ALXO 8-K
Alx Oncology Holdings Inc (ALXO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2026, ALX Oncology Holdings Inc. (the “Company”), issued a press release announcing its financial results for the first quarter ended March 31, 2026. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly stated by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ALX ONCOLOGY HOLDINGS INC. |
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Date: May 8, 2026 |
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By: |
/s/ Harish Shantharam |
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Harish Shantharam |
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Chief Financial Officer |
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Exhibit 99.1 |
ALX Oncology Reports First Quarter 2026 Financial Results and
Provides Corporate Update
- 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 8, 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
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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
ALX2004
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Corporate Update
Upcoming Clinical Milestones
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
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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.
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ALX ONCOLOGY HOLDINGS INC.
Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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March 31, |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
13,606 |
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$ |
23,888 |
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General and administrative |
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5,360 |
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7,932 |
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Total operating expenses |
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18,966 |
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31,820 |
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Loss from operations |
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(18,966 |
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(31,820 |
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Interest income |
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1,182 |
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1,483 |
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Interest expense |
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(331 |
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(406 |
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Other (expense) income, net |
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188 |
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(11 |
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Net loss |
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$ |
(17,927 |
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$ |
(30,754 |
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Net loss per share, basic and diluted |
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$ |
(0.17 |
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$ |
(0.58 |
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Weighted-average shares of common stock used to compute net loss per shares, basic and diluted |
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104,573,657 |
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53,359,338 |
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Consolidated Balance Sheet Data
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(in thousands)
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March 31, |
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December 31, |
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2026 |
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2025 |
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Cash, cash equivalents and investments |
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$ |
169,107 |
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$ |
48,284 |
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Total assets |
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$ |
178,328 |
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$ |
59,046 |
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Total liabilities |
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$ |
26,981 |
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$ |
33,065 |
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Accumulated deficit |
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$ |
(740,744 |
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$ |
(722,817 |
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Total stockholders’ equity |
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$ |
151,347 |
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$ |
25,981 |
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GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
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Three Months Ended |
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March 31, |
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2026 |
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2025 |
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GAAP net loss, as reported |
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$ |
(17,927 |
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$ |
(30,754 |
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Adjustments: |
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Stock-based compensation expense |
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2,509 |
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5,216 |
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Accretion of term loan discount and issuance costs |
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68 |
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67 |
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Total adjustments |
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2,577 |
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5,283 |
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Non-GAAP net loss |
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$ |
(15,350 |
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$ |
(25,471 |
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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.
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Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
Media Contact:
Michele Parisi, SparkPoint Healthcare Communications
(925) 864-5028
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