ALX Oncology Holdings Inc. (ALXO): History, Ownership, Mission, How It Works & Makes Money

ALX Oncology Holdings Inc. (ALXO): History, Ownership, Mission, How It Works & Makes Money

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How does a clinical-stage biotech company, focused on a single immune-oncology pathway, hold a potential key to redefining cancer treatment? ALX Oncology Holdings Inc. is carving out its niche by targeting the CD47 checkpoint pathway, a mechanism cancer cells use to evade the immune system, and their lead candidate, evorpacept, recently delivered compelling clinical results: a 65.0% objective response rate (ORR) in a subset of gastric cancer patients, significantly higher than the control arm's 26.1% ORR. You need to know if this scientific promise is translating into a sustainable financial reality, especially when the company reported a GAAP net loss of $22.1 million for the third quarter of 2025, so let's dig into the history, ownership, and revenue model of this $66.15 million market cap player.

ALX Oncology Holdings Inc. (ALXO) History

ALX Oncology Holdings Inc. (ALXO) began as a focused effort to develop a next-generation immuno-oncology therapy, specifically targeting the CD47 checkpoint pathway, a mechanism cancer cells use to evade the immune system. The company's history is a classic biotech trajectory: intense early venture capital funding, a critical transition to clinical trials, and a public listing to fuel late-stage development.

You need to see how the early capital infusions mapped directly to clinical program advancement; that's the real story here.

Given Company's Founding Timeline

Year established

The company was established in 2015 under the name Alexo Therapeutics, Inc.

Original location

The original location was South San Francisco, California, USA, a central hub for biotechnology innovation.

Founding team members

The company was co-founded by leading scientific and entrepreneurial figures.

  • Dr. Corey Goodman, Ph.D.: Co-founder and Executive Chairman, a veteran biotech entrepreneur and Managing Partner at venBio Partners.
  • Dr. Jaume Pons, Ph.D.: Co-founder and a key figure in the early scientific direction, later serving as President and Chief Executive Officer.
  • K. Christopher Garcia, Ph.D.: Co-founder, a renowned Stanford University professor whose work contributed to the scientific foundation.

Initial capital/funding

ALX Oncology was initially funded by venture capital, securing significant capital to advance its lead candidate, evorpacept (formerly ALX148).

  • Series A (2015): Approximately $12 million.
  • Series B (2017): Approximately $49 million.
  • Series C (2019): Approximately $105 million, led by Vivo Capital.
This pre-IPO funding totaled over $166 million, a substantial war chest for a clinical-stage company. The Initial Public Offering (IPO) in July 2020 then raised approximately $185.7 million in gross proceeds, providing the capital for expanded Phase 2 and Phase 3 trials.

Given Company's Evolution Milestones

Year Key Event Significance
2018 Initiation of First-in-Human Clinical Trial Began testing evorpacept (ALX148) in patients, formally transitioning the company to a clinical-stage operation.
2020 Initial Public Offering (IPO) on Nasdaq (ALXO) Raised approximately $185.7 million in gross proceeds, providing the significant capital needed to expand the clinical development of evorpacept across multiple cancer indications.
2025 (Q1) FDA IND Clearance for ALX2004 Received clearance to start clinical trials for ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), diversifying the pipeline beyond evorpacept.
2025 (Q3) Q3 Financial Results and Strategic Focus Reported cash, cash equivalents, and investments of $66.5 million as of September 30, 2025, with a projected cash runway into Q1 2027, following strategic reprioritization.
2025 (Q4) ASPEN-09-Breast Cancer Trial Enrollment Start Anticipated start of patient dosing for the Phase 2 trial of evorpacept in HER2-positive breast cancer, utilizing a new biomarker-driven strategy.

Given Company's Transformative Moments

The company's trajectory has been defined by calculated pivots, moving from a broad-spectrum CD47 blocker to a biomarker-focused, multi-asset developer. This is defintely a risk-mitigation strategy in a tough market.

The most transformative moment in the near-term was the strategic reprioritization in 2025, which fundamentally shifted the clinical focus and financial outlook.

  • Biomarker-Driven Strategy: Data from the ASPEN-06 trial in gastric cancer in 2025 showed that evorpacept achieved a high objective response rate of 65% in patients with high CD47 expression, compared to 26% in the control arm. This finding was a game-changer, prompting the company to amend its breast cancer trial (ASPEN-Breast) to focus on CD47-high patients.
  • Pipeline Diversification and Resource Optimization: In early 2025, the company announced a strategic prioritization, including a 30% workforce reduction primarily impacting preclinical research. This move was designed to conserve capital and extend the cash runway, which was successfully pushed into Q1 2027. The focus shifted to the two most promising clinical assets: evorpacept and the new EGFR-targeted ADC, ALX2004.
  • Gastric Cancer Program Halt: Following FDA feedback, ALX Oncology decided in Q1 2025 not to pursue U.S. registration for evorpacept in gastric cancer, a major decision that freed up resources but closed a potential accelerated approval pathway.

For a detailed breakdown of how these strategic shifts impact the company's financial stability and future prospects, you should be looking at Breaking Down ALX Oncology Holdings Inc. (ALXO) Financial Health: Key Insights for Investors.

ALX Oncology Holdings Inc. (ALXO) Ownership Structure

ALX Oncology Holdings Inc. is a publicly traded, clinical-stage biotechnology company whose ownership is heavily concentrated in the hands of institutional investors, which is typical for a pre-revenue biotech firm. This structure means that key strategic decisions are defintely driven by a small number of large funds, not retail sentiment.

Given Company's Current Status

ALX Oncology Holdings Inc. (ALXO) is a public company, trading on the Nasdaq Global Select Market (NasdaqGS) under the ticker symbol ALXO. Its status as a clinical-stage immuno-oncology company means it is focused on developing therapies, like its lead candidate evorpacept, to block the CD47 immune checkpoint inhibitor. As of the third quarter of 2025, the company reported a GAAP net loss of $22.1 million, or $0.41 per share, which is a common profile for a company deep in the research and development phase. For investors, this means the stock's value is tied more to clinical trial milestones than to near-term revenue. Breaking Down ALX Oncology Holdings Inc. (ALXO) Financial Health: Key Insights for Investors

Given Company's Ownership Breakdown

The company is governed by a clear majority of institutional shareholders, which gives them substantial control over board elections and major corporate actions. Institutional investors and hedge funds collectively hold the vast majority of shares, and company insiders-executives and directors-own a significant stake of approximately 21.00% of the stock as of November 2025.

Here's the quick math on the shareholder breakdown, showing who controls the float:

Shareholder Type Ownership, % Notes
Institutional 65.62% Includes major holders like venBio Partners LLC, Redmile Group, LLC, and BlackRock, Inc.
Unknown 27.46% Shares not disclosed in major public filings, often held by smaller institutions or brokers.
Other 3.42% Various corporate and minor holdings.
Individuals 3.06% Retail investors and minor individual holdings.

Given Company's Leadership

The executive team steering ALX Oncology Holdings Inc. has seen strategic appointments in 2025, aligning the leadership's expertise with the company's clinical development focus. This is a critical factor for a biotech company, so you need to know who is making the calls.

  • Chief Executive Officer (CEO): Jason Lettmann. He has been vocal about the positive ASPEN-06 trial results, guiding the company's targeted clinical development strategy.
  • Chief Financial Officer (CFO): Harish Shantharam, CFA. Appointed in January 2025, he brings experience from his time at Gilead Sciences, Inc. and CymaBay Therapeutics, Inc., including guiding CymaBay through its $4.3 billion acquisition by Gilead Sciences, Inc.
  • Chief Operations Officer (COO): Allison Dillon, Ph.D. Promoted to this role in August 2025, she previously served as the Chief Business Officer.
  • Interim Chief Medical Officer (CMO): Barbara Klencke, M.D. Appointed in September 2025, she has over 30 years of experience in oncology drug development and serves on the board of directors.
  • Chief Accounting Officer: Shelly Pinto. She has served as SVP Finance and Chief Accounting Officer since August 2023.

This team is structured to manage late-stage clinical trials and the financial complexities that come with them.

ALX Oncology Holdings Inc. (ALXO) Mission and Values

ALX Oncology Holdings Inc. (ALXO) is driven by a singular, crucial purpose: developing novel therapies to treat cancer and extend patients' lives, specifically by unlocking the immune system's power against tumors. This mission, grounded in innovative science, is what guides their significant investment in clinical trials, like the $17.4 million in Research and Development expenses reported for Q3 2025.

Given Company's Core Purpose

You're investing in a clinical-stage biotech, so you need to know what they stand for beyond the market capitalization of around $71 million as of November 2025. The company's core purpose is to tackle cancer's 'don't eat me' signal-the CD47 checkpoint pathway-to make tumors vulnerable to the body's own defenses.

Official mission statement

While a single, formal mission statement isn't always a biotech's focus, their actions define it: ALX Oncology is dedicated to pioneering innovative cancer therapies that enhance the immune system's ability to fight tumors, addressing unmet medical needs in oncology.

  • Focus on blocking the CD47 checkpoint pathway to enhance the immune response.
  • Advance a pipeline of antibody-based therapeutics, like evorpacept and ALX2004.
  • Conduct rigorous clinical trials to prove safety and efficacy for cancer patients.

Here's the quick math on their mission in action: In the ASPEN-06 trial, the Objective Response Rate (ORR) for patients with high CD47 expression was 65% in the evorpacept arm versus only 26% in the control arm, a clear demonstration of their targeted approach working.

Vision statement

The company's vision extends beyond just one drug; it's about fundamentally changing the treatment landscape. They see their lead candidate, evorpacept, as a potential cornerstone therapy for the future of immuno-oncology.

  • Deliver the next generation of breakthrough therapies for cancer treatment.
  • Establish evorpacept as a foundational therapy for a wide range of cancer indications.
  • Build a targeted clinical development strategy based on clear biomarkers like CD47 expression.

To be fair, this is a high-risk, high-reward vision, but the data-like the median Progression-Free Survival (PFS) of over 18 months with evorpacept versus seven months in the control group-shows the potential for meaningful patient impact.

Given Company slogan/tagline

The company's most prominent, action-oriented tagline is simple and powerful, capturing the essence of their scientific approach.

  • Unleashing the Full Power of the Immune System.

This commitment to innovative science is defintely their cultural DNA. It's what drives the decision to have a cash runway of $66.5 million as of September 30, 2025, to fund operations into Q1 2027, ensuring they can see these critical trials through. You can find more detail on their philosophy here: Mission Statement, Vision, & Core Values of ALX Oncology Holdings Inc. (ALXO).

ALX Oncology Holdings Inc. (ALXO) How It Works

ALX Oncology Holdings Inc. operates as a clinical-stage biotechnology company focused on developing novel immunotherapies that block the CD47 checkpoint, which cancer cells use as a 'don't eat me' signal to evade the immune system. The company's value creation is currently driven entirely by advancing its lead candidate, evorpacept, and its second-generation asset, ALX2004, through rigorous clinical trials to achieve key regulatory milestones and attract commercial partners.

ALX Oncology Holdings Inc.'s Product/Service Portfolio

The company's portfolio is centered on two clinical-stage assets, both designed to overcome cancer's defense mechanisms. Their current focus is on combining these therapies with established anti-cancer antibodies to maximize efficacy in specific patient populations.

Product/Service Target Market Key Features
Evorpacept (CD47 Blocker) HER2-Positive Breast Cancer (ENHERTU-experienced) and Gastric/GEJ Cancer A high-affinity fusion protein that blocks the CD47 'don't eat me' signal, activating macrophages to destroy cancer cells. Used in combination with standard-of-care antibodies/chemotherapy.
ALX2004 (EGFR ADC) EGFR-Expressing Solid Tumors A novel, in-house developed Antibody-Drug Conjugate (ADC) with a differentiated linker-payload platform, designed for a wider therapeutic window in tumors like non-small cell lung cancer.

ALX Oncology Holdings Inc.'s Operational Framework

The operational framework is laser-focused on a biomarker-driven clinical development strategy, which is typical for a lean, clinical-stage biotech. They are not a commercial entity yet, so their primary process is R&D execution, not sales or manufacturing.

Here's the quick math: For the third quarter of 2025, the company reported a GAAP net loss of $22.1 million, with R&D expenses accounting for $17.4 million of that, showing where the capital is defintely being spent.

  • Precision Clinical Trial Design: Using data from the ASPEN-06 gastric cancer trial to prospectively select patients with high CD47 expression for the ASPEN-09 breast cancer trial, aiming to increase the objective response rate (ORR).
  • Pipeline Diversification: Expanding beyond the CD47 mechanism with the in-house development of ALX2004, an Antibody-Drug Conjugate (ADC), which entered its Phase 1 clinical trial in August 2025.
  • Cash Runway Management: Strategic streamlining of operations and prioritizing key clinical programs to extend the cash, cash equivalents, and investments of $66.5 million (as of September 30, 2025) to fund operations into Q1 2027.
  • Data-Driven Value Inflection: The entire process is geared toward achieving critical data milestones, such as the initial safety data for ALX2004 in the first half of 2026 and interim data for the ASPEN-09 breast cancer trial in Q3 2026.

You can get a deeper dive into their balance sheet and burn rate by Breaking Down ALX Oncology Holdings Inc. (ALXO) Financial Health: Key Insights for Investors.

ALX Oncology Holdings Inc.'s Strategic Advantages

The company's market success hinges on its ability to prove that its targeted approach is superior to broad-spectrum treatments, which is a significant strategic bet in the competitive immuno-oncology space.

  • Biomarker-Guided Development: The use of CD47 expression as a predictive biomarker is a key differentiator, allowing the company to target the patient population most likely to respond, thereby improving trial efficiency and increasing the probability of success.
  • Differentiated CD47 Inhibitor Profile: Evorpacept is a CD47 blocker designed to avoid binding to red blood cells, which helps mitigate the hematological toxicity (like anemia) that has plagued earlier-generation CD47 inhibitors.
  • Proprietary ADC Platform: The in-house development of ALX2004 leverages a proprietary linker-payload technology, potentially offering a better therapeutic window-more efficacy at lower toxicity-compared to competitor ADCs.
  • Strategic Combination Focus: By positioning evorpacept as a 'cornerstone therapy' to be combined with approved anti-cancer antibodies (like trastuzumab), they are seeking to improve existing standards of care rather than replacing them entirely, which can accelerate adoption.

ALX Oncology Holdings Inc. (ALXO) How It Makes Money

ALX Oncology Holdings Inc. is a clinical-stage biotechnology company, meaning it currently makes money not from selling an approved drug, but primarily through financing activities like stock offerings and strategic collaborations. The financial engine is entirely focused on burning cash to fund research and development (R&D) for its lead candidate, evorpacept, and other pipeline assets like ALX2004, until regulatory approval is achieved. This is a classic biotech model: invest heavily now for a massive payoff later.

You can see the company's core purpose in its Mission Statement, Vision, & Core Values of ALX Oncology Holdings Inc. (ALXO).

Given Company's Revenue Breakdown

As a clinical-stage company, ALX Oncology reported no revenue for the third quarter ended September 30, 2025, which is typical before a drug receives Food and Drug Administration (FDA) approval. The analyst consensus for the full fiscal year 2025 revenue is also $0.0 million. The table below reflects this reality, showing the primary potential future revenue streams are currently at zero.

Revenue Stream % of Total Growth Trend
Product Sales (Evorpacept) 0% Increasing (from zero)
Collaboration Revenue 0% Stable (at zero)

Business Economics

The economic fundamentals of ALX Oncology are not based on gross margin or customer acquisition cost right now; they are centered on cash runway and the success probability of clinical trials. The entire business is a massive R&D investment, a bet on the science.

  • Pricing Strategy: The future pricing for its lead candidate, evorpacept, will be based on a value-based pricing model, common in oncology therapeutics. This means the price will reflect the drug's clinical benefit-like the 65.0% objective response rate (ORR) seen in CD47-high HER2-positive gastric cancer patients in the ASPEN-06 trial, compared to 26.1% for the control group. The better the data, the higher the justified price.
  • Cash Burn Rate: The company's operational cash burn is primarily driven by its Research and Development (R&D) expenses. For the three months ended September 30, 2025, R&D expenses were $17.4 million. Here's the quick math: that's about $5.8 million per month, but this rate can fluctuate defintely based on trial enrollment and manufacturing needs.
  • Funding Source: Since revenue is zero, all operations are funded by the cash, cash equivalents, and investments on the balance sheet, which totalled $66.5 million as of September 30, 2025. This cash position is the lifeblood of the company.

Given Company's Financial Performance

The key financial metrics for ALX Oncology are focused on controlling expenses and extending the cash runway to hit critical clinical milestones, like the Phase 2 ASPEN-09-Breast Cancer trial beginning enrollment in Q4 2025.

  • Cash Runway: The most critical metric is the cash runway, which management believes is sufficient to fund planned operations into the first quarter of 2027. This gives them a clear timeline to deliver on upcoming data readouts for evorpacept and ALX2004.
  • Net Loss (Q3 2025): The GAAP net loss for the third quarter of 2025 was ($22.1) million, an improvement from the ($30.7) million loss in the prior-year period. This lower loss is mostly due to a decrease in R&D expenses.
  • Expenses: General and administrative (G&A) expenses also saw a decrease, falling to $5.1 million in Q3 2025 from $6.1 million a year ago. Controlling these non-R&D costs is essential for a company focused on clinical execution.
  • Full-Year Outlook: Analysts project a consensus loss per share for the full year 2025 of ($1.77). What this estimate hides is that the loss is a necessary investment in the pipeline, not a sign of operational failure.

The company's current valuation is driven by the perceived value of its intellectual property (IP) and the probability of success for its clinical assets, not its income statement. The market capitalization is approximately $71.03 million as of November 2025.

ALX Oncology Holdings Inc. (ALXO) Market Position & Future Outlook

ALX Oncology Holdings Inc. is strategically pivoting from broad-spectrum CD47 inhibition to a focused, biomarker-driven approach, which is crucial after mixed early-stage results, positioning it to capture a significant portion of the HER2-positive cancer market. The company is a clinical-stage entity, so its commercial market share is currently 0%, but its lead candidate, evorpacept, is aiming for a potential $2 billion to $4 billion market opportunity in HER2+/CD47-high breast cancer alone.

Competitive Landscape

The CD47 inhibitor space is highly competitive but volatile, with major players facing setbacks. ALX Oncology Holdings Inc.'s key advantage lies in its drug design and its validated biomarker strategy, which helps mitigate the toxicity and efficacy issues that have plagued competitors.

Company Market Share, % Key Advantage
ALX Oncology Holdings Inc. 0% (Pre-commercial) Fc-inactive CD47 blocker (evorpacept); Biomarker-driven strategy (CD47-high expression).
Gilead Sciences 0% (Clinical Hold) First-mover advantage with Monoclonal Antibody (Magrolimab); Now largely de-risked in hematology due to futility/safety issues.
Shattuck Labs 0% (Pre-commercial) SIRP$\alpha$-Fc Fusion Protein (Maplirpacept); Different mechanism to block CD47 with an alternative safety profile.

Opportunities & Challenges

The company's focus on a predictive biomarker (CD47 expression) is a smart, calculated move, especially after the failure of the non-biomarker-driven PD-1 combination trials (ASPEN-03 and ASPEN-04) in head and neck cancer. Their financial runway, extending into Q1 2027, buys them time, but the pressure to deliver positive Phase 2 data remains intense.

Opportunities Risks
Validation of the CD47-high biomarker in gastric cancer (65.0% ORR in ASPEN-06) guides a high-potential breast cancer trial (ASPEN-09). Clinical trial failure, specifically if the Phase 2 ASPEN-09-Breast Cancer trial's interim data (expected Q3 2026) does not replicate the gastric cancer success.
Targeting a potential $2 billion to $4 billion HER2+/CD47-high breast cancer market opportunity, a high-value niche. Cash burn rate and need for future capital, with an analyst consensus FY 2025 EPS loss of $2.76 and a Q3 2025 GAAP net loss of $22.1 million.
Advancing the second pipeline candidate, ALX2004, a novel EGFR-targeted Antibody-Drug Conjugate (ADC), which entered a Phase 1 trial in August 2025. Regulatory hurdles, such as the FDA's request for a Phase 3 study for the gastric cancer program, which defintely adds cost and time to market.

Industry Position

ALX Oncology Holdings Inc. is positioned as a high-risk, high-reward innovator in the immuno-oncology field, specifically within the macrophage checkpoint space (CD47/SIRP$\alpha$). The company is not a broad-market player; it's a specialist.

The recent discontinuation of the major competitor Gilead Sciences' magrolimab program in hematologic malignancies due to futility and safety issues has significantly de-risked the CD47 space for ALX Oncology Holdings Inc., especially for its Fc-inactive evorpacept, which has shown a more manageable safety profile.

The entire strategy now hinges on the biomarker. Here's the quick math: if only 50% of HER2+ breast cancer patients are CD47-high, as estimated, focusing only on that subset makes the drug development more efficient, but it cuts the addressable patient population in half.

  • Maintain a cash balance of $66.5 million (as of Q3 2025) to fund operations into Q1 2027.
  • Focus development on the ASPEN-09-Breast Cancer trial (Phase 2 enrollment started Q4 2025).
  • Prioritize the new ADC candidate, ALX2004, with initial safety data expected in 1H 2026.

For a detailed breakdown of the company's financial standing, you should review Breaking Down ALX Oncology Holdings Inc. (ALXO) Financial Health: Key Insights for Investors.

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