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 September 30, 2024 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 ...

Exhibit 99.1 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 mad ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share ALXO The Nasdaq Global Select Market 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from t ...

Exhibit 99.1 ALX Oncology Reports Second Quarter 2024 Financial Results and Provides Corporate Update SOUTH SAN FRANCISCO, Calif., August 8, 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 second quarter ended June 30, 2024, and provided a corporate update. "Our team continues to make significant progress in the advance ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share ALXO The Nasdaq Global Select Market 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, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ...

Exhibit 99.1 ALX Oncology Reports First Quarter 2024 Financial Results and Provides Corporate Update SOUTH SAN FRANCISCO, Calif., May 9, 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 first quarter ended March 31, 2024, and provided a corporate update. "We entered the quarter with a great deal of momentum having achiev ...

[ALX Oncology Q4 and Full Year 2023 Results & Corporate Update](index=1&type=section&id=ALX%20Oncology%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Provides%20Corporate%20Update) ALX Oncology reports Q4 and full year 2023 financial results, corporate highlights, and clinical milestones for evorpacept [Corporate Highlights and Outlook](index=1&type=section&id=Corporate%20Highlights%20and%20Outlook) Significant 2023 growth driven by positive evorpacept trial results, capital raise, and upcoming clinical milestones - The CEO emphasized 2023 as a profound growth period, highlighted by positive randomized trial results for evorpacept in solid tumors, a first in the CD47 space[2](index=2&type=chunk) - The company plans to report multiple value-driving data points over the next 12-18 months from nine ongoing trials, aiming to expand evorpacept's application to **breast cancer**, **NHL**, **multiple myeloma**, and **urothelial cancers**[2](index=2&type=chunk) [Fourth Quarter 2023 Highlights](index=1&type=section&id=Fourth%20Quarter%202023%20Highlights) Q4 2023 highlights: leadership transition, positive ASPEN-06 interim data, and a successful **$63.2 million** public offering - Jason Lettmann was appointed CEO, with co-founder Jaume Pons transitioning to Chief Scientific Officer[3](index=3&type=chunk) ASPEN-06 Phase 2 Interim Results (Advanced Gastric/GEJ Cancer) | Metric | Evorpacept Combination Arm | Control Arm (TRP) | | :--- | :--- | :--- | | Confirmed Overall Response Rate (ORR) | 52% | 22% | | Median Duration of Response (mDOR) | Not Reached | 7.4 months | - The company executed an oversubscribed public offering, generating gross proceeds of approximately **$63.2 million**, extending the expected cash runway into early 2026[4](index=4&type=chunk)[5](index=5&type=chunk) [Anticipated 2024 Clinical Milestones](index=2&type=section&id=Anticipated%202024%20Clinical%20Milestones) ALX Oncology anticipates a catalyst-rich 2024 with multiple evorpacept data readouts and a planned Phase 3 trial in Gastric/GEJ Cancer - Key upcoming data presentations and results include: - **Non-Hodgkin Lymphoma:** Phase 1b data at AACR Annual Meeting (April 2024) - **Urothelial Carcinoma:** Phase 1b ASPEN-07 data (Q2 2024) - **Gastric/GEJ Cancer:** Top-line results from the full Phase 2 ASPEN-06 trial (June-July 2024) - **Breast Cancer:** Top-line results from the Phase 1b I-SPY TRIAL (Q4 2024) - **Head and Neck Cancer:** Top-line results from Phase 2 ASPEN-03 and ASPEN-04 trials (Q4 2024/Q1 2025)[6](index=6&type=chunk) - The company plans to initiate a Phase 3 registrational randomized clinical trial for evorpacept in Gastric/GEJ Cancer in Q4 2024[6](index=6&type=chunk) [2023 Full Year and Fourth Quarter Financial Results](index=2&type=section&id=2023%20Full%20Year%20and%20Fourth%20Quarter%20Financial%20Results) ALX Oncology concluded 2023 with **$218.1 million** in cash, a wider net loss due to increased R&D expenses, and a cash runway into early 2026 - As of December 31, 2023, the company held **$218.1 million** in cash, cash equivalents, and investments, with an additional **$40 million** available from a term loan, providing a cash runway into early 2026[7](index=7&type=chunk) Full Year Financial Comparison (2023 vs 2022, in millions) | Metric | FY 2023 ($M) | FY 2022 ($M) | | :--- | :--- | :--- | | R&D Expenses | $141.8 | $98.4 | | G&A Expenses | $28.5 | $29.0 | | GAAP Net Loss | ($160.8) | ($123.5) | | GAAP Net Loss per Share | ($3.74) | ($3.03) | Q4 Financial Comparison (2023 vs 2022, in millions) | Metric | Q4 2023 ($M) | Q4 2022 ($M) | | :--- | :--- | :--- | | R&D Expenses | $41.8 | $25.2 | | G&A Expenses | $6.2 | $7.0 | | GAAP Net Loss | ($45.5) | ($30.7) | | GAAP Net Loss per Share | ($0.93) | ($0.75) | [About ALX Oncology and Evorpacept](index=3&type=section&id=About%20ALX%20Oncology%20and%20Evorpacept) ALX Oncology develops evorpacept, a next-generation CD47 blocking therapeutic with an inactive Fc domain for improved safety and dual immune mechanism - The company's lead product, evorpacept, is a next-generation CD47 blocking therapeutic designed to bridge the innate and adaptive immune systems[12](index=12&type=chunk) - Evorpacept has been dosed in over **500 subjects** and has shown a favorable tolerability profile across various hematologic and solid malignancies[12](index=12&type=chunk) - Evorpacept is rationally engineered with an inactive Fc effector function, which provides a substantially improved safety profile over other anti-CD47 molecules, allowing for higher dosing with minimal overlapping toxicity[13](index=13&type=chunk) - The drug's dual mechanism of action involves: 1) enabling macrophage-mediated phagocytosis when combined with anti-cancer antibodies, and 2) enabling T-cell activation by dendritic cells when combined with PD-1/PD-L1 inhibitors[13](index=13&type=chunk)[14](index=14&type=chunk) [Financial Statements and Non-GAAP Reconciliation](index=5&type=section&id=Financial%20Statements%20and%20Non-GAAP%20Reconciliation) Consolidated financial statements detail operating expenses, net loss, and balance sheet, with a GAAP to non-GAAP net loss reconciliation for stock-based compensation Consolidated Statements of Operations (in thousands) | Line Item | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $41,784 | $25,197 | $141,795 | $98,400 | | General and administrative | $6,239 | $7,022 | $28,483 | $29,036 | | **Total operating expenses** | **$48,023** | **$32,219** | **$170,278** | **$127,436** | | Loss from operations | ($48,023) | ($32,219) | ($170,278) | ($127,436) | | **Net loss** | **($45,472)** | **($30,709)** | **($160,805)** | **($123,482)** | | Net loss per share | ($0.93) | ($0.75) | ($3.74) | ($3.03) | Consolidated Balance Sheet Data (in thousands) | Line Item | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $218,147 | $282,906 | | Total assets | $242,553 | $306,489 | | Total liabilities | $52,841 | $43,025 | | Total stockholders' equity | $189,712 | $263,464 | GAAP to Non-GAAP Net Loss Reconciliation (in thousands) | Line Item | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | GAAP net loss | ($45,472) | ($30,709) | ($160,805) | ($123,482) | | Stock-based compensation | $6,721 | $6,295 | $26,273 | $23,839 | | **Non-GAAP net loss** | **($38,687)** | **($24,370)** | **($134,282)** | **($99,599)** |

Licensing and Commercialization - The company has entered into license agreements with third parties for the development and commercialization of product candidates, including evorpacept, with milestone payments and low single-digit royalties[88]. - The company plans to retain significant development and commercial rights for its product candidates and aims to build the necessary infrastructure for commercialization in the U.S. and potentially other regions[89]. Product Development and Clinical Trials - The existing supply of evorpacept is sufficient to complete clinical trials through Q2 2025, with plans to manufacture additional supplies with existing CMOs[90]. - Clinical trials are conducted in three phases, with Phase 3 trials aimed at providing statistically significant evidence of clinical efficacy[98]. - The BLA submission process requires extensive preclinical and clinical testing, with significant time and financial resources needed[97]. - The BLA must include all relevant data from preclinical studies and clinical trials, along with a substantial application user fee[99]. Regulatory Environment - The FDA regulates biologic products, and the company must navigate extensive regulatory requirements for product development and approval[94]. - The FDA aims to review standard BLA applications within ten months and priority review applications within six months after acceptance for filing[100]. - Products with Fast Track designation can have frequent interactions with the FDA review team and may be eligible for rolling review[101]. - Priority review designation allows the FDA to act on marketing applications within six months, compared to ten months under standard review[102]. - Orphan drug designation is granted for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S., providing seven years of exclusivity upon first approval[103]. - Post-approval, products are subject to ongoing FDA regulation, including facility inspections and compliance with cGMP requirements[104]. - The FDA may withdraw product approval if compliance with regulatory requirements is not maintained[104]. - Accelerated approval may be granted based on surrogate endpoints that predict clinical benefit, with post-marketing trials required[102]. - The FDA's regulations prohibit promotion of off-label uses, and violations can lead to significant penalties[104]. - The company is subject to various regulations in jurisdictions outside the United States, including Europe and Asia, which govern research, development, and marketing of product candidates[107]. - In the European Economic Area (EEA), medicinal products require a Marketing Authorization (MA) before commercialization, with two types: Community MA and National MA[109]. - The Community MA is mandatory for certain products, including biotechnology and orphan medicinal products, while National MAs are issued by individual member states[109]. Financial Overview - As of December 31, 2023, the company had cash, cash equivalents, and investments totaling $218.1 million[253]. - The company had outstanding borrowings of $10.0 million under a Loan Agreement, with interest rates tied to the greater of 1-month term SOFR or 2.33% plus 6.25%[253]. - The company has not experienced any realized losses on its deposits of cash, cash equivalents, or investments during the periods presented[254]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's cash, cash equivalents, and investments[253]. - The company is subject to foreign currency transaction gains or losses, primarily from contracts denominated in euros, but these have not been material to its financial statements[255]. Competition and Market Challenges - The company faces competition from major pharmaceutical and biotechnology companies in the immuno-oncology therapy market, including AstraZeneca, Bristol Myers Squibb, and Merck[91]. - Competitors may have greater financial resources and expertise, which could impact the company's market opportunities if they develop superior products[93]. - The pharmaceutical industry faces pricing pressures due to managed healthcare trends and legislative proposals aimed at controlling drug pricing and reimbursement[113]. - Coverage and reimbursement for products depend on third-party payors, including government programs like Medicare and Medicaid, which may deny coverage based on medical necessity[113]. - The company may need to conduct pharmacoeconomic studies to demonstrate the cost-effectiveness of its products to obtain third-party payor coverage[113]. - U.S. healthcare reform proposals are focused on containing costs and improving access, significantly impacting the pharmaceutical industry[114]. Human Capital and Compliance - The company employs 72 individuals, with 27 holding Ph.D. or M.D. degrees, and 59 engaged in research and development activities[116]. - The company maintains good relations with its employees and emphasizes a diverse, equitable, and inclusive culture[116]. - The company’s human capital resources objectives include recruiting, retaining, and incentivizing employees to achieve business goals[116]. - The company faces potential legal challenges and penalties for non-compliance with healthcare laws, which could harm its business operations and financial results[112]. - The requirements for clinical trials and product licensing vary significantly across countries, complicating the approval process for new products[108].

Financial Performance - Total operating expenses for Q3 2023 were $53.3 million, an increase of 45% compared to $36.7 million in Q3 2022[12]. - Net loss for Q3 2023 was $51.0 million, compared to a net loss of $35.3 million in Q3 2022, representing a 44% increase in losses[12]. - The company reported a net loss per share of $1.24 for Q3 2023, compared to $0.87 for Q3 2022[12]. - The net loss for the nine months ended September 30, 2023, was $115,333, compared to a net loss of $92,773 for the same period in 2022, representing a 24.2% increase in losses[17]. - The company incurred a net loss of $115.3 million for the nine months ended September 30, 2023, compared to $92.8 million for the same period in 2022, reflecting a 24% increase in losses[80]. - The company reported net losses of $51.0 million for Q3 2023, compared to $35.3 million for Q3 2022, marking a 44% increase in losses[80]. Research and Development Expenses - Research and development expenses were $45.8 million in Q3 2023, up from $29.4 million in Q3 2022, reflecting a 56% increase[12]. - Research and development expenses for Q3 2023 were $45.8 million, a 56% increase from $29.4 million in Q3 2022[81]. - For the nine months ended September 30, 2023, research and development expenses rose by $26.8 million (37%) compared to the same period in 2022, driven by a $22.3 million increase in clinical and development costs[82]. - Research and development expenses increased by $16.4 million (56%) for the three months ended September 30, 2023, compared to the same period in 2022, primarily due to a $14.7 million increase in clinical and development costs[82]. Cash and Liquidity - Cash, cash equivalents, and restricted cash at the end of the period were $19,650, down from $49,120 at the end of the previous year, reflecting a decrease of 60%[17]. - As of September 30, 2023, the company had cash, cash equivalents, and investments totaling $196.4 million[88]. - The company experienced a net increase in cash, cash equivalents, and restricted cash of $(29.2) million for the nine months ended September 30, 2023, compared to $(314.5) million for the same period in 2022[92]. - The company has borrowed $10.0 million under a Loan Agreement and has access to draw an additional $40.0 million through the end of 2023, with potential further funding of $50.0 million based on milestones[111]. Equity and Stockholder Information - The company issued 290,000 shares under equity incentive plans during the quarter[16]. - As of September 30, 2023, the company had 41,151,819 shares of common stock outstanding, an increase from 40,861,386 shares as of December 31, 2022[43]. - The total stock options issued and outstanding as of September 30, 2023, were 9,114,886, compared to 6,214,107 for the same period in 2022, indicating a 46.0% increase[55]. - The company completed a follow-on public offering on October 10, 2023, issuing 8,663,793 shares of common stock and receiving net proceeds of approximately $59.0 million after expenses[60]. Debt and Liabilities - Total liabilities increased to $51.4 million from $43.0 million at the end of 2022[10]. - The Company entered into a loan agreement for a secured term loan facility of up to $100.0 million, with an initial draw of $10.0 million and access to an additional $40.0 million through the end of 2023[40]. - As of September 30, 2023, the future maturities under the loan agreement total $10.6 million, with $5.2 million due in 2026 and $4.9 million due in 2027[42]. - Interest expense incurred in connection with the loan agreement was $0.3 million for the three months ended September 30, 2023, and $0.8 million for the nine months ended September 30, 2023[40]. Clinical Trials and Product Development - Evorpacept demonstrated a confirmed overall response rate (ORR) of 52% in combination with trastuzumab, ramucirumab, and paclitaxel for advanced gastric/GEJ cancer, compared to 22% for the control group[65]. - The ASPEN-06 trial included 54 randomized patients previously treated with fam-trastuzumab deruxtecan-nxki and checkpoint inhibitors[65]. - The ASPEN-02 trial, evaluating evorpacept in combination with azacitidine for MDS, was terminated due to insufficient activity to support progression to Phase 2 trials[63]. - The company has initiated multiple clinical studies to explore combinations of evorpacept with anti-cancer antibodies and PD-1/PD-L1 immune checkpoint inhibitors[63]. Regulatory and Compliance Risks - The company must successfully complete clinical trials and obtain regulatory approvals to commercialize evorpacept, which is subject to comprehensive regulation by the FDA[113]. - The FDA may require additional data or clinical trials, potentially delaying clinical timelines for product candidates[114]. - The company faces risks related to the COVID-19 pandemic and geopolitical unrest, which could adversely impact its business and clinical trials[108]. - The company is subject to the Foreign Corrupt Practices Act and similar anti-bribery laws, which could result in serious consequences for violations, including criminal liability[134]. Market and Competitive Landscape - The company faces substantial competition from major pharmaceutical and biotechnology companies in developing immuno-oncology therapies[116]. - The company faces significant competition from various firms developing drugs targeting the CD47 pathway, including major players like Gilead Sciences and Pfizer[117]. - The company’s ability to generate revenue is contingent upon successful product development and regulatory approval, which are subject to various risks and uncertainties[120]. Intellectual Property and Patent Risks - The company faces risks related to potential litigation over intellectual property rights, which could result in significant liabilities and distract management[146]. - The company may need to obtain additional intellectual property rights from others to advance its research or allow commercialization of product candidates, which may not be available on reasonable terms[149]. - The company’s intellectual property rights may not provide competitive advantages due to limitations and potential invalidation of patents[148]. Operational and Management Challenges - The company has limited financial and managerial resources, which may lead to missed opportunities in pursuing potentially profitable product candidates[156]. - The company is vulnerable to product liability claims, and existing insurance coverage may not be sufficient to cover all potential liabilities[156]. - The company must effectively manage its information technology and cloud-based systems to avoid disruptions that could adversely affect business operations[156].

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 ...