With its lead product, a deuterium-tweaked version of tetrabenazine for hyperkinetic movement disorders, in Phase III testing in chorea associated with Huntington’s disease (HD), orphan drug company Auspex Pharmaceuticals Inc. added its name to the initial public offering (IPO) roster.
The San Diego-based biotech filed an S-1 proposing to raise $69 million, though the number of shares and share price have not yet been disclosed. Upon pricing, Auspex, which filed as an emerging growth company, aims to list on Nasdaq under the ticker “ASPX.”
Founded in 2001, Auspex has raised about $87 million in venture funding to date, most recently closing a $28 million Series E round in September. As of Sept. 30, the company had about $11.4 million in cash and equivalents.
Proceeds from the IPO primarily would support work on SD-809 (deutetrabenazine), its formulation of vesicular monoamine transporter 2 inhibitor tetrabenazine that has been modified, with deuterium replacing the usual hydrogen molecule. The end result is a compound designed to enable less frequent dosing, with improved tolerability, reduced drug interactions and a reduced need for genotyping for drug-metabolizing enzymes, Auspex said. (See BioWorld Today, Nov. 9, 2012.)
The company launched a Phase III study in July. Dubbed First-HD, the randomized, double-blind, placebo-controlled, parallel-group study is enrolling 90 patients with chorea associated with HD. Total Maximal Chorea score will serve as the primary endpoint, while secondary endpoints include treatment success measurements based on patient and clinical global impressions of change.
That registration trial is being supported by a second study, an open-label trial called ARC-HD, which is expected to provide long-term safety data, as well as guidance for switching patients currently taking tetrabenazine to SD-809.
Assuming all goes well, Auspex could file for approval under the 505(b)(2) pathway in the fourth quarter of 2014, with commercial launch sometime in 2015.
Chorea, or involuntary movements, is one of the first symptoms of HD and is believed to affect about 90 percent of the estimated 30,000 HD patients in the U.S. Tetrabenazine was approved in 2008 and is sold as Xenazine (H. Lundbeck A/S). For the year ended Sept. 30, Xenazine posted U.S. sales of about $238 million, but adverse events and a short half-life have limited that drug’s use. Auspex is hoping its SD-809 will prove more patient-friendly.
Beyond chorea in HD, Auspex is testing SD-809 in tardive dyskinesia, with plans to start a Phase II/III study. Data from that trial could be available around mid-2015. An open-label Phase Ib study in adolescent patients with tics associated with Tourette syndrome is expected to yield data next year.
Earlier in the pipeline, the company has other deuterium-containing compounds, including SD-254, an analogue of venlafaxine that has completed two Phase I trials; SD-560, an analogue of pirfenidone that is in preclinical testing; and SD-970, a analogue of tofacitinib, which also is in preclinical development.
Auspex will offer bookrunners Stifel and BMO Capital Markets a 30-day option to purchase additional shares to cover overallotments. As of Sept. 30, the company had about 65.2 million shares outstanding.
In other financings news:
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J., filed for an initial public offering to raise up to $50 million. The number of shares and share price have not yet been disclosed. The specialty pharma firm, which develops and sells enhanced injectable products, plans to list on Nasdaq under the symbol “EGRX.” Piper Jaffray and William Blair are acting as joint bookrunners.
Genocea Biosciences Inc., of Cambridge, Mass., filed an S-1 for a proposed $75 million initial public offering, though it has not yet disclosed the number of shares or share price. Proceeds will be used to fund work on the firm’s pipeline of T-cell vaccines, including GEN-003, which is in a Phase I/IIa study in herpex simplex virus-2. Citigroup and Cowen and Co. are acting as joint book-running managers, while Stifel, Nicolaus & Co. is acting as lead manager and Needham & Co. LLC is acting as co-manager. Genocea, while filed as an emerging growth company, aims to list on Nasdaq under the ticker “GNCA.”
Glycomimetics Inc., of Gaithersburg, Md., filed an amended S-1 to resurrect its proposed initial public offering (IPO), which it postponed last month due to market conditions. No terms of the IPO are included in the amended filing, though the firm said existing investors, including partner Pfizer Inc., of New York, have committed to purchase up to about $14 million of shares offered in the deal. Glycomimetics filed for its IPO in October, with proceeds expected to help support work on therapies to treat vaso-occlusive crises and sickle cell disease. It plans to list on Nasdaq under the ticker “GLYC.” Jefferies and Barclays are serving as joint bookrunners. (See BioWorld Today, Oct. 8, 2013.)
Opexa Therapeutics Inc., of The Woodlands, Texas, said it closed its public offering of 4.12 million shares, including the exercise of the full 618,000-share overallotment option granted to underwriters, priced at $1.70 apiece for gross proceeds of about $8.1 million. Funds will be used to support the ongoing Abili-T study testing T-cell immunotherapy candidate Tcelna in patients with secondary progressive multiple sclerosis and for general corporate purposes. Aegis Capital Corp. acted as sole book-running manager.
Tigenix NV, of Leuven, Belgium, said it signed a structured debt financing agreement of up to €10 million (US$13.7 million) with Kreos Capital. The funds will supplement the €12 million in equity financing Tigenix recently secured from Gri-Cel SA and will be used for general growth purposes as Tigenix advances its cell therapy pipeline. (See BioWorld Today, Nov. 21, 2013.) //