Cytori Reports Third Quarter 2017 Business and Financial Results
Third quarter 2017 net loss was
Selected Key Recent Highlights:
- U.S. STAR scleroderma clinical trial data accepted for presentation at
Systemic Sclerosis World Congressin February 2018.
- BARDA executed a
$13.4 millioncontract option to fund the U.S. RELIEF burn clinical trial.
- Received U.S. FDA IDE approval for RELIEF, a thermal burn pilot trial related to ongoing BARDA contract.
Q3 2017 Financial Performance
- Q3 2017 and year-to-date operating cash burn was
$4.0 millionand $13.9 million, compared to $4.6 millionand $15.4 millionfor the same periods in 2016, respectively.
- Q3 2017 and year-to-date total revenues were
$1.8 millionand $4.9 million, compared to $2.6 millionand $8.4 millionfor the same periods in 2016, respectively.
- Cash and debt principal balances at
September 30, 2017were approximately $4.8 millionand $13.0 million, respectively.
- Q3 2017 net loss was
$4.8 millionor $0.14per share, compared to $5.4 millionor $0.26per share for Q3 2016.
- Year-to-date adjusted net loss was
$16.7 million, or $0.57per share, and excludes a $1.7 millionnon-cash charge for in-process research and development expense from the Azaya Therapeutics asset acquisition, compared to $17.1 millionor $1.06per share for the same period in 2016.
- Year-to-date GAAP net loss was
$18.4 millionor $0.62per share, compared to $17.1 millionor $1.06per share for the same period in 2016.
“Based on the completed analysis of our STAR trial data, including the strong safety profile, clinically meaningful improvements in the diffuse scleroderma subgroup and the lack of approved treatments with this orphan condition, we intend to meet with the U.S.
Selected Key Near-Term Milestones:
- Pursue meeting with U.S.
FDAto determine next steps required to obtain Habeo™ Cell Therapy regulatory approval for scleroderma-associated hand dysfunction.
- Begin enrollment of BARDA’s funded U.S. RELIEF burn clinical trial.
- Complete ATI-0918 manufacturing and regulatory activities required to prepare an application for the EMA.
- Complete enrollment of SCLERADEC-II and ADRESU clinical trials in
Franceand Japan, respectively.
2017 Financial Guidance - Updated
The Company expects full year 2017 operating cash burn to be lower than 2016, primarily due to the restructuring announced in
- Updated operating cash burn forecasted to be within a range of
$17 million to $19 million, a reduction from previously guided range of $20 million to $23 million.
Management Conference Call Webcast
Cytori will host a management conference call at
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for 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. Cytori Nanomedicine™ is developing encapsulated therapies for regenerative medicine and oncologic indications using technology that allows Cytori to use the benefits of its encapsulation platform to develop novel therapeutic strategies and reformulate other drugs to optimize their clinical properties. For more information, visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
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 anticipated commercial launch of our Habeo™ therapy and ATI-0918 drug candidate (and timing thereof); completion of manufacturing activities necessary to submit an MAA to the EMA for our ATI-0918 drug candidate; our strategy for addressing our capital requirements through various activities, including operational efficiencies, revenue growth and accessing the capital markets; receipt of feedback from, and related discussions with, BARDA regarding our future contractual relationship with BARDA (and proposed BARDA funding of our thermal burn pilot trial); and our expected 2017 cash burn and reasons for the anticipated cash burn; 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 conduct and completion of the proposed thermal burn trial, as well as the Company’s anticipated submission of data to the EMA from the previously completed bioequivalency trial for ATI-0918 . Specifically, the Company faces risks in the collection and results of the STAR scleroderma and RELIEF thermal burn trials, including enrollment risks, the risks that clinical data from one or more of these clinical trials will fail to demonstrate safety or efficacy of our product candidates, and risks that insufficiently positive clinical data will adversely affect government funding, regulatory approval pathways and commercial prospects for our cell therapy (e.g., Habeo), and nanomedicines product candidates. We also face risks that investigator-initiated trials using our Cytori Cell Therapy fail to fully enroll or otherwise are conducted in a manner that ultimately is injurious to our business. We also face the risk that we will be unable to time successfully manufacture our ATI-0918 drug candidate in time to meet our projected timeline for submission of an MAA to the EMA, or at all. We also face risks regarding execution of our managed access program (MAP) strategy in
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.
CONSOLIDATED CONDENSED BALANCE SHEETS
(in thousands, except share and par value data)
|As of September 30,
|As of December 31,
|Cash and cash equivalents||$||4,783||$||12,560|
|Accounts receivable, net of reserves of $167 in both 2017 and 2016,
|Other current assets||892||870|
|Total current assets||9,842||18,747|
|Property and equipment, net||3,308||1,157|
|Liabilities and Stockholders’ Equity|
|Accounts payable and accrued expenses||$||4,907||$||5,872|
|Current portion of long-term obligations, net of discount||13,497||6,629|
|Total current liabilities||18,404||12,501|
|Long-term deferred rent and other||120||17|
|Long-term obligations, net of discount, less current portion||11,008|
|Commitments and contingencies|
|Series A 3.6% convertible preferred stock, $0.001 par value; 5,000,000 shares
authorized; 13,500 shares issued; no shares outstanding in 2017 and 2016
|Common stock, $0.001 par value; 75,000,000 shares authorized; 34,716,318 and
21,707,890 shares issued and outstanding in 2017 and 2016, respectively
|Additional paid-in capital||404,047||388,769|
|Accumulated other comprehensive income||1,199||1,258|
|Total stockholders’ equity||7,819||10,986|
|Total liabilities and stockholders’ equity||$||26,446||$||34,609|
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
|For the Three Months Ended
|For the Nine Months Ended
|Cost of product revenues||181||561||992||1,533|
|Amortization of intangible assets||306||57||919||237|
|Gross (loss) profit||(20||)||113||116||1,420|
|Government contracts and other||1,306||1,879||2,856||5,163|
|Research and development||3,004||3,960||9,284||13,334|
|Sales and marketing||840||818||3,043||2,742|
|General and administrative||1,785||2,011||6,012||6,623|
|In process research and development acquired from Azaya Therapeutics||—||—||1,686||—|
|Total operating expenses||5,629||6,789||20,025||22,699|
|Other income (expense):|
|Other income, net||5||54||233||928|
|Total other expense||(464||)||(587||)||(1,346||)||(1,011||)|
|Basic and diluted net loss per share||$||(0.14||)||$||(0.26||)||$||(0.62||)||$||(1.06||)|
|Basic and diluted weighted average shares used in calculating net loss per share||34,490,828||20,493,840||29,564,032||16,147,042|
|Other comprehensive loss – foreign currency translation
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
|For the Nine Months Ended September 30,|
|Cash flows from operating activities:|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Depreciation and amortization||1,618||794|
|Amortization of deferred financing costs and debt discount||580||714|
|In process research and development acquired from Azaya Therapeutics||1,686||—|
|Joint Venture acquisition obligation accretion||—||24|
|Provision for expired inventory||413||26|
|Stock-based compensation expense||588||925|
|Loss on asset disposal||9||2|
|Increases (decreases) in cash caused by changes in operating assets and liabilities:|
|Other current assets||(284||)||205|
|Accounts payable and accrued expenses||(1,746||)||(1,013||)|
|Long-term deferred rent||103||(227||)|
|Net cash used in operating activities||(13,904||)||(15,372||)|
|Cash flows from investing activities:|
|Purchases of property and equipment||(271||)||(110||)|
|Proceeds from sale of assets||10||—|
|Purchase of long-lived assets part of Azaya Therapeutics' acquisition||(1,201||)||—|
|Change in restricted cash||(79||)||—|
|Net cash used in investing activities||(1,541||)||(110||)|
|Cash flows from financing activities:|
|Principal payments on long-term obligations||(4,720||)||—|
|Joint Venture purchase payments||—||(1,774||)|
|Proceeds from sale of common stock, net||12,377||17,702|
|Net cash provided by financing activities||7,657||15,928|
|Effect of exchange rate changes on cash and cash equivalents||11||140|
|Net (decrease) increase in cash and cash equivalents||(7,777||)||586|
|Cash and cash equivalents at beginning of period||12,560||14,338|
|Cash and cash equivalents at end of period||$||4,783||$||14,924|
|Cytori Therapeutics contact|