Evaxion A/S

Greetings and welcome to a Vaccine Biotech third quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during today's conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Mr. Corey Davis from LifeSci Advisors. Thank you, sir. You may begin.

Thanks, Laura, and hello, everyone. Thanks for joining us. Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements, as defined in the Private Securities Litigation Reform Act of 95. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance, and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's annual report on Form 20F for the fiscal year ended December 31st, 2020, as filed with the SEC on April 7th, 21. And then the company subsequently filed SEC reports. At this time, I'd like to turn the conference call over to Lars Wegner, the company's president and CEO. Please go ahead, Lars.

Thank you, Corey. Good morning, everyone. Thank you for joining us for this event on biotech. Q3 earnings call. I'm Lars Wigner, Chief Executive Officer of Evaction, and with me today is Evaction's co-founder and Chief Business Officer, Niels Møller, who is currently Interim Chief Financial Officer. We'll give you a short presentation on our business and results, and then open up the call for your questions. Let me begin by saying Evaction has continued to make a very encouraging clinical progress in the third quarter of 2021 towards our goal of becoming a world leader in AI-driven immune therapies. As many of you know, Evaction specializes in decoding the human immune system and using the data to rapidly discover and develop potential effective drug candidates to improve the life of patients with cancer and infectious disease. We believe that our AI models allow us to identify unique drug targets which may translate into a higher likelihood of clinical success. In July of this year, 21, we reported the data which supported advancing two of our lead cancer vaccine programs into Phase IIb clinical trials. The phase 1-2a result of our EVX-01 program showed that 67% of the patient benefited from EVX-01 in combination with anti-PD-1 for the treatment of metastatic melanoma, compared to a historical data of only 40% benefiting for the checkpoint inhibitor load. We also observed a complete response rate of 22%. compared to the historical data of only 7% benefiting from checkpoint inhibitor alone. A phase 2B clinical trial of EDXO1 in melanoma is planned to start at the end of 2021. Last month, we announced a clinical trial and supply agreement with subsidiaries of Merck, one of the world's leading immune oncology companies, to supply its anti-PD-1 therapy, Contruda, in this trial as well as collaborating on the trial design. In addition, EVXO2 showed T cell activation in adjuvant melanoma and appear to be well tolerated. We intend to submit a regulatory filing for phase 2B clinical trial of EVXO2 in combination with EVXO3, our novel patient-specific therapy for multiple cancer indications. as a combination therapy with anti-PD-1 and adjuvant melanoma in the first half of 2022. The EVH-01, 02, and 03 products all come from our pioneer AI platform, which generates patient-specific cancer immune therapy. In other clinical developments, we remain on track for regulatory filing for a clinical trial in the second half of 2022 for the lead candidate on our EVEN platform, which generates vaccines against bacterial diseases. This program, EVXB1, is a vaccine for the prevention of staph aureus in skin and soft tissue infections. We also expect to select the first viral candidate from our RAIM platform in the second half of 2022. Outside of the clinic, Evaction received this year Enabling Technology Leadership Award in the Artificial Intelligence Enabled Drug Discovery Industry by leading global research and consulting firm, Foster & Sullivan. We are honored to receive the award and I'm very proud of the hard work and commitment of the whole Evaction team in advancing our vision for better global health. Evaction also gave a presentation at the UNO UK Conference which was held in London last month. One of our senior scientists, Dr. Emma Christina Japper, introduced Evaction's AI immunological core technology and detailed how the company is using AI to decode the human immune system. She focused on pioneering and demonstrated how Evaction is continuously working to improve the platform through immunological data generation and the development of optimized AI models. This concludes our business and operational update for Q3 2021. I will now turn the call over to Niels for news of our follow-on public offering and the Q3 financial review.