Earnings Call Transcript - EVAX Q3 2025

Operator, Operator

Hello, and welcome to the Evaxion Business Update and Third Quarter 2025 Financial Results. Please be advised that today's conference is being recorded. I would now like to hand over to Birgitte Rono, Interim CEO and CSO. Please go ahead.

Birgitte Rono, Interim CEO and CSO

Thank you. Good morning and good afternoon, and thank you all for joining our Q3 2025 business update and financial results conference call. I'm Birgitte Rono, Chief Scientific Officer and Interim CEO of Evaxion. I'm joined today by Thomas Schmidt, Chief Financial Officer; and Mads Kronborg, Vice President of Investor Relations and Communications. I'll begin by walking through the agenda for today's presentation. I'll start with a brief introduction, followed by an R&D update, and then Thomas will present the Q3 financial results. And lastly, after a few conclusive remarks, we will open for questions. I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risks and uncertainties, and actual results may differ materially. First and foremost, I'm pleased to welcome Dr. Helen Tayton-Martin as the new CEO of Evaxion effective November 24. Dr. Tayton-Martin brings extensive biotech leadership, fundraising, and partnership experience. Helen co-founded Adaptimmune and has held several senior executive roles in Adaptimmune. Helen holds a PhD in molecular immunology and an MBA, and with more than 30 years of experience in early research through project approval, Helen is an ideal candidate to lead the next stages of Evaxion's strategy. This also means that I will return to my previous role as CSO and with Helen's transition from Director in the Board to CEO, Jens Bitsch will join the Board as an adviser and observer with the intention to seek election at the next AGM. Since the last business update, we have made several significant achievements. Historical in-licensing of EVX-B3 by MSD, providing significant cash and validation. The evaluation period for EVX-B2 has been extended. We have several ongoing partnership discussions, though market uncertainty affects the deal climate. We have presented two-year clinical efficacy data for EVX-01 at the ESMO Congress, and we have added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia to our pipeline. Further, we have expanded our AI-Immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time. Lastly, we have strengthened our financial position, and we now have a cash runway extended to the second half of 2027. This is based on a $7.5 million option exercise fee received from MSD and additional capital market funding sources, and Thomas will share details around this. As mentioned, one of the main highlights of the quarter is the MSD transformative deal. On September 25, it was a historical moment for a vaccine with MSD or Merck exercising their option on EVX-B3. This was the first ever in-licensing of an AI discovered vaccine candidate by a major pharma company. The $7.5 million exercise fee extends our cash runway significantly. The deal confirms our strategy of value creation through partnerships even with industry giants like MSD. It also validates our AI-Immunology and R&D pipeline and further ensures the development of EVX-B3 without cost for Evaxion. Not related to the EVX-B3 deal, the EVX-B2 evaluation period has been extended. 2025 is shaping up to be a pivotal year for Evaxion. We have achieved several key milestones since the last business update. As mentioned, MSD exercised the option on EVX-B3. We presented two-year clinical outcome data from our EVX-01 Phase II study, and we have announced the addition of EVX-04 to our pipeline, which is the lead candidate for our precision cancer vaccine. Looking ahead, we are expecting to provide further R&D and business development updates. Let's shift focus to our recent R&D and AI-Immunology progress. EVX-04 is our novel AI designed cancer vaccine candidate targeting nonconventional antigens from the dark genome, specifically expressed in cancers dormant in normal tissue, making them an attractive target. EVX-04 aims to induce immune control in acute myeloid leukemia, where relapses remain a major challenge. The vaccine is based on our AI-Immunology platform, leveraging our discovery engine to identify multiple tumor-specific epitopes that match the expression profile and immune characteristics in patients. We have designed the lead candidate and conducted preclinical studies. Next steps include GMP manufacturing and additional IND-enabling studies to prepare for a first-in-human study. With EVX-01 selected as our lead vaccine candidate, the program has been added to our pipeline. Further changes include the removal of the EVX-02 program as we do not have any active development ongoing for this program. The EVX-02 vaccine serves as proof-of-concept for DNA delivery of neoantigen and has informed the design of both EVX-03 and 04. Our lead program, EVX-01, is a personalized cancer vaccine that includes multiple patient-specific targets, called neoantigens, identified with our AI-Immunology platform from patient tumor material. EVX-01 is administered alongside pembrolizumab, an immune checkpoint inhibitor to enhance clinical efficacy. In October, we presented two-year clinical outcome data from our Phase II trial in an oral session at the ESMO Congress. The results are highly encouraging and were well-received by the scientific and medical community. We reported a 75% overall response rate. Additionally, 11 out of 12 patients that responded had a sustained response at the two-year mark. We also noted a 34% conversion rate, signifying that patients with stable disease or a partial response deepened their response upon EVX-01 treatment. We find the clinical outcome data very encouraging, which we believe compares favorably to historical pembrolizumab monotherapy data. Equally encouraging is the strong immunological activity of EVX-01, critical for long-term efficacy. In all patients treated with EVX-01, we observed a neoantigen-specific T cell response. Assessing individual neoantigen immune responses, we demonstrated that 81% of the vaccine neoantigens administered were immunogenic. This high hit rate provides strong evidence of the predictive power of our AI-Immunology platform, and immune responses were sustained throughout the two-year trial period. Even after dosing ended, T cell activity remained high, indicating lasting immune memory essential for preventing relapses and achieving long-term control of melanoma. This reinforces the potential of EVX-01 as a personalized immunotherapy that drives tumor shrinkage alongside standard care, while also establishing a robust immune defense. Our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and accelerating development timelines. It allows us to optimize vaccine candidates with high precision for both new and approved vaccines. The process is now fully automated, from data input to candidate generation, ensuring optimal sequencing and confirmation of vaccine targets. This new module expedites vaccine development while reducing costs compared to traditional methods, integrating seamlessly with downstream processes that support a smooth transition from design to production. The design module has already been applied in key R&D projects. From identifying regions of an antigen that can be expressed, we realized that the full length of a particular antigen could not be expressed due to solubility constraints. However, with the new module, we determined truncated variants of the antigens could be expressed, facilitating preclinical evaluation. We can also predict the most optimal vaccine target sequences based on antigen protein structure, helping to rescue HER2 express proteins that would otherwise require labor-intensive trial and error design approaches to find expressible constructs. This new design module positions us at the forefront of AI-driven vaccine innovation, enabling faster transition from target discovery to final product candidate. In summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. We look forward to updating you as our programs continue to advance. With that, I would like to give the word to Thomas to present the financial results.

Thomas Schmidt, CFO

Thank you, Birgitte. I am happy to present the financial results for the quarter. Let me start with an overview of the achievements that we have done throughout the year up until now based on the strong execution of our financial strategy. Throughout the year, we have undertaken a number of capital market activities, highlighted by our agreement with the European Investment Bank on debt conversion and the MSD out-licensing of the EVX-B3. Up until the end of October, we have completed activities totaling $31.8 million, all contributing to strengthening our equity and extending our runway into the second half of 2027. We've had a strong quarterly performance. The cash runway has indeed been extended to the second half of 2027. In the quarter, we saw the option exercised by Merck, which not only provides cash income now but also has potential future revenue income of up to $592 million. We are currently on track to meet our financial targets for the full year. We have solidified our equity through the European Investment Bank debt conversion and MSD income. On the profit and loss side, revenue from MSD significantly drives the operational gain, which is our first for the quarter. Importantly, we also managed our operating expenses well, keeping them slightly below last year and at the same level as the previous quarter. We expect to achieve around $14 million in operating cash flow for the year. The net financial contribution this quarter stands at $1.3 million, driven by the debt conversion completed in July at an 89% share price premium at the market close July 10. This premium is recorded as financial income for the quarter, bringing the total income for the quarter to $4.6 million. On the balance sheet front, we have continued to execute well, improving our equity, which totaled $16.6 million at the quarter's end. Our equity includes a derivative liability with a net impact of $1.5 million stemming from our public offering in January and the investor warrants from that date. In October, we have seen warrant exercises totaling $2.7 million, which means by the end of the year, the net impact of the derivative will be minimal. This also reduced our outstanding warrants by 1 million ADSs, leaving us with 2.8 million remaining outstanding warrants. Our cash balance at the end of June is solid at $10.6 million, and we will see further cash flow coming in as we received revenue from MSD and from share sales due to investor warrant exercises. The debt to equity conversion with the European Investment Bank further strengthens our balance sheet, improves our cash flow moving forward, and lowers our leverage. It’s been a great outcome. In summary, we had a solid quarter following our financial strategy. With that, I will hand it back to Birgitte.

Birgitte Rono, Interim CEO and CSO

Thank you, Thomas. Lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum. We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. Business development remains a key priority, and multiple parallel partnership discussions are currently ongoing. The cash runway is extended to the second half of 2027. With that, I would like to thank you for your time and attention, and we will be happy to answer any questions. Please follow the operator's instructions. Thank you.

Operator, Operator

First question comes from Soumit Roy at JonesTrading.

Soumit Roy, Analyst

Congratulations on all the progress this quarter. A quick question on the EVX-01. If you can give us any color on the potential partnership deal, what seems to be the key question that you're getting from a partner? Do they want to wait for much longer-term data or any other key achievements you have to present for a successful deal?

Birgitte Rono, Interim CEO and CSO

Thank you for that question. We just presented the two-year clinical outcome data. We have moved from questions around quality of data and how your platform works to more inquiries on how we can apply your technology in other types of cancer indications. The data has been received well, and we have been discussing it with key opinion leaders and potential partners. Our strategy is to out-license it at the current development stage and partners can decide on the next step. If we continue on the current track with advanced melanoma, the next likely step would be to conduct a larger randomized controlled study comparing EVX-01 plus standard of care to standard of care alone. This is one option, but we also see potential in applying our technology in other cancer indications with high mutational burden, allowing us to select high-quality neoantigens and formulate a beneficial vaccine for patients. Multiple discussions are ongoing, and different questions are coming our way. Generally, questions center not on data quality but on how we can move this forward together, focusing on manufacturing and other indications.

Soumit Roy, Analyst

Got it. One last question. Congrats on unveiling EVX-04 in the AML program. Can you give us some understanding on the target? Is it expressed on AML stem cells, like CD33, CD123? How is it differentiated from this target?

Birgitte Rono, Interim CEO and CSO

This is a very good question. The way we have applied our AI-Immunology platform is by analyzing genomic and transcriptomic data. For this type of antigens, we primarily examine transcriptomic data, focusing on sequences expressed as messenger RNA in tumors. We began by analyzing various types of novel classes of antigens and discovered that in certain indications, including AML, there is a very high expression level of endogenous retroviral sequences from the dark genome. We can find shared sequences across patients and incorporate them into a vaccine, allowing us to support several patients with one single vaccine. This off-the-shelf approach means we can apply the same vaccine across different tumor profiles and immune characteristics. However, we are still utilizing AI-Immunology and our core technology to identify the most optimal antigens, which now comes from the dark genome.

Operator, Operator

The next question comes from Nelson Cox at Lake Street Capital.

Nelson Cox, Analyst

Nelson on for Thomas. Congrats on all the progress this quarter. Can you comment on the overall breadth of partnering conversations you're having across your pipeline and how those have evolved over the last year? Additionally, when looking at the proportion of business development conversations you're having today, how many are focused on target discovery versus already established programs in your pipeline?

Birgitte Rono, Interim CEO and CSO

Thank you for that question. We have multiple dialogues ongoing, and the interest spans across our R&D pipeline while also focusing on our capabilities to identify novel targets, including classical target discovery programs. There's interest in our oncology programs and in our infectious disease programs, indicating a mixed interest overall. Some companies prefer infectious disease, while others have interest in both developed vaccine candidates and target discovery collaborations. While it's challenging to speculate on the timing for these conversations to turn into real deals, we observe increased interest following major data readouts, such as the EVX-01 Phase II data from the last quarter.

Operator, Operator

The next question comes from Swayampakula Ramakanth at H.C. Wainwright.

Swayampakula Ramakanth, Analyst

This is RK from H.C. Wainwright. There are certainly very interesting developments going on at the company. Can we focus on your automated design module? How should we think about this? Can it help design internal molecules only, or is it available for partnerships? Alternatively, could this be monetized independently for partners to use in their own computing systems?

Birgitte Rono, Interim CEO and CSO

Absolutely, it can go in multiple directions. In the past, we utilized AI immunology to identify novel vaccine targets, which underwent manual processing for expression and manufacturing, a labor-intensive process. We have now launched a new module integrating various AI tools, enabling us to transition from target discovery to product candidate selection rapidly. This capability can certainly be applied to our own programs and may also support other companies in ensuring that the antigens or targets they select can be produced cost-effectively. We envision multiple options for monetizing this new module.

Swayampakula Ramakanth, Analyst

Regarding your upcoming presentation at SITC, what additional data do you plan to present from the ongoing trial? How will this strengthen your narrative on EVX-01, for both yourselves and potential partners?

Birgitte Rono, Interim CEO and CSO

At ESMO, we presented clinical outcome data, and we are currently analyzing patient samples. We have collected blood samples before therapy, during vaccination, and as follow-up samples that are undergoing assessment in our labs. We monitor the EVX-01 induced T cell responses and perform deeper phenotypic analysis. Some of this data will be presented at SITC, with further analysis to continue in future conferences. We have not yet analyzed all samples collected from patients, so we expect more detailed insights into the immune profiles. Additionally, we have an extension phase for the EVX-01 trial, where six patients are now receiving EVX-01 as monotherapy, which will also yield more data.

Swayampakula Ramakanth, Analyst

Lastly, regarding the MSD relationship, with the $7.5 million received, do you still need to provide any additional data for the second molecule? Is Merck still completing their due diligence based on the data you provided, or are they running confirmatory studies for the $2.5 million decision?

Birgitte Rono, Interim CEO and CSO

For EVX-B2, MSD is currently evaluating the data provided and generating confirmatory analysis. This is also a reason the evaluation term was extended. We anticipate that they will respond in the first half of next year. The process is ongoing, and we're excited about the possibilities, as we would love to out-license EVX-B2 to MSD.

Operator, Operator

There are no further questions, so I shall hand back to you for final remarks.

Birgitte Rono, Interim CEO and CSO

Thank you for joining us today. Please do not hesitate to reach out should you have any additional questions. Thank you.

Operator, Operator

That concludes today's presentation. Thank you for participating. You may now disconnect. Speakers, please stand by.