Clementia Pharmaceuticals has filed an amended F-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). The company intends to price its 7.15 million shares in the range of $13 to $15, with an overallotment option for an additional 1.07 million shares. At the maximum price, the entire offering is valued up to $123.34 million. The company plans to list its shares on the Nasdaq under the symbol CMTA.
The underwriters for the offering are Morgan Stanley, Leerink Partners, Wedbush PacGrow and BTIG.
This clinical stage biopharmaceutical company is developing disease-modifying treatments for patients suffering from debilitating bone and other diseases with high unmet medical need. Its lead product candidate, palovarotene, is an oral small molecule that binds and activates retinoic acid receptor gamma (an RARg agonist), and it has shown potent activity in preventing abnormal new bone formation as well as scar tissue formation (or fibrosis) in a variety of tissues in animal models.
Clementia is developing palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP) and multiple osteochondroma (MO) and have one Phase 3 trial and one Phase 2/3 trial, for two separate indications, planned to commence in 2017 with data read-outs planned in 2019 and 2020. Management believes that, if approved in FOP or MO, palovarotene could become the standard of care in either or both of these indications.
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The firm detailed its regulatory approvals as follows:
In July 2014, the FDA granted Orphan Drug Designation for palovarotene as a treatment for FOP and in November 2014, we were granted orphan drug status in the EU. Orphan Drug Designation by the FDA allows for seven years of market exclusivity in the U.S. upon approval of the drug for the indication for which it was designated except in certain limited circumstances. In Europe, marketing authorization for an orphan drug generally leads to a ten-year period of market exclusivity. In November 2014 we received Fast Track Designation from the FDA, which allows for more frequent interactions with the FDA during the drug development and review process. Also, in July 2017 the FDA granted Breakthrough Therapy Designation to palovarotene for the prevention of HO in patients with FOP, which allows for intensive guidance on efficient drug development, organizational commitment involving senior management, and rolling review of our application.
Clementia intends to use the net proceeds from the offering to fund expenses incurred in pursing the registration of palovarotene, as well as for clinical trials. The remainder will be used for working capital and general corporate purposes.
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