Gene therapy specialist Applied Genetic Technologies Corp. (AGTC) banked new funds with a stock sale of 2 million shares priced at $15 each, for a net haul of $30 million, following by several months an initial public offering (IPO) that pulled down $50 million.
Gainesville, Fla.-based AGTC said the cash will boost preclinical work and phase I/II trials of potential candidates against wet age-related macular degeneration (AMD). The firm also aims to expand its manufacturing capabilities, create a pilot manufacturing group and in-license, acquire or invest more in gene therapy assets.
In late March, AGTC's IPO priced at $12 per share, $1 below its intended $13 to $15 range, with 4.2 million shares sold and underwriters given a 30-day option to buy as many as 625,000 more shares, an option fully exercised that added $7.5 million to the financing. (See BioWorld Today, March 28, 2014.)
AGTC has a trio of lead programs, all preclinical. The one farthest ahead deploys the company's adeno-associated virus-based vector system to treat X-linked retinoschisis, or XLRS, an inherited retinal disease that can lead to poor visual acuity in young boys and eventual blindness. AGTC plans to submit an investigational new drug application (IND) to the FDA in late 2014, with a phase I/II trial yielding first data in the middle of next year.
Program number two targets achromatopsia, or ACHM, an inherited retinal disease that results in reduced visual acuity, light sensitivity, day blindness and complete loss of color discrimination. An IND and phase I/II trial should start early in 2015, with data before year-end.
There's also an effort against inherited retinal dystrophy, X-linked retinitis pigmentosa. Characterized by the progressive loss of vision, the disease in a dog model appeared responsive to AGTC's therapy, which slowed worsening. A number of other preclinical experiments are under way, too.
In wet AMD, at which AGTC intends to direct some of the recently gained funds, the firm entered a deal with Genzyme, a unit of Paris-based Sanofi SA, in 2004. Preclinical studies showed the product to be safe in rats, mice and primates, and efficacious in the latter two animals. In March 2010, a phase I trial in humans began, and at the same time, the deal was converted to a license agreement under which Genzyme is fully responsible for further development. The terms included options to license AGTC's manufacturing technology for specified genes associated with diseases outside its area of focus.
But Genzyme recently informed AGTC that it no longer intends to use the herpes simplex virus (HSV)-based manufacturing technology to produce the AAV vector being used for the AMD candidate, and the pair accordingly amended their pact in late 2013. The exclusive license to Genzyme for use of the HSV-based method in wet AMD was terminated, except with regard to specified pending research activities. The move took away restrictions on AGTC's work in neovascularization disorders, including AMD.
AGTC also has partners in more than a dozen universities, patient groups and organizations.
The latest offering includes a 30-day option for underwriters to buy as many as 300,000 more shares to cover overallotments. BMO Capital Markets, Stifel and Wedbush PacGrow Life Sciences are acting as the book-running managers for the offering, with Cantor Fitzgerald & Co. and Roth Capital Partners as co-managers. AGTC's stock (NASDAQ:AGTC) closed Friday at 17.99, up 15.3 percent.
In other financing news:
Innocoll AG, of Athlone, Ireland, priced its public offering of 6.5 million American depositary shares (ADS), each representing 1/13.25 ordinary shares, at a public offering price of $9 per ADS. The company's ADSs began trading on July 25 on Nasdaq. Expected to close on July 30, the offering provides a 30-day option for underwriters to buy up to 975,000 more ADSs at the public offering price, less underwriting discounts and commissions, to cover overallotments. The company expects to receive total estimated net proceeds of about $51.5 million, and will use the proceeds to expand its manufacturing infrastructure and develop candidates, including Xaracoll, an implantable, bioresorbable collagen sponge that delivers analgesia for postoperative pain, in phase III trials; Cogenzia, a biodegradable and fully resorbable gentamicin-collagen sponge in phase III for diabetic foot ulcers; and Collaguard, a surgical adhesion barrier, ready for pivotal trials. Innocoll shares (NASDAQ:INNL) closed flat Friday at $9.