Plus Therapeutics (PSTV) 8-K Cytori Provides Business Update and Reports Third Quarter and Nine Month 2012 Results

November 8, 2012

Cytori Provides Business Update and Reports Third Quarter and Nine Month 2012 Results

SAN DIEGO, CA -- During the third quarter and first nine months of 2012, Cytori Therapeutics (NASDAQ: CYTX) advanced its cardiac cell therapy pipeline and achieved important strategic commercial and regulatory milestones. Additionally, Cytori reaffirmed its $9 million revenue guidance for the year. The Company accomplished the following objectives since the end of the second quarter:

Strategic

·   Awarded a U.S. Government contract with the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Department of Health and Human Services.  The contract is valued at up to $106 million and will be used to develop Cytori’s cell therapy for the treatment of thermal burns combined with radiation injury.  Contract activities are currently underway including the initiation of key proof of concept studies in addition to accelerating development of the next generation Celution® system.

Clinical Pipeline

·   Initiated enrollment in ATHENA, the U.S. clinical trial of Cytori’s cell therapy for refractory heart failure; the trial is on track to fully enroll by mid-2013.

·   Resumed enrollment in ADVANCE, a European acute myocardial infarction trial; primary emphasis of the trial continues to be completion of country and site clearances.

Commercial Business

·   Expanded Japanese market access in the third quarter by obtaining a full commercial operational license for Cytori Therapeutics K.K. and Class 1 medical device clearance for the Celution® and Puregraft® based technologies. In combination, these resulted in the highest gross quarterly product shipments to date.

·   Expanded Celution® CE Mark certification to include indications-for-use in wound healing and tissue ischemia.

Operations & Financial Performance

·   Reduced net cash used in operating activities in the first nine months of 2012 compared to the first nine months of 2011, driven by reductions in sales, general and administrative expenses.

“This quarter we made significant progress on both the clinical and commercial fronts which will help drive our growth in 2013 and beyond,” said Christopher J. Calhoun, chief executive officer for Cytori Therapeutics. “Throughout the rest of the year and into 2013, we will look to continue to expand enrollment in our ongoing clinical trials, achieve additional strategic partnerships and secure more approvals that drive revenue growth.”

Financial Results

Product revenues were $1.3 million and $4.7 million for the third quarter and first nine months of 2012, respectively, compared with $2.1 million and $5.9 million for the same periods in 2011. Additionally, based on the receipt of the Japan commercial operational license and Class 1 device clearance late in the third quarter of 2012, Cytori shipped an additional $1.7 million of systems and consumables that we expect to recognize as product revenue in a subsequent quarter. Cytori reaffirms its $9 million revenue guidance for 2012 based on already achieved shipments and anticipated orders.

Gross profit was $0.6 million and $2.2 million for the third quarter and first nine months of 2012, compared to $1.2 million and $3.0 million for the same periods of 2011, respectively.

Research and development expenses increased to $3.6 million and $9.6 million for the third quarter and first nine months of 2012, compared to $2.8 million and $8.9 million, the same periods respectively in 2011.  This planned increase is principally associated with the emergence of the ATHENA trial.  In contrast, sales, general and administrative expenses were reduced to $6.2 million and $18.9 million in the third quarter and first nine months of 2012, a decrease of 13% compared to both the third quarter of 2011 ($7.2 million) and the first nine months of 2011 ($21.8 million) respectively.

Net cash used in operating activities for the third quarter of 2012 was $7.9 million compared to $7.9 million for the same period in 2011 and $8.2 million in the second quarter of 2012. Net loss was $11.2 million, or ($0.19) per share, and $28.5 million, or ($0.49) per share, for the third quarter and first nine months of 2012, respectively. This compares to $8.3 million, or ($0.15) per share, and $25.5 million, or ($0.48) per share for the third quarter and first nine months of 2011, respectively. Net loss for the third quarter and first nine months of 2012 includes a net non-cash charge of $1.2 million and $1.7 million respectively related to the change in the fair value of warrant and option liabilities compared to non-cash credit of $1.0 million and $3.0 million for the same periods, respectively in 2011.

At the end of the third quarter of 2012, Cytori had $17.6 million of cash and cash equivalents and $3.2 million of accounts receivable and expected revenue from the additional product shipments in the third quarter.

Management Conference Call Webcast and Shareholder Letter Information

Cytori will host a management conference call at 5:00 p.m. Eastern Time today to further discuss the company's progress. The webcast will be available live and by replay two hours after the call and may be accessed under "Webcasts" in the Investor Relations section (http://ir.cytori.com) of Cytori's website. If you are unable to access the webcast, you may dial in to the call at +1.877.402.3914, Conference ID: 42763342. More details on our business are contained in the 'November 2012 Shareholder Letter' posted on the homepage of our Investor Relations website.

About Cytori

Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects.  Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® system product family. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, such as our expectation of completion of enrollment of the ATHENA clinical trial by mid-2013, and  our revenue guidance of $9 million for the year. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, such as those associated with the ATHENA clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

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Contact:

Investors                                                      Media

Tom Baker                                            Megan McCormick

tbaker@cytori.com                                                      mmccormick@cytori.com

+1.858.875.5258                                                       +1.858.875.5279

CYTORI THERAPEUTICS, INC.

CONSOLIDATED CONDENSED BALANCE SHEETS

(UNAUDITED)

	As of September 30, 2012			As of December 31, 2011
Assets
Current assets:
Cash and cash equivalents	$	17,628,000		$	36,922,000
Accounts receivable, net of reserves of $455,000 and of $474,000 in 2012 and 2011, respectively		1,463,000			2,260,000
Inventories, net		3,411,000			3,318,000
Other current assets		1,090,000			837,000
Total current assets		23,592,000			43,337,000
Property and equipment, net		2,242,000			1,711,000
Restricted cash and cash equivalents		350,000			350,000
Investment in joint venture		122,000			250,000
Other assets		1,756,000			1,772,000
Intangibles, net		26,000			192,000
Goodwill		3,922,000			3,922,000
Total assets	$	32,010,000		$	51,534,000
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable and accrued expenses	$	5,588,000		$	5,334,000
Current portion of long-term obligations		9,767,000			2,487,000
Total current liabilities		15,355,000			7,821,000
Deferred revenues, related party		1,107,000			3,520,000
Deferred revenues		5,147,000			5,244,000
Warrant liability		1,871,000			627,000
Option liability		2,400,000			1,910,000
Long-term deferred rent		684,000			504,000
Long-term obligations, net of discount, less current portion		15,178,000			21,962,000
Total liabilities		41,742,000			41,588,000
Commitments and contingencies
Stockholders’ equity (deficit):
Preferred stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued and outstanding in 2012 and 2011		—			—
Common stock, $0.001 par value; 95,000,000 shares authorized; 58,720,627 and 56,594,683 shares issued and outstanding in 2012 and 2011, respectively		59,000			57,000
Additional paid-in capital		261,113,000			252,338,000
Accumulated deficit		(270,904,000	)		(242,449,000	)
Total stockholders’ equity (deficit)		(9,732,000	)		9,946,000
Total liabilities and stockholders’ equity (deficit)	$	32,010,000		$	51,534,000

CYTORI THERAPEUTICS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(UNAUDITED)

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2012			2011			2012			2011
Product revenues	$	1,314,000		$	2,134,000		$	4,741,000		$	5,908,000
Cost of product revenues		703,000			942,000			2,588,000			2,893,000
Gross profit		611,000			1,192,000			2,153,000			3,015,000
Development revenues:
Development, related party		—			—			2,413,000			1,231,000
Research grant and other		2,000			5,000			21,000			19,000
		2,000			5,000			2,434,000			1,250,000
Operating expenses:
Research and development		3,555,000			2,830,000			9,615,000			8,948,000
Sales and marketing		2,450,000			3,618,000			7,406,000			10,560,000
General and administrative		3,777,000			3,538,000			11,489,000			11,230,000
Change in fair value of warrant liability		863,000			(1,536,000	)		1,244,000			(3,714,000	)
Change in fair value of option liability		300,000			570,000			490,000			680,000
Total operating expenses		10,945,000			9,020,000			30,244,000			27,704,000
Operating loss		(10,332,000	)		(7,823,000	)		(25,657,000	)		(23,439,000	)
Other income (expense):
Interest income		—			3,000			3,000			7,000
Interest expense		(857,000	)		(489,000	)		(2,582,000	)		(1,923,000	)
Other income (expense), net		(17,000	)		25,000			(91,000	)		(36,000	)
Equity loss from investment in joint venture		(42,000	)		(51,000	)		(128,000	)		(153,000	)
Total other income (expense)		(916,000	)		(512,000	)		(2,798,000	)		(2,105,000	)
Net loss	$	(11,248,000	)	$	(8,335,000	)	$	(28,455,000	)	$	(25,544,000	)
Basic and diluted net loss per common share	$	(0.19	)	$	(0.15	)	$	(0.49	)	$	(0.48	)
Basic and diluted weighted average common shares		58,713,036			53,900,250			58,292,911			52,775,861

CYTORI THERAPEUTICS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)

	For the Nine Months Ended September 30,
	2012			2011
Cash flows from operating activities:
Net loss	$	(28,455,000	)	$	(25,544,000	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		712,000			621,000
Amortization of deferred financing costs and debt discount		706,000			471,000
Provision for doubtful accounts		99,000			274,000
Change in fair value of warrant liability		1,244,000			(3,714,000	)
Change in fair value of option liability		490,000			680,000
Share-based compensation expense		2,907,000			2,578,000
Equity loss from investment in joint venture		128,000			153,000
Increases (decreases) in cash caused by changes in operating assets and liabilities:
Accounts receivable		698,000			(168,000	)
Inventories		(93,000	)		(775,000	)
Other current assets		(253,000	)		132,000
Other assets		16,000			(764,000	)
Accounts payable and accrued expenses		254,000			(396,000	)
Deferred revenues, related party		(2,413,000	)		(1,231,000	)
Deferred revenues		(97,000	)		189,000
Long-term deferred rent		180,000			70,000
Net cash used in operating activities		(23,877,000	)		(27,424,000	)
Cash flows from investing activities:
Purchases of property and equipment		(1,077,000	)		(458,000	)
Net cash used in investing activities		(1,077,000	)		(458,000	)
Cash flows from financing activities:
Principal payments on long-term debt		(210,000	)		(4,460,000	)
Proceeds from long-term debt		—			9,444,000
Debt issuance costs and loan fees		—			(719,000	)
Proceeds from exercise of employee stock options and warrants		988,000			2,849,000
Proceeds from sale of common stock		4,946,000			9,038,000
Costs from sale of common stock		(64,000	)		(135,000	)
Net cash provided by financing activities		5,660,000			16,017,000
Net decrease in cash and cash equivalents		(19,294,000	)		(11,865,000	)
Cash and cash equivalents at beginning of period		36,922,000			52,668,000
Cash and cash equivalents at end of period	$	17,628,000		$	40,803,000