Evaxion A/S

Greetings. Welcome to the Ivaxion first quarter 2021 earnings call. At this time, all participants are in a listening-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Mary Ann Chang of Lifestyle Advisors. You may begin.

Thank you, operator, and good morning, everyone. Welcome to the Avaxian Biotech conference call on the first quarter results. Earlier today, we issued a press release that outlines what we plan to discuss today. This press release is available on Avaxian's website. During the call, Lars Wegner, CEO of Avaxian, will provide a brief corporate update, after which Glenn Vraniak, the CFO, will review the financial results. After the prepared remarks, we will open up the call for Q&A, where Lars and Glenn will be available to answer your questions. Before we begin, I'd like to remind everyone that statements made during this conference call relating to Avaxion's expected future performance, future business prospects, or future events or plans may include forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. All such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. Actual outcomes and results could differ materially from these forecasts due to the impact of many factors beyond the control of a vaccine. A vaccine expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in the vaccines F1 and 20F and other periodic reports filed with the Securities and Exchange Commission. With that said, we'll now turn the call over to Lars.

Thank you, Marianne, and good morning, everyone. Welcome to our call. I'm delighted to provide you an overview on our progress over the quarter before handing it over to Glenn to discuss financials. So moving into the business highlights, Evaction made strong progress in Q1 2021, successfully concluding our US IPO in February and continuing to advance our clinical and preclinical programs. The recruitment of our Phase I and II A trials on our two lead immune oncology product candidates, EVXO1 and EVXO2, remains on track, and we anticipate data readout late in Q2. We plan to assemble the data and provide an update on the results and next step by mid-July for both EVXO1 and EVXO2. As a reminder, EVXO1 is a peptide-based therapy being assessed in advanced metastatic cancer, including melanoma, non-small cell lung cancer, and bladder cancer. Preliminary data showed that EVXO1 to be well tolerated with one complete response and two partial response out of five patients. All patients had reactive T cells with 80.5% of the administered neoibotope, including reactive T cells. The July report will update, will have both the data for the dose escalation and the recommended, and a total of nine patients. EVXO2 is our DNA-based vaccine being assessed in adjuvant melanoma, Five patients have been recruited today and the first part of the trial which assesses this new delivery modality. Our other lead product candidate, EVX03 for multiple cancer indication and EVXB1, a vaccine for the prevention of staph aureus, are also progressing as expected to our preclinical development and CMC. We anticipate a regulatory filing for our clinical trial EVX03 in second half of 2021. And we continue to develop our Raven AI platform for vaccine design and development for viral diseases. As most of you know, we closed our US initial public offering in February, raised the net proceed of 27.9 million after underwriting discount and commission. This contributed to our cash position of 27 million US dollars at the end of the first quarter. We published a paper in the peer-reviewed journal Scientific Reports describing a study to the bacterium Staphylococcus aureus, which may facilitate a better understanding of the host-pattern interaction during invasion infections. and our Director in Genomic Immune Oncology, Jens Kranlund, also made a presentation at the 4th NEO Antigen Summit in Europe, describing EVAXION's recent improvement in determined cancer neoepithelial through measurement and prediction of peptide MHC complex stability. Last but not least, we also moved to our new headquarter and research laboratory facility located in the DTU Science Park in Hørsel, near Copenhagen in Denmark. In terms of expected milestones, I've already mentioned the Phase 1-2A data readout on EVXO-1 and EVXO-2 expected in late Q2. So we will be busy and have a few exciting months ahead of us. With that summary, I will hand it over to Glenn for a brief overview of our financials.