Gut-Brain-Axis Therapeutics: Funding Rounds, Investors & CEO

About Gut-Brain-Axis Therapeutics

Gut-Brain-Axis Therapeutics is developing microbiota transplant therapy, or MTT, for autism and for Pitt-Hopkins syndrome, a rare genetic disorder. MTT removes harmful gut bacteria and adds beneficial bacteria purified from screened healthy donors. It has no approved product yet. Its goal is FDA approval, and it is raising money for the next trial phase.

The company is based in Arizona, and its trials run at Arizona State University (ASU) in Tempe. James Adams, an ASU professor, is president and chief executive. Rosa Krajmalnik-Brown of ASU is chief science officer. Alexander Khoruts is chief medical officer, and Michael Sadowsky is chief manufacturing and operations officer. Both are University of Minnesota researchers, and their team supports more than 15 clinical trials with MTT. More than 100 families affected by autism have invested about $8 million.

Funding Rounds (SEC Form D)

First sale	Filed with SEC	Amount sold	Investors	Avg. check	Terms	Filing
Oct 31, 2025	Nov 6, 2025amended Oct 27, 2026	$1,965,000of $20.0M target	22	$89,318	EquityRule 506(c)	Form D/A ↗1 earlier filing
Sep 25, 2023	Oct 10, 2023	$1,425,000of $8.0M target	23	$61,957	Options, Securities on exerciseRule 506(c)	Form D ↗
Total, two offerings		$3,390,000

First sale is the date the first investor in the offering committed to invest. Companies must file Form D within 15 days of that date, so filing dates run later.

Rounds announced by Gut-Brain-Axis Therapeutics

What the company said publicly about its funding. Announced amounts can differ from Form D figures: an announcement can combine several closings, and some money is raised without a Form D.

Announced	Round	Amount	Investors	Source
—	SAFE	$8M	More than 100 autism-family investors	gutbrainaxistherapeutics.com ↗

Why Investors Backed Gut-Brain-Axis Therapeutics

More than 100 families affected by autism have invested about $8 million in Gut-Brain-Axis Therapeutics. The money backs a gut bacteria transplant that Arizona State University (ASU) researchers first tested in 18 children. Autism affects 1 in 31 U.S. children, and the FDA has approved no drug for its core symptoms. Its leaders are university scientists who ran the earlier trials, and the next step is a larger Phase 3 study.

The problem it targets

CDC data show that 1 in 31 U.S. children has an autism diagnosis. The FDA has approved no drug for the core symptoms. About 85% of children with autism have a poorly working gut microbiome, the community of bacteria in the gut, based on preliminary research. Its second target is Pitt-Hopkins syndrome, a rare genetic disorder with severe intellectual disability and lifelong stomach pain. About 1,500 people in the U.S. have it, and no treatment exists.

What the product does

The treatment is microbiota transplant therapy, or MTT. After a step that removes harmful bacteria, it moves purified bacteria from screened healthy donors into the patient. Patients take it as capsules or as a powder mixed into food or drink. In the adult trial, patients took either an antibiotic or placebo for two weeks, then either MTT capsules or placebo for eight weeks. The U.S. Patent Office had granted a patent for MTT by February 2022, according to ASU News.

Progress so far

In a 2017 study of 18 children run by ASU researchers, stomach symptoms fell about 80%, according to ASU News. The same report said autism symptoms fell 23% at first and nearly 50% two years later. A placebo-controlled trial in 56 adults followed. In a seven-person Pitt-Hopkins trial with a placebo group, stomach pain fell 90%, against 29% on placebo. The FDA granted orphan drug and rare pediatric disease status for Pitt-Hopkins, according to ASU News. Two more Phase 2 studies, one in autism and one in Pitt-Hopkins, began in 2024, according to ClinicalTrials.gov.

Who backs it

More than 100 families affected by autism have put $8 million into a SAFE, a simple agreement that converts to shares later. It is now opening a Series A round to pay for Phase 3 and commercial-scale manufacturing. Adams told ASU News in 2023 that more than 1,000 families had donated to fund the earlier research. The Pitt Hopkins Research Foundation is a collaborator on the Pitt-Hopkins trial, ClinicalTrials.gov shows.

How the market is moving

The FDA approved Vowst on April 26, 2023. It was the first fecal microbiota product taken by mouth. The FDA gave the approval to Seres Therapeutics, for preventing repeat Clostridioides difficile infections. The approval rested on a placebo-controlled study of 182 people, in which 12.4% of Vowst patients had a recurrence, against 39.8% on placebo. Vowst consists of bacteria from donated human stool, so the FDA has already approved a treatment of this kind, though only for that infection.

We wrote this summary from public statements by Gut-Brain-Axis Therapeutics and its investors. It is not investment advice.