附录99.1

Evaxion宣布业务更新和2024年第三季度财务结果

2024年10月31日，丹麦哥本哈根 - 人工智能生物技术公司Evaxion Biotech A/S（纳斯达克股票代码：EVAX）（“Evaxion”）一家专门开发AI-Immunology™技术驱动疫苗的临床阶段科技生物公司，提供业务更新并公布2024年第三季度财务业绩。

业务亮点（自上一季度更新以来）

自2024年第二季度业务更新以来，我们一直在强力执行我们的策略和计划，并取得了几个重要里程碑。主要亮点包括：

• 生物-疫苗研发方面与默沙东（默沙东和公司在美国新泽西州拉赫维）进行了重要的合作扩展，这是Evaxion进行了一项变革性交易。
• 持续增加外部兴趣，并进行了几项有关我们平台和产品线的合作讨论。
• 临床和临床前开发取得了良好的进展，为个性化癌症疫苗EVX-01提供了令人信服的2期数据，并为EVX-B2 mRNA淋病疫苗候选者获得了临床前概念验证。
• 发布了改进的AI-免疫学™ 平台，用于疫苗抗原预测。
• Thomas Schmidt被任命为临时首席财务官。

“在繁忙的第三季度，我们在执行策略方面取得了扎实进展，并非常高兴地宣布，在全公司范围内实现了几个重要里程碑。MSD协议有望在未来几年内改变Evaxion，并且开创性的EVX-01阶段2疗效数据，是我们众多成就中的亮点。我们继续展示作为真正基于人工智能的TechBio公司的强大能力，专注于推进现有合作伙伴关系以及新的合作伙伴关系讨论，推动EVX-01试验并进行基础前临床研究，作为拓展研发管线的基础。”Christain Kanstrup，Evaxion首席执行官说。

2024年里程碑 

* MSD选项和许可协议关于EVX-B2和EVX-B3取代了这个里程碑
** 请查看下方关于业务发展收入目标的更新

研发更新

我们从临床和临床角度保持高研发活动水平。这项工作在第三季度取得了出色的成果，首先是通过我们领先资产EVX-01的进行中2期试验的令人鼓舞的一年数据演示，该资产是一种人工智能免疫™设计的个性化癌症-疫苗，在患有晚期黑色素瘤（皮肤癌）的患者中。

数据显示全面响应率为69％，16名患者中有15名的肿瘤靶病变有所减少，免疫原性率为79％，我们的人工智能-免疫学™平台预测与EVX-01疫苗中个体新抗原诱导的免疫反应之间存在积极相关(p=0.00013)。观察到的免疫原性率意味着EVX-01疫苗的79％目标触发了有针对性的免疫反应，这与其他方法相比效果非常有利。

这些临床发现突显出EVX-01的重要治疗潜力，并进一步验证了AI-免疫学™平台作为领先的人工智能技术，用于快速和有效的生物-疫苗靶点发现和设计。

我们在临床前研究中也取得了成功，在新型mRNA淋病疫苗候选EVX-B2上获得了概念验证。这是基于新数据，表明EVX-B2 mRNA能够触发针对性的免疫反应，导致淋病细菌的消灭。此前蛋白质版EVX-B2也展示了同样的效果，现在已经成为我们与MSD合作的一部分。mRNA数据是在我们与Afrigen生物制品合作的一部分产生的。

除了我们的产品管道外，我们的研发投资也用于持续改进我们的人工智能免疫学™ 平台。在第三季度，我们通过推出新版本的 EDEN™ 人工智能预测模型更新了该平台。除其他改进外，该模型现在能够预测毒素抗原，为改进细菌疫苗的开发铺平了道路。我们预计这一更新将进一步巩固潜在合作伙伴对人工智能免疫学™ 的浓厚兴趣。

业务发展收入

我们的策略基于多合作伙伴方法，有效执行我们的业务发展计划对我们的成功至关重要。在第三季度，我们非常高兴与默沙东签署了规模显著扩大的生物-疫苗开发合作协议。此外，我们持续看到潜在合作伙伴的兴趣日益增加，并对现有的管道资产以及我们的人工智能-免疫学TM平台周围的当前合作机会感到兴奋。

与MSD的协议潜在业务发展收入最高可达2025年的1000万美元，此外还有2024年收到的320万美元的预付款。基于当前的业务发展机会，我们仍然对我们执行多合作伙伴策略并带来显著业务发展收入的能力充满信心。

鉴于某些合作讨论将延至2025年，尽管存在浓厚的兴趣，但我们将无法实现2024年创造业务发展收入或达到1400万美元的现金目标。然而，这些讨论已延至2025年，将支持明年创造业务发展收入，另外还有潜在的来自MSD的高达1000万美元。

纳斯达克对话

根据早前沟通，于2024年5月7日，我们收到了纳斯达克股票市场有限责任公司（“纳斯达克”）的一封不足信函，因未能维持至少250万美元的股东权益，随后我们向纳斯达克提交了一项恢复合规性的计划。纳斯达克给予我们直至2024年11月4日的时间来提供基于提交计划的合规证明。

我们致力于确保符合纳斯达克最低股东权益要求，并维持我们的纳斯达克上市。这将通过通过业务发展收入和资本市场活动的结合来增加股东权益来实现。然而，目前的股票市场环境、地缘政治不确定性以及业务发展活动的时间安排迄今已影响了股东权益完全所需增加的时间。

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.

Third quarter 2024 financial results

Cash position as of September 30, 2024, was $4.6 million, as compared to $5.6 million as of December 31, 2023. The cash position as of September 30, excludes the $3.2 million upfront from the MSD agreement which was received in October. The Company expects that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into March 2025.

Revenue of $3.0 million was recognized for the quarter ending September 30, 2024, as compared to nil for the quarter ending September 30, 2023. A minor proportion of this revenue derives from the existing EVX-B3 collaboration with MSD, while the majority relates to the newly signed option and license agreement with MSD.

Research and Development expenses were $2.6 million for the quarter ending September 30, 2024, as compared to $2.8 million for the quarter ending September 30, 2023. The decrease is primarily related to a reduced headcount.

General and Administrative expenses were $2.1 million for the quarter ending September 30, 2024, as compared to $2.9 million for the quarter ending September 30, 2023. The decrease was primarily due to a decrease in expenses to management remuneration following changes to executive management in 2023 and expenses related to this. In addition, various minor cost reductions related to overhead and professional fees are realized.

We generated a net loss of $1.9 million for the quarter ending September 30, 2024, or $(0.04) per basic and diluted share, as compared to a net loss of $5.7 million, or $(0.21) per basic and diluted share for the quarter ending September 30, 2023. The decreased loss was primarily driven by the recognized revenue and reduced general & administrative expenses. 

Total equity amounts to $0.1 million as of September 30, 2024. Proceeds from the exercise of prefunded warrants amounted to $0.2 million for the quarter. 

Evaxion Biotech A/S
Consolidated Statement of Financial Position Data (Unaudited)
(USD in thousands)

Based on the Company’s current cash position with an expected cash runway into March 2025, income from Business Development deals and/or further funding is required to mitigate the conclusion that there is significant doubt about the Company’s ability to continue as a going concern. Please refer to the Form 20-F, filed March 27, 2024, for additional background on the Company.

Evaxion Biotech A/S
Consolidated Statement of Comprehensive Loss Data (Unaudited)
(USD in thousands, except per share data)

Contact information 

Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion-biotech.com 

About EVAXION

Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology™. 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. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website.

Forward-looking statement 

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. 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: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from the worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia and the Middle East; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.