Evaxion Biotech A/S

Greetings and welcome to the Evaxian corporate call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star 9-0 on your telephone keypad. 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 to all. With me on the line today are Per Norlin, Chief Executive Officer, Beau Caremark, Chief Financial Officer, and Vergeet Rono, Chief Scientifica 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 and other documents filed with the SEC. At this time, I'd like to turn the conference over to Per Norlin, 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 across our pipeline and our core AI technologies over the last 15 months, and I will 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 the vaccine 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 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 Evaction 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 EVX01 and EVX02 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, EVX03, and towards the clinic. I'd like to start by highlighting the initial proof of concept clinical trials in melanoma for EVXO1 and EVXO2, and then provide a high-level overview of our newest oncology programs and technology collaborations. EVXO1 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 two early-stage studies in combination with checkpoint inhibitors in adults with a metastatic melanoma. Results of the first trial, a phase 1 slash 2A 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 non-responsive 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 a high response rate. Six out of the nine first patients had an objective response, with two patients actually demonstrated a complete response. This 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. EVX01 progressed to clinical Phase IIb with dosing of the first patient in September last year, and with accelerated progress of a new generation DNA-based cancer immunotherapy, EVX03, we recently made a decision to enroll a smaller number of patients in the Phase IIb study of EVX01, now 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 one slash two A study. We expect to present interim results of this study in the fourth quarter of this year. Moving to EVXO2, we designed this vaccine as a DNA-based personalized cancer immunotherapy, building on our ability to select the right neoantigens as demonstrated with EVXO1. Shifting from a peptide backbone to a DNA backbone, we believe will allow us to shorten production timelines and manufacturing costs for this product. We were extremely happy to share the positive clinical data from our phase one slash two A first human study of EVXO2 during the late break in research session at AACR on April 18th this year. We evaluated EVXO2 in combination with a checkpoint inhibitor Opdivo or nivolumab in patients who had undergone 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 and schedule of eight immunizations with EVXO2 were relapse-free at their last assessment. Of those patients, nine completed the full study and were relapse-free at 12 months, end-of-study visit. One patient discontinued the trial prior to the completion due to a non-EVXO2-related adverse event and was also relapse-free at the last visit, which was at nine months. From a study perspective, we showed that the combination of EVXO2 and Ebola mub was well-tolerated and only mild EVXO2-associated adverse events were observed. From an immunological perspective, robust and long-lasting neoantigen-specific T cell immune responses were confirmed in all patients, all patients who completed the full course of EDXO2 treatment. In conclusion, we were pleased to report that we met both primary endpoints on safety, tolerability, and immunogenicity, and our secondary endpoint on clinical efficacy. With all 10 patients who completed the EBX02 treatment being relapse-free during the trial, and with robust and treatment-specific immune responses, we see clear signs of a treatment effect. The EBX02 data further affirm our ability to select the right new antigens, 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, EVX03. We believe EVX03 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, Observe, 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 ERVs are often expressed in cancer cells, which holds a lot of promise. We have in fact recently demonstrated in preclinical models that ERVs can be used as highly effective targets for cancer immunotherapy. And we have shown that ERVs 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 EBX03 with a genetic immune stimulant 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 EBX03 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 a CTA in the third quarter to evaluate the combination of EVEXO3 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, a vaccine 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 paved the way for collaborations with other mRNA partners. Turning to our infectious disease portfolio, we have two 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 three infectious disease programs. Let's start with the Staph aureus. Our Staphylococcus aureus program, EVXB1, is a four-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 partner-ready program is IND-enabling toxicology studies. For our gonorrhea program, EVXB2, 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 multi-component vaccine candidate with broad efficacy in a panel of 50 gonorrhea strains, which has shown strong protection in preclinical models. Finally, for our vaccine to cytomegalovirus, or CMV. In December of 2022, we announced an exciting joint research collaboration with the company Expression 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. Bo, comment.

Thanks, Pierre. I will post 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 comparisons, please refer to today's press release and our 20F form which we will file today. Starting with our expenses, research and development expenses for 2022 amounted to US dollar 17.1 million. General and administrative expenses amounted to US dollar 8.2 million. Research and development expenses decreased by US dollar 2.5 million, or about 30% compared to last year. The decrease was primarily driven by decrease in external development costs related to EVX01 and EVX02. The decrease was partly offset by increase in personal costs. General and administrative expenses increased by US dollar 1.9 million or 31% compared to last year. This increase was primarily due to US dollar 1.8 million increase in professional fees and expansion of our corporate functions. The next loss for 2022 amount to a loss of US dollar 23.9 million compared to a loss of US dollar 24.7 million for 2021. As of December 31st, 2022, we had US dollar 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 EVX01 phase 1 slash 2A study during the ASCO conference in June. We'll report interim results from the EVX01 phase 2 trial in patients with melanoma in Q4. Also in Q4, we will initiate patient recruitment in a phase one study for EVXO3 in patients with solid tumors and then moving into non-small cell lung cancer. In conclusion, I'm optimistic about the next year for a vaccine. I believe that a vaccine 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 seven 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 Avexion, 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 Roene, Chief Scientific Officer, will join us for the Q&A segment of today's call.

Operator, over to you for Q&A.

Thank you, sir.

Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star and then 1 now. A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove your question from the queue. Again, if you would like to ask a question, please press star and then one now. The first question we have is from Jeff Jones from Oppenheimer. Please go ahead.

Good afternoon, guys, and thank you for taking the question. I guess two quick questions. With the reduced size of the EPX01 study, And the Phase 2 data, the 1-2 data that you'll report out at ASCO. What are the next steps here? Would you proceed with another Phase 2? Or could you move on to typical studies and what are your plans? And then with respect to EVX03, 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? Thank you.

Yes. Thank you so much, Jeff. This is Per. Per Mullen speaking. And basically, if we start with EVX01, as you say, we will report the phase one data in ADASCO in June. and present the first interim data of the phase two trial in Q4. And if I understand it correctly, you asked the 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 EVXO3 program, where we have both genetic immune adjuvant and DNA technology, and including the herbs. So we will use this EVXO1 trial. It's basically to confirm the very promising data we had in the phase one trial. And that was a relatively small trial run at one clinical site. And now the phase two 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 one trial. So just confirming it, it seems it's a major But to your question, it's more likely, of course, it's depending on emerging data, but EDX03 is the primary focus, and that's the most likely way we'll focus our resources after that Phase II trial. On EDX03, then, I think your question was on the cost of that trial. And we are, if you say the total trial, it's a relatively small-sized trial. And we are in the range of, maybe you can help me, is it five million, five to eight million dollars? And that will be distributed over, say, two 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 up front at the end of the year. So, in that range, up to eight million dollars.

Okay, great. Thank you very much.

Thank you.

Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one now. The next question we have is from Richard Ramirez from Red Eye. Please go ahead.

Hello, good afternoon. My first question is, do you expect to reach any non-diluted funding during this year? Or, for example, for an upfront payment?

Yes, so I mean in terms of non-diluted 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 positive upside of course okay and just the last second last question what kind of interests have you seen for the new uh evix3 um erv platform yes thank you richard and that's uh we get a lot of interest from that as you probably most of you know we had a release recently and we are first mover here with a personalized herb technology for personal cancer immunotherapy And we do get a lot of interest, both from companies looking at neoantigen 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 cancer immunotherapy from patients with only hot tumors like melanoma, renal cell cancer, and so on, to actually completely other patient populations with much fewer cancer mutations that can 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.

Okay, that's all for me. Thank you.

Thank you.

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

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

Thank you, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us.

You may now disconnect your lines.