UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 8-K

Current Report 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 4, 2016

CYTORI THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

3020 Callan Road, San Diego, California 92121

(Address of principal executive offices, with zip code)

(858) 458-0900

(Registrant's telephone number, including area code)

n/a

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

 

 

On August 4, 2016, Cytori Therapeutics, Inc. (Company) issued a press release announcing its financial results for the second quarter ended June 30, 2016. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information disclosed under this Item 2.02 in this report, including Exhibit 99.1 hereto, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

 

*

Exhibit 99.1 hereto is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Exhibit Index

Cytori Reports Second Quarter 2016 Business and Financial Results

SAN DIEGO, August 4, 2016—Cytori Therapeutics (NASDAQ: CYTX) ("Cytori" or the "Company") today announced its second quarter financial results and provided updates on its corporate activity and clinical development.

Second quarter 2016 net loss allocable to common stockholders was $6.4 million and $0.43 per share. Cytori continues to tightly manage its operating cash burn, spending approximately $5.7 million in the second quarter 2016. Cytori ended the second quarter of 2016 with $20 million of cash and cash equivalents.

"In the first half of the year, our team has advanced our development pipeline in the U.S. in multiple indications, most notably completing enrollment in our Phase 3 trial in scleroderma. Additionally, investigator-initiated studies are progressing in Europe and Japan, and we have continued to lay a sound foundation for early clinical adoption and profitable revenue growth in Japan and Europe, which can provide near-term revenue and importantly build longer-term strategic value," said Dr. Marc H. Hedrick, President and Chief Executive Officer for Cytori. "Corporate milestones over the next twelve months include the first readout from our US phase III scleroderma trial in mid-2017, the initiation of an externally funded clinical trial in burn patients later this year, treatment of the first scleroderma patients as part of our compassionate use program, and Japanese revenue growth".

·	Enrollment completion of US STAR phase III trial for scleroderma hand dysfunction

·	Report of 48-week US pilot/phase IIb ACT-OA trial preliminary topline data

·	Limited regulatory approval received by a Cytori customer regarding use of Cytori® Cell Therapy™ for osteoarthritis of the knee at its clinics in Japan

·	Completion of rights offering for gross proceeds of $17.1 million

·	Broad orphan drug designation granted by European Commission, and small or medium-size enterprise (SME) status granted by European Medicines Agency

·	Q2 2016 and year-to-date operating cash burn of $5.6 million and $10.7 million, compared to $4.8 million and $9.8 million for the same periods in 2015, respectively.

·	Cash and debt principal balances at June 30, 2016 of approximately $20 million and $17.7 million, respectively.

·	Q2 2016 and year-to-date total revenues of $2.8 million and $5.7 million, compared to $3.5 million and $5.8 million for the same periods in 2015, respectively.

·

Q2 2016 net loss allocable to common stockholders of $6.4 million or $0.43 per share, compared to a net income of $4.5 million or $0.45 per share (or a net loss of $8.7 million and $0.94 per share when excluding a non-cash credit charge of $13.1 million related to the change in fair value of warrant liabilities) for the same period in 2015.

·

Year-to-date net loss allocable to common stockholders of $11.7 million or $0.84 per share, compared to $18.2 million or $2.22 per share (or a net loss of $15.2 million or $1.86 per share, which excludes a non-cash charge of $2.3 million related to the change in fair value of warrant liabilities and a beneficial conversion feature charge for convertible preferred stock of $0.7 million) for the same period in 2015.

"We reduced our net losses by over 25% from Q2'15 to Q2'16, despite substantial development progress that includes completion of enrollment in our U.S. Phase III scleroderma trial," said Tiago Girao, VP of Finance and CFO of Cytori Therapeutics. "Our current projections indicate that the net proceeds from our Q2 financing activities coupled with ongoing downward pressure on expenses coupled with revenue growth, will provide liquidity for at least the next 12 months of operations."

The ACT-OA trial was a randomized double blind phase II trial comparing a single administration of either low or high doses of ECCO-50 autologous cellular therapeutic placed into the intraarticular space of one knee in 94 patients with knee osteoarthritis of moderate severity. This pilot trial was designed to establish safety, feasibility and explore a number of efficacy endpoints for a more definitive trial with appropriate statistical powering. Topline results concluded:

·	Intraarticular application of a single dose of ECCO-50 is feasible in an outpatient day-surgery setting; no serious adverse events were reported related to the fat harvest, cell injection or to the cell therapy.

·	Consistent trends observed in most secondary endpoints at 12, 24 and 48 weeks in the target knee of the treated group relative to placebo control group; as reported in Q1, 12 week primary endpoint of single pain on walking question did not achieve statistical significance.

·	Consistent trends observed in all 6 pre-specified MRI Osteoarthritis Knee Score (MOAKS) classification scores suggesting decrease in target knee joint pathologic features at 48 weeks for the treated group relative to placebo control group.

"The safety and feasibility goal of this first trial in OA was substantially achieved," said Dr. Mark Marino, Cytori Senior Vice President of Clinical Affairs. "Additionally, even though this first randomized controlled trial was not statistically powered to test for a specific therapeutic hypothesis, it showed evidence of a potential cell effect including in the joint imaging data. Further analysis is ongoing on specific patient subsets and in-depth anatomic assessment of the MRI data."

·	Clarity for European Union Conditional Market Approval in scleroderma hand dysfunction

·	File IDE and obtain approval for burn wound therapy trial related to contract with BARDA (anticipated in 2016)

·	Report of 48-week US pivotal/phase III trial data for scleroderma hand dysfunction

·	Operating cash burn within a range of $18 million to $20 million

·	Total revenues (product and contract) within a range of $12 million to $14 million

Cytori will host a management conference call at 5:30 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 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: 54687177.

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions.  Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair.  As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products.  For more information: visit www.cytori.com.

This press release includes forward-looking statements that involve known and unknown risks and uncertainties. All statements, other than historical facts are forward looking statements. Such statements, including, without limitation, statements regarding having at least 12 months' liquidity (based upon expected expense containment and revenue growth), potential prolonged symptomatic improvement in the target knee of the treated patient group relative to placebo control group in the Company's ACT-OA trial, evidence of a potential cell effect (including in the joint imaging data), status of SCLERADEC II enrollment, status of the Company's efforts regarding a proposed burn wound trial, anticipated receipt and disclosure of 48-week STAR data, and reiterated financial guidance (projected operating cash burn and total revenues), are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical, pre-clinical and regulatory uncertainties, such as those associated with the ACT-OA, STAR, SCLERADEC-I, SCLERADEC-II and possible BARDA wound trial (including risks relating to failure to achieve full enrollment of SCLERADEC II or other Company-sponsored/supported trials, risks in the collection and results of ACT-OA, STAR, SCLERADEC II and other clinical data and related final clinical outcomes), as well as achievement of financial goals (including 2016 operating cash burn and 2016 total revenues), dependence on third party performance and approvals (including performance of investigator-initiated trials, and outcome of FDA review of our proposed burn wound trial pursuant to our contract with BARDA), performance and acceptance of our products in clinical studies/trials and in the marketplace, material changes in the marketplace that could adversely impact revenue projections (including changes in market perceptions of our products, and introduction of competitive products), unexpected costs and expenses that could adversely impact liquidity and shorten our current liquidity projections (which could in turn require us to seek additional debt or equity capital within the next 12 months), our reliance on key personnel, the right of the Federal Government to cut or terminate further support of the thermal burn injury program (including any decision by BARDA not to proceed with a wound trial in 2016), our abilities to capitalize on our internal restructuring and achieve break-even or profitability (or to continue to reduce our operating losses), and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, included in our annual and quarterly reports.

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

CYTORI THERAPEUTICS, INC.

CONSOLIDATED CONDENSED BALANCE SHEETS

(UNAUDITED)

CYTORI THERAPEUTICS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME

(UNAUDITED)

CYTORI THERAPEUTICS, INC.

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(UNAUDITED)