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ALXO 10-K & 10-Q changes, risk factors and insider trading

Alx Oncology Holdings Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1810182 · All filings on SEC.gov

Everything below is quoted or computed from Alx Oncology Holdings Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

8 / 11risk-factor paragraphs added / removed in latest 10-K
1new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
3Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-09 (period ending 2025-12-31) with 10-K filed 2025-03-06 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

8new paragraphs
11removed paragraphs
76reworded paragraphs
41,101 → 41,180words in section

New heading “If we are unable to maintain listing of our securities on the Nasdaq Global Select Market or another reputable stock exchange, it may be more difficult for our stockholders to sell their securities.”

Removed heading “We previously relied on Tallac Therapeutics Inc., a third-party service provider, to conduct substantially all of our preclinical research activities for evorpacept. If we are unable to successfully transition preclinical research activities in-house or identify an alternative provider as needed, there may be disruptions or delays to our evorpacept development pipeline and our business could be harmed.”

Removed heading “Our affiliated principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Reworded topics: russia, ukraine, israel, interest rate

Paragraph as it now reads, with added and removed wording marked:

macroeconomic conditions,conditions and global economic environment, such as inflation, interest rate changes, trade and other global disputes and interruptions, including related to tariffs and trade protection measures, U.S. federal government shutdowns, economic downturns, bank failures or instability in the financial services sector, or geopolitical risks, disasters, and medical or public health crises, such as the COVID-19 pandemic, including the impact of recent bank failures, the ongoing geopolitical unrest related to Russia’s war with Ukraine, and war and instability in Israel and the surrounding regionpandemic;
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New text topics: delist, liquidity
“For example, if at any time the bid price of our common stock closes below $1.00 per share for more than 30 consecutive business days, we may be subject to delisting from the Nasdaq Global Select Market. On April 23, 2025, we received a notice from Nasdaq notifying us that we have not been in compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market set forth in Nasdaq Listing Rule 5450(a)(1) for a period of 30 consecutive business days. …”
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New text topics: tariff, inflation, interest rate, pandemic
“Macroeconomic conditions and global economic environment, such as inflation, interest rate changes, trade and other global disputes and interruptions, including related to tariffs and trade protection measures, U.S. federal government shutdowns, economic downturns, bank failures or instability in the financial services sector, or geopolitical risks, disasters, and medical or public health crises, such as the COVID-19 pandemic, could adversely impact our business including our ongoing and planned clinical trials and preclinical research;”
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New text topics: delist, liquidity
“Nasdaq requires listing issuers to comply with certain standards in order to remain listed on its exchange. If, for any reason, Nasdaq should delist our securities from trading on its exchange and we are unable to obtain listing on another reputable national securities exchange, it could have a materially adverse effect on our ability to raise additional funds as well as on the price and liquidity of our common stock.”
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Removed text topics: russia, ukraine, israel, pandemic
“The outbreaks or public health crises, such as the COVID-19 pandemic, geopolitical unrest related to Russia’s war with Ukraine, and war and instability in Israel and the surrounding region could adversely impact our business including our ongoing and planned clinical trials and preclinical research;”
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Removed text topics: litigation, breach
“Our commercial success depends, in part, on our ability to conduct our research and develop our product pipeline without infringing the intellectual property and other proprietary rights of third parties. …”
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Full comparison: every changed paragraph (95)

Green = added, red = removed. Unchanged paragraphs, 2 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the U.S. Food and Drug Administration, or FDA, or other comparable foreign regulatory authorities;

Added

Macroeconomic conditions and global economic environment, such as inflation, interest rate changes, trade and other global disputes and interruptions, including related to tariffs and trade protection measures, U.S. federal government shutdowns, economic downturns, bank failures or instability in the financial services sector, or geopolitical risks, disasters, and medical or public health crises, such as the COVID-19 pandemic, could adversely impact our business including our ongoing and planned clinical trials and preclinical research;

Removed

The outbreaks or public health crises, such as the COVID-19 pandemic, geopolitical unrest related to Russia’s war with Ukraine, and war and instability in Israel and the surrounding region could adversely impact our business including our ongoing and planned clinical trials and preclinical research;

Reworded

The price of our stock may be volatile, and you could lose all or part of your investment; and In the past, we have identified material weaknesses in our internal control over financial reporting, and ifIf we are unable to implement and maintain effective internal control over financial reporting in the future, investors may lose confidence in our financial reports.

Reworded

We have incurred significant net losses in each reporting period since our inception, have not generated any revenue from product sales, licenses or collaborations to date and have financed our operations principally through public offerings of our common stock and private placements of our convertible preferred stock. Our net losses were $134.9$101.7 million, $160.8$134.9 million and $123.5$160.8 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $621.1$722.8 million. We have devoted substantially all of our resources and efforts to research and development. Our lead product candidate,candidates, evorpacept,evorpacept isand ALX2004, are in early-stage clinical trials. Our other programs are in preclinical discovery and research stages. As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

Reworded

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval for evorpacept and ALX2004 and advance our other programs. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to drug sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations if we are required by the FDA, the European Medicines Agency, or EMA, or other regulatory agencies to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of any product candidate we develop. We have incurred and expect to continue to incur additional costs associated with operating as a public company and compliance with legal, accounting and other regulatory requirements. Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations. If we are unable to raise capital when needed or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts. Further, any decline in our stock price or perceived potential decline in our stock price that may be associated with stock market volatility generally, may negatively impact our ability to raise capital.

Reworded

As of December 31, 2024,2025, we had cash, cash equivalents and investments of $131.3$48.3 million. Based on our current operating plan, we believe that our existing cash, cash equivalents, and investments and net proceeds of $140.3 million raised in our registered offering that closed in February 2026 (the February 2026 Offering) will be sufficient to fund our operations intothrough the fourthfirst quarterhalf of 2026.2028. Our estimate as to how long we expect our existing cash, cash equivalents, investments and funds available from our term loan will be sufficient to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, such as periods of a rising rate of inflation or economic downturns, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

Reworded

We plan to use our cash, cash equivalents and investments to advance the clinical development of evorpacept,evorpacept and ALX2004, as well as for working capital and other general corporate purposes. This may include additional preclinical research, clinical development, hiring additional personnel, capital expenditures, the potential acquisition of businesses or assets and the costs of operating as a public company, as well as for working capital and other general corporate purposes. Advancing the development of evorpacept and ALX2004, and our other programs will require a significant amount of capital. Our current cash, cash equivalents and investments on hand, may not be sufficient to fund all of the actions that are necessary to complete the development of evorpacept and ALX2004, or our other programs.

Reworded

We will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operating activities. Our ability to raise additional funds may be adversely impacted by market perceptions of our ability to maintain our listing on the Nasdaq. Other than the loan and security agreement, or Loan Agreement, we entered into with Oxford Finance LLC, Oxford Finance Credit Fund II LP and Silicon Valley Bank, or SVB, collectively, the Lenders, in the fourth quarter of 2022 and most recently amended in December 2023, we do not have any committed external source of funds. Under the Loan Agreement, $25.0 million is available for us to draw down at the Lenders’ sole discretion as of December 31, 2024.2025. SVB was closed in March 2023, and the FDIC was appointed as receiver to SVB. The FDIC created Silicon Valley Bridge Bank, or SVBB, as successor to SVB, which was acquired by First Citizens Bank, and is now operated as a division of First Citizens Bank, or SVB-First Citizens. Adequate additional financing may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, youra stockholder’s ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect yourone’s rights as a stockholder. Debt financing may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. For example, our Loan Agreement restricts our ability to incur additional indebtedness without the consent of the Lenders. If we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Reworded

We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We were incorporated and commenced operations in 2015, have no products approved for commercial sale and have not generated any revenue from product sales, licenses or collaborations. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, identifying and developing potential product candidates and conducting preclinical and clinical trials of our product candidates, including Phase 1 and Phase 2 clinical trials of evorpacept.evorpacept and Phase 1 clinical trials of ALX2004. We have not yet demonstrated our ability to successfully complete any large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale drug or arrange for a third party to do so on our behalf or conduct sales and marketing activities. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer operating history. In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research focus to a company capable of supporting commercial activities. We have not yet demonstrated an ability to successfully overcome such risks and difficulties or to make such a transition. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer.

Reworded

successful and timely completion of preclinical and clinical development of our lead product candidate,candidates evorpacept,evorpacept and ALX2004, and our other future product candidates;

Reworded

establishing and maintaining relationships with contract research organizations, or CROs, and clinical sites for the clinical development of evorpaceptevorpacept, ALX2004 and our other future product candidates;

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developing an efficient and scalable manufacturing process for evorpaceptevorpacept, ALX2004 and any future product candidates, including establishing and maintaining commercially viable supply and manufacturing relationships with third parties to obtain finished products that are appropriately packaged for sale;

Reworded

commercial acceptance of evorpacept and ALX2004, and any future product candidates as viable treatment options by patients, the medical community and third-party payors;

Reworded

The term loans under the Loan Agreement mature on October 1, 2027. We will beginbegan to make principal payments in equal monthly installments beginning on December 1, 2025, and if either of the milestone related tranche term loans are funded, then we will begin to make principal payments in equal monthly installments beginning on December 1, 2026.2025. The term loans accrue interest at a floating rate as described elsewhere in this report, and interest is payable monthly in arrears. The term loans once repaid or prepaid may not be reborrowed. The term loans may be prepaid in full or in part in increments of $10.0 million, with various prepayment premiums. Upon the earlier of prepayment or maturity of any term loan, we are required to pay a fee of 6.0% of the original principal amount of such funded term loan, and a contingency fee may apply in connection with a prepayment of such term loan under certain circumstances. We are also obligated to pay other customary fees for a loan facility of this type and size.

Reworded

We are substantially dependent on the success of our lead product candidate, evorpacept, or our second product candidate, ALX2004, which isare both in clinical development and which hashave not completed a pivotal trial. If we do not obtain regulatory approval for and successfully commercialize evorpacept or ALX2004 in one or more indications, or we experience significant delays in doing so, we may never generate any revenue or become profitable.

Reworded

We do not have any products that have received regulatory approval and may never be able to develop marketable product candidates. We expect that a substantial portion of our efforts and expenses over the next several years will be devoted to the development of our lead product candidate,candidates evorpacept,evorpacept and ALX2004, in our ongoing clinical trials. As a result, our business currently depends heavily on the successful development, regulatory approval and, if approved, commercialization of evorpacept in one or more of these indications, such as head and neck squamous cell carcinoma, or HNSCC, gastric/gastroesophageal junction, or GEJ, carcinoma, urothelial cancer, breast cancer, NHL,NHL or multiple myeloma, or colorectal cancer.myeloma. We cannot be certain that evorpacept will receive regulatory approval or will be successfully commercialized even if it receives regulatory approval. The research, testing, manufacturing, safety, efficacy and potency, labeling, approval, sale, marketing and distribution of evorpacept is, and will remain, subject to comprehensive regulation by the FDA and comparable foreign regulatory authorities. Our failure to timely complete clinical trials, obtain regulatory approval or, if approved, commercialize evorpaceptevorpacept, ALX2004 or any of our future product candidates, would materially harm our business, financial condition and results of operations. We are not permitted to market or promote evorpacept, ALX2004 or any other product candidate, before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals. If we do not receive marketing approvals for evorpacept,evorpacept or ALX2004, we may not be able to continue our operations.

Reworded

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy/potency of our product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete, and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. For example, in April 2025, we announced that topline data from our Phase 2 ASPEN-03 and ASPEN-04 clinical trials did not meet the primary endpoints, and we will no longer pursue evorpacept in combination with pembrolizumab in head and neck squamous cell carcinoma (HNSCC). The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain approval of their drugs.

Reworded

Positive or timely results from preclinical or early-stage trials do not ensure positive or timely results in future clinical trials or registrational clinical trials because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety, purity and efficacy and potency to the satisfaction of the FDA or comparable international regulatory authorities, despite having progressed through preclinical studies or initial clinical trials. In addition, the FDA or any comparable international regulatory authorities may conclude that the results from our clinical trials are insufficient to support any accelerated approval that we may seek with respect to evorpaceptevorpacept, ALX2004 or any of our future product candidates in general or with respect to any specific indications. Product candidates that have shown promising results in early clinical trials may still suffer significant setbacks in subsequent clinical trials or registration clinical trials. For example, a number of companies in the pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier clinical trials. Additionally, in March 2023, the FDA issued a draft guidance on clinical trial considerations for supporting accelerated approval of oncology therapeutics, noting that although single-arm trials have been commonly used to support accelerated approval, a randomized controlled trial is the preferred approach for providing a more robust efficacy and safety assessment, among other recommendations. To the extent the FDA requires us to collect additional data or to conduct additional clinical trials in accordance with the new guidance, including with respect to our single-arm ASPEN-09-Breast study in HER2-positive breast cancer, our clinical timelines may be delayed.

Reworded

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct preclinical development and then extensive clinical trials (including initiation of aany pediatric study) to demonstrate their safety, purity and efficacy and potency. Clinical trials are expensive and difficult to design and implement. Clinical trials can take many years to complete, and their ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. For example, in April 2025, we announced that topline data from our Phase 2 ASPEN-03 and ASPEN-04 clinical trials did not meet the primary endpoints, and we will no longer pursue evorpacept in combination with pembrolizumab in HNSCC. We will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe, pure and effective or potent for use in a diverse patient population before we can seek regulatory approvals for their commercial sale. Our clinical trials may produce negative or inconclusive results and we may decide, or regulators may require us, to conduct additional and expansive preclinical or clinical testing.

Reworded

the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and regulators revising the requirements for approving our product candidates.

Added

any development and approval of FDA or other comparable foreign regulatory authorities required companion diagnostics necessary for use with our product candidates; and regulators revising the requirements for approving our product candidates.

Reworded

We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials as required by the FDA or comparable international regulatory authorities. Subject enrollment is a significant factor in the timing of clinical trials. In particular, because certain of our clinical trials of evorpacept and ALX2004 are focused on indications with small patient populations, our ability to enroll eligible subjects may be limited or may result in slower enrollment than we anticipate.

Reworded

In the past, clinical trial enrollment and data collection has been adversely impacted by staff shortages, site closures, travel limitations and physical distancing requirements and personal safety concerns resulting from and associated with the COVID-19 pandemic. Going forward we expect to continue to experience some of these clinical trial enrollment difficulties associated with the pandemic. For example, subjects who enroll in our clinical trials and then become infected with the COVID-19 virus may complicate the clinical trial data, procedures and analysis, which could delay the anticipated readouts from our clinical trials and our regulatory submissions and increase the costs associated with clinical trials.

Reworded

From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials such as our topline Phase 2 ASPEN-06 clinical trial results of evorpacept for the treatment of advanced HER2-Positive gastric cancer announced in July 2024 and the updated data from a December 2024 data cutoff announced in January 2025.trials. These interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. Further, interim, topline and preliminary data include certain assumptions, estimations, calculations and conclusions as part of our analyses of data available at that time, and we may not have received or had the opportunity to evaluate all data fully and carefully. As a result, the topline results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as subject enrollment continues and more subject data become available. Adverse changes between interim data and final data could significantly harm our business and prospects. Further, additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common stock. Some may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or our business. If the preliminary or topline data that we report differ from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for product candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.

Reworded

If evorpaceptevorpacept, ALX2004 or any of our other product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. For example, in ALX-Oncology-sponsored clinical trials, the most common adverse events of any grade associated with evorpacept (frequency ≥20%) are fatigue, anemia, nausea, diarrhea, constipation, and neutrophil count decrease. These events have been reported across the program in patients administered evorpacept as a single agent, in combination with pembrolizumab, trastuzumab, rituximab, azacitidine, or azacitidineenfortumab vedotin and as a multiproduct regimen in combination with pembrolizumab, platinum, and 5 FU, or in combination with trastuzumab, ramucirumab, and paclitaxel, or in combination with azacitidine + venetoclax. Such side effects could also affect subject recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Any adverse events as a result of evorpacept or any of our future product candidates, including in combination with therapy, may prevent us from achieving or maintaining market acceptance of the affected product candidate and may harm our business, financial condition and prospects significantly.

Reworded

The development and commercialization of new product candidates is highly competitive. We face competition with respect to evorpacept and ALX2004, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major pharmaceutical, specialty pharmaceutical and biotechnology companies among others. We compete in the segments of the pharmaceutical, biotechnology and other related markets that develop immuno-oncology therapies for the treatment of cancer. There are other companies working to develop immuno-oncology therapies for the treatment of cancer including divisions of large pharmaceutical and biotechnology companies of various sizes. The large pharmaceutical and biotechnology companies that have commercialized and/or are developing immuno-oncology treatments for cancer include, but are not limited to, AstraZeneca, Bristol Myers Squibb, Coherus BioSciences, Gilead Sciences, Merck, Merck KGaA, Novartis, Pfizer, Regeneron Pharmaceuticals and Roche/Genentech. Newly approved therapeutics could change the treatment paradigm or standard of care, which could negatively impact the design of our clinical trials and the prospects of our product candidates.

Reworded

Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approach,approaches, including with respect to the targeting of the CD47 pathwaypathway, targeting epidermal growth factor receptor (EGFR) as an antibody-drug conjugate target, and others are based on entirely different approaches. We are aware that Adagene, Akesobio, Bio-Thera Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Byondis, Centessa, Conjupro Biotherapeutics, CTTQ (SinoBiological), Daiichi Sankyo, Exelixis, GenSci, Gilead Sciences (through its acquisition of Forty Seven), Hanchor Bio, Hisun, Hutchmed, I-Mab, Ichnos, ImmuneOncia Therapeutics, ImmuneOnco Biopharma, Innovent, Kahr, LaNova, Lightchain Bioscience, Mabwell Therapeutics, Mabworks, Novimmune, OSE Immunotherapeutics, Pfizer (through its acquisition of Trillium Therapeutics), Phanes, Pyxis Oncology (through its acquisition of Apexigen), Shandong New Time, Shattuck Labs, Sorrento Therapeutics, Sumgen, SunHo Pharmaceutical, TG Therapeutics, Waterstone, and Zai Lab, among others, are developing or have begun development of drugs targeting the CD47 pathway that may have utility for the treatment of indications that we are targeting. We are also aware that AstraZeneca, BioNTech, Bristol Myers Squibb with Systimmune, CSPC, and Henlius, among others, are developing or have begun development of antibody drug conjugates (ADCs) targeting EGFR. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Reworded

There are already a variety of available drug therapies marketed for cancer and some of the currently approved drug therapies are branded and subject to patent protection and others are available on a generic basis. Many of these approved drugs are well established therapies and are widely accepted by physicians, patients and third-party payors. Insurers and other third-party payors may also encourage the use of generic products. We expect that if evorpaceptevorpacept, ALX2004 and/or any of our other future product candidates are approved, they will be priced at a significant premium over competitive generic products. This may make it difficult for us to achieve our business strategy of using our product candidates in combination with existing therapies or replacing existing therapies with our product candidates.

Reworded

Even after approval, our manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our approved products will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with current good manufacturing practices, or cGMPs, and current good clinical practices, or cGCPs, for any clinical trials that we conduct post-approval. Regulatory approvals may contain significant limitations related to use restrictions for specific target population subsets, e.g., based on biomarker analyses or age groups, warnings, precautions or contraindications, or may include costly and burdensome post-approval study or risk management requirements and regulatory inspection. For example, the FDA may require a risk evaluation and mitigation strategy, or REMS, as a condition for approval of our product candidates, which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk mitigation tools.

Reworded

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and standards. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with a contract supplier, vendor, or facility where the product is manufactured or processed, a regulatory agency may impose restrictions on that product, the manufacturing facility or contractor, or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. In addition, failure to comply with FDA, European Medicines Agency (EMA) and other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions or enforcement actions, including:

Removed

We previously relied on Tallac Therapeutics Inc., a third-party service provider, to conduct substantially all of our preclinical research activities for evorpacept. If we are unable to successfully transition preclinical research activities in-house or identify an alternative provider as needed, there may be disruptions or delays to our evorpacept development pipeline and our business could be harmed.

Removed

We have the ability to independently conduct our preclinical research activities but we previously relied on a third-party service provider to conduct all of our preclinical research activities for evorpacept. Effective as of July 1, 2020, we transferred our preclinical research capabilities at such time and nine of our employees, including a former Chief Scientific Officer, to Tallac Therapeutics Inc., a third-party service provider, formerly known as Tollnine, Inc., or Tallac Therapeutics, and entered into a research and development services agreement, or the Tallac Services Agreement, with Tallac Therapeutics. Under the terms of the Tallac Services Agreement, Tallac Therapeutics provided preclinical research services to us for the cost of these services plus a mark-up equal to 10.0% of such costs. The Tallac Services Agreement terminated on July 1, 2024.

Removed

If we are unable to successfully transition preclinical research activities in-house, or identify an alternative provider as needed, our preclinical research efforts and studies may be extended or delayed, and there may be disruptions or delays to our evorpacept development pipeline. As a result, our evorpacept product candidate research and development efforts may be delayed or harmed, and our costs could increase and our future ability to generate revenues could be delayed.

Removed

Hiring additional internal research and development employees will involve additional efforts and costs and could divert management’s time and focus. In addition, there is a natural transition period to train new employees. As a result, delays may occur, which can materially impact our ability to meet our desired preclinical timelines.

Removed

Our commercial success depends, in part, on our ability to conduct our research and develop our product pipeline without infringing the intellectual property and other proprietary rights of third parties. If we ever become involved in any dispute with Tallac Therapeutics over ownership of intellectual property or proprietary rights in the future because of the access that Tallac Therapeutics had to our intellectual property, including trade secrets, we may need to negotiate or engage in litigation to preserve our intellectual property rights, which may be time-consuming, expensive and ultimately unsuccessful. In addition, our former employees who are now employees of Tallac Therapeutics may possess our proprietary information. Although these former employees have signed confidentiality and invention assignment agreements with us, we cannot guarantee that they will not breach these agreements in the future. If these former employees disclose our proprietary information to Tallac Therapeutics or other third parties, we may not be able to obtain adequate remedies for such breaches.

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Our product candidates may be administered in combination with drugs of other pharmaceutical companies as one regimen. In addition, we currently use, and plan to use in the future, third-party drugs in our development and clinical trials as controls for our studies, such as conducting Phase 2 and Phase 2/3 clinical trials of evorpacept in combination with pembrolizumab for HNSCC and trastuzumab for gastric/GEJ carcinoma, respectively.carcinoma. As a result, both the results of our clinical trials and the sales of our drugs may be affected by the availability of these third-party drugs. For instance, we entered into clinical trial collaboration and supply agreements with Merck, Eli Lilly and Jazz,Lilly, pursuant to which our collaboration counterparties will supply doses of pembrolizumab, ramucirumab, and zanidatamab, respectively,ramucirumab for use in certain clinical trials. If the agreementsagreement with Merck and Eli Lilly areis terminated before the trialstrial areis completed, we may need to find another source of pembrolizumab and ramucirumab, respectively,ramucirumab in order to continue our trials. Zanidatamab is not approved for commercial use by the FDA or any comparable regulatory authority, and as a result, no alternative source of zanidatamab exists. As such, if the agreement with Jazz is terminated before the trials are completed, our ability to continue the trials with zanidatamab would be limited.trial.

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Even if the FDA and applicable foreign regulatory authorities approve the marketing of any product candidates that we develop, physicians, patients, third-party payors or the medical community may not accept or use our product candidates. Efforts to educate the medical community and third-party payors on the benefits of our product candidates may require significant resources and may not be successful. Market acceptance of evorpacept and ALX2004 and any other product candidates, if any are approved, will depend on a number of factors, including, among others:

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the ability of evorpaceptevorpacept, ALX2004, and our other product candidates to treat cancer or other applicable targeted diseases, as compared with other available drugs, treatments or therapies;

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the prevalence and severity of any adverse side effects associated with evorpaceptevorpacept, ALX2004, and our other product candidates;

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limitations or warnings contained in the labeling approved for evorpaceptevorpacept, ALX2004, or our other product candidates by the FDA or foreign regulatory authorities;

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our ability to obtain sufficient third-party coverage or reimbursement,reimbursement by government, insurers or third-party payors, and the willingness of patients to pay out-of-pocket in the absence of third-party coverage; and the likelihood that the FDA or any foreign regulatory authority may impose additional requirements that limit the promotion, advertising, distribution or sales of our product candidates.

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Adverse events in clinical trials for our product candidates or in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the field of immuno-oncology that may occur in the future, could result in a decrease in demand for evorpaceptevorpacept, ALX2004 or any other product candidate that we may develop. If public perception is influenced by claims that the use of cancer immunotherapies is unsafe, whether related to our therapies or those of our competitors, our products may not be accepted by the general public or the medical community. Future adverse events in immuno-oncology or the biopharmaceutical industry generally could also result in greater governmental regulation and stricter labeling requirements.

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Our lead product candidate,candidates, evorpacept,evorpacept isand ALX2004, are at an early stage of clinical development and not all adverse effects can be predicted or anticipated. Unforeseen side effects from evorpaceptevorpacept, ALX2004, or any of our future product candidates may arise at any time during clinical development or, if approved by regulatory authorities, after the approved drug product has been marketed. Any undesirable or unacceptable side effects of evorpaceptevorpacept, ALX2004, or our future product candidates could interrupt, delay or halt clinical trials, and result in delay of, or failure to obtain, marketing approval from the FDA or comparable international regulatory authorities, or result in marketing approval from the FDA or comparable international regulatory authorities with restrictive label warnings or for limited patient populations. Ultimately, such side effects could result in product liability claims. No regulatory agency has made any determination that any of our product candidates or discovery programs is safe or effective for use by the general public for any indication.

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The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. Seeking foreign regulatory approvals could result in significant delays, difficulties and costs for us and may require additional preclinical studies or clinical trials which would be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates in those countries. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. For example, the FDA’s Oncology Center of Excellence initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development and Project FrontRunner to help develop and implement strategies to support approvals in the early clinical setting, among other goals. How the FDA plans to implement these goals and their impact on specific clinical programs and the industry are unclear. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other data. Satisfying these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. Our failure to obtain regulatory approval in any country may delay or have negative effects on the process for regulatory approval in other countries. Even if we eventually complete clinical testing and receive approval of any regulatory filing for our product candidates, the FDA and comparable foreign regulatory authorities may approve our product candidates for a more limited indication or a narrower patient population than we originally requested. We have not submitted for or obtained regulatory approval for any product candidate and it is possible that we may never obtain regulatory approval for evorpacept,evorpacept or ALX2004, or any other product candidates we seek to develop in the future. If we fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

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Further, under the new leadership at the HHS, reorganization of that department, departure of senior leadership at the FDA and other agencies under HHS, mass layoffs at HHS, government shutdown, and a lapse in U.S. government appropriations may impact operations at the FDA as well as other federal agencies, which can materially delay our timelines. The FDA may lack adequate staff and resources to meet current review, approval, and inspection schedules, which could delay our anticipated timelines. These new policies are also expected to lead to fewer agency guidance documents that could result in interference with FDA programs or lead to delays or refusals to approve products. Further, FDA’s “real-time” release of newly issued Complete Response Letters associated with withdrawn or abandoned applications, if applicable to any of our product candidates, can materially impact our competitive advantage and intellectual property. It is unclear how our industry and our clinical programs will be impacted by policies or regulations implemented under the current presidential administration and the new FDA commissioner or other executive orders. To the extent the agency reorganization and other agency changes lead to disruptions in the FDA’s operations, our interactions, correspondence, and regulatory review processes with the FDA may be delayed.

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The FDA granted Fast Track designation for evorpacept in combination with pembrolizumab, platinum, and fluorouracil for the first-line treatment of adult patients with metastatic or unresectable, recurrent HNSCC in February 2020, for evorpacept in combination with trastuzumab, ramucirumab and paclitaxel for the treatment of patients with HER2-overexpressing advanced gastric or GEJ adenocarcinoma with disease progression on or after prior trastuzumab, and fluoropyrimidine or platinum-containing chemotherapy in January 2020, and for evorpacept in combination with pembrolizumab for first-line treatment of adult patients with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1 in July 2022.2020. If a product candidate is intended for the treatment of a serious condition and preclinical or clinical data demonstrate the potential to address unmet medical need for such condition, a sponsor may apply for FDA Fast Track designation. Even though we received these Fast Track designations for evorpacept, Fast Track designation does not ensure that we will receive marketing approval or that approval will be granted within any particular timeframe. We may not experience a faster development or regulatory review or approval process with Fast Track designation compared to conventional FDA procedures. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.

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Under the Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. In January 2022, the FDA’s Office of Orphan Products Development granted Orphan Drug Designation, ODD, to evorpacept for treatment for gastric/GEJ cancer. We may seek ODD for certain additional indications for our product candidates in the future. ODD neither shortens the development time or regulatory review time of a product candidate nor gives the product candidate any advantage in the regulatory review or approval process. Generally, if a product candidate with ODD subsequently receives the first marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity that precludes the FDA from approving another marketing application for the same drug for the same indication for seven years. Therefore, if our competitors are able to obtain orphan product exclusivity for their product candidates in the same indications we are pursuing, we may not be able to have competing product candidates approved in those indications by the FDA for a significant period of time. There are also limited circumstances where the FDA may reduce the seven-year exclusivity for a product candidate with an orphan drug designation where other product candidates show clinical superiority to the product with orphan exclusivity or if the FDA finds that the holder of the orphan exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan product to meet the needs of patients with the disease or condition for which the drug was designated. However, even if one of our product candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture a sufficient supply of our product. In response to recent litigation, the FDA clarified in a January 2023 notice that the FDA will continue tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved, which permits other sponsors to obtain approval of a drug for new uses or indications within the same orphan designated disease or condition that have not yet been approved. ItThe isConsolidated unclearAppropriations howAct futureof litigation,2026, legislation,signed agencyinto decisions,law andin administrativeFebruary actions2026, willcodified impactthis thelongstanding scopeFDA interpretation of the orphanOrphan drugDrug exclusivity.Act, Further, in view of the overturn of the Chevron doctrine, this landmark Supreme Court decision may invite various stakeholders to bring lawsuits againstallowing the FDA to challengeapprove longstandingmultiple decisionsversions of the same orphan drug for different subindications and policies, which could lead to uncertainties in the industry.subpopulations. Changes in the leadership of the FDA and other federal agencies under the current U.S. presidential administration may also lead to new policies and changes in the regulations and operations of the FDA, which may impact our clinical development plans.

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There also has recently been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their drugs, which has resulted in several U.S. congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug products. For example, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Programs rebates that manufacturers pay to state Medicaid programs was eliminated. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have material impact on our business. Further, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at increasing competition for prescription drugs. Congress is considering legislation that, if passed, could have significant impact on prices of prescription drugs covered by Medicare, including limitations on drug price increases. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least seven years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, CMSCenters for Medicare & Medicaid Services, or CMS, selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders, including the U.S. Chamber of Commerce, the National Infusion Center Association, the Global Colon Cancer Association, and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. The One Big Beautiful Bill Act, which was signed into law in July 2025, includes provisions that will impact the U.S. healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions fOr U.S. Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs. Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or that increase generic and biosimilar drug entry sooner than expected, can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The impact of theseongoing and future judicial challenges as well as future judicial challenges in view of the U.S. Supreme Court’s overturn of the Chevron doctrine, and other legislative, executive, and administrative actions and agency rules implemented by the current U.S. presidential administration on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

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The federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, medical devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to Centers for Medicare & Medicaid Services, or CMS,CMS information regarding payments and other transfers of value made to covered recipients, including physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others), and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members.

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Additionally, in many countries, healthcare providers are employed by the government, and the purchasers of biopharmaceuticals are government entities. As a result, our dealings with these providers and purchasers are subject to regulation and such healthcare providers and employees of such purchasers may be considered “foreign officials” as defined in the FCPA. Recently, the SEC and Department of Justice have increased their FCPA enforcement activities with respect to biotechnology companies. In addition to our own employees, we leverage third parties to conduct our business abroad, such as obtaining government licenses and approvals. We and our third-party business partners, representatives and agents may have direct or indirect interactions with officials and employees of government agencies, state-owned or affiliated entities and we may be held liable for the corrupt or other illegal activities of our employees, our third-party business partners, representatives and agents, even if we do not explicitly authorize such activities. There is no certainty that our employees or the employees of our third-party business partners, representatives and agents will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in whistleblower complaints, adverse media coverage, investigations, loss of export privileges, debarment from U.S. government contracts, substantial diversion of management’s attention, significant legal fees and fines, severe criminal or civil sanctions against us, our officers or our employees, disgorgement and other penalties and remedial measures and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results, financial condition and stock price.

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Additionally, if any of our product candidates are approved, we may seek to commercialize those products in the EEA or the United Kingdom or Switzerland. The collection and use of personal information (which includes health data) in the EEA is governed, in part, by the provisions of the General Data Protection Regulation (EU) 2016/679, or the GDPR, or its UK equivalent, the UK General Data Protection Regulation, or, together with the UK’s Data Protection Act 2018, the UK GDPR, or the new Swiss Federal Act on Data Protection, or FADP. These regulations impose requirements relating to having a legal basis for processing personal information and transferring such information outside of the EEA, the United Kingdom and Switzerland, respectively, as applicable, including to the United States, informing concerned individuals about the processing of their personal information, keeping personal information secure, having data processing agreements with third parties who process personal information on our behalf, responding to individuals’ requests to exercise their rights in respect of their personal information, reporting security breaches involving personal information to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping.

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Any actual or alleged failure to comply with the GDPR, UK GDPR, FADP, or relatedother data protection laws may result in regulatory inquiries and other proceedings, substantial fines, other administrative penalties and civil claims being brought against us, which could have a material adverse effect on our business, financial condition and results of operations.

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One primary set of safeguards, the Standard Contractual Clauses adopted by the European Commission, has been updated recently. With regard to data transfers outside of the EEA to the United States, in March 2022, the European Union and United States announced a political agreement onestablished a new framework for personal information transfers, the EU-U.S. Data Privacy Framework, or the EU-U.S. DPF. A related framework, the Swiss-U.S. Data Privacy Framework, or Swiss-U.S. DPF, also was established, and was the subject of an adequacy decision by the Swiss Federal Council on August 14, 2024. On July 10, 2023, the European Commission adopted an adequacy decision relating to the EU-U.S. DPF. Additionally, a UK Extension to the EU-U.S. DPF, became effective on October 12, 2023. We are evaluating whether to make use of the EU-U.S. DPF and the UK Extension to the EU-U.S. DPF to transfer personal information from the EEA to the United States.

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Further, Brexit has created uncertainty with regard to dataData protection regulation in the United Kingdom.Kingdom is subject to some uncertainty. Although the European Commission granted “adequacy” status to the United Kingdom in June 2021, and personal information can flow from the European Union to the United Kingdom and back, the United Kingdom is expected tomay change its policy with respect to the export of personal information to third countries, such as the United States, and the European Commission’s adequacy determination for the United Kingdom requires renewal afterin four years2025 and it may be modified or revoked in the interim. The United Kingdom made targeted amendments to the UK GDPR in the UK Data (Use and Access) Act 2025, or DUAA, which was enacted on June 19, 2025. The European Commission has renewed the UK’s adequacy decision after assessing the DUAA through December 2031. In addition, in February 2022, the United Kingdom’s Information Commissioner’s Office issued new Standard Contractual Clauses for the transfer of personal information outside of the United Kingdom. The data transfers enforcement landscape and the longer termlonger-term stability of the EU-U.S. DPF and related programs remain uncertain, which could require us to modify our policies and practices and increase our compliance costs.

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We may, therefore, incur liabilities, expenses, costs, and other operational losses under the GDPR, the UK GDPR, the FADP, and applicable laws and regulations of European Union member states in connection with any measures we take to comply with them.

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Additionally, the California Privacy Rights Act, or the CPRA, was approved by California voters in November 2020. The CPRA modified and augmented the CCPA significantly, effective as of January 1, 2023, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply. Numerous other states have proposed, and in certain cases enacted similar laws, including comprehensive privacy laws similar to the CCPA enacted in Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Rhode Island, Tennessee, Texas, Utah, and Virginia. Other states have proposed, and in certain cases enacted, legislation addressing privacy and cybersecurity in the context of specific subject matter such as biometrics and health-related personal information. The U.S. Department of Justice also has issued rules regarding certain bulk sensitive personal data transfers. As we expand our operations, preclinical studies and clinical trials, these new state laws and other state laws and regulations relating to privacyprivacy, data security, and the collection, use, transfer, and other processing of data security may increase our compliance costs and potential liability. Privacy and data security lawsLaws and regulations relating to these matters are not consistent across jurisdictions, and they may impose conflicting or uncertain obligations. Compliance with these and any other applicable privacy and data security laws and regulations relating to these matters is a rigorous, costly and time-intensive process, and we may be required to put in place additional mechanisms ensuringto compliance withaddress new and changing data protection obligations under these laws and regulations. Actual or alleged noncompliance with any such laws and regulations may lead to regulatory investigations, enforcement actions, claims and litigation, and if we fail to comply with any such laws or regulations, we may face significant fines and penalties. Any of these could adversely affect our business, financial condition and results of operations.

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We are aware of third-party patents and patent applications containing claims in the immuno-oncology field based on scientific approaches that are the same as or similar to our approach, including with respect to the targeting of the CD47 and signal regulatory protein alpha, or SIRPα, pathways, and others that are based on entirely different approaches. These patents and applications could potentially be construed to cover our product candidates and their use. For example, we are aware of U.S. patent 10,907,209 and U.S. patent application 16/118,038 (now abandoned in favor of a divisional application 18/518,353, which has claims that are not related to polypeptides comprising soluble human SIRPα) owned by University Health Network, or UHN, and The Hospital for Sick Children that may encompass certain therapies for the treatment of cancer using polypeptides comprising soluble human SIRPα, as well as related applications in other jurisdictions. This patent and patent application relate to the treatment of cancer with polypeptides comprising soluble human SIRPα. Pfizer, through its acquisition of Trillium Therapeutics, has an exclusive license to the U.S. patent and application. The European counterpart patent (EP 2 429 574) was revokedsubject by the Opposition Division of theto European Patent Office (Oppositionopposition Division)proceedings, onwhich November 6, 2017. The revocation was appealed by UHN and The Hospital for Sick Children, and on October 18, 2022, the Board of Appeal of the European Patent Office (Board of Appeal) ruledresulted in favor of UHN with respect to the matter on appeal, but remanded the case back to the Opposition Division for consideration of a further ground of invalidity (sufficiency of disclosure). On December 8, 2023, the Opposition Board held that the disclosure in EP 2 429 574 was sufficient and upheld the patent being upheld in amended form. OnAdditionally, Februarywe 15,are 2024, the Boardaware of Appeal announced that it had received a notice of appeal with respect to the Opposition Board’s ruling regarding sufficiency of disclosure. The hearing before the Board of Appeal has been scheduled for December 9, 2025. Additionally, on December 27, 2023, a second European Patent (EP 2 995 315), a divisional of European patent (EP 2 429 574), was granted to UHN and The Hospital for Sick Children. This patent relates to the eradication of hematological CD47+ cancer cells and tumors with polypeptides comprising soluble human SIRPα, or a CD47-binding fragment thereof. OnThis Februarypatent 27,was 2024,upheld as granted by the European Patent Office Opposition Division announcedon thatNovember it28, had2025. receivedThis adecision noticeis ofcurrently oppositionunder with respect to EP 2 995 315. A date for the opposition hearing has not yet been announced.appeal. The patent claims of both EP 2 429 574 and EP 2 995 315, if not revoked or otherwise limited by the European Patent Office,315 could potentially limit our ability to pursue evorpacept in certain indications in certain geographiesterritories in the future.EU in the future unless we obtain a license under these patents, these patents are determined to be invalid or unenforceable by the European Patent Office or a national court in one or more relevant territories, these patents are revoked or otherwise limited by the European Patent Office or a national court, or until these patents expire. A license may however not be available on commercially reasonable terms or at all. With respect to U.S. patent 10,907,209, we believe that we do not infringe claims listed in this U.S. patent. Further, with respect to the development of our ALX2004 program, many companies have filed, and continue to file, patent applications related to ADCs and components thereof that are similar to our approach. As the biotechnology industry expands and more patents are issued, the risk increases that we may be subject to claims of infringement of the patent rights of third parties. There is no assurance that there are not third-party patents or patent applications of which we are aware, but which we do not believe are relevant to our business, which may, nonetheless, ultimately be found to limit our ability to make, use, sell, offer for sale or import our future approved products or impair our competitive position.

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managing our internal development efforts effectively, including the clinical and FDA review process for evorpaceptevorpacept, ALX2004 and any other future product candidates, while complying with applicable contractual obligations to contractors and other third parties; and maintaining and updating our operational, financial and management controls, reporting systems and procedures.

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Our future financial performance and our ability to successfully develop and, if approved, commercialize evorpacept and ALX2004, and any other future product candidates will depend, in part, on our ability to effectively manage any future growth, which may require our management team to divert its attention away from day-to-day activities of the business and devote a substantial amount of time to the added responsibilities associated with managing these growth activities.

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Management's Discussion & Analysis (MD&A) (10-K Item 7)

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New heading “Combination with the HER2-targeted bispecific, zanidatamab, and HER2-targeted ADC, fam-trastuzumab deruxtecan-nxki”

New heading “Combination with the CD20-targeted antibody rituximab”

New heading “Combination with the CD38-targeted antibody isatuximab-irfc”

New heading “Nasdaq Minimum Bid Price Compliance”

New heading “Impairment Charge”

New heading “Impairment Charge”

Removed heading “PD-1/programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (the “don’t activate T-cells” signal): Combining with PD-1/PD-L1 checkpoint inhibitor, where evorpacept activates dendritic cells that are constitutively inhibited by the CD47/ SIRP alpha pathway.”

Removed heading “Combination with anti-cancer antibody or ADC”

Removed heading “Early Pipeline Programs”

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From inception through December 31, 2024,2025, we have raised an aggregate of $643.2$644.8 million to fund our operations, of which $175.1 million were net proceeds from sales of our convertible preferred stock, $5.8 million were net proceeds from borrowings under a term loan, $169.5 million were net proceeds from our initial public offering, $194.9 million were net proceeds from our follow-onregistered offering in December 2020, $9.3 million were net proceeds from borrowings under the Loan Agreement,Agreement (as defined below), $58.9 million were net proceeds from our follow-onregistered offering in October 2023, and $29.7$31.4 million were net proceeds from our at-the-market (ATM) offering. After December 31, 2025, we also raised $140.4 million in net proceeds from our registered offering in February 2026. For more information on the funding of our operations since inception, see section titled “—Liquidity and Capital Resources; Plan of Operations—Funding Requirements” included elsewhere in this Annual Report on Form 10-K.
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“PD-1/programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (the “don’t activate T-cells” signal): Combining with PD-1/PD-L1 checkpoint inhibitor, where evorpacept activates dendritic cells that are constitutively inhibited by the CD47/ SIRP alpha pathway.”
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“Combination with the HER2-targeted bispecific, zanidatamab, and HER2-targeted ADC, fam-trastuzumab deruxtecan-nxki”
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“In March 2022, we filed a universal shelf registration statement (Shelf Registration Statement), which provides for aggregate offerings of up to $450.0 million of the Company’s securities. In May 2022, we filed an amendment to the Shelf Registration Statement, which was declared effective by the Securities and Exchange Commission (SEC) on May 31, 2022. We believe that our Shelf Registration Statement provides us with flexibility to raise additional capital to finance our operations as needed. …”
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We are a clinical-stage immuno-oncologybiotechnology company focusedadvancing ona helpingpipeline patientsof fightnovel therapies designed to treat cancer byand developingextend therapiespatients’ thatlives. blockOur clinical pipeline includes two clinical-stage product candidates, the CD47 immuneblocker checkpointevorpacept and bridgean theepidermal innategrowth andfactor adaptivereceptor immune(EGFR)-targeted system.antibody drug candidate (ADC) ALX2004. Our lead product candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the CD47future blockerof evorpacept,immuno-oncology can be built. Evorpacept is currently being evaluated in multiplecombination with trastuzumab and chemotherapy in patients with metastatic HER2-positive breast cancer in the Phase 12 ASPEN-09-Breast clinical trial and 2is also being studied in clinical trials.trials with other targeted anti-cancer antibodies. Cancer cells leverage CD47, a cell surface protein, as a “don’t eat me” signal to evade macrophage phagocytosis or as a “don’t activate T-cells” signal that prevents activation of T-cells by dendritic cells.phagocytosis. We are developing evorpacept to be a next-generation checkpoint inhibitor designed to have a high affinity for CD47 and to avoid the limitations caused by hematologic toxicities inherent in other CD47 blocking approaches. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action entered into a Phase 1 clinical trial in August 2025.

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Evorpacept is a next-generation CD47 blocking therapeutic that we believe has significantly enhanced properties compared to competing CD47 blocking approaches. Evorpacept is a fusion protein that combines a high-affinity CD47 binding domain with a proprietary inactivated Fc domain. The CD47 binding domain of evorpacept is an affinity enhanced extracellular domain of SIRPα, a protein found on myeloid cells such as macrophages, that is the natural receptor to CD47 found on myeloid cells.CD47. We have engineered the Fc domain of evorpacept so that it does not provide a pro-phagocytic signal while still maintaining an antibody-like half-life for the molecule. We believe our inactive Fc approach improves tolerability when compared to other CD47 blocking approaches that have an Fc domain that engages activating receptors on macrophages, causing phagocytosis and death of healthy cells in addition to cancer cells.

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Evorpacept’s design has several additional advantages that we believe will make it broadly applicable to treating a number of oncology indications. Due to the inactive Fc, evorpacept is specifically designed for use in combination with other anti-cancer agents that provide a positive immune-stimulating signal. We believe evorpacept has a favorable tolerability profile that may enable higher dosing levelslevels, increased tumor penetration, and greater combination potential with other leading anti-cancer agents.

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We are focused on evorpacept development with the standard-of-care agents, revolving around these two cell types: macrophages and dendritic cells. We initially pursued, and continue to pursue, development of evorpacept based on two well-validated mechanisms of action involving SIRP alpha expression on macrophages and dendritic cells as discussed below.

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The distinct mechanism of actions and examples of the combinations of priority are:

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(1)

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Anti-cancerWe antibodiesare (focused on evorpacept development with the “don’tstandard-of-care eatagents me”that provide a stimulatory signal): Combiningto the innate immune system. We are combining evorpacept with anti-cancer targeted antibodies with an active Fc domain, where evorpacept enables the Fc-mediated antibody dependent phagocytosis that is impaired by the expression of CD47 on cancer cells.

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Data from the randomized ASPEN-06 Phase 2 clinical trial supports the clinical validation of this mechanism of action. ASPEN-06 evaluates the contribution of evorpacept to HERCEPTIN® (trastuzumab) plus standard of care (CYRAMZA® (ramucirumab) + paclitaxel) (Evo-TRP), versus trastuzumab, ramucirumab, and paclitaxel (TRP) in second line or later human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction (GEJ) cancer, where all patients had received an anti-HER2 agent in prior lines of therapy. The full data set was previously presented. Results from thea Decemberpre-planned 2024exploratory data cutoffanalysis were presented at an oral presentation at the 2025 American Society for Immunotherapy of Clinical OncologyCancer (ASCOSITC) GastrointestinalAnnual Cancers SymposiumMeeting:

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In a pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer, CD47 overexpression was identified as a key predictive biomarker for response and durable benefit in patients with retained HER2 expression. Retained HER2 expression is defined as patients who are HER-2 positive on a tumor biopsy after receiving a HER2-targeted treatment or by HER2 amplification by circulating tumor DNA (ctDNA). The data was highlighted as part of a poster presentation at the SITC Annual Meeting in November 2025.

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In patients with retained HER2-positive and CD47-high gastric cancer (n=43), Evo-TRP had a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer (n=47), Evo-TRP had a 37.5% ORR compared to 26.1% ORR for TRP.

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The duration of response (DOR) was three times longer in the Evo-TRP arm relative to TRP in these patients. Evo-TRP had a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer, had an mDOR of 11.2 months for Evo-TRP compared to 12 months for TRP. Progression free survival (PFS) and overall survival (OS) data were evaluated in these patients. Treatment with Evo-TRP resulted in a median PFS (mPFS) of 18.4 months versus 7.0 months for TRP, hazard ratio (HR) of 0.39. Treatment with Evo-TRP resulted in a median OS (mOS) of 17 months versus 9.9 months for TRP, HR of 0.70.

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Primary endpoints (December 2024 data cutoff):

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Intent-to-treat (ITT) patient population overall response rate (ORR) (n=127): Evo-TRP demonstrated an ORR of 41.3% compared to 30% for ramucirumab and paclitaxel (RP) historical control and 26.6% for TRP control.

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Fresh HER2-positive biopsy patient population ORR (n=48): Evo-TRP demonstrated an ORR of 59.1% compared to 30% for RP historical control and 23.1% for TRP control.

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In the ITT population, Evo-TRP demonstrated a median duration of response (mDOR) of 15.7 months and a median progression-free survival (mPFS) of 7.5 months compared to an mDOR of 9.1 months and mPFS of 7.4 months in the TRP control group, with a PFS Hazard Ratio (PFS HR) in this population of 0.77.

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In patients with fresh HER2-positive biopsies, Evo-TRP demonstrated an mDOR of 15.7 months and mPFS of 9.5 months compared to an mDOR of 14.5 months and mPFS of 7.1 months in the TRP control group, with a PFS HR of 0.62.

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In patients with confirmed HER2-positive expression as determined by either fresh biopsy or circulating tumor DNA (ctDNA) HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to a 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.

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Evo-TRP was generally well tolerated, with the incidence of adverse events in the evorpacept population consistent with those in TRP control.

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Evorpacept has been combined in clinical trials with multiple anti-cancer antibodies in addition to trastuzumab including the CD20-targeted antibody rituximab, the CD38-targeted antibody isatuximab-irfc, and the HER2-targeted bispecific antibody zanidatamab. Our earlier ASPEN-01 Phase 1 positive data in combination with rituximab in non-Hodgkin lymphoma (NHL) and; the recentPhase clinical data of our1/2 investigator-sponsored trial (IST) collaborator from the ongoing Phase 1/2 IST of evorpacept in combination with rituximab and lenalidomide in patients with relapsed refractory B-cell NHL (R/R B-NHL) and subsequently, in patients with newly diagnosed indolent B-cell NHL (iNHL); and the Phase 1b/2 trial of evorpacept with zanidatamab in patients with HER2-positive breast cancer provide additional support for the clinical validation of this mechanism of action and support exploring combinations of evorpacept with other anti-cancer antibodies.

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Our second product candidate is ALX2004, a novel EGFR-targeted ADC. ALX2004 was created from our proprietary linker-payload library and fully designed and developed in-house by our scientists. ALX2004 comprises a matuzumab-derived affinity-selected EGFR antibody backbone engineered for optimal activity as an ADC, a proprietary topoisomerase I inhibitor payload with enhanced bystander effect, and a linker with enhanced stability. EGFR is clinically validated as a therapeutic target with several U.S. Food and Drug Administration (FDA)-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs and early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads.

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This mechanism of action may also apply to antibody-drug conjugates (ADCs), which are being investigated in two separate Phase 1 trials: one in combination with PADCEV® (enfortumab vedotin-ejfv) in patients with urothelial cancer (ASPEN-07), and the other in combination with ENHERTU® (fam-trastuzumab deruxtecan-nxki) in patients with unresectable or metastatic HER2-positive and HER2-low breast cancer.

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(2)

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PD-1/programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors (the “don’t activate T-cells” signal): Combining with PD-1/PD-L1 checkpoint inhibitor, where evorpacept activates dendritic cells that are constitutively inhibited by the CD47/ SIRP alpha pathway.

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Activated dendritic cells present neoantigens to T-cells that, once activated, will kill cancer cells when the PD-1/PD-L1 inhibitory interaction is blocked by T-cell checkpoint inhibitors. The combination with a PD-1/PD-L1 checkpoint inhibitor allows maximum activity of these newly activated T-cells. This mechanism of action is being investigated in our clinical trials, ASPEN-03 and ASPEN-04, two randomized Phase 2 studies in combination with KEYTRUDA® (pembrolizumab), without or with chemotherapy, respectively, comparing to the same treatments without evorpacept, in first line head and neck squamous cell carcinoma (HNSCC). Validation of this mechanism is supported by our Phase 1 data (n=23) in the same indications and combinations where we saw an improvement in overall survival (OS) at 12 months with respect to historical data.

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We are pursuingengaged in the following clinical programs, collaborations, and investigator-sponsored trials:

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Combination with anti-cancerthe HER2-targeted antibody trastuzumab

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ASPEN-06ASPEN-09-Breast -– Gastric/GEJHER2+ Breast Cancer

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In March 2025, we announced intent to initiate a randomized Phase 2 clinical trial evaluating evorpacept in combination with trastuzumab and chemotherapy for the treatment of patients with HER2-positive metastatic breast cancer after prior treatment with fam-trastuzumab deruxtecan-nxki.

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In August 2025, we announced that based on the magnitude of benefit in patients with high CD47 expression in HER2-positive gastric cancer, the ASPEN-09-Breast study in HER2-positive breast cancer evaluating evorpacept in combination with trastuzumab and chemotherapy has been amended to a single-arm design in all previously treated HER2 positive patients and will be evaluated by CD47 expression.

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In January 2026, we announced that the first patient had been dosed in the trial.

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ASPEN-06 – Gastric/GEJ Cancer

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In January 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for evorpacept in combination with trastuzumab, ramucirumab and paclitaxel for the treatment of patients with HER2-overexpressing advanced gastric or GEJ adenocarcinoma with disease progression on or after prior trastuzumab and fluoropyrimidine or platinum containing chemotherapy.

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In July 2024, we announced the topline data from our ASPEN-06 Phase 2 clinical trial. This topline data reported results from 127 randomized patients with second and third line gastric/GEJ cancer and was generally well-balanced across arms based on prespecified stratification factors including line of therapy, prior ENHERTU® use, Asia region, tumor location (GC or GEJ), HER2 expression level, and having HER2-positive disease based upon a tissue biopsy after anti-HER2 treatment. A confirmed ORR of 40.3% was demonstrated for the Evo-TRP treatment arm compared to 26.6% for the TRP control arm. The mDOR was 15.7 months for the Evo-TRP treatment arm and 7.6 months for the TRP control arm in the full trial population. In patients with fresh HER2-positive biopsies (n=48), Evo-TRP demonstrated an ORR of 54.8% compared to 23.1% for the TRP control.

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In January 2025, we presented updated results from the ASPEN-06 Phase 2 clinical trial in an oral presentation at the 2025 ASCOAmerican Society of Clinical Oncology Gastrointestinal Cancers Symposium. A confirmed ORR of 41.3% was demonstrated for the Evo-TRP treatment arm compared to 26.6% for the TRP control arm in the ITTintent-to-treat patient population. In patients with confirmed HER2-positive expression as determined by either fresh biopsy or ctDNA HER2-positivity (n=96), the addition of evorpacept to TRP resulted in a 48.9% ORR, an mDOR of 15.7 months and mPFS of 7.5 months, compared to a 24.5% ORR, an mDOR of 9.1 months and mPFS of 6.7 months in the TRP control group, with a PFS HR of 0.64.

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In April 2025, we received guidance from the FDA that the ASPEN-06 Phase 2 trial data evaluating Evo-TRP was not eligible for submission for accelerated approval given the availability of ENHERTU. A Phase 3 versus ENHERTU trial would be needed to pursue a regulatory approval of evorpacept in the second-line setting for HER2-positive gastric and GEJ. Given our disciplined focus and the allocation of our resources, we will not pursue a U.S. registrational path with a Phase 3 trial in gastric cancer and will consider exploring development partnerships to advance this program in gastric cancer.

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In August 2025, we announced topline results from pre-planned exploratory analysis of the ASPEN-06 trial in gastric cancer, where CD47 overexpression was identified as a key predictive biomarker for response and durable benefit.

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In November 2025, we presented a pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer in which CD47 overexpression was identified as a key predictive biomarker for response and durable benefit in patients with retained HER2 expression.

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In patients with retained HER2-positive and CD47-high gastric cancer (n=43), Evo-TRP had a 65.0% ORR versus 26.1% ORR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer (n=47), Evo-TRP had a 37.5% ORR compared to 26.1% ORR for TRP.

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The DOR was three times longer in the Evo-TRP arm relative to TRP in these patients. Evo-TRP had an mDOR of 25.5 months versus 8.4 months mDOR for TRP, while patients with retained HER2-positive and CD47-low gastric cancer, had an mDOR of 11.2 months for Evo-TRP compared to 12 months for TRP. PFS and OS data were evaluated in these patients. Treatment with Evo-TRP resulted in an mPFS of 18.4 months versus 7.0 months for TRP, HR of 0.39. Treatment with Evo-TRP resulted in an mOS of 17 months versus 9.9 months for TRP, HR of 0.70.

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ASPEN-Breast - Breast Cancer

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In March 2025, we announced intent to initiate a Phase 2 study evaluating evorpacept in combination with trastuzumab and chemotherapy for the treatment of patients with metastatic HER2-positive breast cancer.

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ASPEN-CRC - Colorectal Cancer (CRC)

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In March 2025, we announced intent to initiate a Phase 1b study evaluating evorpacept in combination with the epidermal growth factor receptor (EGFR)-targeted antibody cetuximab and chemotherapy for the treatment of patients with metastatic CRC.

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Combination with antibody-drugthe conjugateEGFR-targeted (ADC)antibody cetuximab

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ASPEN-07ASPEN-CRC -– UrothelialColorectal Cancer (UCCRC)

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In FebruaryMarch 2023,2025, we announced theintent dosingto of the first patient in the ASPEN-07 trial,initiate a Phase 11b study evaluating evorpacept in combination with anthe ADC,EGFR-targeted enfortumabantibody vedotin-ejfvcetuximab (EV),and FOLFIRI for the second-line treatment of locallypatients advancedwith orsecond-line metastatic UC.CRC.

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In August 2025, we streamlined evorpacept development program to focus our resources on the ASPEN-09-Breast trial and paused the ASPEN-CRC study announced earlier in March 2025.

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In June 2024, interim Phase 1 data were presented in a poster presentation at the 2024 ASCO Annual Meeting. The ASCO poster presentation data-cut reported an unconfirmed ORR of 59% (n=22) with evorpacept plus EV (EV single agent ORR benchmark is 41%). Following the April data cut-off, four additional response evaluable patients yielded an unconfirmed ORR of 61% (n=26) including two confirmed complete responses and six confirmed partial responses. These findings represent the first evorpacept combination data with an ADC from ASPEN-07’s ongoing, open-label, single-arm, clinical trial of evorpacept in combination with EV in patients with locally advanced or metastatic urothelial cancer. Continued follow-up for patients who are EV-naïve on ASPEN-07 is ongoing and, enrollment of a new cohort of patients who have received prior EV has begun.

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ASPEN-03 - Head and Neck Squamous Cell Carcinoma

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In May 2021, we announced the dosing of the first patient in the ASPEN-03 trial, a randomized Phase 2 trial of evorpacept in combination with pembrolizumab for the treatment of first-line advanced PD-L1 positive HNSCC.

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In July 2022, the FDA granted Fast Track designation for evorpacept in combination with pembrolizumab for first-line treatment of adult patients with metastatic or unresectable, recurrent HNSCC whose tumors express PD-L1.

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ASPEN-04 - Head and Neck Squamous Cell Carcinoma

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In February 2020, the FDA granted Fast Track designation for evorpacept in combination with pembrolizumab, platinum, and fluorouracil for the first-line treatment of adult patients with metastatic or unresectable, recurrent HNSCC.

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In July 2021, we announced the dosing of the first patient in the ASPEN-04 trial, a randomized Phase 2 trial of evorpacept in combination with pembrolizumab, platinum, and fluorouracil for the treatment of first-line advanced HNSCC.

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Combination with the HER2-targeted bispecific, zanidatamab, and HER2-targeted ADC, fam-trastuzumab deruxtecan-nxki

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Combination with anti-cancer antibody or ADC

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Jazz Pharmaceuticals plc -– Breast Cancer

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Our collaborator, Jazz Pharmaceuticals plc (Jazz), is sponsoringsponsored and managingmanaged an ongoingthe Phase 11b/2 trial of zanidatamab, a HER2-targeted anti-cancer antibody, for the treatment of advanced HER2-expressing breast cancer and other solid tumors in combination with evorpacept (Zanidatamab Trial). We announced the dosing of the first patient in this trial in October 2021.

Reworded

In December 2024, Phase 1b/2 data were presented in a poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS). The SABCS poster presentation data-cut reported on efficacy findings from all three of the part-two trial cohorts: Cohort 1 (n=21) consisted of patients with HER2-positive breast cancer who had received prior ENHERTU and also a median of six prior systemic therapies in the metastatic setting. Patients were enrolled based on local assessment of tumor samples or central assessment. Of the 21 patients enrolled in Cohort 1, nine were found to be HER2-positive based on central assessment. Cohort 2 (n=15) consisted of patients with HER2-low breast cancer who had received a median of five prior systemic therapies. Cohort 3 (n=8) consisted of patients with other HER2-expressing cancers. Patients in Cohort 1 who were HER2-positive by central assessment (n=9) showed the greatest anti-tumor activity with a confirmed ORR of 55.6% and aan median progression free survival (mPFS) of 7.4 months. Overall, patients in Cohort 1 (n=21) had a confirmed ORR and mPFS of 33.3% and 3.6 months, respectively. Patients in Cohort 2 had a confirmed ORR and mPFS of 20.0% and 1.9 months, respectively. As of the August 2024 data cutoff, median follow-up was 9.6 months, with six patients still on treatment. The median duration of responsemDOR was not reached for Cohort 1 patients (range: 3.6-25.9 months) and was 5.5 months for Cohort 2 patients (range: 3.6-11.0 months), with responses ongoing, including the longest observed response, in each cohort. The combination therapy was well tolerated with a manageable safety profile that was consistent with prior experience of each agent.

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In January 2026, we announced that an exploratory biomarker analysis showed responses in the trial were largely restricted to patients with higher CD47 expression.

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Comparing 10-Q filed 2026-08-06 (period ending 2026-06-30) with 10-Q filed 2026-05-08 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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New text topics: tariff, china, regulation
“These and other risks associated with our planned international operations may materially adversely affect our ability to attain profitable operations. Further, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. …”
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TheseIn and other risks associated with our planned international operations may materially adversely affect our ability to attain profitable operations. Further, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. For example, legislation has been introducedaddition, in Congress to limit certain U.S. biotechnology companies from using equipment or services produced or provided by select Chinese biotechnology companies. In February and April 2025, the current U.S. presidential administration imposed new tariffs on China and China responded with tariffs on select U.S. goods. While we cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, if we are unable to obtain or use services or products from existing service providers, including those of contract development and manufacturing organizations, or if alternative service providers cannot be secured at an acceptable cost or at all, or if such actions cause broader disruption in drug manufacturing and related industries that impact drug product availability or pricing, our business, liquidity, financial condition, and/or results of operations would be materially and adversely affected.
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The term loans under the HSBC Loan Agreement mature on OctoberJune 1, 2027.2030. WeThe beganterm toloans makewill principal paymentsamortize in equal monthly installments beginning on DecemberJuly 1, 2025.2028. However, upon the occurrence of the Interest Only Extension Event (as defined in the HSBC Loan Agreement), the term loans will begin to amortize in equal monthly installments beginning on July 1, 2029. The term loans accrue interest at a floating rate as described elsewhere in this report, and interest is payable monthly in arrears. The term loans once repaid or prepaid may not be reborrowed. The term loans may be prepaid in full or in part in increments of $10.0 million, with various prepayment premiums. Upon the earlier of prepayment or maturity of any term loan, we are required to pay a fee of 6.0%2.0% of the original principal amount of such funded term loan, and a contingency fee may apply in connection with a prepayment of such term loan under certain circumstances.loan. We are also obligated to pay other customary fees for a loan facility of this type and size.
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Reworded topics: inflation

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There also has recently been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their drugs, which has resulted in several U.S. congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug products. For example, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Programs rebates that manufacturers pay to state Medicaid programs was eliminated. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have material impact on our business. Further, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at increasing competition for prescription drugs. Congress is considering legislation that, if passed, could have significant impact on prices of prescription drugs covered by Medicare, including limitations on drug price increases. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least seven years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, Centers for Medicare & Medicaid Services, or CMS, selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders, including the U.S. Chamber of Commerce, the National Infusion Center Association, the Global Colon Cancer Association, and the Pharmaceutical Research and Manufacturers of America,stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. In June 2026, the CMS issued a proposed rule that would codify policies established in guidance documents for the Medicare Drug Price Negotiation Program for initial price applicability year 2029 and beyond. CMS plans to release guidance to implement policies related to the effectuation of the MFP for the Medicare Drug Price Negotiation Program for 2028, consistent with the Inflation Reduction Act. Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. The One Big Beautiful Bill Act, which was signed into law in July 2025, includes provisions that will impact the U.S. healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions fOr U.S. Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs. Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or that increase generic and biosimilar drug entry sooner than expected, can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The impact of ongoing and future judicial challenges as well as other legislative, executive, and administrative actions and agency rules implemented by the current U.S. presidential administration on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.
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We have experienced and, ifIf we continue to experience delays or difficulties in the enrollment of subjects in clinical trials and/or retention of subjects in clinical trials in the future,trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.
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We will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operating activities. Our ability to raise additional funds may be adversely impacted by market perceptions of our ability to maintain our listing on the Nasdaq. Other than the loan and security agreement,agreement orthe LoanCompany’s Agreement,wholly-owned wesubsidiary, ALX Oncology Inc., entered into with OxfordHSBC FinanceVentures LLC,USA OxfordInc. Finance(HSBC CreditLender) Fundfor IIa LPsecured andmulti-tranche Siliconterm Valleyloan Bank, or SVB, collectively, the Lenders, in the fourth quarterfacility of 2022up andto most$50.0 recentlymillion amended(the inHSBC DecemberLoan 2023,Agreement), we do not have any committed external source of funds. Under the Loan Agreement, $25.0 million is available for us to draw down at the Lenders’ sole discretion as of March 31, 2026. SVB was closed in March 2023, and the FDIC was appointed as receiver to SVB. The FDIC created Silicon Valley Bridge Bank, or SVBB, as successor to SVB, which was acquired by First Citizens Bank, and is now operated as a division of First Citizens Bank, or SVB-First Citizens. Adequate additional financing may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, a stockholder’s ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect one’s rights as a stockholder. Debt financing may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. For example, our HSBC Loan Agreement restricts our ability to incur additional indebtedness without the consent of the Lenders.HSBC Lender. If we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
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We will require substantial additional capital to finance our operations, and such capital may not be available to us when needed or may only be available on terms that are unfavorable to us;

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We have incurred significant net losses in each reporting period since our inception, have not generated any revenue from product sales, licenses or collaborations to date and have financed our operations principally through public offerings of our common stock and private placements of our convertible preferred stock. Our net losses were $17.9$18.0 million and $30.8$25.9 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $740.7$758.7 million. We have devoted substantially all of our resources and efforts to research and development. Our product candidates, evorpacept and ALX2004, are in early-stage clinical trials. As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

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As of MarchJune 31,30, 2026, we had cash, cash equivalents and investments of $169.1$153.4 million. Based on our current operating plan, we believe that our existing cash, cash equivalents, and investments and net proceeds of $140.4 million raised in our registered offering that closed in February 2026 (the February 2026 Offering) will be sufficient to fund our operations through the first half of 2028. Our estimate as to how long we expect our existing cash, cash equivalents, investments and funds available from our term loan will be sufficient to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, such as periods of a rising rate of inflation or economic downturns, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.

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We will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operating activities. Our ability to raise additional funds may be adversely impacted by market perceptions of our ability to maintain our listing on the Nasdaq. Other than the loan and security agreement,agreement orthe LoanCompany’s Agreement,wholly-owned wesubsidiary, ALX Oncology Inc., entered into with OxfordHSBC FinanceVentures LLC,USA OxfordInc. Finance(HSBC CreditLender) Fundfor IIa LPsecured andmulti-tranche Siliconterm Valleyloan Bank, or SVB, collectively, the Lenders, in the fourth quarterfacility of 2022up andto most$50.0 recentlymillion amended(the inHSBC DecemberLoan 2023,Agreement), we do not have any committed external source of funds. Under the Loan Agreement, $25.0 million is available for us to draw down at the Lenders’ sole discretion as of March 31, 2026. SVB was closed in March 2023, and the FDIC was appointed as receiver to SVB. The FDIC created Silicon Valley Bridge Bank, or SVBB, as successor to SVB, which was acquired by First Citizens Bank, and is now operated as a division of First Citizens Bank, or SVB-First Citizens. Adequate additional financing may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, a stockholder’s ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect one’s rights as a stockholder. Debt financing may result in imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. For example, our HSBC Loan Agreement restricts our ability to incur additional indebtedness without the consent of the Lenders.HSBC Lender. If we raise additional funds through upfront payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

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We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We were incorporated and commenced operations in 2015, have no products approved for commercial sale and have not generated any revenue from product sales, licenses or collaborations. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, identifying and developing potential product candidates and conducting preclinical and clinical trials of our product candidates, including Phase 1 and Phase 2 clinical trials of evorpacept and Phase 1 clinical trialstrial of ALX2004. We have not yet demonstrated our ability to successfully complete any large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale drug or arrange for a third party to do so on our behalf or conduct sales and marketing activities. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer operating history. In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research focus to a company capable of supporting commercial activities. We have not yet demonstrated an ability to successfully overcome such risks and difficulties or to make such a transition. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer.

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In OctoberJune 2022,2026, wethe Company’s wholly-owned subsidiary, ALX Oncology Inc., entered into the HSBC Loan Agreement, most recently amended in December 2023, under which we have borrowed $10.0 million. Under the HSBC Loan Agreement, $25.0we may draw up to an additional $20.0 million through June 30, 2028. A further $20.0 million is potentially available for us to drawus, $10.0 million upon the achievement of pre-determined development milestones and $10.0 million at the Lenders’HSBC Lender’s sole discretion as of March 31, 2026.discretion. The proceeds of the loans may be used by us for working capital and to fund our general business requirements.

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The term loans under the HSBC Loan Agreement mature on OctoberJune 1, 2027.2030. WeThe beganterm toloans makewill principal paymentsamortize in equal monthly installments beginning on DecemberJuly 1, 2025.2028. However, upon the occurrence of the Interest Only Extension Event (as defined in the HSBC Loan Agreement), the term loans will begin to amortize in equal monthly installments beginning on July 1, 2029. The term loans accrue interest at a floating rate as described elsewhere in this report, and interest is payable monthly in arrears. The term loans once repaid or prepaid may not be reborrowed. The term loans may be prepaid in full or in part in increments of $10.0 million, with various prepayment premiums. Upon the earlier of prepayment or maturity of any term loan, we are required to pay a fee of 6.0%2.0% of the original principal amount of such funded term loan, and a contingency fee may apply in connection with a prepayment of such term loan under certain circumstances.loan. We are also obligated to pay other customary fees for a loan facility of this type and size.

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The term loans under the HSBC Loan Agreement are secured by substantially all of our assets, except our intellectual property, which is the subject of a negative pledge, and will be guaranteed by our future subsidiaries, subject to certain limitations.

Reworded

The HSBC Loan Agreement contains customary affirmative and negative covenants, including covenants limiting our ability to, among other things, dispose of assets, effect certain mergers, incur debt, grant liens, pay dividends and distributions on our capital stock, make investments and acquisitions, and enter into transactions with affiliates, in each case subject to customary exceptions for a loan facility of this size and type.

Reworded

If we default under the HSBC Loan Agreement, the LendersHSBC Lender will be able to declare all obligations immediately due and payable and take control of our pledged assets, potentially requiring us to renegotiate our agreement on terms less favorable to us or to immediately cease operations. The events of default under the HSBC Loan Agreement include, among others, payment defaults, material misrepresentations, breaches of covenants, cross defaults with certain other material indebtedness, bankruptcy and insolvency events, and judgment defaults. The occurrence of an event of default could result in the acceleration of our obligations under the HSBC Loan Agreement, the termination of the Lenders’HSBC Lender’s commitments, a 5.0%3.0% increase in the applicable rate of interest and the exercise by the HSBC Lender of other rights and remedies provided for under the HSBC Loan Agreement. Any declaration by the LendersHSBC Lender of an event of default could significantly harm our business and prospects and could cause the price of our common stock to decline.

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We have experienced and, ifIf we continue to experience delays or difficulties in the enrollment of subjects in clinical trials and/or retention of subjects in clinical trials in the future,trials, our regulatory submissions or receipt of necessary marketing approvals could be delayed or prevented.

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We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials as required by the FDA or comparable international regulatory authorities. Subject enrollment is a significant factor in the timing of clinical trials. In particular, because certain of ourIf clinical trials of evorpacept and ALX2004 are focused on indications with small patient populations, our ability to enroll eligible subjects may be limited or may result in slower enrollment than we anticipate.

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Some of these competitive products and therapies are based on scientific approaches that are the same as or similar to our approaches, including with respect to the targeting of the CD47 pathway, targeting epidermal growth factor receptor (EGFR) as an antibody-drug conjugate target, and others are based on entirely different approaches. We are aware that Adagene, Akesobio, Bio-Thera Solutions, Boehringer Ingelheim, Bristol Myers Squibb, Byondis, Centessa, Conjupro Biotherapeutics, CTTQ (SinoBiological), D3 Bio, Daiichi Sankyo, Exelixis, GenSci, Gilead Sciences (through its acquisition of Forty Seven), Hanchor Bio, HanxBio, Henlius, Hisun, Hutchmed, I-Mab, Ichnos, ImmuneOncia Therapeutics, ImmuneOnco Biopharma, Innovent, Kahr, LaNova, Lightchain Bioscience, Mabwell Therapeutics, Mabworks, Novimmune, OSE Immunotherapeutics, Pfizer (through its acquisition of Trillium Therapeutics), Phanes, Pyxis Oncology (through its acquisition of Apexigen), Shandong New Time, Shattuck Labs, Sorrento Therapeutics, Sumgen, SunHo Pharmaceutical, TG Therapeutics, Waterstone, and Zai Lab, among others, are developing or have begun development of drugs targeting the CD47 pathway that may have utility for the treatment of indications that we are targeting. We are also aware that AstraZeneca,Allink Biotherapeutics, Avenzo Therapeutics, BeOne, BioNTech, BlissBio, Bristol Myers Squibb with Systimmune, CSPC, Doma, GenSci, Hansoh Pharma, Henlius, Innovent, Junshi Biopharma, Miracogen, Merck, Novatim, and Henlius,VelaVigo, among others, are developing or have begun development of antibody drug conjugates (ADCs) targeting EGFR. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

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Our product candidates may be administered in combination with drugs of other pharmaceutical companies as one regimen. In addition, we currently use, and plan to use in the future, third-party drugs in our development and clinical trials as controls for our studies, such as conducting Phase 2/3 clinical trials of evorpacept in combination with trastuzumab for gastric/GEJ carcinoma.studies. As a result, the results of our clinical trials and the sales of our drugs may be affected by the availability of these third-party drugs. For instance, we have entered and may in the future enter into clinical trial collaboration and supply agreements with Eliother Lilly,pharmaceutical companies, pursuant to which our collaboration counterparties will supply doses of ramucirumabthird-party drugs for use in certain clinical trials. If theany such agreement with Eli Lilly is terminated before the trial is completed, we may need to find another source of ramucirumabthe third-party drug in order to continue ourthe trial.

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There also has recently been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their drugs, which has resulted in several U.S. congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drug products. For example, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Programs rebates that manufacturers pay to state Medicaid programs was eliminated. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have material impact on our business. Further, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at increasing competition for prescription drugs. Congress is considering legislation that, if passed, could have significant impact on prices of prescription drugs covered by Medicare, including limitations on drug price increases. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Only high-expenditure single-source drugs that have been approved for at least seven years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, Centers for Medicare & Medicaid Services, or CMS, selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced. CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027. For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected. Various industry stakeholders, including the U.S. Chamber of Commerce, the National Infusion Center Association, the Global Colon Cancer Association, and the Pharmaceutical Research and Manufacturers of America,stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. In June 2026, the CMS issued a proposed rule that would codify policies established in guidance documents for the Medicare Drug Price Negotiation Program for initial price applicability year 2029 and beyond. CMS plans to release guidance to implement policies related to the effectuation of the MFP for the Medicare Drug Price Negotiation Program for 2028, consistent with the Inflation Reduction Act. Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation price and directing the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States. The One Big Beautiful Bill Act, which was signed into law in July 2025, includes provisions that will impact the U.S. healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage. In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions fOr U.S. Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs. Government agreements with pharmaceutical companies and other measures that use most-favored-nation pricing targets for prescription drugs, including the use of international pricing reference to set drug prices in the United States, or that increase generic and biosimilar drug entry sooner than expected, can have a material adverse effect on our industry, ability to set adequate pricing for new drugs to recover R&D costs, ability to attract potential investors and potential buyers in the future. We cannot predict the full impact of the executive orders focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States. The impact of ongoing and future judicial challenges as well as other legislative, executive, and administrative actions and agency rules implemented by the current U.S. presidential administration on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved.

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Additionally, the California Privacy Rights Act, or the CPRA, was approved by California voters in November 2020. The CPRA modified and augmented the CCPA significantly, effective as of January 1, 2023, resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply. Numerous other states have proposed, and in certain cases enacted similar laws, including comprehensive privacy laws similar to the CCPA enacted in Alabama, Colorado, Connecticut, Delaware, Florida, Indiana, Iowa, Kentucky, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oklahoma, Oregon, Rhode Island, Tennessee, Texas, Utah, Vermont, and Virginia. Other states have proposed, and in certain cases enacted, legislation addressing privacy and cybersecurity in the context of specific subject matter such as biometrics and health-related personal information. The U.S. Department of Justice also has issued rules regarding certain bulk sensitive personal data transfers. As we expand our operations, preclinical studies and clinical trials, these new state laws and other state laws and regulations relating to privacy, data security, and the collection, use, transfer, and other processing of data may increase our compliance costs and potential liability. Laws and regulations relating to these matters are not consistent across jurisdictions, and they may impose conflicting or uncertain obligations. Compliance with these and any other applicable laws and regulations relating to these matters is a rigorous, costly and time-intensive process, and we may be required to put in place additional mechanisms to address new and changing obligations under these laws and regulations. Actual or alleged noncompliance with any such laws and regulations may lead to regulatory investigations, enforcement actions, claims and litigation, and if we fail to comply with any such laws or regulations, we may face significant fines and penalties. Any of these could adversely affect our business, financial condition and results of operations.

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As of MarchJune 31,30, 2026, we had 4348 employees, including 2832 employees engaged in research and development. In order to successfully implement our development and commercialization plans and strategies, and as we continue to operate as a public company, we expect we will need additional managerial, scientific, technical, medical, operational, sales, marketing, financial and other personnel. Future growth may impose significant added responsibilities on members of management, including:

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Our product candidates are based on a novel technology,technologies, which makes it difficult to predict the time and cost of product candidate development.

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We have concentrated our product research and development efforts on our novel immuno-oncology approach,approaches, and our future success depends on the successful development of our product candidates, evorpacept and ALX2004, and any future product candidates that we develop. There can be no assurance that any development problems we experience in the future related to our novel immuno-oncology approachapproaches will not cause significant delays or unanticipated costs or that such development problems can be solved. We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process to commercial partners, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely or profitable basis, if at all.

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Our spending on current and future research and development programs, such as evorpacept, for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate. For example, we entered into clinical trial collaborations with our collaborators, including Sanofi, Jazz and the ISTs,investigator-sponsored trials, to supply evorpacept for clinical trials to advance new combination therapies. We have limited control over the amount and timing of resources that our collaborators dedicate to the development of our products. Any termination or disruption of collaborations could result in delays in the development of products, increases in our costs to develop the products or the termination of development of a product.

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Under the U.S. Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in the ownership of its equity by its shareholders holding 5% or more over a rolling three-year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income and taxes may be limited. We may have experienced such ownership changes in the past, and we may experience ownership changes in the future, in either case as a result of shifts in our stock ownership, some of which are outside our control. As of December 31, 2025, we had net operating loss carryforwards of approximately $305.4 million and $69.0 million for U.S. federal and state income tax purposes, respectively. Our ability to utilize those net operating loss carryforwards could be limited by an “ownership change” as described above, which could result in increased tax liability to our company. The federal net operating losses carry forward indefinitely but may only offset 80% of taxable income in periods of future utilization. The state net operating loss carryforwards will begin to expire beginning in 2038. Other limitations may apply under state law. For example, California legislation suspends the use of state net operating losses by taxpayers with net business income or modified adjusted gross income of $1 million or more for tax years beginning on or after January 1, 2024 and before January 1, 2027.

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We may from time to timetime-to-time issue additional shares of common stock at a discount from the current trading price of our common stock. As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such discount. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or common stock. For example, our 2025 Shelf Registration Statement provides for aggregate offerings of up to $364.1 million of the Company’s securities inclusive of up to $119.1 million of shares of our common stock through the at-the-market, or ATM, offering. From December 2021 to MarchJune 31,30, 2026, we sold an aggregate of 3,183,109 shares of common stock under our ATM offering. On October 10, 2023, we completed a registered offering (the October 2023 Offering) for the issuance and sale of an aggregate of 8,663,793 shares of common stock at an offering price of $6.38 per share and pre-funded warrants to purchase 1,250,000 shares of common stock at an offering price of $6.379 per pre-funded warrant. On February 2, 2026, we completed the February 2026 Offering for the issuance and sale of an aggregate of 76,979,112 shares of common stock at an offering price of $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at an offering price of $1.569 per pre-funded warrant. Our stockholders may be further diluted by the exercise of the pre-funded warrants issued in the October 2023 Offering and February 2026 Offering. As of MarchJune 31,30, 2026, 2,563,5076,100,317 shares underlying the pre-funded warrants had been exercised. If we issue common stock or securities convertible into common stock, our stockholders will experience additional dilution and our stock price may decline.

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any increase in interest expense due to an increase in the floating rate under the HSBC Loan Agreement as described elsewhere in this Quarterly Report on Form 10-Q;

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These and other risks associated with our planned international operations may materially adversely affect our ability to attain profitable operations. Further, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. For example, the President recently signed into law the 2026 National Defense Authorization Act, which includes Section 851 regarding a “[p]rohibition on contracting with certain biotechnology providers" (the BIOSECURE Act), which restricts federal government contracts, grants, and loans from being issued to companies that use biotechnology equipment or services from any designated “biotechnology company of concern,” as part of such companies’ performance of those agreements with the U.S. government. This legislation, including its implementing regulations, or similar legislation in the future, could adversely impact our current or future third-party arrangements with certain companies, including those in China or Chinese-owned U.S. companies. Once the implementing regulations of Section 851 come into effect, which will be no later than the second half of 2028, some of our business partners may be designated as biotechnology companies of concern through the criteria and process established by the implementing regulations. Even if we do not seek any covered federal government contracts, grants, or loans, it is possible that commercial partners, government agencies, or other third parties may view our business less favorably if we contract with entities that ultimately become biotechnology companies of concern.

Reworded

TheseIn and other risks associated with our planned international operations may materially adversely affect our ability to attain profitable operations. Further, there is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. For example, legislation has been introducedaddition, in Congress to limit certain U.S. biotechnology companies from using equipment or services produced or provided by select Chinese biotechnology companies. In February and April 2025, the current U.S. presidential administration imposed new tariffs on China and China responded with tariffs on select U.S. goods. While we cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, if we are unable to obtain or use services or products from existing service providers, including those of contract development and manufacturing organizations, or if alternative service providers cannot be secured at an acceptable cost or at all, or if such actions cause broader disruption in drug manufacturing and related industries that impact drug product availability or pricing, our business, liquidity, financial condition, and/or results of operations would be materially and adversely affected.

Reworded

On October 10, 2023, we completed the October 2023 Offering and on February 2, 2026, we completed the February 2026 Offering. Our stockholders may be further diluted by the exercise of the pre-funded warrants issued in the October 2023 Offering and February 2026 Offering. As of MarchJune 31,30, 2026, 2,563,5076,100,317 shares underlying the pre-funded warrants had been exercised. Furthermore, we currently have an effective resale shelf registration statement which enables the selling stockholders thereunder, three of our largest stockholders, to sell shares in the public market which could cause our stock price to decline. In addition, any future sales of shares of common stock or other securities under our 2025 Shelf Registration Statement, including pursuant to our ATM facility, could put downward pressure on our stock price. Moreover, certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. Registration of these shares under the Securities Act would result in the shares becoming freely tradeable in the public market, subject to the restrictions of Rule 144 in the case of our affiliates. If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

Reworded

To the extent that we raise additional capital through the sale of equity or convertible debt securities, a stockholder’s ownership interest will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect one’s rights as a common stockholder. Sales of equity securities may be made under our 2025 Shelf Registration Statement and pursuant to our related ATM facility described therein. Additionally, our stockholders may be further diluted by the exercise of the pre-funded warrants issued in the October 2023 Offering and the February 2026 Offering. As of MarchJune 31,30, 2026, 2,563,5076,100,317 shares underlying the pre-funded warrants had been exercised. Debt financing, if available, may involve fixed payment obligations or agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. OurThe HSBC Loan Agreement with the LendersHSBC Lender restricts our ability to incur additional indebtedness without the consent of the Lenders.HSBC Lender. If we raise additional funds through partnerships, collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, product candidates or future revenue streams, or grant licenses on terms that are not favorable to us. We cannot assure you that we will be able to obtain additional funding if and when necessary. If we are unable to obtain adequate financing on a timely basis, we could be required to delay, scale back or eliminate one or more of our clinical or discovery programs or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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“In March 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) to act as receiver. The FDIC created Silicon Valley Bridge Bank, N.A. (SVBB) as successor to SVB. First Citizens BancShares, Inc. (First Citizens Bank) acquired SVBB from the FDIC and operates SVBB as Silicon Valley Bank, a division of First Citizens Bank (SVB-First Citizens). While we have cash in operating accounts with SVB, the majority of our cash, cash equivalents and investments are deposited in custodial accounts held by U.S. …”
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In the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities of $24.7$48.1 million was attributable to a net loss of $30.8$56.7 million,million offset byand a change in our net operating assets and liabilities of $0.6$2.5 millionmillion, andoffset by non-cash charges of $5.4$11.2 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable, payable and accrued liabilities due to related party, and accrued expenses and other current liabilities of $0.8$1.7 million primarily due to timing of invoices and payments, (ii) a decrease in prepaid and other current assets of $1.9$0.7 million andmillion, (iii) a decrease in other non-current liabilities of $0.5$1.0 million and (iv) an increase in other assets of $0.4 million. Non-cash charges consisted primarily of stock-based compensation expense of $5.2$7.4 million, non-cash lease costs of $0.5$0.9 million, and depreciation and amortization costs of $0.2$0.4 million, and lease impairment charge of $3.2 million offset by net amortization of premiums and accretion of discounts on investments of $0.5$0.8 million.
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We are a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. Our clinical pipeline includes two clinical-stage product candidates, the CD47 blocker evorpacept and an epidermal growth factor receptor (EGFR)-targeted antibody drug candidate (ADC) ALX2004. Our lead product 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 in combination with trastuzumab and chemotherapy in patients with metastatic HER2-positive breast cancer in the Phase 2 ASPEN-09-Breast clinical trial and is also being studied in clinical trials with other targeted anti-cancer antibodies. Cancer cells leverage CD47, a cell surface protein, as a “don’t eat me” signal to evade macrophage phagocytosis. We are developing evorpacept to be a next-generation checkpoint inhibitor designed to have a high affinity for CD47 and to avoid the limitations caused by hematologic toxicities inherent in other CD47 blocking approaches. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of actiondesign and entered into a Phase 1 clinical trial in August 2025.

Reworded

Evorpacept is a next-generation CD47 blocking therapeutic that we believe has significantly enhanced properties compared to competing CD47 blocking approaches. Evorpacept is a fusion protein that combines a high-affinity CD47 binding domain with a proprietary inactivated Fc domain. The CD47 binding domain of evorpacept is an affinity enhanced extracellular domain of SIRPα, a protein found on myeloid cells such as macrophages, that is the natural receptor to CD47. We have engineered the Fc domain of evorpacept so that it does not provide a pro-phagocytic signal while still maintaining an antibody-like half-life for the molecule. We believe our inactive Fc approach improves tolerability when compared to other CD47 blocking approaches that have an Fc domain that engages activating receptors on macrophages, causing phagocytosis and death of healthy CD47-expressing cells in addition to cancer cells.

Reworded

In a pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer, CD47 overexpression was identified as a key predictive biomarker for response and durable benefit in patients with retained HER2 expression. Retained HER2 expression is defined as patients who are HER-2HER2 positive on a tumor biopsy after receiving a HER2-targeted treatment or by HER2 amplification by circulating tumor DNA (ctDNA). The data was highlighted as part of a poster presentation at the SITC Annual Meeting in November 2025.

Reworded

In August 2025, we announced that based on the magnitude of benefit in patients with high CD47 expression in HER2-positive gastric cancer, the ASPEN-09-Breast study in HER2-positive breast cancer evaluating evorpacept in combination with trastuzumab and chemotherapy has been amended to a single-arm design in all previously treated HER2 positive patients and will be evaluated by CD47 expression.

Reworded

Collaborations and Investigator-Sponsored Trials (ISTs)

Reworded

From inception through MarchJune 31,30, 2026, we have raised an aggregate of $785.2$795.0 million to fund our operations, of which $175.1 million were net proceeds from sales of our convertible preferred stock, $5.8 million were net proceeds from borrowings under a term loan, $169.5 million were net proceeds from our initial public offering, $194.9 million were net proceeds from our registered offering in December 2020, $9.3 million were net proceeds from borrowings under the Oxford-SVB Loan Agreement (as defined below), $58.9 million were net proceeds from our registered offering in October 2023, $140.4 million in net proceeds from our registered offering in February 2026, $9.7 million were net proceeds from borrowings under the HSBC Loan Agreement (as defined below), and $31.4 million were net proceeds from our at-the-market (ATM) offering. For more information on the funding of our operations since inception, see section titled “—Liquidity and Capital Resources; Plan of Operations—Funding Requirements” included elsewhere in this Quarterly Report on Form 10-Q.

Reworded

We have incurred net losses in each year since inception. Our net losses were $17.9$18.0 million and $30.8$25.9 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and $35.9 million and $56.7 million for the six months ended June 30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $740.7$758.7 million. Substantially all of our operating losses are a result of expenses incurred in connection with our research and development programs, primarily evorpacept, and from general and administrative expenses associated with our operations.

Added

Lease Termination (Gain) and Impairment Charge

Added

Our lease termination (gain) and impairment charge consists of a gain from lease termination and impairment of long-lived assets related to the Palo Alto lease.

Reworded

Other Income (Expense),Expense, Net

Reworded

Our other income (expense),expense, net consists primarily of realized foreign currency transaction gains and losses.losses and losses on the disposal of fixed assets.

Added

Loss on Debt Extinguishment

Added

Our loss on debt extinguishment consists of a loss from the early extinguishment of the Oxford-SVB Loan.

Reworded

The following table summarizes our results of operations for the three months and six months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Reworded

The following table summarizes our research and development (R&D) expenses incurred for the three months and six months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Reworded

R&D expenses decreased by $10.3$4.9 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease was primarily attributable to a decrease of $4.4 million in personnel and related costs primarily driven by the reduction in workforce in early 2025, a decrease of $2.3$4.7 million in clinical and development costs primarily due to change in clinical development strategy reducing the number of active clinical trials in the current quarter compared to prior period, a decrease of $1.8$0.4 million in other research costs, and a decrease of $0.1 million in personnel and related costs. These decreases were offset by an increase of $0.4 million in stock-based compensation expense due to absence of terminations from the reduction in workforce,workforce awhich decrease of $1.3 millionoccurred in preclinicalearly costs due to pipeline prioritization strategy, and a decrease of $0.5 million in other research costs.2025.

Added

R&D expenses decreased by $15.2 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decrease was primarily attributable to a decrease of $7.0 million in clinical and development costs primarily due to change in clinical development strategy reducing the number of active clinical trials in the current period compared to prior period, a decrease of $4.5 million in personnel and related costs primarily driven by the reduction in workforce in early 2025, a decrease of $1.4 million in preclinical costs due to pipeline prioritization strategy, a decrease of $1.4 million in stock-based compensation expense due to terminations from the reduction in workforce, and a decrease of $0.9 million in other research costs.

Reworded

The following table summarizes our general and administrative (G&A) expenses incurred for the three months and six months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Reworded

G&A expenses decreased by $2.6$0.3 million during the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The decrease was primarily attributable to a decrease of $1.0 million in personnel and related costs primarily driven by the reduction in workforce in early 2025, a decrease of $0.9 million in stock-based compensation expense due to terminations from the reduction in workforce, and a decrease of $0.7$0.4 million in other G&A costs from corporate legal costs.and patent costs, offset by an increase of $0.1 million in stock-based compensation expense due to absence of terminations from the reduction in workforce which occurred in early 2025.

Added

G&A expenses decreased by $2.9 million during the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decrease was primarily attributable to a decrease of $1.1 million in other G&A costs from corporate legal and patent costs, a decrease of $1.0 million in personnel and related costs primarily driven by the reduction in workforce in early 2025, and a decrease of $0.8 million in stock-based compensation expense due to terminations from the reduction in workforce.

Added

Lease Termination (Gain) and Impairment Charge

Added

In May 2025, we made a decision to sublease our leased property in Palo Alto, resulting in a long-lived asset impairment charge of $3.2 million based on the performed impairment analysis for the three months and six months ended June 30, 2026. In June 2026, we terminated our leased property in Palo Alto, resulting in a lease termination gain of $0.2 million for the three months and six months ended June 30, 2025.

Reworded

Interest income decreasedincreased by $0.3$0.4 million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 and by $0.1 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decreasesincreases were primarily attributable to lowerhigher interestcash ratesand investment balances during first quarter of 2026 as compared to first quarter of 2025.

Reworded

Interest expense remaineddecreased flatby $0.1 million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025,2025 and by $0.2 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The decreases were primarily due to similarlower interest rates during the2026 periods.as compared to 2025.

Reworded

Other Income (Expense),Expense, Net

Reworded

Other income (expense),expense, net increased by $0.2$0.3 million for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025 due to insuranceloss claimincurred refundon receiveddisposal duringof thisfixed period.assets related to the lease termination of our Palo Alto office and laboratory space in May 2026. Other expense, net remained flat for the six months ended June 30, 2026 compared to the six months ended June 30, 2025.

Added

Loss on Debt Extinguishment

Added

Loss on debt extinguishment increased by $0.9 million for the three months and six months ended June 30, 2026 compared to the three months and six months ended June 30, 2025 due to the early termination of the Oxford-SVB Loan in June 2026.

Reworded

Since our inception, we have incurred significant operating losses and have not generated any product revenue. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all, subject to regulatory and marketing approval of any of our product candidates. To date, we have funded our operations with proceeds from the sales of shares of our common stock and convertible preferred stock and borrowings under our term loan. As of MarchJune 31,30, 2026, we had cash, cash equivalents and investments of $169.1$153.4 million.

Reworded

We have incurred losses and negative cash flows from operations since inception and anticipate that we will continue to incur net losses for the foreseeable future. As of MarchJune 31,30, 2026, we had an accumulated deficit of $740.7$758.7 million. We expect our expenses to incur significant expenses in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development. In addition, we expect to incur additional costs associated with operating as a public company. Management recognizes the need to raise additional capital to fully implement its business plan. The timing and amount of such future capital requirements are difficult to forecast and will depend on many factors, including:

Reworded

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. Other than a loan and security agreement (asthe amended, theHSBC Loan Agreement) we entered into with OxfordHSBC FinanceVentures LLC,USA Oxford Finance Credit Fund II LP, and Silicon Valley BankInc. (SVBHSBC) (collectively, the LendersHSBC Lender), for a secured multi-tranche term loan facility of up to $100.0$50.0 million in OctoberJune 2022,2026, we do not have any committed external source of funds. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide. To the extent that we raise additional capital through the sale of equity or convertible debt securities, a stockholder’s ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect one’s rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market drug candidates that we would otherwise prefer to develop and market ourselves.

Reworded

In October 2022, we entered into the loan and security agreement (the Oxford-SVB Loan Agreement) aswith describedOxford above.Finance LLC, Oxford Finance Credit Fund II LP, and Silicon Valley Bank (SVB) (collectively, the Oxford-SVB Lenders) for a secured term loan facility of up to $100.0 million. Upon closing of the Oxford-SVB Loan Agreement, we drew $10.0 million. Under the original terms of the Oxford-SVB Loan Agreement, we had the right to draw an additional $40.0 million through the end of 2023. A further $50.0 million was potentially available to us, $25.0 million upon the achievement of pre-determined development milestones and $25.0 million at the Oxford-SVB Lenders’ sole discretion. For a description of the terms of the Oxford-SVB Loan Agreement, see “Note 7. Term Loan” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On May 31, 2023, we entered into a second amendment to the Oxford-SVB Loan Agreement. The primary purpose of the second amendment was to reduce the percentage of the amount required to be held in our collateral account with SVB-First Citizens from 100% to not less than 50% of the aggregate dollar value of all our collateral accounts.

Removed

In March 2023, SVB was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) to act as receiver. The FDIC created Silicon Valley Bridge Bank, N.A. (SVBB) as successor to SVB. First Citizens BancShares, Inc. (First Citizens Bank) acquired SVBB from the FDIC and operates SVBB as Silicon Valley Bank, a division of First Citizens Bank (SVB-First Citizens). While we have cash in operating accounts with SVB, the majority of our cash, cash equivalents and investments are deposited in custodial accounts held by U.S. Bank for which SVB Asset Management is the investment advisor. There has been no material negative impact to our cash liquidity as a result of the closure of SVB or the subsequent acquisition of SVBB by First Citizens Bank. Under the Loan Agreement, 50% of the funding comes from SVB, one of the three Lenders. Given the SVBB acquisition by First Citizens Bank, SVB-First Citizens will continue to fulfill SVB’s obligations under the Loan Agreement.

Reworded

In October 2023, we completed a registered offering pursuant to the 2022 Shelf Registration Statement. In this registered offering, we issued and sold an aggregate of 8,663,793 shares of common stock, including the underwriters’ exercise in full of their overallotment option of 1,293,103 shares of common stock, and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,250,000 shares of common stock at an offering price of $6.38 per share and $6.379 per pre-funded warrant. Net proceeds were approximately $58.9 million, after deducting underwriting discounts and commissions of $3.8 million and offering-related expenses of $0.6 million. As of MarchJune 31,30, 2026, no shares underlying these pre-funded warrants had been exercised.

Reworded

In December 2023, we entered into a third amendment to the Oxford-SVB Loan Agreement. The primary purpose of the third amendment was to (i) extend the draw period for the first tranche loans from December 31, 2023 to June 30, 2024, (ii) add as a condition for the funding of any first tranche loans after the effective date of the amendment, the requirement that the Phase 2 portion of the ASPEN-06 study in gastric/GEJ cancer either remains ongoing or the achievement of a milestone related to the development of the ASPEN-06 study, and (iii) add a contingency fee in the amount of $0.6 million to the Oxford-SVB Lenders if the Company prepays any of the loans under the Oxford-SVB Loan Agreement other than in connection with refinancing of the Oxford-SVB Loan Agreement with the Oxford-SVB Lenders and their affiliates.

Reworded

We decided not to draw down on any portion of the $40.0 million available to us under the Oxford-SVB Loan Agreement by the deadline of June 30, 2024. As a result of this decision, the $40.0 million was added to the $25.0 million available upon the achievement of pre-determined development milestones for a total of $65.0 million available, split equally between each of the two tranches. We did not achieve all of the requirements needed to gain access to each of the two tranches available upon the achievement of pre-determined development milestones by the deadline of December 31, 2024. As a result, only the $25.0 million tranche available at the Lenders’ sole discretion was available to us as of March 31, 2026. The term loans under the Oxford-SVB Loan Agreement maturewould have matured on October 1, 2027. We began to make principal payments in equal monthly installments beginning on December 1, 2025.

Reworded

On March 6, 2025, we filed a shelf registration statement with the SEC that became effective on April 24, 2025 (the 2025 Shelf Registration Statement). The 2025 Shelf Registration Statement replaced the 2022 Shelf Registration Statement and registered the unsold securities from the 2022 Shelf Registration Statement, including those available under the ATM program. From December 2021 to MarchJune 31,30, 2026, we sold an aggregate of 3,183,109 shares of common stock under our Sales Agreement for net proceeds of $31.4 million, after deducting commissions. We may terminate this ATM program and the Sales Agreement at any time, pursuant to its terms.

Reworded

On February 2, 2026, we completed a registered offering and issued an aggregate of 76,979,112 shares of common stock at an offering price of $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at an offering price of $1.569 per pre-funded warrant. We received net proceeds of approximately $140.4 million, after deducting underwriting discounts and commissions of $9.0 million and other offering-related expenses of $0.6 million. As of MarchJune 31,30, 2026, 2,563,5076,100,317 shares underlying these pre-funded warrants had been exercised.

Added

In June 2026, we entered into the HSBC Loan Agreement as described above. Pursuant to the HSBC Loan Agreement, we borrowed $10.0 million of loans at closing (through our wholly owned subsidiary, ALX Oncology Inc.), the proceeds of which were used to refinance and pay all outstanding principal, interest and other amounts owing under the existing Oxford-SVB Loan Agreement and to pay closing fees and expenses. Under the terms of the HSBC Loan Agreement, subject to the satisfaction of customary conditions, we have the right to draw an additional $20.0 million through June 30, 2028. A further $20.0 million is potentially available to us, $10.0 million upon the achievement of pre-determined development milestones and $10.0 million at the HSBC Lender’s sole discretion. The proceeds of the loans may be used by us for general corporate purposes. For a description of the terms of the HSBC Loan Agreement, see “Note 7. Term Loan” to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Reworded

We believe our existing cash, cash equivalents and investments will enable us to fund our operating expenses and capital expenditure requirements through the first half of 2028. Additionally, the Company also has the ability to further utilize the ATM program. We have based these estimates on assumptions in which actuals may materially differ,differ and we could utilize our available capital resources sooner than we expect.

Reworded

The following table presents a summary of the net cash flow activity for the threesix months ended MarchJune 31,30, 2026 and 2025 (in thousands):

Reworded

In the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities of $18.6$34.7 million was attributable to a net loss of $17.9$35.9 million and a change in our net operating assets and liabilities of $3.6$3.1 million, offset by non-cash charges of $2.9$4.3 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable and accrued expenses and other current liabilities of $4.2$3.6 million primarily due to timing of invoices and payments, (ii) a decrease in prepaid and other current assets of $0.7$0.9 million, (iii) a decrease in other non-current liabilities of $0.4$0.7 million and (iv) a decrease in other assets of $0.3 million. Non-cash charges consisted primarily of stock-based compensation expense of $2.5$5.2 million, loss on debt extinguishment of $0.9 million, non-cash lease costs of $0.4$0.7 million, and depreciation and amortization costs of $0.1$0.2 million, offset by a gain on lease termination of $2.6 million and net accretion of discounts on investments of $0.2$0.5 million.

Reworded

In the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities of $24.7$48.1 million was attributable to a net loss of $30.8$56.7 million,million offset byand a change in our net operating assets and liabilities of $0.6$2.5 millionmillion, andoffset by non-cash charges of $5.4$11.2 million. The change in operating assets and liabilities was primarily due to (i) a decrease in accounts payable, payable and accrued liabilities due to related party, and accrued expenses and other current liabilities of $0.8$1.7 million primarily due to timing of invoices and payments, (ii) a decrease in prepaid and other current assets of $1.9$0.7 million andmillion, (iii) a decrease in other non-current liabilities of $0.5$1.0 million and (iv) an increase in other assets of $0.4 million. Non-cash charges consisted primarily of stock-based compensation expense of $5.2$7.4 million, non-cash lease costs of $0.5$0.9 million, and depreciation and amortization costs of $0.2$0.4 million, and lease impairment charge of $3.2 million offset by net amortization of premiums and accretion of discounts on investments of $0.5$0.8 million.

Reworded

In the threesix months ended MarchJune 31,30, 2026, net cash used in investing activities of $105.0$98.5 million was attributable to purchases of short-term and long-term investments of $130.2 million, offset by cash received for maturities of investments of $19.5 million, offset by purchases of short-term and long-term investments of $124.5 million and purchases of property and equipment of $0.1$31.8 million.

Reworded

In the threesix months ended MarchJune 31,30, 2025, net cash provided by investing activities of $27.6$50.0 million was attributable to cash received for maturities of investments of $43.5$91.2 million, offset by purchases of short-term and long-term investments of $15.8$41.2 million and purchases of property and equipment of $0.1 million.

Reworded

In the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities of $139.6$139.7 million was attributable to proceeds from equity offerings of $150.0 million, proceeds from issuance of term loan of $10.0 million, proceeds from exercise of stock options under equity incentive plan of $0.7 million, offset by payments for issuance costs related to equity offerings of $9.5$9.6 million, payments for early debt extinguishment of $8.2 million, principal payments on term loan of $1.3$2.6 million, and principal payments on finance leases of $0.3$0.5 million, and payments for debt issuance costs of $0.1 million.

Reworded

In the threesix months ended MarchJune 31,30, 2025, net cash providedused byin financing activities of $0.1$0.2 million was attributable to principal payments on finance leases of $0.5 million offset by proceeds from our ATM offering program of $0.4 million offset by principal payments on finance leases of $0.3 million.

Reworded

Our significant accounting policies and critical accounting estimates are more fully described in the notes to our audited consolidated financial statements and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates,” respectively, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. During the threesix months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies and estimates from those discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 9, 2026.

ALXO insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 3 filings (2 insiders, 2 trade dates, 4,207 shares, about $8.3K). Net open-market shares: -4,207 (purchases minus sales); net value about -$8.3K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-08-17Lettmann Jason
Director, CHIEF EXECUTIVE OFFICER
Open-market sale 2,230$1.93 $4.3K294,379 SEC
2026-08-17Wong Shelly
SVP, FINANCE AND CAO
Open-market sale 573$1.93 $1.1K87,828 SEC
2026-07-01Wong Shelly
SVP, FINANCE AND CAO
Open-market sale 1,404$2.04 $2.9K88,401 SEC

Well-known investors holding ALXO (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
Two Sigma Investments COM2026-06-302,178,176$4.5M0.0%Added 37%
Millennium Management (Israel Englander) COM2026-06-301,543,594$3.2M0.0%Reduced 22%
Renaissance Technologies COM2026-06-30603,797$1.2M0.0%Reduced 18%
Point72 Asset Management (Steve Cohen) COM2026-06-3041,095$82.4K—Sold out

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when ALXO files, watchlists and downloadable comparisons.