Aimmune Therapeutics, Inc. filed an S-1 form with the Securities and Exchange Commission (SEC) for its initial public offering. The expected price range was set as $14 to $16 for 8.33 million shares with an overallotment option for an additional 1.25 million shares. At the maximum price the entire offering is valued up to $153.33 million. The company plans to list its shares on the NASDAQ Global Select Market under the symbol AIMT.

The underwriters for the offering are Merrill Lynch, Credit Suisse and Piper Jaffray.

The company is a clinical-stage biopharmaceutical company advancing a new therapeutic approach, for the treatment of peanut and other food allergies. It is estimated that over 30 million people in the U.S. and Europe have a food allergy, with peanut allergy being the most prevalent.

The therapeutic approach, which Aimmune refer to as Characterized Oral Desensitization Immunotherapy (CODIT) is a system designed to desensitize patients to food allergens using rigorously characterized biologic products, defined treatment protocols and tailored support services.

Currently there are no approved medical therapies to cure food allergies or prevent their effects. Avoidance is the primary method of managing a food allergy and successfully practicing avoidance can be virtually impossible, as allergic reactions can often be triggered by trace amounts of food proteins, or allergens.

Aimmune described its pipeline in the filing:

In ARC001, our recently completed Phase 2 study of our lead CODIT product candidate, AR101, all of the 23 patients who completed the AR101 treatment regimen were desensitized to a clinically meaningful level of peanut protein of at least 443 mg, a level that substantially exceeds the amount of peanut protein typically encountered in an accidental exposure, which we believe to be approximately 100 mg or less. We intend to initiate a Phase 3 registration trial of AR101 in early 2016 and Phase 2 studies of other CODIT product candidates for two additional food allergies in 2016. AR101 has been granted Fast-Track designation and Breakthrough Therapy designation by the U.S. Food and Drug Administration, or FDA, and, if our planned Phase 3 program is successful, we intend to file a Biologics License Application with the FDA and a Marketing Authorization Application with the European Medicines Agency. We have worldwide commercial rights to all of our product candidates and, if approved, intend to commercialize in the United States and Europe with our own specialty sales force.

The company intends to use the proceeds from this offering to fund the continued clinical development of AR101 as well as the development of additional product candidates.

FULL FILING

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