A letter from the principal on what we are funding in the second half of 2026, and why.
The thesis has not changed. Personal capital, deployed by an operator, into FDA-regulated frontier medicine. Multi-decade horizons. No quarterly chase. No portfolio padding for the sake of optics. Three priorities, one horizon.
What we funded this quarter
The second quarter was a writing quarter, not a buying quarter. The mesenchymal exosome biologics program completed its CMC scoping work in preparation for pre-IND engagement with FDA CBER. Work on the Targeted Osmotic Lysis program remained preclinical. The published TOL mechanism literature is authored principally by Dr. Harry J. Gould III at LSU Health Sciences Center and Dr. Dennis Paul, and appears in Biomedicines, Cancers, Current Oncology, Case Reports in Veterinary Medicine, and the LSU Digital Scholar archive.
Exosome and mesenchymal stem cell derived extracellular vesicle products are not approved by the FDA for any indication. References here describe investment focus and published scientific literature. They do not describe an available treatment.
Targeted Osmotic Lysis is investigational. It is not approved by the FDA for any use, it has not been shown to be safe or effective in humans, and there are no registered clinical trials of it. Mesenchymal exosome and MSC-derived products are likewise investigational and are not FDA-approved for any indication. Nothing here is an offer of treatment or a statement about results in patients.
Conflict of interest disclosure. An author affiliation on part of the cited TOL literature includes an entity in which Andrew Hillman holds a financial interest. This literature should not be read as a fully independent evidence base.
The patent estate has been audited. EP2734214A1 anchors the international IP position. We are evaluating a parallel U.S. continuation filing.
What we passed on
Two new family-office syndicate opportunities in cell therapy. Both had credible science. Neither had the regulatory pathway clarity we require. The lesson here is the same one we have written about for years. The science is the easy part. The 351(a) pathway, the CMC discipline, the chemistry-manufacturing-controls hygiene, the cGMP capacity. That is where money lives.
What we are watching
Three signals over the next six months. First, the regulatory and reimbursement debate around minimal-manipulation versus 351(a) classification. Second, the European Union's pending Advanced Therapy Medicinal Product framework adjustments. Third, the U.S. Right-to-Try posture under the current administration. Each of these moves the IRR math on the entire portfolio.
What the holding structure is doing
Hillman Ventures is not a fund. It is the holding entity for the operating subsidiaries. Consolidation is reserved for governance, tax, and capital allocation. The operating teams report to their own boards. Our role is to write the check and stay out of the lab.
The holding structure was reorganized in the first quarter to align international partnerships under a consistent legal framework.
What the writing is doing
The Hillman Letter on Substack has now published three issues. The publication is intentionally narrow. It exists to explain to capital and to clinicians what frontier biotech looks like from inside the operator seat, with primary sources. The audience is regulators, founders, family offices, and the journalists who cover the sector. The publication is free. The work behind it is not.
What we expect to learn
Two things between now and year-end. Whether the mesenchymal exosome biologics pre-IND meeting confirms our 351(a) thesis. Whether the OIG application submission in July 2025 resolves the last administrative item carried from the federal matter. Each answer changes the next quarter's letter.
Exosome and mesenchymal stem cell derived extracellular vesicle products are not approved by the FDA for any indication. References here describe investment focus and published scientific literature. They do not describe an available treatment.
Concentration over coverage. The portfolio you choose not to expand is as much of an investment decision as the one you fund. We have written before that capital discipline is itself a competitive advantage. The second half of 2026 is a test of that proposition.
Nothing on this site is an offer to sell or a solicitation of an offer to buy any security, and nothing on this site is investment advice.
Investigational status. Exosome, mesenchymal stem cell derived extracellular vesicle, and Targeted Osmotic Lysis products referenced on this site are investigational and are not approved by the FDA for any indication. They are not available as a treatment.