ALX Oncology Holdings Inc.

Greetings and welcome to the AOX Syncology second quarter 2025 financial results conference 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 requires 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, Jason Letman, you may begin.

Thanks, everyone, and welcome to our Q2 2025 results.

I appreciate everybody spending some time this afternoon with us and looking forward to this update. On slide two, before we start our presentation as housekeeping, here are our forward-looking statements for your review. So, in terms of slide three, this is the agenda and plan for today. We're going to be providing an update on our key accomplishments in the second quarter of 2025. Most notably, we are very excited to share with you new data from our analysis of our Aspen 6 trial that showed CD47 expression as a key predictive biomarker for increasing clinical response with the 4-percept. So our goals for today are most importantly to share this new data with you all, then give you a sense of how this data now impacts our development strategy for Evo, then provide a quick update on our novel EGFR-targeted ADC, ALX 2004, which is set to enter the clinic imminently, as well as share revised guidance on our financials and cash position. So in terms of the agenda, our CMO, Alan, will first present these top-line results and also provide an update of our clinical programs with Evo. Harish will then conclude by an update on our cash runway as well as our near-term key milestones. And last, we'll open it up to you all for a Q&A. On the next slide, on slide four in the second quarter, we made significant advances in both our Vorpacept and ALX2004 clinical programs. On the EVOL front, we again are excited to share data that is demonstrating the potential of CD47 expression as a predictive biomarker and highlight a clear opportunity to now identify patients who are most likely to achieve the greatest benefit from a Vorpacept. As Alan will present in detail in his clinical section in this analysis, we saw that patients with high CD47 expression derived the greatest benefit from a Vorpacept versus those with low expression. And as a result of these findings, we have modified our Phase II clinical trial in breast cancer to enable pursuing a CD47 and HER2 biomarker-driven strategy in this study. These results support the potential to pursue targeted oncology approaches in additional tumor types with EVO. And given the broad overexpression of CD47 in both solid tumors and hematologic malignancies, gives us an opportunity to really focus EVO as a targeted IO therapy. In terms of process and progress, we remain on track to dose our first patient with our second pipeline product, our novel EGFR antibody AOX-2004, which is a highly differentiated ADC. We're very excited to be in the clinic this month. We are also excited about the progress made in our partnered randomized phase one slash two umbrella study with our partner Sanofi, which is evaluating a Vorpacept with Sarclisa and dexamethasone in patients with previously treated multiple myeloma. That phase of the study is now complete, which we're excited to announce. And Sanofi will now begin the dose optimization portion of the study and be moving forward with that combination. Turning to our financials, the prioritization of our efforts in avaricept and breast cancer and ALX 2004 has now enabled us to further extend our cash runway guidance into the first quarter of 2027. which solidly positions us to achieve multiple value-enhancing data milestones that we have ahead of us this year and next year. Turning to slide five in terms of the punchline on our CD47 expression analysis, as I mentioned, we now have clear data to support that CD47 overexpression is a clear predictive biomarker for patients. As a reminder, we've shared top-line results previously for Aspen-06, at ASCO GI earlier this year in January, and today we are sharing new data of a pre-planned analysis of that same data set. In this analysis, we analyzed CD47 expression levels using IHC, and we found that patients with both confirmed FER2 positivity and CD47 high expression had a dramatic response to Ivorpacept as compared to those in the control group. As you can see here, on the ITT, we saw 41 versus 27% ORR. And if you look at the data now in patients that clearly have CD47 high expression, we showed a significant magnitude of benefit for those patients, where we had an ORR of 65% versus 26% in the control arm, with a nominal p-value of less than 0.05. This strong magnitude of benefit for EVO in combination, in this case, with TRP in CD47 high patients was also reflected in both DOR, PFS, as well as survival. And we are planning to present this full data set at an upcoming medical conference in the fourth quarter of this year. Turning to slide six, as a reminder, EVO is a unique CD47 blocker that sets it apart from CD47 inhibitors that have been developed in the past with its differentiated safety profile and clinical activity. With its inactive SC domain, which delivers best-in-class safety and combination potential across a wide range of biologics and targets, it's truly a different CD47, and we're now seeing that in the clinic. And following the encouraging results that we have shared today and are looking forward to sharing more later this year, we clearly see that CD47 is a biomarker. And this biomarker-driven enhanced efficacy from EVO and HER2-positive gastric is a clear demonstration of the drug's potential to be a first-in-class and best-in-class targeted IO therapeutic and to drive superior outcomes for patients with CD47 overexpressing cancers. Turning to slide seven, CD47 is overexpressed across a wide range of both solid and liquid tumors. This has been well, well published in the literature, and it's clear that CD47 is a marker that both solid and liquid tumors use to evade the immune system. And as you can see in this slide, CD47 is overexpressed across a very wide range of solid and heme malignancies, making it a very compelling target, not only where we're focused, but beyond. Now turning to slide eight, it is also clear that this overexpression matters. And when you look at research in CD47 over the last decade plus, it's a very strong foundation that CD47 is a negative prognostic biomarker. What you can see here is in the meta-analysis of 38 cohorts across 17 publications, which includes over 7,000 patients, CD47 is clearly associated with shorter survival and worse outcomes. And you can see on the right the wide range of tumor types where this has been documented. But turning to slide nine, this sums up what we're most excited about now, which is really driving a targeted IO breakthrough and a first-in-class drug with Evo. So what does this mean for our program? What does this mean in terms of future development? Well, as you know, our CD47 blocker has been successful where no other has in terms of its manageable toxicity profile. In addition, we've now demonstrated efficacy in a randomized study and we've identified an actionable and predictive biomarker for response to Evo in our gastric cancer study. And again, this biomarker is on mechanism. We are developing a CD47 biomarker, and therefore it is really no surprise to see CD47 overexpression showing such a strong impact to our data. So what this allows is us to use CD47 to select for patients in both current and future cases trials with the goal of replicating the results we have seen here with gastric cancer and demonstrating the same significant and transformational benefit for patients. As you know, a predictive biomarker could also facilitate smaller and faster future studies given the potential for a wide magnitude of a benefit. And importantly, we estimate that CD47 overexpression is in roughly 50 to 70% of HER2 positive breast patients. which opens the door to a very significant commercial opportunity and more importantly, a significant patient population to benefit. And finally, we also know from existing data that CD47 expression, again, is found to be high across multiple tumor types, which enables us to go in many directions following this breast study. So now, next, Alan will take over and provide more details both on this data as well as how it impacts our plans going forward in BRSSD. Alan?