Evaxion announces business update and third quarter 2024 financial results
Evaxion Biotech (NASDAQ: EVAX) announced Q3 2024 financial results and business updates. Key highlights include an expanded collaboration with MSD, positive phase 2 data for EVX-01 cancer vaccine showing 69% Overall Response Rate, and preclinical Proof-of-Concept for EVX-B2 mRNA Gonorrhea vaccine. Q3 revenue was $3.0 million compared to nil in Q3 2023. Net loss decreased to $1.9 million ($0.04 per share) from $5.7 million ($0.21 per share) year-over-year. Cash position was $4.6 million as of September 30, 2024, with runway into March 2025. The company faces Nasdaq compliance issues regarding minimum stockholder's equity requirements.
Evaxion Biotech (NASDAQ: EVAX) ha annunciato i risultati finanziari del terzo trimestre del 2024 e aggiornamenti aziendali. I punti salienti includono una collaborazione ampliata con MSD, dati positivi della fase 2 per il vaccino contro il cancro EVX-01 che mostrano un tasso di risposta complessivo del 69%, e la prova di concetto preclinica per il vaccino mRNA contro la gonorrea EVX-B2. I ricavi del terzo trimestre sono stati di 3,0 milioni di dollari rispetto a zero nel terzo trimestre del 2023. La perdita netta è diminuita a 1,9 milioni di dollari (0,04 dollari per azione) rispetto ai 5,7 milioni di dollari (0,21 dollari per azione) dell'anno precedente. La posizione di cassa era di 4,6 milioni di dollari al 30 settembre 2024, con una proiezione di liquidità fino a marzo 2025. L'azienda affronta problemi di conformità con il Nasdaq riguardo ai requisiti minimi di equità per gli azionisti.
Evaxion Biotech (NASDAQ: EVAX) anunció los resultados financieros del tercer trimestre de 2024 y actualizaciones empresariales. Los aspectos más destacados incluyen una colaboración ampliada con MSD, datos positivos de la fase 2 para la vacuna contra el cáncer EVX-01 que muestran una tasa de respuesta general del 69% y una prueba de concepto preclínica para la vacuna de ARNm contra la gonorrea EVX-B2. Los ingresos del tercer trimestre fueron de 3,0 millones de dólares en comparación con cero en el tercer trimestre de 2023. La pérdida neta se redujo a 1,9 millones de dólares (0,04 dólares por acción) desde los 5,7 millones de dólares (0,21 dólares por acción) del año anterior. La posición de efectivo era de 4,6 millones de dólares a 30 de septiembre de 2024, con un margen de liquidez hasta marzo de 2025. La empresa enfrenta problemas de cumplimiento con Nasdaq en relación con los requisitos mínimos de capital de los accionistas.
Evaxion Biotech (NASDAQ: EVAX)는 2024년 3분기 재무 결과 및 사업 업데이트를 발표했습니다. 주요 내용으로는 MSD와의 협력 확대, EVX-01 암 백신의 긍정적인 2상 데이터(69% 전체 반응률 표시), EVX-B2 mRNA 임질 백신에 대한 전임상 개념 증명이 포함됩니다. 3분기 수익은 300만 달러로, 2023년 3분기의 제로와 비교됩니다. 순손실은 190만 달러(주당 0.04달러)로 감소했으며, 지난해 570만 달러(주당 0.21달러)에서 감소했습니다. 2024년 9월 30일 기준 현금 보유고는 460만 달러로, 2025년 3월까지의 운영 자금이 확보되어 있습니다. 이 회사는 최소 주주 자본 요구 사항에 대한 나스닥 준수 문제에 직면해 있습니다.
Evaxion Biotech (NASDAQ: EVAX) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour sur l'activité. Les éléments clés comprennent une collaboration élargie avec MSD, des données positives de phase 2 pour le vaccin contre le cancer EVX-01 montrant un taux de réponse global de 69 %, et une preuve de concept préclinique pour le vaccin ARNm contre la gonorrhée EVX-B2. Les revenus du troisième trimestre ont atteint 3,0 millions de dollars contre rien au troisième trimestre 2023. La perte nette a diminué à 1,9 million de dollars (0,04 dollar par action) contre 5,7 millions de dollars (0,21 dollar par action) l'année précédente. La position de trésorerie était de 4,6 millions de dollars au 30 septembre 2024, avec un budget prévu jusqu'en mars 2025. L'entreprise fait face à des problèmes de conformité avec le Nasdaq concernant les exigences minimales en matière de capitaux propres des actionnaires.
Evaxion Biotech (NASDAQ: EVAX) hat die finanziellen Ergebnisse für das 3. Quartal 2024 und Unternehmensupdates bekannt gegeben. Zu den wichtigsten Punkten gehören eine erweiterte Zusammenarbeit mit MSD, positive Phase-2-Daten für den EVX-01 Krebsimpfstoff, die eine Gesamtansprechrate von 69 % zeigen, und ein präklinischer Proof-of-Concept für den EVX-B2 mRNA Gonorrhoe-Impfstoff. Der Umsatz im 3. Quartal betrug 3,0 Millionen Dollar im Vergleich zu null im 3. Quartal 2023. Der Nettverlust verringerte sich auf 1,9 Millionen Dollar (0,04 Dollar pro Aktie) von 5,7 Millionen Dollar (0,21 Dollar pro Aktie) im Vergleich zum Vorjahr. Die Liquiditätsposition betrug am 30. September 2024 4,6 Millionen Dollar mit einer Finanzierung bis März 2025. Das Unternehmen steht vor Nachverpflichtungsproblemen bei Nasdaq hinsichtlich der Mindestanforderungen an das Eigenkapital der Aktionäre.
- Expanded collaboration deal with MSD including $3.2M upfront payment and potential $10M in 2025
- Phase 2 trial of EVX-01 showed 69% Overall Response Rate and 79% immunogenicity rate
- Q3 revenue increased to $3.0M from zero in previous year
- Net loss improved to $1.9M from $5.7M year-over-year
- Operating expenses decreased in both R&D and G&A segments
- Cash runway only extends into March 2025, requiring additional funding
- Failed to meet 2024 business development income target of $14M
- Risk of Nasdaq delisting due to insufficient stockholder's equity
- Total equity at critical low of $0.1M as of September 30, 2024
- Going concern warning issued due to financial position
Insights
The Q3 2024 results reveal a mixed financial picture for Evaxion. Revenue of
The company faces significant challenges with Nasdaq compliance due to insufficient stockholders' equity, requiring urgent action through business development income or capital raising. The missed
The clinical data for EVX-01 shows promising results with a
The expanded MSD collaboration validates the platform's potential, but the company needs to accelerate partnership discussions to support continued development of its promising pipeline.
COPENHAGEN, Denmark, October 31, 2024 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces third quarter 2024 financial results.
Business highlights (since last quarterly update)
Since the second quarter 2024 business update, we have continued to execute strongly on our strategy and plans with several major milestones achieved. Key highlights include:
- Significant expansion of the infectious disease vaccine development collaboration with MSD (tradename of Merck & co., Inc., Rahway, NJ, USA) in a transformative deal for Evaxion
- Continuously increasing external interest and several ongoing partnerships discussions covering both our platform and pipeline
- Strong progress in clinical and preclinical development with convincing phase 2 data presented for personalized cancer vaccine EVX-01 and preclinical Proof-of-Concept obtained for EVX-B2 mRNA Gonorrhea vaccine candidate
- Launch of improved AI-Immunology™ platform for vaccine antigen prediction
- Thomas Schmidt appointed as interim Chief Financial Officer
“We continued to make solid progress on our strategy execution in a busy third quarter and are very pleased to have achieved several important milestones across our company. The MSD agreement, which holds the potential to transform Evaxion over the coming years, and the groundbreaking EVX-01 phase 2 efficacy data, stand out among our many achievements. We continue to demonstrate our strong capabilities as a truly AI-based TechBio company and remain focused on advancing on-going partnerships as well as new partnership discussions, progressing the EVX-01 trial and carrying through preclinical studies as a basis for expanding our R&D pipeline,” says Christian Kanstrup, CEO of Evaxion.
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 (ECCB, September) ✓ |
| EVX-B2-mRNA | EVX-B2-mRNA preclinical Proof-of-Concept obtained | Q3 2024 (18th Vaccine Congress, September) ✓ |
| EVX-01 | Phase 2 one-year readout | Q3 2024 (ESMO Congress, September) ✓ |
| EVX-B3 | Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA)* | 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 or cash in equal to 2024 cash burn (excluding financing activities) of |
* MSD option and license agreement on EVX-B2 and EVX-B3 supersedes this milestone
** See update on the business development income ambition below
Research & Development update
We maintain a high activity level in Research & Development (R&D) from both a preclinical and clinical perspective. This work yielded outstanding results in the third quarter, first and foremost with the presentation of encouraging one-year data from the ongoing phase 2 trial with our lead asset EVX-01, an AI-Immunology™ designed personalized cancer vaccine, in patients with advanced melanoma (skin cancer).
The data demonstrates
These clinical findings underscore the significant therapeutic potential of EVX-01 and are yet another validation of the AI-Immunology™ platform as a leading AI technology for fast and effective vaccine target discovery and design.
We were also successful in our preclinical research, obtaining Proof-of-Concept for novel mRNA Gonorrhea vaccine candidate EVX-B2. This was based on new data documenting that EVX-B2 mRNA triggers a targeted immune response that leads to the elimination of the gonorrhea bacteria. The same had earlier been shown for the protein-based version of EVX-B2, which is now part of our partnership with MSD. The mRNA data has been generated as part of our partnership with Afrigen Biologics.
Further to our pipeline, our R&D investments are also allocated to the continued improvement of our AI-Immunology™ platform. During the third quarter, we updated the platform with the launch of a new version of its EDEN™ AI prediction model. Among other improvements, the model can now predict toxin antigens, allowing for the development of improved bacterial vaccines. We expect this update to further solidify the strong interest seen in AI-Immunology™ from potential partners.
Business development income
Our strategy is based upon a multi-partner approach, making effective execution upon our business development plans crucial to our success. We were thrilled to sign the significantly expanded vaccine development collaboration with MSD during the third quarter. Further, we continue to see an increasing interest from potential partners and are excited by the current partnership opportunities both around existing pipeline assets as well as our AI-Immunology™ platform.
The agreement with MSD carries potential business development income of up to
Given that certain partnership discussions will be moving into 2025, we will - despite the strong interest - not be able to meet our 2024 ambition of generating business development income or cash in of
Nasdaq dialogue
As communicated earlier, on May 7, 2024, we received a deficiency letter from Nasdaq Stock Market LLC (“Nasdaq”) for failure to maintain stockholders’ equity of at least
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.
Third quarter 2024 financial results
Cash position as of September 30, 2024, was
Revenue of
Research and Development expenses were
General and Administrative expenses were
We generated a net loss of
Total equity amounts to
Evaxion Biotech A/S
Consolidated Statement of Financial Position Data (Unaudited)
(USD in thousands)
| Sep 30, 2024 | Dec 31, 2023 | ||
| Cash and cash equivalents | 4,576 | 5,583 | |
| Total assets | 15,185 | 12,889 | |
| Total liabilities | 15,111 | 17,618 | |
| Share capital | 8,732 | 5,899 | |
| Other reserves | 106,245 | 99,946 | |
| Accumulated deficit | (114,903) | (107,860) | |
| Total equity before derivative warrant liability | 74 | (2,015) | |
| Effect from derivative liabilities from investor warrants | - | (2,714) | |
| Total equity | 74 | (4,729) | |
| Total liabilities and equity | 15,185 | 12,889 |
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)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Revenue | 3,017 | — | 3,222 | — |
| Research and development | (2,614) | (2,830) | (8,202) | (9,618) |
| General and administrative | (2,134) | (2,932) | (5,728) | (8,215) |
| Operating loss | (1,731) | (5,762) | (10,708) | (17,833) |
| Finance income | 84 | 72 | 5,922 | 404 |
| Finance expenses | (384) | (182) | (2,665) | (786) |
| Net loss before tax | (2,031) | (5,872) | (7,451) | (18,215) |
| Income tax benefit | 96 | 194 | 513 | 613 |
| Net loss for the period | (1,935) | (5,678) | (6,938) | (18,215) |
| Net loss attributable to shareholders of Evaxion Biotech A/S | (1,935) | (5,678) | (6,938) | (18,215) |
| Loss per share – basic and diluted | (0.04) | (0.21) | (0.13) | (0.66) |
| Number of shares used for calculation (basic and diluted) | 55,255,329 | 27,659,878 | 51,905,948 | 26,754,440 |
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.
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