Capstone Therapeutics Will Provide an Operating Update and Announces 2012 Financial Results

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TEMPE, Ariz., March 14, 2013 (GLOBE NEWSWIRE) -- Capstone Therapeutics (OTCQB:CAPS); (the "Company"), today will hold a conference call and webcast to provide an operating update and 2012 financial results.

Operating Results

We incurred a net loss attributable to Capstone Therapeutics stockholders in 2012 of $3.6 million compared to a net loss of $9.7 million in 2011. The decrease in the net loss for the year ended December 31, 2012 compared to 2011 resulted primarily from the reduction in staff in the fourth quarter of 2011 and other actions taken by the Company to wind down internal operations and move to a virtual operating model. This decrease was partially offset by costs of approximately $139,000 related to the LipimetiX Development, LLC joint venture transaction we entered into on August 3, 2012, and the research and development expenses of LipimetiX Development, LLC, of $1,133,000 (net of intercompany transactions of $50,000) net of the net loss of $473,000 allocated to noncontrolling interest for 2012.

On August 3, 2012, we contributed $6.0 million to the LipimetiX Development, LLC joint venture. For 2012, we used $3.6 million of cash, of which $1.5 million was used by LipimetiX Development, LLC. At December 31, 2012, we had cash and cash equivalents of $10.2 million, of which $4.5 million is held in, and reserved for use by, LipimetiX Development, LLC and unavailable for general use by the Company.

Conference Call Information

Management will hold a conference call and webcast on Thursday, March 14, 2013 at 4:30 pm EDT. The call may be accessed at 877-303-2908 (U.S.), 408-427-3860 (outside U.S.); accompanying slides may be viewed by logging onto the Investors section of the Company's website, www.capstonethx.com. A replay will be available beginning March 14, 2013 at 7:30 pm EDT until midnight March 17, 2013 and may be accessed at 855-859-2056 (U.S.) or 404-537-3406 (outside U.S.) with conference ID 19854610.

About Capstone Therapeutics

Capstone Therapeutics is a biotechnology company committed to developing a pipeline of novel therapeutic peptides aimed at helping patients with under-served medical conditions. The Company is focused on development and commercialization of two product platforms: AZX100 and ApoE Mimetic Peptide Molecule AEM-28 and its analogs (through the LipimetiX Development, LLC joint venture).

AZX100 is a novel synthetic 24-amino acid peptide, one of a new class of compounds in the field of smooth muscle relaxation and fibrosis. AZX100 has been evaluated for commercially significant medical applications such as the prevention or reduction of hypertrophic and keloid scarring and treatment of pulmonary and peridural fibrosis. In the first quarter of 2012 we ceased clinical development of AZX100 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 are currently focused on development partnering or licensing opportunities for AZX100 in dermal scarring, pulmonary fibrosis and peridural fibrosis.

Apolipoprotein E (Apo E) is a 299 amino acid protein that plays an important role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E that contains a domain that anchors into a lipoprotein surface while also providing the Apo E binding domain that is removed by heparin sulfate receptors in the liver. AEM-28 as an Apo E mimetic has the potential to restore the ability of atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28. For patients that lack LDL receptors (Homozygous Familial Hypercholesterolemia, HoFH), have Severe Refractory Hypercholesterolemia, or have acute coronary syndrome, AEM-28 may provide a therapeutic solution.

AEM-28 and its analogs are being developed by our joint venture, LipimetiX Development, LLC. The joint venture's initial development plan is to file an IND and pursue FDA approval of AEM-28 as treatment for Severe Refractory Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (as an Orphan Drug). The initial funded development plan will extend through Phase 1a and 1b/2a clinical trials over an expected twenty-seven month period with a biomarker endpoint test targeting reduction of LDL cholesterol. The joint venture may also fund research or studies to investigate Apo E mimetic molecules, including AEM-28 and analogs, for treatment of acute coronary syndrome.

Capstone's corporate headquarters are in Tempe, Arizona. For more information, please visit the Company's website: www.capstonethx.com.

The Capstone Therapeutics logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5429

Statements in this press release or otherwise attributable to Capstone regarding our business that are not historical facts are forward looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted results. These risks include the factors discussed in our Form 10-K for the fiscal year ended December 31, 2012, and other documents we file with the U.S. Securities and Exchange Commission

Editor's Note: This press release is also available under the Investors section of the Company's website at www.capstonethx.com.

CAPSTONE THERAPEUTICS CORP.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
December 31,
2012
December 31,
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 40,775,411 shares in 2011 issued and outstanding 20 20
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)
CONSOLIDATED STATEMENTS OF OPERATIONS
(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
CAPSTONE THERAPEUTICS CORP.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
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

CONTACT: FOR FURTHER INFORMATION: Investor Relations (602) 286-5250 investorinquiries@capstonethx.com

Source:Capstone Therapeutics