Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”)
today announced Q3 2018 financial results and provided updates on
corporate activities.
Q3 2018 net loss was $2.3 million, or $0.27 per
share. Operating cash burn for Q3 was approximately $2.6 million.
Cytori ended Q3 with approximately $6.8 million of cash and cash
equivalents.
Cytori is developing its lead chemotherapy drug,
ATI-0918, a generic version of pegylated liposomal doxorubicin
hydrochloride, with the goal of submitting a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) next year. We previously completed a bioequivalence
study against the European reference drug and are in the process of
completing manufacturing-related activities to support the MAA.
The Company also continues to evaluate potential commercial
partnering opportunities for ATI-0918 with a focus on Europe, which
has a current estimated market size of over $120 million.
Cytori is also developing another chemotherapy
drug, 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 intends to pursue
FDA’s 505(b)(2) new drug application (NDA) pathway in the U.S.
which may offer accelerated and lower cost development.
In the first half of 2019, Cytori expects a
1-year data readout from the 45 patient, multi-center, potential
pivotal clinical trial in stress urinary incontinence conducted in
Japan called ADRESU.
Later in 2018, Cytori expects a 6-month data
readout from the 40 patient, French SCLERADEC II clinical trial in
scleroderma patients.
Cytori is actively conducting the U.S. Phase I
RELIEF trial in thermal burn injury trial sponsored by BARDA.
Cytori completed a successful In-Process Review meeting with BARDA
this past June.
Commercially, Cytori is focusing its efforts in
Japan and continues to see favorable growth trends in the use of
its cell therapy products approved under the Regenerative Medicine
Law in the aesthetic and orthopedic markets. The Company remains on
track to see continued double digit year-over-year growth in
Celution® System consumable utilization.
Finally, Cytori recently received the first $1.0
million royalty milestone from Bimini Technologies, LLC (Bimini).
In 2013, Cytori divested the Puregraft® product line that includes
periodic royalty payments of up to $10.0 million and certain other
economic benefits based on Bimini achieving gross profits
milestones.
“A key corporate objective is to complete
manufacturing support activities and seek European marketing
authorization for ATI-0918, our lead oncology drug product.
Furthermore, we have recently expanded development activities for
the ATI-1123 phase II oncology program and its potential 505(b)(2)
acceptability,” said Dr. Marc Hedrick, President and Chief
Executive Officer of Cytori. “In cell therapy, we are focused on
continued revenue growth based on positive quarter-over-quarter and
year-over-year consumable utilization trends. In the meantime, we
are awaiting pivotal clinical data from our Japanese stress urinary
incontinence trial."
Q3 2018 and year-to-date Financial
Performance
- Q3 2018 and year-to-date operating cash burn was $2.6 million
and $9.5 million, compared to $4.0 million and $13.9 million for
the same periods in 2017, respectively.
- Q3 2018 and year-to-date product revenues were $0.9 million and
$2.2 million, compared to $0.5 million and $2.0 million for the
same periods in 2017, respectively.
- Q3 2018 and year-to-date contract revenues were $0.5 million
and $2.3 million, compared to $1.3 million and $2.9 million for the
same periods in 2017, respectively.
- Q3 2018 and year-to-date consumable utilization in Japan grew
by approximate 90% and 70%, when comparing to the same periods in
2017, respectively.
- Cash and debt principal balances at September 30, 2018 were
approximately $6.8 million and $13.0 million, respectively.
- Q3 2018 adjusted net loss was $4.0 million or $0.45 per share,
compared to a net loss of $4.8 million or $1.39 per share for the
same period in 2017. The adjusted net loss excludes a non-cash
beneficial conversion feature (a non gaap measure) related to the
issuance of our Series C convertible preferred shares in the third
quarter of 2018 of $2.5 million, as well as a credit of $1.7
million related to a change in fair value of warrant liability (a
non gaap measure). Q3 2018 net loss allocable to common
stockholders was $4.8 million, or $0.55 per share.
- Year-to-date 2018 adjusted net loss was $12.1 million or $1.73
per share, compared to $18.4 million or $6.22 per share for the
same period in 2017. The adjusted net loss excludes a non-cash
beneficial conversion feature (a non gaap measure) related to the
issuance of our Series C convertible preferred shares in the third
quarter of 2018 of $2.5 million, as well as a credit of $1.7
million related to a change in fair value of warrant liability (a
non gaap measure). Year-to-date 2018 net loss allocable to common
stockholders was $12.9 million, or $1.85 per share.
Selected Key Anticipated
Milestones:
- Complete ATI-0918 development and
manufacturing required to prepare and file a MAA with the EMA.
- Seek FDA 505(b)(2) pathway
applicability for ATI-1123 product.
- Obtain Japan MHLW Class III
approval for Celution® System consumables.
- Report 1-year Japanese ADRESU
pivotal clinical trial data for post-surgical male stress urinary
incontinence.
- Enrollment update in the
BARDA-funded U.S. RELIEF clinical trial.
- Report French investigator
initiated SCLERADEC II clinical trial data in scleroderma hand
dysfunction.
Management Conference Call
Webcast
Cytori will host a management conference call at
5:30 p.m. Eastern Time today to further discuss its 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: 9699923.
About Cytori
Cytori is developing, manufacturing, and
commercializing nanoparticle-delivered oncology drugs and
autologous adipose-derived regenerative cell (ADRC) therapies
within its Nanomedicine™ and Cell Therapy™ franchises,
respectively. Cytori Nanomedicine™ is focused on the
liposomal encapsulation of anti-neoplastic chemotherapy agents,
which may enable the effective delivery of the agents to target
sites while reducing systemic toxicity. The Cytori
Nanomedicine™ product 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. Cytori Cell
Therapy™, prepared within several hours with the proprietary
Celution® System and administered to the patient the same day, has
been shown in preclinical and clinical studies to act 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.
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 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; 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 Company-sponsored RELIEF 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. 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. Some of these risks also include risks relating to
regulatory challenges the Company faces (including the U.S., EU,
China, Japan and its other key geographies) due to a number of
factors including novelty of the Company’s technology and product
offerings, changes in and /or evolution of regulatory approaches to
cellular therapeutics like the Company’s in its key geographies,
and similar matters. It is possible that the Company could face
unexpected revenue shortfalls, expense increases or other
occurrences that adversely affect our cash burn and cash management
strategies. Further the Company face risks pertaining to
dependence on third party performance and approvals (including
performance of investigator-initiated trials, outcome of BARDA’s
review of the Company’s proposed burn wound trial pursuant to its
contract with BARDA, and outcome of the EMA’s review of our
ATI-0918 MAA); performance and acceptance of the Company’s products
in clinical studies/trials and in the marketplace (including
commercial acceptance of the Company’s products in Japan and other
markets where are products are commercially available, and similar
risks); material changes in the marketplace that could adversely
impact revenue projections (including changes in market perceptions
of the Company’s products, and introduction of competitive
products); unexpected costs and expenses that could adversely
impact liquidity and shorten the Company’s current liquidity
projections (which could in turn require the Company to seek
additional debt or equity capital sooner than currently
anticipated); the Company’s reliance on key personnel; the
Company’s ability to identify and develop new programs or assets to
expand the Company’s clinical pipeline; the right of the U.S.
government (BARDA) to cut or terminate further support of the
thermal burn injury program (including any decision by BARDA not to
proceed with our proposed thermal burn trial); the Company’s
abilities to capitalize on its 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 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 September 30,2018 |
|
|
As of December 31,2017 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
6,806 |
|
|
$ |
9,550 |
|
Accounts
receivable, net of reserves of $185 in 2018 and $167 in 2017 |
|
|
440 |
|
|
|
145 |
|
Restricted cash |
|
|
40 |
|
|
|
675 |
|
Inventories, net |
|
|
2,814 |
|
|
|
3,183 |
|
Other
current assets |
|
|
654 |
|
|
|
1,311 |
|
Total
current assets |
|
|
10,754 |
|
|
|
14,864 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
2,648 |
|
|
|
3,052 |
|
Other assets |
|
|
1,938 |
|
|
|
2,570 |
|
Intangibles, net |
|
|
6,270 |
|
|
|
7,207 |
|
Goodwill |
|
|
3,922 |
|
|
|
3,922 |
|
Total
assets |
|
$ |
25,532 |
|
|
$ |
31,615 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
3,645 |
|
|
$ |
4,790 |
|
Term loan
obligations, net of discount |
|
|
14,007 |
|
|
|
13,624 |
|
Total
current liabilities |
|
|
17,652 |
|
|
|
18,414 |
|
|
|
|
|
|
|
|
|
|
Deferred revenues |
|
|
187 |
|
|
|
94 |
|
Long-term deferred rent
and other |
|
|
83 |
|
|
|
107 |
|
Warrant liability |
|
|
1,472 |
|
|
|
— |
|
Total
liabilities |
|
|
19,394 |
|
|
|
18,615 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; 23,500 shares
issued; 4,624 and 2,431 shares outstanding in 2018 and 2017,
respectively |
|
|
— |
|
|
— |
|
Common
stock, $0.001 par value; 100,000,000 shares authorized; 11,691,293
and 5,782,573 shares issued and outstanding in 2018 and 2017,
respectively |
|
|
67 |
|
|
|
58 |
|
Additional paid-in capital |
|
|
417,036 |
|
|
|
413,304 |
|
Accumulated other comprehensive income |
|
|
1,182 |
|
|
|
1,387 |
|
Accumulated deficit |
|
|
(412,147 |
) |
|
|
(401,749 |
) |
Total
stockholders’ equity |
|
|
6,138 |
|
|
|
13,000 |
|
Total
liabilities and stockholders’ equity |
|
$ |
25,532 |
|
|
$ |
31,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
September 30, |
|
|
For the Nine Months Ended
September 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Product revenues |
|
$ |
858 |
|
|
$ |
467 |
|
|
$ |
2,249 |
|
|
$ |
2,027 |
|
Cost of product
revenues |
|
|
322 |
|
|
|
181 |
|
|
|
918 |
|
|
|
992 |
|
Amortization of
intangible assets |
|
|
306 |
|
|
|
306 |
|
|
|
919 |
|
|
|
919 |
|
Gross
profit (loss) |
|
|
230 |
|
|
|
(20 |
) |
|
|
412 |
|
|
|
116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government contracts and other |
|
|
454 |
|
|
|
1,306 |
|
|
|
2,270 |
|
|
|
2,856 |
|
|
|
|
454 |
|
|
|
1,306 |
|
|
|
2,270 |
|
|
|
2,856 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
1,916 |
|
|
|
3,004 |
|
|
|
6,366 |
|
|
|
9,284 |
|
Sales and
marketing |
|
|
453 |
|
|
|
840 |
|
|
|
1,656 |
|
|
|
3,043 |
|
General
and administrative |
|
|
1,486 |
|
|
|
1,785 |
|
|
|
5,199 |
|
|
|
6,012 |
|
Change in
fair value of warrants |
|
|
(1,676 |
) |
|
|
— |
|
|
|
(1,676 |
) |
|
|
— |
|
In
process research and development acquired from Azaya
Therapeutics |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,686 |
|
Total
operating expenses |
|
|
2,179 |
|
|
|
5,629 |
|
|
|
11,545 |
|
|
|
20,025 |
|
Operating
loss |
|
|
(1,495 |
) |
|
|
(4,343 |
) |
|
|
(8,863 |
) |
|
|
(17,053 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
11 |
|
|
|
5 |
|
|
|
30 |
|
|
|
24 |
|
Interest
expense |
|
|
(512 |
) |
|
|
(474 |
) |
|
|
(1,379 |
) |
|
|
(1,603 |
) |
Other
income (expense), net |
|
|
9 |
|
|
|
5 |
|
|
|
157 |
|
|
|
233 |
|
Issuance
costs of warrants |
|
|
(343 |
) |
|
|
— |
|
|
|
(343 |
) |
|
|
— |
|
Total
other expense |
|
|
(835 |
) |
|
|
(464 |
) |
|
|
(1,535 |
) |
|
|
(1,346 |
) |
Net
loss |
|
$ |
(2,330 |
) |
|
$ |
(4,807 |
) |
|
$ |
(10,398 |
) |
|
$ |
(18,399 |
) |
Beneficial conversion feature for convertible preferred stock |
|
|
(2,487 |
) |
|
$ |
— |
|
|
|
(2,487 |
) |
|
$ |
— |
|
Net loss
allocable to common stockholders |
|
$ |
(4,817 |
) |
|
$ |
(4,807 |
) |
|
$ |
(12,885 |
) |
|
$ |
(18,399 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share attributable to common stockholders |
|
$ |
(0.55 |
) |
|
$ |
(1.39 |
) |
|
$ |
(1.85 |
) |
|
$ |
(6.22 |
) |
Basic and diluted
weighted average shares used in calculating net loss per share
attributable to common stockholders |
|
|
8,716,194 |
|
|
|
3,449,083 |
|
|
|
6,972,615 |
|
|
|
2,956,403 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,330 |
) |
|
$ |
(4,807 |
) |
|
$ |
(10,398 |
) |
|
$ |
(18,399 |
) |
Other comprehensive
loss – foreign currency translation adjustments |
|
|
(55 |
) |
|
|
16 |
|
|
|
(205 |
) |
|
|
(59 |
) |
Comprehensive loss |
|
$ |
(2,385 |
) |
|
$ |
(4,791 |
) |
|
$ |
(10,603 |
) |
|
$ |
(18,458 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYTORI THERAPEUTICS,
INC.CONSOLIDATED CONDENSED STATEMENTS OF CASH
FLOWS(UNAUDITED)(in
thousands)
|
|
For the Nine Months Ended
September 30, |
|
|
|
2018 |
|
|
2017 |
|
Cash flows from
operating activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,398 |
) |
|
$ |
(18,399 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,465 |
|
|
|
1,618 |
|
Amortization of deferred financing costs and debt discount |
|
|
383 |
|
|
|
580 |
|
In
process research and development acquired from Azaya
Therapeutics |
|
|
— |
|
|
|
1,686 |
|
Provision
for excess inventory |
|
|
433 |
|
|
|
413 |
|
Issuance
costs of warrants |
|
|
343 |
|
|
|
— |
|
Change in
fair value of warrants |
|
|
(1,676 |
) |
|
|
— |
|
Share-based compensation expense |
|
|
325 |
|
|
|
588 |
|
Loss on
asset disposal |
|
|
23 |
|
|
|
9 |
|
Increases
(decreases) in cash caused by changes in operating assets and
liabilities: |
|
|
|
|
|
|
|
|
Accounts
receivable |
|
|
(316 |
) |
|
|
991 |
|
Inventories |
|
|
615 |
|
|
|
457 |
|
Other
current assets |
|
|
514 |
|
|
|
(284 |
) |
Other
assets |
|
|
7 |
|
|
|
74 |
|
Accounts
payable and accrued expenses |
|
|
(1,274 |
) |
|
|
(1,746 |
) |
Deferred
revenues |
|
|
93 |
|
|
|
6 |
|
Long-term
deferred rent |
|
|
(24 |
) |
|
|
103 |
|
Net cash
used in operating activities |
|
|
(9,487 |
) |
|
|
(13,904 |
) |
Cash flows from
investing activities: |
|
|
|
|
|
|
|
|
Purchases of property
and equipment |
|
|
(128 |
) |
|
|
(271 |
) |
Proceeds from sale of
assets |
|
|
— |
|
|
|
10 |
|
Purchase of long-lived
assets part of Azaya Therapeutics' acquisition |
|
|
— |
|
|
|
(1,201 |
) |
Net cash
used in investing activities |
|
|
(128 |
) |
|
|
(1,462 |
) |
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
Principal payments on
long-term obligations |
|
|
— |
|
|
|
(4,720 |
) |
Proceeds from sale of
common and preferred stock, net |
|
|
6,246 |
|
|
|
12,377 |
|
Net cash
provided by financing activities |
|
|
6,246 |
|
|
|
7,657 |
|
Effect of
exchange rate changes on cash and cash equivalents |
|
|
(10 |
) |
|
|
11 |
|
Net
decrease in cash and cash equivalents |
|
|
(3,379 |
) |
|
|
(7,698 |
) |
Cash, cash equivalents,
and restricted cash at beginning of period |
|
|
10,225 |
|
|
|
12,910 |
|
Cash, cash equivalents,
and restricted cash at end of period |
|
$ |
6,846 |
|
|
$ |
5,212 |
|
|
|
|
|
|
|
|
|
|
CYTORI THERAPEUTICS CONTACTTiago
Girao+1.858.458.0900ir@cytori.com
Cytori Therapeutics (NASDAQ:CYTX)
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Cytori Therapeutics (NASDAQ:CYTX)
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From Sep 2023 to Sep 2024