UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ 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 001-39386 ALX ONCOLOGY HOLDINGS INC. (Exact name of Registrant as specified in its Charter) Delaware 85-0642577 (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ 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 001-39386 ALX ONCOLOGY HOLDINGS INC. (Exact name of Registrant as specified in its Charter) Delaware 85-0642577 (State or other juri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ 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 001-39386 ALX ONCOLOGY HOLDINGS INC. (Exact name of Regis ...

Licensing and Commercialization - The company has entered into license agreements with third parties for the development and commercialization of product candidates, including evorpacept, with customary payment terms including milestone payments and low single-digit royalties [147]. - The company plans to retain significant development and commercial rights to its product candidates and aims to build the necessary infrastructure for commercialization in the U.S. and potentially other regions [148]. Clinical Trials and Regulatory Compliance - The existing supply of evorpacept drug product is sufficient to complete clinical trials through Q1 2023, with plans to manufacture additional supplies with existing CMOs [151]. - The FDA regulates biologic products, and the company must navigate extensive regulatory requirements for product development and approval [157]. - The BLA submission process requires substantial data from preclinical and clinical studies, and the FDA aims to review standard applications within ten months [173]. - Clinical trials are conducted in three phases, with Phase 1 focusing on safety and dosage, Phase 2 on preliminary efficacy, and Phase 3 on larger populations for clinical efficacy [170]. - The company relies on contract manufacturing organizations (CMOs) for drug substance and product, as it does not intend to establish its own manufacturing facilities [150]. - The company must comply with cGMP requirements to ensure consistent production quality and safety of its biologic products [171]. - The FDA may issue an approval letter or a Complete Response letter after evaluating a BLA, with the latter outlining deficiencies in the submission [176]. - Products may receive expedited development and review through programs like Fast Track, which allows for frequent interactions with the review team and potential priority review [178]. - Breakthrough therapy designation can expedite development for products showing substantial improvement over existing therapies, involving more intensive FDA interaction [179]. - Priority review aims for FDA action on marketing applications within six months, compared to ten months under standard review [181]. - Accelerated approval may be granted if a product shows effects on a surrogate endpoint likely to predict clinical benefit, with post-marketing trials required [182]. - Orphan drug designation is available for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S. [184]. - Orphan drug exclusivity grants seven years of market exclusivity following FDA approval for the designated disease [185]. - The FDA requires ongoing compliance with regulations post-approval, including potential modifications to labeling and manufacturing processes [188]. - Non-compliance with FDA regulations can lead to severe consequences, including product recalls and fines [190]. - The BPCIA created an abbreviated approval pathway for biosimilars, with a 12-year exclusivity period for reference products [196]. - The European Union's Clinical Trials Regulation EU No 536/2014 aims to harmonize clinical trial authorization and improve transparency [201]. - Medicinal products in the European Economic Area require a Marketing Authorization (MA), which can be either Community MA or National MA [202]. - The Community MA is mandatory for certain products, including biotechnology and orphan medicinal products, while National MAs are issued by individual member states [202]. - The assessment of the risk-benefit balance of a product is conducted by the EMA or competent authorities before granting the MA [203]. Market Competition and Financial Risks - The company faces significant competition in the immuno-oncology market from major pharmaceutical and biotechnology companies, including AstraZeneca, Bristol Myers Squibb, and Merck [152]. - Competitors may have greater financial resources and expertise, which could impact the company's market position if they develop safer or more effective products [155]. - The pharmaceutical industry faces pricing pressures due to managed healthcare trends and legislative proposals affecting coverage and reimbursement [211]. - Third-party payors may deny coverage if a product is deemed not medically necessary or cost-effective, impacting sales potential [210]. - The Affordable Care Act (ACA) significantly changed healthcare financing and includes provisions affecting pharmaceutical pricing and rebates [214]. - The ACA introduced a new methodology for calculating Medicaid Drug Rebate Program rebates for certain drug administration methods [216]. - The pharmaceutical industry is subject to extensive regulations, including compliance with federal and state fraud and abuse laws [205]. - Companies may face significant penalties for violations of healthcare laws, which could adversely affect business operations and financial results [208]. Financial Position and Employee Relations - As of December 31, 2021, the company had cash and cash equivalents of $363.7 million, with $363.4 million exceeding the Federal Deposit Insurance Corporation insurance limit of $250,000 [580][581]. - The company is exposed to interest rate risk, but an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of its cash and cash equivalents [580]. - The company has limited exposure to foreign currency risk, primarily with contracts denominated in Euros, and a 10% change in exchange rates would not materially affect financial results [582]. - The company employs 43 individuals, with 19 holding Ph.D. or M.D. degrees, and 29 engaged in research and development activities [222]. - The company emphasizes a diverse, equitable, and inclusive culture to attract and retain skilled employees in a competitive biopharmaceutical industry [222]. - The company maintains good relations with employees and offers a collaborative work environment, flexible work arrangements, and professional development opportunities [222]. Legislative and Regulatory Changes - Legislative changes have resulted in aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, affecting the company's financial operations [218]. - The company is subject to heightened governmental scrutiny regarding product pricing, which may lead to additional regulations impacting financial operations [219]. - The Right to Try Act allows certain patients to access investigational drugs without enrolling in clinical trials, but manufacturers are not obligated to provide these drugs [220]. Corporate Structure - The company has undergone a reorganization, becoming ALX Oncology Holdings Inc. on April 1, 2020, with ALX Oncology Limited as its wholly-owned subsidiary [223].