false000181018200018101822025-03-062025-03-06
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 6, 2025
ALX ONCOLOGY HOLDINGS INC.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-39386 |
85-0642577 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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323 Allerton Avenue, South San Francisco, California |
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94080 |
(Address of Principal Executive Offices) |
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(Zip Code) |
650-466-7125
(Registrant’s Telephone Number, Including Area Code)
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
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ALXO |
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The Nasdaq Global Select Market |
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.
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
•At the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January 2025, reported updated results from the multi-center, international ASPEN-06 Phase 2 clinical trial (NCT05002127) evaluating evorpacept in combination with HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (Evo-TRP) against trastuzumab, CYRAMZA (ramucirumab) and paclitaxel (TRP) for the treatment of patients with HER2-positive gastric/gastroesophageal junction (GEJ) cancer, where all patients had received an anti-HER2 agent in prior lines of therapy.
oData highlighted evorpacept as the first CD47-blocker to show substantial tumor response and a well-tolerated safety profile in a prospective randomized trial.
oGreatest benefit observed among patients with confirmed HER2-positive cancer, as demonstrated by either fresh biopsy or ctDNA HER2-expression, with a confirmed objective response rate (cORR) of 48.9% and median duration of response (mDOR) of 15.7 months vs. 24.5% ORR and mDOR of 9.1 months in the control group, and a progression-free survival Hazard Ratio of 0.64.
oEvo-TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control.
•At the San Antonio Breast Cancer Symposium (SABCS) 2024, presented new data from the Phase 1b/2 clinical trial demonstrating evorpacept in combination with zanidatamab generates promising antitumor activity in metastatic breast cancer (mBC).
oPatients who were HER2-positive by central assessment (n=9) showed the greatest anti-tumor activity with a cORR of 55.6% and a median progression-free survival (mPFS) of 7.4 months.
oCombination therapy was well tolerated with a manageable safety profile consistent with prior experience with each investigational agent.
•Announced strategic prioritization and resource optimization efforts, including approximately 30% workforce reduction primarily in preclinical research, expected to extend cash runway into Q4 2026.
•Announced key additions to our leadership team and Board of Directors throughout 2024 and early 2025.
oAllison Dillon, Ph.D., an experienced drug development, commercial strategy and business development leader, as Chief Business Officer.
oAlan Sandler, M.D., a distinguished leader with more than 30 years of experience in oncology and drug development, as Chief Medical Officer.
oHarish Shantharam, CFA, a proven biotech industry executive with over two decades of senior leadership experience in finance, commercial and corporate operations, as Chief Financial Officer.
oBarbara Klencke, M.D., a seasoned clinical leader in oncology drug development with more than 20 years of industry experience, appointed to ALX Oncology’s Board of Directors.
oChris H. Takimoto, M.D., Ph.D., FACP, a distinguished researcher and drug developer with a proven track record in oncology with 17 years of industry experience, appointed to ALX Oncology’s Board of Directors.
•Announced that Jaume Pons, Ph.D., Founder, President and Chief Scientific Officer, will be departing from his current position and transitioning to the role of Senior Scientific Advisor in Q2 2025.
Upcoming Clinical Milestones
•Head and Neck Squamous Cell Carcinoma: Topline results from Phase 2 ASPEN-03 randomized clinical trial of evorpacept with KEYTRUDA® (pembrolizumab) anticipated in Q2 2025
•Head and Neck Squamous Cell Carcinoma: Topline results from Phase 2 ASPEN-04 randomized clinical trial of evorpacept with KEYTRUDA and chemotherapy anticipated in Q2 2025
•Urothelial Cancer: Updated results from Phase 1 ASPEN-07 clinical trial of evorpacept in combination with PADCEV® (enfortumab vedotin) anticipated in Q2 2025
•Gastric/GEJ Cancer: Regulatory guidance on the gastric cancer registrational path to be provided in Q2 2025
•Breast Cancer: Topline results from Phase 1b I-SPY clinical trial of evorpacept with ENHERTU® (fam-trastuzumab deruxtecan-nxki) anticipated in 2H 2025
•Breast Cancer: Patient dosing anticipated to initiate for ASPEN-BREAST Phase 2 clinical trial in mid-year 2025
•Colorectal Cancer (CRC): Patient dosing anticipated to initiate for ASPEN-CRC Phase 1b clinical trial in mid-year 2025
•New ADC Clinical Candidate: Novel EGFR-directed ADC, ALX2004, planned IND submission in March 2025
2024 Full Year and Fourth Quarter Financial Results:
•Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of December 31, 2024, were $131.3 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations into Q4 of 2026. Potential impact of near-term catalysts related to ASPEN-03/04 HNSCC read out and FDA interaction on ASPEN-06 (for e.g., gastric cancer accelerated approval and/or Phase 3 initiation) are excluded from cash runway guidance.
•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 lead product candidate, evorpacept, and R&D personnel-related expenses including stock-based compensation. R&D expenses for the three months ended December 31, 2024 were $23.5 million compared to $41.8 million for the prior-year period or a decrease of $18.3 million. This decrease was primarily attributable to a decrease of $17.3 million in clinical and development costs primarily due to less manufacturing of clinical trial materials to support active clinical trials for our lead product candidate, evorpacept, and a decrease in stock-based compensation expense slightly offset by increased preclinical costs for development of new targets and increased personnel and related costs. R&D expenses for the year ended December 31, 2024 were $116.4 million, compared to $141.8 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, 2024 were $7.1 million compared to $6.2 million for the prior year period or an increase of $0.8 million. This increase was primarily attributable to an increase in personnel and related costs. G&A expenses for the year ended December 31, 2024 were $26.1 million compared to $28.5 million for the prior-year period.
•Net loss: GAAP net loss was ($29.2) million for the three months ended December 31, 2024, or ($0.55) per basic and diluted share, as compared to a GAAP net loss of ($45.5) million for the three months ended December 31, 2023, or ($0.93) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. GAAP net loss was ($134.9) million for the year ended December 31, 2024, or ($2.58) per basic and diluted share, as compared to a GAAP net loss of ($160.8) million for the year ended December 31, 2023, or ($3.74) per basic and diluted share. Non-GAAP net loss was ($23.2) million for the three months ended December 31, 2024, as compared to a non-GAAP net loss of ($38.7) million for the three months ended December 31, 2023. Non-GAAP net loss was ($107.5) million for the year ended December 31, 2024, as
compared to a non-GAAP net loss of ($134.3) million for the year ended December 31, 2023. 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 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.
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 |
) |
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
used to compute net loss per shares, basic
and diluted |
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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)
(in thousands)
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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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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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- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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| Period Type: |
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| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
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dei_SolicitingMaterial |
| Namespace Prefix: |
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- DefinitionTrading symbol of an instrument as listed on an exchange.
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| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
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ALX Oncology (NASDAQ:ALXO)
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