ALXO

– On track for mid-2027 topline data readout from 80 patients in the Phase 2 ASPEN-09-Breast clinical trial evaluating evorpacept in combination with trastuzumab and chemotherapy in HER2-positive metastatic breast cancer – – Presented encouraging Phase 1b/2 breast cancer data at ESMO Breast Cancer 2026 that further validate a biomarker-driven development strategy for evorpacept – – Strong enrollment momentum in Phase 1 clinical trial of ALX2004 in EGFR expressing solid tumors with initial safety data on-track for 2H 2026 – – Strengthened leadership team with the appointments of Scott Garland as Chairman of the Board of Directors and Michael Listgarten as General Counsel – SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology," Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. "We continue to execute against our strategy with discipline and focus, advancing both of our clinical programs toward meaningful value-creating milestones," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "Enrollment in our ASPEN-09-Breast trial remains on track as we work toward a topline data readout from 80 patients in mid-2027, while ALX2004 continues to advance through dose escalation with initial safety data expected later this year. The encouraging clinical data we presented at ESMO Breast Cancer further strengthens our confidence in evorpacept’s biomarker-driven strategy, while ALX2004 continues to advance as a differentiated EGFR-targeted ADC built around a clinically validated target with broad applicability across multiple EGFR-expressing solid tumors. Together, these programs highlight the breadth of our pipeline. Combined with our strong balance sheet, an experienced leadership team, and multiple upcoming catalysts, we believe ALX is well-positioned to advance innovative therapies for cancer patients while creating long-term value for shareholders." ALX Oncology Q2 2026 Highlights and Recent Developments Evorpacept In May, ALX Oncology presented new data at ESMO Breast Cancer 2026 from exploratory analyses of its Phase 1b/2 clinical trial evaluating the Company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA®). The new data demonstrated promising and durable responses in heavily pre-treated metastatic breast cancer (mBC) patients previously treated with ENHERTU® (fam-trastuzumab deruxtecan-nxki), particularly among patients with centrally confirmed HER2-positive (ccHER2-positive) disease and high CD47 expression. Enrollment in the ongoing ASPEN-09-Breast Phase 2 trial evaluating evorpacept in combination with trastuzumab remains on track, with topline data from 80 patients expected in mid-2027. ALX2004 Enrollment continues in the dose-escalation portion of the Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, and is on track to report safety data in the second half of 2026. Corporate Update In June, the Company strengthened its leadership team and Board of Directors with the appointments of Scott Garland as Chairman of the Board and Michael Listgarten as General Counsel. A Board member since 2022, Mr. Garland brings more than three decades of biopharmaceutical commercial, operational, and strategic leadership experience, while Mr. Listgarten adds deep expertise in legal affairs, corporate governance, and business development, with a proven track record of guiding biopharmaceutical companies through critical stages of growth and transformation. Together, these appointments reinforce ALX's leadership foundation and enhance the company's ability to execute on its strategic priorities, capitalize on future opportunities, and support long-term growth. Also in June, ALX Oncology strengthened its balance sheet by refinancing its existing $10 million debt with HSBC Ventures USA Inc. and securing the ability to draw up to an additional $20 million at the Company’s discretion through the end of June 2028. The Loan Agreement in totality provides for a secured multi-tranche term loan facility in an aggregate principal amount of up to $50 million, of which $10 million is uncommitted. This new debt facility replaces the Company’s prior loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, significantly lowering ALX Oncology’s cost of capital, enhances financial flexibility and supports the continued advancement of the Company’s clinical portfolio. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2026, were $153.4 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations through the first half of 2028. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of clinical and development costs related to the development of the Company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended June 30, 2026 were $13.1 million compared to $18.0 million for the prior-year period, or a decrease of $4.9 million. This decrease was primarily attributable to a decrease of $4.8 million in clinical and development costs, reflecting lower expenses associated with legacy trials, partially offset by continued investment in evorpacept ASPEN-09 Phase 2 trial and ALX2004 Phase 1 study. General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended June 30, 2026 were $5.1 million compared to $5.5 million for the prior year period, or a decrease of $0.4 million. This decrease was primarily attributable to a decrease in $0.4 million in corporate legal and patent costs. Net loss: GAAP net loss was ($18.0) million for the three months ended June 30, 2026, or ($0.13) per basic and diluted share, as compared to a GAAP net loss of ($25.9) million for the three months ended June 30, 2025, or ($0.49) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses as well absence of the $3.2 million lease impairment charge recorded in the three months ended June 30, 2025 related to leased lab space following the workforce reduction in preclinical research in March 2025. Non-GAAP net loss was ($14.3) million for the three months ended June 30, 2026, as compared to a non-GAAP net loss of ($20.6) million for the three months ended June 30, 2025. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. ZIIHERA® and ENHERTU® are the registered trademarks of their respective owners. About ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn and X. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact:Kevin LuiDirector, Investor RelationsPrecision [email protected] Media Contact:Genevieve BrittonSenior Director, Public RelationsPrecision [email protected]

Image source: The Motley Fool. Friday, May 8, 2026 at 8:30 a.m. ET Chief Executive Officer — Jason Lettmann Chief Medical Officer — Barbara Klencke Guest Clinical Expert — Dr. Sara Hurvitz Need a quote from a Motley Fool analyst? Email [email protected] Jason Lettmann: Thanks, everyone, and welcome to our Q1 2026 results. I really appreciate you all spending time with us this morning and are looking forward to sharing these updates with you. On Slide 2 and before we start our presentation as housekeeping, here are our forward-looking statements for your review. On Slide 3, here's the agenda and plan for today. We're going to be providing an update on our key accomplishments in the first quarter of 2026. Most notably, we are very excited to share with you the data set that was presented yesterday in Munich at ESMO Breast 2026 from the analysis of our trial evaluating evorpacept and zanidatamab, which clearly showed again that CD47 expression is a key predictive biomarker for increasing durable clinical response in heavily pretreated HER2-positive patients. This further validates the results we saw with Evo and HER2-positive gastric cancer from our ASPEN-6 trial. We are also very excited today to be joined by Dr. Sara Hurvitz from the Fred Hutch Cancer Center at the University of Washington, who is a well-recognized expert in metastatic breast cancer. She will be presenting the ESMO breast data in detail and also share her views on evorpacept's significant potential within the current treatment paradigm for HER2-positive metastatic breast cancer. Our CMO, Barb Klencke, will then recap our findings to date with Evo and HER2-positive cancers across now two different independent trials and indications, showing that patients with high CD47 expression derive the greatest benefit across all key efficacy markers, including overall response rates, duration of response and PFS versus those with low expression. These results support our targeted oncology approach with Evo, notably our ongoing ASPEN-09 breast cancer Phase II trial. Barb will then provide an update from our ongoing Phase I trial with our novel EGFR-targeted ADC, ALX2004, which also continues to track to plan, and we are enthusiastic about its potential to also change care in EGFR-expressing cancers. So on Slide 4, we continue to advance both our programs, Evo and ALX2004 and are pleased with the progress on both fronts over the course of Q1 and remain well positioned to report on significant data readouts from these programs in the coming 12 to 18 months. On the Evo front, CD47, as you know, is incredibly important in oncology and has been a very difficult target to crack, yet it plays a fundamental role in tumor evasion and resistance. We've been happy to see Evo's differentiated approach to this target further validated in the clinic over now 5 different data sets, including randomized data. Further, the new data from this week's ESMO meeting and over the last year support CD47 as a strong and predictive biomarker. These new findings further support the drug is working as designed and also enables a targeted strategy, which allows us to focus on the patients who will benefit most. On ALX2004, as you know, it is a highly differentiated EGFR-targeted ADC, which was developed in-house by ALX and has the potential to be a first-in-class EGFR-targeted ADC. EGFR has also been a difficult target for ADCs historically, and ALX2004 was designed to address this with a novel epitope and linker payload construct. We have been pleased to see the strong preclinical data to date translate to the clinic and with the continued strong progress in dose escalation, where we have been able to further increase dose. Overall, both programs remain on track and well positioned. Now on Slide 4, Q1 was a quarter of continued good execution and additional positive data as well as completion of key hires and a strong financing. As you'll hear more about shortly, this week's data validate again the power of CD47 in a late-stage patient population. Here, we observed that all patients who were confirmed HER2-positive and CD47 high achieved a response, including one complete response. We also yet again saw the durability that one hopes to see with an IO mechanism with a median duration of response of 20 months and a median PFS of 22 months, which is clearly far improved over the benchmarks. While the focus for today will be on this new data set with Evo, ALX2004 is also progressing through dose escalation very well and remains on track for initial safety readout in the second half of this year. We remain as excited here about its potential as we do with Evo. Further, the financing from February, which was anchored by very strong investors, further strengthens the balance sheet and enables us to execute through these important data milestones. And last but certainly not least, we added Jeff Knight, who is now our Chief Development and Chief Operating Officer, which really further strengthens our leadership team. Jeff, as you may know, is one of the best operators in biotech in terms of building companies at our stage through the next phase, including commercialization. On Slide 6, briefly, this just highlights the execution, clinical development progress and time lines, which remain on track for both programs. Our evorpacept Phase II breast trial continues to progress well with strong enrollment globally and increasing site enthusiasm. Overall, clinical time lines remain on track as we're expected to read out 80 patients mid next year. ALX2004, as I mentioned, is also progressing well with enrollment and dose escalation ramping and are on track there for an initial safety readout in the second half of this year. Our goal and vision for both of these programs also remains unchanged as we aim to have both programs ready for registrational studies by end of next year. On Slide 7 and my last slide, here is also a snapshot of our clinical pipeline. As you know, we're advancing 2 novel cancer treatments with key near-term catalysts. And again, ASPEN-Breast is on track. And we continue to also be encouraged by our ongoing study with our partner, Sanofi, testing Evo in multiple myeloma. Our two studies in HER2-positive cancers have now been completed as we'll focus on today and ALX2004 also remains on track. I'd like to now turn the call to Barb, who will provide a quick reminder of our MOA, which is very important as we're clearly seeing it translate to the clinic, and we'll then turn the call over to Dr. Hurvitz to review the new data. Barb? Barbara Klencke: Thank you, Jason. These next few slides describe evorpacept's mechanism of action. What's so compelling to me is that the mechanism of action is entirely consistent with what we see in the clinical trials. So let me just go through this. Cancer cells commonly upregulate CD47 expression to evade immune detection. Evorpacept blocks the CD47 signaling, but it does so without an active Fc domain. So evorpacept by itself does not engage the phagocytic activity of a macrophage. We need to combine evorpacept with an anticancer antibody. And then the combination together strongly augments the ADCP activity of the antibody. And that's likely what results in the efficacy that we see in the studies that we'll talk about today. Essentially, the antibody stimulates the eat-me signal, and the evorpacept inhibits the don't eat me signal. Therefore, the combinations of evorpacept with an antibody are selectively enhancing or augmenting macrophage phagocytosis of cells that express HER2, for example, in the case of a HER2-targeted antibody while also blocking the don't eat me signal. On the next slide, we see how this mechanism of action translates into safety. Our clinical safety database is now more than 800 evorpacept-treated patients. And it also -- the clinical safety data is also entirely consistent with this mechanism of action that we show here. Evorpacept was designed again without an active Fc domain. That's shown on the right side of the slide. So when we block the don't eat me signal on normal healthy cells, such as red blood cells, there is no macrophage activation, and we avoid on-target toxicities. This is really fundamentally different than what's been tried in the past by conventional CD47 inhibitors, which have essentially failed in the clinic. They attempted to use CD47 as a tumor-associated antigen with both an active Fc domain to activate macrophage at the same time of blocking CD47. That ended up being an indiscriminate approach because CD47 is so widely expressed on healthy cells, especially hematologic cells in particular. And that led to the potential for significant on-target toxicity. So with that description of evorpacept, its mechanism of action and its differentiation, let me now turn the conversation over to Dr. Sara Hurvitz. On Slide 12, you can see her background here. She is a steering committee member for our ASPEN-09 Phase II study of evorpacept in HER2-positive breast cancer patients. She was an investigator on the evorpacept and zanidatamab trial that we'll discuss today. And she's a Senior Vice President, a Professor of Clinical Research and the Director of the Clinical Research Division at the Fred Hutch Cancer Center at the University of Washington in Seattle, where she's also the Head of the Division of Hematology and Oncology and the Smith Family and Dow Chair of Women's Health. She's an expert in the management of breast cancer and in the development of novel targeted therapies for breast cancer. Sara? Sara Hurvitz: Thanks, Barb. I'm really excited to be here today. There have been remarkable changes in the management of HER2-positive breast cancer, especially since 2020, with new agents like trastuzumab, deruxtecan and tucatinib demonstrating benefits in pretreated disease. And with the results of DESTINY-Breast09 showing benefits with T-DXd in combination with pertuzumab, we have a new standard of care according to our NCCN guidelines as of this February. What we don't know is how we should be treating patients after they've received ENHERTU. This remains an area of unmet need. On Slide 14, you can see this graph showing the outcomes that we have from patients who've received prior ENHERTU treatment with a median progression-free survival of only 4.1 months. What we don't have are randomized prospective data telling us as clinicians how we should manage patients after T-DXd, but observational and retrospective data sets are fairly consistent, showing that PFS rates of under 6 months is what patients experience post T-DXd. On the next slide, on Slide 15, you can see the list of HER2-directed therapies that we have approved and in late-stage development on the left side. These include HER2-targeted antibodies and bispecifics, HER2-targeted antibody drug conjugates and HER2-targeted tyrosine kinase inhibitors as well. What we don't have are immuno-oncology therapies approved or in late-stage development outside of evorpacept. And so this remains an area that's very exciting to see developed now. On Slide 16, you can see the range of CD47 expression in normal cells versus tumor cells. As explained before, CD47 is expressed on all cell types and is a marker of cells and cancer cells can take advantage of this by overexpressing CD47, allowing them to hide from the immune system. Focusing on the left there, you can see highlighted in blue, breast cancer cell lines, which actually do have higher expression of CD47 in tumors compared to normal, which is highlighted in black. On Slide 17, you can see a meta-analysis of 38 cohorts across 17 publications, which included over 7,000 patients, demonstrating fairly consistently that CD47 overexpression was correlated with shorter survival in patients with cancer. So it's a negative prognostic biomarker. On Slide 18, there are data here relating to CD47 expression in breast cancer, in particular, in HER2-positive breast cancer. On the left, you can see that CD47 expression is higher on HER2-positive breast cancer cells versus HER2-negative on the right. High expression is denoted in the dark blue, moderate expression in green and low expression in blue. So HER2-positive breast cancer cells appear to have a lot more CD47 expressed than HER2-negative breast cancer cells. And in fact, if you look on the right side, you can see that CD47 high cells are more common in recurrent HER2-positive breast cancer shown on the left side compared to primary or initially diagnosed breast cancer. And so these data provide strong rationale for us to be evaluating evorpacept in HER2-positive recurrent or metastatic pretreated disease. On Slide 19, you can see some elegant data demonstrating that T-DXd treatment may actually upregulate expression of CD47, again, providing strong rationale to treat HER2-positive recurrent T-DXd pretreated breast cancer with evorpacept. On Slide 20, you can see the title slide for the data presented recently at ESMO breast. This is an exploratory biomarker analysis from our Phase Ib/II trial of zanidatamab, a HER2-targeted bispecific in combination with evorpacept in patients with HER2-positive metastatic disease. Slide 21 gives you an overview of the study design. This is a Phase Ib/II study, and we presented the safety dose escalation cohort data from 3 patients with HER2-positive breast cancer enrolled and data from Cohort 1, where 21 patients with HER2-positive breast cancer were enrolled who had received at least 3 prior regimens. The exploratory biomarker analyses focused on these 24 patients, and it's notable that all of the HER2-positive cohort received prior T-DXd and a median of 5 prior lines of HER2-targeted therapies. This is extremely heavily pretreated disease. The patients were allowed to enter the study based on prior local HER2 testing of their archival tissue. However, fresh baseline biopsies were obtained in most patients and tested retrospectively for HER2 status by central assessment. And we will be reviewing outcome results based on the central assessment as well as the intent-to-treat population. In addition, patients' tumors were tested for CD47 expression on the fresh baseline tumor biopsies or on archival tissue if fresh biopsies were not available. Patients were treated with zanidatamab at 1,200 milligrams for those patients weighing less than 70 kilograms and at 1,600 milligrams for patients 70 kilograms or greater. The evorpacept was given at 20 mg per kg for these 3 patients enrolled in the Ia or at 30 mg per kg IV every 2 weeks for the rest of the patients. Going on to Slide 22, we're jumping to the efficacy outcome data. What you can see here are the confirmed objective response rate on the top row based on all 24 patients, which is 33%. I find personally these data to be quite impressive in patients who've received a median of 5 prior lines of therapy, including T-DXd. If you go down to the duration of response, those patients who experienced a response had a duration of response of 20 months and a median progression-free survival of 3.6 months. The next column shows the outcomes for the 6 -- excuse me, for the 10 patients who had centrally confirmed HER2-positive breast cancer, where the objective response rate was now 60%. The duration of response was 20.2 months and the median PFS was 8.3 months. These data, I think, are impressive as we reflect back on the fact that our retrospective and observational data suggests that patients pretreated with T-DXd have a median PFS of less than 6 months. So I find these data to be quite compelling and exciting. Those patients who did not have centrally confirmed HER2-positive disease had a lower objective response rate of 14%. On Slide 23, we can now see breakdown based on the tumor CD47 expression levels. Using a cutoff of at least 20% for CD47 expression, there are 5 patients who had both centrally confirmed HER2-positive disease and CD47 positive or greater than or equal to 20% expression. All patients had an objective response in this cohort of 5 patients with a median DOR of 20.2 months. However, those patients whose CD47 expression was less than 20%, that's 4 patients, only one had an objective response. So this is beginning to give us data that CD47 expression level may be a marker to help us select patients particularly responsive to this targeted therapy. On Slide 24, you can see a Kaplan-Meier curve for progression-free survival based on CD47 expression levels. So the progression-free survival with the CD47 expression level of at least 20%, you can see the PFS is 22 months, for those patients less than 20% of the PFS is 3.4 months. Again, although these numbers are very small, we're talking about 9 patients total. The data are quite interesting, and I'm excited to see them hopefully confirmed in the larger study. On Slide 25 are our conclusions for this exploratory analysis of our Phase Ib/II study. Evorpacept and zanidatamab showed promising antitumor activity in patients with heavily pretreated HER2-positive metastatic breast cancer, median of 5 prior lines of therapy, all of whom received prior T-DXd. Greater antitumor activity was seen in patients with centrally confirmed HER2-positive disease. Durable responses were seen in this patient population and seem to be largely observed in patients with higher CD47 expression, supporting a CD47dependent HER2-driven biology that resulted in this prolonged progression-free survival. It's notable that most patients with centrally confirmed HER2-positive disease remained HER2 amplified at progression with T-DXd, supporting the continued use of HER2-targeted therapies. And so a biomarker-driven approach incorporating CD47 may optimize patient selection for this combination regimen and warrants further study. So with that, I will turn it back over to Barb. Barbara Klencke: Thank you, Sara for that excellent presentation. As we've seen, all of the patients who were centrally assessed as HER2-positive and who overexpressed CD47 in their cancer cells achieved confirmed response to the combination of evorpacept plus zanidatamab. What's new on Slide 27 in the table on the right side of this slide are the individual CD47 expression levels and the confirmed response assessments for each of the 10 patients with centrally assessed HER2-positive disease. An IHC assay was used to quantify the total membrane staining for CD47. A positive result was defined retrospectively as a score of 20% or higher, which we observed in the patients shown in the top 5 rows highlighted with deep blue. All 5 of these patients with CD47 expression responded, including one patient with a complete response. That patient happened to be the only patient from the dose escalation cohort that was centrally assessed as HER2-positive. There was no evidence of CD47 overexpression in the 4 patients highlighted in light gray, one of whom responded to the evorpacept and zanidatamab combination. And then in the last row in this table is a patient who was unevaluable for either response or CD47 expression level. On Slide 28, I want to highlight the consistency that we see between the results of the evorpacept, zanidatamab trial in HER2-positive breast cancer patients and in the previously reported HER2-positive gastric study. On the top half of the slide, you'll see the data that we've just reviewed. This includes a 33% response rate in the 24 patients enrolled based on archival HER2 status, the 60% response rate in the 10 patients centrally assessed as HER2-positive and the 100% response rate in the 5 patients who were also CD47 overexpressing. On the bottom half of this slide, you see the data from ASPEN-06. This is a randomized Phase II study of evorpacept, trastuzumab, paclitaxel and ramucirumab versus the TRP regimen alone. Here, you see the response rate climb as we look across the slide at the same subset. In the ITT, the response rates in patients randomized to the evorpacept arm was 41%. Response rate was over 49% in the patients that retained HER2-positive disease, and it was 65% in patients whose tumors also expressed CD47. And recall, this was a large Phase II study of 127 patients. As you see, the data trends here are consistent across these 2 independent trials of evorpacept when combined with a HER2-targeted antibody. On Slide 29, I'm again showing the results of the Evo-Zani study on the top and the ASPEN-06 HER2-positive gastric study on the bottom. The graph -- these graphs show the duration of response in the subset of patients who were HER2-positive and CD47 overexpressing in the 2 independent studies. The duration of response was remarkable in both settings at 20.2 months and 25.5 months, respectively. On Slide 30, the same consistency across the 2 independent studies as seen with the PFS results in the subset of HER2-positive CD47 high patients. Both studies show a remarkably long PFS, especially in light of the later line settings for both indications. On the left, we see the median PFS for these patients in the evorpacept-zanidatamab study of 22.1 months, while the median PFS for those without CD47 expression was only 3.4 months. And then in the gastric study, shown on the right, the median PFS was 18.4 months for the patients in the evorpacept arm and the hazard ratio in this subset in the randomized trial was 0.39. So these data are really why we're so excited about moving forward with the development of evorpacept in HER2-positive breast cancer. Slide 31 shows our ongoing ASPEN-09 study in the HER2-positive breast cancer setting. Like the zanidatamab-evorpacept study population, all of these patients will have had to have had prior ENHERTU. This is going to -- this is a single-arm study that will enroll up to 120 patients and has a primary endpoint of response rate in the subset of patients who overexpress CD47. We're making very good progress with enrollment, and we're very much on track to achieve our stated milestone of having interim top line data from approximately 80 patients by the middle of 2027. On Slide 32, we show the market opportunity. Ultimately, our aim, of course, is to bring this drug to market. We estimate that there are approximately 20,000 addressable patients who are HER2-positive and overexpress CD47, representing a $2 billion to $4 billion market opportunity in the United States, the 5 major European markets and Japan. I'm now going to turn for the last few minutes of this talk to our second molecule. Slide 34 shows ALX2004, our EGFR antibody drug conjugate. This is actually a very unique molecule. It was designed by protein engineers and cancer biologists within ALX. EGFR is obviously a very validated target, but it's been very difficult to target EGFR in the past with an antibody drug conjugate. We selected amituzumab-derived EGFR antibody to minimize off-tumor skin toxicity and to maximize the therapeutic window. Also, the epitope is distinct from that of FDA-approved EGFR antibodies, minimizing the likelihood of resistance to prior EGFR antibody treatment. The proprietary linker allows for lysosomal cleavage of the linker payload like other deruxtecan ADCs, but the stability of the linker antibody has been enhanced to minimize systemic payload release. The molecule also contains a proprietary TOPO1 inhibitor payload. It has an antibody drug ratio of 8, and the payload has similar direct cytotoxic potency, but it has enhanced bystander activity compared to deruxtecan. On Slide 35, we show the Phase I design. This is an ongoing study, and the study is designed for dose escalation, dose exploration and expansion cohorts. The study is limited to patients who have lung cancer, head and neck cancer, colorectal cancer or esophageal cancer as EGFR expression is higher in these indications. And in this study, we're also making very good progress with enrollment. We are certainly on track to achieve our stated milestone of reporting initial safety data within the second half of 2026. We previously publicly released information that we began dose escalation at 1 milligram. We then said we escalated to 2 milligrams. And then we announced that we had escalated to 4 milligram per kilogram dose cohort. But as we advance the enrollment and dose escalation in this trial, we are now shifting from providing granular updates to reporting initial safety data in the second half of 2026. And I'll now turn the presentation back to Jason. Jason Lettmann: Thanks, Barb. And also a big thank you to Dr. Hurvitz for joining us today to share her views. At ALX, we're advancing 2 novel cancer treatments with key near-term catalysts that have the potential to be both best-in-class and first-in-class and change care. And with this new data today, we have now demonstrated in 2 studies in 2 HER2-positive cancers that EVO is a very active drug and that a CD47 targeted approach can drive transformational benefit to patients. And again, although not the focus for today, we remain as excited about the potential of our EGFR-targeted ADC, which is also progressing quite well. We now have a stronger balance sheet to fully execute through key milestones over the next year to 2 years, and this really sets us up well for further execution and further catalysts. In sum, Q1 was a strong quarter for us in terms of new data, new leadership within our team and a new financing. So the message for today is one of building momentum as our conviction in both programs remains high, and we're looking forward to additional updates very soon. With that, I'll turn the call back over to the operator for questions. And again, thanks again for the time this morning. Operator: [Operator Instructions] Our first question will come from Michael Yee with UBS Securities. Kaiyue Yang: Congrats on the updates and progress. This is Kaiyue Yang for Michael Yee from UBS. Two for us. The first question for management. So congrats on the data today. So for your upcoming interim data readout in mid-2027 from your ongoing Phase II ASTENBreast study, what would you say is compelling results in terms of ORR and also DOR? And do you plan to put out data on mPFS? And what would be good data for mPFS? The second question for Dr. Hurvitz, could you please help us understand how do you plan to use this drug in the clinical setting if this is approved? Do you expect to test everybody for CD47 expression? Jason Lettmann: Great. Thanks, Kyle. Appreciate the question. So yes, on the first one, and I'll let Barb weigh in as well. I think we've been very pleased with enrollment to date on our breast study. It's going quite well. Certainly, this data, which we've been able to share just over the last couple of months with the investigators has furthered that enthusiasm. So I think as Barb highlighted well in her comments, feel very good about our time lines and delivering really meaningful data mid-'27. But Barb, do you want to weigh in more on just what we hope in terms of durability and PFS at that time? Barbara Klencke: Yes, absolutely. Well, as Dr. Hurvitz said, most of the available therapies are not producing very good outcomes for patients after ENHERTU. Much of the data suggests that the response rate may be 15% if you were to receive a trastuzumab chemotherapy treatment alone without evorpacept. So a 30% response rate would be a doubling of what we would expect to see without the evorpacept. So I think anything north of 30% would be a very, very good outcome with a duration of 6 months plus. As you've seen in the data that we reported previously, one of the things that's so compelling about evorpacept is that when we see a response, we see a very good duration of response. By middle of 2027, I think the duration of response will be pretty preliminary. So I'm expecting that with 80 patients worth of data that we can assess response rate pretty well. Duration of response may be somewhat truncated, but I would hope to see somewhere in the range of 6 months plus with immature data. And I would think that PFS might be too immature to report, but it really depends on the continued progress. So we'll have to see. Yes. And Dr. Hurvitz, whether you have comments on your expectations for the ASPEN-09 data or in particular, the second part of the question about the role of CD47 testing in the clinical practice if evorpacept is able to get to market. Sara Hurvitz: Yes. Thank you, Barb. I fully agree with your -- what you stated about the ASPEN-09 study. I mean I think seeing anything around 30% objective response rate and a PFS of 6 months would be pretty important in patients that heavily pretreated. So I echo your comments. In terms of the additional question regarding how we would use CD47 expression, I think this is something that's really very compelling and interesting. And the ASPEN-09 study is going to allow patients, as Barb stated, with both CD47 low and high tumor expression so that we can validate these data. We have to keep in mind, it was a small number of patients, but the data were really pretty interesting and compelling. So if CD47 is validated as being a predictive marker for benefit from evorpacept, then I do think we will be probably seeing it developed as a companion diagnostic. But it's too little data at this point to see -- to make that statement definitively that's how we'll be doing -- using it. I've been treating breast cancer patients for over 20 years. And the data with ENHERTU were really exciting when we first saw them come out in 2019. I feel that same flurry of excitement seeing these data because it's pretty tough to treat patients post T-DXd now. Their progression-free survival, their duration of response to the next line of therapy is pretty short. And so these data provide patients a lot of hope. So I'm excited to see the data validated just taking into consideration that it is a small number of patients. Operator: Our next question will come from Derek Archila with Wells Fargo. Derek Archila: Congrats on the update here. Just a few questions from us. I think, first, you alluded in the prepared remarks, but just remind us the population in ASPEN-09 and then how it compares to some of the patients from the update today, that would be helpful. And then just 2 quick ones. So I think you mentioned the 20,000 patients CD47 high post HER2. So does that assume greater than 20% CD47 expression? Or I just want to make sure the cutoff is the same? And then with the data here and the proof of concept with the zani combo, I guess, how do you think about further developing this? Jason Lettmann: Yes, sure. Those are great questions. Thanks, Derek. So I think in terms of the population that we're studying now, it is this population. That's what I think really derisk, if you will, this current study. I think as we walk through today, this is a late-line breast population. 100% of the patients in this cohort had seen prior in HER2. On average, it's seen 5 prior lines of HER2-directed therapy, et cetera. So I think the beauty of this design that we're pursuing now is it's effectively the same. So I do think that definitely contributes to our confidence in this study. Then on the second question, and I can have Barb weigh in on this. I think we do know from the literature, we expect that the expression profiles will be different across different tumor types. That's certainly what we've seen when we look at breast and gastric. But again, I think what's so encouraging is that there's just a lot of room here in terms of choosing a cutoff, if you will. So Barb, do you want to speak to that a little more? Barbara Klencke: Yes. I think one of the most important things about what we will understand with the data from ASPEN-09 is what's the optimal cut point? Where on the total membrane staining scale, would we see the greatest differential between high response rate in the CD47 positive versus CD47 low. And it's likely to be a continuum, and we're likely to be able to not see a cliff where it's crystal clear. What we've seen in both the gastric and the breast study, though, is we're seeing about half of patients overexpress CD47. At least in our gastric study with a larger sample size, we shared at SITC in the fall of 2025, a variety of different cut points that range from 45% to 57%. Gastric may be different than breast, though. And so with the Zani data, we have just such a small number of patients. So -- but what we saw in the Zani trial, again, about 50% were CD47 high. One of the biggest reasons we increased the sample size from 80 to 100 is just so that we could get more data because this point exactly what is the cut point? How does it differentiate response rates? And what does it do to the population in terms of potential commercial opportunity balanced against finding the best treatment effect for patients is a really important question. So ASPEN-09 will help us optimize the cut point. My best guess today is it will be somewhere in the range of 50%, 60%, 70% of patients could be CD47 overexpressing, but we'll see. What also, of course, are the 2 slides that Dr. Hurvitz showed where the rates are higher in patients who have more advanced disease. They are higher in the cell lines post ENHERTU, and they are higher in patients who are HER2 positive. So it could even be higher than 50%. We'll learn a lot from the ASPEN-09 on that exact question. Jason Lettmann: And I think your last question, Derek, just on zani, a couple of comments there. I think, one, really pleased with the partnership with Jazz and what we're seeing here for patients. I think no question that very strong activity with this combination. The second thing, and I think why it's important to look back at our mechanism is EVO works in combination with an Fc active antibody, and it was designed to do so. And so I think what's really promising about the totality of the data is whether we're combining EVO with traz, with zani, with Rituxan, with an anti-CD38 like Sarclisa, we see activity. And I think that's right on mechanism. And so for us, taking the combination of Evo plus traz going forward makes sense. Again, it's the exact same combination that we utilized in our ASPEN-6 study, which is a randomized study, as you know. So I do think that gives us a lot of conviction here going forward. Operator: Moving next to Allison Bratzel with Piper Sandler. Ashleigh Acker: This is Ashleigh on for Ally. Just two questions from us. So just curious to learn what's the latest on the companion diagnostic development. I know you guys have talked about this on previous earnings calls. So just looking for some updated thoughts there. And also just based on the data today and this data set, it looks like the CD47 biomarker strategy is being further validated. So does this impact the statistical powering at all for ASPEN-09? Jason Lettmann: Sure. That's great question. Do you want to go on the CDx front, Barb? Barbara Klencke: Yes. Sorry, Jason. Yes, the Ventana Laboratory is our partner. We are working right now on developing a companion diagnostic. What we want is by the time we are finishing the full data set of ASPEN-09, as I alluded to earlier, setting a cut point that could then be available for preselection of patients potentially in a Phase III trial. That's our base case assumption is that our Phase III would be in preselected patients. So we will have an assay available. And then if that Phase III study is positive, of course, then we would work with our Ventana partner to not only bring evorpacept to market, but to ensure that the companion diagnostic were then commercially available. In terms of statistical powering -- go ahead. Go ahead, Jason. Jason Lettmann: No, go ahead, Barb. I just -- I mean, to kick that off, I mean, I think, of course, we're not going to power the study at 100% ORR, and that's not what we're going to do. And I think -- but if you look at the beauty of a targeted approach, I think it allows and our hope is it will allow a much more targeted Phase III where we can run a tighter registrational study with assumptions that I think are reflective of what we've seen, which has been a really strong spread, if you will, both in terms of ORR as well as DOR and PFS. But go ahead, Barb, I know I cut you off there. Barbara Klencke: No, no, that's exactly right. I think with a single-arm trial, ASPEN-09, the statistics are really around estimating the point estimate of the response rate and narrowing the confidence intervals with a larger sample size. But what ASPEN-09 does is it allows us potentially greater precision with this larger trial of 120 patients such that we can then have a lot of confidence walking into a Phase III subsequently and really understanding the treatment effect in patients based on their CD47 status. Operator: Moving next to Li Watsek with Cantor. Daniel Bronder: This is Daniel Bronder on for Li Watsek. We have a couple, one more technical and then one regulatory. We'll start with the technical one. On the poster from ESMO breast, you have the concordance of HER2 amplification by ctDNA and FISH. I was just curious how that translates into HER2 positivity in IHC. And then on the regulatory front, you mentioned registrational trials a few times in your opening remarks and in the previous response as well. Does that mean you're ruling out a potential accelerated approval based on ASPEN-09? Or are you keeping optionality here? Jason Lettmann: Those are great questions. Go ahead. Barbara Klencke: I'm sorry, I should stop doing that. And Dr. Hurvitz, I'll have you make some comments after I'll address the regulatory one first, give you a chance, but I'll have you talk a little bit to the HER2 data that was in the poster. So the regulatory strategy, Jason said a few minutes ago that we do not have an expectation that we could replicate 100% response rate. That would be fabulous if we could. And if we do, I think absolutely, we would talk to the health authorities, U.S. FDA about an accelerated approval strategy. I just think that, that is such a high bar, and we're also very, very aware that an advantage for patients would be anything north of, say, 30%. So we'll just have to wait and see what those response rate -- what the response rate is in ASPEN-09. I think regulatory approvals for single-arm trials when you have a combination of two agents, very difficult to get an accelerated approval. It's also true that it's very difficult to get an accelerated approval with retrospective application of a companion diagnostic. We would need at least some additional prospectively selected patients. So there are a lot of regulatory considerations. But I think at this case, that is not our base case. Our base case is that a Phase III trial will be required because the bar is high for accelerated approval, but we'll just have to wait and see what the response rate is. If it's extraordinary, we'll talk about it. If it's somewhere north of 30%, but less than 100%, it's going to be an uphill battle. But obviously, that would benefit patients if we could bring it to market sooner, but we'll wait and see. So maybe I'll flip it back to Dr. Hurvitz to talk a little bit about some of this HER2 data in the poster. Sara Hurvitz: Yes. Thank you, Barb. The HER2 data is actually kind of interesting. So there are 2 aspects. First, there was a difference in the central confirmation of HER2-positive disease that was shown in the poster where 10 of the patients out of the 24 were noted to have centrally confirmed HER2-positive disease and 14 were not. And I would just call out that this is not uncommon. It's been reported in other studies that there is discordance. And it may not necessarily mean that there's been HER2 loss that's occurred over time. It may actually be related to artifact from testing older tissue. It's important to keep in mind that in order for patients to enroll in the study, HER2 status was based on archival tissue that was read locally. But once they got on the study, the assays that were done were done on fresh biopsy samples obtained at the start of the study from most patients, and those were tested centrally. And so the testing changed from local to central and also from archival tissue to fresh tissue after in HER2 for the vast majority of subjects. So either of those factors could have contributed to the differences between local HER2 positive results and central positive results. Another point was in the poster in Table 2, there were some data presented looking at concordance between HER2 amplification status by the central tissue-based FISH as well as plasma ctDNA next-generation sequencing. And it's important to call out that of the 6 patients with HER2 amplification by FISH -- or excuse me, the 7 patients, 6 of them were also noted to have amplification by ctDNA. Just one of the patients there did not, and that may have just been due to the fact that there wasn't enough circulating. There was a low tumor fraction. It was below the threshold of expression. But those that were negative centrally by FISH were also negative by ctDNA. And so that's reassuring and provides sort of validation that the central HER2 amplification is correlating well with circulating tumor DNA. Operator: We'll go to our next question from Roger Song with Jefferies. Jiale Song: Congrats on the positive data and excited about the momentum going into ASPEN-09. Maybe two from us. So you previously mentioned we're seeing roughly half of HER2-positive patients being CD47 high. As we're into the early ASPEN-09 screening, is the observations you're seeing consistent with that half of HER2-positive patients being CD47 high? And then is tissue adequacy and turnaround time any potential gating factor here for enrollment? Jason Lettmann: Yes, sure. Good question. So I think on the ASPEN-09 front, of course, we're going to monitor that closely. And then in terms of the disclosure, we'll wait and disclose that when we get to the data readout on 80 patients. Obviously, I think it's something that's important, and we're able to monitor really quite quickly. So the lag has not been a concern. And of course, I think our team is focused on that. But Barb, do you want to add anything there? Barbara Klencke: Only that the ASPEN-09 study enrolls patients irrespective of CD47. So there is no urgency in terms of the turnaround. You're absolutely right that it would be something that we need to ensure that we work through those processes for a future Phase III, assuming that, that future Phase III requires CD47 overexpression for entry. But this study does not. So the urgency is not there. But as Jason says, we're not going to disclose prevalence rates or any of the biomarker data until we come out with data in the middle of 2027. Operator: Moving next to Sam Slutsky with LifeSci Capital. Oliver McCammon: This is Oliver McCammon on for Sam Slutsky. So in the Phase Ib/II breast cancer study, you defined CD47 high as total membrane staining of 20% or greater. And in the past, you talked about 10% or greater IHC 3+ as being a cutoff for CD47 high. Can you just discuss the nuances of the 2 cutoffs used and the selection process? Jason Lettmann: Sure. Thanks, Oliver. Again, I think Barb hit on this, but we fully anticipated even ahead of this data that the expression profiles would be different. There's, of course, a lot of similarities between HER2 positive tumor types. Insofar as typically a drug that works in one will work in the other. That said, I think there will be a difference in expression, and we're seeing that here. And again, I would just highlight that if you think about defining a cutoff when you see ORR as high as we're seeing across both of those studies, it suggests there's probably many different right answers, if you will, in terms of the cutoff we could use. But Barb, do you want to expand on that? Barbara Klencke: Just in terms of total membrane staining and how that's calculated. So the proportion of cells that are 1 plus are multiplied by 1, the proportion of cells that are 2 plus IHC stain staining intensity would be multiplied by 2 and so forth. So IHC 3, multiply the proportion of cells that are IHC 3+ by -- and then you add those. So it's a cumulative total. So if I were to look at the threshold for gastric 10% or more of cells being 3 plus, that would potentially be about a score of 30. It may be that different labs and slightly different methods. But to put it in context, it's similar, but it's -- cut point was a little bit lower in the zanidatamab trial. It was zanidatamab-evorpacept was a very small trial. So we will look again once we have data from ASPEN-09 and optimize that. So it may change. In fact, that likely change much, much sample size, but technically we are doing it. And we modified it a bit once we start work towards development [indiscernible] with our partners at [indiscernible]. Operator: This now concludes our question-and-answer session. I would like to turn the floor back over to Jason Lettmann for closing comments. Jason Lettmann: Great. Thanks, everybody. It was a strong quarter for us. I appreciate all the engagement here today. Both programs, as we mentioned, are on track and super excited about what we're seeing in both. So again, I appreciate the questions and support and looking forward to future updates. Enjoy your Friday and your weekend. Thanks so much. Operator: Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a wonderful day. Before you buy stock in ALX Oncology, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and ALX Oncology wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $463,900!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,294,401!* Now, it’s worth noting Stock Advisor’s total average return is 978% — a market-crushing outperformance compared to 211% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of June 1, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. ALX Oncology (ALXO) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the quarter's success to clinical data demonstrating that high CD47 expression is a key predictive biomarker for durable response in HER2-positive cancers. The evorpacept (Evo) mechanism is designed to block 'don't eat me' signals without an active Fc domain, avoiding the on-target toxicities that caused previous CD47 inhibitors to fail. Clinical results from the zanidatamab combination trial showed a 100% response rate in centrally confirmed HER2-positive/CD47-high patients, validating the targeted oncology strategy. Strategic positioning focuses on the post-ENHERTU (T-DXd) setting, an area of high unmet need where current standard-of-care treatments typically yield poor progression-free survival. The company strengthened its leadership and balance sheet through a February financing, providing the runway needed to reach major data milestones over the next 12 to 18 months. Operational execution remains on track for the ALX2004 program, an EGFR-targeted ADC designed with a novel epitope to minimize skin toxicity and maximize the therapeutic window. Interim top-line data from approximately 80 patients in the ASPEN-09 Phase II breast cancer trial is expected by mid-2027. Initial safety data for the ALX2004 EGFR-targeted ADC is on track for a readout in the second half of 2026. Management aims to have both evorpacept and ALX2004 ready for registrational studies by the end of 2027. The ASPEN-09 study is designed to optimize the CD47 cut-point, which will likely inform the pre-selection strategy for a future Phase III trial. The company estimates a $2 billion to $4 billion market opportunity across the US, Europe, and Japan for HER2-positive/CD47-high patients. Management noted that while the 100% response rate in the biomarker-high subset is compelling, the sample size was small (5 patients) and requires validation in larger cohorts. The regulatory path for accelerated approval remains difficult for combination therapies and retrospective biomarker applications, making a Phase III trial the base-case assumption. Discordance between local archival HER2 testing and central fresh biopsy testing was noted, highlighting the importance of central assessment in late-line clinical trials. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management considers an objective response rate (ORR) north of 30% to be a very good outcome, effectively doubling the expected 15% rate of current therapies. A duration of response (DOR) of 6 months or more would be significant, though early data in mid-2027 may be somewhat immature for full PFS assessment. Dr. Hurvitz indicated that if validated, CD47 would likely be developed as a companion diagnostic to select patients most likely to benefit from evorpacept. Current screening for ASPEN-09 does not use CD47 as an entry gate, allowing the company to collect data across both high and low expression levels to define the optimal cut-point. ALX is partnering with Ventana to develop a companion diagnostic assay intended to be available for patient pre-selection in a potential Phase III trial. The company expects roughly 50% to 70% of the target population to overexpress CD47, particularly in advanced, post-T-DXd settings.

Interested in ALX Oncology Holdings Inc.? Here are five stocks we like better. Evorpacept data presented at ESMO indicate CD47 expression may predict benefit — centrally confirmed HER2‑positive patients with CD47 ≥20% had a 100% ORR, median DOR ~20.2 months and median PFS ~22 months versus 3.4 months in CD47‑low patients, consistent with ASPEN‑06 gastric results. ASPEN‑09 is a single‑arm phase 2 (up to 120 patients) targeting the CD47‑overexpressing subset, with interim top‑line data from ~80 patients expected by mid‑2027; ALX says a ~30% ORR and DOR ≥6 months would be considered a compelling outcome versus historical ~15% post‑ENHERTU response rates. ALX2004, the company’s EGFR‑targeted ADC, remains in dose escalation with enrollment progressing and an initial safety readout expected in the 2H 2026 timeframe. ALX Oncology (NASDAQ:ALXO) executives used the company’s first-quarter 2026 earnings call to highlight new clinical data for its lead CD47 blocker, evorpacept, and to provide updates on its EGFR-targeted antibody-drug conjugate program, ALX2004. CEO Jason Lettmann said the quarter featured “continued good execution,” including a February financing and the addition of Jeff Knight as chief development and chief operating officer. Lettmann said the company was “very excited” to share data presented at ESMO Breast Cancer 2026 in Munich from an analysis of a phase 1b/2 trial evaluating evorpacept in combination with zanidatamab in heavily pre-treated HER2-positive metastatic breast cancer. He said the analysis “clearly showed again that CD47 expression is a key predictive biomarker for increasing durable clinical response,” and characterized the findings as consistent with prior results in HER2-positive gastric cancer from the company’s ASPEN-06 trial. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Fred Hutch Cancer Center’s Dr. Sara Hurvitz, a steering committee member for ALX’s ongoing ASPEN-09 breast cancer study and an investigator on the zanidatamab plus evorpacept trial, described the post-trastuzumab deruxtecan (T-DXd/ENHERTU) setting as an area of unmet need. Hurvitz pointed to observational and retrospective datasets suggesting median progression-free survival (PFS) “under 6 months” after T-DXd, and referenced a figure showing “median progression-free survival of only 4.1 months” following prior ENHERTU treatment. Hurvitz said the exploratory biomarker analysis covered 24 patients from the dose-escalation cohort and cohort 1, noting the group was “extremely heavily pretreated,” with all patients having received prior T-DXd and a median of five prior lines of HER2-targeted therapies. Patients entered based on local HER2 testing of archival tissue, but most had fresh baseline biopsies with retrospective central HER2 assessment, and tumors were also tested for CD47 expression. → Light Speed Returns: Corning Cashes In on NVIDIA Growth Hurvitz reported that in the full 24-patient intent-to-treat population, the confirmed objective response rate (ORR) was 33%, with a median duration of response (DOR) of 20 months and median PFS of 3.6 months. In the subset of 10 patients with centrally confirmed HER2-positive disease, ORR increased to 60%, with median DOR of 20.2 months and median PFS of 8.3 months. Patients without centrally confirmed HER2-positive disease had a lower ORR of 14%, according to the presentation. Breaking the centrally confirmed HER2-positive group down by CD47 expression using a retrospective cutoff of at least 20% total membrane staining, Hurvitz said all five patients who were HER2-positive and CD47-high responded (100% ORR) with a median DOR of 20.2 months. Among four centrally confirmed HER2-positive patients with CD47 expression below 20%, one responded. A Kaplan-Meier analysis presented on the call showed median PFS of 22 months in the CD47 ≥20% group versus 3.4 months in the CD47 <20% group, though Hurvitz cautioned the numbers were small and said she hoped to see the findings confirmed in a larger study. → Years in the Making, AMD’s Upside Movement Has Just Begun Chief Medical Officer Barbara Klencke added that an IHC assay quantified CD47 total membrane staining and that a “positive result was defined retrospectively as a score of 20% or higher.” She said all five CD47-high patients responded, including one complete response, while four patients without CD47 overexpression included one responder, and one additional patient was unevaluable. Klencke emphasized what she called consistency across two independent HER2-positive cancer studies. In ASPEN-06, a randomized phase 2 trial of evorpacept added to trastuzumab, paclitaxel, and ramucirumab versus the regimen alone, she said response rates in the evorpacept arm were 41% in the intent-to-treat population, “over 49%” in patients who retained HER2-positive disease, and 65% in tumors that also expressed CD47. She noted ASPEN-06 enrolled 127 patients. She also highlighted durability metrics in CD47-high subsets, citing DOR of 20.2 months in the breast study and 25.5 months in ASPEN-06. For PFS, Klencke cited a median of 22.1 months in the breast CD47-high cohort versus 3.4 months in CD47-low, and in the gastric CD47-high subset, a median PFS of 18.4 months in the evorpacept arm with a hazard ratio of 0.39. ALX’s ongoing ASPEN-09 phase 2 breast cancer study will evaluate evorpacept plus trastuzumab in patients previously treated with ENHERTU. Klencke said the single-arm study will enroll up to 120 patients and has a primary endpoint of response rate in the subset that overexpresses CD47. The company said it remains on track to provide interim top-line data from approximately 80 patients by “the middle of 2027,” with Lettmann separately noting an expectation to read out 80 patients “mid next year” in prepared remarks. In response to an analyst question on what would be compelling ASPEN-09 outcomes, Klencke said available therapies after ENHERTU “are not producing very good outcomes,” adding that “much of the data suggests that the response rate may be 15%” with trastuzumab plus chemotherapy alone. She said a 30% response rate would represent a doubling versus that expectation, and that “anything north of 30% would be a very, very good outcome” with DOR of six months or more. She said DOR may be preliminary at the 80-patient mark and that PFS could be too immature to report, depending on follow-up. Hurvitz said she would view “anything around 30% objective response rate and a PFS of 6 months” as important in such heavily pre-treated patients. On biomarker implementation, Hurvitz said if CD47 is validated as predictive, she would expect work toward a companion diagnostic, though she said it was “too little data at this point” to be definitive. Klencke said Ventana is the company’s partner on companion diagnostic development, with a goal of having an assay and cut point set by the time ASPEN-09 is complete to potentially enable patient selection in a phase 3 study. Asked about the prospect of accelerated approval, Klencke said the company’s “base case is that a phase III trial will be required,” citing regulatory challenges for single-arm combination trials and “retrospective application of a companion diagnostic.” She added the company would discuss accelerated approval with regulators if the response rate were “extraordinary.” ALX also reiterated progress with ALX2004, its in-house EGFR-targeted ADC. Klencke said the molecule was designed to minimize off-tumor skin toxicity, target a distinct epitope from approved EGFR antibodies, and use a proprietary linker and a proprietary topoisomerase-1 inhibitor payload with an antibody-drug ratio of eight. The phase 1 study includes dose escalation, exploration, and expansion cohorts in lung, head and neck, colorectal, and esophageal cancers. The company said enrollment is progressing and reiterated it remains on track to report initial safety data in the second half of 2026. Klencke noted the company had previously disclosed dose escalation from 1 mg/kg to 2 mg/kg and then to a 4 mg/kg cohort, and said ALX is now shifting away from granular dose-escalation updates until the initial safety report. Closing the call, Lettmann said the company believes the new dataset adds to evidence across two HER2-positive cancers that evorpacept can deliver meaningful benefit and that a CD47-targeted approach “can drive transformational benefit to patients.” He added that the company’s balance sheet was strengthened by the February financing and said ALX expects “additional updates very soon.” ALX Oncology, Inc is a clinical-stage biopharmaceutical company headquartered in Redwood City, California, focused on developing next-generation immuno-oncology therapies. The company's mission is to harness and amplify both innate and adaptive immune responses to improve outcomes for patients with a range of solid tumors and hematologic malignancies. The lead candidate in ALX Oncology's pipeline is evorpacept (ALX148), a high-affinity CD47-blocking Fc-silenced fusion protein designed to enhance macrophage-mediated phagocytosis of cancer cells when combined with standard therapeutic antibodies or immune checkpoint inhibitors. The article "ALX Oncology Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

- Data from Phase 1b/2 trial of evorpacept + zanidatamab presented at ESMO Breast Cancer 2026 showed all patients with confirmed HER2-positive disease and high CD47 expression experienced durable responses to this combination - - Evorpacept data from two independent HER2-positive trials strengthens confidence in the CD47-selection hypothesis and potentially derisks path forward in HER2-positive breast cancer - - Phase 2 ASPEN-09-Breast trial evaluating evorpacept in combination with trastuzumab and chemotherapy in HER2-positive metastatic breast cancer is on track for topline data mid-2027 - - Phase 1 trial evaluating ALX2004 continues to enroll well, on track for safety data in 2H 2026 - - ALX strengthens leadership team with the appointment of Jeff Knight as Chief Development and Operating Officer - - Company to host webcast including presentation of ESMO Breast data by breast cancer expert Sara Hurvitz, M.D., FACP, on Friday, May 8, at 5:30 a.m. PT / 8:30 a.m. ET - SOUTH SAN FRANCISCO, Calif., May 08, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology” Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. “We are encouraged by the data presented yesterday at the ESMO Breast Cancer 2026 congress, which reinforce the potential of our CD47-inhibitor evorpacept to provide durable responses in patients with HER2-positive cancers that express high levels of CD47,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Coupled with the previous results from the ASPEN-06 gastric cancer trial, these findings validate our development strategy and reinforce our confidence in the ongoing Phase 2 ASPEN-09-Breast trial. Additionally, we are pleased with the progress of the Phase 1 trial for ALX2004, which remains on track to report dose-escalation safety data this year. With a strengthened balance sheet, we are well-positioned to deliver key data readouts from both ongoing clinical programs.” “It is encouraging to see clinical improvements in patients with heavily pre-treated HER2-positive breast cancer. As the landscape for HER2-positive advanced breast cancer continues to evolve, there remains a clear need for new options once patients’ disease progresses following treatment with currently available therapies, including trastuzumab deruxtecan,” said Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center, University of Washington. “The findings from this Phase 1b/2 trial suggest that combining evorpacept with HER2-targeted agents, guided by CD47 biomarker-driven selection, may offer a promising strategy to address this unmet need.” ALX Oncology Q1 2026 Highlights and Recent Developments Evorpacept Data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA®) in patients with heavily pre-treated metastatic breast cancer (mBC), all of whom had received prior ENHERTU® (fam-trastuzumab deruxtecan-nxki) therapy, were presented for the first time in a poster session at the ESMO Breast Cancer 2026 congress on Thursday, May 7. The findings show that patients with centrally confirmed HER2-positive (ccHER2-positive) mBC and high CD47 expression experienced promising, durable responses. The exploratory analyses comprised 24 patients, including 10 with ccHER2-positive disease. Seventeen of 24 samples were evaluable for CD47 expression, including samples from nine of the 10 ccHER2-positive patients. Patients received zanidatamab plus evorpacept at dosages of 20 mg/kg (n=3) or 30 mg/kg (n=21). As of the August 1 2024, data cut-off, key findings from the analyses include: The confirmed objective response rate (cORR) among all 24 patients was 33% and the median progression free survival (mPFS) was 3.6 months. Patients with ccHER2-positive disease (n=10) had higher response rates, with a cORR of 60% and mPFS of 8.3 months. All of the patients (n=5/5) with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) responded (including one complete response and four partial responses), with a median duration of response (mDOR) of 20.2 months and mPFS of 22.1 months. In comparison, among the patients with ccHER2-positive disease and low CD47 expression (defined as total membrane staining of <20%), cORR was 25% (n=1/4) and mPFS was 3.4 months. The findings are consistent with previous results from the randomized ASPEN-06 trial in HER2-positive gastric cancer, which indicated CD47 was predictive of evorpacept activity, and support a biomarker-driven approach. Together, these two independent trials suggest that adding evorpacept can yield positive, durable responses in heavily pretreated HER2-positive patients. The ongoing ASPEN-09-Breast Phase 2 trial evaluating evorpacept plus trastuzumab and physician’s choice of chemotherapy in patients with HER2-positive breast cancer previously treated with ENHERTU is designed to enable this biomarker-driven approach. Enrollment in the trial remains on track globally and the Company expects to provide topline data for 80 patients in mid-2027. ALX2004 The dose-escalation portion of the Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, continues to enroll patients at ascending dose levels and is on track to report safety data in 2H 2026. Corporate Update In February 2026, the company completed a registered equity offering, selling 76,979,112 shares of common stock at $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at $1.569 per underlying share. Gross proceeds from the offering were $150 million. Net proceeds of the offering were $140.4 million, after deducting the underwriting discount and other offering expenses. In April 2026, ALX Oncology appointed Jeff Knight as Chief Development and Operating Officer, strengthening the Company’s development capabilities and operational infrastructure to support high-quality execution and deliver on upcoming milestones. Mr. Knight has more than 30 years of experience across the biopharmaceutical industry, with demonstrated success advancing programs from early development through commercialization, including multiple oncology programs. Upcoming Clinical Milestones Phase 2 ASPEN-09-Breast trial: Topline data readout for 80 patients anticipated in mid-2027. Phase 1 ALX2004 trial: Safety data from the dose-escalation phase of the trial anticipated in 2H 2026. Q1 2026 Results Conference Call and Webcast Details ALX Oncology management will host a webcast today, May 8, to provide an overview of Q1 2026 financial results. Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center; Professor and Head, Division of Hematology and Oncology, Department of Medicine, University of Washington will join the call to discuss and provide perspective on the Phase 1b/2 trial data shared at the ESMO Breast Cancer congress. Date & Time: Friday, May 8, 2026, 8:30 a.m. ET Guest Speaker: Sara Hurvitz, MD, Head of the Division of Hematology and Oncology, University of Washington Webcast Access: https://viavid.webcasts.com/starthere.jsp?ei=1758590&tp_key=2800839c82 Participant Listening Options by Phone: To access the conference call, please dial 1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology First Quarter 2026 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call Me™ link below: https://callme.viavid.com/viavid/?callme=true&passcode=13755276&h=true&info=company&r=true&B=6 A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event. First Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2026, were $169.1 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations through the first half of 2028. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended March 31, 2026 were $13.6 million compared to $23.9 million for the prior-year period, or a decrease of $10.3 million. This decrease was primarily attributable to a decrease of $4.4 million in personnel and related costs driven by the reduction in workforce in early 2025, a decrease of $2.3 million in clinical and development costs due to change in clinical development strategy reducing the number of active clinical trials, a decrease of $1.8 million in stock-based compensation expense, and a decrease of $1.3 million in preclinical costs due to pipeline prioritization strategy. General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended March 31, 2026 were $5.4 million compared to $7.9 million for the prior year period, or a decrease of $2.6 million. This decrease was primarily attributable to a decrease of $1.0 million in personnel and related costs driven by the reduction in workforce in early 2025, a decrease of $0.9 million in stock-based compensation expense, and a decrease of $0.7 million in legal and corporate costs. Net loss: GAAP net loss was ($17.9) million for the three months ended March 31, 2026, or ($0.17) per basic and diluted share, as compared to a GAAP net loss of ($30.8) million for the three months ended March 31, 2025, or ($0.58) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. Non-GAAP net loss was ($15.4) million for the three months ended March 31, 2026, as compared to a non-GAAP net loss of ($25.5) million for the three months ended March 31, 2025. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. “Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact: Elhan Webb, CFA, IR Consultant [email protected] Media Contact: Michele Parisi, SparkPoint Healthcare Communications [email protected] (925) 864-5028

This article first appeared on GuruFocus. Cash Equivalents and Investments: $48.3 million as of the end of Q4 2025. Net Proceeds from Equity Financing: $140.4 million in February 2026. GAAP Net Loss: $22.8 million for Q4 2025, or $0.42 per basic and diluted share. Previous Year GAAP Net Loss: $29.2 million for Q4 2024, or $0.55 per basic and diluted share. Response Rate in HER2-Positive Gastric Cancer Study: 65% with evorpacept vs. 26% in control arm. Median PFS in Gastric Cancer Study: 18.4 months with evorpacept vs. 7 months in control arm. Median Overall Survival in Gastric Cancer Study: 17 months with evorpacept vs. 10 months in control arm. Complete Response Rate in Indolent NHL Patients: 92% with evorpacept combined with R-squared regimen. Warning! GuruFocus has detected 3 Warning Signs with ALXO. Is ALXO fairly valued? Test your thesis with our free DCF calculator. Release Date: February 27, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. ALX Oncology Holdings Inc (NASDAQ:ALXO) announced the permanent appointment of Dr. Barb Klencke as Chief Medical Officer, bringing extensive experience in oncology and drug development. The company reported significant progress in its clinical programs, particularly with Evorpacept (EVO) and ALX2004, positioning them for pivotal studies by the end of next year. Evorpacept demonstrated promising results in HER2-positive gastric and breast cancer trials, showing high response rates and durability, particularly in patients with high CD47 expression. ALX Oncology Holdings Inc (NASDAQ:ALXO) successfully completed a $150 million financing, strengthening its balance sheet and extending its cash runway through the first half of 2028. The company is on track with its clinical timelines and expects to provide meaningful data readouts from its ongoing trials over the next 12 to 18 months. The interim data readout for the ASPEN-09-Breast trial has been pushed to mid-2027, delaying insights into the trial's progress. There is a need to expand the ASPEN-09-Breast trial to 120 patients to ensure robust data, indicating potential concerns about statistical power or biomarker prevalence. The safety data for ALX2004 has been delayed to the second half of 2026, potentially impacting investor confidence in the program's progress. The company faces challenges in determining the optimal CD47 cut point for patient selection, which is crucial for the success of its trials. There are concerns about the impact of subsequent ADC use on CD47 expression, which could affect the efficacy of Evorpacept in certain patient populations. Q: Could you confirm if the interim look at ASPEN-09-Breast is off the table in favor of the 80-patient readout next year? Also, could you elaborate on the rationale behind upsizing to 120 patients and the change in the primary endpoint? A: Yes, we are guiding towards 80 patients, with full data expected in mid-next year. The upsizing to 120 patients ensures robust numbers across various subpopulations. The primary endpoint has been updated to focus on response rate in patients with high CD47 expression, as CD47 has shown to be a powerful predictive biomarker. Investigators are excited about the biomarker approach, and enrollment trends are positive, with strong interest from sites. Q: It seems like you've pushed out the safety data for ALX2004. Can you explain the reasons for this? A: The change is to ensure we communicate robust data. By the end of the year, we expect to have comprehensive data from the dose escalation phase, allowing us to be clearer about the expected dose range. This approach ensures that updates are meaningful and full. Q: For the ASPEN-09 study, what's the expected ratio of patients with high versus low CD47 expression? Also, could you explain the difference in the therapeutic dose range for ALX2004 compared to other EGFR ADCs? A: We expect about half of the patients to have high CD47 expression, consistent with literature. Regarding ALX2004, the highest non-severely toxic dose in primates was 20 mg/kg, suggesting a potential patient dose around 6.5 mg/kg. We anticipate a wider therapeutic window, allowing for better efficacy. Q: With the expansion of the ASPEN-09 trial to 120 patients, is this driven by statistical power or concerns about biomarker prevalence? Also, how are you monitoring interstitial lung disease and skin toxicity for ALX2004? A: The expansion ensures a robust Phase 2 trial to de-risk Phase 3. We expect CD47 high prevalence to be consistent with previous studies. For ALX2004, we monitor interstitial lung disease through regular CT scans and skin toxicity through clinical examinations, with guidelines in place for early detection. Q: Is the IHC cutoff for ASPEN-09's primary endpoint locked in, and how do you handle borderline cases with insufficient tissue? A: The IHC cutoff is informed by previous studies, but the current study will help refine it. We don't anticipate significant issues with tissue evaluability, as CD47 is stable and IHC is a standard assay. We expect measurable CD47 in nearly all patients. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Management is transitioning evorpicept (EVO) to a targeted oncology approach after clinical data identified CD47 as a critical predictive biomarker for durable response. Performance in HER2-positive gastric and breast cancer trials demonstrated that clinical benefit is largely restricted to patients overexpressing CD47, validating the drug's mechanism in combination with Fc-active antibodies. The company achieved a strategic financing of $150,000,000 in February 2026, extending the cash runway through 2028 and supporting expanded clinical cohorts. Operational focus has narrowed to two core programs: advancing EVO in breast cancer and escalating doses for the EGFR-targeted ADC, ALX 2004. The 'R-squared' combination in non-Hodgkin’s lymphoma yielded a 92% complete response rate, nearly doubling benchmark results and reinforcing EVO's potential in hematologic malignancies. Management attributes a year-over-year decrease in net loss to disciplined pipeline prioritization and reduced spending on legacy clinical trials. The company aims to have both evorpicept and ALX 2004 ready for pivotal phase studies by the end of 2027. The phase 2 ASPEN-9 breast cancer trial has been expanded from 80 to 120 patients to ensure a robust sample of CD47-overexpressing participants for regulatory validation. Top-line efficacy and safety data from the expanded ASPEN-9 trial, including response rates and biomarker results, are anticipated in mid-2027. ALX 2004 safety data from the dose-escalation phase is expected in the second half of 2026, with current dosing at 4 mg/kg considered the lower end of the therapeutic range. Development of a companion diagnostic for CD47 expression has been initiated to support a prospective selected registration study. Dr. Barbara Klencke was appointed as permanent Chief Medical Officer following a successful interim period driving clinical development. The primary endpoint for the ASPEN-9 trial was updated to focus specifically on response rates in patients with high CD47 expression. Management noted that while in-HER2 has shifted the treatment landscape, real-world evidence suggests a significant unmet need for effective subsequent therapies where EVO could be first-in-class. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. The expansion to 120 patients is intended to provide a robust dataset to define the optimal CD47 cut-point for future FDA registration studies. Management shifted the primary endpoint because CD47 has proven to be a more powerful predictor of response than HER2 status alone in recent datasets. The 4 mg/kg dose is currently being tested; management believes the therapeutic window may extend up to 6-7 mg/kg based on non-human primate data. The unique protein design of the metuzumab antibody is expected to result in lower skin toxicity and interstitial lung disease compared to other EGFR-targeted therapies. Management expects approximately 50% of the breast cancer population to be CD47-high, consistent with findings in their gastric cancer studies. Literature suggests CD47 expression may actually increase after exposure to in-HER2, potentially expanding the addressable patient population for evorpicept. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Evorpacept shows promising activity in CD47‑overexpressing HER2+ tumors — a randomized phase 2 gastric subset reported a 65% response rate versus 26% control, median DOR >2 years, and median PFS 18.4 vs 7 months (HR 0.39), supporting CD47 as a predictive biomarker. The phase 2 ASPEN‑09‑Breast study has been expanded from 80 to up to 120 patients and refocused on response rate in CD47‑high patients, with management guiding a top‑line readout from 80 patients in mid‑2027. ALX strengthened its balance sheet by closing a $150 million financing (≈$140.4 million net), and says cash and investments should fund operations through the first half of 2028. Interested in ALX Oncology Holdings Inc.? Here are five stocks we like better. ALX Oncology (NASDAQ:ALXO) outlined progress across its two core programs—CD47 blocker evorpacept and EGFR-targeted antibody-drug conjugate ALX2004—while providing updated clinical timelines and financial runway during its fourth-quarter and full-year 2025 results call. Chief Executive Officer Jason Lettmann said the company’s priority remains execution and positioned 2025 as a year that generated extensive evorpacept clinical data to refine development strategy. ALX also announced that Dr. Barbara Klencke, who joined in an interim capacity in September 2025, will remain as permanent Chief Medical Officer. Lettmann highlighted her prior CMO experience at Sierra Oncology and senior roles at Onyx and Genentech. → SoundHound’s New Sales Assist Agent Put Voice AI Back in the Spotlight Management reiterated its objective to advance both evorpacept and ALX2004 to a stage “ready for pivotal studies” by the end of next year, while emphasizing that clinical development timelines remain on track. ALX emphasized CD47 expression as an increasingly validated biomarker for response to evorpacept-based combinations in HER2-positive cancers. Lettmann said the company has treated more than 750 patients with evorpacept to date and is increasingly confident about where the drug works best. → Diamondback Sees Resilient Demand Despite Cautious Guidance Klencke reviewed results from a randomized phase 2 HER2-positive gastric cancer study presented at SITC in November 2025, focusing on patients whose tumors were HER2-positive and overexpressed CD47. In that subset, she said: Response rate was 65% in second- and third-line patients receiving evorpacept plus a trastuzumab-based regimen, versus 26% in the control arm. Median duration of response was more than two years and more than three times longer than in the control arm. Median progression-free survival was 18.4 months versus 7 months (hazard ratio 0.39). Median overall survival was 17 months versus approximately 10 months (hazard ratio 0.7). She said the findings support CD47’s potential as a predictive biomarker and strengthen confidence in ongoing breast cancer development. → Keurig Dr Pepper’s Split Plan Could Unlock Hidden Value Separately, the company discussed a phase 1/2 study conducted with partner Jazz evaluating evorpacept in combination with zanidatamab in HER2-positive metastatic breast cancer patients who had progressed on prior HER2-directed therapies and had all received ENHERTU. Klencke noted ALX first presented data from this trial at the San Antonio Breast Cancer Symposium in December 2024, reporting that among nine late-line patients with confirmed HER2 expression by central assessment, the response rate was 56%, with duration of response ranging from 5.5 to nearly 26 months and median PFS of 7.4 months. She said the company concluded CD47 biomarker analysis in January 2026, finding that responders were “predominantly restricted” to patients with CD47 overexpression. Full biomarker results are expected at the ESMO Breast Cancer Conference in Q2 2026. ALX provided an update on its ongoing phase 2 ASPEN-09-Breast study evaluating evorpacept with trastuzumab and single-agent chemotherapy in HER2-positive metastatic breast cancer patients who have progressed on ENHERTU. Klencke said the company has decided to expand the study from 80 to up to 120 patients to increase the number of patients with CD47 overexpression and to help define an optimal CD47 cut point. The company also updated the primary endpoint to response rate in patients with high CD47 expression, with a key secondary endpoint tracking response rate by HER2 status informed by ctDNA. In the Q&A, management confirmed it is now guiding to a top-line readout from 80 patients in mid-2027, rather than an interim look sooner. Lettmann described the shift as an effort to provide more “robust” and “meaningful” data, including sufficient representation of CD47-high patients. Klencke said investigators have expressed enthusiasm for a biomarker-driven strategy. On expected prevalence, Lettmann said ALX observed roughly 40% to 57% CD47-high rates across cutoffs in its gastric study, and expects about half of patients could be CD47-high in breast cancer based on literature, while acknowledging the cut point and expression profile may differ by tumor type. Management also cited literature suggesting CD47 overexpression may rise after ENHERTU exposure. Enrollment remains early, with Klencke noting the first patient was enrolled in January and that global site activations are progressing on plan. ALX said it expects to share “meaningful efficacy and safety data,” including response rate, biomarker results, and early durability trends, by mid-2027. ALX also highlighted progress for ALX2004, its EGFR-targeted ADC, noting the challenge of developing EGFR ADCs due to a narrow therapeutic window. Klencke discussed preclinical attributes, including broad antitumor activity across models and the absence of EGFR-related skin toxicity and interstitial lung disease (ILD) in GLP toxicology studies in non-human primates. She said the ADC uses the matuzumab antibody, described as having an affinity-tuned epitope, combined with a proprietary topoisomerase I inhibitor linker-payload designed for stability and bystander effect. Clinically, the company has cleared the first two dose cohorts and is enrolling patients in the third dose cohort at 4 mg/kg after seeing no dose-limiting toxicities at 1 mg/kg and 2 mg/kg. Klencke said ALX believes 4 mg/kg may be at the lower end of the therapeutic range and expects smaller incremental escalations from here. The phase 1 trial is enrolling patients with non-small cell lung cancer, colorectal cancer, head and neck cancer, or esophageal squamous cell cancer. Management guided to providing ALX2004 dose-escalation safety data in the second half of 2026. In Q&A, Lettmann said the timing reflects a focus on delivering a more complete dataset, and indicated it is reasonable to expect up to four dose levels may have been tested by the time of disclosure. Klencke said ILD monitoring includes regular CT imaging per protocol and that skin toxicity will be assessed at clinic visits, while noting matuzumab was selected in part for lower skin toxicity compared with other EGFR antibodies. CFO Harish Shantharam said ALX ended Q4 2025 with $48.3 million in cash, equivalents, and investments prior to a February financing. The company closed a $150 million financing with $140.4 million in net proceeds after underwriting discounts and offering expenses. Following the raise, Shantharam said ALX believes its cash and investments are sufficient to fund operating expenses through the first half of 2028. For the quarter ended Dec. 31, 2025, ALX reported a GAAP net loss of $22.8 million, or $0.42 per share, compared with a GAAP net loss of $29.2 million, or $0.55 per share, in the year-ago quarter. Shantharam attributed the year-over-year decrease primarily to lower stock-based compensation, lower personnel-related costs, and lower preclinical costs following pipeline prioritization. ALX’s guided milestones include the ESMO Breast Cancer biomarker presentation in May 2026, ALX2004 dose escalation safety data in the second half of 2026, and ASPEN-09-Breast top-line data from 80 patients in mid-2027. ALX Oncology, Inc is a clinical-stage biopharmaceutical company headquartered in Redwood City, California, focused on developing next-generation immuno-oncology therapies. The company's mission is to harness and amplify both innate and adaptive immune responses to improve outcomes for patients with a range of solid tumors and hematologic malignancies. The lead candidate in ALX Oncology's pipeline is evorpacept (ALX148), a high-affinity CD47-blocking Fc-silenced fusion protein designed to enhance macrophage-mediated phagocytosis of cancer cells when combined with standard therapeutic antibodies or immune checkpoint inhibitors. The article "ALX Oncology Q4 Earnings Call Highlights" was originally published by MarketBeat.

- Clinical development for both the investigational CD47-inhibitor evorpacept and the novel EGFR-targeted antibody-drug conjugate ALX2004 remains on track following strong 2025 execution; company anticipates multiple meaningful data sets and milestones in the coming 12 to 18 months - - Evorpacept biomarker strategy validated by data from both the Phase 2 ASPEN-06 gastric cancer trial and the Phase 1b/2 breast cancer trial, independently suggesting CD47 overexpression is predictive of evorpacept activity and drives durable benefit in HER2-positive cancers - - Full biomarker analysis from Phase 1b/2 evorpacept-zanidatamab combination trial accepted for poster presentation at ESMO Breast Cancer 2026 Annual Congress - - Phase 2 ASPEN-09 breast cancer trial is currently enrolling patients and will evaluate evorpacept efficacy by CD47 expression levels, with topline data anticipated mid-2027 - - Phase 1 trial evaluating ALX2004 continues to enroll patients in the third dose cohort; safety data from dose-escalation phase expected in 2H 2026 - - Company completed a $150 million registered offering of common stock and pre-funded warrants, extending cash runway through 1H 2028 inclusive of key clinical program milestones for evorpacept and ALX2004 - - Barbara Klencke, M.D., appointed to Chief Medical Officer on a permanent basis - - Company to host webcast on Friday, February 27, at 5:30 a.m. PT / 8:30 a.m. ET - SOUTH SAN FRANCISCO, Calif., Feb. 27, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology”; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the fourth quarter and full year 2025, and provided a corporate update. “Through strong execution of our targeted clinical development strategy in 2025, we have positioned ourselves to achieve multiple significant catalysts in the clinical programs for evorpacept and ALX2004, two potentially best- and first-in-class agents, in the coming 12 to 18 months,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “We are particularly pleased that recent topline biomarker data from the Phase 1b/2 trial evaluating evorpacept with zanidatamab in advanced HER2-positive breast cancer reinforce findings from the ASPEN-06 HER2-positive gastric cancer trial, suggesting that CD47 is a predictive biomarker for evorpacept response. These findings strengthen our confidence in the ongoing Phase 2 ASPEN-09-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 has progressed following ENHERTU. “Additionally, we are pleased with the clinical progress of ALX2004, which has successfully cleared the first two dose cohorts in the ongoing Phase 1 trial. 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. 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,” said Lettmann. ALX Oncology Q4 and Full Year 2025 Highlights and Recent Developments Evorpacept Data from a pre-planned exploratory analysis of the Phase 2 ASPEN-06 clinical trial in gastric cancer showed that CD47 overexpression is a key predictive biomarker for evorpacept response and durable benefit in patients whose tumors have retained HER2 expression. Retained HER2 expression is defined as tumors that are HER2-positive following HER2-targeted treatment, as assessed by either a repeat tumor biopsy or HER2 gene amplification in circulating tumor DNA (ctDNA). These data were highlighted as part of a poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2025. In patients with retained HER2-positive and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (TRP) generated a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP alone. The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP alone in these patients. Evorpacept + TRP generated a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP alone. Progression-free survival (PFS) and overall survival (OS) data were also evaluated in these patients. Treatment with evorpacept + TRP resulted in a median PFS (mPFS) of 18.4 months versus 7.0 months for TRP alone, with a hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in a median OS of 17 months versus 9.9 months for TRP alone, with an HR of 0.70. Consistent with the results from the ASPEN-06 trial, topline data from an exploratory analysis in the Phase 1b/2 trial of evorpacept with investigational zanidatamab in advanced HER2-positive breast cancer suggest that CD47 expression level helps predict therapeutic response. Researchers had previously reported primary trial results showing a 56% (5/9) confirmed objective response rate (cORR) and an mPFS of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination (2024 San Antonio Breast Cancer Symposium). In January 2026, ALX Oncology announced topline data from the exploratory analysis conducted to identify biomarkers of response to the evorpacept/zanidatamab combination. These findings show that among patients with centrally confirmed HER2-positive breast cancer, responses were largely restricted to patients with higher CD47 expression. The full Phase 1b/2 trial biomarker analysis has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Breast Cancer 2026 Annual Congress on May 7, 2026, in Berlin. The Phase 2 ASPEN-09-Breast trial evaluating evorpacept plus trastuzumab and physician’s choice of chemotherapy in patients with HER2-positive breast cancer previously treated with ENHERTU® (fam-trastuzumab deruxtecan-nxki) began enrollment in January 2026, and site activation remains on track globally. ALX Oncology has updated the primary objective of this trial to assess the overall response rate in patients whose tumors overexpress CD47. The company now plans to expand the number of patients enrolled in ASPEN-09-Breast – from 80 to up to 120 -- to increase the number of patients whose cancer overexpresses this biomarker. The company expects to provide topline data for 80 patients in mid-2027. The Sanofi-partnered, randomized Phase 1/2 UMBRELLA study evaluating evorpacept with SARCLISA® (isatuximab-irfc) and dexamethasone in patients with previously treated multiple myeloma continues to enroll patients in the dose-optimization portion of the trial. Data presented at the American Society of Hematology (ASH) Annual Meeting 2025 from a Phase 2 investigator-sponsored trial (IST) of evorpacept in combination with standard-of-care rituximab and lenalidomide for patients with previously untreated, indolent B-cell non-Hodgkin lymphoma (iNHL) demonstrated a 100% ORR and 92% complete response (CR) rate (with historical control around 50%), and a one-year PFS rate of 91%. While longer follow-up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluated. ALX2004 The Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, began enrolling patients in the third dose cohort at 4mg/kg in January 2026, after no dose-limiting toxicities were observed in the prior two dose cohorts. ALX Oncology plans to share safety data from the dose-escalation phase of this trial in 2H 2026. The ongoing ALX2004 Phase 1 dose-escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). ALX2004 preclinical data presented at the World ADC 2026 Conference and at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer demonstrated potent preclinical anti-tumor activity in EGFR-expressing in vivo tumor models across multiple tumor types with differing levels of EGFR expression and varied mutational status across the EGFR signaling pathway. A favorable preclinical safety profile, including no skin toxicity or interstitial lung disease, was observed in pre-clinical toxicology studies at clinically relevant doses of ALX2004. Corporate Update In February 2026, the company completed a registered equity offering, selling 76,979,112 shares of common stock at $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at $1.569 per underlying share. Gross proceeds from the offering were $150 million. Net proceeds of the offering were $140.4 million, after deducting the underwriting discount and other offering expenses. After serving as Chief Medical Officer in an interim capacity since September 2025, Barbara Klencke, M.D., has been appointed to the position permanently. Dr. Klencke was instrumental in ALX Oncology’s clinical development progress over the past five months. Upcoming Clinical Milestones Phase 1b/2 trial evaluating evorpacept in combination with investigational zanidatamab in advanced HER2-positive breast cancer: Full biomarker analysis to be presented in a poster session on May 7, 2026, at the ESMO Breast Cancer 2026 Annual Congress. Phase 2 ASPEN-09 breast cancer trial: Topline data readout for 80 patients anticipated in mid-2027. Phase 1 ALX2004 trial: Safety data from the dose-escalation phase of trial anticipated in 2H 2026. Fourth Quarter and Full Year 2025 Webcast Information To access the conference call, please dial +1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology Fourth Quarter and Full Year 2025 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call me™ link below: https://callme.viavid.com/viavid/?callme=true&passcode=13755276&h=true&info=company&r=true&B=6 A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the company's website, www.alxoncology.com. An archived webcast will be available on the company's website after the event. Date & Time: Friday, February 27, 2026, 5:30 a.m. PT / 8:30 a.m. ET Webcast Access: https://viavid.webcasts.com/starthere.jsp?ei=1753123&tp_key=d6cfaba210 Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Investments: ALX held $48.3 million in cash, cash equivalents and investments as of December 31, 2025. Along with the $140.4 million in net proceeds from the February 2026 financing, the cash, cash equivalents and investments on hand are expected to be sufficient to fund ALX’s operating expenses through the first half of 2028. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended December 31, 2025 were $17.6 million compared to $23.5 million for the prior-year period, or a decrease of $5.9 million. This decrease was primarily attributable to a decrease of $2.7 million in stock-based compensation expense, a decrease of $2.5 million in personnel and related costs, and a decrease of $1.5 million in preclinical costs due to pipeline prioritization strategy. These decreases were partially offset by an increase of $0.6 million in clinical and development costs to support active clinical trials for ALX product candidates, evorpacept and ALX2004. R&D expenses for the year ended December 31, 2025, were $77.0 million compared to $116.4 million for the prior-year period. General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended December 31, 2025 were $5.4 million compared to $7.1 million for the prior year period, or a decrease of $1.7 million. This decrease was primarily attributable to a decrease in stock-based compensation expense and decreases in legal and corporate costs. G&A expenses for the year ended December 31, 2025 were $23.9 million compared to $26.1 million for the prior-year period. Net loss: GAAP net loss was ($22.8) million for the three months ended December 31, 2025, or ($0.42) per basic and diluted share, as compared to a GAAP net loss of ($29.2) million for the three months ended December 31, 2024, or ($0.55) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. GAAP net loss was ($101.7) million for the year ended December 31, 2025, or ($1.90) per basic and diluted share, as compared to a GAAP net loss of ($134.9) million for the year ended December 31, 2024, or ($2.58) per basic and diluted share. Non-GAAP net loss was ($20.1) million for the three months ended December 31, 2025, as compared to a non-GAAP net loss of ($23.2) million for the three months ended December 31, 2024. Non-GAAP net loss was ($88.8) million for the year ended December 31, 2025, as compared to a non-GAAP net loss of ($107.5) million for the year ended December 31, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (“SEC”), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. “Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact: Elhan Webb, CFA, IR Consultant [email protected] Media Contact: Michele Parisi, SparkPoint Healthcare Communications [email protected] (925) 864-5028

SOUTH SAN FRANCISCO, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced plans to report its fourth quarter and full year 2025 financial results and a business update on Friday, February 27th, 2026 before market open. The company will host a teleconference in conjunction with its financial results press release. Fourth Quarter and Full Year 2025 Results Webcast Information Date & Time: Friday, February 27, 2026 at 5:30am PT / 8:30am ET Webcast Access: https://viavid.webcasts.com/starthere.jsp?ei=1753123&tp_key=d6cfaba210 Participant Listening Options by Phone: To access the conference call, please dial 1-877- 407-0755 or +1-201-389-0913 and ask to be joined into the ALX Oncology Fourth Quarter and Full Year 2025 Financial Results Conference Call. Another option for instant telephone access to the event is to use the Call me™ link below: https://callme.viavid.com/viavid/?callme=true&passcode=13755276&h=true&info=company&r=true&B=6 A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company's website, www.alxoncology.com. An archived webcast will be available on the Company's website after the event. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1 dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Investor Relations Contact: Elhan Webb, CFA, IR Consultant [email protected] Media Contact: Michele Parisi, SparkPoint Healthcare Communications [email protected] (925) 864-5028