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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 16, 2011
Aastrom Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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Michigan
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000-22025
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94-3096597 |
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(State or other jurisdiction
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(Commission
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(I.R.S. Employer |
of incorporation)
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File Number)
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Identification No.) |
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24 Frank Lloyd Wright Drive, P.O. Box
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376, Ann Arbor, Michigan |
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48106 |
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(Address of principal executive
offices)
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(Zip Code) |
Registrants telephone number, including area code: (734) 418-4400
Not Applicable
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition
On May 16, 2011, the Registrant issued a press release, a copy of which is attached hereto as
Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1 Press release, dated May 16, 2011.
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SIGNATURE
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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Date: May 16, 2011 |
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Aastrom Biosciences, Inc. |
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By:
Name:
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/s/ Timothy Mayleben
Timothy
Mayleben |
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Title:
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Chief Executive Officer and President |
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exv99w1
Exhibit 99.1
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Aastrom Biosciences
Dominos Farms, Lobby K
24 Frank Lloyd Wright Drive
Ann Arbor, MI 48105
T 734 418-4400 F 734 665-0485
www.aastrom.com |
FOR IMMEDIATE RELEASE
Aastrom Biosciences Reports First Quarter 2011 Financial
Results and Corporate Developments
Conference Call Today at 4:30 PM ET
ANN ARBOR, Mich., May 16, 2011 Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading
developer of patient-specific, expanded multi-cellular therapies for the treatment of severe,
chronic cardiovascular diseases, today reported financial results for the first quarter ended March
31, 2011, and provided an update on corporate developments.
Over the past several months, Aastrom has increased exposure to US and European investors and
analysts, supported late stage clinical development with a fully validated manufacturing partner,
and bolstered our intellectual property estate for a proprietary cellular therapy product derived
from our technology, stated Timothy Mayleben, president and CEO of Aastrom Biosciences.
Anticipated Corporate Developments in 2011
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Report final top-line results from the Phase 2b RESTORE-CLI clinical trial in patients
with critical limb ischemia (CLI). This will be the final 12-month follow-up report on all
patients who participated in this study, which the company plans to submit for presentation
at a major medical conference later this year. This report is expected by the end of the
second quarter. |
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Finalize a special protocol assessment (SPA) application to begin the first of two
proposed Phase 3 clinical studies of ixmyelocel-T in patients with CLI. The SPA is expected
to be completed and submitted to the FDA in the second quarter. |
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Report and present the final 12-month results from the Phase 2 dilated cardiomyopathy
(DCM) surgical study in the third quarter. |
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Announce 6-month results from the Phase 2 DCM catheter study in the third quarter. |
- more -
First Quarter 2011 Financial Results
As of March 31, 2011, the company had $24.6 million in cash and cash equivalents, compared to $31.2
million in cash and cash equivalents at December 31, 2010.
Research and development expenses for the quarter were $4.4 million versus $2.9 million for the
same period a year ago. The increase in R&D expenses was primarily attributable to advanced
preparation related to the Phase 3 clinical program for ixmyelocel-T, including increased employee
costs, clinical site identification and set-up, as well as regulatory expenses.
General and administrative expenses for the quarter were $1.9 million compared to $1.4 million for
the same period a year ago. The increase in G&A expenses is primarily due to expenses associated
with the previously announced restatement of the companys historical financial results, as well as
consulting and employee-related expenses.
Aastrom had other income of $1.3 million compared to $1.6 million for the same period a year ago.
The majority of this income for both quarters relates to non-cash changes in the fair value of our
outstanding warrants. The change in the fair value of the warrants was primarily due to
fluctuations in the market value of Aastroms common stock during these periods.
Net loss for the quarter ended March 31, 2011, was $5.0 million, or $0.13 per share, compared to a
net loss of $2.7 million, or $0.10 per share, for the same period a year ago.
At March 31, 2011, Aastrom had 38.6 million shares outstanding.
Aastrom Conference Call Information
Aastroms management will host a conference call to discuss these results at 4:30 p.m. (ET) today.
Interested parties should call toll-free (877) 312-5881, or from outside the U.S. (253) 237-1173
and use conference ID 64380457. The call will be available live in the Investors section of
Aastroms website at http://www.aastrom.com/investor.cfm. A replay of the call will be available
by calling (800) 642-1687, or from outside the U.S. at (706) 645-9291 and using conference ID
64380457.
About Aastrom Biosciences
Aastrom Biosciences is developing patient-specific, expanded multi-cellular therapies for use in
the treatment of severe, chronic cardiovascular diseases. The companys proprietary cell-processing
technology enables the manufacture of ixmyelocel-T, mixed-cell therapies expanded from a patients
own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into
late-stage clinical development, including a
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planned Phase 3 clinical program for the treatment of patients with critical limb ischemia and two
ongoing Phase 2 clinical trials in patients with dilated cardiomyopathy. For more information,
please visit Aastroms website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
Media contact
Bill Berry
Berry & Company
+1 (212) 253-8881
bberry@berrypr.com
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
+1 (646) 378-2924
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 Aastroms 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 managements 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.
- more -
AASTROM BIOSCIENCES, INC.
(in thousands, except per share amounts)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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December 31, |
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March 31, |
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2010 |
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2011 |
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ASSETS |
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Cash and cash equivalents |
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$ |
31,248 |
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$ |
24,621 |
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Other current assets |
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451 |
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457 |
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Property and equipment, net |
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1,128 |
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1,153 |
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Total assets |
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$ |
32,827 |
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$ |
26,231 |
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LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT) |
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Warrant liabilities |
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$ |
25,954 |
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$ |
24,700 |
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Other current liabilities |
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3,910 |
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2,934 |
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Long-term debt |
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41 |
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43 |
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Shareholders equity (deficit) |
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2,922 |
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(1,446 |
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Total liabilities and shareholders equity (deficit) |
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$ |
32,827 |
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$ |
26,231 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Quarter Ended March 31, |
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2010 |
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2011 |
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REVENUES |
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$ |
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$ |
9 |
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COSTS AND EXPENSES |
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Cost of product sales and rentals |
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2 |
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Research and development |
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2,845 |
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4,372 |
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Selling, general and administrative |
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1,418 |
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1,895 |
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Total costs and expenses |
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4,263 |
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6,269 |
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LOSS FROM OPERATIONS |
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(4,263 |
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(6,260 |
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OTHER INCOME (EXPENSE) |
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Decrease in fair value of warrants |
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1,559 |
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1,254 |
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Other income, net |
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25 |
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18 |
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Total other income |
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1,584 |
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1,272 |
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NET LOSS |
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$ |
(2,679 |
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$ |
(4,988 |
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NET LOSS PER SHARE (Basic and Diluted) |
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$ |
(0.10 |
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$ |
(0.13 |
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Weighted average number of common
shares outstanding (Basic and Diluted) |
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26,737 |
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38,617 |
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