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 March 6, 2025, ALX Oncology Holdings Inc. (the "Company"), issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2024. 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.
Exhibit Number |
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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: March 6, 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 Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
– Presented positive updated data from ASPEN-06 Phase 2 trial demonstrating evorpacept generates strong response and durable clinical benefit in patients with HER2-positive gastric cancer in an oral presentation at 2025 ASCO GI
– Presented Phase 1b/2 data demonstrating evorpacept in combination with zanidatamab generates promising anti-tumor activity in advanced breast cancer at SABCS 2024
– Announced focused development plan during R&D Day, including introduction of clinical trials evaluating evorpacept plus anti-cancer antibodies in breast and colorectal cancers and novel EGFR-targeted antibody-drug conjugate (ADC) clinical candidate ALX2004
– Strategic prioritization and resource optimization efforts expected to extend cash runway into Q4 2026
– Announced multiple key additions to leadership team and Board of Directors
SOUTH SAN FRANCISCO, Calif., March 6, 2025 (GLOBE NEWSWIRE) – ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a corporate update.
“In 2024, we delivered strong progress and continued momentum for our clinical development program evaluating evorpacept as a potential first- and best-in-class CD47 blocker with the ability to deepen and enhance responses to a variety of important, available therapies across a wide range of cancer types,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “With multiple important clinical trial readouts, significant momentum for our ongoing clinical studies and key additions to our leadership team, we have positioned ALX Oncology for near- and long-term success. Yesterday during our R&D Day webcast, we shared updates on how we are prioritizing operations and capital to support our new and ongoing clinical programs that are expected to extend our cash runway into the fourth quarter of 2026, including taking the difficult decision to streamline our organization aligned to these priorities.”
Fourth Quarter 2024 Highlights and Recent Developments
1
Upcoming Clinical Milestones
2
2024 Full Year and Fourth Quarter Financial Results:
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About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system 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. 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.
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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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Year Ended |
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December 31, |
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December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
23,532 |
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$ |
41,784 |
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$ |
116,373 |
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$ |
141,795 |
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General and administrative |
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7,081 |
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6,239 |
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26,094 |
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28,483 |
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Total operating expenses |
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30,613 |
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48,023 |
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142,467 |
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170,278 |
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Loss from operations |
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(30,613 |
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(48,023 |
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(142,467 |
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(170,278 |
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Interest income |
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1,878 |
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2,995 |
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9,366 |
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10,649 |
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Interest expense |
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(427 |
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(415 |
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(1,729 |
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(1,565 |
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Other (expense) income, net |
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(1 |
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(29 |
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(20 |
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389 |
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Net loss |
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$ |
(29,163 |
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$ |
(45,472 |
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$ |
(134,850 |
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$ |
(160,805 |
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Net loss per share, basic and diluted |
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$ |
(0.55 |
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$ |
(0.93 |
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$ |
(2.58 |
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$ |
(3.74 |
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Weighted-average shares of common stock |
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52,802,409 |
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48,995,998 |
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52,174,904 |
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42,987,767 |
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Consolidated Balance Sheet Data
(unaudited)
(in thousands)
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December 31, |
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December 31, |
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2024 |
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2023 |
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Cash, cash equivalents and investments |
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$ |
131,281 |
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$ |
218,147 |
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Total assets |
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$ |
147,775 |
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$ |
242,553 |
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Total liabilities |
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$ |
34,157 |
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$ |
52,841 |
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Accumulated deficit |
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$ |
(621,122 |
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$ |
(486,272 |
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Total stockholders’ equity |
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$ |
113,618 |
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$ |
189,712 |
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GAAP to Non-GAAP Reconciliation
(unaudited)
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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GAAP net loss, as reported |
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$ |
(29,163 |
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$ |
(45,472 |
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$ |
(134,850 |
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$ |
(160,805 |
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Adjustments: |
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Stock-based compensation expense |
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5,858 |
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6,721 |
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27,093 |
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26,273 |
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Accretion of term loan discount and issuance costs |
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69 |
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64 |
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265 |
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250 |
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Total adjustments |
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5,927 |
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6,785 |
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27,358 |
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26,523 |
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Non-GAAP net loss |
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$ |
(23,236 |
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$ |
(38,687 |
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$ |
(107,492 |
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$ |
(134,282 |
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5
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
ewebb@alxoncology.com
Media Contact:
Audra Friis, Sam Brown, Inc.
audrafriis@sambrown.com
(917) 519-9577
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