On November 9, 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 third quarter 2021 financial results and provided an operational update (Press release, Evaxion Biotech, NOV 9, 2021, View Source [SID1234594843]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion has continued to make very encouraging clinical progress in the third quarter of 2021, reporting data in July 2021 which we believe support advancing two of our lead programs into Phase 2b clinical trials. Phase 1/2a clinical trial data on our lead product candidate, 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 clinical trial for EVX-01 in melanoma by the end of 2021 in collaboration with Merck and initiate a Phase 2b clinical trial of EVX-02, in conjunction with our third product candidate, EVX-03, in Q2 2022. Our cash reserves of $11.9 million as of the end of the third quarter, combined with the follow-on financing provide a solid financial foundation and will facilitate the continued development of our lead programs."

Operational and Business Highlights in Q3 2021

Reported new clinical data in early July 2021 from Phase 1/2a clinical 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, for metastatic melanoma. Results from the combination therapy compares favorably to historical data from anti-PD-1 treatment alone. A Phase 2b clinical trial of EVX-01 is planned to start by the end of 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. We intend to submit a regulatory filing for a Phase 2b clinical trial of EVX-02 and EVX-03, in combination with anti-PD-1 in adjuvant melanoma in a three-arm trial, in the first half of 2022.
Events after the Reporting Period

Announced clinical trial and supply agreement with subsidiaries of Merck & Co., Inc. (known as MSD outside of the United States and Canada) to evaluate the combination of Evaxion’s cancer immunotherapy EVX-01 with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a new Phase 2b clinical trial in patients with metastatic melanoma
Awarded this year’s Enabling Technology Leadership Award in the artificial intelligence-enabled drug discovery industry by global research and consulting firm Frost & Sullivan
Presentation at the Immuno UK 2021 conference held in London in October
Announced pricing of our FPO on November 5, 2021, and expect to raise gross proceeds of $27.6 million before deducting underwriting discounts and commissions and other offering expenses.
Expected milestones in 2021 & 2022

Phase 2b Investigational New Drug (IND) / Clinical Trial Application (CTA) of EVX-01 in metastatic melanoma – H2 2021.
Phase 2b IND / CTA filing for EVX-02 in combination with EVX-03 in adjuvant melanoma – H1 2022.
Phase 1a IND / CTA filing for EVX-B1 for S. aureus in skin and soft tissue infections (SSTIs) – H2 2022.
First viral candidate selected from RAVEN platform – H2 2022.
Third Quarter 2021 Financial Results

Cash position: As of September 30, 2021, cash and cash equivalents were $11.9 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 deducting underwriting discounts and commissions, but before offering expenses.
Research and Development expenses were $4.4 million for the quarter ended September 30, 2021, compared to $3.0 million for the same period in 2020. The increase of $1.4 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 $1.5 million for the quarter ended September 30, 2021, compared to $1.7 million for the same period in 2020. The decrease of $0.2 million was primarily related to higher share-based compensation in the period ended September 30, 2020 due to accelerated vesting period and sign-on warrants issued associated with the IPO.
Net loss was $5.3 million for the quarter ended September 30, 2021 or ($0.27) loss per basic and diluted share, compared to $4.0 million, or ($0.26) loss per basic and diluted share, for the same period in 2020.
Guidance

We expect the net proceeds from our IPO and FPO combined with our existing cash reserves will be sufficient to fund our operating expenses and capital expenditure requirements through at least 12 months from September 30, 2021.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, November 9, at 8:30 a.m. EST.