Highlights of the third quarter of 2013 and subsequent weeks include:
- Completed patient enrollment in the Phase 2 clinical trial of ARIKACE®, or liposomal amikacin for inhalation, for patients with recalcitrant nontuberculous mycobacteria (NTM) lung disease in the U.S. and
Canada ;
- Commenced the
Scientific Advice Working Party (SAWP) process withEuropean Medicines Agency (EMA) for clarity on the path forward for ARIKACE to treat NTM lung disease inEurope ;
- Strengthened the Company's intellectual property position with the addition of another European patent allowance;
- Completed an underwritten public offering of 6.9 million shares of common stock, including the underwriters' exercise in full of their over-allotment option of 900,000 shares, which provided net proceeds to the Company of approximately
$67.0 million .
"During the third quarter we made significant progress advancing ARIKACE closer to our goal of treating patients with NTM lung disease. With no approved treatments for this indication, completion of enrollment in our U.S. and Canadian Phase 2 study is a significant milestone in bringing ARIKACE to patients with NTM lung disease who are in great need of an effective treatment option," stated
"We continue work to build
Third Quarter Financial Results
For the third quarter of 2013,
Research and development expenses for the third quarter of 2013 increased to
General and administrative expenses for the third quarter of 2013 increased to
Balance Sheet Highlights and Cash Guidance
As of
The Company plans to fund further clinical development of ARIKACE, invest in third-party manufacturing capacity and fund its efforts to obtain regulatory approvals and prepare for commercialization. As a result,
Conference Call
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About
Forward-looking Statements
This release contains forward-looking statements. Words, and variations of words, such as "intend," "expect," "will," "anticipate," "believe," "continue," "propose" and similar expressions are intended to identify forward-looking statements. Investors are cautioned that such statements in this release, including statements relating to the status, results and timing of clinical trials and clinical data, the anticipated benefits of
-Tables to Follow -
| Consolidated Balance Sheets | ||||||||||
| (in thousands, except par value, share and per share data) | ||||||||||
| (unaudited) | ||||||||||
| Assets | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 128,025 | $ | 90,782 | ||||||
| Certificate of deposit | - | 2,153 | ||||||||
| Prepaid expenses and other current assets | 1,720 | 643 | ||||||||
| Total current assets | 129,745 | 93,578 | ||||||||
| In-process research and development | 58,200 | 58,200 | ||||||||
| Other assets | 101 | 117 | ||||||||
| Fixed assets, net | 1,904 | 1,666 | ||||||||
| Total assets | $ | 189,950 | $ | 153,561 | ||||||
| Liabilities and shareholders' equity | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 4,661 | $ | 7,060 | ||||||
| Accrued expenses | 5,652 | 2,933 | ||||||||
| Accrued compensation | 1,953 | 2,207 | ||||||||
| Accrued lease expense, current | 303 | 295 | ||||||||
| Deferred rent | 134 | 149 | ||||||||
| Capital lease obligations, current | 64 | 96 | ||||||||
| Current portion of long term debt | 7,055 | 3,007 | ||||||||
| Total current liabilities | 19,822 | 15,747 | ||||||||
| Accrued lease expense, long-term | 449 | 647 | ||||||||
| Capital lease obligations, long-term | 16 | 64 | ||||||||
| Debt, long-term | 12,538 | 16,221 | ||||||||
| Total liabilities | 32,825 | 32,679 | ||||||||
| Shareholders' equity: | ||||||||||
| Common stock, |
391 | 315 | ||||||||
| Additional paid-in capital | 532,141 | 455,325 | ||||||||
| Warrant to purchase common stock | - | 790 | ||||||||
| Accumulated deficit | (375,407 | ) | (335,548 | ) | ||||||
| Total shareholders' equity | 157,125 | 120,882 | ||||||||
| Total liabilities and shareholders' equity | $ | 189,950 | $ | 153,561 | ||||||
| See accompanying notes to consolidated financial statements | ||||||||||
| Consolidated Statements of Comprehensive Loss | ||||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||||
| Three Months Ended |
Nine Months Ended |
|||||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||||
| Other revenue | $ | - | $ | - | $ | 11,500 | $ | - | ||||||||||
| Operating expenses: | ||||||||||||||||||
| Research and development | 12,095 | 5,706 | 34,654 | 18,190 | ||||||||||||||
| General and administrative | 4,747 | 3,647 | 16,267 | 8,410 | ||||||||||||||
| Total operating expenses | 16,842 | 9,353 | 50,921 | 26,600 | ||||||||||||||
| Operating loss | (16,842 | ) | (9,353 | ) | (39,421 | ) | (26,600 | ) | ||||||||||
| Investment income | 40 | 193 | 141 | 901 | ||||||||||||||
| Interest expense | (525 | ) | (222 | ) | (1,802 | ) | (225 | ) | ||||||||||
| Gain on sale of assets, net | - | - | 2 | 5 | ||||||||||||||
| Loss before income taxes | (17,327 | ) | (9,382 | ) | (41,080 | ) | (25,919 | ) | ||||||||||
| Provision (benefit) for income taxes | - | - | (1,221 | ) | 4 | |||||||||||||
| Net loss | $ | (17,327 | ) | $ | (9,382 | ) | $ | (39,859 | ) | $ | (25,923 | ) | ||||||
| Basic and diluted net loss per share | $ | (0.46 | ) | $ | (0.38 | ) | $ | (1.19 | ) | $ | (1.04 | ) | ||||||
| Weighted average basic and diluted common shares outstanding | 37,389 | 25,013 | 33,577 | 24,916 | ||||||||||||||
| Net loss | $ | (17,327 | ) | $ | (9,382 | ) | $ | (39,859 | ) | $ | (25,923 | ) | ||||||
| Comprehensive loss: | ||||||||||||||||||
| Unrealized (loss) gain on short-term investments, net of taxes | - | 199 | - | 385 | ||||||||||||||
| Comprehensive loss | $ | (17,327 | ) | $ | (9,183 | ) | $ | (39,859 | ) | $ | (25,538 | ) | ||||||
| See accompanying notes to consolidated financial statements | ||||||||||||||||||
Contacts:
LHA
Senior Vice President
212-838-3777
afields@lhai.com
Managing Director
310-691-7100
bvoss@lhai.com
