Cytori Reports Q1 2019 Business and Financial Results
May 14 2019 - 4:50PM
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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