Immix Biopharma is targeting an $11 bln market. How is it as an equity investment?

Small-cap biotech Immix Biopharma is aiming to reshape the treatment landscape for AL amyloidosis, a serious disease that can lead to heart, kidney, and liver failure. The latest clinical data suggest its experimental therapy has a strong chance of winning regulatory approval, according to investment bank HC Wainwright. Overall, Grand View Research estimates that the global AL amyloidosis treatment market could reach $11.13 billion by 2033.

Immix Biopharma was founded in 2012. The idea for the company came from Ilya Rachman, a physician-scientist and cell biologist who, according to the company, wanted to translate academic discoveries into real-world treatments.

By the time he founded Immix, Rachman had extensive experience conducting clinical research. He was among the first researchers to test therapies targeting a specific protein whose activity can contribute to inflammation, severe viral diseases, and tumor growth. He later founded an organization that conducted clinical trials for pharmaceutical companies.

Rachman's business partners were patent attorney Sean Senn and scientist Vladimir Torchilin.

Immix describes Torchilin as a "scientific cofounder." One of the world's leading experts in medical nanotechnology, Torchilin graduated from the Chemistry Department of Moscow State University and worked at the Institute of Experimental Cardiology. Among other projects, he helped develop therapies for blood clots, strokes, and heart attacks. Drug-delivery approaches pioneered by his team are still used today. Torchilin moved to the U.S. in 1991 and continued his scientific career there. In 2024, ScholarGPS, which ranks researchers within their fields based on citations by other scientists, named Torchilin a "Highly Ranked Scholar," a distinction obtained by just 0.05% of scholars worldwide.

As originally envisioned by Rachman, Immix focused on developing oncology and anti-inflammatory therapies. Its lead asset was IMX-110, a molecule designed to treat solid tumors. The therapy first blocks the same proteins that help tumors grow and then destroys the cancer cells. Clinical trials of IMX-110 are ongoing in Australia and the U.S.

In 2022, Immix expanded its pipeline by acquiring rights from Jerusalem-based Hadassah Medical Organization to NXC-201, a CAR-T cell therapy that could potentially treat certain cancers as well as AL amyloidosis, a condition in which amyloid proteins accumulate in the heart, kidneys, liver, and other vital organs, ultimately leading to organ failure and death. The deal was valued at $20 million in licensing fees and future milestone payments, plus a commitment to invest $12 million in Hadassah's clinical program over four years.

Current treatment for AL amyloidosis involves combinations of targeted therapies and chemotherapy. However, there are still no approved therapies for patients with relapsed or refractory AL amyloidosis. Unlike those regimens, NXC-201 is a one-time CAR-T treatment.

In May, Immix published data showing that NXC-201 produced a complete response in 95% of patients with relapsed/refractory AL amyloidosis. One year after treatment, 19 of 20 patients in one of the study cohorts were in complete remission. No signs of disease were detected even among patients whose disease had failed to respond to four previous lines of therapy.

Immix plans to present data from the second study cohort in September 2026 and March 2027, after which it intends to submit a biologics license application and begin commercial operations.

The company also plans to evaluate the therapy as a frontline treatment in patients who have not previously received therapy.

Immix notes that NXC-201 has orphan drug designation in both the U.S. and Europe. That means competing companies cannot market a comparable therapy for the same indication for seven years in the U.S. and 10 years in the EU.

In its early years, Immix funded operations through grants, promissory notes, and debt offerings. In 2021, it completed an IPO, selling 4.2 million shares at $5 apiece and raising $21 million before underwriters' options. Since then, the stock has gained 70%.

Following the release of the updated NXC-201 clinical data, HC Wainwright raised its target price on the stock by a third to $20 per share, implying upside of 2.4 times versus the Friday closing price. The analysts believe the results increased the probability of regulatory approval from 85% to 95%. They forecast that NXC-201 could eventually capture 55% of its target market at peak sales, versus 40% previously projected.

According to Grand View Research, the AL amyloidosis treatment market is expected to expand at an annual rate of 7.5% and reach $11.13 billion by 2033, the company said in its 2025 report.

The company does not currently generate revenue. Immix cautions that it does not expect to become profitable for many years, if ever. Moreover, operating losses are expected to increase as clinical development continues, the company said. Among other risks facing its business, Immix cites rising competition. According to its annual report, companies developing treatments for AL amyloidosis include pharmaceutical giants AbbVie and Janssen, the pharmaceutical subsidiary of Johnson & Johnson.

Wall Street currently has four "buy" ratings on Immix shares. The average target price is $18.50 per share, implying upside of more than 100%.