Cytori Reports Q1 2019 Business and Financial Results

Date : 05/14/2019 @ 9:50PM
Source : GlobeNewswire Inc.
Stock : Cytori Therapeutics (MM) (CYTX)
Quote : 0.2401  0.0 (0.00%) @ 2:00PM

Cytori Reports Q1 2019 Business and Financial Results

Cytori Therapeutics (MM) (NASDAQ:CYTX)
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Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced Q1 2019 financial results and provided updates on corporate activities. 

Q1 2019 net loss was $3.2 million, or $0.18 per share. Operating cash burn for Q1 was approximately $3.3 million. Cytori ended Q1 with approximately $3.9 million of cash and cash equivalents.

Cytori is developing two clinical stage chemotherapy drugs. ATI-0918, a generic version of pegylated liposomal doxorubicin hydrochloride, is the lead product candidate. The Company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) next year based on a successful bioequivalence study completed against the European reference drug. The Company is in the process of completing manufacturing-related activities to support the MAA and is evaluating commercial partners for ATI-0918 with a focus on Europe, which has a current estimated market size of over $120 million.

Cytori is also developing ATI-1123, a patented, albumin-stabilized pegylated liposomal docetaxel. The Company recently received an orphan drug designation from the U.S. FDA for small cell lung cancer and is seeking FDA’s 505(b)(2) new drug application (NDA) and Accelerated Approval pathway.

“The Company’s recent divestiture of its cell therapy businesses allows us to fundamentally reposition and refocus of the Company around our nanotechnology and oncology drug development,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. We intend to begin communicating our plan later in Q2.

Q1 2019 Financial Performance

  • Q1 2019 operating cash burn was $3.3 million, compared to $4.1 million for Q1 2018.
  • Q1 2019 product revenues were $0.7 million, compared to $0.7 million for Q1 2018.
  • Q1 2019 contract revenues were $0.7 million, compared to $0.9 million for Q1 2018.
  • Q1 2019 Celution® consumable utilization grew by approximately 20% as compared to Q1 2018.
  • Cash and debt principal balances at March 31, 2019 were approximately $3.9 million and $13.0 million, respectively.
  • Q1 2019 net loss was $3.2 million or $0.18 per share, compared to a net loss of $4.4 million or $0.73 per share for Q1 2018.

About Cytori

Cytori is developing, manufacturing, and commercializing nanoparticle-delivered oncology drugs.  Cytori is focused on the liposomal encapsulation of anti-neoplastic chemotherapy agents or other drugs which may enable the effective delivery of the agents to target sites while reducing systemic toxicity and improving pharamacokinetics.  Our pipeline consists of ATI-0918 pegylated liposomal doxorubicin hydrochloride for breast cancer, ovarian cancer, multiple myeloma, and Kaposi’s sarcoma, a complex/hybrid generic drug, and ATI-1123 patented albumin-stabilized pegylated liposomal docetaxel for multiple solid tumors.  For more information, visit www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements about our anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; the potential size of the market for our products; future development and/or expansion of our products and therapies in our markets, our ability to generate  product or development revenues and the sources of such revenues; our ability to effectively manage our gross profit margins; our ability to obtain and maintain regulatory approvals; expectations as to our future performance; portions of the “Liquidity and Capital Resources” section of this report, including our potential need for additional financing and the availability thereof; our ability to continue as a going concern; our ability to remain listed on the Nasdaq Capital Market; our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future; and the potential enhancement of our cash position through development, marketing, and licensing arrangements.   Our actual results will likely differ, perhaps materially, from those anticipated in these forward-looking statements as a result of various factors, including: the early stage of our product candidates and therapies, the results of our research and development activities, including uncertainties relating to the clinical trials of our product candidates and therapies; our need and ability to raise additional cash, the outcome of our partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to us, market conditions, product performance, potential litigation, and competition within the regenerative medicine field, to name a few. The forward-looking statements included in this report are subject to a number of additional material risks and uncertainties, including but not limited to the risks described under the “Risk Factors” in the Cytori's Securities and Exchange Commission Filings, included in the Company’s annual and quarterly reports.

There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. Federal securities laws to do so.

CYTORI THERAPEUTICS, INC. CONSOLIDATED CONDENSED BALANCE SHEETS(UNAUDITED)(in thousands, except share and par value data)

  As of March 31,2019  As of December 31,2018 
Assets        
Current assets:        
Cash and cash equivalents $3,872  $5,261 
Accounts receivable, net of reserves of $185 in 2019 and $185 in 2018  455   286 
Restricted cash  40   40 
Inventories, net  3,003   2,947 
Other current assets  1,092   1,114 
Total current assets  8,462   9,648 
         
Property and equipment, net  2,607   2,559 
Operating lease right-of-use assets  2,153    
Other assets  1,827   1,905 
Intangibles, net  5,645   5,957 
Goodwill  3,922   3,922 
Total assets $24,616  $23,991 
Liabilities and Stockholders’ Equity        
Current liabilities:        
Accounts payable and accrued expenses $3,224  $3,357 
Operating lease liability  700    
Term loan obligations, net of discount  14,371   14,202 
Total current liabilities  18,295   17,559 
         
Deferred revenues  142   167 
Other noncurrent liabilities  98   124 
Noncurrent operating lease liability  1,518    
Warrant liability  706   916 
Total liabilities  20,759   18,766 
         
Commitments and contingencies        
         
Stockholders’ equity:        
Preferred stock, $0.001 par value; 5,000,000 shares authorized; 30,233 shares  issued; 4,540 and 4,606 shares outstanding in 2019 and 2018, respectively      
Common stock, $0.001 par value; 100,000,000 shares authorized; 21,905,795 and  14,830,414 shares issued and outstanding in 2019 and 2018, respectively  22   15 
Additional paid-in capital  420,290   418,375 
Accumulated other comprehensive income  1,078   1,218 
Accumulated deficit  (417,533)  (414,383)
Total stockholders’ equity  3,857   5,225 
Total liabilities and stockholders’ equity $24,616  $23,991 

CYTORI THERAPEUTICS, INC. CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)(in thousands, except share and per share data)

  For the Three Months Ended March 31, 
  2019  2018 
Product revenues $703  $731 
Cost of product revenues  (353)  (273)
Amortization of intangible assets  (306)  (306)
Gross profit  44   152 
         
Development revenues:        
Government contracts and other  737   917 
   737   917 
Operating expenses:        
Research and development  1,846   2,499 
Sales and marketing  428   678 
General and administrative  1,508   2,244 
Total operating expenses  3,782   5,421 
Operating loss  (3,001)  (4,352)
         
Other income (expense):        
Interest income  7   14 
Interest expense  (515)  (423)
Other income (expense), net  149   352 
Change in fair value of warrants  210    
 Total other expense  (149)  (57)
Net loss $(3,150) $(4,409)
         
Basic and diluted net loss per share attributable to common stockholders $(0.18) $(0.73)
Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders  17,657,108   6,017,791 
         
Comprehensive loss:        
Net loss $(3,150) $(4,409)
Other comprehensive loss – foreign currency translation adjustments  (140)  (281)
Comprehensive loss $(3,290) $(4,690)

CYTORI THERAPEUTICS, INC.CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS(UNAUDITED)(in thousands)

  For the Three Months Ended March 31,
  2019  2018 
Cash flows from operating activities:       
Net loss $(3,150) $(4,409)
Adjustments to reconcile net loss to net cash used in operating activities:       
Depreciation and amortization  443   497 
Amortization of deferred financing costs and debt discount  168   105 
Provision for excess inventory     326 
Change in fair value of warrants  (210)   
Share-based compensation expense  49   143 
Loss on asset disposal     22 
Increases (decreases) in cash caused by changes in operating assets and liabilities:       
Accounts receivable  (212)  (747)
Inventories  16   141 
Other current assets  16   301 
Other assets  1   (24)
Accounts payable and accrued expenses  (405)  (556)
Deferred revenues  (25)  84 
Other long-term liabilities  39   (2)
   Net cash used in operating activities  (3,270)  (4,119)
Cash flows from investing activities:       
Purchases of property and equipment  (6)  (53)
   Net cash used in investing activities  (6)  (53)
Cash flows from financing activities:       
Payment of financing lease liability  (28)   
Proceeds from sale of common stock, net  1,919   (150)
   Net cash provided by (used in) financing activities  1,891   (150)
   Effect of exchange rate changes on cash and cash equivalents  (4)  39 
   Net decrease in cash and cash equivalents  (1,389)  (4,283)
Cash, cash equivalents, and restricted cash at beginning of period  5,301   10,225 
Cash, cash equivalents, and restricted cash at end of period $3,912  $5,942 

CYTORI THERAPEUTICS CONTACTGary Titus+1.858.458.0900ir@cytori.com 

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