Good day, and thank you for standing by. Welcome to the Evaxion Biotech Q2 results call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Per Norlén. Please go ahead.
Thank you, operator. Good morning and good afternoon, everyone. I'm Per Norlén, Chief Executive Officer at Evaxion, and with me today is Jesper Nyegaard Nissen, Chief Operating Officer and Interim Chief Financial Officer at Evaxion since August first. First, before we start, a note on forward-looking statements. Let me 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 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, Form 20-F, and the company's current and future reports submitted to the Securities and Exchange Commission, SEC.
With that said, 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 on our core AI technologies over the past six months. I will then, then turn the call over to Jesper, who will review our financial report for the second quarter of 2023. Then we will open up the line of questions. We have a presentation which you can follow. This is slide one. We will start by taking a quick look at today's agenda, which is on slide two. Slide slide. I will start with our recent communication on our Staphylococcus aureus vaccine, EVX-B1, where we were pleased to present preclinical approval concept data showing that the vaccine candidate can clear Staphylococcus infections.
We will also show the early-stage clinical data reported on AACR 2023 and ASCO 2023, indicating that patients treated with our, our vaccines, EVX-01 or EVX-02, in combination with a checkpoint inhibitor, experienced a treatment benefit and with good overall tolerability. Further, I will provide an update on our next generation personalized cancer vaccine candidate, EVX-03, which is approaching the clinic, as well as our novel AI technology ObsERV, that's been used to identify a new source of antigens for personalized cancer vaccines. That's planned for clinical validation through the EVX-03 program. Of course, the financial update with second quarter financial results as presented by Jesper. Let's start with EVX-B1 on slide three. Move to slide three. In late July, we presented novel data on our vaccine candidate for prevention of Staphylococcus aureus disease, EVX-B1, at the Gordon Research Conference in New Hampshire, USA.
The vaccine candidate has been generated using our AI technology. Apart from the protective effect demonstrated in the sepsis disease model, which we have shown previously and that you can see for reference on the left-hand side, we have now assessed the ability of EVX-B2 to clear bacteria from internal organs. If you take a brief look at the graph on the right-hand side, the results are quite clear. No bacteria could be detected in any organs four weeks after a bacterial challenge. The program is currently in late preclinical development. We are in discussions with a potential partner on its future development and commercialization in accordance with our strategy. Now let's switch to oncology and our clinical programs for personalized cancer vaccines. That's slide four.
If you have the right slide in front of you, you should be able to read EVX-01 on the top, and it should show the readout of our clinical phase I, II clinical trial in metastatic melanoma. EVX-01 is a personalized peptide-based cancer vaccine, where patient-specific tumor mutations, so-called neoantigens, are identified using our AI technology, Pioneer. These neoantigens are ideal targets for cancer vaccine, and that they derive from tumor mutations and therefore only exists in tumor cells. Which means that a treatment can become very specific for the tumor with less risk of negative effects on healthy tissue. In the first human trial, 6 biweekly doses of EVX-01 were given in combination with PD-1 therapy. The treatment was well tolerated, and of the 12 patients that completed the trial, eight showed an objective response to the treatment.
If you look, look on the graph on the right-hand side, you should see a horizontal black line indicating the tumor size at the start of treatment. You can see 12 bars, which represents the best objective responses for each patient in the trial. If the bar goes up, tumors increase in size, and if the bar goes down, this means that tumors decrease in size. To our excitement, most bars do actually go down. For eight of the patients, the outcome fulfills the criteria of a treatment response. We're obviously really enthusiastic about these, these results. It's better than what you would expect from PD-1 alone, and it speaks to the strength of our AI technology in selecting the right neoantigens for personalized cancer vaccine. This was EVX-01, but we have also reported data from our DNA-based cancer vaccine, EVX-02. That's on the next slide, slide five.
It should say EVX-02 at the top. This is a clinical trial of EVX-02 in combination with nivolumab, a PD-1 blocker, as adjuvant therapy to prevent cancer relapse after complete surgical resection of malignant melanoma over 12 months. It's a DNA-based therapy. The image shows a DNA plasmid carrying the genes for patient-specific neoantigens. The vaccine is administered as DNA and then translated to neoantigens in the patient. The results look very promising. All 10 patients that have completed the vaccination with EVX-02 were relapse-free at the end of the trial. The vaccine was well tolerated in all patients and induced a neoantigen-specific T cell immune response in all patients, which can be seen as a proof of mechanism for our DNA vaccine technology. We do not plan to develop this vaccine candidate further for the time being. Why, you may ask?
Well, it's because we have already developed a next generation vaccine based on EVX-02, and the new vac candidate is called EVX-03, and which we intend to prioritize. Let's move to slide six. EVX-03 is the first ever personalized ERV cancer vaccine. It builds on EVX-02, meaning that it's a DNA-based personalized cancer vaccine, but it has two major upgrades. One upgrade is the addition of a genetic immune adjuvant, which aims to boost the immune system's immune response to the vaccine. The other upgrade is the addition of a novel vaccine target, so-called ERVs, which I will come back to in a minute. Let's start with a genetic immune adjuvant. This is a chemoattractant molecule, which is incorporated into the DNA plasmid, as shown for EVX-03 to the right of the picture.
EVX-02 is a plasmid on the left-hand side, incorporating DNA coding for neoantigens, whereas EVX-03, on the right-hand side, in addition, incorporates the DNA sequence for the genetic immune adjuvant, which is shown in green. The DNA plasmid is administered to the patient, and the adjuvant, a chemoattractant molecule called CCL19, is produced inside the cells of the patient at the injection site. The consequence of this is that the genetic adjuvant attracts immune cells to the vaccination site, which is thought to make the vaccine much more effective. Preclinical data supporting these claims were presented in detail at our R&D Day in May, and you're welcome to visit those presentations at our homepage. The second upgrade of EVX-03 is on the antigen side. Personalized cancer vaccines are usually dependent on neoantigens, which are created by mutations in the tumor.
This is how the immune system can identify and attack tumors. It's not the only way for the immune system to identify a tumor. Using artificial intelligence, and specifically our novel AI tech, technology ObsERV, we have identified a novel source of tumor-selective antigens that can be used for personalized cancer vaccines, so-called ERVs, which stands for endogenous retroviruses, and which are also included in svh-340 as shown to the right. Let's switch to Slide seven and our novel AI platform, ObsERV. Slide , ObsERV. It's our AI technology for identification of ERVs, and ERVs constitute a novel source of cancer vaccine antigens that may allow effective treatment also patients who are unresponsive to today's cancer immunotherapies. What are ERVs? Well, ERVs are viral DNA leftovers from historical infections throughout human history, and we all have it.
In fact, about 80% of our DNA has viral origin. No need to worry, this DNA is resting and do no harm to us, at least not under normal conditions, where ERVs are under tight control by our genetic machinery. In cancer cells, these control mechanisms often break down, leading to selective expression of ERVs on human cancer cells. These ERVs are, of course, ideal targets for the immune system. The cancer cell basically waves with a red flag saying, "I don't belong here. I'm infected by a virus," and potentially leading to an immune attack. That seems to happen quite regularly. We have recently shown that patients that produce ERVs in their tumors may survive longer.
If you take a look on the left-hand side in this slide, you can see two survival curves in patients with low tumor mutational burden or TMB, which means that there are few tumor mutations. The red line shows the survival in patients with few ERVs, whereas the blue line shows the longer survival in patients with a lot of ERVs, presumably because such tumors with a lot of ERVs, are more likely to be attacked by the immune system, and hence, the better survival. In preclinical models, we have shown that this can be used to make a personalized cancer vaccine that effectively combats tumors. We believe that EVX-03 may be more effective than current vaccines that are based only on neoantigens, and notably, that it can be broadened, we can broaden the target population quite significantly.
Why is that? Why do we think we can broaden the target population? It's because today's immunotherapies are more or less restricted to patients with hot tumors, which are tumors where there are many tumor mutations called, tumors with high tumor mutational burden or high TMB. ERVs seem to be equally highly expressed in tumors with few mutations, or also called cold tumors. These actually make up the majority of all patients' tumors. Potentially, a much larger target population, and we should remember that EVX-03 will contain both neoantigens and ERVs, and also our novel genetic immune adjuvant technology. That's why we refer to EVX-03 as a next generation personalized cancer vaccines with potential for superior effect.
We plan to submit an application for start a phase I clinical trial for EVX-03 in Q4 this year, and expect to be first in the world with a personalized ERV vaccine in patients. In addition to the operational progress, we have recently signed an agreement with the Global Growth Holding Ltd., including financial commitments totaling up to $20 million, available in tranches over the next three years, subject to SEC approval. The financing is intended to cover the company's working capital needs, including the advancement of EVX-03 to phase I readiness, while the actual initiation of clinical activities for EVX-03 are subject to additional funding. This was the updates from the operations. Now I would like to turn the call over to Jesper.
Thank you, Per. I will focus my comments on our financial results for Q2 2023 compared to Q2 2022. All of the numbers that I will review in this discussion will be approximate for easy sharing and during the call. For additional information regarding our second quarter results and prior period comparisons, please refer to the business update and second quarter 2023 financial results, press release, and our Form 6-K, both filed last week. Starting with our expenses, research and development expenses for Q2 2023 amounted to $2.9 million, and general and administrative expenses to $2.7 million for the period. Research and development decreased by $1.2 million, or about 29% compared to the same period last year.
The decrease was primarily driven by a decrease in external development cost of $0.7 million related to clinical trial activities. Further, a decrease was seen in employee-related costs of $0.5 million due to reduced headcount in personnel. General and administrative expenses increased by $0.6 million or 28% compared to the same period last year. The increase was primarily due to an increase of $0.3 million in external costs related to professional fees and overhead, and an increase in employee-related costs of $0.2 million. These increases are due to the timing of funding projects and business initiatives compared to 2022, and the expansion of the organization throughout 2022 to meet the requirements as a listed company.
The net loss for Q2 2023 amounted to a loss of $5.7 million, compared to a loss of $4.8 million for the same period last year. As of June 30, 2023, we have $7.1 million in cash and cash equivalents. We expect our cash balance to be sufficient to fund operations into December 2023. I would like to turn the call back to you, Per, for a few closing remarks before Q&A.
Thank you, Jesper. Now a brief look into the future. Looking into the rest of 2023, we expect to deliver on two important and near-term milestones. We plan to report interim results from the ongoing EVX-01 phase II trial in patients with metastatic melanoma in Q4 this year, and also in Q4, to submit a clinical trial application to start a phase I study for EVX-03. As mentioned before, this is subject to additional funding in the range of $5 million-$10 million secured before initiation. In conclusion, I'm very happy about the progress and believe we have potential to develop vaccines that may truly improve the treatment of cancer, as well as the prevention of infectious disease around the world.
On behalf of everyone at Evaxion, I invite you to continue to stay in touch with the company and follow our progress in 2023 and beyond. Operator, over to you for Q&A.
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take the first question. From the line of Thomas Flaten, please state your company name and ask your question.
Yeah. Hey, guys, this is Thomas from Lake Street. A couple quick questions. Per, you mentioned in your prepared remarks that you were discussing the Staph aureus program with a partner. Has a deal been struck there, or is this part of a partnership discussion for a deal yet to be announced?
Say that again, what was the question? If we already have announced the partner or?
Well, you mentioned that you were discussing with a partner the future for the Staph aureus program. I was curious if there was a partnership that had already been struck, or is this with...
No
a potential partner?
Yes. Thank you for that question, Thomas. Yes. Sorry if that was confusing. Yes, I would refer to our strategy for these infectious disease programs, which is to find partnerships quite early. We are in partnership discussion on some of our assets and including this product, and we have not yet announced a partnership, so that will be done in due time when a partnership is in place. We do not have, we have not signed a partnership yet.
Got it. Then for the EVX-01 readout in the fourth quarter, I believe last time, last quarter, you thought that you might have up to 20 patients in that readout. Do you have any updates for us on how many patients you expect to have and what format that release will come in, press release versus scientific meeting?
Yes. We intend to present the interim data at the end of this year, at the one of the important, well, cancer conferences. SITC could be one such conference, but it's yet to be finally determined. We expect to present data from the first, say, handful of patients. As you say, we have recruited patients, but we have also reduced the size of the trial. Currently it looks to be slightly less than 20 patients, the exact number of patients to be determined. As you say, we will report the first handful of patients towards end of the year at the conference
Excellent. Then just 1one final one. The cash runway into the fourth quarter, does that depend on additional use of the ATM or the Lincoln Park facility, or can you get into December using the $7.1 that you had at the end of June?
Yeah, that's correct. That, the runway is currently communicated without the assumption that we get additional funding.
Excellent. I appreciate you taking the question. Thank you.
Thanks so much.
Thank you. We will now take the next question from the line of Ahu Demir. Please state your company name and ask your question.
Good morning and good afternoon. I am Ahu Demir, calling from Ladenburg Thalmann. Two questions from us. One follow-up to Thomas's question about EVX-01 phase II studies. How many of the patients are in the, priming stage? Are all patients are the, in the priming stage versus boosting stage? Do you plan to follow up these patients and continue with the boosting stage as well?
Yeah. To the trial, and as you referred to, thank you, Ahu, for the question. We have, this is a trial where we combine with PD-1, and we, which is, given to the patients the first 3 months, and then they continue, and then we give the vaccine in combination. We have initiated the vaccine treatment with EVX-01 in a bit more than 12 patients, and we are expecting to administer the vaccine to the last few patients quite soon. It's, it's all more or less closing in on the number of patients we, we have in the trial. Sure. Did that answer your question?
All the patients will actually have the boosting, basically. It will be, as I understand, between week 12 to 24, you have the priming section. These are the patients you have a much longer follow-up?
Ah, yes, sorry. Now I understand. Yes, we, we do not know that yet, of course. It's quite a lot of patients has been entering the trial during the spring, so we are not yet there where we will know if they will go into the next phase of boosting. That is the plan for patients if they stay on the trial and if, they are not progressing, that they will be offered boosting.
I see. All the patients will see end of this year will be at the priming stage, basically. Is that-
Yeah, that, that will be the date that we will present at the end of this year. Yes.
I see. Okay. Helpful to know. My second question is on the HERVs. This is something relatively new compared to neoantigen approach. I am curious, how do you select your HERV? How specific are they among patients or within an indication? Just curious if you could elaborate on the HERV side.
Yes. I, I can give some more background. There's a lot of HERV DNA in all humans, and as, as I said before, they- these are more or less randomly expressed in some cancers when the control machinery breaks down. There seem to be around, say, 10 or 20,000 different HERVs that can be expressed. Finding, they are very different from each, from patient to patient. That said, there are sometimes in some patients there could be overlapping HERVs. We are in this trial looking for producing a fully personalized vaccine towards HERVs. That's really where we are unique. These HERVs they are selected based on likelihood to induce a strong immune response.
Given that they are relatively long, foreign peptides, there can be actually quite large number of epitopes on each HERV. We can find very, so say high quality antigens, whenever we find strong expression of these ERVs in patients. It's based more or less in the same way, as you when you select the neoantigens, that you look for, how well they match the immune system of that patient. You need to predict the shape of the patient's immune receptors and also the shape of the epitopes on the ERV, and then how likely they are to adhere to one another. That is one of the key factors we look at, but there are many more aspects to it.
Got it. Thank you very much for taking my call.
Thanks so much, Erin.
Thank you. We will now take the next question. It comes from the line of Swayampakula Ramakanth, Ramakant. Please state your company name and ask your question.
Thank you. This is R. K. from H.C. Wainwright. Good afternoon, Per Norlén. A quick question on EVX-01. On the phase I portion of that study, you had presented some interim data on the 9 patients. Is there going to be additional data in the next update that you're going to be presenting at the end of this year? Or is it mostly going to be initial data from the phase II portion of the study?
u, R. K., for that question. So, at ASCO this year, we presented the full data set. So as you mentioned, we previously have shown interim data from nine patients, but at ASCO in June, we presented. And the slide that's in the presentation today is actually on 12 patients, which is a full patient set, where we do have sight responders. So there we have already presented the data. We will likely publish this more scientific details later on, but we don't intend to present additional clinical outcome data on this program. So that's already final.tertain
At the end of this year, we will focus on the interim data of the phase II trial, which is a slightly different design, and it's then sites in Australia and in Europe, so it's a multicenter trial.
Very good. Then on the ERVs, I'm just trying to understand a little bit more on the ERV. Are the ERVs expressed uniquely based on the patient, or are they expressed uniquely based on the indication?
Yeah, that question I would say is uniquely based on the patient. We think there could be some overlaps sometimes depending on the cancer, and maybe if you reason around how they're expressed, if the sort of, if there is a signal to express a certain part of the genes in a patient, then, if that signal is common between patients, there may be an overlap between those ERVs. Usually, the expression of those is completely independent. To answer your question a bit more simply, we think it's highly patient specific, but with the potential to find some overlap.
We are not looking for overlap in the first trial, so there it's fully personalized, but, it's possible that you can find a subpopulation where there is some overlap, and you can produce a common drug for several patients.
One last question on the ERV again. Is there a certain threshold in terms of expression of the ERV for you to make a personalized vaccine against it? Or, you know, how are you-
Yeah, and that's a very good question, I think, because, this is really the key challenge with neoantigens, that you need a lot of mutations in order to find enough high-quality neoantigens to make a vaccine. That's really why personalized cancer vaccines today are restricted to, say, melanoma, a few more indications, lung cancer, and so on. In other indications where there are few mutations, maybe it's just a few percent of the patients where you can actually make a personalized neoantigen vaccine. With ERVs, we find a slightly different profile. It's not the same indications where they're highly expressed. It's often expressed in patients with cold tumors. It really allows for treating, making a cancer vaccine for patients with a completely cold tumor without any neoantigens. In EVX-03, we actually plan to do both.
We will sequence the tumor, and if they have good neoantigens, they will-- this will be included in the vaccine, and then it will be complemented by strong ERVs at the same time. So we try to pick the best from both worlds, and hopefully, we can also expand the page target group quite significantly.
Thank you. Thanks for taking all my questions.
Thank you so much, R.K.
Thank you. Once again, as a reminder, if you wish to ask a question, please press star one and one on your telephone keypad. That's star one and one, if you wish to ask a question. There are no further questions at this time. I would like to hand back over to Per for final remarks.
Okay. Thank you, everyone, for joining, and thank you for all the questions, and we look forward to stay in touch. Thank you. Bye. Bye.
That does conclude our conference for today. Thank you for participating. You may now disconnect.