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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): May 14, 2019
CYTORI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
|
Delaware |
001-34375 |
33-0827593 |
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(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
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):
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company □
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. □
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
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Common Stock, par value $0.001 |
CYTX |
Nasdaq Capital Market |
Item 2.02Results of Operations and Financial Condition
On May 14, 2019, Cytori Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2019. 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.
Item 9.01Financial Statements and Exhibits
(d)Exhibits
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Exhibit No. |
Description |
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99.1 |
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.
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CYTORI THERAPEUTICS, INC. |
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Date: May 14, 2019 |
By: /s/ Gary Titus |
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Gary Titus |
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Chief Financial Officer |
Exhibit 99.1
Cytori Reports Q1 2019 Business and Financial Results
SAN DIEGO, May 14, 2019—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
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Q1 2019 operating cash burn was $3.3 million, compared to $4.1 million for Q1 2018. |
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Q1 2019 product revenues were $0.7 million, compared to $0.7 million for Q1 2018. |
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Q1 2019 contract revenues were $0.7 million, compared to $0.9 million for Q1 2018. |
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• |
Q1 2019 Celution® consumable utilization grew by approximately 20% as compared to Q1 2018. |
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Cash and debt principal balances at March 31, 2019 were approximately $3.9 million and $13.0 million, respectively. |
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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)
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As of March 31, 2019 |
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As of December 31, 2018 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
3,872 |
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$ |
5,261 |
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Accounts receivable, net of reserves of $185 in 2019 and $185 in 2018 |
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455 |
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286 |
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Restricted cash |
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40 |
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40 |
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Inventories, net |
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3,003 |
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2,947 |
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Other current assets |
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1,092 |
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1,114 |
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Total current assets |
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8,462 |
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9,648 |
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Property and equipment, net |
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2,607 |
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2,559 |
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Operating lease right-of-use assets |
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2,153 |
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— |
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Other assets |
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1,827 |
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1,905 |
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Intangibles, net |
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5,645 |
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5,957 |
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Goodwill |
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3,922 |
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3,922 |
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Total assets |
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$ |
24,616 |
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$ |
23,991 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
3,224 |
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$ |
3,357 |
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Operating lease liability |
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700 |
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— |
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Term loan obligations, net of discount |
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14,371 |
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14,202 |
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Total current liabilities |
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18,295 |
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17,559 |
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Deferred revenues |
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142 |
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167 |
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Other noncurrent liabilities |
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98 |
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124 |
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Noncurrent operating lease liability |
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1,518 |
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— |
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Warrant liability |
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706 |
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916 |
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Total liabilities |
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20,759 |
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18,766 |
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Commitments and contingencies |
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Stockholders’ equity: |
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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 |
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— |
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— |
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Common stock, $0.001 par value; 100,000,000 shares authorized; 21,905,795 and 14,830,414 shares issued and outstanding in 2019 and 2018, respectively |
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22 |
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15 |
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Additional paid-in capital |
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420,290 |
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418,375 |
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Accumulated other comprehensive income |
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1,078 |
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1,218 |
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Accumulated deficit |
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(417,533 |
) |
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(414,383 |
) |
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Total stockholders’ equity |
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3,857 |
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5,225 |
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Total liabilities and stockholders’ equity |
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$ |
24,616 |
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$ |
23,991 |
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CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(in thousands, except share and per share data)
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For the Three Months Ended March 31, |
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2019 |
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2018 |
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Product revenues |
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$ |
703 |
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$ |
731 |
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Cost of product revenues |
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(353 |
) |
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(273 |
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Amortization of intangible assets |
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(306 |
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(306 |
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Gross profit |
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44 |
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152 |
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Development revenues: |
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Government contracts and other |
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737 |
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917 |
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737 |
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917 |
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Operating expenses: |
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Research and development |
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1,846 |
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2,499 |
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Sales and marketing |
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428 |
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678 |
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General and administrative |
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1,508 |
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2,244 |
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Total operating expenses |
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3,782 |
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5,421 |
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Operating loss |
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(3,001 |
) |
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(4,352 |
) |
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Other income (expense): |
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Interest income |
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7 |
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14 |
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Interest expense |
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(515 |
) |
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(423 |
) |
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Other income (expense), net |
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149 |
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352 |
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Change in fair value of warrants |
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210 |
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— |
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Total other expense |
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(149 |
) |
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(57 |
) |
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Net loss |
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$ |
(3,150 |
) |
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$ |
(4,409 |
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Basic and diluted net loss per share attributable to common stockholders |
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$ |
(0.18 |
) |
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$ |
(0.73 |
) |
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Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders |
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17,657,108 |
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6,017,791 |
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Comprehensive loss: |
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Net loss |
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$ |
(3,150 |
) |
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$ |
(4,409 |
) |
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Other comprehensive loss – foreign currency translation adjustments |
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(140 |
) |
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(281 |
) |
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Comprehensive loss |
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$ |
(3,290 |
) |
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$ |
(4,690 |
) |
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
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For the Three Months Ended March 31, |
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2019 |
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2018 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(3,150 |
) |
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$ |
(4,409) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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443 |
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497 |
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Amortization of deferred financing costs and debt discount |
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168 |
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105 |
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Provision for excess inventory |
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— |
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326 |
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Change in fair value of warrants |
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(210 |
) |
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— |
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Share-based compensation expense |
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49 |
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143 |
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Loss on asset disposal |
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— |
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22 |
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Increases (decreases) in cash caused by changes in operating assets and liabilities: |
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Accounts receivable |
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(212 |
) |
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(747) |
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Inventories |
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16 |
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141 |
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Other current assets |
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16 |
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301 |
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Other assets |
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1 |
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(24) |
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Accounts payable and accrued expenses |
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(405 |
) |
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(556) |
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Deferred revenues |
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(25 |
) |
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84 |
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Other long-term liabilities |
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39 |
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(2) |
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Net cash used in operating activities |
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(3,270 |
) |
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(4,119) |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(6 |
) |
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(53) |
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Net cash used in investing activities |
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(6 |
) |
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(53) |
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Cash flows from financing activities: |
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Payment of financing lease liability |
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(28 |
) |
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— |
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Proceeds from sale of common stock, net |
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1,919 |
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(150) |
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Net cash provided by (used in) financing activities |
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1,891 |
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(150) |
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Effect of exchange rate changes on cash and cash equivalents |
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(4 |
) |
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39 |
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Net decrease in cash and cash equivalents |
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(1,389 |
) |
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(4,283) |
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Cash, cash equivalents, and restricted cash at beginning of period |
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5,301 |
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10,225 |
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Cash, cash equivalents, and restricted cash at end of period |
|
$ |
3,912 |
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$ |
5,942 |