Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
reported financial results for the quarter and six months ended
June 30, 2013.
Aastrom reported a net loss attributable to common shareholders
for the quarter and six months ended June 30, 2013 of $4.9 million,
or $0.11 per share, and $11.7 million, or $0.26 per share,
respectively, compared to $8.6 million, or $0.22 per share, and
$18.3 million, or $0.47 per share, for the same periods a year ago.
The substantial decrease in net loss attributable to common
shareholders from the prior year is primarily due to the non-cash
change in the fair value of warrants and decreases in research and
development and general and administrative expenses.
Research and development expenses for the quarter and six months
ended June 30, 2013 were $3.7 million and $9.2 million,
respectively, versus $7.1 million and $13.9 million for the same
periods a year ago. The decrease is due to a reduction in clinical
trial expenses due to stopping enrollment in the Phase 3 REVIVE
clinical trial, the execution of a corporate restructuring that
substantially reduced headcount and operating expenses, and the
reversal of non-cash stock compensation expenses due to the
forfeiture of stock options.
General and administrative expenses for the quarter and six
months ended June 30, 2013 were $1.6 million and $3.2 million,
respectively, compared to $2.2 million and $4.0 million for the
same periods a year ago. The decrease is due to the reduction of
operating expenses resulting from the corporate restructuring and
the reversal of non-cash stock compensation expense related to the
forfeiture of stock options.
Other income for the quarter and six months ended June 30, 2013
was $0.3 million and $2.0 million, respectively, compared to $2.0
million and $1.1 million for the same periods a year ago. The
change in value was primarily due to non-cash changes in the fair
value of warrants, resulting from the change in the price of the
company's common stock during each period and a reduction in the
number of warrants outstanding during 2012.
As of June 30, 2013, the company had $4.5 million in cash and
cash equivalents, compared to $13.6 million in cash and cash
equivalents at December 31, 2012. For the quarter and six
months ended June 30, 2013, cash used for operations was $4.7
million and $11.5 million, respectively.
Recent Business Highlights
During and since the second quarter of 2013, the company
has:
- Initiated and continued enrollment and treatment of patients in
the Phase 2b ixCELL-DCM clinical study of ixmyelocel-T for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy (DCM).
- Completed a successful meeting with Health Canada regarding
submission of a clinical trial application (CTA) to initiate
clinical trial activities for the Phase 2b ixCELL-DCM study in
Canada.
- Launched a Steering Committee of internationally-renowned
cardiovascular and cell therapy clinical investigators to support
the ixCELL-DCM clinical study, including Dr. Amit Patel, University
of Utah; Dr. Timothy Henry, Minneapolis Heart Institute Foundation;
Dr. Gary Schaer, Rush University Medical Center; and Dr. Anthony
DeMaria, UC San Diego.
- Filed an amended registration statement with the Securities and
Exchange Commission to sell up to $15 million of stock (or $17.3
million if the underwriters' over-allotment option is exercised in
full) to support ongoing and future clinical programs and expand
the company's product portfolio.
- Amended the REVIVE-CLI study protocol to evaluate enrolled
patients for safety and certain efficacy endpoints at 12
months.
- Continued to support clinical evaluation of ixmyelocel-T at the
University of Michigan for patients with craniofacial defects
undergoing reconstructive surgery.
- Received a Notice of Acceptance in Australia of the patent
application covering the composition of matter and methods of use
for ixmyelocel-T.
"Proceeds from the completion of our current follow-on stock
offering will position us to advance our ongoing clinical and
preclinical programs, which remains our primary focus moving
forwards," said Nick Colangelo, president and chief executive
officer of Aastrom. "We remain very encouraged by progress in
both site activation and patient enrollment in the Phase 2b
ixCELL-DCM clinical trial, which we expect to complete by the end
of the first quarter next year, as well as by our continuing
clinical activities in CLI and craniofacial reconstruction. We
believe that our current follow-on offering, together with the
advancement of our clinical programs and other portfolio expansion
initiatives, are positioned to create significant value for the
company going forward."
Conference Call Information
Aastrom's management will host a conference call to discuss
these results on Thursday, August 15, 2013 at 4:30 p.m. Eastern
time. Interested parties should call toll-free (877)
312-5881, or from outside the U.S. (253) 237-1173 and use
conference ID 28894780. The call will be available live in
the Investors section of Aastrom's website at
http://investors.aastrom.com/investors.cfm. A replay of the
call will be available until August 19, 2013 by calling (855)
859-2056, or from outside the U.S. at (404) 537-3406 and using
conference ID 28894780. The webcast will also be available
after the live event at http://investors.aastrom.com/events.cfm
until August 7, 2014.
About Aastrom Biosciences
Aastrom Biosciences is the leader in developing
patient-specific, expanded multicellular therapies for use in the
treatment of patients with severe, chronic cardiovascular diseases.
The company's proprietary cell-processing technology enables
the manufacture of ixmyelocel-T, a patient-specific multicellular
therapy expanded from a patient's own bone marrow and delivered
directly to damaged tissues. Aastrom has advanced
ixmyelocel-T into late-stage clinical development, including a
Phase 2b clinical trial in patients with ischemic dilated
cardiomyopathy. For more information, please visit Aastrom's
website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including,
without limitation, statements concerning clinical trial plans and
progress, objectives and expectations, clinical activity timing,
intended product development, the performance and contribution of
certain individuals and expected timing of collecting and analyzing
treatment data, all of which involve certain risks and
uncertainties. These statements are often, but are not always, made
through the use of words or phrases such as "anticipates,"
"intends," "estimates," "plans," "expects," "we believe," "we
intend," and similar words or phrases, or future or conditional
verbs such as "will," "would," "should," "potential," "could,"
"may," or similar expressions. Actual results may differ
significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are the inherent uncertainties associated with clinical
trial and product development activities, regulatory approval
requirements, competitive developments, and the availability of
resources and the allocation of resources among different potential
uses. These and other significant factors are discussed in greater
detail in Aastrom's Registration Statement on Form S-1/A, Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q and other
filings with the Securities and Exchange Commission. These
forward-looking statements reflect management's current views and
Aastrom does not undertake to update any of these forward-looking
statements to reflect a change in its views or events or
circumstances that occur after the date of this release except as
required by law.
AASTROM BIOSCIENCES,
INC. |
(in thousands, except
per share amounts) |
|
|
|
CONDENSED CONSOLIDATED
BALANCE SHEETS (Unaudited) |
|
|
|
|
December 31, |
June 30, |
|
2012 |
2013 |
ASSETS |
|
|
Cash and cash equivalents |
$13,638 |
$4,494 |
Other current assets |
352 |
236 |
Property and equipment, net |
1,188 |
953 |
Total assets |
$15,178 |
$5,683 |
|
|
|
LIABILITIES CONVERTIBLE PREFERRED
STOCK AND SHAREHOLDERS' DEFICIT |
|
|
Warrant liabilities |
$1,995 |
$31 |
Other current liabilities |
3,664 |
3,811 |
Long-term debt |
6 |
-- |
Series B-1 non-voting convertible
preferred stock |
3,923 |
5,186 |
Series B-2 voting convertible preferred
stock |
37,690 |
37,690 |
Shareholders' deficit |
(32,100) |
(41,035) |
Total liabilities, convertible preferred
stock and shareholders' deficit |
$15,178 |
$5,683 |
|
|
|
|
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (Unaudited) |
|
|
|
|
|
|
Quarter
Ended |
Six Months
Ended |
|
June
30, |
June
30, |
|
2012 |
2013 |
2012 |
2013 |
|
|
|
|
|
REVENUES |
$ -- |
$3 |
$2 |
$11 |
|
|
|
|
|
COSTS AND EXPENSES |
|
|
|
|
Cost of product sales and rentals |
-- |
1 |
2 |
3 |
Research and development |
7,069 |
3,676 |
13,865 |
9,214 |
Selling, general and administrative |
2,231 |
1,560 |
3,993 |
3,193 |
Total costs and expenses |
9,300 |
5,237 |
17,860 |
12,410 |
|
|
|
|
|
LOSS FROM OPERATIONS |
(9,300) |
(5,234) |
(17,858) |
(12,399) |
|
|
|
|
|
OTHER INCOME |
|
|
|
|
Decrease in fair value of warrants |
1,948 |
345 |
1,048 |
1,964 |
Other income, net |
17 |
-- |
20 |
2 |
Total other income |
1,965 |
345 |
1,068 |
1,966 |
|
|
|
|
|
NET LOSS |
(7,335) |
(4,889) |
(16,790) |
(10,433) |
|
|
|
|
|
ACCRETION OF CONVERTIBLE PREFERRED
STOCK |
1,231 |
-- |
1,520 |
1,263 |
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO COMMON
SHAREHOLDERS |
($8,566) |
($4,889) |
($18,310) |
($11,696) |
|
|
|
|
|
NET LOSS PER SHARE ATTRIBUTABLE TO
COMMON SHAREHOLDERS (Basic and Diluted) |
($0.22) |
($0.11) |
($0.47) |
($0.26) |
|
|
|
|
|
Weighted average number of common shares
outstanding (Basic and Diluted) |
38,882 |
45,664 |
38,812 |
45,266 |
CONTACT: Media contact
Andrea Coan
Berry & Company
acoan@berrypr.com
(212) 253-8881
Investor contact
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
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