附錄99.1

Evaxion宣佈業務更新和2024年第三季度財務結果

2024年10月31日，丹麥哥本哈根 - 人工智能生物技術公司Evaxion Biotech A/S（納斯達克股票代碼：EVAX）（「Evaxion」）一家專門開發AI-Immunology™技術驅動疫苗的臨床階段科技生物公司，提供業務更新並公佈2024年第三季度財務業績。

業務亮點（自上一季度更新以來）

自2024年第二季度業務更新以來，我們一直在強力執行我們的策略和計劃，並取得了幾個重要里程碑。主要亮點包括：

• 生物-疫苗研發方面與默沙東（默沙東和公司在美國新澤西州拉赫維）進行了重要的合作擴展，這是Evaxion進行了一項變革性交易。
• 持續增加外部興趣，並進行了幾項有關我們平台和產品線的合作討論。
• 臨床和臨床前開發取得了良好的進展，爲個性化癌症疫苗EVX-01提供了令人信服的2期數據，併爲EVX-B2 mRNA淋病疫苗候選者獲得了臨床前概念驗證。
• 發佈了改進的AI-免疫學™ 平台，用於疫苗抗原預測。
• Thomas Schmidt被任命爲臨時首席財務官。

「在繁忙的第三季度，我們在執行策略方面取得了紮實進展，並非常高興地宣佈，在全公司範圍內實現了幾個重要里程碑。MSD協議有望在未來幾年內改變Evaxion，並且開創性的EVX-01階段2療效數據，是我們衆多成就中的亮點。我們繼續展示作爲真正基於人工智能的TechBio公司的強大能力，專注於推進現有合作伙伴關係以及新的合作伙伴關係討論，推動EVX-01試驗並進行基礎前臨床研究，作爲拓展研發管線的基礎。」Christain Kanstrup，Evaxion首席執行官說。

2024年裏程碑 

* MSD選項和許可協議關於EVX-B2和EVX-B3取代了這個里程碑
** 請查看下方關於業務發展收入目標的更新

研發更新

我們從臨床和臨床角度保持高研發活動水平。這項工作在第三季度取得了出色的成果，首先是通過我們領先資產EVX-01的進行中2期試驗的令人鼓舞的一年數據演示，該資產是一種人工智能免疫™設計的個性化癌症-疫苗，在患有晚期黑色素瘤（皮膚癌）的患者中。

數據顯示全面響應率爲69％，16名患者中有15名的腫瘤靶病變有所減少，免疫原性率爲79％，我們的人工智能-免疫學™平台預測與EVX-01疫苗中個體新抗原誘導的免疫反應之間存在積極相關(p=0.00013)。觀察到的免疫原性率意味着EVX-01疫苗的79％目標觸發了有針對性的免疫反應，這與其他方法相比效果非常有利。

這些臨床發現突顯出EVX-01的重要治療潛力，並進一步驗證了AI-免疫學™平台作爲領先的人工智能技術，用於快速和有效的生物-疫苗靶點發現和設計。

我們在臨床前研究中也取得了成功，在新型mRNA淋病疫苗候選EVX-B2上獲得了概念驗證。這是基於新數據，表明EVX-B2 mRNA能夠觸發針對性的免疫反應，導致淋病細菌的消滅。此前蛋白質版EVX-B2也展示了同樣的效果，現在已經成爲我們與MSD合作的一部分。mRNA數據是在我們與Afrigen生物製品合作的一部分產生的。

除了我們的產品管道外，我們的研發投資也用於持續改進我們的人工智能免疫學™ 平台。在第三季度，我們通過推出新版本的 EDEN™ 人工智能預測模型更新了該平台。除其他改進外，該模型現在能夠預測毒素抗原，爲改進細菌疫苗的開發鋪平了道路。我們預計這一更新將進一步鞏固潛在合作伙伴對人工智能免疫學™ 的濃厚興趣。

業務發展收入

我們的策略基於多合作伙伴方法，有效執行我們的業務發展計劃對我們的成功至關重要。在第三季度，我們非常高興與默沙東簽署了規模顯著擴大的生物-疫苗開發合作協議。此外，我們持續看到潛在合作伙伴的興趣日益增加，並對現有的管道資產以及我們的人工智能-免疫學TM平台周圍的當前合作機會感到興奮。

與MSD的協議潛在業務發展收入最高可達2025年的1000萬美元，此外還有2024年收到的320萬美元的預付款。基於當前的業務發展機會，我們仍然對我們執行多合作伙伴策略並帶來顯著業務發展收入的能力充滿信心。

鑑於某些合作討論將延至2025年，儘管存在濃厚的興趣，但我們將無法實現2024年創造業務發展收入或達到1400萬美元的現金目標。然而，這些討論已延至2025年，將支持明年創造業務發展收入，另外還有潛在的來自MSD的高達1000萬美元。

納斯達克對話

根據早前溝通，於2024年5月7日，我們收到了納斯達克股票市場有限責任公司（「納斯達克」）的一封不足信函，因未能維持至少250萬美元的股東權益，隨後我們向納斯達克提交了一項恢復合規性的計劃。納斯達克給予我們直至2024年11月4日的時間來提供基於提交計劃的合規證明。

我們致力於確保符合納斯達克最低股東權益要求，並維持我們的納斯達克上市。這將通過通過業務發展收入和資本市場活動的結合來增加股東權益來實現。然而，目前的股票市場環境、地緣政治不確定性以及業務發展活動的時間安排迄今已影響了股東權益完全所需增加的時間。

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.