Immunity Bio: The Platform Begins.

This is an update of my original Immunity Bio deep dive. I initiated a position in this company on January 21st 2026.

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The immune system is an integral component of the human body: without it, our organism cannot fight off pathogens and we die. ImmunityBio is building a platform that brings immune system rejuvenation to the world at a marginal cost. The foundation of this platform is the IL15 superagonist named Anktiva, which instructs the body to produce more natural killer and T cells. These are the basic building blocks the immune system uses to kill, and they can be trained to target specific threats, which is how the platform comes to be.

If you have good natural killer and T cell counts, your immune system can work properly and your mortality trends down, and vice versa. If GLP1s have made Eli Lilly a $1T company, Anktiva can make ImmunityBio a $2T company (200 times bigger than today) or more because everyone will need to rejuvenate their immune system multiple times throughout their lives.

Three things stand out from the Q4 2025 earnings report:

1. Net product revenue is up 700% YoY, which is driven by a 750% increase in unit sales volume. Meaning, both physicians and patients want Anktiva, because it’s solving a real problem.

2. Immunity Bio has demonstrated an organisational ability to drive approvals, ever since obtaining the FDA J code in January 2025. Each quarter of 2025 stronger than the last, with Anktiva now authorised across 33 countries and 4 major regulatory jurisdictions, including the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the entire European Union.

3. The company is tentatively accelerating as it scales.

The vast majority of Immunity Bio’s revenue today comes from the US, where the regulators remain somewhat reticent: this is similar to the situation Grail’s early-cancer-detection test Galleri is in. Anktiva was approved by the FDA in April 2024 for use in combination with BCG (Bacillus Calmette-Guérin, a live weakened strain of the bacterium Mycobacterium bovis that jolts the immune system into action) for BCG-unresponsive non-muscle invasive bladder cancer. However, as discussed, on a first principles basis there’s no difference between this cancer and any other.

If the immune system is strong enough (has enough natural killer and T cells), it can kill any tumor. And if the patient isn’t in enough health to naturally train the NK and T cells Anktiva produces, Immunity Bio has additional platform layers which can help:

1. NaNT (N-803 + Allogeneic NK Cells): built on top of the Anktiva foundation, this arm of the platform combines Anktiva with allogeneic natural killer cells: meaning NK cells derived from a donor rather than the patient.

   1. The Leonardo robotics platform is how ImmunityBio manufactures these off-the-shelf NK cells at scale.

   2. Anktiva then acts as a persistence signal, keeping these infused NK cells alive and active longer than they would otherwise survive in a foreign host, solving one of the core challenges of allogeneic cell therapy.

2. DNA Vaccine (Antigen Targeting): this layer adds specificity to the platform. While Anktiva raises the overall count of NK and T cells and the allogeneic NK cells provide additional firepower, the DNA vaccine trains those cells to recognise and kill specific targets: tumor antigens, viral antigens, and so on.

   1. This transforms the platform from a broad immune amplifier into a precision weapon, capable of directing a now-enlarged and reinforced immune army toward a defined threat.

There’s value in building solutions on top of Anktiva because the pathogenosphere is nuanced. For example, tumors will sometimes hide certain receptors (things that help T cells locate a tumor, like MHC-I) when they sense a T cell coming towards them. For millions of years NK cells have been acting as the backstop in this scenario. NK cells operate on an inverse logic: they kill anything that lacks the markers of a healthy cell. Leonardo can engineer the following NK cell types:

1. CAR-NK: NK cells engineered to express chimeric antigen receptors that lock onto specific tumor antigens. This gives NK cells the targeting precision of CAR-T therapy while retaining their innate killing logic, circumventing tumors’ ability to hide receptors. And without the cytokine storm risk that has historically made CAR-T a difficult therapy to administer safely.

2. PD-L1 NK: many tumors survive by expressing PD-L1, a signal that tells the immune system (T cells specifically) to stand down. PD-L1 NK cells are engineered to target exactly that take out that signal, letting T and NK cells kill the tumor.

The platform isn’t exhaustive just yet, but powering up the immune system at the root and then deploying additional laters that collapse time to value in specific problems is the path to getting there. At the current rate of execution, Immunity Bio will be an API you query with your biomarkers and it just ships a personalised reset button for your immune system that clears tumors and pathogens with minimal side effects.

For example, consider the “DNA vaccine” layer of the platform. It leverages an adenovirus to deliver a specific antigen to dendritic cells. The adenovirus has an icosahedric shape (a polyhedron with 20 faces) that per its shape, tends to “swim” towards the lungs when injected into the body.

Remember, shape determines function in the proteome.

The adenovirus reaches dendritic cells in the lungs, offloads the antigens, which the dendritic cells then transport to T cells (previously matured in the thymus gland), helping initiate a specific response. As shown in the diagram above, the dendritic cells take up the antigens and internalise them, then follow a chemokine gradient through the lymphatic vessels and migrate to the nearest lymph node.

Upon arrival, the mature dendritic cells present the processed adenoviral peptides on their MHC molecules to naïve T cells. This interaction, aided by co-stimulatory signals like interferon-gamma (this one will come up a lot in my writing), activates the T cells, triggering clonal expansion and differentiation into effector, specific T cells. The result is a targeted adaptive immune response: CD8+ cytotoxic T cells primed to destroy virally infected cells, and CD4+ helper T cells coordinating a broader immunological defense, including the activation of B cells to produce adenovirus-specific antibodies.

If you don’t have T cells, this doesn’t work. But if you take Anktiva before your dendritic cells receive the antigen, your immune system can kill the pathogen successfully. In turn, many cancers stem from the persistence of viruses that meddle with the p53 gene, like HPV. Elephants never get cancer because they have lots of copies of this gene (while we only have one), which expresses p53 proteins which tend to suppress tumors. This is just one example of how cancer is multidimensional chess, that we can play and win by turning immune system rejuvenation and modulation into an API query.

Obviously, this is where Hims Labs comes into the picture, but we’ve talked about that plenty lately.

In the background, two structural shifts are taking place:

1. Consumers have exponentially more information each day and thanks to AI, an ability to process it that’s rising in tandem - meaning, it’s harder every day to gate keep things.

2. The ability to synthesise biochemical structures at will turns health into a compute problem, in which all you have to do is figure out the right key-lock configurations.

I’ve discussed the above at length before many times. If you know exactly what biomarkers are going wrong today, you’re increasingly able to figure out what molecules you need to put inside your body to revert those biomarkers to an optimal state. As always, that’s not medical advice, but rather an observation of where this industry is headed. And as Immunity Bio founder Dr. Patrick Soon remarked during the Q4 2025 earnings call, the FDA knows and they’re changing regulations accordingly:

This concept of the plausible mechanism of action, which is the new policy put forth by Dr. Makary and published in the New England Journal of Medicine, speaks to a very exciting opportunity that the plausible mechanism of action is a pathway.

[…]

He says, “For instance, a single disease with 150 different genetic mutations with the same functional implications may require 150 different therapies and the plausible mechanism pathway would be ideally suited to such therapies.”

So, obviously, with 150 different mutations, 150 different therapies, one wouldn’t be expected to do 150 different trials.

He goes on to say and this is important and this is in the article by Commissioner Makary, “An appropriately designed study with a small sample size can support licensure of a product for which pharmacological effect is aligned with biological plausibility.”

In other words, every pathogen is going to present highly specific circumstances. But if jacking up the immune system and training it to kill the specific pathogen works across the board, it doesn’t make a lot of sense to run a trial for each specific pathogen. The pharmacological effect will tend to track the biological mechanisms on a first principles basis: pointing the platform at a new pathogen is largely a matter of swapping the target antigen, not reinventing the science. In other words, the upside of an immune system platform that goes from general restoration to specialised cytotoxic training is vast.

I continue to buy more $IBRX.

Until next time!

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