Operator
Operator
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.
Evaxion Biotech A/S (EVAX)
Q4 2022 Earnings Call· Thu, Apr 27, 2023
$4.34
+3.83%
Operator
Operator
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.
Corey Davis
Analyst
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. At this time, I'd like to turn the conference over to Per Norlen, the company's President and CEO. Go ahead, Per.
Per Norlen
Analyst
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…
Bo Karmark
Analyst
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.
Per Norlen
Analyst
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
Operator
[Operator Instructions] The first question we have is from Jeff Jones from Oppenheimer.
Jeffrey Jones
Analyst
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?
Per Norlen
Analyst
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?
Jeffrey Jones
Analyst
Yes.
Per Norlen
Analyst
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
Operator
[Operator Instructions] The next question we have is from Richard Ramanius from Redeye. Please go ahead.
Richard Ramanius
Analyst
My first question is, do you expect to reach a nondilutive funding during this year? Or for example, for an upfront payment?
Per Norlen
Analyst
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.
Richard Ramanius
Analyst
Okay. And just the last -- second to the last question. What kind of interest have you seen for the new EVX-03 ERV platform?
Per Norlen
Analyst
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.
Operator
Operator
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.
Per Norlen
Analyst
Yes. So thank you so much for joining this call, and I hope to meet you again in the future. Thank you.
Operator
Operator
Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.