Greetings. Welcome to Evaxion First Quarter 2021 Earnings Call. At this time all participants are in a listen only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, Mary-Ann Chang of LifeSci Advisors.

You may begin..

Thank you, operator, and good morning, everyone. Welcome to the Evaxion 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 Evaxion website.

During the call Lars Wegner, CEO of Evaxion will provide a brief corporate update, after which Glenn Vraniak the CFO will review the financial results. After the prepared remarks we'll 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 Evaxion'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 this forecast due to the impact of many factors beyond the control of Evaxion.

Evaxion expressly disclaims any duty to provide updates to forward looking statements, whether as a result of new information, future events or otherwise, participants are directed to the risk factors set forth Evaxion's F1and 20-F [ph] another periodic reports filed with the Securities and Exchange Commission.

With that said, I will now turn the call over to Lars..

Thank you, Mary-Ann. 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, Evaxion made strong progress in Q1 2020.

Successfully completing our US IPO in February, and continuing to advance our clinical and preclinical programs. The recruitment of our phase 1 and 2A trials on our two lead immune oncology product candidates EVX-01 and EVX-02 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 EVX-01 and EVX-02. As a reminder, EVX-01 is a peptide based therapy being assessed in advanced metastatic cancer including melanoma, non-small cell lung cancer and bladder cancer.

But in that data showed that the EVX-01 to be well tolerated with one complete response and two partial response out of five patients or patient had reacted to cells with 80.5% of the administered new epitope including reactive shots [ph].

The July report, update will have both the data fall, the dose escalation and the recommended and a total of nine patient. EVX-02 is our DNA based vaccine being assessed in adjuvant melanoma. Five patients have been recruited today and the first part trial which assists this new delivery modality.

Our lead product candidate EVX-03 for multiple cancer indication and EVX-B1, a vaccine for the prevention of Staphylococcus are also progressing as expected to our preclinical development and CMC. We anticipate regulatory filing for our clinical trial EVX-03 in second half of ‘21.

And we continue to develop our RAVEN AI platform for vaccine design and development for viral disease. As most of you know, we closed our US initial public offering in February raised the net proceeds of $27.9 after underwriting discount and condition. This contributed while cash proceeds of $27 million at the end of the first quarter.

We published a paper in the peer reviewed Journal Scientific Reports describing the story to the bacterium, Staphylococcus aureus, which may facilitate a better understanding of the host pathogen interaction during invasion infections.

And our Director in normal immune-oncology is kind of automated presentation at the FAS [ph] New Antigen Summit in Europe, describing Evaxion's recent improvements in determined cancer new intro to measurement and prediction of peptides image c-complex stability.

Last but not least, we also move to our new headquarters and research laboratory facility located in the DTU Science Park in Hoersholm near Copenhagen, Denmark. In terms of expected milestones, I've already mentioned the phase 1 2A data readout on EVX-01 and EVX-02 expected in late Q2.

So we will be busy and exciting, have a few exciting month ahead of us. With that summary, I will hand it over to Glenn for brief overview of our financials..

Thank you, Lars and good morning everyone. On February 9, 2021 as mentioned by Lars we closed our US IPO raising net proceeds of $27.9 million after underwriting discounts and commissions. This contributed to our cash position of $27 million as of March 31, 2021, as compared to $5.8 million as of December 31 2020.

Research and Development expenses were $3.9 million for the quarter ended March 31 2021 as compared to $2.5 million for the same period in 2020. The increase of $1.4 million was primarily related to increase spending net of grants income for ongoing development on our platforms, preclinical product candidates and clinical trials.

In addition, employee related expenses increased due to higher headcount. General and administrative expenses were $1.3 million for the quarter ended March 31, 2021, as compared $2.8 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 for our initial public offering.

Net loss was $4.1 million for the quarter ended March 31 2021, or a $0.23 loss per basic and diluted share as compared to $3.1 million or $0.20 loss per basic and diluted share for the same period in 2020. In terms of guidance, we reaffirm our guidance that our existing cash resources will be sufficient to support our operations into 2022.

And that concludes the financial review of Q1 and we will now open the call for your questions. .

[Operator Instructions] Our first question is from Kevin DeGeeter with Oppenheimer. Please proceed with your question. .

Hey, thanks so much for taking my question. You know, maybe two on 01 and 02, and then follow up 03. Looking at the data update, should we expect to learn more about the recommended phase 2 dose for 01 during that update, and with regard to 02, realistic expectation in terms of duration of follow up on those five patients? Thank you. .

Thank you, Kevin. So I'm on EVX-01 we have nine patients and we expect to be able to determine the dose that we're going to move forward. But we also expect to have the full readout in logical and clinical on those patients for EVX-01 for the update in late Q2.

For EVX-02 we are basically primarily looking at immunogenicity for a decision of moving into a potential phase two and we'll be expecting to have an immunological picture of our DNA technology in the new epitope space as the foundation for that decision.

As you are probably aware of the EVX-02 is run in Agilent melanoma looking for relapse free survival. So the base decision for potential phase 2 on EVX-02 will be based immunological data. .

Thank you. I'm sorry you largely had more..

Nope, proceed Kevin. .

Okay, and then with 03, can you just walks us through what needs to be completed with regard to and see the support, potential IND filing and reminders how you're thinking about patient population for potential phase 1 for that compound. .

So, our EVX-03 is a DNA, a targeted therapy, basically challenges the antigen presenting cell. We are currently running out tox stories on that program, and everything is running according with plan. So we expect to be ready for the IND filing as we have previously mentioned.

We have not yet chosen the indication for EVX-03 but we will when we are done with the talks, and of course, prior to the IND filing, we'll of course, share the clinical development plan for EVX-03.

And maybe just to add to that new epitope therapists, we have a lot of different indications to choose for the majority of the solid tumors have a lot of mutations and hit our potential candidate for new therapists. And we're doing that exercise analysis as we speak. Thank you. .

And our next question is from [indiscernible]. Please proceed with your questions. .

Thanks for taking my question.

The 01, 02 any color on the timing on your Phase 2 kind of decision and design after you reported the data in the second quarter? Where you started the Phase 2 immediately, quickly or will that take some time? Just any color on the kinetics [ph]?.

Thank you. So we of course, as most other companies also doing we of course, already preparing for potential phase two, we have not communicated any timelines for the phase two. But of course, we plan to move it forward if the data support as fast as possible but no exact data has been shared with the markets yet.

And we'll do so together with the readout..

Okay, understood. And then, your story -- I understand you're still selecting the indication but high levels of design will be like all-commerce [ph] but different have a tumor or selective model with tumors or will be different cohorts for each tumor type.

And accordingly, how do you evaluate the immunogenicity data in different tumor types?.

Yes, that's a good question. So we haven't settled for design yet. And we will probably design the story as a potential phase 1 to that extent into two arms, we've not made a decision if it's one indication or multiple indication at the numbers of arms yet. So I can't share any more details on that.

As you also mentioning, and I think there are some similarities between the tumor types. So you will be able to compare immunological data across tumor types but I will still say there will be noise in the data set like that and preferable if you want to compare immunogenicity want it from the same story in the same tumor much.

But our expectation in these high mutation tumor types is that you will see pretty similar immunogenicity, at least that's what we expect. So that also what will be expect among technologies, even if they aren't different indications as long as they are high mutational burden tumors.

If you go down to some of the very low mutational burden tumors, I would also be a bit concerned on concluding from high mutational burden to low mutational burden to low mutational burden on new epitope therapies. We believe that will be a difference here.

I hope that makes sense?.

Yes, it makes sense. Thanks a lot for answering my questions..

[Operator Instructions] And our next question is from Kevin DeGeeter with Oppenheimer. Please proceed with your question..

Hey, Lars just want to [indiscernible].

What you're thinking about internal investment, RAVEN verses opportunities for third-party funding, whether they be government-related or other entities? And then just kind of -- here from a bandwidth standpoint, just -- how are you thinking about the right way to optimize the learning embedded within RAVEN? Thanks..

Yes, I think it's an excellent question. So the RAVEN platform has always been supported by non-dilutive grants, which basically means that the majority of the research is actually financed by government grants. As most of you are aware of, in cancer the T cell components are pretty similar to the viral space.

So we are, of course, moving very rapidly forward on the viral platform based on all the experience we have from the cancer space. We do believe that they will both need that platform that they will rapidly take not, just Corona but any virus and find the right target.

But also find target that are broadly protective, also when you see mutation and strain mutations within a virus or on viruses. And that's what we're currently building.

So, as we announced the start of this program, we already moved it pretty rapidly forward on the software side and are now of course, starting to test the platform in different preclinical models. And of course, as soon as we have some interesting data, and proof of concept to share, we will of course, share it with everyone. .

Thanks for taking my questions. .

And it looks like we have reached the end of the question-and-answer session. And I now turn the call over to Lars Wegner for closing remarks. .

Perfect, so there are no more questions. So that concludes this call. Thank you all for your interest in Evaxion. And we look forward to speaking again soon. Thank you. .

This concludes today's conference and you may disconnect your lines at this point. Thank you for your participation..