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Cytori Reports Third Quarter 2015 Business and Financial Results

SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ: CYTX) today announced its third quarter financial results and provided updates on its corporate activity and clinical development.

“We continue to seek to hold the overall cash burn down while expanding the overall spending in research and development”

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Third quarter 2015 net income allocable to common stockholders was $1.5 million, or a net loss of $5.8 million and $0.04 per share when excluding a non-cash charge of $7.3 million related to the change in fair value of warrant liabilities. Cytori continued to reduce its operating cash burn, spending approximately $6.1 million in the third quarter 2015. Cytori ended the second quarter of 2015 with $19 million of cash and cash equivalents.

“This has been a good quarter for us; our trials are progressing on schedule and we have a number of anticipated milestones over the next 12 months related to our lead programs in scleroderma and osteoarthritis,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “In parallel, we are preparing for commercial success through expansion of our market access activities in Europe for scleroderma, broadening our business development efforts and strengthening our leadership team. Also, we are analyzing additional opportunities to cost effectively expand our clinical pipeline and better develop the technology platform upon which it is based.”

Select Q3 Highlights:

  • Publication of extended follow-up data showing sustained benefit of results in pilot/phase I/II trial for scleroderma hand dysfunction
  • Initiated enrollment in two late stage trials for scleroderma hand dysfunction in both the US (STAR trial) and Europe (SCLERADEC-II trial)
  • Initiated enrollment of Japanese pivotal/phase III trial for stress urinary incontinence (ADRESU trial)
  • Publication of twelve-month follow up data in patients with intractable inflammatory bowel disease

Q3 and Year-To-Date Financial Performance

  • Q3 and year-to-date operating cash burn of $6.1 million and $15.9 million, compared to $7.2 million and $25.4 million for the same periods in 2014, respectively.
  • Cash and debt principal balances at September 30, 2015 of approximately $19 million and $17.7 million, respectively.
  • Q3 and year-to-date product revenues of $0.8 million and $3.3 million, compared to $0.5 million and $2.5 million for the same periods in 2014, respectively.
  • Q3 and year-to-date contribution (profit/loss) from our sales and marketing organization, excluding share based compensation, of a loss of $0.3 million and $1.1 million, compared to a loss of $1.2 million and $4.0 million for the same periods in 2014, respectively.
  • Q3 and year-to-date contract revenue of $1.7 million and $5.0 million, compared to $0.6 million and $1.3 million for the same periods in 2014, respectively.
  • Q3 and year-to-date net loss/income allocable to common stockholders was a net income of $1.5 million (or $0.01 per share, or a net loss of $5.8 million and $0.04 per share when excluding a non-cash charge of $7.3 million related to the change in fair value of warrant liabilities) and a net loss of $16.6 million (or $0.12 per share, or $21.6 million and $0.16 per share when excluding a non-cash charge of $5 million related to the change in fair value of warrant liabilities), compared to a net loss of $9.4 million (or $0.12 per share, or $9.5 million and $0.12 per share when excluding a non-cash charge of $0.1 million related to the change in fair value of warrant liabilities) and $31.6 million (or $0.41 per share, or $31.7 million and $0.41 per share when excluding a non-cash charge of $0.1 million related to the change in fair value of warrant liabilities) for the same periods in 2014, respectively.

“We continue to seek to hold the overall cash burn down while expanding the overall spending in research and development,” said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. “We have been successful at this thus far through the implementation of ‘across-the-board’ operational efficiencies, tighter management of working capital, better support from key stakeholders and service providers, and ultimately by maintaining a clear company-wide focus on only those activities than management feels will bring shareholder value in the most compressed time frame possible.”

Upcoming Near Term Catalysts:

  • Evaluate and release 24-week data from 94 patient US pilot/phase IIb ACT-OA trial (anticipated Q1 2016) and identify partner for late stage US clinical development
  • Complete enrollment of US STAR trial (anticipated mid 2016) for scleroderma hand dysfunction
  • Complete enrollment of EU pivotal/phase III SCLERADEC-II trial (anticipated mid 2016) for scleroderma hand dysfunction
  • Complete enrollment of Japanese pivotal/phase III ADRESU trial (anticipated 2017) for stress urinary incontinence
  • Work with...

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