UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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(I.R.S. Employer |
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Registrant’s telephone number, including area code:
Former name, former address, and former fiscal year, if changed since last report:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of November 8, 2021, the registrant had
Table of Contents
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Page |
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PART I. |
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Item 1. |
1 |
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Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020 |
1 |
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2 |
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3 |
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5 |
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6 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
17 |
Item 3. |
26 |
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Item 4. |
27 |
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PART II. |
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Item 1. |
28 |
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Item 1A. |
28 |
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Item 2. |
72 |
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Item 3. |
72 |
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Item 4. |
72 |
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Item 5. |
72 |
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Item 6. |
73 |
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74 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding our 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, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:
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our financial performance; |
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the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements; |
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the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; |
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our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and our ability to grow a sales team; |
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the implementation of our strategic plans for our business and product candidates; |
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our ability to obtain and maintain regulatory approval of our product candidates and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations, such as orphan drug designation, for our product candidates for various diseases; |
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our reliance on third parties to conduct preclinical research activities, clinical trials, and for the manufacture of our product candidates; |
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the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; |
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the progress and focus of our current and future clinical trials, and the reporting of data from those trials; |
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our ability to advance product candidates into and successfully complete clinical trials; |
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the ability of our clinical trials to demonstrate the safety and efficacy of our product candidates, and other positive results; |
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the success of competing therapies that are or may become available; |
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developments relating to our competitors and our industry, including competing product candidates and therapies; |
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our plans relating to the further development and manufacturing of our product candidates, including additional indications that we may pursue; |
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existing regulations and regulatory developments in the United States and other jurisdictions; |
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our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; |
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our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates; |
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our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; |
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the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform and product candidates; |
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our ability to retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel; |
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our expectations regarding the impact of the COVID-19 pandemic on our business; |
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our plans for and prospects of our acquisitions and other business development activities, and our ability to successfully capitalize on these opportunities; and |
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our anticipated use of our existing cash and cash equivalents. |
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this Quarterly Report, whether as a result of any new information, future events or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.
PART I—FINANCIAL INFORMATION
Item 1 – Financial Statements
ALX Oncology Holdings Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share data)
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September 30, |
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December 31, |
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2021 |
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2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Payable and accrued liabilities due to related party |
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Accrued expenses and other current liabilities |
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Total current liabilities |
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Other non-current liabilities |
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Total liabilities |
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Commitments and contingencies (Note 11) |
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Stockholders’ equity |
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Common stock, $ 2021 and December 31, 2020, respectively; and outstanding as of September 30, 2021 and December 31, 2020, respectively |
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Additional paid-in capital |
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Accumulated deficit |
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( |
) |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to these condensed consolidated financial statements (unaudited).
1
ALX ONCOLOGY HOLDINGS INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(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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2021 |
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2020 |
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2021 |
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2020 |
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Related-party revenue |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
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Operating expenses: |
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Research and development |
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General and administrative |
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Cost of services for related-party revenue |
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— |
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— |
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— |
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Total operating expenses |
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Loss from operations |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Interest expense |
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( |
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( |
) |
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( |
) |
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( |
) |
Other income (expense), net |
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( |
) |
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( |
) |
Loss before income taxes |
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( |
) |
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( |
) |
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( |
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( |
) |
Income tax provision |
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— |
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( |
) |
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— |
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( |
) |
Net loss and comprehensive loss |
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( |
) |
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( |
) |
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( |
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( |
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Cumulative dividends allocated to preferred stockholders |
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— |
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( |
) |
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— |
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( |
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Net loss attributable to common stockholders |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Net loss per share attributable to common stockholders, basic and diluted |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted |
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See accompanying notes to these condensed consolidated financial statements (unaudited).
2
ALX ONCOLOGY HOLDINGS INC.
Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(unaudited)
(in thousands, except share amounts)
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Three Months Ended September 30, 2021 |
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Convertible Preferred Stock |
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Stockholders' Equity |
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Total Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance as of June 30, 2021 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Issuance of common stock under equity incentive plan |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance as of September 30, 2021 |
|
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— |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Three Months Ended September 30, 2020 |
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Convertible Preferred Stock |
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Stockholders' Equity (Deficit) |
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Total Stockholders' Equity |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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(Deficit) |
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|||||||
Balance as of June 30, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
Vesting of early exercised stock options |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Reclassification of warrants from liability to equity |
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— |
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— |
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— |
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— |
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— |
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Conversion of convertible preferred stock into common stock |
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|
( |
) |
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( |
) |
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— |
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Cumulative dividends |
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( |
) |
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— |
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— |
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Issuance of common stock in connection with initial public offering, net of underwriter discounts and issuance costs |
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— |
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— |
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— |
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Issuance of common stock under equity incentive plans |
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— |
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— |
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Issuance of common stock upon net exercise of warrants |
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— |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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( |
) |
|
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( |
) |
Balance as of September 30, 2020 |
|
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— |
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$ |
— |
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$ |
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|
$ |
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|
$ |
( |
) |
|
$ |
|
|
See accompanying notes to these condensed consolidated financial statements (unaudited).
3
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Nine Months Ended September 30, 2021 |
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Convertible Preferred Stock |
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Stockholders' Equity |
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||||||||||||||||||||||
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Total Stockholders' |
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|||||||||||||
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
|
|||||||
Balance as of December 31, 2020 |
|
|
— |
|
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$ |
— |
|
|
|
|
|
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|
$ |
|
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|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
Issuance of common stock under equity incentive plan |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
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— |
|
|
|
|
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|
|
— |
|
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Issuance of common stock under employee stock purchase plan |
|
|
— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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|
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— |
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|
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— |
|
|
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|
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|
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— |
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Net loss |
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— |
|
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— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of September 30, 2021 |
|
|
— |
|
|
$ |
— |
|
|
|
|
|
|
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$ |
|
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$ |
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$ |
( |
) |
|
$ |
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Nine Months Ended September 30, 2020 |
|
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|
Convertible Preferred Stock |
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Stockholders' Equity (Deficit) |
|
||||||||||||||||||||||
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|
|
Common Stock |
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Additional Paid-In |
|
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Accumulated |
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Total Stockholders' Equity |
|
|||||||||||||
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
|
|
Deficit |
|
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(Deficit) |
|
|||||||
Balance as of December 31, 2019 |
|
|
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|
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$ |
|
|
|
|
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|
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$ |
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|
$ |
|
|
|
$ |
( |
) |
|
$ |
( |
) |
Issuance of convertible preferred stock, net of issuance costs |
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|
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$ |
|
|
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— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Vesting of early exercised stock options |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Reclassification of warrants from liability to equity |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Conversion of convertible preferred stock into common stock |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
Cumulative dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
— |
|
|
|
— |
|
Issuance of common stock in connection with initial public offering, net of underwriter discounts and issuance costs |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
Issuance of common stock under equity incentive plans |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
|
|
Issuance of common stock upon net exercise of warrants |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of September 30, 2020 |
|
|
— |
|
|
$ |
— |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
( |
) |
|
$ |
|
|
See accompanying notes to these condensed consolidated financial statements (unaudited).
4
ALX ONCOLOGY HOLDINGS INC.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
|
|
Nine Months Ended |
|
|||||
|
|
September 30, |
|
|||||
|
|
2021 |
|
|
2020 |
|
||
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
Non-cash lease costs |
|
|
|
|
|
|
— |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
Amortization of term loan discount and issuance costs |
|
|
— |
|
|
|
|