Evaxion Biotech A/S (EVAX) 2022 Q1 法說會逐字稿

Greetings, and welcome to Evaxion Biotech First Quarter 2022 Earnings Call. (Operator Instructions) 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 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. So 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 IIb 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 I/IIa clinical trial for our second cancer therapy, EVX-02. And we are advancing this product candidate into a dedicated Phase IIb 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 possibly 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 '22, we received regulatory clearance to initiate our Phase IIb 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 '22. Also in January '22, we completed recruitment for our Phase I/IIa clinical trial for EVX-02, advancing into a dedicated Phase IIb clinical adjuvant trial in patients with resectable melanoma, and plan to file for regulatory clearance in patients with resectable melanoma by the first half of '22 and have 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're also progressing on our lead candidate on the EDEN platform, which generate vaccines against bacteria 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 '22.

Furthermore, we plan to select the first vial candidate from our RAVEN platform in the second half of '22. Outside of the clinic, we announced publications on personalized therapy with EVX-01 in patients with metastatic melanoma in the open-access, peer-reviewed medica science journal, OncoImmunology. Evaxion also hosted a Key Opinion Leader webinar, which acclaimed expert on the metastatic melanoma and personalized cancer immune therapies.

This concludes our business and operation update for Q1 2022. I will now turn the call over to Jesper for our first quarter '22 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 USD 7.8 million gross proceeds from our European Investment Bank loan. As of March 31, 2022, cash and cash equivalents were USD 31.4 million as compared to USD 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 USD 4.8 million for the quarter ended March 31, 2022, as compared to USD 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 head count.

General and administrative expenses were USD 1.6 million for the quarter ended March 31, 2022, as compared to USD 1.3 million for the quarter ended March 31, 2021. The increase was primarily due to an increase in external cost.

Net loss was USD 5.8 million for the quarter ended March 31, 2022, or a USD 0.25 loss per basic and diluted shares as compared to USD 4.1 million or USD 0.23 loss per basic and diluted shares for the quarter ended March 31, 2021. And 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.

(Operator Instructions) Our first question is from the line of Kevin DeGeeter with Oppenheimer.

Great. Appreciate the update today. I guess 3 questions from us. First, Lars, how should we think about a potential timing for an update on the Phase IIa EVX-01, specifically in the context of durability of response for the patients previously dosed?

Thank you, Kevin. So as you know, we presented the first data readout on our EVX-01 Phase I/IIa in July of '21. And we were very happy with the results. We, of course, continuously 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 9 months to actually have that data available. But 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, very durable responses. And of course, we want follow them for a significant time period. I hope that answered the question, Kevin?

Yes. And then our second question really is around the initiation of the EVX-01 Phase IIb study. How should we think about number of sites being opened initially for that study and some of the earlier metrics or targets for pace of enrollment?

Yes. Good question. So we are already very far, as you can probably see from our announcement with the Australian authorities. We have experienced 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 this half, first half of '22. And 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 are targeting to open up more than 10 to 12 global sites, but we are aiming to work with the larger sites such as we're doing in Australia with the National Institute of Melanoma, basically size that has large patient recruitment base. So we expect around 10 to 12 in total of sites across the globe to be able to recruit for our Phase IIb trial. And everything is moving according to plan.

Great. And then just lastly for us, and 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 02 into IIb study? How should we think about future investment into 03?

Yes. Both are based on our DNA technology. And to be pretty clear, they're both DNA based on the PIONEER platform. And we're currently getting data on both programs. Our EVX-02 just finalized recruitment. And also -- we also recently, actually yesterday announced that all own manufacturing process are actually run according with plan, which is quite an achievement for a company making personalized medicine and unique products for each patient. We are thinking about if we want to 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. So as soon as the final design is finalized for the Phase IIb, we will be sharing that with the market. But 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.

Our next question is from Ahu Demir with Ladenburg.

I have 2 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 time line? And maybe you could update us on EVX-03 as well.

Thank you, Ahu. Excellent question. Yes, so 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. We are actually already now capable of manufacturing dedicated and personalized medicine in 10 to 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 03 future trials because the manufacturing process needs to be controlled and fast to have a high likelihood of success in the clinic. So we're very happy with actually being able to manufacture for all patients in our trial. So it basically creates a foundation and experience to be able to execute well on a Phase IIb with both EVX-02 and potentially EVX-03.

Very helpful. My second question is on the Personalis ImmunoID NeXT Platform. I know you plan to implement that. When are we expecting to see data? And maybe a bit more color what it would include would be very helpful.

So just to clarify around the [AIB] platform, our prediction platform, right? Did I hear correct?

ImmunoID, I think that's for the biomarker part. That's what I understand.

Yes. So as we also shared previously with the market, based on the macro environment and expression profiles around the new system, our AI system is actually capable of selecting which patient will actually react to immunotherapy, both our's 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. So 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, for a very long time. That's basically -- our plan is quite simple. So first of all, we'll, of course, be collecting data for our existing trials and future Phase IIb. But 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.

And that we expect to materialize during this year. So that means 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.

Our next question is from Thomas Flaten with Lake Street.

Just 2 for me. Now that the enrollment is complete in EVX-02, optimistically, when do you think would be the first time we could see a data readout on that?

So 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. So we will have to follow the patients for a number of months before we start giving 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 would be the safety, hematological 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 this therapy.

So in '22, more immunological safety data, clinical efficacy, we expect to be able to share that on this cohort of patients in '23.

Great. And then with respect to the regulatory submissions for 01 in the EU and the U.S., could you just give us some sense of which 1 will be first and when we might expect those?

Yes. So we're not guiding on the exact dates for it, but I can share with everyone that the process is moving according with what we planned. We are expecting first in EMA and started up in Europe and then FDA. And high-level time lines would be one of these for basically each quarter. So 2 to 3 months apart, we will start up new sites and new jurisdictions for that trial.

And then, finally, the legal proceeding with SSI around CAF09. 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. So 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 CAF09 as adjuvant for this therapy. The only discussion we currently have around SSI. We already have a license to CAF09, so it's not really something that will block any of our (inaudible) regardless of how this actually ends up. What we are not agreeing on is who has the inventorship on using CAF09 broadly in high dose. So 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 want to grab it. But it will have no impact on our EVX-01, not previous collaboration or the Phase IIb or our possibility to utilize this commercially regardless of the outcome as we have a license to CAF09 already with SSI.

I think this concludes the Q&A session for today. I'll hand it over to the operator, and I want to 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.