Greetings, and welcome to Evaxion Biotech first quarter 2022 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Corey Davis of LifeSci Advisors. Please go ahead, sir.
Thanks, Peter. Hello, everyone, and thanks for joining us. I'd like to remind everyone 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 prospectus filed on November 5, 2021, and the company's current and future reports are filed with or submitted to the Securities and Exchange Commission. At this time, I'd like to turn the conference call over to Lars Wegner, the company's President and CEO. Please go ahead, Lars.
Thank you, Corey, and good morning to everyone. Thank you for joining us for this Evaxion Biotech's Q1 earnings call. I'm Lars Wegner, Chief Executive Officer of Evaxion. With me today is Evaxion's Chief Operating Officer, Jesper Nyegaard Nissen, who is currently Interim Chief Financial Officer. We'll give you a short presentation on our business and results, and then open the call for your questions.
Let me begin by saying Evaxion continues exciting clinical momentum in the first quarter of 2022, progressing our lead cancer therapy towards a new Phase 2B clinical trial. The upcoming trial will combine EVX-01 with Merck's KEYTRUDA for treatment of patients with metastatic melanoma, a condition for which there is significant unmet medical need.
We also completed recruitment for the Phase 1/2 A clinical trial for our second cancer therapy, EVX-02, and we are advancing this product candidate into a dedicated Phase 2 B clinical trial in patients with resectable melanoma. We believe that these are significant steps forward for Evaxion in our pursuit to use our existing pipeline of cancer therapies to improve the treatment landscape in melanoma and possible other cancers as well.
We are also actively discussing potential partnerships with pharmaceutical and biotech companies, and we are optimistic about achieving solid progress on this during 2022. In January 2022, we received regulatory clearance to initiate our Phase 2 B trial of EVX-01 with Merck's KEYTRUDA. We plan to have the first patient first visit for EVX-01 in the first half of 2022.
Also in January 2022, we completed recruitment for our Phase 1/2 A clinical trial for EVX-02, advancing into a dedicated Phase 2 B clinical adjuvant trial in patients with resectable melanoma. We plan to file for regulatory clearance in patients with resectable melanoma by the first half of 2022 and have our first patient first visit in by the second half of 2022.
The EVX-01/02 and 03 products all come from our PIONEER AI platform, which generate patient-specific cancer immune therapies. We believe that our AI models allow us to identify unique drug targets which may translate into a higher likelihood of clinical success. We are also progressing on our lead candidate on the EDEN platform, which generate vaccines against bacterial diseases. The program EVX-B1 is a vaccine for the prevention of Staph aureus in skin and soft tissue infections.
We also plan to select our second bacteria product candidate in the second half of 2022. Furthermore, we plan to select the first viral candidate from our RAVEN platform in the second half of 2022. Outside of the clinic, we announced publications on personalized therapy with EVX-01 in patients with metastatic melanoma in the open access peer-reviewed medical science journal, OncoImmunology.
Evaxion also hosted a key opinion leader webinar with acclaimed expert on the metastatic melanoma and personalized cancer immune therapies. This conclude our business and operation update for Q1 2022. I will now turn the call over to Jesper for our first quarter 2022 financial review.
Thank you, Lars. In the first quarter of 2022, we completed a drawdown and received our first tranche of EUR 7 million or $7.8 million gross proceeds from our European Investment Bank loan. As of March 31, 2022, cash and cash equivalents were $31.4 million as compared to $32.2 million as of December 31, 2021.
We expect our existing cash and cash equivalents, combined with funds from the draws on amounts available under our EIB loan, will be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 12 months. Research and development expenses were $4.8 million for the quarter ended March 31, 2022, as compared to $3.9 million for the quarter ended March 31, 2021.
The increase was primarily due to an increase in employee-related costs as a result of a higher headcount. General and administrative expenses were $1.6 million for the quarter ended March 31, 2022, as compared to $1.3 million for the quarter ended March 31, 2021.
The increase was primarily due to an increase in external costs. Net loss was $5.8 million for the quarter ended March 31, 2022, or a $0.25 loss per basic and diluted shares, as compared to $4.1 million or $0.23 loss per basic and diluted shares for the quarter ended March 31, 2021. Back to you, Lars.
Thank you, Jesper. That concludes our presentation today. Now it's time to open up the call for any questions, and I hand it over to the operator to facilitate this.
Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue.
You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question is from the line of Kevin DeGeeter with Oppenheimer. Please go ahead.
Great. Appreciate the update today. I guess three questions from us. First, you know, Lars, how should we think about a potential timing for an update on the Phase 2A EVX-01, specifically in the context of durability of response for the patients previously dosed? Thanks.
Thank you, Kevin. As you know, we presented the first data readout on our EVX-01 Phase 1/2 A in July 2021, and we were very happy with the results. We of course continue to following up on these patients and we will be looking at the durability of the response.
We would be expecting within the next half to nine months to actually have that data available. Since of course it's durability, it do take time and of course we can't predict that timing as we have had some patients in that study that had very durable responses and of course we want to follow them for a significant time period. I hope that answered the question, Kevin.
Yes. Our second question, you know, really is around the initiation of the EVX-01 Phase 2B study. You know, how should we think about number of sites being opened, you know, initially for that study and some of the earlier, you know, metrics or targets for per pace of enrollment?
Yeah. Good question. We are already very far, as you can probably see from our announcement, with the Australian authorities. We have experience running melanoma trials there as our EVX-02 trials run there. We're working with the lead sites in Australia, and we expect that we will be starting the recruitment in the first half of 2022.
We'll start out in Australia with multiple sites, and then we'll build on as we achieve regulatory clearance in Europe and U.S. to open up multiple sites. We're targeting to open up more than 10-12 global sites, but we are aiming to work with the larger site, such as we're doing in Australia with the Melanoma Institute Australia.
Basically sites that has a large patient recruitment base. We expect around 10-12 in total of sites across the globe to be able to recruit for our Phase 2B trial. Everything's moving according to plan.
No. Great. Then just lastly from us, then we'll join the queue. Can you provide an update on EVX-03, particularly in the light of, the comments that you're advancing, you know, EVX-02 into 2B study? You know, how should we think about future investment into EVX-03?
Yeah, both are based on our DNA technology. To be pretty clear, they are both DNA based on the PIONEER platform, and we're currently getting data on both programs. Our EVX-02 just finalized the recruitment, and also we also recently actually yesterday announced that all manufacturing processes are actually running according to plan, which is quite an achievement for a company making personalized medicine and unique products for each patient.
We are thinking about if we wanna speed up EVX-03 in the light of the EVX-02 data, and we are receiving data on both these programs on a continuous basis. As soon as the final design is finalized for the Phase 2B, we will be sharing that with the market. We're quite happy actually with the progress of EVX-03. In our preclinical model it seems to be even more powerful than EVX-02.
Thanks for taking our questions.
Anytime.
Thank you. Our next question is from Ahu Demir with Ladenburg. Please go ahead.
Good morning. Thank you very much for taking my questions. I have two questions. First one, yesterday you announced the production of EVX-02 update. Could you provide more color on what was achieved? What is the production timeline? Maybe you could update us on EVX-03 as well.
Thank you, Ahu. Excellent question. Yeah. EVX-02, as many on this call are probably aware, is our DNA technology. We already successfully set up personalized manufacturing process for our peptide technology in EVX-01. EVX-02 is a different process.
W e are actually already now capable of manufacturing dedicated and personalized medicine in 10-12 weeks with the DNA in our first trial. We expect that we will continuously improve the speed. This is, of course, super important in the planning of our EVX-02 and EVX-03 future trials because the manufacturing process needs to be controlled and fast to have a high likelihood of success in the clinic. We're very happy with actually being able to manufacture for all patients in our trial.
It basically creates a foundation and experience to be able to execute well on a Phase 2B with both EVX-02 and potential EVX-03.
Very helpful. My second question is on the personalized ImmunoID NeXT platform. I know you plan to implement that. When are we expecting to see data? Maybe a bit more color, what it would include would be very helpful.
Just to clarify, around the AI platform, our prediction platform, right? Did I hear correct?
ImmunoID, I think that's for the biomarker part. That's what I understand.
Yeah. As we also shared previously with the market, based on the microenvironment and expression profiles around the immune system, our AI system is actually capable of selecting which patient will actually react to immune therapy, both ours and checkpoint inhibitors. That's what we've seen with the data we have had available from our current clinical trial.
That's of course not a huge number of patients. What we're doing now to validate this, because if we can validate this, we definitely have a product that the world has been looking for a very long time. That's basically our plan. It's quite simple. First of all, we will of course be collecting data for our existing trials and future Phase 2B.
We're also working with different groups that are already running clinical trial where we could get a lot faster access to that data already that we expect to materialize during this year. The minute we have enough data to validate this on a larger external database, it's of course something we're looking very much forward to both publish but also share with the world, as a lot of diagnostic companies have been looking for technologies like this.
Sounds great. Thank you very much for taking my question.
You're welcome.
Thank you. Our next question is from Thomas Flaten with Lake Street. Please go ahead.
Hey, good morning. Thanks for taking the question. It's just two for me. Now that the enrollment is complete in EVX-02, you know, optimistically, when do you think would be the first time we could see a data readout on that?
that we expect to be able to share next year. As you know, this is in the adjuvant melanoma setting, which really means we are looking for relapses, right? That's people that actually after operation and receiving our therapy together with the standard of care, how many actually relapse? That do take some time in this setting. We will have to follow the patients for a number of months before we start getting events, so we can share interesting clinical data.
What we will be sharing and already have been sharing and also will share more data around will be the safety, immunological profiling, et cetera, and are people actually reacting to the therapy by creating a strong T-cell response, which we've seen in patients so far, but we still, of course, have patients that are going in and getting the therapy. In 2022 more immunological safety data clinical efficacy, we expect to be able to share that on this cohort of patients in 2023.
Great. With respect to the regulatory submissions for EVX-01 in the EU and the U.S., could you just give us some sense of which one will be first and when we might expect those?
Yes. We're not guiding on the exit dates for it, but I can share with everyone that the process is moving according to what we planned. We are expecting first in EMA and start it up in Europe and then FDA. High-level timelines would be one of these for basically each quarter. Two to three months apart, we'll start up the new sites and new jurisdictions for that trial.
Finally the legal proceeding with SSI around CAF09b. Could you just maybe provide some color around that if there's any material risk to the conduct of the studies?
No, there's not. This is a minor part of one of our program, our EVX-01 program, which consists of the PIONEER platform, our peptides, and then we use CAF09b as adjuvant for this therapy. The only discussion we currently have around SSI, we already have a license to CAF09b, so it's not really something that will block any of our activity regardless of how this actually ends up.
What we are not agreeing on is who has the inventorship on using CAF09b broadly in high dose. It's a small part of that. We're a bit surprised that they went in that direction, but of course we are also happy that our inventions are so attractive that other people wants to grab it.
It will have no impact on our EVX-01, not previous collaboration or the Phase 2B or our possibility to utilize this commercially. Regardless of the outcome, as we have a license to CAF09b already with SSI.
I appreciate you taking the question. Thank you so much.
No problem. Thank you.
Thank you.
Concludes Q&A session for today. I'll hand it over to the operator, and wanna thank everyone for your time.
Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.