On May 31, 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 its first quarter 2023 financial results and provided a business update (Press release, Evaxion Biotech, MAY 31, 2023, View Source [SID1234632269]).
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"Evaxion continues to make significant progress towards our mission of advancing AI-powered immunotherapies to save lives," said Per Norlén, Chief Executive Officer of Evaxion. "Data, reported at AACR (Free AACR Whitepaper) 2023 and to be presented at ASCO (Free ASCO Whitepaper) 2023, show that in our trials in melanoma with EVX-02 and EVX-01, respectively, patients experienced promising clinical responses, with good overall tolerability. These data provide important validation for Evaxion’s AI-driven approach to personalized cancer vaccines and underscore our enthusiasm for our next-generation vaccine candidate, EVX-03, slated to begin clinical trials by the end of this year."
"We have also announced important advances in our proprietary AI-technology, including the new platform ObsERV, which enables Evaxion to identify new patient-specific tumor targets, called ERVs, based on ancient viral remnants in our genome. It has the potential to further enhance the efficacy of our personalized cancer vaccine EVX-03, as well as broadening immunotherapy to patients that are currently unresponsive to such treatments" said Per, concluding, "We believe that the promising clinical data from our first-generation programs and the exciting technology advancement with our genetic adjuvant technology, position Evaxion at the forefront of the recent resurgence in interest for nucleic acid-based vaccines."
Anticipated milestones
June 2023 – Full readout of EVX-01 Phase 1/2a trial at ASCO (Free ASCO Whitepaper)
Q3 2023 – CTA filing for EVX-03*
Q4 2023 – Interim results of EVX-01 Phase 2 trial in melanoma
Q4 2023 – Initiate enrollment of EVX-03 Phase 1 trial*
*Subject to additional funding in the range of $ 5-10 million
Promising clinical data presented for EVX-01 and EVX-02
Clinical readout for the Phase 1/2a trial of EVX-02 was presented at AACR (Free AACR Whitepaper) in April. 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.
EVX-01 will be presented at ASCO (Free ASCO Whitepaper) on June 3. The overall outcome of the trial was made public on May 25 with 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.
R&D Day Highlights Preclinical Data on genetic adjuvant technology
On May 25, Evaxion hosted a series of talks from its scientists and collaborators, sharing preclinical data on its proprietary genetic adjuvant technology developed to enhance the effectiveness of DNA and mRNA vaccines. The genetic adjuvant carries the code for CCL19, a molecule known to attract immune cells, notably antigen presenting cells, and can be encoded into either DNA or mRNA vaccines to boost the immune response. 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.
Next-generation cancer immunotherapy based on ERVs
On March 23, Evaxion announced that it has developed a new proprietary AI platform technology, ObsERV, identifying a new source of targets for personalized cancer therapy. ObsERV makes it possible to identify patient-specific virus targets, so-called ERVs (endogenous retroviruses), selectively expressed in cancer. Evaxion has demonstrated that ERVs are strongly associated with the overall survival of cancer patients, and notably of patients with cold tumors that are normally unresponsive to immunotherapy. Evaxion anticipates filing a clinical trial application (CTA) with the European Medicines Agency in Q3 2023 for its next-generation DNA-based cancer immunotherapy utilizing the OBsERV technology and intends to begin a Phase 1 trial in Q4 2023 in patients with solid tumors, subject to additional funding being obtained.
First Quarter of 2023 Financial Results
Cash position: As of March 31, 2023, cash and cash equivalents were $10.2 million as compared to $13.2 as of December 31, 2022. Operating spending for the first 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 early December 2023.
Research and Development expenses were $3.9 million for the quarter ended March 31, 2023 as compared to $4.8 million for the quarter ended March 31, 2022. The decrease was primarily due to a decrease in external costs offset by an increase in employee-related costs as a result of higher headcount.
General and Administrative expenses were $2.5 million for the quarter ended March 31, 2023 as compared to $1.6 million for the quarter ended March 31, 2022. The increase was primarily due to an increase in external costs for planning of equity financing.
Net loss was $6.2 million for the quarter ended March 31, 2023 or ($0.24) per basic and diluted share as compared to a net loss of $5.8 million, or ($0.25) per basic and diluted share for the quarter ended March 31, 2022.