On August 10, 2022 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 second quarter 2022 financial results and provided an operational and business update (Press release, Evaxion Biotech, AUG 10, 2022, View Source [SID1234618057]).

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Lars Wegner, CEO of Evaxion, said: "Evaxion announced multiple exciting milestones in the second quarter of 2022. We expanded our DNA oncology vaccine program into non-small cell lung cancer, identified gonorrhea as our second bacterial product target and successfully produced our personalized melanoma immunotherapies for our dedicated clinical trial of EVX-02 for resectable melanoma. We expect to begin the Phase 2b trial combining EVX-01 with Merck’s KEYTRUDA, for treatment of patients with metastatic melanoma, in the second half of 2022. We believe that these significant steps, including the progression of our clinical programs and the manufacture of clinical supplies, highlight the potential for our exciting pipeline of cancer therapies to improve the treatment landscape in melanoma and other cancers."

Dr. Wegner continued, "Evaxion’s goal is to develop our programs through Phase 2 before seeking to out-license them. We are actively discussing potential partnerships with multiple pharmaceutical and biotechnology companies. As of June 30, 2022, our cash reserves totaled $25.3 million. We expect these funds to support our product development efforts for the next 12 months."

Operational and Business Highlights in the Second Quarter of 2022

Selected EVX-03 as product candidate within our DNA technology platform to target new indication, NSCLC, due to encouraging data in the pre-clinical study
Announced successful production of all batches of personalized cancer immunotherapies for all patients enrolled in Phase 1/2a clinical trial for EVX-02 for resectable melanoma
Announced gonorrhea as second bacterial product target for treatment with our EVX-B2 vaccine product candidate
Hosted Key Opinion Leader webinar on metastatic melanoma and personalized cancer immunotherapies
Entered into equity financing arrangement for up to $40 million with Lincoln Park Capital Fund, LLC
Events after the Reporting Period

Announced executive leadership changes. Lars Wegner, M.D. to resign as Chief Executive Officer (CEO) and remain with the Company in advisory role to new CEO and Board of Directors. Per Norlén, M.D., PhD. to succeed Dr. Wegner as CEO within the next six months.
Expected Milestones in the Second Half of 2022

Initiation of Phase 2b first patient, first visit with EVX-01, in combination with Merck’s PD-1 inhibitor KEYTRUDA, for the treatment of metastatic melanoma (peptide-based, personalized cancer therapy)
Phase 1 regulatory filing for EVX-03 in patients with non-small cell lung cancer (targeted DNA-based personalized cancer therapy). Initiation of the study is contingent upon securing new capital to fund the costs of the clinical trial.
Phase 1 regulatory filing for EVX-B1 (S. aureus) in skin and soft tissue infections
Selection of first viral candidate from our RAVEN platform
Expected Milestones in First Half of 2023

Clinical readout of Phase 1/2a clinical study to evaluate EVX-02 in patients with resectable melanoma
Second Quarter 2022 Financial Results

Cash position: As of June 30, 2022, cash and cash equivalents were $25.3 million as compared to $32.2 million as of December 31, 2021. The decrease in cash and cash equivalents during the first six months of 2022 was primarily attributable to our operating expenses for the first six months of 2022, partially offset by the proceeds received from the first tranche of our loan from the European Investment Bank.
Research and Development expenses were $4.1 million for the three months ended June 30, 2022, compared to $5.1 million for the same period in 2021. The decrease was primarily due to lower external costs related to the clinical trials.
General and Administrative expenses were $2.1 million for the three months ended June 30, 2022 as compared to $1.9 million for the same period in 2021. The slight increase was primarily due to an increase in fees associated with the expansion of our business as a listed company.
Net loss was $4.8 million for the three months ended June 30, 2022, or ($0.20) loss per basic and diluted share as compared to $6.8 million, or ($0.36) loss per basic and diluted share for the three months ended June 30, 2021.
Guidance

We expect our existing cash and cash equivalents, including use of financing facilities, will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months.
Webcast and Conference Call

Evaxion will host a webcast and conference call today, August 10, at 8:30 a.m. EDT.

To dial-in for the conference call, please use the following details:

Alternatively to access the audio webcast, please visit the events page of Evaxion’s website at:
View Source

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.