Radioligand therapy delivery  ·  United States and South Africa

The medicine exists. The places to give it do not.

The medicine exists, yet the places to give it remain scarce. A patient with metastatic prostate cancer who qualifies for lutetium based therapy has to find a facility licensed to hold unsealed radioactive material, a physician who satisfies 10 CFR 35.390, a shielded hot laboratory, a medical physicist and an accredited scanner. There are not enough of them, and they cluster in academic centres. Aletheia builds them.

half life 6.6 days Lu-177 activity time
Lutetium-177 loses half its activity in 6.6 days. A dose cannot be stockpiled, shipped slowly or held for a convenient appointment. Everything about this business follows from that.
Jurisdictions
Two
Sites at full build
18
Structure
Delaware parent
Stage
Pre seed, Series A open

The thesis

Two markets that share almost nothing, and solve each other's problem.

United States

Demand without sites

The constraint is not the medicine and not the evidence. It is the licensed site. In July 2026 the FDA approved the leading agent in hormone sensitive metastatic disease, so it can now be used across all stages of PSMA positive metastatic prostate cancer. The manufacturer states this nearly doubles the eligible population. Demand roughly doubled. The number of licensed sites did not.

South Africa

Isotope without delivery

SAFARI-1 at Pelindaba and its commercial arm NTP Radioisotopes supply a very large share of the world's molybdenum-99 and also produce lutetium-177, serving customers in more than sixty countries. The country exports the raw material of nuclear medicine and treats almost none of its own patients with the therapeutic form of it.

The market, built from the bottom up

A share of the eligible population, not a share of the market.

333,830 New United States prostate cancer diagnoses in 2026
~26,700 Diagnosed at distant stage, being eight per cent of new cases
~89,000 Annual incident metastatic pool. The CDC finds seventy per cent of men with metastatic disease were first diagnosed localised
~71,000 PSMA positive, the biomarker being present in more than eighty per cent of prostate cancer patients
<5% The share of that eligible pool Aletheia treats at full build

Sources: American Cancer Society, Cancer Statistics 2026; Centers for Disease Control and Prevention analysis of metastatic prostate cancer; Novartis media release, 31 July 2026. This plan does not require winning the market. It requires a small share of a market whose binding constraint is licensed sites rather than eligible patients.

The platform

Two operating structures and one research layer.

United States

Freestanding centres

Outpatient theranostics centres in secondary metropolitan areas, co located with urology and medical oncology groups. Each holds its own radioactive materials licence and hot laboratory, and runs three service lines off one licence: radioligand therapy, PSMA imaging, and adjacent radionuclide therapies.

South Africa

Hosted centres

Centres placed inside existing private hospital campuses under hosting agreements, so we rent capability into beds that already exist. Each carries a licensed compounding radiopharmacy and supplies Lu-177 PSMA I&T under section 21 rather than importing a branded product.

Both jurisdictions

Clinical research

Not a separate business. A capability layer that sells sponsors the one thing they cannot buy at scale anywhere: the ability to enrol radioligand therapy patients quickly, in sites that already hold the licences and already employ the physicists.

Aletheia is not a drug developer, not an isotope producer and not a hospital operator.

Why this has not been done

Everyone who could build this has a reason not to.

Manufacturers
Build the medicine and the manufacturing. Their economic interest is in more delivery sites, not fewer. A counterparty, not a competitor.
Academic cancer centres
Hold most of the current administration capacity, run waiting lists, and do not expand into secondary metropolitan areas.
Hospital systems
A shielded hot laboratory competes for capital against a surgical robot on the same committee, and radiopharmacy is treated as a cost centre rather than a service line.
Freestanding operators
A small number run two to four centres each. They prove the model works and they are subscale.
Imaging platforms
Own the scanners. They do not hold a licence for unsealed therapeutic material and do not employ an Authorised User.

The barrier is a named physician satisfying 10 CFR 35.390, eight to nine months of licence review, four to six months of payer contracting, and a nine figure working capital book at scale. None of that is bought with software.

The shape of the investment

The same line, drawn the other way.

A dose decays in days. A site recovers its cash over about a decade. One site absorbs capital for three years before it turns, and the return comes from owning a licensed, accredited, payer contracted asset rather than from payback.

break even peak capital absorbed, site year 3 cash on cash payback site year 0 year 10
Illustrative shape of cumulative unlevered site cash flow. Figures are in the investor materials.

Financial detail, the full cost stack, the three case model and the returns are not published on this page. They are in the investment memorandum and the analyst model, released to accredited investors on request.

Leadership

A specialist operating team.

Healthcare delivery, nuclear medicine operations and investment discipline

The leadership structure is being built around operators and advisors with direct experience in healthcare infrastructure, regulated clinical services, nuclear medicine delivery, payer contracting and capital formation.

The company is deliberately independent of any unrelated employer, listed investment vehicle or hospital group. Its work is focused only on building licensed theranostics delivery capacity for Aletheia Theranostics.

Why this combination

This business asks a team to hold an operating healthcare network in an emerging market, a United States reimbursement and licensing environment, a capital structure that must survive four years of negative earnings, and a regulatory regime in two jurisdictions where the binding constraint is legal and administrative rather than clinical.

A conventional healthcare operator would build the sites and be destroyed by the receivables. A conventional financier would build the model and be defeated by the licensing.

Investor access

Request the materials.

The investment memorandum, the investor presentation and the analyst model are released to accredited and professional investors. The model is a three statement build with a scenario switch and no hardcoded results in any calculated cell. We would welcome your team pulling it apart.

Direct enquiries: Email investor relations

Materials are released only to accredited or professional investors. Status is verified before release.