Greetings and welcome to the Evaxion Corporate Call. [Operator Instructions] As a reminder, this conference is being recorded. .

It is now my pleasure to introduce your host, Corey Davis. Please go ahead, sir. .

Thank you, operator. Good morning in the U.S. and good afternoon in Europe. Thank you for joining us today. With me on the line today are Per Norlen, Chief Executive Officer; Bo Karmark, Chief Financial Officer; and Birgitte Rønø, Chief Scientific Officer, who will join us for Q&A.

Today's call will be available for replay as indicated in our press release. .

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 1995.

Because forward-looking statements involve risks and uncertainties, they're 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 20-F and other documents filed with the SEC.

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At this time, I'd like to turn the conference over to Per Norlen, the company's President and CEO. Go ahead, Per. .

Thank you, Corey, and good morning and good afternoon to everyone. I'm pleased to welcome you to today's conference call. During the call, I will provide you with a brief overview of the excellent progress we made over -- across our pipeline and our core AI technologies over the last 15 months, and I'll share our outlook for 2023.

I'll then turn the call over to Bo, who will review our 2022 financial report. Then we will open up the line for questions. .

Before going into our programs, I'd like to spend a few moments on our strategy. I joined Evaxion in October 2022 based on my belief that the company's proprietary artificial intelligence, or AI technology, is world leading and has the potential to generate superior immunotherapies for cancer and infectious disease.

This aligns perfectly with our strategic focus on our leading AI platforms for vaccine target discovery, on our excellence in target validation and on building a pipeline through partnerships. With increased focus and associated organizational changes we've made, we've been able to extend our cash runway into December of this year.

And I want to start by recognizing the performance, dedication and commitment of the entire Evaxion team in setting up the company for success. .

Now I would like to take you through the recent progress in our product development portfolio, starting with oncology. Our program is focused on developing personalized cancer immunotherapies, aiming to substantially improve disease outcomes for patients with advanced cancers. The foundation of our oncology program is PIONEER, the PIONEER AI platform.

PIONEER has enabled us to successfully identify patient-specific, tumor-specific mutations called neoantigens. These neoantigens can be incorporated into personalized drug and be delivered to produce an enhanced antitumor response.

Clinical data from our clinical programs in EVX-01 and EVX-02 have provided important validation for our approach to developing personalized cancer vaccines. .

Building on those learnings, important technology advances and new discoveries have allowed us to advance a third-generation vaccine candidate, EVX-03, and towards the clinic.

I'd like to start by highlighting the initial proof-of-concept clinical trials in melanoma for EVX-01 and EVX-02 and then provide a high-level overview of our newest oncology programs and technology collaborations. .

EVX-01 is our first-generation peptide-based vaccine. It's provided us with proof of concept, that our PIONEER technology can identify the right neoantigens and generate a potent antitumor immune response. We've been evaluating this vaccine in 2 early-stage studies in combination with checkpoint inhibitors in adults with metastatic melanoma.

Results of the first trial, a Phase I/IIa study in 12 patients will be presented at the American Society of Clinical Oncology, or ASCO, in June in Chicago. .

Patients in this study are heavily pretreated, and many are nonresponsive to immune checkpoint inhibitors. As a result, a low treatment response would be expected with current standard treatments such as checkpoint inhibitors. Interim data reported last fall showed that we see high response rates.

6 out of the 9 first patients had an objective response, with 2 patients who actually demonstrated a complete response. These data compares very favorably to results from historical controls, and we are now eagerly looking forward to presenting the full study readout at ASCO in June. .

EVX-01 progressed to clinical Phase IIb with dosing of the first patient in September last year. And with accelerated progress of our new generation DNA-based cancer immunotherapy EVX-03, we recently made a decision to enroll a smaller number of patients in the Phase IIb study of EVX-01, now we intended to enroll up to 20 patients.

The study is conducted in collaboration with Merck, which provides KEYTRUDA, and the objective is still to confirm the results of the Phase I/IIa study. We expect to present interim results of this study in the fourth quarter of this year. .

Moving to EVX-02. We designed this vaccine as a DNA-based personalized cancer immunotherapy, building on our ability to select the right neoantigens, as demonstrated with EVX-01. Shifting from a peptide backbone to a DNA backbone we believe will allow us to shorten production time lines and manufacturing costs for this product.

We were extremely happy to share the positive clinical data from our Phase I/IIa first-in-human study of EVX-02 during the late-breaking research session at AACR on April 18 this year.

We evaluated EVX-02 in combination with a checkpoint inhibitor Opdivo or nivolumab in patients who had undergone a complete surgical resection of late-stage melanoma and were at high risk for recurrence. .

The primary objective of the 12-month study were to assess the safety, tolerability and immunogenicity of the combination as well as to evaluate relapse-free survival. All 10 patients who received the full dose in schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment.

Of those patients, 9 completely full study and were relapse-free at 12 months end of study visits. One patient discontinued the trial prior to the completion due to non-EVX-02 adverse events and was also relapse-free at the last visit, which was at 9 months. .

From a study perspective, we showed that the combination of EVX-02 and nivolumab was well tolerated and only mild EVX-02-associated adverse events were observed. From an immunological perspective, robust and long-lasting neoantigen-specific T cell immune responses were confirmed in all patients who completed the full course of EVX-02 treatment. .

In conclusion, we were pleased to report that we met both primary endpoints on safety, tolerability and immunogenicity and our secondary endpoint of clinical efficacy.

With all 10 patients who completed the EVX-02 treatment being relapse-free during the trial and with robust and treatment-specific immune responses, we see clear signs of a treatment effect.

The EVX-02 data further affirm our ability to select the right neoantigens, match to the cancer of each patient and demonstrates the value of our PIONEER platform. .

Now I'd like to highlight our newest oncology program, the third-generation cancer vaccine, EVX-03. We believe EVX-03 could be a game changer in personalized cancer immunotherapy. This vaccine is also a DNA-based vaccine and contains several exciting improvements.

It was designed to incorporate novel targets based on our new AI platform ObsERV that identifies patient-specific endogenous retroviruses. It may sound surprising, but about 8% of our genes are in fact composed of DNA leftovers from viral infections that happened over the course of human history. .

And such viral fragments or herbs are often expressed in cancer cells, which holds a lot of promise. We have, in fact, recently demonstrated in preclinical models that herbs can be used as highly effective targets for cancer immunotherapy. And we have shown that herbs are often expressed in patients with few tumor mutations.

Based on this discovery, adding personalized herbs to the neoantigen therapy, that may help us to treat cancer patients who are today considered unresponsive to immunotherapy. This is, we believe, the first time that a personalized herb therapy will be assessed in a clinical trial. .

In addition to adding herbs to the program, we have also boosted EVX-03 with a genetic immunostimulant that attracts antigen-presenting cells to the vaccination site and improves the immune activation.

So collectively, we believe these technological improvements will enhance the efficacy of EVX-03 and supported by data from preclinical models showing superior potency compared to products based on standard DNA technologies.

So subject to additional funding, we expect to file a clinical trial application, or CTA, in the third quarter to evaluate the combination of EVX-03 and an immune checkpoint inhibitor in patients with metastatic cancer. Patient recruitment is expected to begin in the fourth quarter of this year. .

Before we switch gears to infectious disease, I'd like to make a note regarding our collaboration with Pantherna. As mentioned before, Evaxion continues to explore technologies that will enhance and support the development and delivery of our product candidates.

In February this year, we announced data from a preclinical study showing that the combination of tumor neoantigens identified by our PIONEER platform and Pantherna's mRNA vaccine delivery technology drove a strong immune response and led to the complete tumor growth inhibition.

This data validated the combination of our vaccine candidates with mRNA platforms and they paveed the way for collaborations with other mRNA partners. .

Turning to our infectious disease portfolio. We have 2 proprietary AI-driven technologies called EDEN and RAVEN to identify novel unique targets or antigens for the development of superior vaccines to prevent bacterial and viral infections. I'm very enthusiastic about our 3 infectious disease programs. Let's start with S. aureus.

Our staphylococcus aureus program, EVX-B1, is a 4-component vaccine for prevention of skin and soft tissue infections and has shown significant protection in validated preclinical models of sepsis and of skin infections. The next step for this partnering-ready program is IND-enabling toxicology studies. .

For our gonorrhea program, EVX-B2, we announced in the fall of 2022 that we, in collaboration with the University of Massachusetts Chan Medical School has received an NIH grant for the development of a lead vaccine candidate.

We are currently developing a multicomponent vaccine candidate with broad efficacy in a panel of 50 gonorrhea strains, which has shown strong protection in preclinical models. .

Finally, [ pro vaccine ] to cytomegalovirus or CMV, in December of 2022, we announced an exciting joint research collaboration with the company ExpreS2ion to develop the next-generation CMV vaccine candidate that elicits both cellular and humoral antibody responses. The initial phase of this collaboration will be jointly funded until 2025.

After that, the parties could expand the research collaboration into development and commercialization agreement. .

Each of these infectious diseases represent a significant global health issue, affecting millions of people around the world and currently lacking effective vaccinations. And for staphylococcus and gonorrhea, antibiotic resistance is increasing fast, making this an extremely hot area.

Our strong data, unique technology platform and market need form the basis of a very attractive preclinical partnering opportunity. .

Now I'd like to turn the call over to Bo Karmark. .

Thanks, Per. I will focus my comments on our financial results for 2022 compared to 2021. All the numbers will be approximate for easy sharing during the call. For additional information regarding our fourth quarter results and prior period comparisons, please refer to today's press release and our 20-F form, which we will file today. .

Starting with our expenses. Research and development expenses for 2022 amounted to USD 17.1 million. General and administrative expenses amounted to USD 8.2 million. Research and development expenses decreased by USD 2.5 million or about 30% compared to last year.

The decrease was primarily driven by a decrease in external development costs related to EVX-01 and EVX-02. The decrease was partly offset by increase in personnel costs. .

General and administrative expenses increased by USD 1.9 million or 31% compared to last year. This increase was primarily due to USD 1.8 million increase in professional fees and expansion of our corporate functions. .

The net loss for 2022 amounted to a loss of USD 23.9 million (sic) [ USD 23.2 million ] compared to a loss of USD 24.7 million (sic) [ USD 24.5 million ] for 2021. As of December 31, 2022, we had USD 13.2 million in cash and cash equivalents.

With the recent cost savings, we expect our cash balance to be sufficient to fund our operations into December 2023. .

Now I would like to turn the call back to Per for a few closing remarks before the Q&A. .

Thank you, Bo. Looking out to the rest of 2023 and beyond, I'd like to highlight a few things. We will present the full readout of the EVX-01 Phase I/IIa study during the ASCO conference in June. We'll report interim results from the EVX-01 Phase II trial in patients with melanoma in Q4.

Also in Q4, we will initiate patient recruitment in a Phase I study for EVX-03 in patients with solid tumors and then moving into non-small cell lung cancer. .

In conclusion, I'm optimistic about the next year for Evaxion. I believe that Evaxion has the potential to develop immunotherapies to substantially improve the treatment of cancer and vaccines to prevent infections that impact the world.

Over the last 7 months as we have refined our strategy and focus, we are invigorated by the data and the promise that our programs can make a difference. On behalf of everyone at Evaxion, I invite you to continue to keep in touch with the company and follow our progress in 2023 and beyond. .

Before I turn the call over to the operator for the Q&A, note that Birgitte Rønø, Chief Scientific Officer, will join us for the Q&A segment of today's call. Operator, over to you for Q&A. .

[Operator Instructions] The first question we have is from Jeff Jones from Oppenheimer. .

I guess 2 quick questions.

With the reduced size of the EVX-01 study and the Phase II data -- I/II data that we reported out at ASCO, what are the next steps here? Would you proceed with another Phase II? Or could you move on to pivotal studies? And what are your plans? And then with respect to EVX-03 and you mentioned needing additional financing to kick those studies off, how much money would you be looking to raise to support that next clinical trial? Or how much money would you need to run the clinical trial?.

Yes. This is Per Norlen speaking. Basically, if we start with EVX-01, as you say, we will report the Phase I data in -- at ASCO in June and present the first interim data of the Phase II trial in Q4.

And if I understand it correctly, you asked a bit of question for the clinical development plan beyond that trial, is that correct?.

Yes. .

Yes. So today, we have -- the focus of the strategy is actually to move more towards our most unique technology, which is in our EVX-03 program, where we have both the genetic immunoadjuvants and the DNA technology and including the herbs. So we will use this EVX-01 trial. It's basically to confirm the very promising data we had in the Phase I trial.

And that was a relatively small trial run at 1 clinical sites. And now the Phase II trial is run at multiple sites in both Australia and Europe and confirming the data in a larger population, even if it's not very large. That's a major objective here since we do have strikingly good data in the Phase I trial.

So just confirming it, it's a major importance. But to your question, it's more likely -- it, of course -- it's depending on emerging data, but EVX-03 is a primary focus, and that's the most likely where we will focus our resources after that Phase II trial. .

On EVX-03 then, I think your question was on the cost of that trial. And we are -- if you say the total -- it's a relatively small size trial, and we are in the range of -- maybe you can help me, is it -- $5 million to $8 million, and that will be distributed over, say, 2 years of time.

So in fact, it's more -- we, of course, need to raise additional capital to start the trial, but we don't need to have the full cover for that trial upfront at the end of the year. So in that range, up to $8 million. .

[Operator Instructions] The next question we have is from Richard Ramanius from Redeye. Please go ahead. .

My first question is, do you expect to reach a nondilutive funding during this year? Or for example, for an upfront payment?.

Yes. So I mean in terms of nondilutive funding, if we talk on the one hand on grants, we are applying for grants, and that is possible, but of course, not something we calculate on. We also have a very active business development discussions. And actually, there's a lot of interest in our early programs.

So we have high hopes of getting additional funds into the company. But again, it's -- that's something we can't control, but it will be really a positive upside, of course. .

Okay. And just the last -- second to the last question.

What kind of interest have you seen for the new EVX-03 ERV platform?.

Yes. Thank you, Richard. That's -- we get a lot of interest from that. As probably most of you know, we had a release recently, and we are first mover here with a personalized herb technology for personalized cancer immunotherapy.

And we do get a lot of interest both from companies looking at neoantigen, that's all -- themselves and from other potential partners. So it's a very promising opportunity here.

And of course, as you know, what we can do is expand the potential target population for immune -- cancer immunotherapy from patients with only hot tumors like melanoma, renal cell cancer and so on. Two is actually complete the other patient populations with much fewer cancer mutations that could potentially respond equally well to immunotherapy.

So it's opening up the field tremendously if it works, and that's what we aim to show. .

Ladies and gentlemen, at this stage, there are no further questions. I would like to turn the floor back over to Per Norlen for closing comments. Please go ahead, sir. .

Yes. So thank you so much for joining this call, and I hope to meet you again in the future. Thank you. .

Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines..