the deficiency during the second compliance period. The Company fully intends to resolve the deficiency and regain compliance with the Listing Rules. Tillkännagivande • Sep 28
Evaxion Biotech A/S Expands Preclinical Bacterial Vaccine Pipeline in Collaboration with Leading Pharmaceutical Company Evaxion Biotech A/S announced the initiation of a novel pipeline program, EVX-B3, an AI-designed vaccine candidate against an undisclosed bacterial pathogen. The new vaccine project will be a collaboration between the company and an undisclosed leading pharmaceutical company, leveraging unique assets and know-how from both organizations. To develop an effective vaccine, the company has initiated discovery activities for EVX-B3 using both its EDEN and RAVEN AI platforms to identify protective antigens capable of eliciting both a humoral (antibody) and cellular response to the pathogen. EVX-B3 aims to address a serious global medical issue, targeting a pathogen associated with repeated infections, increasing incidence and often serious medical complications, and for which no vaccines are currently available. The project will be a collaborative and co-funded effort between the two companies. Tillkännagivande • Sep 12
Evaxion Biotech A/S Announces New Data Validates Evaxion AI Platform, Offering Promise to Reduce Risk and Cost in Infectious Disease Vaccine Development Evaxion Biotech A/S has achieved a milestone in vaccine discovery with the validation of its AI-powered vaccine discovery platform, EDEN. Data will be shared at the Vaccines Europe conference in Berlin, Germany, taking place from September 14th to 15th. EDEN is a proprietary AI platform capable of rapidly identifying those antigens that will trigger a robust and highly protective immune response against virtually any bacterial infectious disease. EDEN is fully AI-drivenand designed to identify vaccine candidates faster and cheaper than current state-of-the-art methods. Tillkännagivande • Aug 30
Evaxion Biotech A/S Appoints Christian Kanstrup as Chief Executive Officer Evaxion Biotech A/S announced: Evaxion has hired a new Chief Executive Officer (“CEO”) to accelerate the strategic development and execution of the vast business opportunities at hand after having matured the Company’s AI platforms over the past 15 years. Christian Kanstrup brings 25 years of life science experience and comes with a very strong track record in leading strategy development as well as business development and with a broad understanding of capital markets and investor relations in listed and unlisted companies. Christian has held several senior leadership positions at Novo Nordisk, including Head of Biopharma Operations. are more than confident that Christian Kanstrup is the right person to harvest on Evaxion’s broad AI developments that created the link to Progression Free Survival (PFS) of patients. Tillkännagivande • Aug 03
Evaxion Biotech A/S announced that it expects to receive $20 million in funding from Negma Group Investment Ltd Evaxion Biotech A/S announced that it has entered into into a binding agreement with new investor Negma Group Investment Ltd to issue convertible notes for the gross proceeds of $20 million on August 1, 2023. The convertible bonds carry a zero coupon and will be issued at a subscription price corresponding to their par value. The conversion price will be determined as 83.5% of the second lowest closing volume weighted average share price (VWAP) of at least 8 trading days immediately preceding the issuance of each conversion request by Negma. Financing is available in tranches of up to $700,000 over a period of 36 months. Tillkännagivande • Aug 02
Evaxion Biotech A/S Plans to Announce the Interim Results of the Clinical Phase 2 Study with EVX-01 in Patients with Metastatic Melanoma in Fourth Quarter 2023 Evaxion Biotech A/S plans to announce the interim results of the clinical Phase 2 study with EVX-01 in patients with metastatic melanoma in fourth quarter2023, a program where promising Phase 1/2a data were presented at ASCO in June 2023. In addition, the Company plans to initiate a Phase 1 clinical trial with EVX-03 in patients with lung cancer and other solid tumors. EVX-03 is based on the use of Evaxion´s proprietary AI-technology and novel ObsERV™ platform, which enables the Company to identify new patient-specific tumor targets called ERVs to enhance the efficacy of its personalized cancer vaccines, with potential to broaden the utility to patients unresponsive to current immunotherapies. Tillkännagivande • Jun 08
Evaxion Unveils Genetic Adjuvant Technology to Boost Vaccines Evaxion Biotech continues to deliver in its efforts to develop novel cancer immunotherapies. After launching the new ObsERV AI drug discovery platform last month, the company has now introduced its genetic adjuvant technology to boost the effect of DNA and mRNA vaccines. At the same time, Evaxion has announced the successful completion of the phase I trial with the personalised cancer vaccine EVX-01. Breakeven Date Change • Jun 01
Forecast to breakeven in 2024 The 2 analysts covering Evaxion Biotech expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$14.0m in 2024. Average annual earnings growth of 88% is required to achieve expected profit on schedule. Tillkännagivande • May 26
Evaxion Unveils Proprietary Genetic Aduvant Technology to Boost the Effect of Dna and Mrna Vaccines Evaxion Biotech A/S unveils the technology behind its novel, proprietary genetic adjuvant developed to enhance the effectiveness of DNA and mRNA vaccines for infectious diseases and cancer. Latest data from the adjuvant program were presented at Evaxion's live stream R&D Day, May 25, 2023. Latest data from the adjUvant program were presented at EvAX's live stream R&D day, May 25, 20 23. Latest data show that the genetic adjuvant technology boosts the antitumor effect in preclinical tumor models, and induces neutralizing antibodies and T-cell responses against both viral and bacterial antigens: Delivery of DNA or mRNA cancer neoantigen vaccines induced strong neoantigen-specific T-cell responses and complete antitumor responses; Delivery of a COVID-19 T-cell epitope DNA vaccine resulted in a strong and specific T-cell response and protected against a lethal dose of the virus (90% survival); Delivery of a Neisseria Gonorrhoeae antigen DNA vaccine induced high antibody titers and specific T-cell responses towards the bacterial antigens. Evaxion aims to bring the genetic adjuvant technology into clinical trials later this year as part of the personalized cancer immunotherapy program EVX-03. Tillkännagivande • May 05
Evaxion Biotech A/S, Annual General Meeting, May 24, 2023 Evaxion Biotech A/S, Annual General Meeting, May 24, 2023, at 14:00 Central European Standard Time. Location: Evaxion Biotech A/S, Dr. Neergaards Vej 5F, 2970 H rsholm, Denmark Hørsholm Denmark Agenda: To elect the chairman of the meeting; to approve the board of directors' report on activities of the Company in the past year; to approve the adoption of Presentation of the audited annual report; to consider the appropriation of the loss recorded in the approved annual report; to consider election of members to the board of directors and auditor; to consider any motion from the board of directors and/or the shareholders; and to consider similar issues. Tillkännagivande • Feb 09
Evaxion Biotech A/S and Pantherna Therapeutics GmbH Announce Promising Preclinical mRNA Vaccine Data Evaxion Biotech A/S and Pantherna Therapeutics GmbH announced preclinical proof of concept for the combination of the two companies’ key technologies. The preclinical data demonstrate that tumor neoantigens identified by Evaxion’s AI platform, PIONEER, drive a strong immune response and lead to complete inhibition of tumor growth in a preclinical model when delivered using Pantherna’s proprietary lipid nanoparticle mRNA platform (PTX?LNP®, PTXmRNA®). In continuation of these positive findings, Evaxion and Pantherna will further explore optimal LNP formulations to effectively deliver mRNA and DNA-encoded antigens identified by Evaxion’s AI platforms. Tillkännagivande • Jan 20
Evaxion Receives FDA Fast-Track Designation for Personalized Cancer Immunotherapy Evaxion Biotech A/S announced that the U.S. Food and Drug Administration ("FDA") has granted fast track designation for the Company's personalized cancer therapy, EVX-01, in combination with KEYTRUDA(R) . In December 2023, Evaxion received FDA approval to proceed with its Phase 2b clinical trial, where EVX-01 is given in combination with KEYTRUDA(R) to patients with metastatic melanoma. On January 17, 2023, Evaxion furthermore receivedfast track designation for the vaccine candidate. The fast track is designed to expedite the FDA's review of innovative, new drugs that demonstrate the potential to address an unmet medical need. EVX-01 is a peptide-based cancer immunotherapy and is Evaxion's most advanced clinical asset. Under the program, a unique drug is generated for each patient based on gene analysis of their tumors and on matching with their immune system. This process is made possible by the Company's proprietary AI platform, PIONEER. The ongoing Phase 2b study is conducted at clinical sites across the United States, Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA(R) . The trial was initiated in Australia with the enrollment of the first patient in September 2022. Tillkännagivande • Jan 17
Evaxion Receives Phase IIb Go-Ahead from FDA Evaxion Biotech started 2022 with a green light from the Australian authorities to conduct a phase IIb study with lead drug candidate EVX-01 in metastatic melanoma. 2023 for the Danish immunotherapy company begins with the FDA-approval to expand the phase IIb study to the US. BioStock contacted CEO Per Norlén to learn more about what this means for the project. Tillkännagivande • Jan 04
Evaxion Biotech A/S Receives Approval from FDA to Proceed with the Clinical Phase 2B Study for Evx-01 Evaxion Biotech A/S announced that the U.S. Food and Drug Administration ("FDA") determined that the Company may proceed with its Phase 2b clinical trial of EVX-01. In November 2022, the Company submitted an Investigational New Drug Application ("IND") along with a Fast Track designation application to the FDA for a Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA(R) for the treatment of patients with metastatic melanoma. On December 22, 2022, the FDA issued approval for the Company to proceed with its Phase 2b trial. The Company anticipates a response to the Fast Track designation submission in the first quarter of 2023. Tillkännagivande • Dec 31
Evaxion Biotech Reaches an Important Milestone When Enrolled Its First Patient in Perth, Australia in the Company's Global Phase 2B Clinical Trial of EVX-01 As previously announced on September 21, 2022, Evaxion Biotech A/S reached an important milestone when it enrolled its first patient in Perth, Australia in the Company's global Phase 2b clinical trial of EVX-01, the Company's personalized, peptide-based cancer immunotherapy targeting melanoma, in combination with KEYTRUDA an anti-PD-1 inhibitor developed by Merck &Co. Inc. ("Merck"). In November 2022, the Company submitted an Investigational New Drug Application ("IND") along with a Fast Track designation request to the U.S. Food and Drug Administration ("FDA") for the Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA for the treatment of patients with metastatic melanoma. On December 22, 2022, the FDA notified the Company that it had reviewed the Company's IND and determined that the Company may proceed with its Phase 2b trial. The Company anticipates a reply from the FDA on its Fast Track designation submission in the first quarter of 2023. It is anticipated that the trial will be conducted globally at clinical sites across the United States, Europe, and Australia in collaboration with Merck, which is supplying the trial with its PD-1 inhibitor, KEYTRUDA. Patients enrolled in the Phase 2b clinical trial will receive standard of care treatment along with KEYTRUDA in combination with EVX-01, or in the event of progression, another standard of care treatment in combination with EVX-01. The Company is responsible for the conduct of the trial. The Company and Merck will continue to collaborate as the data mature. The Phase 2b clinical trial is a single arm trial evaluating the efficacy and safety of EVX-01 in combination with KEYTRUDA (pembrolizumab) in adults with unresectable or metastatic melanoma. The trial will evaluate if EVX-01 improves the best overall response (BOR) in patients with an initial assessment of stable disease (SD) or partial response (PR) after initiating KEYTRUDA treatment, as compared to historical outcomes with KEYTRUDA alone in metastatic or unresectable melanoma. The Company has received approval of its Clinical Trial Applications for the Phase 2b trial from regulatory authorities in Australia, Italy and France. The Company subsequently informed the French regulators that it currently does not intend to conduct the trial in France. In addition, the Company submitted a CTA in Spain and is awaiting approval by the Spanish regulatory authorities. Tillkännagivande • Nov 18
Evaxion Biotech A/S Announces Promising Results from Phase 1/2a Clinical Trial of Personalized DNA Cancer Immunotherapy EVX-02 Evaxion Biotech A/S announced promising clinical data from the Phase 1/2a first-in-human study of its DNA-based cancer immunotherapy, EVX-02. In the clinical study, EVX-02 is given in combination with a checkpoint inhibitor and targets cancer mutations, neoantigens, in patients with resected melanoma. The Company reported encouraging interim safety and immunogenicity data from the Phase 1/2a study of its personalized DNA-based immunotherapy, EVX-02. The results are summarized below. Personalized cancer immunotherapy, like EVX-02, is particularly challenging to produce because a new and unique drug is manufactured for each patient. Safety: Treatment appeared to be well tolerated in all patients, with only very mild adverse events (AEs) observed in relation to EVX-02 treatment. EVX-02 induced CD4+ and CD8+ specific T-cell responses in all patients, providing proof of mechanism for our DNA-delivery technology, in that the delivered EVX-02-DNA gave rise to immune reactions to its encoded neoantigen peptides. The T-cell responses were robust and long-lasting. A full clinical trial report for the EVX-02 Phase 1 study is expected in the second quarter of 2023. Price Target Changed • Nov 17
Price target decreased to US$14.67 Down from US$17.33, the current price target is an average from 3 analysts. New target price is 535% above last closing price of US$2.31. Stock is down 58% over the past year. The company is forecast to post a net loss per share of US$0.96 next year compared to a net loss per share of US$1.26 last year. Tillkännagivande • Oct 06
Evaxion Biotech A/S Welcomes Per Norlén as New CEO Evaxion Biotech A/S announced that its new Chief Executive Officer (CEO) Per Norlén has joined the company on October 3rd. Dr. Norlén is a board-certified physician and associate professor with more than 20 years in the biotech sector, of which the last decade has been in executive leadership roles. He brings a wealth of experience from being CEO of listed drug development companies. He has a proven business development track record, including major out-licensing deals with biotech and Pharma. Tillkännagivande • Oct 04
Evaxion Biotech A/S Enrols First Patient in Phase Iib Melanoma Study Evaxion enrols first patient in phase IIb melanoma study Evaxioniotechch's lead immunotherapy candidate, EVX-01, developed through one of the company'AI platforms,, has entered clinical development phase IIb in metastatic melanoma patients. With the announcement of the first patient enrolled in the study, BioStock spoke with Evaxion's CMO Erik Heegaard to learn more about this important milestone. Tillkännagivande • Sep 22
Evaxion Biotech A/S Enrolls First Patient in the Global Phase 2B Clinical Trial of EVX-01 Evaxion Biotech A/S announcing that it had enrolled its first patient in the global phase 2b clinical trial of EVX-01, the Company’s personalized cancer therapy for the treatment of melanoma. In the company’s first phase 2b clinical trial, Evaxion is evaluating the efficacy and safety of EVX-01 in adults with metastatic melanoma. The trial is being conducted globally at clinical sites across the US, Europe, and Australia in collaboration with Merck & Co. Inc., which is supplying the trial with its PD-1 inhibitor, KEYTRUDA®. Patients enrolled in the phase 2b clinical trial will receive standard of care treatment along with KEYTRUDA® in combination with EVX-01. Evaxion is responsible for the conduct of the trial and Merck will supply the required KEYTRUDA®. Evaxion and Merck will continue to collaborate as the data mature. Background: EVX-01 is a novel personalized cancer immunotherapy based on Evaxion’s proprietary PIONEER™ AI technology, for the treatment of patients with melanoma. Data from the Phase 1/2a clinical trial of EVX-01 has shown that 67% of nine patients benefitted from EVX-01 in combination with a PD-1 inhibitor (KEYTRUDA®) for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from a PD-1 inhibitor alone 22% of the patients in the Phase 1/2a clinical trial achieved a complete response (full recovery) with EVX-01 in combination with a PD-1 inhibitor (KEYTRUDA®). The first patient in the Phase 2b clinical trial has now been enrolled. The Company anticipates interim topline data readout in second half of 2023. Breakeven Date Change • Aug 12
Forecast to breakeven in 2024 The 4 analysts covering Evaxion Biotech expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$19.0m in 2024. Average annual earnings growth of 33% is required to achieve expected profit on schedule. Tillkännagivande • Aug 03
Evaxion Biotech A/S Announces Executive Management Changes Evaxion Biotech A/S Announced Lars Staal Wegner has decided to resign as the Company's Chief Executive Officer (CEO). Dr. Wegner will remain with the Company in an advisory role to the Company's new CEO and Board of Directors. In Dr. Wegner's place, the Company is pleased to have appointed Per Norlén, M.D., PhD., a physician and board certified specialist in Clinical Pharmacology with extensive research experience and over 20 years of working in clinical drug development and management within biopharmaceutical industry. Most recently, Dr. Norlén was Chief Executive Officer of Targinta AB and Chief Medical Officer of Xintela AB, Targinta is a wholly owned subsidiary of Xintela. Before that, Dr. Norlén was the Chief Executive Officer and Chief Medical Officer at Alligator Bioscience AB, a publicly listed company on the Nasdaq Stockholm market. Dr. Norlén holds an M.D. and a PhD. In Clinical Pharmacology from Lund University, where Wegner is an Associate Professor of Experimental and Clinical Pharmacology. Dr. Norlén will take over from Dr. Wegner as the Company's CEO within the next six months. Tillkännagivande • Jul 01
Evaxion Biotech A/S Announces Gonorrhea as Second Bacterial Product Target Evaxion Biotech A/S announced that the Company has identified Gonorrhea as its second bacterial target for treatment with the Company’s EVX-B2 vaccine product candidate. As its second bacterial target, Evaxion has chosen to develop a prophylactic vaccine against Gonorrhea, a sexually transmitted disease that has quickly developed resistance to antibiotics. The company believe that Evaxion’s proprietary AI platform EDEN has identified promising antigen candidates for the vaccine based on preliminary findings in pre-clinical models. Tillkännagivande • Jun 24
Evaxion Biotech Expands its EVX-03 DNA Vaccine Program into Non-Small Cell Lung Cancer Evaxion Biotech A/S announced that it has selected EVX-03 as the product candidate within its DNA technology platform to target a new indication with planned regulatory filing in the second half of 2022. The company currently have two product candidates in its DNA technology platform, EVX-02, and EVX-03. Based on very encouraging results from the company's pre-clinical studies of EVX-03, the company have decided to use this candidate in an upcoming clinical trial in a new indication. Enhanced DNA technology in EVX-03: EVX-03 is optimized with an APC-targeting unit (Antigen-Presenting Cell), which has shown promising pre-clinical data and significant tumor reduction at very low doses as well as a clear dose-response relationship in all the company's preclinical models. New Indication: Evaxion has decided to continue the development of EVX-03 in patients with advanced disease and plans to target non-small cell lung cancer (NSCLC) with EVX-03. Tillkännagivande • Jun 08
Evaxion Biotech A/S announced that it expects to receive $40 million in funding from Lincoln Park Capital, LLC Evaxion Biotech A/S announced that it has entered into a committed equity purchase agreement with new investor Lincoln Park Capital Fund, LLC for the issuance and sale, from time to time, of up to $40 million of its American Depositary Shares each of which represents one ordinary share, DKK 1 nominal value of the company. Under the terms of the Agreement, the company has the right, at its sole discretion, but not the obligation, to sell to Lincoln Park Capital Fund, LLC up to $40 million of its ADSs over the 36-month term of the Agreement, subject to certain conditions. Tillkännagivande • May 20
Evaxion Biotech A/S Approves Election of Niels Iversen Møller as New Member of the Board of Directors Evaxion Biotech A/S at its Annual General Meeting held on May 3, 2022 elected Niels Iversen Møller as a new member of the board of directors. 