On August 17, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported a business update and announced its second quarter 2023 financial results (Press release, Evaxion Biotech, AUG 17, 2023, View Source [SID1234634466]).
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"At Evaxion, we believe that AI-powered, personalized cancer vaccines have the potential to transform the care of patients with melanoma and other cancers. Early-stage clinical data reported at AACR (Free AACR Whitepaper) 2023 and ASCO (Free ASCO Whitepaper)23 indicated that patients treated with our vaccines, EVX-01 or EVX-02, in combination with a checkpoint inhibitor, experienced a treatment benefit, with good overall tolerability" said Per Norlén, Chief Executive Officer of Evaxion. "These data support the potential clinical utility for personalized cancer immunotherapy and the opportunity to advance our next-generation, DNA-based candidate, EVX-03, towards clinical trials in cancer patients."
"Additionally, at a time of positive industry data and renewed interest in personalized cancer vaccines, Evaxion is making excellent scientific progress. Utilization of two new, proprietary technologies, including the AI platform ObsERV, which enables identification of novel cancer antigens called ERVs, which are patient-specific cancer targets of viral origin, plus our novel genetic adjuvant, are believed to further enhance the efficacy of EVX-03," said Per, concluding, "On a separate note, we were pleased to present preclinical proof-of-concept data at the Gordon Conference showing that EVX-B1 can clear staphylococcus infections. Taken together, these clinical advances and proof-of-concept milestones highlight the potential for Evaxion’s AI-powered technology to address unmet medical needs in oncology and infectious diseases. The recent completion of an up to $20 million USD financing will support progression of our current studies and operations, while initiation of EVX-03 phase 1 activities are subject to additional funding."
Anticipated milestones
· Q4 2023 – Interim results of EVX-01 Phase 2 trial in melanoma
· Q4 2023 – Clinical trial application for EVX-03*
*Subject to additional funding in the range of $5-10 million secured before initiation
Recent Milestones (April to August 2023)
Completion of financing commitments totaling up to USD 20 million
[Press Release with hyperlink]. Evaxion announced completion of a financing commitment totaling up to $20 million with Global Growth Holding Limited, available in tranches over the next three years.
The financing is intended to cover the company’s working capital needs, including the advancement of EVX-03 to Phase 1 readiness.
Promising preclinical data presented at the Staphylococcal Diseases Gordon Research Conference
[Press Release with hyperlink]. Preclinical data showed EVX-B1, a vaccine against Staphylococcus aureus (S. aureus) containing AI-identified antigens, is highly protective against S. aureus disease in pre-clinical models and that EVX-B1 effectively clears S. aureus infections.
Promising early clinical data presented for EVX-01 and EVX-02
· EVX-01 presentation at ASCO (Free ASCO Whitepaper)23. Phase 1 results showed positive clinical responses in 8 out of 12 patients receiving EVX-01 in combination with a checkpoint inhibitor. The trial also met primary endpoints for tolerability and safety, with only mild AEs being related to EVX-01.
· EVX-02 presentation at AACR (Free AACR Whitepaper) 2023. Phase 1/2a results showed that all 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment.
R&D Day Highlights Preclinical Data on genetic adjuvant technology
R&D Day 2023. In a series of talks from its scientists and collaborators, Evaxion provided an introduction to its proprietary genetic adjuvant technology developed to enhance the effectiveness of DNA and mRNA vaccines. The genetic adjuvant can be encoded into either DNA or mRNA vaccines to boost the immune response. Preclinical data show that the technology boosts both B cell and T cell immune responses, making it applicable to a wide range of vaccines, both for cancer and for infectious disease.
Second Quarter of 2023 Financial Results
· Cash position: As of June 30, 2023, cash and cash equivalents were $7.1 million as compared to $13.2 as of December 31, 2022. Operating spending for the second quarter of 2023 was offset by the proceeds from issue of shares and exercise of warrants. We expect that our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements into December 2023.
· Research and Development expenses were $2.9 million for the quarter ended June 30, 2023 as compared to $4.1 million for the quarter ended June 30, 2022. The decrease in research and development expenses was primarily due to a decrease of $0.7 million in external costs related to finalized clinical trials and a decrease in employee-related costs of $0.5 million due to reduced headcount.
· General and Administrative expenses were $2.7 million for the quarter ended June 30, 2023 as compared to $2.1 million for the quarter ended June 30, 2022. The increase in general and administrative expenses was primarily due to an increase of $0.3 million in external costs related to overhead and professional fees and an increase in employee-related costs of $0.2 million. These increases are due to the timing of funding projects and business initiatives compared to 2022 and the expansion of the organization throughout 2022 to meet the requirements as a listed company.
· Net loss was $5.7 million for the quarter ended June 30, 2023 or ($0.21) per basic and diluted share as compared to a net loss of $4.8 million, or ($0.20) per basic and diluted share for the quarter ended June 30, 2022.
Webcast
Evaxion will host a webcast on Tuesday, August 22, at 8:00 a.m. EDT.
To access the webcast, please visit:
Notes and abbreviations:
ASCO23 = the 2023 Annual Meeting of the American Society for Clinical Oncology, AACR (Free AACR Whitepaper) 2023 = the 2023 Annual Meeting for the American Association for Cancer Research (AACR) (Free AACR Whitepaper), ERVs = endogenous retroviruses