Gene therapy player Affinia aims to go public, hoping to raise big money in effort to remake AAVs

Nine months after Affinia Therapeutics raised $110 million in a Series B, the biotech has set its eyes on the Nasdaq.

The MA-based preclinical gene therapy biotech, which got $60 million in startup capital from New Enterprise Associates, F-Prime and Atlas in 2019, filed an S-1 with the SEC on Tuesday, announcing initial plans to go public and penciling in a $100 million raise. Affinia plans to list under the ticker $AFTX.

Affinia, founded back in 2019 by AveXis veterans Sean Nolan and Rick Modi and an Endpoints 11 winner last year, has been focused on trying to solve the limitations of AAV gene therapy, as highlighted by the safety scares and setbacks of the last two years.

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

In terms of current financial stake in the company, NEA managing partner Ed Mathers — on Affinia’s board of directors — is the largest shareholder, owning over 11.8 million shares and equivalent to 20.5% of the company. Other big shareholders currently include Atlas Venture with just shy of 7.5 million shares, or 13% of Affinia; F-Prime with almost a 10% stake and 5.7 million shares; and Lonza Houston with 4.9 million shares and an 8.6% stake.

CEO Rick Modi has a 1.4% stake with over 800,000 shares, and Vandenberghe has 1.5 million shares, or a 2.7% stake.

While the biotech has already raked in over $200 million in deals and private financings, Affinia wants to use whatever money it raises in an IPO to push towards clinical trials, pipeline expansion and manufacturing — although no specific dollar amounts for those objectives were listed. The money should fund operations through 2024, it said.

Its lead candidate, AFTX-001, is being developed for the treatment of metachromatic leukodystrophy, a rare genetic disorder that leads to fat buildup in the body. Its second candidate, AFTX-002, is in development to treat brain metastases secondary to HER2+ breast cancer.

Affinia expects to file INDs on the two candidates in 2023 — the first candidate in the first half of the year, and the other candidate in the second half of 2023.

But those aren’t the only things Affinia is working on: They also have a substantial deal with Vertex that Affinia signed in 2020. The S-1 gave further details on the deal, showing it could net Affinia up to $4.7 billion to engineer capsids for use in programs for Duchenne muscular dystrophy (DMD), myotonic dystrophy 1 (DM1) and cystic fibrosis (CF).

Source: Endpoints News