Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI), a
biopharmaceutical company discovering and developing targeted
therapeutic and imaging radiopharmaceuticals for use in oncology,
today announced the financial and operational results for the third
quarter ended September 30, 2010.
Financial Highlights
Third Quarter Results For the third
quarter 2010, the Company reported a net loss of $18.3 million,
compared to a net loss of $21.4 million in the third quarter of
2009. The decrease in net loss is attributable to the decrease in
operating expenses of $3.1 million and increase in grant revenues
of $0.4 million, offset by an increase in other expenses of $0.4
million. Operating expenses were $13.3 million in the third quarter
of 2010, a decrease of 19 percent from the third quarter of 2009,
primarily due to a decrease in research and development expenses of
$3.5 million, offset by an increase in general and administrative
expenses of $0.3 million.
Research and development expenses were $5.5 million compared to
$9.0 million for the same period last year. The decrease is
primarily due to decreased payroll costs as a result of a reduction
in headcount and decreased manufacturing and preclinical costs for
our Azedra™ and Trofex™ programs, respectively.
General and administrative expenses were $7.7 million for the
third quarter of 2010, compared to $7.4 million in the third
quarter of 2009. This increase primarily reflects increased legal
and consulting fees incurred in connection with ongoing discussions
and negotiations with our Bond holders regarding the restructuring
of our debt obligations. This increase was offset by decreases in
compensation and personnel-related expenses due to a reduction in
headcount and decreases in depreciation and facility costs.
Year-to-Date Results For the nine months
ended September 30, 2010, Molecular Insight reported a net loss of
$53.2 million, or $2.11 per share, compared to $53.3 million, or
$2.12 per share, in 2009. The decrease in net loss is attributable
to the increase in grant revenues of $0.9 million, offset by an
increase in other expenses of $0.9 million. Operating expenses
remained generally consistent period over period.
Research and development expenses were $19.7 million in 2010,
compared to $22.1 million for 2009. The $2.4 million decrease is
primarily attributable to reduced clinical activities and costs for
Onalta™ and Trofex.
General and administrative expenses were $18.6 million in 2010,
compared to $16.5 million in 2009. This increase primarily reflects
increased legal and consulting fees incurred in connection with
ongoing discussions and negotiations with our Bond holders
regarding the restructuring of our debt obligations. This increase
was offset by lower corporate marketing fees, decreases in
compensation and personnel-related expenses due to a reduction in
headcount and decreases in depreciation and facility costs.
As of September 30, 2010, the Company had approximately $23.2
million of cash and cash equivalents, and $198.6 million of Bonds
and accrued and unpaid interest. As previously announced, the
Company is in default of certain covenants under the Bond
Indenture. Such defaults have been temporarily waived by the Bond
holders under a waiver agreement that expires on 11:59 PM Eastern
Standard Time on November 19, 2010, subject to earlier termination
by the Bond holders upon certain circumstances.
Operational Update In October, Molecular
Insight presented positive data from clinical and preclinical
studies suggesting the utility of the Company's lead novel
radiotherapeutic Trofex (123 I-MIP-1072) for diagnosing and
monitoring prostate cancer, as well as for visualizing and
monitoring disease treatment.
The Company presented data from Phase 1 clinical studies
comparing Trofex to ProstaScint® (111 In-capromab pendetide), an
imaging radiopharmaceutical now used to visualize metastatic
prostate cancer. The data, presented at the Annual Congress of the
European Association of Nuclear Medicine (EANM) in Vienna,
demonstrated that Trofex rapidly detected prostate cancer localized
in the prostate bed, soft tissues and bone within four hours post
injection. In contrast, ProstaScint required five days before
imaging and was unable to detect metastatic disease in bone. In a
second EANM presentation, Molecular Insight reported new Trofex
preclinical data. Company scientists have developed an analog of
Trofex that carries the therapeutic iodine radionuclide I-131,
creating a molecularly targeted radiotherapeutic that specifically
binds prostate specific membrane antigen (PSMA) on prostate cancer
cells and offers the potential for treatment of metastatic prostate
cancer. PSMA is a protein highly expressed by prostate cancer with
high affinity and specificity.
At the American Society of Clinical Oncology (ASCO) Annual
Molecular Markers in Cancer Conference in Hollywood, Florida,
Molecular Insight presented data from a preclinical study that
indicate Trofex may be used to visualize changes in tumor volume in
response to treatment of the disease. Molecular Insight reported
that the uptake of Trofex in animal models of human prostate cancer
was shown to be proportional to tumor mass, suggesting that Trofex
may enable visualization of changes in tumor volume and therefore
response to treatment or progression.
Molecular Insight has been awarded approximately $1.5 million in
grants under the Qualifying Therapeutic Discovery Project Tax
Credit Program. The Program is part of the government's Patient
Protection and Affordable Care Act enacted on March 23, 2010. The
grants seek to stimulate therapeutic discovery projects with a
potential to prevent, detect or treat chronic or acute diseases;
reduce long-term health care costs; or significantly advance the
goal of curing cancer.
Conference Call The Company expects to
host its next conference call upon the conclusion of debt
restructuring discussions with its Bond holders.
About Molecular Insight Pharmaceuticals,
Inc. Molecular Insight Pharmaceuticals is a clinical-stage
biopharmaceutical company and pioneer in molecular medicine. The
Company is focused on the discovery and development of targeted
therapeutic and imaging radiopharmaceuticals for use in oncology.
Molecular Insight has five clinical-stage candidates in
development. For further information on Molecular Insight
Pharmaceuticals, please visit www.molecularinsight.com.
Forward-Looking Statements Statements in
this release that are not strictly historical in nature are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, statements about positive potential of
Trofex for treatment of metastatic prostate cancer and
visualization of changes in tumor volume and continuing discussions
and negotiations with our Bond holders regarding the restructuring
of our debt obligations. Such forward-looking statements involve
known and unknown risks, uncertainties, and other factors that may
cause the actual results of Molecular Insight to be materially
different from historical results or from any results expressed or
implied by such forward-looking statements. Such factors include,
but are not limited to, risks and uncertainties related to the
progress, timing, and results of our negotiations with the Bond
holders regarding the debt restructuring, risks related to product
development and clinical trial design, performance and completion,
and the additional risks discussed in filings with the Securities
and Exchange Commission (SEC). The Company's SEC filings are
available through the SEC's Electronic Data Gathering Analysis and
Retrieval system (EDGAR) at http://www.sec.gov. Press releases for
Molecular Insight Pharmaceuticals, Inc. are available on our
website: http://www.molecularinsight.com. If you would like to
receive press releases via e-mail, please contact:
investor@molecularinsight.com. All forward-looking statements are
qualified in their entirety by this cautionary statement, and the
Company undertakes no obligation to revise or update this release
to reflect events or circumstances after the date hereof.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except per share amounts and except weighted
average shares)
Three Months Nine Months
Ended September 30, Ended September 30,
------------------------ ------------------------
2009 2010 2009 2010
----------- ----------- ----------- -----------
Revenue:
Research and
development grants $ 101 $ 457 $ 450 $ 1,353
Operating expenses:
Cost of product
revenue - 117 - 261
Research and
development 8,964 5,472 22,076 19,665
General and
administrative 7,454 7,730 16,545 18,618
----------- ----------- ----------- -----------
Total operating
expenses 16,418 13,319 38,621 38,544
----------- ----------- ----------- -----------
Loss from operations (16,317) (12,862) (38,171) (37,191)
Total other expenses,
net (5,065) (5,487) (15,086) (15,962)
----------- ----------- ----------- -----------
Net loss $ (21,382) $ (18,349) $ (53,257) $ (53,153)
=========== =========== =========== ===========
Basic and diluted net
loss per share $ (0.85) $ (0.73) $ (2.12) $ (2.11)
Weighted average shares
used to calculate
basic and diluted net
loss per share 25,199,097 25,235,420 25,159,153 25,235,420
Non-cash stock-based
compensation included
in:
Research and
development $ 526 $ 132 $ 1,269 $ 1,033
General and
administrative 1,349 161 2,077 688
----------- ----------- ----------- -----------
Total
stock-based
compensation $ 1,875 $ 293 $ 3,346 $ 1,721
=========== =========== =========== ===========
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(in thousands)
As of As of
December 31, September 30,
2009 2010
--------------- --------------
Cash and cash equivalents $ 15,467 $ 23,154
Investments 48,515 -
Accounts receivable, prepaid expenses and
other current assets 1,553 4,682
Debt issuance costs -- net 4,527 3,435
Property and equipment -- net 4,044 4,219
Restricted cash 500 963
--------------- --------------
Total assets $ 74,606 $ 36,453
=============== ==============
Other current liabilities $ 9,762 $ 7,864
Other long-term liabilities 478 663
Deferred revenue 25 25
Bond payable, net of discount 174,838 189,829
--------------- --------------
Total liabilities 185,103 198,381
Total stockholders' deficit (110,497) (161,928)
--------------- --------------
Total liabilities and stockholders'
deficit $ 74,606 $ 36,453
=============== ==============
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
Nine Months Ended
September 30,
------------------------------
2009 2010
--------------- --------------
Cash, cash equivalents and investments --
beginning of period $ 105,786 $ 63,982
Net cash burn (33,967) (40,828)
--------------- --------------
Cash, cash equivalents and investments --
end of period $ 71,819 $ 23,154
=============== ==============
Contact: Investors Chuck Abdalian Senior Vice President of
Finance Chief Financial Officer (617) 871-6618
cabdalian@molecularinsight.com Media Martin A. Reynolds Manager
Corporate Communications (617) 871-6734
mreynolds@molecularinsight.com Susan Pietropaolo BCC Partners (201)
923-2049 spietropaolo@bccpartners.com
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