Amcius (FOLD) to Spin-Off Gene Therapy Arm, Form New Firm With ARYA

Amicus (NASDAQ:FOLD) Therapeutics, Inc. FOLD has announced its intent to spin-off its gene therapy business and form a next-generation genetic medicine company, Caritas Therapeutics, Inc.

The new company will be formed through a definitive business combination agreement whereby Amicus’ gene therapy business will be acquired by ARYA Sciences Acquisition Corp IV ARYD, a special purpose acquisition company or SPAC. Caritas will have a headcount of 115 people.

Consequently, there will be two independent publicly traded companies. Amicus will become the largest shareholder in Caritas with a 36% stake and retain co-development and commercialization rights to the Fabry and Pompe gene therapy programs as well as negotiation rights on select future muscular dystrophy programs.

Amcius’ stock has slumped 57% in the year so far compared with the industry’s decline of 5.8%.

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Amicus also announced that a syndicate of leading healthcare biotechnology investors, including Redmile Group, Avoro Capital Advisors, Perceptive Advisors, Invus, Sphera Healthcare, and Janus Henderson Investors have agreed to a private investment in Amicus of approximately $200 million. The company expects to use the net proceeds to commercialize Galafold further and in the anticipated global launch of AT-GAA.

Amicus plans to invest $50 million in cash in Caritas in exchange for additional equity. In addition to the approximately $150 million held in ARYA’s trust account, a group of leading global investors will invest in Caritas through a common stock private investment in public equity of approximately $200 million at $10 per share. In total, Caritas is expected to receive proceeds of about $400 million at the closing of the transactions.

Caritas pipeline will include two Batten disease programs with clinical proof of concept in CLN6 and CLN3, six active preclinical programs, including Fabry disease, Pompe disease, and CDKL5 Deficiency Disorder (CDD), as well as multiple discovery programs. It will also own exclusive, global rights to gene therapy programs for nearly 50 rare genetic diseases through its broad collaboration with Dr. Jim Wilson and the Penn team, including a majority of next-generation lysosomal disease programs as well as 11 more prevalent rare diseases.

The separation of the gene therapy business will enable Amicus focus on its rare disease business – primarily on Fabry disease and Pompe disease indications. The company has one marketed drug in its portfolio, Galafold (migalastat) for Fabry disease. The lead candidate in Amicus pipeline is AT-GAA, a differentiated biologic for Pompe disease. The influx of funds should help the company focus on the launch of AT-GAA, assuming a tentative approval.

Separately, the FDA has accepted for review the company’s biologics license application (BLA) for cipaglucosidase alfa and the new drug application (NDA) for miglustat for AT-GAA, the company’s investigational two-component therapy for the treatment of Pompe disease. The regulatory body has set an action date of May 29, 2022 for the NDA and Jul 29, 2022, for the BLA.

Zacks Rank & Stocks to Consider

Amicus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector are Regeneron (NASDAQ:REGN) REGN and Horizon Therapeutics (NASDAQ:HZNP) HZNP. While Regeneron sports a Zacks Rank #1 (Strong Buy), Horizon currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised upward by 22.8% for 2021 and 12.4% for 2022 over the past 60 days. The stock has surged 26.3% year to date.

Horizon’s earnings estimates have been revised upward by 21.1% for 2021 and 17.4% for 2022 over the past 60 days. The stock has surged 51.9% year to date.

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