- Precision vaccine project initiated with the ambition to obtain Preclinical Proof-of-Concept by H2 2024. The novel concept entails AI-identification of a new class of cancer vaccine targets, named endogenous retroviruses (ERVs), broadening the potential of cancer vaccines.
- Successful completion of initial phases of vaccine collaboration with MSD (tradename of Merck & Co., Inc.,
Rahway, NJ , USA). MSD revealed as pharma partner for the EVX-B3 bacterial vaccine development program. - Closing of
$5.3 million private placement onDecember 21, 2023 , with participation ofMSD Global Health Innovation Fund (MSD GHI), a corporate venture arm of Merck & Co., Inc.,USA . - Closing of
$15 million Public Offering onFebruary 5, 2024 , with participation of MSD GHI. MSD GHI is now the single largest shareholder in Evaxion, with ownership of around 15%. - Evaxion hosted an R&D Day on
March 19, 2024 . The event focused on Evaxion’s core AI-Immunology™ platform for vaccine target discovery, design and development. All presentations can be accessed here.
Christian continues: “With our refined strategy centered around AI-Immunology™ focusing on value realization via Targets, Pipeline and Responders based upon a muti-partner approach, we are enthusiastic about the prospects this brings for 2024. Further, we are executing to progress our ambition to fund our projected
Business Updates Since Last Quarterly Update
In
In
Evaxion hosted an R&D Day on
- The proprietary AI-Immunology™ platform brings the potential for a new era in vaccine discovery, design and development using advanced AI and machine learning technologies.
- AI-Immunology™ outcompetes standard vaccine target discovery approaches and holds the promise of addressing serious unmet needs.
- With a unique modular architecture, AI-Immunology™ is scalable and adaptable towards partner needs.
- The potential of AI-Immunology™ is validated by established partnerships, including the ongoing vaccine collaboration with MSD.
In the initial months of 2024, we showcased our differentiated AI-Immunology™ platform for vaccine target discovery, design and development, alongside our refined strategy for value generation, at the following conferences:
CEO | |
Chief | |
CEO | |
VP of AI & Innovation, Jens Kringelum, presented the 5th Biologics World Nordics 2024 Conference. | |
CEO | |
Anticipated 2024 Milestones | ||
Milestones | Target | |
EVX-B1 | Conclusion of final MTA study with potential partner | Q1 2024 |
AI-Immunology™ | Launch of EDEN™ model version 5.0 | Mid 2024 |
EVX-B2-mRNA | EVX-B2-mRNA preclinical Proof-of-Concept obtained | Q3 2024 |
EVX-01 | Phase 2 one-year readout | Q3 2024 |
EVX-B3 | Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., | H2 2024 |
Precision ERV cancer vaccines | Preclinical Proof-of-Concept obtained | H2 2024 |
Funding | Ambition for full year 2024 is to generate business development income equal to 2024 cash burn (excluding financing activities) of | |
* No assurances can be made that we will generate such business development income |
Full Year 2023 Financial Results
- Cash position: As of
December 31, 2023 , cash and cash equivalents were$5.6 million compared to$13.2 as ofDecember 31, 2022 . Cash position was strengthened by a private placement with gross proceeds of$5.3 million , which closed onDecember 21, 2023 . The private placement included participation from existing and new shareholders, with the largest new shareholder beingMSD Global Health Innovation Fund (MSD GHI), a corporate venture capital arm of Merck & Co., Inc.,Rahway, NJ , USA, accounting for some 25% of the total aggregate offering amount. Further, the Private Placement included significant participation by all members of the Company’s management and the Company’s board of directors. After a public offering inFebruary 2024 , resulting in net proceeds of$12.7 million , we expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements intoFebruary 2025 . If all pre-funded warrants included in the public offering are exercised, we expect necessary funding will be in place intoApril 2025 . - Research and Development expenses were
$11.9 million for the year endedDecember 31, 2023 , as compared to$17.1 million for the year endedDecember 31, 2022 . The decrease was primarily due to a reduction in external costs. - General and Administrative expenses were
$10.4 million for the year endedDecember 31, 2023 , as compared to$8.2 million for the year endedDecember 31, 2022 . The increase was primarily due to an increase in external costs in connection with funding activities. - Net loss was
$22.1 million for the year endedDecember 31, 2023 , or ($0.81 ) per basic and diluted share, as compared to a net loss of$23.2 million , or ($0.98 ) per basic and diluted share for the year endedDecember 31, 2022 .
Based on the Company’s current cash position, with an estimated cash runway into
Webcast
Evaxion will host a Business Update and Full Year 2023 Financial Results webcast on
Evaxion Biotech A/S | |||||||
Consolidated Statement of Financial Position Data (Audited) | |||||||
(USD in thousands) | |||||||
2023 | 2022 | ||||||
Cash and cash equivalents | $ | 5,583 | $ | 13,184 | |||
Total assets | 12,889 | 22,025 | |||||
Total liabilities | 17,618 | 13,722 | |||||
Share capital | 5,899 | 3,886 | |||||
Other reserves | 97,342 | 90,262 | |||||
Accumulated deficit | (107,970) | (85,845) | |||||
Total equity | (4,729) | 8,303 | |||||
Total liabilities and equity | $ | 12,889 | $ | 22,025 |
Evaxion Biotech A/S | |||||||||||
Consolidated Statement of Comprehensive Loss Data (Audited) | |||||||||||
(USD in thousands, except per share data) | |||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Revenue | $ | 73 | $ | — | $ | 73 | $ | — | |||
Research and development | (2,298) | (4,073) | (11,916) | $ | (17,056) | ||||||
General and administrative | (2,138) | (2,452) | (10,354) | (8,208) | |||||||
Operating loss | (4,363) | (6,525) | (22,197) | (25,264) | |||||||
Finance income | 559 | 70 | 963 | 2,831 | |||||||
Finance expenses | (895) | (590) | (1,681) | (1,508) | |||||||
Net loss before tax | $ | (4,699) | $ | (7,045) | $ | (22,915) | $ | (23,941) | |||
Income tax benefiT | 177 | 173 | 790 | 772 | |||||||
Net loss for the period | $ | (4,522) | $ | (6,872) | $ | (22,125) | $ | (23,169) | |||
Net loss attributable to shareholders of | $ | (4,522) | $ | (6,872) | $ | (22,125) | $ | (23,169) | |||
Loss per share – basic and diluted | $ | (0.16) | $ | (0.29) | $ | (0.81) | $ | (0.98) | |||
Number of shares used for calculation (basic and diluted) | 29,061,036 | 24,082,247 | 27,335,829 | 23,638,685 |
About EVAXION
Forward-Looking Statements
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
Contact Information Evaxion Biotech A/S Christian Kanstrup Chief Executive Officer cka@evaxion-biotech.com Source:Evaxion Biotech
Source:
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