RANCHO CORDOVA, Calif.,
May 14, 2019 /PRNewswire/
-- Cesca Therapeutics Inc. (Nasdaq: KOOL), a market leader in
automated cell processing and autologous cell therapies for
regenerative medicine, today announced financial and operating
results for the first quarter ended March
31, 2019 and provided a corporate update.
First Quarter 2019 Highlights:
- Cesca entered into a reorganization of the business and equity
ownership of its majority-owned ThermoGenesis Corp. subsidiary. In
the reorganization, the cell-processing assets acquired by
ThermoGenesis from SynGen Inc. in July
2017 were contributed to a newly formed subsidiary of
ThermoGenesis named CARTXpress Bio, Inc., and a third party's 20%
interest in ThermoGenesis was exchanged for a 20% interest in
CARTXpress Bio. As a result of the reorganization, Cesca has become
the 100% owner of ThermoGenesis and holds, through ThermoGenesis,
an 80% equity interest in CARTXpress Bio.
- ThermoGenesis completed construction of a 1,000 square foot
in-house clean room, significantly expanding the company's
manufacturing capacity and ability to meet demand for its
X-Series® cartridges.
- Expanded adoption of ThermoGenesis' CAR-TXpress platform
technology to over 20 institutional customers by the end of the
quarter.
- ThermoGenesis signed a supply agreement with Orthohealing
Center Management, enabling Orthohealing's network of physicians to
prepare precise cell concentrates for its patients from autologous
bone marrow using ThermoGenesis's PXP® System.
- ThermoGenesis received clearance for labeling by TÜV Rheinland
for the X-Series Control Module and Docking Stations. This
clearance signifies that the company's CAR-TXpress platform tools
have been tested and comply with international standards for
electrical safety.
- ThermoGenesis received Health Canada approval for the
PXP® System for POC harvesting of purified mononuclear
cells and platelets from blood or bone marrow, an important step in
the company's commercialization efforts.
"The actions we have undertaken in just the first few months of
2019 have allowed us to more solidly position the company as an
emerging provider of highly differentiated cellular processing
solutions to the cell-based therapy market," said Chris Xu, PhD, Chief Executive Officer of Cesca.
"Of note, activities within our device division, ThermoGenesis,
have been robust, as we continue to expand visibility and sales of
our three proprietary platform technologies:
AutoXpress® for stem cell banking; POCXpress™ for
clinical cell therapy applications; and CAR-TXpress™ for large
scale CAR-T therapeutics manufacturers. Approval of our
PXP® system by Health Canada during the first quarter
further validates the value of this important technology."
Financial results for the first quarter 2019 showed a material
improvement compared to the same quarter a year ago. Revenues
increased by 59% and loss from operations dropped by 72% compared
to the first quarter of 2018. "The company is seeing the
positive impact of the reorganization it completed in 2018.
Increased revenues with lower overhead expenses have dramatically
improved the company's gross profit as compared to the same quarter
last year. These changes are helping to drive the company
towards its goal of being cash flow positive by the end of 2019,"
stated Jeff Cauble, Vice President
of Finance of Cesca.
Financial Results for the Quarter Ended March 31, 2019
Net revenues. Net revenues for the three months
ended March 31, 2019 were $3.0 million compared
to $1.9 million for the first quarter in 2018, an
increase of $1.1 million or 59% year
over year. The increase was driven by sale of AXP
disposables, which had shipments of approximately 250 cases to
distributors in China and
Europe during the quarter ended
March 31, 2019.
BioArchive® device sales also increased, driven by the
sale of more devices in the quarter ended March 31, 2019 as compared to the quarter ended
March 31, 2018.
Gross profit. Gross profit for the three months
ended March 31, 2019 was $1.3 million, or 42% of net
revenue, compared to $352,000, or 19.0% of net revenue, for
the comparable period in 2018. The gross profit margin
increase was driven by reduced overhead expenses as a result of the
June 2018 reorganization, lower
disposable costs through price efficiencies from contract
manufacturers and increased service revenue.
Sales and marketing expenses. Sales and marketing
expenses for the three months ended March 31,
2019 were $341,000 compared
to $325,000 for the comparable period in 2018.
Research and development expenses. Research and
development (R&D) expenses for the three months
ended March 31, 2019 were $563,000, compared
to $1.0 million for the comparable period in
2018. The decrease was driven primarily by a reduction in
personnel costs as a result of the June
2018 reorganization and reduced spending on R&D
projects.
General and administrative expenses. General and
administrative expenses for the three months ended March 31,
2019 were $1.3 million, compared to $2.2
million for the comparable period in 2018. The decrease was
driven by a decline in personnel costs due to the reorganization
completed in 2018, a reduction in legal expenses and lower employee
benefit costs as compared to the first quarter of 2018.
Loss from operations. For the quarter ended
March 31, 2019, loss from operations
was $906,000 as compared to
$3.3 million for the first quarter in
2018, a 72% decrease over the prior year comparable period. This
represents an increase in profitability from operations of
$2.4 million or 72% over the
comparable quarter from the prior year.
Net loss. For the three months ended March 31,
2019, the company reported a net loss attributable to common
stockholders of $1.9 million, or ($0.08) per share, based
on approximately 24.6 million weighted average basic and diluted
common shares outstanding. This compares to a net loss of $3.0
million, or ($0.27) per
share, based on approximately 11.1 million weighted average basic
and diluted common shares outstanding for the three months
ended March 31, 2018. The net loss for the quarter ended
March 31, 2019 included $586,000 of non-cash amortization relating to the
related party note payable, as compared to $0 for the quarter ended March 31, 2018.
At March 31, 2019, the company had
cash and cash equivalents totalling approximately $2.2 million, compared with approximately
$2.4 million at December 31, 2018.
Conference Call and Webcast Information
Cesca will
host a conference call today at 1:30pm
PT/4:30pm ET. To participate
in the conference call, please dial 1-844-889-4331 (domestic),
1-412-380-7406 (international) or 1-866-605-3852 (Canada). To access a live webcast of the call,
please visit:
http://investors.cescatherapeutics.com/events-and-presentations/events.
A replay of the call will be available for three weeks, until
June 4, and can be accessed by dialing 1-877-344-7529
(domestic), 1-412-317-0088 (international) or 855-669-9658
(Canada), and referencing access
code 10130653. The webcast will be available for three months.
About Cesca Therapeutics Inc.
Cesca Therapeutics
develops, commercializes and markets a range of automated
technologies for CAR-T and other cell-based therapies. Its device
division, ThermoGenesis develops, commercializes and markets a full
suite of solutions for automated clinical biobanking, point-of-care
applications, and automation for immuno-oncology. The company has
developed an automated, functionally-closed CAR-TXpress™ platform
to streamline the manufacturing process for the emerging CAR-T
immunotherapy market. For more information about Cesca,
please visit: www.CescaTherapeutics.com. For additional
information about ThermoGenesis, please visit:
www.thermogenesis.com.
Forward-Looking Statement
The statements contained
herein may include statements of future expectations and other
forward-looking statements that are based on management's current
views and assumptions and involve known and unknown risks and
uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in such
statements. A more complete description of risks that could cause
actual events to differ from the outcomes predicted by Cesca
Therapeutics' forward-looking statements is set forth under the
caption "Risk Factors" in Cesca Therapeutics' annual report on Form
10-K and other reports it files with the Securities and Exchange
Commission from time to time, and you should consider each of those
factors when evaluating the forward-looking statements.
Company Contact:
Wendy
Samford
916-858-5191
ir@thermogenesis.com
Investor Contact:
Paula
Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com
Financials
Cesca Therapeutics
Inc.
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
March 31,
2019
|
|
December
31,
2018
|
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$2,237,000
|
|
$2,400,000
|
|
|
Accounts
receivable, net
|
|
1,994,000
|
|
1,509,000
|
|
|
Inventories
|
|
4,309,000
|
|
4,493,000
|
|
|
Prepaid
expenses and other current assets
|
|
313,000
|
|
224,000
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
8,853,000
|
|
8,626,000
|
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
1,000,000
|
|
1,000,000
|
|
|
Equipment,
net
|
|
2,443,000
|
|
2,562,000
|
|
|
Right-of-use
operating lease assets, net
|
|
941,000
|
|
--
|
|
|
Goodwill
|
|
781,000
|
|
781,000
|
|
|
Intangible assets,
net
|
|
1,561,000
|
|
1,591,000
|
|
|
Other
assets
|
|
51,000
|
|
51,000
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$15,630,000
|
|
$14,611,000
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$2,464,000
|
|
$2,423,000
|
|
|
Other
current liabilities
|
|
3,143,000
|
|
3,942,000
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
5,607,000
|
|
6,365,000
|
|
|
|
|
|
|
|
|
|
Long-term
liabilities
|
|
3,744,000
|
|
1,515,000
|
|
|
|
|
|
|
|
|
|
Cesca Therapeutics
Inc. stockholders' equity
|
|
5,323,000
|
|
8,442,000
|
|
|
|
|
|
|
|
|
|
Noncontrolling
interests
|
|
956,000
|
|
(1,711,000)
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
|
$15,630,000
|
|
$14,611,000
|
|
Cesca Therapeutics
Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
|
2019
|
|
2018
|
|
Net
revenues
|
$2,962,000
|
|
$1,867,000
|
|
|
|
|
|
|
Cost of
revenues
|
1,704,000
|
|
1,515,000
|
|
|
|
|
|
|
Gross profit
|
1,258,000
|
|
352,000
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
Sales
and marketing
|
341,000
|
|
325,000
|
|
|
|
|
|
|
Research
and development
|
563,000
|
|
1,041,000
|
|
|
|
|
|
|
General
and administration
|
1,260,000
|
|
2,242,000
|
|
|
|
|
|
|
Total operating
expenses
|
2,164,000
|
|
3,608,000
|
|
|
|
|
|
|
Loss from
operations
|
(906,000)
|
|
(3,256,000)
|
|
|
|
|
|
|
Fair value change of
derivative instruments
|
--
|
|
259,000
|
|
Interest
expense
|
(1,132,000)
|
|
(361,000)
|
|
Other
(expenses)
|
(9,000)
|
|
(12,000)
|
|
|
|
|
|
|
Net loss
|
(2,047,000)
|
|
(3,370,000)
|
|
|
|
|
|
|
Loss attributable to
noncontrolling interests
|
(176,000)
|
|
(410,000)
|
|
|
|
|
|
|
Net loss attributable
to common stockholders
|
$(1,871,000)
|
|
$(2,960,000)
|
|
Cesca Therapeutics
Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2019
|
|
2018
|
Cash flows from
operating activities:
|
|
|
|
Net
cash used in operating activities
|
$(2,443,000)
|
|
$(2,063,000)
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
Capital
expenditures
|
(38,000)
|
|
(290,000)
|
Cash flows from
financing activities:
|
|
|
|
Payments on capital lease
obligations
|
--
|
|
--
|
Proceeds from issuance of
common stock, net
|
--
|
|
1,213,000
|
Proceeds from long-term
debt-related party
|
1,513,000
|
|
500,000
|
Proceeds from note payable
|
800,000
|
|
--
|
Proceeds from exercise of pre-funded warrants
|
5,000
|
|
--
|
|
|
|
|
Net
cash provided by financing activities
|
2,318,000
|
|
1,713,000
|
|
|
|
|
Effects of foreign
currency rate changes on cash and cash equivalents
|
--
|
|
(1,000)
|
Net decrease in cash,
cash equivalents and restricted cash
|
(163,000)
|
|
(641,000)
|
|
|
|
|
Cash, cash
equivalents and restricted cash at beginning of period
|
3,400,000
|
|
4,513,000
|
Cash, cash
equivalents and restricted cash at end of period
|
$3,237,000
|
|
$3,872,000
|
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SOURCE Cesca Therapeutics Inc.