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, 2025, ALX Oncology Holdings Inc. (the “Company”), issued a press release announcing its financial results for the first quarter ended March 31, 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.
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: May 8, 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 First Quarter 2025 Financial Results and Provides Corporate Update
– Following announcement of prioritized development strategy for evorpacept in combination with anti-cancer antibodies at R&D Day in March, Company is on track to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025
– IND clearance received from U.S. FDA for novel EGFR-targeted antibody-drug conjugate (ADC), ALX2004, paving way for mid-year clinical program initiation; Company to host webcast focused on ALX2004 research program on May 20
– Company will not pursue U.S. registrational path in gastric cancer following receipt of FDA feedback that accelerated approval pathway is not feasible based on ASPEN-06 due to standard-of-care evolving to ENHERTU®
– Data milestones expected across Company’s three clinical programs in 2026
– Cash runway has been extended into Q4 2026
SOUTH SAN FRANCISCO, Calif., May 8, 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 first quarter ended March 31, 2025, and provided a corporate update.
“In the first quarter of the year, we focused our development strategy for evorpacept on the anti-cancer antibody combinations, as we now have proof-of-concept for this mechanism in gastric cancer, breast cancer and NHL,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “In addition to the evorpacept program, we diversified our pipeline by moving our in-house ADC candidate, ALX2004, through IND clearance and look forward to beginning clinical trial enrollment by mid-year for this potentially first- and best-in-class EGFR ADC. We also made the difficult but critical decision to streamline the company and, by doing so, extended cash runway into Q4 2026. We are now hyper-focused on pursuing the validated mechanism of action for evorpacept in combination with anti-cancer antibodies and delivering data in breast cancer in combination with HERCEPTIN®, in colorectal cancer in combination with ERBITUX®, as well as from ALX2004, in 2026.”
ALX Oncology Q1 2025 Highlights and Recent Developments
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Upcoming Clinical Milestones
First 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
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EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. 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.
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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March 31, |
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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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$ |
23,888 |
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$ |
31,717 |
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General and administrative |
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7,932 |
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6,045 |
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Total operating expenses |
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31,820 |
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37,762 |
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Loss from operations |
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(31,820 |
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(37,762 |
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Interest income |
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1,483 |
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2,622 |
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Interest expense |
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(406 |
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(427 |
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Other (expense) income, net |
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(11 |
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(14 |
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Net loss |
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$ |
(30,754 |
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$ |
(35,581 |
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Net loss per share, basic and diluted |
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$ |
(0.58 |
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$ |
(0.71 |
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Weighted-average shares of common stock used to |
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53,359,338 |
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50,120,758 |
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Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)
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March 31, |
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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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$ |
106,992 |
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$ |
131,281 |
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Total assets |
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$ |
120,900 |
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$ |
147,775 |
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Total liabilities |
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$ |
32,605 |
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$ |
34,157 |
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Accumulated deficit |
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$ |
(651,876 |
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$ |
(621,122 |
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Total stockholders’ equity |
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$ |
88,295 |
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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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March 31, |
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2025 |
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2024 |
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GAAP net loss, as reported |
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$ |
(30,754 |
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$ |
(35,581 |
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Adjustments: |
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Stock-based compensation expense |
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5,216 |
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7,031 |
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Accretion of term loan discount and issuance costs |
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67 |
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64 |
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Total adjustments |
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5,283 |
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7,095 |
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Non-GAAP net loss |
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$ |
(25,471 |
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$ |
(28,486 |
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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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