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(Mark One)
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þ
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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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Large accelerated filer
o
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Accelerated filer
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Non-accelerated filer
o
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Smaller reporting company
þ
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(Do not check if a smaller reporting company)
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ITEM 2.
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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•
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ProctiGard™ received 510(K) marketing clearance from the FDA on July 22, 2014 for the treatment of symptomatic management of rectal mucositis. ProctiGard is our product for the treatment of radiation proctitis, a frequent side effect of radiation treatment to the pelvic region. Radiation proctitis, or RP, is the inflammation and damage to the lower portion of the colon after exposure to x-rays or ionizing radiation as part of radiation therapy. RP is most common after treatments for cancer, such as cervical, colon and prostate cancer. RP can be acute, occurring within weeks of initiation of therapy, or can occur months or years after treatment. We intend to commercialize ProctiGard in a manner similar to the commercialization of MuGard, which may include confirmatory clinical trials, with the objective of commercialization in collaboration with marketing partners globally.
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•
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We are also developing additional products using our proprietary mucoadhesive hydrogel technology as a mucoprotectant and/or delivery vehicle, as well as our vitamin B-12 mediated delivery technology.
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Compound
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Originator
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Technology
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Indication
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Clinical
Stage (1)
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MuGard
®
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PlasmaTech
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Mucoadhesive
liquid
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Mucositis
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- Launched in U.S.
- Licensed to AMAG:
U.S. rights
- Licensed to Norgine:
European Union rights
- Licensed to RHEI:
China rights and other
SE Asian countries
- Licensed to Hanmi:
South Korea rights
- Licensed to Norgine:
Australia & New
Zealand rights
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Proctigard™
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PlasmaTech
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Mucoadhesive
hydrogel
technology
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Radiation proctitis
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FDA clearance 7/22/14
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Alpha 1 Protease Inhibitor (A1PI)
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Licensor
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Proprietary
biological
processing
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Various
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Process validation
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Intravenous immune globulin
(IVIG)
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Licensor
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Proprietary
biological
processing
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Various
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Process validation
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·
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C-1-esterase inhibitor treats hereditary angioma (HAE). Its genetic incidence: 1:10,000 − 1:50,000.
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Protein C is used to treat venous thromboembolic events. Prevalence of Protein C deficiency is 0.2 − 0.5%.
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Antithrombin III inactivates thrombin and is used to treat thrombotic disorders. Its deficiency occurs in 1:2000 − 1:5000 in a normal population, but can also be acquired as a result of various diseases.
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·
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increased development work on our new product A1PI ($279,000);
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increased salary and related costs ($99,000) from the rehiring of scientific staff;
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offset by decreased stock based compensation expense ($59,000); and
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other net decreases in research spending ($10,000).
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increased salary and related costs ($343,000) from hiring additional general and administrative staff;
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increased legal fees ($249,000);
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increased investor relations fees ($235,000);
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offset by decreased stock based compensation expense ($562,000); and
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other net increases in general and administrative expenses ($32,000)
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ITEM 3.
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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ITEM 2.
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UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
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ITEM 6.
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EXHIBITS.
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Exhibits:
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3.1
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Amendment to Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 8-K filed January 5, 2015)
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3.2
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Amendment to Bylaws (Incorporated by reference to Exhibit 3.1 of our Form 8-K filed March 5, 2015)
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31.1
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Principal Executive Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Principal Financial Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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32.1*
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Principal Executive Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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32.2*
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Principal Financial Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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101**
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The following materials formatted in XBRL (Extensible Business Reporting Language): (i) Consolidated Balance Sheets at March 31, 2015 and December 31, 2014, (ii) Consolidated Statements of Operations for the months ended March 31, 2015 and March 31, 2014, (iii) Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2015, (iv) Consolidated Statements of Cash Flows for the three months ended March 31, 2015 and March 31, 2014, and (v) Notes to Consolidated Financial Statements, tagged as blocks of text.
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Date:
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May 14, 2015
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By:
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/s/ Steven H. Rouhandeh
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Steven H. Rouhandeh
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Executive Chairman
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(Principal Executive Officer)
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Date:
May 14, 2015
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By:
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/s/ Stephen B. Thompson
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Stephen B Thompson
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Vice President Finance
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(Principal Accounting Officer)
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ASSETS
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March 31, 2015
(unaudited)
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December 31,
2014
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Current assets
Cash and cash equivalents
Receivables
Prepaid expenses and other current assets
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$
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7,948,000
144,000
98,000
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$
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11,520,000 35,000 - | ||||
| Total current assets | 8,190,000 | 11,555,000 | ||||||
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Property and equipment, net
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11,000 | 4,000 | ||||||
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Licensed technology, net
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4,875,000 | 4,991,000 | ||||||
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Other assets
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41,000 | 32,000 | ||||||
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Total assets
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$ | 13,117,000 | $ | 16,582,000 | ||||
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Current liabilities
Accounts payable
Short-term notes payable
Current portion of deferred revenue
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$
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638,000
-
602,000
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$
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1,896,000 400,000 602,000 | ||||
| Total current liabilities | 1,240,000 | 2,898,000 | ||||||
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Payable due Licensor
Long-term deferred revenue
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4,000,000 4,718,000 | 4,000,000 4,868,000 | ||||||
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Total liabilities
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9,958,000 | 11,766,000 | ||||||
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Commitments and contingencies
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Stockholders' equity
Common stock - $.01 par value; authorized 200,000,000 shares;
issued, 19,998,801 at March 31, 2015 and 19,960,801 at
December 31, 2014
Additional paid-in capital
Accumulated deficit
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200,000
301,033,000
(298,074,000)
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200,000
300,690,000
(296,074,000
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) | |||||
| Total stockholder's equity | 3,159,000 | 4,186,000 | ||||||
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Total liabilities and stockholders' equity
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$ | 13,117,000 | $ | 16,582,000 | ||||
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Three Months ended March 31,
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2015
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2014
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Revenues
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License revenues
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$ | 151,000 | $ | 146,000 | ||||
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Royalties
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107,000 | 62,000 | ||||||
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Total revenues
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258,000 | 208,000 | ||||||
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Expenses
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Research and development
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453,000 | 144,000 | ||||||
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General and administrative
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1,689,000 | 1,392,000 | ||||||
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Depreciation and amortization
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118,000 | - | ||||||
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Total expenses
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2,260,000 | 1,536,000 | ||||||
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Loss from operations
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(2,002,000 | ) | (1,328,000 | ) | ||||
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Interest and miscellaneous income
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3,000 | 8,000 | ||||||
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Interest and other expense
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(1,000 | ) | (122,000 | ) | ||||
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Gain on change in fair value of derivative – preferred stock
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- | 583,000 | ||||||
| 2,000 | 469,000 | |||||||
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Net loss
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(2,000,000 | ) | (859,000 | ) | ||||
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Less preferred stock dividends
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- | 725,000 | ||||||
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Net loss allocable to common stockholders
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$ | (2,000,000 | ) | $ | (1,584,000 | ) | ||
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Basic and diluted loss per common share
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$ | (0.10 | ) | $ | (3.06 | ) | ||
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Weighted average number of common shares outstanding
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19,983,751 | 517,539 | ||||||
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Common Stock
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||||||||||||||||||||
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Shares
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Amount
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Additional
paid-in
capital
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Accumulated
deficit
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Total stockholders’
equity
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||||||||||||||||
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Balance December 31, 2014
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19,960,801 | $ | 200,000 | $ | 300,690,000 | $ | (296,074,000 | ) | $ | $4,816,000 | ||||||||||
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Common stock issued
to employees
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10,000 | - | 32,000 | - | 32,000 | |||||||||||||||
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Common stock issued for
services
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28,000 | - | 87,000 | - | 87,000 | |||||||||||||||
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Stock option compensation
expense
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- | - | 224,000 | - | 224,000 | |||||||||||||||
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Net loss
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- | - | - | (2,000,000 | ) | (2,000,000 | ) | |||||||||||||
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Balance March 31, 2015
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19,998,801 | $ | 200,000 | $ | 301,033,000 | $ | (298,074,000 | ) | $ | 3,159,000 | ||||||||||
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Three Months ended March 31,
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||||||||
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2015
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2014
|
|||||||
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Cash flows from operating activities:
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Net loss
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$ | (2,000,000 | ) | $ | (859,000 | ) | ||
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Adjustments to reconcile net loss to cash used
in operating activities:
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(Gain) on change in fair value of derivative –
preferred stock
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- | (583,000 | ) | |||||
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Depreciation and amortization
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118,000 | - | ||||||
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Stock option compensation expense
Stock issued to directors, employees and consultants
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224,000 32,000 | 795,000 - | ||||||
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Stock issued for services
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87,000 | 75,000 | ||||||
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Change in operating assets and liabilities:
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||||||||
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Receivables
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(109,000 | ) | 15,000 | |||||
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Prepaid expenses and other current assets
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(98,000 | ) | (5,000 | ) | ||||
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Other assets
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(9,000 | ) | - | |||||
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Accounts payable and accrued expenses
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(1,258,000 | ) | 212,000 | |||||
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Interest payable on dividends
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- | 122,000 | ||||||
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Deferred revenue
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(150,000 | ) | 103,000 | |||||
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Net cash used in operating activities
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(3,163,000 | ) | (125,000 | ) | ||||
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Cash flows from financing activities:
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Capital expenditures
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(9,000 | ) | - | |||||
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Net cash used in investing activities
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(9,000 | ) | - | |||||
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Cash flows from financing activities:
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Payment of short-term debt
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(400,000 | ) | - | |||||
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Net cash used in financing activities
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(400,000 | ) | - | |||||
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Net decrease in cash and cash equivalents
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(3,572,000 | ) | (125,000 | ) | ||||
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Cash and cash equivalents at beginning of period
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11,520,000 | 424,000 | ||||||
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Cash and cash equivalents at end of period
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$ | 7,948,000 | $ | 299,000 | ||||
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Supplemental cash flow information:
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||||||||
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Cash paid for interest
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$ | - | $ | - | ||||
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Supplemental disclosure of noncash transactions:
|
||||||||
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Preferred stock dividends in dividends payable
|
$ | - | $ | 725,000 | ||||
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(1)
|
Interim Financial Statements
|
|
March 31, 2015
|
December 31, 2014
|
|||||||||||||||
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Gross
carrying
value
|
Accumulated
amortization
|
Gross
carrying
value
|
Accumulated
Amortization
|
|||||||||||||
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Amortizable intangible assets
Licensed technology
|
$ | 5,000 | $ | 125 | $ | 5,000 | $ | 9 | ||||||||
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Three months ended
March 31
,
|
||||||||
|
2015
|
2014
|
|||||||
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Research and development
|
$ | 18 ,000 | $ | 77 ,000 | ||||
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General and administrative
|
206 ,000 | 718 ,000 | ||||||
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Stock-based compensation expense
included in operating expense
|
$ | 224 ,000 | $ | 795 ,000 | ||||
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 |
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| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|