Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI), a
biopharmaceutical company discovering and developing targeted
therapeutic and imaging radiopharmaceuticals primarily for use in
oncology, today announced financial results for the third quarter
and nine months ended September 30, 2009.
Financial Highlights
Third Quarter Results
For the third quarter of 2009, the Company reported a net loss
of $21.4 million, compared to a net loss of $24.7 million in the
third quarter of 2008. Third quarter operating expenses of $16.4
million declined by 17 percent, or $3.4 million, from the prior
year due to a decrease in research and development expenses of $2.9
million and in general and administrative expenses of $0.5
million.
Research and development expenses were $9.0 million, compared to
$11.9 million for the same period last year. The decrease is
primarily attributable to the completion of a Phase 2 Zemiva(TM)
clinical trial in 2008 and lower external support costs, offset by an
increased investment in Trofex(TM) preclinical studies.
General and administrative expenses were $7.5 million for the third
quarter of 2009, compared to $8.0 million in the third quarter of
2008. This decrease reflects cost-cutting initiatives put in place at
the end of 2008, primarily to reduce legal and consulting fees, as
well as staffing levels.
Year-to-Date Results
For the nine months ended September 30, 2009, the Company
reported a net loss of $53.3 million, compared to a net loss of
$65.4 million in the first nine months of 2008.
Operating expenses for the nine months ended September 30, 2009
declined by 25 percent, or $12.9 million, from the same period of
the previous year. This decrease in operating expenses is due to a
decline in research and development expenses of $9.9 million and in
general and administrative expenses of $3.0 million.
Research and development expenses were $22.1 million for the
nine-months ended September 30, 2009, compared to $32.0 million for
the same period last year. The $9.9 million decrease is primarily
attributable to the completion of a Phase 2 Zemiva clinical trial and
Solazed(TM) preclinical studies in 2008 and lower external support
costs in 2009, offset by increased investments in Trofex(TM)
preclinical studies and build-out of a commercial-scale Azedra(TM)
manufacturing suite.
General and administrative expenses were $16.5 million for the
nine-month period in 2009, compared to $19.5 million in the
nine-month period in 2008. The $3.0 million reduction reflects the
implementation of cost-cutting initiatives as stated above.
At September 30, 2009, the Company had approximately $71.8
million in cash, cash equivalents, and short-term investments and
25,268,327 shares of common stock outstanding.
Clinical and Business Development Updates
"In the third quarter we made a number of positive strides in
clinical development, strategic partnering and in initiating
financing activities and negotiations with our bondholders," said
Daniel L. Peters, President and Chief Executive Officer of
Molecular Insight Pharmaceuticals. "In our oncology pipeline, we
commenced a pivotal Phase 2 trial for Azedra, a new clinical trial
for Trofex and received an NCI grant to support the development of
Solazed. In line with our strategy to build value in our product
pipeline, we formed a highly beneficial agreement covering select
international territories with BioMedica Life Sciences, an ideal
partner based on its orphan drug and radiopharmaceuticals
experience. The Onalta supply agreement with BioMedica will
generate milestone payments and near-term revenues while advancing
Phase 3 development, regulatory approval and commercialization of
our product."
Oncology Pipeline Advancement
Azedra(TM) Commences Pivotal Study
-- In August, Molecular Insight announced initiation of a
pivotal Phase 2 clinical trial for registration of Azedra in adult
patients with malignant pheochromocytoma. Currently, patients are
being enrolled. MDS Nordion will manufacture and supply Azedra for
Phase 2 clinical trials and for commercial use, upon U.S. Food and
Drug Administration approval.
-- At the North American Neuroendocrine Tumor Society (NANETS)
2009 Neuroendocrine Tumor Symposium, the Company presented one-year
follow-up data from a Phase 1 dose-escalation clinical study of
Azedra demonstrating a positive safety profile and durable
objective tumor responses in patients with neuroendocrine
cancers.
Trofex(TM) Advances Clinical Program
-- Findings from the first Trofex Phase 1 (Tx-P101) dosimetry,
safety and pharmacokinetics trial in prostate cancer patients were
presented at the 2009 Annual Congress of the European Association
of Nuclear Medicine meeting. The Company presented clinical trial
data demonstrating Trofex's diagnostic retention in the tumor and
clearance from the body, allowing early detection of metastatic
prostate cancer in soft tissue and bone.
-- In August, Molecular Insight initiated a second Phase 1
(Tx-P102) imaging study of Trofex to define the distribution and
pharmacokinetics of Trofex in normal men to confirm subject
dosimetry and Trofex distribution in non-cancerous prostate
glands.
Solazed(TM) Program Awarded National Cancer Institute Grant
-- In July, Molecular Insight was awarded a two-year grant from
the National Cancer Institute that could total as much as $1.5
million to support development of Solazed, the Company's molecular
targeting radiotherapeutic for malignant metastatic melanoma. The
grant provides funding for a Phase 1 proof-of-concept clinical
trial of Solazed and will be shared with the University of
Pennsylvania, where the trial will be initiated.
Business Development Activities
Onalta(TM) Sub-license Generates $4.4 Million Upfront
Payment
-- In September, Onalta was sub-licensed to BioMedica Life Sciences S.A.,
Athens, Greece, for use in certain countries in Europe, the Middle East,
North Africa, Russia and Turkey. BioMedica is expected to commence
European pivotal Phase 3 clinical studies in 2010. Under the terms of
this agreement, Molecular Insight received a $4.4 million upfront
payment and may earn up to $10 million in total regulatory milestone
payments, net of license payments, in addition to milestone and tiered
royalties on sales.
-- In October, Molecular Insight finalized a 10-year supply agreement
with BioMedica and entered into an agreement with Eckert & Ziegler
to manufacture Onalta. Molecular Insight is eligible to receive
near- and long-term revenues from supplying Onalta for compassionate
use, clinical trial supplies and, upon regulatory approval,
commercial supply to the licensed BioMedica territories.
Financing Update
Molecular Insight also announced its plan to commence a private
placement of convertible preferred stock with accredited investors
for gross proceeds of up to $50 million. Contemporaneously with
this financing, the Company has entered into discussions with the
holders of its Senior Secured Floating Rate Bonds due in 2012 to
obtain relief of certain financial covenants to facilitate the
private placement. Proceeds of the private placement are expected
to support the further clinical development of Azedra and Trofex.
The convertible preferred stock will not be registered under the
Securities Act of 1933, as amended (the "Act"), and may not be
offered or sold in the United States or to or for the account of
U.S. persons unless registered under the Act or unless an exemption
from registration is available. This news release does not
constitute an offer to sell, or the solicitation of an offer to
buy, nor shall there be any sale of the securities in the United
States or any jurisdiction in which such offer, solicitation or
sale would be unlawful.
Investor Update Call
Molecular Insight management will host a conference call and
webcast Monday, November 9, 2009 at 4:30 p.m. U.S. Eastern Standard
Time. To access the live audio broadcast or the subsequent archived
recording of the call, please visit the Investor Center section of
the Molecular Insight website at http://www.molecularinsight.com.
Please log onto Molecular Insight's website several minutes prior
to the start of the call to ensure adequate time for any software
download that may be required. The webcast is also being
distributed through the Thomson StreetEvents Network to both
institutional and individual investors. Individual investors can
listen to the call at http://www.fulldisclosure.com and
institutional investors can access the call via
http://www.streetevents.com.
To access the call on November 9, 2009 at 4:30 p.m., dial
888.713.4214 (or 617.213.4866 for international participants) at
least five minutes prior to the start of the call. The participant
pass code is 53802606. For one week following the call, an audio
replay can be accessed by dialing 888.286.8010 (or 617.801.6888 for
international callers) and using the pass code 47943423.
About Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals is a clinical-stage
biopharmaceutical company and pioneer in the emerging field of
molecular medicine. The Company is focused on the discovery and
development of targeted therapeutic and imaging
radiopharmaceuticals, primarily 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 constitute "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 our
financial performance, our corporate strategy, our clinical and
business developments, our clinical trials of, Azedra™, Onalta™,
Trofex™, and Solazed(TM) and anticipated regulatory requirements,
our business development strategy regarding the European rights to
Onalta(TM) and anticipated compassionate use and clinical trials in
the licensed European territories, anticipated revenues from
product supply to BioMedica, from regulatory milestone payments and
from milestone and tiered royalties on sales, as well as estimated
amount of proceeds and use of proceeds of the proposed private
placement of our convertible preferred stock, and proposed
modifications to certain financial covenants made to the holders of
Senior Secured Floating Rate Bonds. 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. These
factors include, but are not limited to, risks and uncertainties
related to the progress, timing, cost, and results of clinical
trials and product development programs; difficulties or delays in
obtaining regulatory approval for product candidates; risks and
uncertainties related to the progress and consummation of the
proposed financing; difficulties or delays in generating the
revenue as anticipated; competition from other pharmaceutical or
biotechnology companies; 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
Molecular Insight 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 Ended Nine Months Ended
2008 2009 2008 2009
---------- ---------- ---------- ----------
Total revenue - research
and development grants $ 62 $ 101 $ 238 $ 450
Operating expenses:
Research and development 11,867 8,964 31,985 22,076
General and
administrative 7,950 7,454 19,487 16,545
---------- ---------- ---------- ----------
Total operating
expenses 19,817 16,418 51,472 38,621
---------- ---------- ---------- ----------
Loss from operations (19,755) (16,317) (51,234) (38,171)
Total other expenses, net (4,923) (5,065) (14,198) (15,086)
---------- ---------- ---------- ----------
Net loss $ (24,678) $ (21,382) $ (65,432) $ (53,257)
========== ========== ========== ==========
Basic and diluted net loss
per share $ (0.99) $ (0.85) $ (2.62) $ (2.12)
Weighted average shares
used to calculate basic
and diluted net loss per
share 24,981,674 25,199,097 24,969,594 25,159,153
Non-cash stock-based
compensation included in:
Research and development $ 417 $ 526 $ 1,028 $ 1,269
General and
administrative 1,673 1,349 2,537 2,077
---------- ---------- ---------- ----------
Total stock-based
compensation $ 2,090 $ 1,875 $ 3,565 $ 3,346
========== ========== ========== ==========
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
As of As of
December 31, June 30,
2008 2009
----------- -----------
(Unaudited)
Cash and cash equivalents $ 25,495 $ 18,254
Investments 80,291 53,565
Accounts receivable, prepaid expenses and other
current assets 1,542 5,235
Property and equipment -- net 5,452 4,996
Debt issuance costs -- net 5,897 4,881
Restricted cash 500 500
----------- -----------
Total assets $ 119,177 $ 87,431
=========== ===========
Current liabilities $ 11,588 $ 10,598
Other long-term liabilities 452 290
Deferred Revenue 25 4,425
Bond payable, net of discount 154,932 169,964
----------- -----------
Total liabilities 166,997 185,277
Total stockholders deficit (47,820) (97,846)
----------- -----------
Total liabilities and stockholders deficit $ 119,177 $ 87,431
=========== ===========
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(in thousands)
Nine Months Ended
September 30,
2008 2009
----------- -----------
Cash, cash equivalents and investments -
beginning of period $ 162,996 $ 105,786
Net cash burn (44,973) (33,967)
----------- -----------
Cash, cash equivalents and investments - end of
period $ 118,023 $ 71,819
=========== ===========
Contact: Investors Chuck Abdalian 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 (845)
638-6290 (201) 923-2049 spietropaolo@bccpartners.com
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