e8vk
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 12, 2008
Aastrom Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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Michigan
(State or other jurisdiction of
incorporation)
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0-22025
(Commission File No.)
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94-3096597
(I.R.S. Employer Identification
No.) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(Address of principal executive offices)
Registrants telephone number, including area code:
(734) 930-5555
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
TABLE OF CONTENTS
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Item 2.02 |
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Results of Operations and Financial Condition. |
On May 12, 2008, we issued a press release announcing financial results and achievements for our
third fiscal quarter ended March 31, 2008. A copy of the press release is attached hereto as
Exhibit 99.1.
Pursuant to General Instruction B.2 of Form 8-K, this report and the exhibit are not deemed to be
filed for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall this report
and the exhibit be incorporated by reference into our filings under the Securities Act of 1933 or
the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such
future filing.
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Item 9.01 |
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Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated May 12, 2008 |
SIGNATURES
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.
Date: May 12, 2008
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AASTROM BIOSCIENCES, INC.
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By: |
/s/George W. Dunbar, Jr.
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George W. Dunbar, Jr. |
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Chief Executive Officer and President |
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exv99w1
Exhibit 99.1
FOR IMMEDIATE RELEASE
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CONTACTS:
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Kris M. Maly
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Kevin McGrath |
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Investor Relations Department
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Cameron & Associates (Investors) |
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Aastrom Biosciences, Inc.
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Phone: (212) 245-4577 |
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Phone: (734) 930-5777 |
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Stephen Zoegall |
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Berry & Company (Media) |
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Phone: (212) 253-8881 |
AASTROM REPORTS THIRD QUARTER FISCAL YEAR 2008
FINANCIAL RESULTS
Ann Arbor, Michigan, May 12, 2008 Aastrom Biosciences, Inc. (Nasdaq: ASTM), a leading
regenerative medicine company, today reported financial results for the third fiscal quarter ended
March 31, 2008. Since the beginning of the third fiscal quarter, the Company also reported
clinical achievements in the cardiac regeneration area, including:
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Encouraging clinical data from the first two patients treated with Aastroms autologous
stem cell therapy for dilated cardiomyopathy (DCM), a type of severe chronic heart failure.
This milestone marked the first human application of the Companys Cardiac Repair Cell
(CRC) product to regenerate damaged heart tissue in patients with severely impaired cardiac
function. Interim data reported on the first two EU compassionate use patients treated
with CRCs included: |
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The first patient, a 74 year old male diagnosed with ischemic DCM who
also suffered from extensive three-vessel coronary heart disease, renal
insufficiency and unstable angina pectoris (chest pain), was treated in November
2007. He presented in class IV heart failure (under New York Heart Association
classification guidelines), with a left ventricular ejection fraction of 10% (below
the normal range of 60-75% for a typical healthy person), and experiencing severe
shortness of breath without physical activity and lying in bed. After CRC treatment
and upon hospital discharge, his ejection fraction has improved to 25-30% and
clinical improvement to his heart failure stage has been reported. |
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The second patient, a 69 year old female diagnosed with severe DCM, also
suffered from extensive three-vessel coronary heart disease and had experienced
multiple previous heart attacks, was treated in December 2007. This patient had
previously undergone coronary artery bypass grafting, several interventional
treatments by catheter and had no other treatment options. After CRC treatment she
had experienced an increase in ejection fraction from 25-30% to 45% upon discharge
from the hospital. |
The clinical improvement observed in these patients is very encouraging and further supports the
development of our U.S. cardiac regeneration program. Similar to the EU compassionate use
treatments, our U.S. clinical trial will target the most severe patients suffering from DCM who,
other than heart transplant, have no treatment options, said George Dunbar, President and Chief
Executive Officer of Aastrom. Aastroms technology is already addressing a range of unmet medical
needs in the vascular and bone regeneration areas for patients who are suffering from severe
diseases or injuries and currently have limited or no treatment options. We look forward to
reporting developments from our U.S. cardiac program as they occur.
Aastrom Biosciences
§ dominos Farms, Lobby
K § 24
Frank Lloyd Wright Dr. § Ann Arbor, MI 48105 USA
Tel: 734-930-5555 § Fax: 734-665-0485 § mail@aastrom.com § www.aastrom.com
Aastrom- 3rd Q FY2008 Fin Results
May 12, 2008
Page 2
Third Fiscal Quarter Ended March 31, 2008 Results
Total revenues for the quarter and nine months ended March 31, 2008, consisting of grant funding
and product sales, were $202,000 and $373,000, respectively, compared to $258,000 and $520,000 for
the same periods in fiscal year 2007.
Total costs and expenses for the quarter and nine months ended March 31, 2008 increased to
$5,491,000 and $16,599,000, respectively, from $5,180,000 and $14,766,000 for the same periods in
fiscal year 2007.
As a result of the continued expansion of research and development and manufacturing activities to
support regulatory submissions, on-going and planned tissue regeneration clinical trials and
activities in the U.S. and EU, research and development expenses increased to $4,032,000 and
$11,800,000, respectively, for the quarter and nine months ended March 31, 2008 compared to
$3,096,000 and $7,963,000 for the same periods in fiscal year 2007. Research and development
expenses for the quarter and nine months ended March 31, 2008, included a non-cash charge of
$204,000 and $641,000, respectively, compared to $202,000 and $492,000 for the same periods in
fiscal year 2007, relating to share-based compensation expense.
Selling, general and administrative expenses decreased to $1,429,000 and $4,768,000, respectively,
for the quarter and nine months ended March 31, 2008 from $2,070,000 and $6,786,000 for the same
periods in fiscal year 2007. For the quarter and nine months ended March 31, 2008, selling,
general and administrative expenses included a non-cash charge of $324,000 and $994,000,
respectively, compared to $501,000 and $1,656,000 for the same periods in fiscal year 2007,
relating to share-based compensation expense.
Interest income for the quarter and nine months ended March 31, 2008 decreased to $266,000 and
$1,017,000, respectively, from $439,000 and $1,481,000 for the same periods in fiscal year 2007.
The fluctuations in interest income are due primarily to corresponding changes in the level of
cash, cash equivalents and short-term investments during the periods.
Interest expense was $25,000 and $61,000, respectively, for the quarter and nine months ended March
31, 2008 related to long-term debt for equipment acquired during the fiscal year ended June 30,
2007.
Net loss for the quarter ended March 31, 2008 was $5,048,000, or $.04 per common share, compared to
a net loss of $4,483,000, or $.04 per share for the same period in fiscal year 2007. Net loss for
the nine months ended March 31, 2008, was $15,270,000, or $.12 per common share, compared to
$12,765,000, or $.11 per share for the same period in fiscal year 2007. The increases in net loss
are primarily the result of increased costs and expenses offset in part on a per share basis by an
increase in the weighted average number of common shares outstanding.
At March 31, 2008, the Company had $26.7 million in cash, cash equivalents and short-term
investments as compared to $28.3 million at June 30, 2007. It is expected that our monthly cash
utilization will average approximately $1.8 million for the remainder of fiscal year 2008. If we
continue to utilize cash at $1.8 million per month, our available cash would support operations for
approximately 15 months.
For the past 6-10 months, the global economy and capital markets have been challenging for the
small cap biotech sector. This situation makes the timing and potential for our future equity
financings uncertain. We are taking action to reprioritize our development and clinical programs
by redirecting our primary focus to our cardiac regeneration program. This program
reprioritization, along with reductions in overhead and staff of approximately 20 to 25 employees
is intended to reduce our average cash utilization to approximately $1.2 million per month for
fiscal year ended June 30, 2009.
In an attempt to regain compliance with the $1.00 minimum closing bid price deficiency, we brought
a proposal to our shareholders to authorize the Board of Directors to amend our Restated Articles
of
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Aastrom- 3rd Q FY2008 Fin Results
May 12, 2008
Page 3
Incorporation to execute a reverse split of our issued and outstanding common stock if they
determine it is in the best interests of Aastrom and its shareholders in March 2008. On April 8,
2008 our Special Meeting of Shareholders was adjourned because the Board determined it was
essential to provide additional time to continue to obtain greater shareholder turnout and achieve
the necessary two-thirds vote required by our charter for this proposal. The Special Meeting
reconvened on May 6, 2008, and the proposal was withdrawn by the Board of Directors. Even though
more than seventy-five percent (75%) of the shares that were actually voted, were cast in
favor of the reverse stock split proposal, it did not receive approval of two-thirds (or 66-2/3%)
of all outstanding shares as required by our charter for this proposal. Due to the high
number of outstanding shares that were not voted at all, the two-thirds requirement was not
obtained. As a result, our management and Board of Directors will continue to evaluate options to
preserve our current Nasdaq Capital Market listing and to fund our regenerative medicine clinical
programs
Aastrom Conference Call Information
George W. Dunbar, President and Chief Executive Officer and Elmar R. Burchardt, M.D., Ph.D., Vice
President Medical Affairs of Aastrom Biosciences, Inc., will host a conference call to review and
discuss the third quarter fiscal year 2008 financial results at 4:15 p.m. (EDT) today, May 12,
2008. Interested parties should call toll-free (877) 407-9205, or from outside the U.S. (201)
689-8054, fifteen minutes before the start of the call to register and identify themselves as
registrants of the Aastrom Conference Call. Any registered caller on the toll-free line may ask
to be placed in the queue for the Question & Answer session. The call will be simulcast on the web
at http://www.investorcalendar.com/IC/CEPage.asp?ID=128408. A podcast of the call may be
downloaded from the web at the internet address above. If you are unable to participate during the
live call, the webcast will be available for replay at http://www.investorcalendar.com/
until August 13, 2008. Also, through May 22, 2008, an audio replay of the call will be available
by dialing toll-free (877) 660-6853, or from outside the U.S. (201) 612-7415; when prompted on the
phone line, the Account # is: 286 and the Conference ID# is: 282280.
About Aastrom Biosciences, Inc.
Aastrom is a leading regenerative medicine company engaged in the development of autologous cell
products for the repair or regeneration of human tissue. The Companys proprietary Tissue Repair
Cell (TRC) technology involves the use of a patients own cells to manufacture products to treat a
range of chronic diseases and serious injuries affecting vascular, bone, cardiac and neural
tissues. Aastroms TRC-based products contain increased numbers of stem and early progenitor
cells, produced from a small amount of bone marrow collected from the patient. The TRC technology
platform has positioned Aastrom to advance multiple products into clinical development. Currently,
the Company has a vascular regeneration product in clinical development for the treatment of
critical limb ischemia (called the RESTORE-CLI trial), a bone regeneration product in Phase III
development for the treatment of osteonecrosis of the femoral head (called the ON-CORE trial), a
cardiac regeneration product in clinical development for dilated cardiomyopathy and a preclinical
research program targeting unmet needs in neural health. Aastrom product candidates to treat
osteonecrosis of the femoral head and dilated cardiomyopathy have been designated for orphan drug
status by the FDA. For more information, visit Aastroms website at www.aastrom.com.
(astmf)
This document contains forward-looking statements, including without limitation, statements
concerning clinical trial plans and expectations, clinical activity timing, intended product
development and commercialization objectives, adequacy of existing capital to support operations
for a specified time, future capital needs, and potential advantages and application of Tissue
Repair Cell (TRC) Technology, 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, estimates, plans, expects, management believes, we believe, we intend,
and similar words or phrases, or future or conditional verbs such as will, would, should,
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 and
other filings with the Securities and Exchange Commission.
Financial Table Follows
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AASTROM BIOSCIENCES, INC.
(Unaudited)
(In thousands, except per share amounts)
CONSOLIDATED STATEMENTS OF OPERATIONS DATA:
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Quarter ended March 31, |
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Nine months ended March 31, |
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2007 |
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2008 |
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2007 |
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2008 |
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REVENUES: |
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Total revenues |
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$ |
258 |
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$ |
202 |
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$ |
520 |
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$ |
373 |
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COSTS AND EXPENSES: |
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Cost of product sales and rentals |
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14 |
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30 |
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17 |
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31 |
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Research and development |
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3,096 |
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4,032 |
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7,963 |
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11,800 |
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Selling, general and administrative |
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2,070 |
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1,429 |
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6,786 |
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4,768 |
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Total costs and expenses |
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5,180 |
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5,491 |
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14,766 |
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16,599 |
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OTHER INCOME (EXPENSE): |
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Interest income |
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439 |
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266 |
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1,481 |
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1,017 |
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Interest expense |
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(25 |
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(61 |
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Total other income |
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439 |
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241 |
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1,481 |
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956 |
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NET LOSS |
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$ |
(4,483 |
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$ |
(5,048 |
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$ |
(12,765 |
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$ |
(15,270 |
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NET LOSS PER COMMON SHARE |
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(Basic and Diluted) |
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$ |
(.04 |
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$ |
(.04 |
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$ |
(.11 |
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$ |
(.12 |
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Weighted average number of common shares
outstanding |
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119,640 |
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132,705 |
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119,443 |
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127,909 |
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CONSOLIDATED BALANCE SHEET DATA:
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June 30, |
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March 31, |
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2007 |
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2008 |
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ASSETS |
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Cash and cash equivalents |
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$ |
13,439 |
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$ |
26,713 |
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Short-term investments |
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14,886 |
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Receivables, net |
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78 |
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63 |
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Inventories |
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8 |
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Other current assets |
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1,766 |
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1,865 |
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Property and equipment, net |
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2,671 |
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2,321 |
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Total assets |
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$ |
32,848 |
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$ |
30,962 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities |
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$ |
3,500 |
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$ |
1,836 |
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Long-tem debt |
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1,097 |
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898 |
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Shareholders equity |
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28,251 |
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28,228 |
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Total liabilities and shareholders equity |
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$ |
32,848 |
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$ |
30,962 |
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