Gene therapy biotech Affinia Therapeutics aims to go public, files for a US$100 million IPO

USA – Affinia Therapeutics, a preclinical biotech developing novel gene therapies for rare diseases and cancer, filed with the Securities and Exchange Commission (SEC) for an initial public offering of up to US$100 million.

Affinia Therapeutics, which raised $US110 million in a Series B round nine months ago, has set its sights on the Nasdaq. Affinia intends to list under the symbol $AFTX.

The Massachusetts-based preclinical gene therapy biotech, which received US$60 million in startup capital in 2019 from New Enterprise Associates (NEA), F-Prime, and Atlas, filed an S-1 with the SEC, announcing initial plans to go public and estimating a US$100 million raise.

Affinia, founded in 2019 by AveXis veterans Sean Nolan and Rick Modi, has been focused on attempting to solve the limitations of Adeno-associated virus (AAV) gene therapy, as highlighted by the recent safety scares and setbacks.

Its three scientific co-founders include Luk Vandenberghe, an associate professor at Harvard Medical School and the director of the Grousbeck Gene Therapy Center at Massachusetts Eye and Ear Infirmary in Boston — and a co-inventor of the more widely used AAV9.

In terms of current financial stake in the company, NEA managing partner Ed Mathers, who sits on Affinia’s board of directors, is the largest shareholder, owning more than 11.8 million shares, or 20.5 percent of the company.

Other major shareholders include Atlas Venture, which owns just under 7.5 million shares, or 13% of Affinia; F-Prime, which owns nearly 10% of the company and 5.7 million shares; and Lonza Houston, which owns 4.9 million shares and has an 8.6 percent stake.

CEO Rick Modi owns 1.4 percent of the company with over 800,000 shares, and Vandenberghe owns 1.5 million shares, or 2.7 percent.

While the biotech has already raised more than US$200 million in deals and private financings, Affinia intends to use any money raised in an IPO to fund clinical trials, pipeline expansion, and manufacturing — though no dollar amounts for these goals were specified.

According to the statement, the funds will be used to fund operations through 2024.

AFTX-001, the company’s lead candidate, is being developed for the treatment of metachromatic leukodystrophy, a rare genetic disorder that causes fat buildup in the body.

AFTX-002, its second candidate, is being developed to treat brain metastases caused by HER2+ breast cancer.

Affinia anticipates filing investigational new drugs (INDs) on both candidates in 2023, the first in the first half of the year and the second in the second half of the year 2023.

But those aren’t the only projects Affinia is working on: they also have a significant deal with Vertex that they signed in 2020.

The S-1 disclosed additional details about the deal, indicating that Affinia could earn up to US$4.7 billion to engineer capsids for use in programs for Duchenne muscular dystrophy (DMD), myotonic dystrophy 1 (DM1), and cystic fibrosis (CF).

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