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 7, 2024
ALX ONCOLOGY HOLDINGS INC.
(Exact name of Registrant as Specified in Its Charter)
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:
☐ |
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)) |
☐ |
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:
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 7, 2024, ALX Oncology Holdings Inc. (the "Company"), issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2023. 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) |
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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 thereunto duly authorized.
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ALX ONCOLOGY HOLDINGS INC. |
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Date: March 7, 2024 |
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By: |
/s/ Peter Garcia |
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Peter Garcia |
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Chief Financial Officer |
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Exhibit 99.1 |
ALX Oncology Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
SOUTH SAN FRANCISCO, Calif., March 7, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
“This past year proved to be a profound growth period for ALX Oncology highlighted by evorpacept’s positive results in the prespecified randomized interim analysis of the ASPEN-06 Phase 2 clinical trial in advanced HER2-positive gastric/GEJ cancer,” said Jason Lettmann, Chief Executive Officer (“CEO”) of ALX Oncology. “Notably, this outcome is particularly important as it represents the first promising activity in a randomized trial in solid tumors in the CD47 space and further underscores evorpacept’s differentiation. Over the next 12-18 months, we expect to report multiple value inflection datapoints, with the goal of advancing evorpacept’s potential beyond anti-cancer antibodies through ongoing combination studies with ADCs and checkpoint inhibitors. With nine ongoing trials, our goal is to expand evorpacept’s value to other tumor types including breast, NHL, multiple myeloma and urothelial cancers as well as accelerate our efforts to identify new indications around this highly differentiated asset.”
Fourth Quarter 2023 Highlights
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Anticipated 2024 Clinical Milestones for Evorpacept’s Maturing Pipeline Development
2023 Full Year and Fourth Quarter Financial Results:
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About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 immune checkpoint inhibitor and bridge the innate and adaptive immune system. ALX Oncology’s lead product candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. To date, evorpacept has been dosed in over 500 subjects and has demonstrated promising activity and a favorable tolerability profile across a range of hematologic and solid malignancies in combination with various leading anti-cancer antibodies. ALX Oncology is currently focusing on combining evorpacept with anti-cancer antibodies, ADCs, and PD-1/PD-L1 immune checkpoint inhibitors.
Evorpacept’s Unique Profile: Anchored by a Rational Design and Dual Development Pillars
Rationally engineered with an inactive Fc effector function, evorpacept’s clinical data to date has demonstrated a substantially improved safety profile over other anti-CD47 molecules in the clinic with an active Fc (i.e., binding the Fc gamma receptor on macrophages). This best-in-class safety profile allows for higher dosage with minimal overlapping toxicity in the combination treatment setting. CD47 expressed on cancer cells binds to its receptor SIRP alpha, which is predominantly expressed on two cell types: macrophages and dendritic cells. The Company’s pipeline of therapeutic candidates with standard-of-care agents include:
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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 objects 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 for the three months ended December 31, 2023 and 2022)
(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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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
41,784 |
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$ |
25,197 |
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$ |
141,795 |
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$ |
98,400 |
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General and administrative |
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6,239 |
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7,022 |
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28,483 |
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29,036 |
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Total operating expenses |
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48,023 |
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32,219 |
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170,278 |
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127,436 |
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Loss from operations |
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(48,023 |
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(32,219 |
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(170,278 |
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(127,436 |
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Interest income |
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2,995 |
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1,807 |
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10,649 |
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4,278 |
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Interest expense |
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(415 |
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(231 |
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(1,565 |
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(238 |
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Other income (expense), net |
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(29 |
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(2 |
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389 |
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(22 |
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Loss before income taxes |
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(45,472 |
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(30,645 |
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(160,805 |
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(123,418 |
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Income tax (provision) benefit |
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— |
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(64 |
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— |
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(64 |
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Net loss |
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$ |
(45,472 |
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$ |
(30,709 |
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$ |
(160,805 |
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$ |
(123,482 |
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Net loss per share, basic and diluted |
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$ |
(0.93 |
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$ |
(0.75 |
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$ |
(3.74 |
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$ |
(3.03 |
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Weighted-average shares of common stock |
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48,995,998 |
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40,755,520 |
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42,987,767 |
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40,699,612 |
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Consolidated Balance Sheet Data
(in thousands)
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December 31, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents and investments |
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$ |
218,147 |
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$ |
282,906 |
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Total assets |
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$ |
242,553 |
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$ |
306,489 |
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Total liabilities |
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$ |
52,841 |
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$ |
43,025 |
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Accumulated deficit |
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$ |
(486,272 |
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$ |
(325,467 |
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Total stockholders’ equity |
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$ |
189,712 |
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$ |
263,464 |
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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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2023 |
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2022 |
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2023 |
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2022 |
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GAAP net loss, as reported |
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$ |
(45,472 |
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$ |
(30,709 |
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$ |
(160,805 |
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$ |
(123,482 |
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Adjustments: |
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Stock-based compensation expense |
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6,721 |
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6,295 |
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26,273 |
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23,839 |
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Accretion of term loan discount and issuance costs |
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64 |
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44 |
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250 |
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44 |
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Total adjustments |
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6,785 |
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6,339 |
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26,523 |
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23,883 |
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Non-GAAP net loss |
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$ |
(38,687 |
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$ |
(24,370 |
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$ |
(134,282 |
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$ |
(99,599 |
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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 and Media Contact:
Caitlyn Doherty
Manager, Investor Relations and Corporate Communications, ALX Oncology
cdoherty@alxoncology.com
(650) 466-7125
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