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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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 November 7, 2025, ALX Oncology Holdings Inc. (the “Company”), issued a press release announcing its financial results for the third quarter and full year ended September 30, 2025. 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: November 7, 2025 |
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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 Third Quarter 2025 Financial Results and Provides Corporate Update
– ASPEN-06 data to be presented at SITC demonstrates that evorpacept drove durable clinical benefit across all efficacy measures in HER2+ gastric cancer patients with high CD47 expression
– Phase 2 ASPEN-09-Breast Cancer trial remains on track for FPI in Q4 2025 and will evaluate evorpacept efficacy by CD47 expression levels
– Phase 1 trial for ALX2004, a novel EGFR-targeted ADC, is currently enrolling patients in the second dose cohort and on track to deliver initial safety data in 1H 2026
– Cash runway expected into Q1 2027 to support key milestones, including ALX2004 initial safety data in 1H 2026, interim data for ASPEN-09-Breast Cancer in Q3 2026
– Appointed Board Member Barbara Klencke, M.D., as Chief Medical Officer
– Company to host webcast including perspective from Breast Cancer Expert Dr. Peter Schmid on Friday, November 7, at 5:30 a.m. PT / 8:30 a.m. ET
SOUTH SAN FRANCISCO, Calif., November 7, 2025 (GLOBE NEWSWIRE) – ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (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 third quarter ended September 30, 2025, and provided a corporate update.
“We are pleased to share data at SITC this weekend from an analysis of our ASPEN-06 trial demonstrating compelling benefit in all outcomes measured for patients with high CD47-expressing HER2-positive gastric cancer treated with evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “This insight is guiding our targeted clinical development strategy for breast cancer where we will be enrolling patients with HER2-positive tumors that have previously received ENHERTU® and we will evaluate responses by CD47-expression level in our Phase 2 ASPEN-09-Breast Cancer trial. Additionally, we are excited about the progress of our ALX2004 clinical program, where we are currently enrolling the second dose cohort at 2mg/kg after clearing the dose 1 cohort at 1mg/kg, a milestone for this Phase 1 program. We look forward to providing an update with initial safety data from this program in the first half of next year. Given the promising preclinical findings we have seen to date for ALX2004 which demonstrate a favorable toxicity profile and potent anti-tumor activity, we remain very optimistic about the potential success for this approach in treating EGFR+ tumors.”
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“The analysis from the evorpacept gastric cancer data is especially interesting for two reasons. First, it is great to see this level of improvement across all efficacy measures among HER2-positive gastric cancer patients with CD47-high expression. Second, I’m eager to evaluate this approach for patients with HER2+ breast cancer in the ASPEN-09 trial since we will be combining evorpacept and chemotherapy with trastuzumab, the same HER2-targeted antibody used in the gastric cancer study,” said Peter Schmid, FRCP, M.D., Ph.D., Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre at Queen Mary University of London. “We hope that by using this combination we are able to offer meaningful clinical benefit to patients with HER2-positive breast cancer who have previously received ENHERTU®, and we know this is a patient population in need of new targeted therapies.”
ALX Oncology Q3 2025 Highlights and Recent Developments
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Upcoming Clinical Milestones
Third Quarter 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 Third Quarter 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, November 7 at 5:30 a.m. PT / 8:30 a.m. ET
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Webcast Access: https://viavid.webcasts.com/starthere.jsp?ei=1740362&tp_key=b49359356f
Third Quarter 2025 Financial Results
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 and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.
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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.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
17,441 |
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$ |
26,471 |
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$ |
59,351 |
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$ |
92,841 |
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General and administrative |
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5,091 |
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6,096 |
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18,474 |
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19,013 |
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Impairment charge |
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— |
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— |
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3,175 |
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— |
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Total operating expenses |
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22,532 |
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32,567 |
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81,000 |
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111,854 |
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Loss from operations |
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(22,532 |
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(32,567 |
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(81,000 |
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(111,854 |
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Interest income |
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802 |
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2,303 |
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3,391 |
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7,488 |
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Interest expense |
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(408 |
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(446 |
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(1,219 |
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(1,302 |
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Other (expense) income, net |
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(6 |
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3 |
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(19 |
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(19 |
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Net loss |
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$ |
(22,144 |
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$ |
(30,707 |
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$ |
(78,847 |
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$ |
(105,687 |
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Net loss per share, basic and diluted |
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$ |
(0.41 |
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$ |
(0.58 |
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$ |
(1.48 |
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$ |
(2.05 |
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Weighted-average shares of common stock used to compute net loss per shares, basic and diluted |
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53,577,066 |
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52,693,878 |
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53,452,319 |
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51,544,501 |
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Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
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September 30, |
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December 31, |
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2025 |
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2024 |
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Cash, cash equivalents and investments |
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$ |
66,464 |
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$ |
131,281 |
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Total assets |
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$ |
82,723 |
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$ |
147,775 |
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Total liabilities |
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$ |
37,923 |
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$ |
34,157 |
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Accumulated deficit |
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$ |
(699,969 |
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$ |
(621,122 |
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Total stockholders’ equity |
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$ |
44,800 |
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$ |
113,618 |
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GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2025 |
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2024 |
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2025 |
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2024 |
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GAAP net loss, as reported |
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$ |
(22,144 |
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$ |
(30,707 |
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$ |
(78,847 |
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$ |
(105,687 |
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Adjustments: |
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Stock-based compensation expense |
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2,521 |
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6,952 |
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9,873 |
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21,235 |
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Accretion of term loan discount and issuance costs |
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72 |
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66 |
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208 |
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196 |
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Total adjustments |
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2,593 |
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7,018 |
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10,081 |
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21,431 |
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Non-GAAP net loss |
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$ |
(19,551 |
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$ |
(23,689 |
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$ |
(68,766 |
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$ |
(84,256 |
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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:
Audra Friis, Sam Brown LLC
(917) 519-9577
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