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 November 7, 2024, ALX Oncology Holdings Inc. (the "Company"), issued a press release announcing its financial results for the third quarter ended September 30, 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Departure of Chief Financial Officer
On November 5, 2024, Peter Garcia, Chief Financial Officer of the Company informed the Company of his resignation from his position effective November 8, 2024, due to personal reasons. Mr. Garcia’s resignation is not the result of any disagreement with the Company related to its operations, policies, or practices. The Company has commenced a search for a new Chief Financial Officer. The Company thanks Mr. Garcia for his dedication over many years of service to the Company in pursuing its mission of helping patients fight cancer.
Appointment of Interim Chief Financial Officer
On November 7, 2024, the Board of Directors (the “Board”) of the Company appointed Shelly Pinto, the Company’s Senior Vice President, Finance and Chief Accounting Officer, as the Company’s interim Chief Financial Officer, effective upon Mr. Garcia’s resignation. In this position, Ms. Pinto will serve as the principal financial officer of the Company as such term is used for purposes of the rules and regulations of the Securities and Exchange Commission (“SEC”).
For Ms. Pinto’s biographical information, see the disclosure included under the heading “Executive Officers” included in the Company’s definitive proxy statement for the 2024 annual meeting of stockholders filed with the SEC on April 22, 2024, which disclosure is incorporated by reference herein.
Ms. Pinto is continuing under the terms of her existing compensation arrangement with the Company. There are no arrangements or understandings between Ms. Pinto and any other persons in connection with Ms. Pinto’s appointment as the Interim Chief Financial Officer and the principal financial officer. Ms. Pinto does not have any family relationships with any directors or officers of the Company. Ms. Pinto is not a party to any transaction, or series of transactions, required to be disclosed pursuant to Item 404(a) of Regulation S-K.
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: November 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 Third Quarter 2024 Financial Results and Provides Corporate Update
SOUTH SAN FRANCISCO, Calif., November 7, 2024 (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 in new ways and extend patients’ lives, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update.
“We made substantial clinical progress during the third quarter, most notably announcing topline data from our ASPEN-06 Phase 2 trial in which our lead candidate evorpacept became the first and only CD47-blocking agent to show a durable clinical benefit and a well-tolerated safety profile in a prospective randomized clinical trial,” said Jason Lettmann, Chief Executive Officer of ALX Oncology. “These results provided further validation for evorpacept’s novel mechanism of action and our robust evorpacept clinical program. We anticipate achieving several additional clinical milestones in the near-term that could advance evorpacept towards being a best-in-class, combinable therapeutic across a wide range of cancer types.”
Third Quarter 2024 Highlights and Recent Developments
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Upcoming Clinical Milestones for Evorpacept’s Development Pipeline
Third Quarter 2024 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 in new ways 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 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.
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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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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$ |
26,471 |
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$ |
45,766 |
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$ |
92,841 |
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$ |
100,011 |
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General and administrative |
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6,096 |
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7,509 |
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19,013 |
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22,244 |
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Total operating expenses |
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32,567 |
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53,275 |
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111,854 |
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122,255 |
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Loss from operations |
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(32,567 |
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(53,275 |
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(111,854 |
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(122,255 |
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Interest income |
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2,303 |
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2,677 |
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7,488 |
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7,654 |
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Interest expense |
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(446 |
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(391 |
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(1,302 |
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(1,150 |
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Other (expense) income, net |
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3 |
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(1 |
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(19 |
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418 |
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Net loss |
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$ |
(30,707 |
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$ |
(50,990 |
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$ |
(105,687 |
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$ |
(115,333 |
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Net loss per share, basic and diluted |
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$ |
(0.58 |
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$ |
(1.24 |
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$ |
(2.05 |
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$ |
(2.82 |
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Weighted-average shares of common stock |
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52,693,878 |
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41,147,938 |
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51,544,501 |
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40,963,015 |
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Condensed Consolidated Balance Sheet Data
(in thousands)
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September 30, |
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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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$ |
162,610 |
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$ |
218,147 |
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Total assets |
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$ |
185,715 |
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$ |
242,553 |
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Total liabilities |
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$ |
48,908 |
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$ |
52,841 |
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Accumulated deficit |
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$ |
(591,959 |
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$ |
(486,272 |
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Total stockholders’ equity |
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$ |
136,807 |
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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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Nine Months Ended |
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September 30, |
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September 30, |
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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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$ |
(30,707 |
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$ |
(50,990 |
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$ |
(105,687 |
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$ |
(115,333 |
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Adjustments: |
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Stock-based compensation expense |
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6,952 |
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6,964 |
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21,235 |
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19,552 |
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Accretion of term loan discount and issuance costs |
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66 |
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63 |
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196 |
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186 |
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Total adjustments |
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7,018 |
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7,027 |
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21,431 |
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19,738 |
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Non-GAAP net loss |
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$ |
(23,689 |
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$ |
(43,963 |
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$ |
(84,256 |
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$ |
(95,595 |
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4
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.
Company Contact: Caitlyn Doherty, Manager, Corporate Communications, ALX Oncology, cdoherty@alxoncology.com, (650) 466-7125
Investor Contact: Malini Chatterjee, Ph.D., Blueprint Life Science Group, mchatterjee@bplifescience.com, (917) 330-4269
Media Contact: Audra Friis, Sam Brown, Inc., audrafriis@sambrown.com, (917) 519-9577
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