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| Delaware | 86-0585310 |
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
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Title of each class
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Name of each exchange on which registered
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Common Stock, par value $.0005 per share
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OTCQB
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PAGE
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Item
1.
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Business
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·
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We ceased clinical development of AZX100, formerly our principal drug candidate, in dermal scarring. Certain pre-clinical, manufacturing and regulatory projects related to AZX100 that are either required from a statutory perspective or have been contracted will continue to their completion.
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·
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We ceased all activities related to the development of TP508, our initial drug candidate, and returned the patent and other intellectual property we owned related to TP508 to the original licensor, the University of Texas Medical Branch at Galveston, Texas. We no longer have any interest in or rights to TP508.
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Item
1A.
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Risk Factors
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·
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the impact of our plan to preserve cash during ongoing partnering efforts, including the reduction from eighteen employees to two employees and additional steps taken towards a virtual operating model;
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·
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unfavorable results of our product candidate development efforts;
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·
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unfavorable results of our pre-clinical or clinical testing;
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·
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delays in obtaining, or failure to obtain FDA approvals;
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·
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increased regulation by the FDA and other agencies;
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·
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the introduction of competitive products;
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·
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impairment of license, patent or other proprietary rights;
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·
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the impact of present and future collaborative, partnering or development agreements or the lack thereof;
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·
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failure to successfully implement our drug development strategy;
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·
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failure to obtain additional funds required to complete clinical trials and supporting research and production efforts necessary to obtain FDA approval for our product candidates; and
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·
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effect of the ongoing
qui tam
litigation on our stock price, liquidity, and our ability to execute corporate or other transactions, or our ability to continue operations.
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AZX100:
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·
Scarring
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IND filed in 2007, Phases 1a and 1b safety studies completed in 2008. Phase 2 studies on keloid scar revision and dermal scarring following shoulder surgery commenced in the first quarter of 2009. Phase 2 studies in keloid scar revision were completed and results reported in 2010 and our Phase 2 study in dermal scarring following shoulder surgery was completed and results reported in 2011.
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·
Pulmonary Fibrosis
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Pre-clinical studies
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·
Epidural/Peridural Fibrosis (Spine)
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Pre-clinical studies
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AEM-28
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·
Homozygous Familial Hypercholesterolemia
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Pre-clinical studies
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·
Severe Refractory Hypercholesterolemia
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Pre-clinical studies
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·
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the FDA finds some or all of our product candidates ineffective or unsafe;
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·
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we do not receive necessary regulatory approvals;
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·
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we are unable to get some or all of our product candidates to market in a timely manner;
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·
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we are not able to produce our product candidates in commercial quantities at reasonable costs;
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·
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our products undergo post-market evaluations resulting in marketing restrictions or withdrawal of our products; or
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·
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the patients, insurance and/or physician community does not accept our products.
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·
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adverse or ambiguous results;
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·
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undesirable side effects which delay or extend the trials;
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·
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inability to locate, recruit, qualify and retain a sufficient number of patients for our trials;
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·
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regulatory delays or other regulatory actions;
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·
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difficulties in obtaining sufficient quantities of the particular product candidate or any other components needed for our pre-clinical testing or clinical trials;
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·
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change in the focus of our development efforts;
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·
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re-evaluation of our clinical development strategy; and
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·
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lack of sufficient funds to pay for development costs.
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·
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pay substantial damages;
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·
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stop using our technologies;
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·
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stop certain research and development efforts;
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·
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develop non-infringing products or methods; and
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·
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obtain one or more licenses from third parties.
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·
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announcement of the results of, or delays in, preclinical and clinical studies;
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·
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fluctuations in our operating results;
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·
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developments in litigation to which we or a competitor is subject;
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·
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announcements and timing of potential partnering, development collaboration or licensing transactions, merger, acquisitions, divestitures, capital raising activities or issuance of preferred stock;
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·
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announcements of technological innovations or new products by us or our competitors;
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·
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FDA and other regulatory actions;
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·
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developments with respect to our or our competitors’ patents or proprietary rights;
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·
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public concern as to the safety of products developed by us or others and
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·
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changes in stock market analyst recommendations regarding us, other drug development companies or the pharmaceutical industry generally;
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·
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a classified board of directors with three-year staggered terms;
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·
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advance notice procedures for stockholder proposals to be considered at stockholders’ meetings;
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·
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the ability of our board of directors to fill vacancies on the board;
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·
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a prohibition against stockholders taking action by written consent;
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·
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super majority voting requirements for the stockholders to modify or amend our bylaws and specified provisions of our certificate of incorporation, and
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·
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the ability of our board of directors to issue up to 2,000,000 shares of preferred stock without
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stockholder approval.
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Item
1B.
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Unresolved Staff Comments
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Item
2.
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Properties
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Item
3.
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Legal Proceedings
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Item
4.
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Mine Safety Disclosures
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Item
5.
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Market for Registrant’s Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities
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2012
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2011
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|||||||||||||||
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High
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Low
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High
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Low
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|||||||||||||
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First Quarter
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$ | 0.28 | $ | 0.19 | $ | 0.69 | $ | 0.40 | ||||||||
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Second Quarter
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$ | 0.21 | $ | 0.15 | $ | 0.48 | $ | 0.21 | ||||||||
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Third Quarter
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$ | 0.21 | $ | 0.12 | $ | 0.40 | $ | 0.23 | ||||||||
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Fourth Quarter
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$ | 0.20 | $ | 0.12 | $ | 0.29 | $ | 0.21 | ||||||||
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Item
6.
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Selected Financial Data
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Years Ended December 31,
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August 5, 2004
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|||||||||||||||||||||||
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to
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||||||||||||||||||||||||
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December 31, 2007
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||||||||||||||||||||||||
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2012
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2011 (1)
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2010 (1)
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2009(2)
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2008(3)
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(4) (5) (6) | |||||||||||||||||||
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Operating expenses
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General and administrative
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$ | 1,764 | $ | 3,506 | $ | 3,240 | $ | 2,901 | $ | 2,991 | $ | 17,084 | ||||||||||||
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Research and development
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2,385 | 6,394 | 8,168 | 11,968 | 10,693 | 62,826 | ||||||||||||||||||
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Purchased in-process research and development
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- | - | - | - | - | 34,311 | ||||||||||||||||||
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Other
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- | - | - | - | - | (375 | ) | |||||||||||||||||
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Total operating expenses
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4,149 | 9,900 | 11,408 | 14,869 | 13,684 | 113,846 | ||||||||||||||||||
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Interest and other income, net
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(96 | ) | (31 | ) | (356 | ) | (737 | ) | (2,082 | ) | (10,552 | ) | ||||||||||||
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Loss from continuing operations before taxes
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4,053 | 9,869 | 11,052 | 14,132 | 11,602 | 103,294 | ||||||||||||||||||
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Income taxes expense (benefit)
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- | (158 | ) | (181 | ) | (1,009 | ) | (363 | ) | 356 | ||||||||||||||
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Loss from continuing operations
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4,053 | 9,711 | 10,871 | 13,123 | 11,239 | 103,650 | ||||||||||||||||||
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Discontinued operations
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||||||||||||||||||||||||
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Net gain on the sale of the bone device business
net of taxes $0, $0, $0, $0, $0, ($363) respectively
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- | - | - | - | - | (2,202 | ) | |||||||||||||||||
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NET LOSS
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4,053 | 9,711 | 10,871 | 13,123 | 11,239 | 101,448 | ||||||||||||||||||
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Less: Net loss attributable to the
noncontrolling interests
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(473 | ) | - | - | - | - | - | |||||||||||||||||
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Net loss attributable to Capstone stockholders
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3,580 | 9,711 | 10,871 | 13,123 | 11,239 | $ | 101,448 | |||||||||||||||||
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Per Share Information:
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||||||||||||||||||||||||
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Net loss basic and diluted
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$ | 0.09 | $ | 0.24 | $ | 0.27 | $ | 0.32 | $ | 0.27 | ||||||||||||||
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Basic and diluted shares outstanding
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40,879 | 40,775 | 40,775 | 40,775 | 41,078 | |||||||||||||||||||
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1.
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The 2011 and 2010 income tax benefits result from Arizona state income tax legislation passed in 2010 that provides for the refund of seventy five percent of the 2011 and 2010 Arizona state research and development tax credits for entities that would otherwise not be able to utilize their 2011 and 2010 Arizona research and development tax credits to reduce 2011 and 2010 Arizona state income taxes currently payable.
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2.
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The income tax benefit in 2009 of $1,009,000 results from the carryback of our net operating loss for federal income tax purposes for the year ended December 31, 2008 to the year ended December 31, 2003, as allowed by federal tax legislation passed in 2009.
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3.
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The income tax benefit in 2008 resulted from a reversal of an expected income tax liability recorded on the initial adoption on January 1, 2007 of Financial Accounting Standards Board (“FASB”) Interpretation No. 48 “Accounting for Uncertainty in Income Taxes – an interpretation of FASB Statement No. 109”.
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4.
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Research and development expenses in 2006 include recognition of a $2,100,000 Chrysalin patent cost impairment loss. Operating expenses in 2006 included $8,471,000 of purchased in-process research and development costs associated with the AzERx acquisition in February 2006. Income tax expenses in 2006 included the recording of a $1,106,000 valuation allowance for a deferred tax asset related to an Alternative Minimum Tax credit carryover.
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5.
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On August 5, 2004, we completed the acquisition of CBI. Capstone expensed in-process research
and development and acquisition costs of $25.8 million.
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6.
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A net gain of $2,048,000 was recognized on the sale of the Bone Device Business primarily due to a decrease in the risk related to the potential exposure of the representations and warranties provided in the governing asset purchase agreement.
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December 31,
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||||||||||||||||||||
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2012
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2011
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2010
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2009
|
2008
|
||||||||||||||||
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Working capital
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$ | 10,294 | $ | 14,417 | $ | 23,214 | $ | 34,395 | $ | 44,865 | ||||||||||
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Total assets
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$ | 11,591 | $ | 14,696 | $ | 25,288 | $ | 37,135 | $ | 49,514 | ||||||||||
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Potentially redeemable equity
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$ | - | $ | - | $ | 15,556 | $ | - | $ | - | ||||||||||
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Capstone Stockholders’ equity
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$ | 11,104 | $ | 14,577 | $ | 7,916 | $ | 34,728 | $ | 47,522 | ||||||||||
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Item
7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
·
|
We ceased clinical development of AZX100, formerly our principal drug candidate, in dermal scarring. Certain pre-clinical, manufacturing and regulatory projects related to AZX100 that are either required from a statutory perspective or have been contracted will continue to their completion.
|
|
·
|
We ceased all activities related to the development of TP508, our other drug candidate, and returned the patent and other intellectual property we own related to TP508 to the original licensor, the University of Texas Medical Branch at Galveston, Texas. We no longer have any interest in or rights to TP508.
|
|
·
|
We ceased clinical development of AZX100, formerly our principal drug candidate, in dermal scarring. Certain pre-clinical, manufacturing and regulatory projects related to AZX100 that are either required from a statutory perspective or have been contracted will continue to their completion.
|
|
·
|
We ceased all activities related to the development of TP508, our other drug candidate, and returned the patent and other intellectual property we own related to TP508 to the original licensor, the University of Texas Medical Branch at Galveston, Texas. We no longer have any interest in or rights to TP508.
|
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Item
7A.
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
Item
8.
|
Financial Statements and Supplementary Data
|
|
Item
9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
|
Item
9A.
|
Controls and Procedures
|
|
Item
9B.
|
Other Information
|
|
Item
10.
|
Directors, Executive Officers and Corporate Governance
|
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(1)
|
Member of the Audit Committee
|
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(2)
|
Member of the Compensation Committee
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(3)
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Member of the Corporate Governance/Nominating Committee
|
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Name
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Age
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Title
|
|
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John M. Holliman, III
|
59
|
Executive Chairman and Principal Executive Officer
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Randolph C. Steer, MD, Ph.D.
|
63
|
Consultant
|
|
|
Les M. Taeger
|
62
|
Senior Vice President, Chief Financial Officer and Principal Financial and Accounting Officer
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Item
11.
|
Executive Compensation
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Name
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Fees Earned or Paid in
Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($) (1)
|
Non-Equity Incentive Plan Compensation
($)
|
Nonqualified
Deferred
Compensation
Earnings
($)
|
All Other
Compensation
($)
|
Total
($)
|
|
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
|
Fredric J. Feldman, Ph.D.
|
22,000
|
3,000
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9,000
|
-
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-
|
-
|
34,000
|
|
Elwood D. Howse, Jr.
|
22,000
|
3,000
|
9,000
|
-
|
-
|
-
|
34,000
|
|
Robert J. Spiegel, MD (2)
|
4,000
|
3,000
|
1,000
|
-
|
-
|
-
|
8,000
|
|
William M. Wardell, MD, Ph.D.
(2)
|
4,000
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3,000
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1,000
|
-
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-
|
-
|
8,000
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Augustus A. White, III,
MD, Ph.D. (2)
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4,000
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3,000
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1,000
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-
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-
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-
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8,000
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(1)
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Fair value of the grants at the date of the grants was determined using the Black-Scholes model as described in Note 5 to the Financial Statements included in this Annual Report on Form 10-K.
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(2)
|
Drs. Spiegel, Wardell and White resigned from the Board on January 17, 2012.
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Name
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Option Awards
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|||||
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options
(#)
Unexercisable
|
Equity Incentive Plan
Awards: Number of
Securities Underlying
Unexercised Unearned
Options (#)
|
Options
Exercise
Price
($)
|
Option
Expiration Date
|
||
|
(a)
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(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
|
|
John M. Holliman, III
|
||||||
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200,000
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1.75
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5/12/2016
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||||
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50,000
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1.02
|
2/21/2018
|
||||
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125,000
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0.45
|
2/3/2019
|
||||
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100,000
|
0.82
|
2/4/2020
|
||||
|
25,000
|
0.70
|
10/30/2018
|
||||
|
|
*
|
32,500
|
32,500
|
0.17
|
5/18/2022
|
|
|
65,000
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0.16
|
8/9/2022
|
||||
|
Various directors:
|
||||||
|
(1) (2) (3)
|
10,000
|
6.13
|
12/31/2013
|
|||
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(1) (2) (3)
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30,000
|
7.40
|
1/23/2014
|
|||
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(1) (2) (3)
|
10,000
|
6.25
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12/31/2014
|
|||
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(1) (2) (3)
|
10,000
|
4.90
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1/2/2016
|
|||
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(1) (2) (3)
|
25,000
|
1.75
|
5/12/2016
|
|||
|
(1) (2) (3)
|
10,000
|
1.43
|
1/1/2017
|
|||
|
(1) (2) (3)
|
10,000
|
1.35
|
1/1/2018
|
|||
|
(1) (3)
|
25,000
|
0.70
|
10/30/2018
|
|||
|
(1) (2) (3)
|
10,000
|
0.42
|
1/1/2019
|
|||
|
(1) (2) (3)
|
10,000
|
0.72
|
1/1/2020
|
|||
|
(1)(2)(3)
|
10,000
|
0.58
|
1/1/2021
|
|||
|
(1) (2) (3)
|
10,000
|
0.26
|
1/1/2022
|
|||
|
(1) (2)
|
* |
17,500
|
17,500
|
0.17
|
5/18/2022
|
|
|
(1) (2)
|
42,500
|
0.16
|
8/9/2022
|
|||
|
Feldman, Fred (1)
|
||||||
|
Holliman, John (2)
|
* Vest on 5/18/2013
|
|||||
|
Howse, Elwood (3)
|
All other directors options were fully vested on 12/31/2012
|
|||||
|
Name
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($)
|
Non-Equity
Incentive
Plan
Compen-
sation
($)
|
Nonqualified
Deferred
Compensation
Earnings ($)
|
All
Other
Compensation
($)
|
Total
($)
|
|
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
|
John M. Holliman, III
Executive Chairman
(Principal
Executive
Officer)
|
2012
2011
2010
|
100,000
179,000 (1)
200,000
|
-
-
-
|
3,000(3)
19,000(3)
-
|
14,000(1)
3,000
50,000(1)
|
-
-
-
|
-
-
-
|
16,000(1)
264,000(1)(2)
64,000(1)
|
133,000
465,000
314,000
|
|
Randolph C. Steer, MD, Ph.D.,
Consultant
(former President)
|
2012
2011
2010
|
120,000
276,000
325,000
|
25,000
-
88,000
|
-
-
-
|
12,000
19,000
23,000
|
-
-
-
|
-
-
-
|
-
325,000 (2)
-
|
157,000
620,000
436,000
|
|
Les M. Taeger
Chief Financial Officer
(Principal Financial Officer)
|
2012
2011
2010
|
120,000
237,000
242,000
|
25,000
-
68,000
|
-
-
-
|
8,000
10,000
16,000
|
-
-
-
|
-
-
-
|
-
242,000 (2)
-
|
153,000
489,000
326,000
|
|
1.
|
Mr. Holliman is a member of the Board of Directors and as a director, received compensation of $16,000, $64,000 and $64,000, in cash, in 2012, 2011 and 2010, respectively, and an annual grant of an option to purchase 10,000 shares of the Company’s Common Stock. Mr. Holliman received total director’s compensation (Board fees, stock awards and option grants) of $20,000, $67,000 and $68,000 in 2012, 2011 and 2010, respectively, as more fully described in the Compensation of Directors section of this Annual Report on Form 10-K. Fair value of the grants at the date of the grants was determined using the Black-Scholes model as described, for 2012, in Note 5 to the Financial Statements included in this Annual Report on Form 10-K, for 2011, in Note 5 to our Annual Report on form 10-K filed with the Securities and Exchange Commission on March 21, 2012 and for 2010, in Note 5 to the Annual Report on form 10-K/A filed with the Securities and Exchange Commission on March 29, 2011.
|
|
2.
|
On October 31, 2011, the employment of Mr. Holliman and Dr. Steer was terminated and Mr. Taeger’s salary was reduced from $242,000 per year to $120,000. These actions triggered severance clauses in their employment agreements requiring the payment of severance of one year’s base salary to each executive officer. For a description of the employment agreements with our named executive offers, please see “Employment Contract, Termination of Employment, and Change-in-Control Arrangements” below.
|
|
3.
|
On January 17, 2011, Mr. Holliman was awarded 50,000 shares of restricted stock which vested on January 17, 2012. On January 1, 2012, along with the other members of the Board of Directors, Mr. Holliman was awarded 10,000 shares of common stock.
|
|
Name
|
Grant
Date
|
All Other
Stock
Awards:
Number of
Shares
of Stock
or Units
(#)
|
All Other
Option
Awards:
Number of
Securities
Underlying
Options
(#)
|
Exercise or
Base Price
of Option
Awards
($/Share)
|
Grant Date Fair
Value of Stock
and Option
Awards (1)
($)
|
|
(a)
|
(b)
|
(i)
|
(j)
|
(k)
|
(l)
|
|
John M. Holliman, III
Executive Chairman
|
1/1/12
1/1/12
5/18/12
8/9/12
|
-
10,000
-
-
|
10,000
-
65,000
65,000
|
0.26
-
0.17
0.16
|
1,000
3,000
6,000
6,000
|
|
Randolph C. Steer, MD, Ph.D.
Consultant
|
5/18/12
8/9/12
|
-
-
|
65,000
65,000
|
0.17
0.16
|
6,000
6,000
|
|
Les M. Taeger
Chief Financial Officer
|
5/18/12
8/9/12
|
-
-
|
45,000
45,000
|
0.17
0.16
|
4,000
4,000
|
|
Name
|
Option Awards
|
|||
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option
Exercise
Price
($)
|
Option
Expiration
Date
|
|
|
(a)
|
(b)
|
(c)
|
(e)
|
(f)
|
|
John M. Holliman, III
|
||||
|
10,000
|
-
|
6.13
|
12/31/2013
|
|
|
30,000
|
-
|
7.40
|
1/23/2014
|
|
|
10,000
|
-
|
6.25
|
12/31/2014
|
|
|
10,000
|
-
|
4.90
|
1/2/2016
|
|
|
25,000
|
-
|
1.75
|
5/12/2016
|
|
|
200,000
|
-
|
1.75
|
5/12/2016
|
|
|
10,000
|
-
|
1.43
|
12/31/2017
|
|
|
10,000
|
-
|
1.35
|
12/31/2018
|
|
|
50,000
|
-
|
1.02
|
2/21/2018
|
|
|
25,000
|
-
|
0.70
|
10/30/2018
|
|
|
10,000
|
-
|
0.42
|
1/1/2019
|
|
|
125,000
|
-
|
0.45
|
2/3/2019
|
|
|
10,000
|
-
|
0.72
|
1/1/2020
|
|
|
100,000
|
0.82
|
2/4/2020
|
||
|
10,000
|
-
|
0.58
|
1/1/2021
|
|
|
10,000
|
0.26
|
1/1/2022
|
||
|
*
|
32,500
|
32,500
|
0.17
|
5/18/2022
|
|
65,000
|
0.16
|
8/9/2022
|
||
|
Randolph C. Steer, MD, Ph.D.
|
||||
|
200,000
|
-
|
1.75
|
5/12/2016
|
|
|
50,000
|
-
|
1.53
|
5/21/2017
|
|
|
50,000
|
-
|
1.02
|
2/21/2018
|
|
|
75,000
|
-
|
0.45
|
2/3/2019
|
|
|
50,000
|
-
|
0.82
|
2/4/2020
|
|
|
50,000
|
-
|
0.67
|
1/17/2021
|
|
|
*
|
32,500
|
32,500
|
0.17
|
5/18/2022
|
|
65,000
|
0.16
|
8/9/2022
|
||
|
Les M. Taeger
|
||||
|
150,000
|
-
|
5.15
|
1/16/2016
|
|
|
150,000
|
-
|
1.70
|
6/2/2016
|
|
|
14,706
|
-
|
1.02
|
2/21/2018
|
|
|
50,000
|
-
|
0.45
|
2/3/2019
|
|
|
35,000
|
-
|
0.82
|
2/4/2020
|
|
|
**
|
23,958
|
1,042
|
0.67
|
1/17/2021
|
|
*
|
22,500
|
22,500
|
0.17
|
5/18/2022
|
|
45,000
|
0.16
|
8/9/2022
|
||
|
* Vest on 5/18/13
|
||||
|
** Vesting over two years monthly
|
||||
|
Item
12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
|
Common Stock
|
||||||||
|
Beneficially Owned (1)
|
||||||||
|
Beneficial Owner
|
Number
|
Percent of Class
|
||||||
|
Fredric J. Feldman (2)
|
485,064 | 1.2 | ||||||
|
John M. Holliman, III (3)
|
1,323,272 | 3.2 | ||||||
|
Elwood D. Howse, Jr. (4)
|
507,203 | 1.2 | ||||||
|
Randolph C. Steer (5)
|
701,298 | 1.7 | ||||||
|
Les M. Taeger (6)
|
588,280 | 1.4 | ||||||
|
BVF Group (7)
|
7,755,688 | 19.0 | ||||||
|
Lloyd Miller, III (8)
|
6,399,889 | 15.7 | ||||||
|
All directors and executive officers as a group (9)
|
3,605,117 | 8.3 | ||||||
|
(1)
|
Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission (“SEC”) and generally includes voting or investment power with respect to securities. In accordance with SEC rules, shares, which may be acquired upon exercise of stock options which are currently exercisable or which become exercisable within 60 days of the date of the table, are deemed beneficially owned by the optionee. Except as indicated by footnote, and subject to community property laws where applicable, the persons or entities named in the table above have sole voting and investment power with respect to all shares of Common Stock shown as beneficially owned by them.
|
|
(2)
|
Includes 284,500 shares Dr. Feldman has a right to acquire upon exercise of stock options. Voting and investment power shared with spouse.
|
|
(3)
|
Includes 836,000 shares Mr. Holliman has a right to acquire upon exercise of stock options, 3,000 shares indirectly owned as trustee and 1,658 shares indirectly owned as trustee of Valley Ventures III, LP.
|
|
(4)
|
Includes 284,500 shares Mr. Howse has a right to acquire upon exercise of stock options.
|
|
(5)
|
Includes 656,000 shares Dr. Steer has a right to acquire upon exercise of stock options.
|
|
(6)
|
Includes 543,706 shares Mr. Taeger has a right to acquire upon exercise of stock options.
|
|
(7)
|
BVF Group (Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P. BVF Investments, L.L.C., Investment 10, L.L.C., BVF Partners, L.P., BVF Inc.) is not a related party or otherwise affiliated with the Company, its directors or officers, and the principal business office of the Reporting Persons comprising the Group is located at 900 North Michigan Avenue, Suite 1100, Chicago, IL 60611.
|
|
(8)
|
Lloyd Miller, III, is not a related party or otherwise affiliated with the Company, its directors or officers, and the principal business office of the Reporting Person is located at 222 Lakeview Avenue, Suite 160-365, West Palm Beach, Florida 33401
|
|
(9)
|
Includes 2,419,706 shares directors and executive officers have a right to acquire upon exercise of stock options.
|
|
Number of securities to
|
Weighted average
|
Number of securities remaining
|
||||||||||
|
be issued upon exercise
|
exercise price of
|
available for future issuance
|
||||||||||
|
of outstanding options,
|
outstanding options,
|
under equity compensation plans
|
||||||||||
|
warrants and rights
|
warrants and rights
|
(excluding securities reflected in
|
||||||||||
|
column (a)
|
||||||||||||
|
Plan Category:
|
(c)
|
(b)
|
(c)
|
|||||||||
|
Equity Compensation Plans
approved by Security Holders
|
3,218,264 | $ | 1.71 | 131,061 | ||||||||
|
Equity Compensation Plans
not approved by Security Holders
|
N/A | N/A | N/A | |||||||||
|
Total
|
3,218,264 | $ | 2.08 | 131,061 | ||||||||
|
Item
13.
|
Certain Relationships and Related Transactions, and Director Independence
|
|
Item
14.
|
Principal Accountant Fees and Services
|
|
Type of Fee
|
Amount
|
|||||||
|
2012
|
2011
|
|||||||
|
Audit Fees (1)
|
$ | 132,000 | $ | 59,000 | ||||
|
Audit-Related Fees (2)
|
7,000 | - | ||||||
|
Total Audit and Audit-Related Fees
|
139,000 | 59,000 | ||||||
|
Tax Fees (3)
|
- | - | ||||||
|
All Other Fees (4)
|
- | - | ||||||
|
Total Fees
|
139,000 | 59,000 | ||||||
|
(1)
|
Audit fees include fees for services rendered in connection with the audits of the Company’s financial statements for the fiscal years ended December 31, 2012 and 2011 and reviews of the financial statements included in the Company’s quarterly reports on Form 10-Q during the applicable fiscal year.
|
|
(2)
|
Audit-related fees would include fees for services rendered for matters such as a business combination, sales of shares of the Company’s common stock, and responses to accounting and reporting-related matters.
|
|
(3)
|
Tax fees would include fees for services rendered for tax compliance, preparation of original and amended tax returns, claims for refunds and other tax services.
|
|
(4)
|
Our principal accounting firms did not perform nor bill the Company for any other services during the fiscal years ended December 31, 2012 and 2011 that are appropriately classified as “All Other Fees.”
|
|
Item
15.
|
Exhibits and Financial Statement Schedules
|
|
(a)
|
The following documents are filed as part of this report
:
|
|
1.
|
Financial Statements.
|
|
2.
|
Financial Statement Schedules have been omitted since they are not applicable.
|
|
3.
|
All management contracts and compensatory plans and arrangements are specifically identified on the attached Exhibit Index.
|
|
(b)
|
Exhibits
|
|
(c)
|
Financial Statements and Schedules
- See Item 15(a)(1) and Item 15(a)(2) above.
|
|
CAPSTONE THERAPEUTICS CORP.
|
||
| Date: March 14, 2013 | By | /s/ John M. Holliman, III |
|
John M. Holliman, III
Executive Chairman
|
||
|
Signature
|
Title
|
Date
|
|
/s/ John M. Holliman, III
John M. Holliman, III
|
Executive Chairman
(Principal Executive Officer)
and Director
|
March 14, 2013
|
|
/s/ Fredric J. Feldman
Fredric J. Feldman, Ph.D.
|
Director
|
March 14, 2013
|
|
/s/ Elwood D. Howse, Jr.
Elwood D. Howse, Jr.
|
Director
|
March 14, 2013
|
|
/s/ Les M. Taeger
Les M. Taeger
|
Senior Vice President and Chief
Financial Officer (Principal
Financial and Accounting Officer)
|
March 14, 2013
|
|
Exhibit
No.
|
Description
|
Incorporated by Reference To
:
|
Filed
Or Furnished
Herewith
|
|||
|
3.1
|
Amended and Restated Certificate of Designation of Series A Preferred Stock, executed June 19, 2007
|
Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission (“SEC”) on June 25, 2007 (“June 25
th
2007 8-K”)
|
||||
|
3.2
|
Bylaws of the Company
|
Exhibit 3.4 to the Company’s Amendment No. 2 to Registration Statement on Form S-1 (No. 33-47569) filed with the SEC on January 25, 1993 (“January 1993 S-1”)
|
||||
|
3.3
|
Certificate of Incorporation, as amended through May 21, 2010
|
Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2010, filed with the SEC on August 9, 2010
|
||||
|
4.1
|
Class A Warrant Agreement dated February 24, 2006, between OrthoLogic Corp. and PharmaBio Development Inc. (d/b/a NovaQuest)
|
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 3, 2006
|
||||
|
4.2
|
Class A Warrant Agreement dated June 30, 2006 by and between OrthoLogic Corp. and PharmaBio Development Inc
|
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 6, 2006
|
||||
|
4.3
|
Amended and Restated Class B Warrant Agreement dated February 24, 2006, and amended and restated as of June 30, 2006, between OrthoLogic Corp. and PharmaBio Development Inc. (d/b/a NovaQuest) (asterisks located within exhibit denote information that has been redacted pursuant to a request for confidential treatment filed with the SEC)
|
Exhibit 4.4 to the Company’s Amendment No. 1 to Registration Statement on Form 8-A/A, filed with the SEC on May 25, 2010.
|
||||
|
10.1
|
Form of Indemnification Agreement(*)
|
Exhibit 10.16 to the Company’s January 1993 S-1
|
||||
|
10.2
|
1997 Stock Option Plan of the Company, as amended and approved by the stockholders (1)
|
Exhibit 4.3 to the Company’s Registration Statement on Form S-8, filed with the SEC on March 2, 2005
|
||||
|
10.3
|
Form of Incentive Stock Option Grant Letter for use in connection with the Company’s 1997 Stock Option Plan (**)
|
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 4, 2005
|
||||
|
10.4
|
Form of Non-qualified Stock Option Grant Letter for use in connection with the Company’s 1997 Stock Option Plan (**)
|
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 19, 2006
|
||||
|
10.5
|
Director Compensation Plan, effective June 10, 2005 (1)
|
Exhibit 10.2 to the Company’s Quarterly Report Form 10-Q for the quarterly period ended June 30, 2005, filed with the SEC on August 9, 2005
|
||||
|
10.6
|
Employment Agreement dated January 10, 2006 between the Company and Les M. Taeger (1)
|
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 11, 2006 (the “January 11
th
8-K”)
|
||||
|
10.7
|
Intellectual Property, Confidentiality and Non-Competition Agreement between the Company and Les M. Taeger dated January 10, 2006 (1)
|
Exhibit 10.2 to the January 11
th
8-K
|
|
10.8
|
Common Stock and Warrant Purchase Agreement by and between OrthoLogic Corp. and PharmaBio Development Inc., dated February 24, 2006.
|
Exhibit 10.1 to the Company’s Registration Statement on Form S-3 filed with the SEC on April 13, 2006 (April 2006 S-3)
|
||||
|
10.9
|
Registration Rights Agreement by and between OrthoLogic Corp. and PharmaBio Development Inc., dated February 24, 2006
|
Exhibit 4.8 to the Company’s Amendment No. 1 to Registration Statement on Form 8-A/A, filed with the SEC on May 25, 2010.
|
||||
|
10.10
|
Registration Rights Agreement by and between OrthoLogic Corp., AzERx, Inc., and Certain Shareholders, dated February 27, 2006
|
Exhibit 10.3 to the Company’s April 2006 S-3
|
||||
|
10.11
|
Amended and Restated License Agreement dated February 23, 2006 by and between OrthoLogic Corp. and Arizona Science Technology Enterprises, LLC
|
Exhibit 10.5 to the Company’s Registration Statement on Form S-3 filed with the SEC on April 25, 2006
|
||||
|
10.12
|
2005 Equity Incentive Plan (2005 Plan) (1)
|
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2006
|
||||
|
10.13
|
Form of Incentive Stock Option Grant Letters for Grants under the 2005 Plan (**)
|
Exhibit 10.1 to the Company’s Report on Form 10-Q for the quarterly period ended June 30, 2006, filed on August 8, 2006 (“June 2006 10-Q”)
|
||||
|
10.14
|
Form of Non-Qualified Stock Options Grant Letter for Grants under the 2005 Plan (**)
|
Exhibit 10.2 to the Company’s June 2006 10-Q
|
||||
|
10.15
|
Form of Restricted Stock Grant Letters for Grants under the 2005 Plan (**)
|
Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2006
|
||||
|
10.16
|
Amendment to Employment Agreement dated January 10, 2006 between OrthoLogic Corp. and Les Taeger (1)
|
Exhibit 10.3 to the Company’s June 2006 10-Q
|
||||
|
10.17
|
Lease Agreement dated July 19, 2007, by and between the Company and Phoenix Investors #13, L.L.C.
|
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 23, 2007
|
||||
|
10.18
|
First Amendment to Lease dated April 28, 2010 by and between OrthoLogic Corp. and Phoenix Investors #20, L.L.C.
|
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2010, filed with the SEC on August 9, 2010
|
||||
|
10.19
|
Second Amendment to Lease Agreement dated January 5, 2004 by and between Phoenix Investors #20, L.L.C. and Capstone Therapeutics Corp.
|
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2011 filed with the SEC on May 13, 2011.
|
||||
|
10.20
|
Contribution Agreement by and among LipimetiX, LLC, Capstone Therapeutics Corp., LipimetiX Development, LLC, The UAB Research Foundation, Dennis I. Goldberg, Ph.D. (“Goldberg”), Philip M. Friden, Ph.D., Eric Morrell, Ph.D., G. M. Anantharamaiah, Ph.D. and Palgunachari Mayakonda, Ph.D., Frederick Meyer, Ph.D., Michael Webb, and Jeffrey Elton, Ph.D., effective as of August 3, 2012.
|
Exhibit 10.1 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
||||
|
10.21
|
Limited Liability Company Agreement of LipimetiX Development, LLC, by and among LipimetiX Development, LLC, Capstone Therapeutics Corp., and the other members and managers party thereto, effective as of August 3, 2012.
|
Exhibit 10.2 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
|
10.22
|
First Amendment and Consent to Assignment of Exclusive License Agreement by and among The UAB Research Foundation, LipimetiX, LLC and LipimetiX Development, LLC, dated as of August 3, 2012.
|
Exhibit 10.3 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
||||
|
10.23
|
Management Agreement by and among LipimetiX Development, LLC, Benu BioPharma, Inc., Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D., and Eric M. Morrel, Ph.D., effective as of August 3, 2012.
|
Exhibit 10.4 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
||||
|
10.24
|
Accounting Services Agreement by and among LipimetiX Development, LLC and Capstone Therapeutics Corp., effective as of August 3, 2012.
|
Exhibit 10.5 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
||||
|
10.25
|
Escrow Agreement by and among Capstone Therapeutics Corp., LipimetiX Development, LLC dated as of August 3, 2012
|
Exhibit 10.6 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
||||
|
10.26
|
Exclusive License Agreement between the UAB Research Foundation and LipimetiX LLC dated August 26, 2011
|
Exhibit 10.7 to the Company’s Quarterly Report on form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012
|
||||
|
10.27
|
Capstone Therapeutics Corp. Joint Venture Bonus Plan
|
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2012, filed with the SEC on November 8, 2012
|
||||
|
23.1
|
Consent of independent registered public accounting firm.
|
X
|
||||
|
31.1
|
Certification of Principal Executive Officer Pursuant to Rule 13a -14(a) of the Securities Exchange Act of 1934, as amended
|
X
|
||||
|
31.2
|
Certification of Principal Financial and Accounting Officer Pursuant to Rule 13a - 14(a) of the Securities Exchange Act of 1934, as amended
|
X
|
||||
|
32.1
|
Certification of Principal Executive Officer and Principal Financial and Accounting Officer Pursuant to 18 U.S.C. Section 1350***
|
|||||
|
101
|
The following financial information from our Annual Report on Form 10-K for the fiscal year 2012, filed with the SEC on March 14, 2013 formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Balance Sheets as December 31, 2012 and 2011, (ii) the Consolidated Statements of Operations for the years ended 2012 and 2011 and one hundred and one months ended December 31, 2012, (iii) the Consolidated Statements of Cash Flows for the two years ended December 31, 2012 and 2011 and the one hundred and one months ended December 31, 2012, and (iv) Notes to Consolidated Financial Statements. ***
|
|
(1)
|
Management contract or compensatory plan or arrangement.
|
|
*
|
Capstone Therapeutics Corp. has entered into separate indemnification agreements with each of its current directors and executive officers that differ only in party names and dates. Pursuant to the instructions accompanying Item 601 of Regulation S-K, Capstone has filed the form of such indemnification agreement.
|
|
**
|
Capstone Therapeutics from time to time issues stock options to its employees, officers and directors pursuant to its 1997 and 2005 Stock Option Plan, as amended. The incentive stock option grant letters and non-qualified stock option grant letters that evidence these issuances differ only in such terms as the identity of the recipient, the grant date, the number of securities covered by the award, the price(s) at which the recipient may acquire the securities and the vesting schedule. Pursuant to the instructions accompanying Item 601 of Regulation S-K, Capstone has filed the form of such incentive stock option grant letter and non-qualified stock option grant letter.
|
|
***
|
Furnished herewith.
|
|
December 31,
|
December 31,
|
|||||||
|
2012
|
2011
|
|||||||
|
ASSETS
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents, $4,499 reserved at December 31, 2012
|
$ | 10,205 | $ | 13,778 | ||||
|
Other current assets
|
383 | 758 | ||||||
|
Total current assets
|
10,588 | 14,536 | ||||||
|
Patent license rights, net
|
980 | - | ||||||
|
Furniture and equipment, net
|
23 | 160 | ||||||
|
Total assets
|
$ | 11,591 | $ | 14,696 | ||||
|
LIABILITIES AND EQUITY
|
||||||||
|
Current liabilities
|
||||||||
|
Accounts payable
|
$ | 233 | $ | 77 | ||||
|
Accrued compensation
|
6 | 13 | ||||||
|
Other accrued liabilities
|
55 | 29 | ||||||
|
Total current liabilities
|
294 | 119 | ||||||
|
Equity
|
||||||||
|
Capstone Therapeutics Corp. Stockholders' Equity
|
||||||||
|
Common Stock $.0005 par value;
100,000,000 shares authorized; 40,885,411 shares in 2012
and 40,775,411shares in 2011 issued and outstanding
|
||||||||
|
Additional paid-in capital
|
189,181 | 189,074 | ||||||
|
Accumulated deficit ($150,335 at December 31, 2012 and
$146,755 at December 31, 2011, accumulated during
development stage period)
|
(178,097 | ) | (174,517 | ) | ||||
|
Total Capstone Therapeutics Corp. stockholders' equity
|
11,104 | 14,577 | ||||||
|
Noncontrolling interest
|
193 | - | ||||||
|
Total equity
|
11,297 | 14,577 | ||||||
|
Total liabilities and equity
|
$ | 11,591 | $ | 14,696 | ||||
|
CAPSTONE THERAPEUTICS CORP.
|
|
(A Development Stage Company)
|
|
|
|
(in thousands, except per share data)
|
|
As a Development
|
||||||||||||
|
Years ended December 31,
|
Stage Company
|
|||||||||||
|
August 5, 2004 -
|
||||||||||||
|
2012
|
2011
|
December 31, 2012
|
||||||||||
|
OPERATING EXPENSES
|
||||||||||||
|
General and administrative
|
$ | 1,764 | $ | 3,506 | $ | 31,486 | ||||||
|
Research and development
|
2,385 | 6,394 | 102,434 | |||||||||
|
Purchased in-process research and development
|
- | - | 34,311 | |||||||||
|
Other
|
- | - | (375 | ) | ||||||||
|
Total operating expenses
|
4,149 | 9,900 | 167,856 | |||||||||
|
Interest and other income, net
|
(96 | ) | (31 | ) | (13,854 | ) | ||||||
|
Loss from continuing operations before taxes
|
4,053 | 9,869 | 154,002 | |||||||||
|
Income tax benefit
|
- | (158 | ) | (1,355 | ) | |||||||
|
Loss from continuing operations
|
4,053 | 9,711 | 152,647 | |||||||||
|
Discontinued operations - net gain on sale of
the bone device business, net of taxes of $267
|
- | - | (2,202 | ) | ||||||||
|
Net Loss
|
4,053 | 9,711 | 150,445 | |||||||||
|
Less: Net Loss attributable to the noncontrolling
interest
|
(473 | ) | - | (473 | ) | |||||||
|
Net Loss attributable to Capstone Therapeutics
Corp. stockholders
|
$ | 3,580 | $ | 9,711 | $ | 149,972 | ||||||
|
Per Share Information:
|
||||||||||||
|
Net loss, basic and diluted, attributable to
Capstone Therapeutics Corp. stockholders
|
$ | 0.09 | $ | 0.24 | ||||||||
|
Basic and diluted shares outstanding
|
40,879 | 40,775 | ||||||||||
|
CAPSTONE THERAPEUTICS CORP.
|
|
(A Development Stage Company)
|
|
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
|
|
(in thousands)
|
|
Capstone Therapeutics Corp. Stockholders' Equity
|
||||||||||||||||||||||||||||
|
Potentially
|
Non
|
|||||||||||||||||||||||||||
|
Redeemable
|
Common Stock
|
Additional
|
Accumulated
|
controlling
|
||||||||||||||||||||||||
|
Equity
|
Shares
|
Amount
|
Paid in Capital
|
Deficit
|
Interest
|
Total
|
||||||||||||||||||||||
|
Balance August 5, 2004 (prior to the acquisition of CBI)
|
$ | - | 34,550 | $ | 17 | $ | 146,125 | $ | (27,762 | ) | $ | - | $ | 118,380 | ||||||||||||||
|
Acquisition of CBI, August 5, 2004
|
- | 3,248 | 2 | 23,451 | - | - | 23,453 | |||||||||||||||||||||
|
Acquisition of AzERx, February 27, 2006
|
- | 1,355 | 1 | 7,763 | - | - | 7,764 | |||||||||||||||||||||
|
Exercise of common stock options
|
- | 997 | - | 4,579 | - | - | 4,579 | |||||||||||||||||||||
|
Stock-based compensation cost
|
- | - | - | 3,346 | - | - | 3,346 | |||||||||||||||||||||
|
Compensation earned on stock awards
|
- | 494 | - | 1,200 | - | - | 1,200 | |||||||||||||||||||||
|
Sale of common stock
|
- | 1,263 | 1 | 3,375 | - | - | 3,376 | |||||||||||||||||||||
|
Common stock purchased and retired
|
- | (1,132 | ) | (1 | ) | (1,040 | ) | - | - | (1,041 | ) | |||||||||||||||||
|
Recognized uncertain tax position
|
- | - | - | - | (363 | ) | - | (363 | ) | |||||||||||||||||||
|
Reclassification of share-based awards liability
|
- | - | - | (541 | ) | - | - | (541 | ) | |||||||||||||||||||
|
Recognition of potentially redeemable equity,
net of amortization
|
15,556 | - | - | - | (15,556 | ) | - | (15,556 | ) | |||||||||||||||||||
|
Net loss August 5, 2004 through December 31, 2010
|
- | - | - | - | (136,681 | ) | - | (136,681 | ) | |||||||||||||||||||
|
Balance December 31, 2010
|
15,556 | 40,775 | 20 | 188,258 | (180,362 | ) | - | 7,916 | ||||||||||||||||||||
| - | ||||||||||||||||||||||||||||
|
De-recognition of potentially redeemable equity,
net of amortization
|
(15,556 | ) | - | - | - | 15,556 | - | 15,556 | ||||||||||||||||||||
|
Stock-based compensation cost
|
- | - | - | 159 | - | - | 159 | |||||||||||||||||||||
|
Reclassification of share-based awards liability
|
- | - | - | 657 | - | - | 657 | |||||||||||||||||||||
|
Net loss
|
- | - | - | - | (9,711 | ) | - | (9,711 | ) | |||||||||||||||||||
|
Balance December 31, 2011
|
- | 40,775 | 20 | 189,074 | (174,517 | ) | - | 14,577 | ||||||||||||||||||||
|
Formation of Joint Venture
|
- | - | - | - | - | 666 | 666 | |||||||||||||||||||||
|
Stock-based compensation cost
|
- | 110 | - | 107 | - | - | 107 | |||||||||||||||||||||
|
Net loss
|
- | - | - | - | (3,580 | ) | (473 | ) | (4,053 | ) | ||||||||||||||||||
|
Balance December 31, 2012
|
$ | - | 40,885 | $ | 20 | $ | 189,181 | $ | (178,097 | ) | $ | 193 | $ | 11,297 | ||||||||||||||
|
(A Development Stage Company)
|
|
As a
|
||||||||||||
|
Development
|
||||||||||||
|
Stage Company
|
||||||||||||
|
Years Ended December 31,
|
August 5, 2004 -
|
|||||||||||
|
2012
|
2011
|
December 31, 2012
|
||||||||||
|
OPERATING ACTIVITIES
|
||||||||||||
|
Net loss
|
$ | (4,053 | ) | $ | (9,711 | ) | $ | (150,445 | ) | |||
|
Non cash items:
|
||||||||||||
|
Deferred tax expense
|
- | - | 770 | |||||||||
|
Depreciation and amortization
|
29 | 117 | 3,971 | |||||||||
|
Non-cash stock-based compensation
|
107 | 159 | 4,931 | |||||||||
|
Gain on sale of bone device business
|
- | - | (2,298 | ) | ||||||||
|
In-process research and development
|
- | - | 34,311 | |||||||||
|
Change in other operating items:
|
- | |||||||||||
|
Interest, income taxes and other current assets
|
375 | (115 | ) | 1,325 | ||||||||
|
Accounts payable
|
156 | (169 | ) | (738 | ) | |||||||
|
Accrued liabilities
|
19 | (871 | ) | (2,956 | ) | |||||||
|
Cash flows used in operating activities
|
(3,367 | ) | (10,590 | ) | (111,129 | ) | ||||||
|
INVESTING ACTIVITIES
|
||||||||||||
|
Expenditures for furniture and equipment, net
|
- | (19 | ) | (1,044 | ) | |||||||
|
Proceeds from sale of assets
|
172 | - | 7,172 | |||||||||
|
Cash paid for assets of AzERx/CBI
|
- | - | (4,058 | ) | ||||||||
|
Cash paid for patent rights
|
(378 | ) | - | (1,028 | ) | |||||||
|
Purchases of investments
|
- | - | (282,538 | ) | ||||||||
|
Maturities of investments
|
- | - | 340,476 | |||||||||
|
Cash flows provided by (used in) investing activities
|
(206 | ) | (19 | ) | 58,980 | |||||||
|
FINANCING ACTIVITIES
|
||||||||||||
|
Net proceeds from stock option exercises
|
- | - | 4,612 | |||||||||
|
Net proceeds from sale of stock
|
- | - | 3,376 | |||||||||
|
Common stock purchases
|
- | - | (1,041 | ) | ||||||||
|
Cash flows provided by financing activities
|
- | - | 6,947 | |||||||||
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(3,573 | ) | (10,609 | ) | (45,202 | ) | ||||||
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
13,778 | 24,387 | 55,407 | |||||||||
|
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
$ | 10,205 | $ | 13,778 | $ | 10,205 | ||||||
|
Supplemental Disclosure of Non-Cash Investing Activities -
|
LipimetiX
|
LipimetiX/AzERx/CBI
|
||||||||||
|
LipimetiX/AzERx/CBI Acquisitions:
|
||||||||||||
|
Current assets acquired
|
$ | - | $ | 29 | ||||||||
|
Patent rights acquired
|
1,045 | 3,187 | ||||||||||
|
Liabilities acquired, and accrued acquisition costs
|
- | (457 | ) | |||||||||
|
Original investment reversal
|
- | (750 | ) | |||||||||
|
In-process research and development acquired
|
- | 34,311 | ||||||||||
|
Noncontrolling interest
|
(667 | ) | (667 | ) | ||||||||
|
Common stock issued for acquisition
|
- | (31,217 | ) | |||||||||
|
Cash paid
|
$ | 378 | $ | 4,436 | ||||||||
|
1.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
·
|
We ceased clinical development of AZX100, formerly our principal drug candidate, in dermal scarring. Certain pre-clinical, manufacturing and regulatory projects related to AZX100 that are either required from a statutory perspective or are under contract will continue to their completion.
|
|
·
|
We ceased all activities related to the development of TP508, our initial drug candidate, and returned the patent and other intellectual property we owned related to TP508 to the original licensor, the University of Texas Medical Branch at Galveston, Texas. We no longer have any interest in or rights to TP508.
|
|
2.
|
INVESTMENTS
|
|
3.
|
FURNITURE AND EQUIPMENT
|
|
December 31,
|
||||||||
|
2012
|
2011
|
|||||||
|
Machinery and equipment
|
$ | 601 | $ | 1,215 | ||||
|
Furniture and fixtures
|
57 | 69 | ||||||
|
Leasehold improvements
|
36 | 36 | ||||||
| 694 | 1,320 | |||||||
|
Less accumulated depreciation and amortization
|
(671 | ) | (1,160 | ) | ||||
|
Total
|
$ | 23 | $ | 160 | ||||
|
4.
|
INCOME TAXES
|
|
December 31,
|
||||||||
|
2012
|
2011
|
|||||||
|
Accruals and reserves
|
$ | 1 | $ | 2 | ||||
|
Valuation allowance
|
(1 | ) | (2 | ) | ||||
|
Total current
|
- | - | ||||||
|
NOL, AMT and general business
credit carryforwards
|
55,039 | 53,801 | ||||||
|
Difference in basis of fixed assets
|
114 | 93 | ||||||
|
Accruals and reserves
|
522 | 898 | ||||||
|
Difference in basis of intangibles
|
13 | 443 | ||||||
|
Valuation allowance
|
(55,688 | ) | (55,235 | ) | ||||
|
Total non current
|
- | - | ||||||
|
Total deferred income taxes
|
$ | - | $ | - | ||||
|
As a
|
||||||||||||
|
Development
|
||||||||||||
|
Stage Company
|
||||||||||||
|
Years Ended December 31
|
August 5, 2004 -
|
|||||||||||
|
2012
|
2011
|
December 31, 2012
|
||||||||||
|
Provision (benefit) for income taxes
|
||||||||||||
|
Current
|
$ | - | $ | (158 | ) | $ | (2,461 | ) | ||||
|
Deferred
|
- | - | 1,106 | |||||||||
|
Income tax provision (benefit)
|
$ | - | $ | (158 | ) | $ | (1,355 | ) | ||||
|
As a
|
||||||||||||
|
Development
|
||||||||||||
|
Stage Company
|
||||||||||||
|
Years Ended December 31
|
August 5, 2004 -
|
|||||||||||
|
2012
|
2011
|
December 31, 2012
|
||||||||||
|
Income tax provision (benefit) at statutory rate
|
$ | (1,217 | ) | $ | (3,356 | ) | $ | (52,198 | ) | |||
|
State income taxes
|
(165 | ) | (454 | ) | (5,958 | ) | ||||||
|
Purchased in-process
research and development
|
- | - | 12,533 | |||||||||
|
Research credits
|
9 | (366 | ) | (5,938 | ) | |||||||
|
Change in uncertain tax position reserve
|
- | - | (363 | ) | ||||||||
|
Expiration of state NOL
|
450 | 867 | 3,481 | |||||||||
|
Other
|
472 | 118 | 2,021 | |||||||||
|
Change in valuation allowance
|
451 | 3,033 | 45,067 | |||||||||
|
Net provision (benefit)
|
$ | - | $ | (158 | ) | $ | (1,355 | ) | ||||
|
5.
|
STOCKHOLDERS’ EQUITY
|
|
2012
|
2011
|
|||
|
Risk free interest rate
|
0.8%
|
2.0 - 2.7%
|
||
|
Volatility
|
74%
|
66%
|
||
|
Expected term from vesting
|
4.0 Years
|
3.9 Years
|
||
|
Dividend yield
|
0%
|
0%
|
|
2012
|
2011
|
|||||||||||||||||||
|
Weighted
|
||||||||||||||||||||
|
Weighted
|
average
|
Weighted
|
||||||||||||||||||
|
average
|
remaining
|
average
|
||||||||||||||||||
|
Number of
|
exercise
|
contractual term
|
Number of
|
exercise
|
||||||||||||||||
|
Options
|
price
|
(years)
|
Options
|
price
|
||||||||||||||||
|
Options outstanding
at the beginning of the year:
|
3,372,501 | $ | 2.08 | 3,610,173 | $ | 2.32 | ||||||||||||||
|
Granted
|
595,000 | $ | 0.17 | 210,000 | $ | 0.64 | ||||||||||||||
|
Exercised
|
- | - | ||||||||||||||||||
|
Expired / Forfeited
|
(749,237 | ) | $ | 2.16 | (447,672 | ) | $ | 3.33 | ||||||||||||
|
Outstanding at end of year
|
3,218,264 | $ | 1.71 | 4.96 | 3,372,501 | $ | 2.08 | |||||||||||||
|
Options exercisable at year-end
|
3,083,680 | $ | 1.78 | 4.77 | 3,284,426 | $ | 2.12 | |||||||||||||
|
Options vested and expected
to vest at year end
|
3,123,618 | $ | 1.76 | 4.83 | 3,352,886 | $ | 2.32 | |||||||||||||
|
6.
|
COMMITMENTS
|
|
7.
|
401(K) PLAN
|
|
8.
|
AUTHORIZED PREFERRED STOCK
|
|
9.
|
AUTHORIZATION OF COMPANY BUY-BACK OF COMMON STOCK
|
|
10.
|
JOINT VENTURE FOR DEVELOPMENT OF APO E MIMETIC
PEPTIDE MOLECULE AEM-28 AND ANALOGS
|
|
Patent license rights
|
$ | 1,045 | |||
|
Noncontrolling interests
|
$ | ( 667 | ) | ||
|
Cash paid at formation
|
$ | 378 |
|
11.
|
CONTINGENCY – LEGAL PROCEEDINGS
|
|
12.
|
STAFF REDUCTIONS
|
|
13.
|
PUT RIGHTS AND POTENTIALLY REDEEMABLE EQUITY
|
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 |
|---|