On August 12, 2021 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer, bacterial diseases and viral infections, reported the second quarter 2021 financial results and provided an operational update (Press release, Evaxion Biotech, AUG 12, 2021, View Source [SID1234586414]).
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Lars Wegner, CEO of Evaxion, said: "Evaxion has made very encouraging clinical progress in the second quarter of 2021, reporting data in July which we believe support advancing both of our lead programs into Phase 2b trials. Phase 1/2a data on our lead program EVX-01 showed that 67% of the patients benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to the historical data of only 40% benefiting from the check point inhibitor alone. In addition, EVX-02 showed T-cell activation in adjuvant melanoma and appeared to be well tolerated. We plan to initiate a Phase 2b trial for EVX-01 in melanoma in December 2021 and initiate a Phase 2b trial of EVX-02, in conjunction with our third program, EVX-03, in Q2 2022. We also reported preclinical proof of concept data for our RAVEN AI platform for vaccine design and development for viral infections, which we believe has the potential to make a significant contribution in addressing coronavirus infections and other viral diseases. Our cash reserves of $18.8 million provide a solid financial foundation and will facilitate the continued development of these four lead programs."
Operational and Business Highlights in Q2 2021
Reported preclinical proof of concept data in June for the Adaptive and Intelligent Vaccine for a Rapid Response against Corona Viruses (AICoV) program, supporting next-generation coronavirus vaccine technology. First-generation SARS-COV-2 vaccines are focused on the generation of neutralizing antibodies by B cells that bind to the spike protein of the virus and inhibit infection. Activation of T cells may help broaden the immune system’s response to coronavirus and protect against mutations on the spike protein that have been shown to circumvent immunity. Early data demonstrate our RAVEN platform identifies novel immunogenic T-cell epitopes beyond just the spike protein. The proof-of-concept data show RAVEN’s potential to rapidly support the design of novel SARS-COV-2 vaccines capable of tackling newly emerging coronavirus variants.
EVX-03, a novel patient-specific therapy for multiple cancer indications and EVX-B1, a vaccine for the prevention of Staphylococcus aureus including MRSA, continue to progress as expected through preclinical and Chemistry, Manufacturing and Controls (CMC) development.
Presentation in April at the 4th Neoantigen Summit Europe, described Evaxion’s recent improvement in determining cancer neoepitopes through measurement and prediction of peptide-MHC (pMHC) complex stability. We believe this is a significant improvement over AI models trained on traditional mass spectrometry ligand data and the data have already proven valuable in improving our discovery and design of patient-specific neoepitopes used to derive our cancer therapies.
Acceptance of a scientific paper by the International Conference on Machine Learning describing a novel predictive system based on deep probabilistic programming that enables the rapid conversion of sequence data into structural information on protein fragments, which we believe may be useful for drug and vaccine design.
Events after the Reporting Period
Reported new clinical data in early July from Phase 1/2a trials of EVX-01 and EVX-02.
EVX-01, our peptide-based patient-specific cancer therapy, demonstrated anti-tumor effect in combination with anti-PD-1 treatment, a checkpoint inhibitor anticancer drug, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b trial of EVX-01 is planned to start in December 2021.
Preliminary data with EVX-02, our DNA-based patient-specific cancer therapy, demonstrated T-cell activation induced by EVX-02 and appeared to be well tolerated. A Phase 2b trial of EVX-02, in combination with EVX-03, our novel patient-specific therapy for multiple cancer indications, is planned to start in Q2 2022 as a combination therapy with anti-PD-1 in adjuvant melanoma.
Expected milestones in 2021 & 2022
Phase 2b trial initiation of EVX-01 in metastatic melanoma – Q4 2021.
Phase 2b trial regulatory filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – Q2 2022.
Phase 1a trial regulatory filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
First viral candidate selected from RAVEN platform – Q1 2022.
Second Quarter 2021 Financial Results
Cash position: As of June 30, 2021, cash and cash equivalents were $18.8 million compared to $5.8 million as of December 31, 2020. On February 9, 2021, we closed our IPO raising net proceeds of $27.9 million after underwriting discounts and commissions, but before offering expenses.
Research and Development expenses were $5.1 million for the quarter ended June 30, 2021, compared to $2.6 million for the same period in 2020. The increase of $2.5 million was primarily related to increased spending, net of grant income, for ongoing development utilizing our AI platforms, preclinical product candidates, and clinical trials. In addition, employee-related costs increased due to higher headcount.
General and Administrative expenses were $1.9 million for the quarter ended June 30, 2021, compared to $1.4 million for the same period in 2020. The increase of $0.5 million was primarily related to increases in overhead and professional fees related to the expansion of our corporate function.
Net loss was $6.8 million for the quarter ended June 30, 2021 or ($0.36) loss per basic and diluted share, compared to $3.6 million, or ($0.24) loss per basic and diluted share, for the same period in 2020.
Guidance
Evaxion’s current cash position of $18.8 million is expected to be sufficient to fund key clinical programs into 2022.
Webcast and Conference Call
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