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2/27/2026
and welcome to the ALX Oncology fourth quarter 2025 financial results call and webcast. 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 upwards or 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 call over to your host, Jason Letman, Chief Executive Officer. Thank you. You may begin.
Thank you, and welcome to our Q4 and fiscal year 2025 results call.
Appreciate you all spending some time with us this morning. As usual, we will be making forward-looking statements during the call, so please refer to our FOS slide in our corporate deck. With me today, we have Harish Antharam, our CFO, as well as our CMO, Dr. Barb Klinke. And in terms of the first bit of news, we're delighted to announce today that Barb will continue leading our clinical efforts as our permanent chief medical officer. Welcome, Barb. As many of you know, after joining in an interim capacity in September 2025, Barb has been absolutely instrumental in driving our development programs forward over the last five months. Barb, as many of you also know, is an incredibly experienced oncologist and drug developer. having served as CMO at Sierra Oncology and having senior roles at both Onyx and Genentech before that. We're beyond fortunate to add Barb during this critical inflection for the company and thrilled to welcome her permanently. And I'll turn the call over to her later today to walk through some of our clinical updates. In terms of the agenda and the goals for today, we will review our key Q4 2025 and year-to-date accomplishments. referencing our press release and corporate deck available on our website. Then at the end, plan to open it up for any questions you may have. In general, our focus at AOX remains on execution. We have made great progress on both of our programs, Vorpacept and AOX 2004 and 2025, and positioned ourselves to achieve significant catalysts from these programs in the coming 12 to 18 months. Our goal and vision for each is to advance both programs to a stage where they're ready for pivotal studies by end of next year. Execution has been strong over the last quarter, and I'm very pleased to report that our clinical development progress and timelines remain on track. In terms of Avorpacept or Evo, in 2025, we're coming off a year of massive amounts of data really demonstrating the potential for Avorpacept. across a variety of combos and tumor types, which well informed our development strategy for Evo today. We've treated over 750 patients with Evo to date and are now highly confident where the drug works and, most importantly, where it works best. The MOA of combining Evo with antibodies and bispecifics has been well validated in the clinic and will pave the way for us going forward. Importantly, CD47's key role as a biomarker for increasing durable response with Avorpacept in HER2-positive gastric cancer patients was further strengthened and validated by additional data in November at the CITSE meeting. Here, we shared further data from our gastric study demonstrating a transformative benefit for patients, both in terms of durability and PFS. In addition, we recently shared top-line data from the phase one of Vorpacept and Xanidatomab breast cancer trial, which is now a second data set validating the role of CD47 and its importance as a biomarker. The follow-up analysis of this trial from the HER2-positive cohort showed that the responders to this combination treatment in a post- and HER2 setting were largely restricted to CD47 over expressors, which is a similar finding that we had in our gastric study. Full biomarker analysis from this trial is expected to be presented at a medical conference in Q2 of this year. These findings taken together strengthen our confidence in the ongoing Phase II Aspen-9 breast trial. where we will evaluate patient responses by CD47 level to further define the predictive potential of this biomarker among patients with HER2-positive disease that have progressed following an HER2. We launched the study last year and continue with site activations globally at a strong pace. We remain on track with our clinical timelines here and expect to provide top-line data for 80 patients from this study in mid-2027. As shifts to the treatment landscape occur in breast cancer, Evo has the potential to provide both a best and first in class option for the 50,000 patients in the second line plus breast cancer setting. And Evo is also poised to be the only therapy that can address CD47 expression in this large patient population. Overall, the results for Evo from these two HER2 positive cancer trials support the potential for us to pursue a targeted oncology approach to additional tumor types with EVO. And given the broad overexpression of CD47 in both solid tumors and heme malignancies, it gives us a real opportunity to pursue focused development strategy for EVO in combination with anti-cancer antibodies and biospecifics. We're excited about our study in breast. We're also excited about the NHL data, which we recently shared in December, which furthers the findings of EVO and the heme pregnancies. We are also ongoing partnering with Synelphy, and we are excited about what we're seeing across both of those studies, and Barb will go into both in more detail. In terms of AOX 2004, turning to our ADC now, we are also very pleased with the clinical progress of AOX 2004, which, as you know, is our novel and potentially best-in-class EGFR-targeted ADC. We cleared the first two dose cohorts and continue to progress development per plan with the four mg per kg dose now in the phase one trial. We are now expecting full AOX2004 safety data from the dose escalation cohort later this year in second half 26. The potential of these two novel therapies coupled with our substantial progress on their respective clinical programs contributed to the successful completion of our recent financing of $150 million, which we closed a few weeks ago. With our newly strengthened balance sheet, we now have the opportunity to deliver more robust and meaningful data readouts in both of our ongoing clinical programs, as reflected in our milestone updates here. Our mission, again, is to have these two programs ready for a pivotal phase study by the end of next year, and we believe we can do so with continued focus on execution. I will now turn it over to Barb to walk through some of the clinical data and findings and plans in more depth. Barb?
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