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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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94-3171943
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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| Large accelerated filer | o | Accelerated filer | o | |
| Non-accelerated filer | o | (Do not check if a smaller reporting company) | Smaller reporting company | x |
| Page | ||
| Item 1. | Financial Statements | 1 |
| 1 | ||
| 2 | ||
| 3 | ||
| 4 | ||
| Item 2. | 11 | |
| Item 4. | 24 | |
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PART II - OTHER INFORMATION
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| Item 1. | 25 | |
| Item 1A. | 25 | |
| Item 2. | 37 | |
| Item 5. | Other Information | 37 |
| Item 6. | 37 | |
| 38 | ||
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●
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the risk that, if we are unable for any reason to introduce, or if there is a significant delay in the commercial introduction of, SURFAXIN and AFECTAIR in the U.S. and other markets as planned, we may be unable to secure additional capital, from strategic alliances or other sources, to sustain our operations, which could have a material adverse effect on our ability to continue investments in our commercialization activities, as well as our research and development programs;
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●
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the risk that, if we fail to successfully commercialize SURFAXIN and AFECTAIR, or if SURFAXIN and AFECTAIR do not gain market acceptance for any reason, our revenues would be limited, which ultimately could have a material adverse effect on our business, financial condition and results of operations;
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| ● |
risks relating to our ability to manufacture our KL
4
surfactant drug products for commercialization of our approved products, which must be processed and tested using sophisticated and extensive analytical methodologies and quality control release and stability tests to satisfy the requirements of the regulatory authorities;
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●
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the risk that we may be unable to enter into strategic alliances or collaboration agreements to support the development of our KL
4
surfactant pipeline products, beginning with AEROSURF
®
(our aerosolized KL
4
surfactant using our CAG technology) and SURFAXIN LS™ (our lyophilized (freeze-dried) dosage form of SURFAXIN), and, if approved, commercialization of these products in markets outside the United States; and to support the commercialization of SURFAXIN in countries where regulatory marketing authorization is facilitated by the information contained in the SURFAXIN new drug application (NDA) approved by the United States Food and Drug Administration (FDA);
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●
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risks relating to the ability of our sales and marketing organization to effectively market SURFAXIN and AFECTAIR in the United States, and our other product candidates, if approved, in a timely manner, if at all, and that we or our marketing and advertising consultants will not succeed in developing market awareness of our products or that our product candidates will not gain market acceptance by physicians, patients, healthcare payers and others in the medical community;
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●
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risks relating to our plans to secure marketing and distribution capabilities in certain markets through third-party strategic alliances and/or marketing alliances and/or distribution arrangements, that could require us to give up rights to our drug products, drug product candidates and drug delivery technologies;
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●
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the risk that we, our contract manufacturers or any of our third-party suppliers, many of which are single-source providers, may encounter problems or delays in manufacturing our drug KL
4
surfactant drug products, related substances used in the manufacture of our drug product, AFECTAIR ventilator circuit / patient interface connectors and related componentry, CAG devices and other materials on a timely basis or in an amount sufficient to support the commercial introduction of SURFAXIN and AFECTAIR devices, as well as our research and development activities for our other product candidates;
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risks relating to the transfer of our manufacturing technology to third-party contract manufacturers and assemblers;
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risks relating to the rigorous regulatory approval processes, including pre-filing activities, required for approval of any drug, combination drug-device product or medical device that we may develop, whether independently, with strategic development partners or pursuant to collaboration arrangements;
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risks related to our efforts to gain regulatory approval, in the United States and elsewhere, for our drug product and medical device candidates, including (i) drug and drug-device combination products that we are developing to address RDS in premature infants: AEROSURF and SURFAXIN LS; and (ii) AFECTAIR, our novel ventilator circuit / patient interface connectors;
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the risk that we and the FDA or other regulatory authorities will not be able to agree on matters raised during the regulatory review process, or that we may be required to conduct significant additional activities to potentially gain approval of our product candidates, if ever;
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the risk that the FDA or other regulatory authorities may not accept, or may withhold or delay consideration of, any applications that we may file, or may not approve our applications or may limit approval of our products to particular indications or impose unanticipated label limitations;
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risks relating to our research and development activities, which among other things involve time-consuming and expensive preclinical studies and potentially multiple clinical trials that may be subject to potentially significant delays or regulatory holds or fail;
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●
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risks relating to our ability to develop and manufacture drug-device combination products based on our KL
4
surfactant and CAG technology for preclinical and clinical studies of our product candidates and, if approved, for commercialization;
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the risk that we or our strategic partners or collaborators will not be able to attract or retain qualified personnel, which could affect our ability to develop and market our products;
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the risk that market conditions, the competitive landscape or other factors may make it difficult to launch and profitably sell our products;
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risks that reimbursement and health care reform may adversely affect us or that our products will not be accepted by physicians and others in the medical community;
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the risk that changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval of our drug product and medical device candidates;
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the risk that we may be unable to maintain compliance with continued listing requirements of The Nasdaq Capital Market
®
(Nasdaq), which could increase the probability that our stock will be delisted, which could cause our stock price to decline;
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●
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risks that the unfavorable credit and economic environment will adversely affect our ability to fund our activities, that our Committed Equity Financing Facility (CEFF) may be unavailable, for any reason, or may expire or be exhausted, and that additional equity financings could result in substantial equity dilution or result in a downward adjustment to the exercise price of five-year warrants that we issued in February 2011 (which contain price-based anti-dilution revisions);
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the risks that we may be unable to maintain and protect the patents and licenses related to our products and that other companies may develop competing therapies and/or technologies;
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the risks that we may become involved in securities, product liability and other litigation and that our insurance may be insufficient to cover costs of damages and defense; and
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other risks and uncertainties detailed in “Risk Factors” and in the documents incorporated by reference in this report.
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September 30,
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December 31,
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|||||||
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2012
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2011
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|||||||
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(Unaudited)
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||||||||
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ASSETS
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||||||||
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Current Assets:
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||||||||
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Cash and cash equivalents
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$ | 36,064 | $ | 10,189 | ||||
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Inventory
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128 | – | ||||||
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Prepaid expenses and other current assets
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1,165 | 442 | ||||||
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Total Current Assets
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37,357 | 10,631 | ||||||
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Property and equipment, net
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1,995 | 2,293 | ||||||
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Restricted cash
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400 | 400 | ||||||
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Total Assets
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$ | 39,752 | $ | 13,324 | ||||
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LIABILITIES & STOCKHOLDERS’ EQUITY
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Current Liabilities:
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Accounts payable
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$ | 208 | $ | 1,111 | ||||
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Accrued expenses
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3,665 | 2,972 | ||||||
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Common stock warrant liability
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11,923 | 6,996 | ||||||
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Equipment loans and capitalized leases, current portion
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68 | 68 | ||||||
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Total Current Liabilities
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15,864 | 11,147 | ||||||
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Equipment loans and capitalized leases, non-current portion
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167 | 224 | ||||||
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Other liabilities
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670 | 689 | ||||||
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Total Liabilities
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16,701 | 12,060 | ||||||
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Stockholders’ Equity:
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||||||||
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Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued or outstanding
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– | – | ||||||
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Common stock, $0.001 par value; 100,000 shares authorized; 43,539 and 24,603 shares issued, 43,518 and 24,582 shares outstanding at September 30, 2012 and December 31, 2011, respectively
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44 | 25 | ||||||
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Additional paid-in capital
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453,981 | 401,713 | ||||||
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Accumulated deficit
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(427,920 | ) | (397,420 | ) | ||||
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Treasury stock (at cost); 21 shares at September 30, 2012 and December 31, 2011, respectively
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(3,054 | ) | (3,054 | ) | ||||
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Total Stockholders’ Equity
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23,051 | 1,264 | ||||||
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Total Liabilities & Stockholders’ Equity
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$ | 39,752 | $ | 13,324 | ||||
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Three Months Ended
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Nine Months Ended
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|||||||||||||||
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September 30,
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September 30,
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|||||||||||||||
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2012
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2011
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2012
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2011
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|||||||||||||
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Grant Revenue
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$ | – | $ | – | $ | – | $ | 582 | ||||||||
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Expenses:
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||||||||||||||||
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Research and development
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5,743 | 3,981 | 15,482 | 13,216 | ||||||||||||
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Selling, general and administrative
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4,255 | 2,189 | 9,912 | 5,975 | ||||||||||||
| 9,998 | 6,170 | 25,394 | 19,191 | |||||||||||||
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Operating loss
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(9,998 | ) | (6,170 | ) | (25,394 | ) | (18,609 | ) | ||||||||
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Change in fair value of common stock warrant liability
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(3,309 | ) | 1,422 | (5,063 | ) | 1,957 | ||||||||||
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Other income / (expense):
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||||||||||||||||
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Interest and other income
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1 | 3 | 5 | 10 | ||||||||||||
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Interest and other expense
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(40 | ) | (6 | ) | (48 | ) | (22 | ) | ||||||||
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Other income / (expense), net
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(39 | ) | (3 | ) | (43 | ) | (12 | ) | ||||||||
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Net loss
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$ | (13,346 | ) | $ | (4,751 | ) | $ | (30,500 | ) | $ | (16,664 | ) | ||||
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Net loss per common share –
Basic and diluted
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$ | (0.31 | ) | $ | (0.20 | ) | $ | (0.80 | ) | $ | (0.75 | ) | ||||
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Weighted-average number of common shares outstanding – basic and diluted
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43,444 | 24,106 | 38,061 | 22,104 | ||||||||||||
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Nine Months Ended
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||||||||
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September 30,
|
||||||||
|
2012
|
2011
|
|||||||
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Cash flows from operating activities:
|
||||||||
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Net loss
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$ | (30,500 | ) | $ | (16,664 | ) | ||
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Adjustments to reconcile net loss to net cash used in operating activities:
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Depreciation and amortization
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855 | 954 | ||||||
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Stock-based compensation and 401(k) match
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1,805 | 871 | ||||||
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Fair value adjustment of common stock warrants
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5,063 | (1,957 | ) | |||||
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Loss on sale or disposal of equipment
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36 | 16 | ||||||
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Changes in:
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Inventory
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(128 | ) | – | |||||
| Prepaid expenses and other current assets | (723 | ) | (42 | ) | ||||
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Accounts payable
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(903 | ) | (299 | ) | ||||
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Accrued expenses
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693 | (284 | ) | |||||
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Other assets
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– | 174 | ||||||
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Other liabilities and accrued interest
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(19 | ) | 57 | |||||
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Net cash used in operating activities
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(23,821 | ) | (17,174 | ) | ||||
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Cash flows from investing activities:
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Purchase of property and equipment
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(593 | ) | (88 | ) | ||||
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Net cash used in investing activities
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(593 | ) | (88 | ) | ||||
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Cash flows from financing activities:
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Proceeds from issuance of securities, net of expenses
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43,605 | 22,583 | ||||||
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Proceeds from exercise of common stock warrants
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6,741 | – | ||||||
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Repayment of equipment loans and capital lease obligations
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(57 | ) | (121 | ) | ||||
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Net cash provided by financing activities
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50,289 | 22,462 | ||||||
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Net increase in cash and cash equivalents
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25,875 | 5,200 | ||||||
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Cash and cash equivalents – beginning of period
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10,189 | 10,211 | ||||||
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Cash and cash equivalents – end of period
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$ | 36,064 | $ | 15,411 | ||||
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Supplementary disclosure of cash flows information:
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||||||||
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Interest paid
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$ | 10 | $ | 16 | ||||
|
o
|
On March 21, 2012, we completed a public offering of 16,071,429 shares of common stock, resulting in net proceeds to us (after underwriter fees and anticipated expenses) of approximately $42.1 million.
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o
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On March 7, 2012, we delivered a sales notice under our ATM Program to sell shares of common stock. We terminated the offering on March 8, 2012. In connection with that offering, we issued 350,374 shares of our common stock at an aggregate purchase price of approximately $1.6 million, resulting in net proceeds to us of approximately $1.5 million, after deducting commissions due to the sales agent.
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|
o
|
Holders of the 15-month warrants that we issued in February 2011 exercised warrants to purchase 2,238,000 shares of our common stock at an exercise price of $2.94 per share, resulting in proceeds to us of $6.6 million. The remaining 15-month warrants to purchase 2,762,000 shares expired unexercised on May 22, 2012.
|
|
o
|
Holders of the five-year warrants that we issued in February 2011 (February 2011 five-year warrants) exercised warrants to purchase 51,250 shares of our common stock at an exercise price ranging from $2.80 to $3.20 per share, resulting in proceeds to us of $162,000.
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|
o
|
We are engaged in discussions with potential strategic partners who could provide development and commercial expertise as well as financial resources (potentially in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses) to support the development of AEROSURF and SURFAXIN LS and, if approved, the introduction of these products in the European Union and various markets outside the United States.
|
|
o
|
I
f our efforts are successful, we believe that debt could be a component of our capital structure and financing plans. We could potentially enter into capital equipment financing facilities, revolving working capital lines of credit, term loans and other similar transactions to satisfy our working capital requirements.
|
|
o
|
In addition to potential debt arrangements, we believe that we may raise non-dilutive capital through a synthetic royalty arrangement that provides for the receipt of funds in exchange for a royalty to be paid on future revenues earned on our approved products. There can be no assurance, however, that we will enter into any synthetic royalty arrangement in the near future, if at all, or on favorable terms or otherwise.
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|
o
|
Our CEFF with Kingsbridge Capital Ltd. (Kingsbridge) allows us, in our discretion, to raise capital (subject to certain conditions, including volume limitations) at a time and in amounts we deem suitable to support our business plans. Based on the closing market price of our common stock on November 2, 2012 ($2.31) and assuming the issuance of all available shares, the potential availability under our CEFF is approximately $2.3 million. There can be no assurance, however, that the CEFF will be available at any time, or, even if available, that we will utilize the CEFF prior to its expiration in June 2013, or that we will undertake any financings or similar transactions, on favorable terms or otherwise.
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·
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Level 1 – Quoted prices in active markets for identical assets and liabilities.
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·
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Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
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·
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Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
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Fair Value
|
Fair value measurement using
|
|||||||||||||||
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September 30,
2012
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
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Assets:
|
||||||||||||||||
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Money Market
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$ | 33,377 | $ | 33,377 | $ | – | $ | – | ||||||||
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Certificate of Deposit
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400 | 400 | – | – | ||||||||||||
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Total Assets
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$ | 33,777 | $ | 33,777 | $ | – | $ | – | ||||||||
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Liabilities:
|
||||||||||||||||
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Common stock warrant liability
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$ | 11,923 | $ | – | $ | – | $ | 11,923 | ||||||||
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Fair Value
|
Fair value measurement using
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|||||||||||||||
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December 31,
2011
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
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Assets:
|
||||||||||||||||
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Money Market
|
$ | 9,377 | $ | 9,377 | $ | – | $ | – | ||||||||
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Certificate of Deposit
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400 | 400 | – | – | ||||||||||||
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Total Assets
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$ | 9,777 | $ | 9,777 | $ | – | $ | – | ||||||||
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Liabilities:
|
||||||||||||||||
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Common stock warrant liability
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$ | 6,996 | $ | – | $ | – | $ | 6,996 | ||||||||
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(in thousands)
|
Fair Value Measurements of
Common Stock Warrants Using
Significant Unobservable Inputs
(Level 3)
|
|||
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Balance at December 31, 2011
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$ | 6,996 | ||
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Exercise of warrants
(1)
|
(136 | ) | ||
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Change in fair value of common stock warrant liability
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5,063 | |||
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Balance at September 30, 2012
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$ | 11,923 | ||
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(1)
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See,
Note 6 – Common Stock Warrant Liability.
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(in thousands)
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Fair Value Measurements of
Common Stock Warrants Using
Significant Unobservable Inputs
(Level 3)
|
|||
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Balance at December 31, 2010
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$ | 2,469 | ||
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Issuance of common stock warrants
|
8,087 | |||
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Change in fair value of common stock warrant liability
|
(1,957 | ) | ||
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Balance at September 30, 2011
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$ | 8,599 |
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Significant Unobservable Input
Assumptions of Level 3 Valuations
|
September 30,
2012
|
December 31, 2011
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Historical Volatility
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62% -104% | 98% - 116% | ||||||
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Expected Term (in years)
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1.6 – 3.4 | 2.4 - 4.2 | ||||||
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Risk-free interest rate
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0.23% - 0.31% | 0.31% - 0.60% | ||||||
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Fair Value of Warrants
(in thousands)
|
||||||||||||||
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Issuance
Date
|
Number of
Warrant Shares
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Exercise
Price
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Warrant
Expiration
Date
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Issuance
Date
|
September 30,
2012
|
|||||||||
|
5/13/2009
|
466,667
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$ |
17.25
|
5/13/2014
|
$ 3,360
|
$ |
17
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|||||||
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2/23/2010
|
916,669
|
12.75
|
2/23/2015
|
5,701
|
497
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|||||||||
|
2/22/2011
|
4,948,750
|
2.80
|
2/22/2016
|
8,004
|
11,409
|
|||||||||
|
September 30,
|
||||||||
|
2012
|
2011
|
|||||||
|
Weighted-average expected volatility
|
110% | 112% | ||||||
|
Weighted-average expected term
|
4.8 years
|
4.9 years
|
||||||
|
Weighted-average risk-free interest rate
|
0.79% | 1.47% | ||||||
|
Expected dividends
|
– | – | ||||||
|
(in thousands)
|
Three Months Ended
|
Nine Months Ended
|
||||||||||||||
|
September 30,
|
September 30,
|
|||||||||||||||
|
2012
|
2011
|
2012
|
2011
|
|||||||||||||
|
Research & Development
|
$ | 150 | $ | 67 | $ | 388 | $ | 203 | ||||||||
|
Selling, General & Administrative
|
324 | 81 | 889 | 309 | ||||||||||||
|
Total
|
$ | 474 | $ | 148 | $ | 1,277 | $ | 512 | ||||||||
|
●
|
SURFAXIN
®
for the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants at High Risk for RDS
|
|
We have made progress in our efforts to prepare for the commercial introduction of SURFAXIN. We have successfully established our own specialty commercial and medical affairs organizations focused on neonatal respiratory critical care and consisting of highly-qualified commercial and medical affairs management, marketing and field force personnel and medical affairs liaisons. These teams are focused on neonatal respiratory critical care generally and are preparing to execute the commercial launch of SURFAXIN in the field and provide to the neonatal medical community medical and scientific information regarding our proprietary KL
4
surfactant and aerosol drug delivery technologies. We also expect that these organizations will be able to leverage the experience and relationships that we gain from the introduction of SURFAXIN to more effectively support the introductions of our KL
4
surfactant pipeline products, if approved, beginning with AEROSURF and SURFAXIN LS. We have completed training and deployed these teams in the field with the primary goal of engaging with hospitals that have NICUs, meeting the requirements to have SURFAXIN included on each hospital’s formulary (the approved list of drugs and therapeutics that the hospital will purchase) and securing the adoption of AFECTAIR devices.
In addition, to prepare for initiation of commercial activities, we have executed or are finalizing group purchasing organization and national account agreements, established supply chain distribution and warehouse arrangements, and enhanced our quality control and assurance infrastructure with the hiring of additional highly-qualified scientific, technical and analytical personnel and systems implementation. During a recent review of the results and processes related to the analytical testing and quality control of SURFAXIN drug product, we determined that one of our analytical chemistry methods used to assess drug product conformance to specifications requires improvement and that an update to product specifications will be necessary. We have proactively communicated these findings to the FDA, have initiated a plan to improve and validate the analytical method, and are implementing a plan to submit updated product specifications to the FDA. Based on the anticipated time required to improve the method, submit updated specifications, and await confirmation from the FDA, we anticipate that, if our plan is successful, the availability of SURFAXIN drug product will be delayed until early in the second quarter of 2013.
Although there can be no assurance that we will be successful in initiating the introduction of SURFAXIN as planned, if we are successful, the anticipated delay is not expected to have a material adverse effect on our business or financial position, in part, because our commercial launch plans for SURFAXIN during this period have always been to focus initially on formulary acceptance.
|
|
In addition, to facilitate proper preparation and administration of SURFAXIN drug product, we plan to make available to hospitals a dry block-warming device called a WARMING CRADLE
®
that is designed to warm drug vials at the same temperature that is designated in the SURFAXIN prescribing information. Accordingly, we are also working with hospitals to make WARMING CRADLE devices available for use in the NICU.
|
| ● |
AFECTAIR
®
|
|
AFECTAIR is our disposable ventilator circuit / patient interface connector and related componentry that introduces inhaled therapies directly to the patient interface and minimizes the number of connections in the regulatory circuit without compromising ventilatory support. We expect that our commercial and medical affairs organizations will support the planned commercial introduction of AFECTAIR in the United States (
see,
“– SURFAXIN”). With extensive relationships and contacts in the neonatal community, we expect that we will be able to gain important information, develop data, and clearly define the benefits that we expect this product will provide in the care of infants in the NICU and PICU. After we have initiated the launch of the AFECTAIR device for infants in the United States, we will focus on introducing this AFECTAIR device in markets outside the United States. Currently, we are exploring various opportunities that may be available to introduce our AFECTAIR device in the European Union, including potential strategic alliances and/or a network of medical device distributors. We currently expect to initiate the commercial introduction of the AFECTAIR device for infants in the European Union in mid-2013. We plan in the future to register our AFECTAIR devices in other major markets worldwide.
Should other AFECTAIR devices in development become available for commercial sale, we plan to assess the available methods to distribute those products and will determine at that time which approach would be more likely to maximize returns and result in the successful introduction of those AFECTAIR devices. There can be no assurance that we will successfully develop and introduce additional AFECTAIR devices in the future.
|
| ● |
AEROSURF
®
|
|
To advance our AEROSURF program, we continue our efforts to optimize the design of our CAG with our own engineering staff and third-party medical device experts. In June 2012, we entered into a Research and Development Services Agreement (“Agreement”) with Battelle Memorial Institute (“Battelle”). Battelle is the world’s largest nonprofit research and development organization, with over 20,000 employees at more than 100 locations globally, with a particular expertise in developing and integrating aerosol devices using innovative and advanced technologies. Pursuant to the Agreement, Battelle will provide technical support and expertise and assist in the development of device components in a series of phased programs focused on design, testing, and manufacturing of clinic-ready CAG devices for our planned AEROSURF phase 2 clinical trials, which we expect to initiate in late 2013. We have retained authority for all final decisions and all responsibility for the formulation, design, manufacture, assembly, packaging, marketing, distribution and sale of our products. The initial term of the Agreement is two years, unless terminated earlier pursuant to its terms. Either party may terminate the Agreement upon 15 days’ written notice to the other party for any good-faith reason, provided, that Battelle does not have the right to terminate the Agreement until it has substantially completed the then-current phase of the project. In addition, Battelle has the right to terminate the Agreement upon 15 days’ written notice to us if we are in material breach under the Agreement and the breach is not cured within the 15-day notice period. If fully implemented through all proposed phases, the Agreement could involve an investment by us of up to approximately $4.6 million. If our development work is successful, we plan to seek regulatory guidance for AEROSURF for the United States and Europe, finalize our development strategy and potentially initiate our Phase 2 clinical program after we have secured the necessary strategic alliances and/or capital.
|
| ● |
SURFAXIN LS™
|
|
We are also continuing our development activities for our lyophilized KL
4
surfactant, SURFAXIN LS, and are advancing the technology transfer of our manufacturing process to a third-party contract manufacturer with expertise in lyophilized formulations. We expect to have further interactions with the FDA regarding our SURFAXIN LS development program as well as obtain regulatory guidance with respect to our planned development program in Europe. We expect to initiate our clinical programs for SURFAXIN LS in late 2013, but only after we have developed a final development and regulatory strategy and after we have secured the necessary strategic alliances and/or capital.
|
|
(in thousands)
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
Research and Development Expenses
(1)
|
2012
|
2011
|
2012
|
2011
|
||||||||||||
|
Product development and manufacturing
|
$ | 4,258 | $ | 2,957 | $ | 11,298 | $ | 9,275 | ||||||||
|
Medical and regulatory operations
|
1,400 | 832 | 3,475 | 2,605 | ||||||||||||
|
Direct preclinical and clinical programs
|
85 | 192 | 709 | 1,336 | ||||||||||||
|
Total Research & Development Expenses
|
$ | 5,743 | $ | 3,981 | $ | 15,482 | $ | 13,216 | ||||||||
|
(1)
|
Certain 2011 expenses have been reclassified to conform to the 2012 presentation.
|
|
SURFAXIN
®
|
|
●
|
Preclinical data from a study assessing SURFAXIN in the well-established preterm lamb model of RDS was published in
Pediatric Research
, a peer-reviewed medical journal widely distributed among neonatologists and other neonatal health care professionals. The study investigators concluded that early intervention with SURFAXIN may mitigate progression of pulmonary pathophysiological consequences of RDS when compared with animal-derived surfactants, Curosurf
®
(poractant alfa, Chiesi Farmaceutici, Parma, Italy) and Survanta
®
(beractant, Abbott Laboratories, Columbus, OH). According to the study findings, subjects receiving surfactant replacement therapy (SRT) using SURFAXIN had improved sustained oxygenation and lower ventilatory pressure requirements (p < 0.05) compared with no SRT or SRT using Curosurf or Survanta. In addition, SURFAXIN treatment resulted in an attenuated lung and systemic inflammatory response as well as a more uniform and robust preservation of lung structural integrity. Investigators found that the lungs of preterm lambs that were treated with SURFAXIN were more homogenously expanded both within and between lung regions, a finding that is suggestive of more uniform distribution of surfactant throughout the lung. Investigators also found that the lungs of SURFAXIN treated lambs had less cellular debris and fewer inflammatory cells when compared with the lungs of non-treated lambs and the lambs treated with Curosurf and Survanta. The investigators also noted lower levels of inflammatory mediators following treatment with SURFAXIN compared with negative controls as well as both animal-derived surfactants.
|
|
●
|
Data from a new pharmacoeconomic analysis were presented at the 2012 Pediatric Academies Society Annual Conference (2012 PAS, April 28 – May 1, 2012) in Boston, MA. The analysis demonstrates that the lower rate of reintubation previously observed in infants treated with SURFAXIN, when compared with infants treated with Curosurf and Survanta, also resulted in a potential hospital cost savings of $160,000 to $252,000 per 100 infants. As previously reported
in the
Journal of Neonatal- Perinatal Medicine
(Volume 4, Number 2, 2011) in a manuscript entitled “Reintubation and risk of morbidity and mortality in preterm infants after surfactant replacement therapy” (Guardia et al.), retrospective analysis of data from our two Phase 3 trials, which involved a total of 1546 patients, shows that the reintubation rate in SURFAXIN-treated infants ranged from 33 to 35 percent and was significantly lower (
p
< 0.05) than Curosurf-treated infants (47 percent), the current global market leader, and Survanta-treated infants (43 percent). Although the retrospective analysis also demonstrates that reintubation results in an increase in morbidities, such as bronchopulmonary dysplasia and air leak, the estimated cost savings from the pharmacoeconomic modeling reported at the 2012 PAS Conference does not include the additional costs associated with these morbidities. We anticipate that additional analyses will be conducted and potentially presented at congresses in 2012 and 2013.
|
|
|
SURFAXIN LS™
|
|
●
|
Preclinical data from a study of SURFAXIN LS were published in the May 2012 issue of
Pediatric Research.
The objective of the study was to compare the effects of SURFAXIN LS and Curosurf on pulmonary function, as well as the physiologic reactions to surfactant administration in preterm lambs with RDS. The results of this study, which were previously presented at the 2010 Pediatric Academic Societies Annual Congress in May 2010, demonstrate that both surfactants significantly improved pulmonary function (p < 0.05). However, lambs treated with SURFAXIN LS required significantly lower mechanical ventilator pressures to maintain pulmonary function compared with Curosurf-treated lambs (p < 0.05); in contrast to lambs treated with SURFAXIN LS, lambs treated with Curosurf experienced significant reductions in heart rate and rapidly increased brain oxygenation during the peridosing period (p < 0.05); and the investigators concluded that SURFAXIN LS may enable ventilation at lower mean airway pressures, thereby potentially reducing the incidence of chronic lung disease, and as such may be an effective substitute for the currently-marketed surfactant products.
|
|
|
AFECTAIR
®
|
|
●
|
Data from performance studies conducted using the AFECTAIR device for infants were presented at 2012 PAS. The study evaluated the difference between the calculated inhaled dose and the actual delivered dose in an
in vitro
simulated infant ventilation system using the AFECTAIR device for infants as compared to standard of care. Albuterol was aerosolized with a jet nebulizer and delivered using both the AFECTAIR device for infants and standard of care. The investigators observed a 10-14 fold increase in the
in vitro
inhaled dose of albuterol at various ventilation conditions when using the AFECTAIR device for infants compared with standard of care. The study concluded that the AFECTAIR device for infants delivered a higher amount of albuterol
in vitro
that was more representative of the calculated inhaled dose of albuterol compared with standard of care, and that clinical use of the AFECTAIR device for infants may allow for a more accurate approximation of actual delivered dose of inhaled therapies when targeting a calculated inhaled dose for critical care patients.
|
|
●
|
Data from two studies were presented at the 11
th
European Congress on Pediatric and Neonatal Ventilation in Switzerland in June 2012. The first study simulated neonatal mechanical ventilation conditions using an
in vitro
model and compared delivery of aerosolized inhaled nitrous oxide using the AFECTAIR device for infants with standard of care. The study concluded that use of the AFECTAIR device for infants resulted in the achievement of target nitric oxide concentrations using less nitric oxide when compared to the SoC delivery apparatus. The second study was conducted in an
in vitro
model of neonatal mechanical ventilation conditions and compared the AFECTAIR device for infants with a conventional wye connector. The study found that use of the AFECTAIR device for infants resulted in improved delivery of aerosolized albuterol sulfate, including a nine-fold increase in delivered dose under simulated CPAP conditions, a 14-fold increase in delivered dose under simulated mechanical ventilation conditions, and a smaller difference in particle size distribution between aerosol output from the nebulizer and aerosol output from the patient interface.
KL
4
surfactant technology
|
|
●
|
In September 2012, we announced the initiation of four research projects that are partially funded though various U.S. government-sponsored, biodefense-related initiatives and designed to explore the potential use of our proprietary KL
4
surfactant for the prevention and treatment of acute lung injury (ALI), including:
●
A two-year, Small Business Innovation Research (SBIR) Phase I award of $600,000 from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) Center for Medical Counter Measures Against Radiation and Nuclear Threats to assess the ability of KL
4
surfactant to mitigate the effects of acute radiation exposure to the lung, including acute pneumonitis and delayed lung injury. We are collaborating with the University of Pennsylvania on this project.
●
A collaboration with the University of Rochester Center for Medical Countermeasures against Radiation, an NIH/NIAID-funded Center of Excellence, to evaluate the use of KL
4
surfactant to protect the lung in a radiation-induced, multi-organ dysfunction animal model.
●
A collaboration with the CounterACT Efficacy Research Facility (CERF), supported under an Interagency Agreement with the Department of Defense through the NIH Office of the Director and the Countermeasures Against Chemical Threats (CounterACT) program. The CounterACT program supports basic, translational, and clinical research aimed at the discovery and/or identification of better therapeutic and diagnostic countermeasures against chemical threat agents, and facilitates their movement through the regulatory process. We plan to explore the utility of KL
4
surfactant for the treatment of chemical-induced ALI in a chemical-induced ALI model currently being developed by the CERF.
●
A program under NIAID’s Animal Models of Infectious Disease program to investigate the use of KL
4
surfactant as a treatment for influenza-induced ALI with NIAID-funded contractors.
|
|
●
|
The United States Patent and Trademark Office (USPTO) granted us a patent entitled “Pulmonary Surfactant Formulations and Methods for Promoting Mucus Clearance.” The claims of the patent (U.S. Patent Number 8,221,772) provide coverage for a method for promoting mucus clearance in a patient with a pulmonary condition characterized by excessive mucus secretion or impaired mucus clearance such as CF, COPD, bronchiectasis, ciliary diskinesia, and sinusitis. The patent term expires in September 2027.
|
|
o
|
On March 21, 2012, we completed a public offering of 16,071,429 shares of common stock, resulting in net proceeds to us (after underwriter fees and anticipated expenses) of approximately $42.1 million.
|
|
o
|
On March 7, 2012, we delivered a sales notice under our ATM Program to sell shares of common stock. We terminated the offering on March 8, 2012. In connection with that offering, we issued 350,374 shares of our common stock at an aggregate purchase price of approximately $1.6 million, resulting in net proceeds to us of approximately $1.5 million, after deducting commissions due to the sales agent.
|
|
o
|
Holders of the 15-month warrants that we issued in February 2011 exercised warrants to purchase 2,238,000 shares of our common stock at an exercise price of $2.94 per share, resulting in proceeds to us of $6.6 million. The remaining 15-month warrants to purchase 2,762,000 shares expired unexercised on May 22, 2012.
|
|
o
|
Holders of the five-year warrants that we issued in February 2011 (February 2011 five-year warrants) exercised warrants to purchase 51,250 shares of our common stock at an exercise price ranging from $2.80 to $3.20 per share, resulting in proceeds to us of $162,000.
|
|
o
|
We are engaged in discussions with potential strategic partners who could provide development and commercial expertise as well as financial resources (potentially in the form of upfront payments, milestone payments, commercialization royalties and a sharing of research and development expenses) to support the development of AEROSURF and SURFAXIN LS and, if approved, the introduction of these products in the European Union and various markets outside the United States.
|
|
o
|
I
f our efforts are successful, we believe that debt could be a component of our capital structure and financing plans. We could potentially enter into capital equipment financing facilities, revolving working capital lines of credit, term loans and other similar transactions to satisfy our working capital requirements.
|
|
o
|
In addition to potential debt arrangements, we believe that we may raise non-dilutive capital through a synthetic royalty arrangement that provides for the receipt of funds in exchange for a royalty to be paid on future revenues earned on our approved products. There can be no assurance, however, that we will enter into any synthetic royalty arrangement in the near future, if at all, or on favorable terms or otherwise.
|
|
o
|
Our CEFF with Kingsbridge Capital Ltd. (Kingsbridge) allows us, in our discretion, to raise capital (subject to certain conditions, including volume limitations) at a time and in amounts we deem suitable to support our business plans. Based on the closing market price of our common stock on November 2, 2012 ($2.31) and assuming the issuance of all available shares, the potential availability under our CEFF is approximately $2.3 million. There can be no assurance, however, that the CEFF will be available at any time, or, even if available, that we will utilize the CEFF prior to its expiration in June 2013, or that we will undertake any financings or similar transactions, on favorable terms or otherwise.
|
|
(In millions)
|
Nine Months Ended
September 30,
|
|||||||
|
2012
|
2011
|
|||||||
|
Financings pursuant to common stock offerings
|
$ | 42.1 | $ | 21.6 | ||||
|
Financings under the ATM Program
|
1.5 | – | ||||||
|
Exercise of warrants
|
6.7 | – | ||||||
|
Financings under the CEFF
|
– | 1.0 | ||||||
|
Debt service payments
|
(0.0 | ) | (0.1 | ) | ||||
|
Cash flows from financing activities, net
|
$ | 50.3 | $ | 22.5 | ||||
|
ITEM 4.
|
|
ITEM 1.
|
|
ITEM 1A.
|
|
|
·
|
the number of hospitals and critical care centers that agree to place SURFAXIN drug product on their formulary lists and the length of time required to achieve broad formulary acceptance;
|
|
|
·
|
the number of hospitals and critical care centers that agree to include AFECTAIR devices on their approved materials list and the degree of use of AFECTAIR devices for critical care patients;
|
|
|
·
|
the effectiveness of our marketing, sales and medical affairs organizations and their ability to (a) accurately describe SURFAXIN consistent with its approved labeling, (b) educate and provide critical care providers and hospitals with medical and scientific education and information concerning our products, and (c) educate critical care providers and hospitals regarding the potential utility of AFECTAIR devices;
|
|
|
·
|
our ability to gain access to the entire market with our commercial organizations and, if we so determine, through any third-party distributor arrangements;
|
|
|
·
|
the safety and efficacy of SURFAXIN, our ability to provide hospitals acceptable evidence of the safety and efficacy of SURFAXIN, and the perceived advantages of SURFAXIN and AFECTAIR over alternative treatment methods;
|
|
|
·
|
the budget impact of adding our products and devices to relevant formulary and medical device hospital lists and the availability, cost and potential advantages of alternative treatments, including less expensive generic drugs and other competitive products;
|
|
|
·
|
the claims, limitations, warnings and other information that appear in the package insert and labeling of SURFAXIN drug product;
|
|
|
·
|
the willingness of third-party payers, including government payers, to provide coverage and reimbursements to patients, physicians and other providers who wish to prescribe and use our products;
|
|
|
·
|
our ability to secure and maintain regulatory marketing approvals from the United States and foreign regulatory authorities;
|
|
|
·
|
the number of infants who are diagnosed with respiratory distress syndrome (RDS) and the number treated with SURFAXIN;
|
|
|
·
|
the degree of acceptance of AFECTAIR devices as the standard of care for delivery of inhaled therapies for patients requiring ventilatory support;
|
|
|
·
|
our ability to finalize development of AFECTAIR devices for use with children and adults, and for various types of aerosol generating devices;
|
|
|
·
|
the growth of commercial sales; and
|
|
|
·
|
our ability to meet commercial demand for SURFAXIN and AFECTAIR, including through maintenance of commercial supplies of our active drug substances and other excipients, and manufacturing capabilities, by ourselves and through third-party manufacturers; and commercial inventory supplies of our medical device products
.
|
|
|
·
|
the safety and efficacy of our products as perceived by the medical community, regulatory agencies and insurers and other payers, on both a short and long-term basis;
|
|
|
·
|
the potential advantages over alternative treatments;
|
|
|
·
|
the relative convenience and ease of administration;
|
|
|
·
|
the prevalence and severity of any adverse events, including any unexpected adverse events of which we become aware;
|
|
|
·
|
the willingness of physicians to utilize our products;
|
|
|
·
|
the degree to which the market believes that we are able to manufacture our products and produce supply sufficient to meet market demand;
|
|
|
·
|
the rate of preterm births;
|
|
|
·
|
the availability of different size drug vials and medical devices to meet the specific needs of healthcare practitioners;
|
|
|
·
|
the pharmacoeconomic benefits (which are determined by comparing, among other things, the cost and effects of a product when compared to different treatment options) and cost-effectiveness of our products;
|
|
|
·
|
the willingness of the target hospitals to accept and employ the WARMING CRADLE
®
dry block heater;
|
|
|
·
|
the effectiveness of our marketing strategy and distribution support; and
|
|
|
·
|
the sufficiency of coverage or reimbursement by third parties.
|
|
●
|
our distributors or collaborators may require that we transfer to them important rights to our products and/or product candidates;
|
|
●
|
we may not be able to control the amount and timing of resources that our distributors or collaborators devote to the commercialization of our products;
|
|
●
|
if our distributors or collaborators fail to perform their obligations under our arrangements to our satisfaction, we may not achieve our projected sales and our revenues would suffer. We also may incur additional expense to terminate such arrangements and to identify and enter into arrangements with replacement distributors or collaborators;
|
|
●
|
our distributors or collaborators may experience financial difficulties; and
|
|
●
|
business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to perform its obligations under any arrangement, which would adversely affect our business.
|
|
|
·
|
the number of clinical sites;
|
|
|
·
|
the size of the patient population;
|
|
|
·
|
the proximity of patients to the clinical sites;
|
|
|
·
|
the eligibility and enrollment criteria for the study;
|
|
|
·
|
the willingness of patients or their parents or guardians to participate in the clinical trial;
|
|
|
·
|
the existence of competing clinical trials;
|
|
|
·
|
the existence of alternative available products; and
|
|
|
·
|
geographical and geopolitical considerations.
|
|
●
|
the need to make necessary modifications to qualify and validate a facility;
|
|
●
|
difficulties with production and yields, including manufacturing and completing all required release testing on a timely basis to meet demand;
|
|
●
|
availability of raw materials and supplies;
|
|
●
|
quality control and assurance problems related to, among other things, the release and stability testing of our drug product, or materials and drug substances;
|
|
●
|
casualty damage to a facility; and
|
|
●
|
shortages of qualified personnel.
|
|
●
|
equipment malfunctions or failures;
|
|
●
|
technology malfunctions;
|
|
●
|
work stoppages or slowdowns;
|
|
●
|
damage to or destruction of the facility;
|
|
●
|
regional power shortages; and
|
|
●
|
product tampering.
|
|
|
·
|
developing products;
|
|
|
·
|
undertaking preclinical testing and human clinical trials;
|
|
|
·
|
obtaining FDA and other regulatory approvals or products; and
|
|
|
·
|
manufacturing and marketing products.
|
|
OTHER INFORMATION
|
|
ITEM 6.
|
|
Discovery Laboratories, Inc.
|
|||
|
(Registrant)
|
|||
|
Date: November 14, 2012
|
By:
|
/s/ W. Thomas Amick | |
|
W. Thomas Amick, Chairman of the Board and
|
|||
| Chief Executive Officer | |||
|
Date: November 14, 2012
|
By:
|
/s/ John G. Cooper | |
|
John G. Cooper
|
|||
|
President and Chief Financial Officer (Principal Financial Officer)
|
|
Exhibit No.
|
Description
|
Method of Filing
|
||
|
3.1
|
Amended and Restated Certificate of Incorporation of Discovery Laboratories, Inc. (Discovery), as amended as of and October 3, 2011
|
Incorporated by reference to Exhibit 3.1 to Discovery's Form 8-K, as filed with
the SEC on October 3, 2011.
|
||
|
3.2
|
Certificate of Designations, Preferences and Rights of Series A Junior Participating Cumulative Preferred Stock of Discovery, dated February 6, 2004
|
Incorporated by reference to Exhibit 2.2 to Discovery’s Form 8-A, as filed with the SEC on February 6, 2004.
|
||
|
3.3
|
Amended and Restated By-Laws of Discovery, as amended effective September 3, 2009
|
Incorporated by reference to Exhibit 3.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on September 4, 2009.
|
||
|
4.1
|
Shareholder Rights Agreement, dated as of February 6, 2004, by and between Discovery and Continental Stock Transfer & Trust Company
|
Incorporated by reference to Exhibit 10.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 6, 2004.
|
||
|
4.2
|
Warrant Agreement dated May 22, 2008 by and between Kingsbridge Capital Limited and Discovery
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K as filed with the SEC on May 28, 2008.
|
||
|
4.3
|
Warrant Agreement dated December 12, 2008 by and between Kingsbridge Capital Limited and Discovery
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on December 15, 2008.
|
||
|
4.4
|
Form of Stock Purchase Warrant issued in May 2009
|
Incorporated by reference to Exhibit 10.3 to Discovery’s Current Report on Form 8-K, as filed with the SEC on May 8, 2009.
|
||
|
4.5
|
Form of Stock Purchase Warrant issued in February 2010
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 18, 2010.
|
||
|
4.6
|
Warrant Agreement, dated as of April 30, 2010, by and between Discovery and PharmaBio
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on April 28, 2010.
|
||
|
4.7
|
Warrant Agreement dated June 11, 2010 by and between Kingsbridge Capital Limited and Discovery
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on June 14, 2010.
|
||
|
4.8
|
Form of Five-Year Warrant issued on June 22, 2010
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on June 17, 2010.
|
|
Exhibit No.
|
Description
|
Method of Filing
|
||
|
4.9
|
Warrant Agreement, dated as of October 12, 2010, by and between Discovery and PharmaBio
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on October 13, 2010.
|
||
|
4.10
|
Form of Voting Agreement between RSA Holders and Discovery dated November 12, 2010
|
Incorporated by reference to Exhibit 4.13 to Discovery’s Annual Report on Form 10-KSB for the year ended December 31, 2010, as filed with the SEC on March 31, 2011.
|
||
|
4.11
|
Form of Five-Year Warrant issued on February 22, 2011
|
Incorporated by reference to Exhibit 4.1 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 16, 2011.
|
||
|
4.12
|
Form of Short Term Warrant issued on February 22, 2011
|
Incorporated by reference to Exhibit 4.2 to Discovery’s Current Report on Form 8-K, as filed with the SEC on February 16, 2011.
|
||
|
Certification of Chief Executive Officer and Principal Executive Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
Filed herewith.
|
|||
|
Certification of Chief Financial Officer and Principal Accounting Officer pursuant to Rule 13a-14(a) of the Exchange Act
|
Filed herewith.
|
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|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith.
|
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|
101.1
|
The following consolidated financial
statements from the Discovery Laboratories,
Inc. Quarterly Report on Form 10-Q for the
quarter ended September 30, 2012, formatted in Extensive Business Reporting Language
(“XBRL”): (i) Balance Sheets as of
September 30, 2012 (unaudited) and December 31, 2011, (ii) Statements of Operations (unaudited) for the three and nine months ended September 30. 2012 and September 30, 2011, (iii) Statements of Cash Flows (unaudited) for the nine months ended September 30, 2012 and September 30, 2011, and (v) Notes to consolidated financial statements.
|
|||
|
101.INS
|
Instance Document
|
Filed herewith.
|
|
Exhibit No.
|
Description
|
Method of Filing
|
||
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
Filed herewith.
|
||
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
Filed herewith.
|
||
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
Filed herewith.
|
||
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
Filed herewith.
|
||
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
Filed herewith.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|