Molecular Insight Pharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007...

Molecular Insight Pharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2007 Financial and Operational Results

Conference Call Today at 10:00 a.m. Eastern Time

2007 Highlights Include:

-- Raised Gross Aggregate of $220 Million in IPO and Bond
Financing

-- Progressed Azedra(TM) into Phase 1/2 Trial in Malignant
Pheochromocytoma

-- Reported Two Positive Data Sets From Phase 2 Zemiva(TM) Trials
and Initiated Zemiva Planned Pivotal Trial for the Diagnosis
of Cardiac Ischemia

-- In-licensed Exclusive, Worldwide Rights to Radiotherapeutics
Onalta(TM) and Solazed(TM)

-- Presented Promising Preclinical Data on Trofex(TM) for
Detection of Prostate Cancer

-- Acquired Radiopharmaceutical Manufacturing Facility in Denton,
Texas
CAMBRIDGE, Mass.--(Business Wire)--
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today
announced financial results for the fourth quarter and year ended
December 31, 2007. For the fourth quarter of 2007, Molecular Insight
reported a loss of ($21.7) million, on revenues of $151,777 and
operating expenses of $19.6 million. For the full year, the company
had a loss attributed to common shareholders of ($61.2) million, on
revenues of $730,672 and operating expenses of $58.4 million. At
December 31, 2007, the company had $62.1 million in cash and cash
equivalents and $109 million of short and long-term investments,
principally U.S. Treasury bills.

"2007 marked another strong year for Molecular Insight in
executing its strategy to discover, develop and commercialize
innovative targeted radiopharmaceuticals for the detection, staging,
monitoring and treatment of life-threatening diseases," stated David
S. Barlow, President and CEO of Molecular Insight. "In a year filled
with the achievement of several important milestones, we are now more
strongly positioned to advance our risk-contained clinical stage
pipeline and prepare for the commercialization of our first drug
candidate. Azedra, our lead radiotherapeutic, forms the cornerstone of
our portfolio of oncology radiopharmaceuticals, while Zemiva made
significant clinical progress toward becoming an important innovation
for the detection of cardiac ischemia."

Mr. Barlow continued, "Molecular Insight capitalized on the
potential of its advancing pipeline, technology base and management
team by completing its successful IPO and innovative bond financing
that together generated gross proceeds of $220 million dollars."

-0-
*T
Molecular Insight 2007 Product Development Highlights
-- Initiated Phase 1 of Azedra's planned two-stage, Phase 1/2
therapeutic trial for the treatment of malignant
pheochromocytoma, a type of neuroendocrine cancer. The trial
follows a successfully completed dosimetry trial and is designed
to determine the optimally safe and effective dose in Phase 1 and
confirm safety and efficacy of Azedra in Phase 2. The U.S. FDA
has designated Azedra an Orphan Drug with Fast Track development
status for the treatment of neuroendocrine tumors. Azedra
combines the known MIBG molecule with the company's proprietary
Ultratrace(TM) radiolabeling technology.
-- Initiated a planned pivotal registration Phase 2 trial with
Zemiva, the company's lead molecular imaging radiopharmaceutical,
for the diagnosis of cardiac ischemia in patients presenting with
chest pain in the emergency department setting. The trial builds
upon previous data that demonstrated the ability of Zemiva to
detect cardiac ischemia at rest up to 30 hours after an ischemic
event. This trial is expected to enroll 600 to 700 patients at up
to 70 sites in North America and is designed to be the first of
two planned pivotal registration trials.
-- Presented two positive Zemiva data sets at American Society for
Nuclear Cardiology (ASNC):
-- Validation of Zemiva Normals reference database using
gender-based and cardiac ischemia risk stratification
parameters. Results indicated that the database
accurately differentiated normal from abnormal metabolic
heart activity in patients dosed with Zemiva.
-- Comparison study using the validated Zemiva Normals
reference database demonstrating that Zemiva compares
favorably to published performance parameters of approved
cardiac blood flow tracers used to detect cardiac
ischemia and myocardial infarction, or heart attack. The
study indicated that Zemiva demonstrates strong
sensitivity and negative predictive value for the rule-
in/rule-out of patients having heart attacks and cardiac
ischemia. Additionally, Zemiva was positive in 100% of
patients with elevated serum troponins, the biomarker for
heart attack diagnosis that typically requires 6 to 12
hours to reach measurable levels in a heart attack
patient's blood.
-- Presented preclinical data from Trofex development program for
two promising molecular imaging radiopharmaceutical candidates,
MIP-1072 and MIP-1095, for potential use in the detection and
monitoring of prostate cancer. Both compounds are radiolabeled
small molecules that target and identify the presence of prostate
tumors specifically and non-invasively by targeting prostate-
specific membrane antigen (PSMA), a protein that is highly
expressed by prostate tumor cells. The studies were presented on
October 24th in a poster session at the annual "Molecular Targets
and Cancer Therapeutics" meeting in San Francisco, California,
which was organized by the American Association for Cancer
Research, National Cancer Institute, and European Organization
for Research and Treatment of Cancer (AACR-NCI-EORTC).
-- The Society of Nuclear Medicine (SNM) recognized Molecular
Insight Trofex preclinical research with the 2007 Berson-Yalow
Award for the most original scientific abstract that made the
most significant contribution to basic or clinical radioassay.
*T

2007 Corporate Highlights

-- Completed an initial public offering in February of 5.0
million shares of common stock that raised a gross amount of
$70 million

-- Priced $150 million in bonds due in 2012 with a syndicate of
institutional investors

-- In-licensed from Novartis Pharma AG the exclusive, worldwide
rights to Onalta ((90)Y edotreotide, previously known as
OctreoTher(TM)), a Phase 2 clinical-stage, targeted
radiotherapeutic that the company intends to develop for the
treatment of metastatic pancreatic neuroendocrine and
carcinoid tumors. Onalta, a synthetic analog of the peptide
somatostatin, has been studied in three Phase 1 and three
Phase 2 clinical trials involving more than 300 patients. It
has been designated an Orphan Drug by the U.S. FDA for the
treatment of pancreatic neuroendocrine tumors.

-- In-licensed from Bayer Schering Pharma the exclusive,
worldwide rights to Solazed, a targeted, small molecule
radiotherapeutic in late-stage preclinical development for the
treatment of malignant melanoma, the most aggressive type of
skin cancer.

-- Appointed Norman LaFrance, M.D., to the position of Senior
Vice President, Clinical Development and Chief Medical
Officer; Donald E. Wallroth as Chief Financial Officer; Brian
Abeysekera, Ph.D., as Vice President, Manufacturing; and
Christine Huh as Vice President, Human Resources.

-- Elected Scott Gottlieb, M.D., to the Molecular Insight Board
of Directors. Dr. Gottlieb has served as a senior policy maker
at the U.S. Food and Drug Administration (FDA), most recently
as Deputy Commissioner for Medical and Scientific Affairs. He
has also served as a senior official at the Centers for
Medicare and Medicaid Services (CMS)

-- Purchased a commercial-scale radiopharmaceutical manufacturing
facility in Denton, Texas

-- Entered a commercial manufacturing and supply agreement with
MDS Nordion for Zemiva

Financial Highlights of the Fourth Quarter and Fiscal Year 2007

Fourth quarter 2007 net loss attributable to common shareholders
was ($21.7) million. Fiscal year ended December 31, 2007 net loss
attributable to common shareholders was ($61.2) million. The cash and
cash equivalents balance at December 31, 2007 totaled $62.1 million.

Fourth quarter 2007 revenue was $151,777. Fiscal year ended
December 31, 2007 revenue was $730,762.

Research and development expenses totaled $13.4 million in the
fourth quarter of 2007. Research and development expenses were $40.5
million for the year ended December 31, 2007. The year 2007 included
$12.0 million of costs for the Zemiva and Azedra clinical trials, as
well as $1.3 million of manufacturing set-up costs for future Zemiva
and Azedra clinical trials.

General and administrative expenses were $6.2 million for the
fourth quarter of 2007. General and administrative expense totaled
$17.9 million for the year ended December 31, 2007.

2008 Milestones

First Half 2008

-- Complete Zemiva's planned pivotal registration Phase 2 trial
enrollment

-- Initiate Azedra's neuroblastoma clinical trial in children

-- Complete Azedra's Phase 1 dose-ranging clinical trial in
pheochromocytoma

-- Initiate Trofex's Phase 1 dosimetry trial for diagnosis of
prostate cancer

-- Initiate Onalta's additional Phase 1 dosimetry trial for the
treatment of neuroendocrine tumors

-- Initiate Solazed's Phase 1 dosimetry trial in malignant
melanoma

Second Half 2008

-- Initiate Zemiva's planned confirmatory Phase 3 pivotal trial

-- Initiate Azedra's planned Phase 2 pivotal trial

-- Report Zemiva's planned pivotal registration Phase 2 trial
results

-- Initiate Trofex's dose and image optimization trial

-- Complete Trofex's dosimetry trial

Conference Call Details

Molecular Insight management will host a conference call today,
March 31, 2008, at 10:00 AM Eastern Time. To access the call, dial
(888) 713-4209 or (617) 213-4863 (for international participants) at
least five minutes prior to the start of the call. The participant
pass code is 16791809. For one week following the call, an audio
replay can be accessed by dialing (888) 286-8010 or (617) 801-6888
(for international participants) and using the pass code 31412345.

A live audio webcast of the call will also be available in the
"Investor Relations" section of the company's website,
www.molecularinsight.com. The company will present a short PowerPoint
presentation during the call. An archived webcast will be available on
the company's website after the event and will be archived for 30
days.

About Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals (NASDAQ: MIPI) is a
biopharmaceutical company specializing in the emerging field of
molecular medicine, applying innovations in the identification and
targeting of disease at the molecular level to improve healthcare for
patients with life-threatening diseases. The company is focused on
discovering, developing and commercializing innovative molecular
radiotherapeutics and molecular imaging pharmaceuticals with initial
applications in the areas of oncology and cardiology. Its lead
molecular radiotherapeutic product candidates, Azedra and Onalta, are
being developed for detection and treatment of cancer. The company's
lead molecular imaging pharmaceutical product candidate, Zemiva, is
being developed for the diagnosis of cardiac ischemia, or insufficient
blood flow to the heart. In addition, the company has a growing
pipeline of product candidates resulting from application of its
proprietary platform technologies to new and existing compounds.
Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts
and its website address is: www.molecularinsight.com.

Forward-Looking Statements

Statements in this release that are not strictly historical in
nature constitute "forward-looking statements." Such statements
include, but are not limited to, statements about Azedra(TM), Onalta
(TM), Zemiva(TM) and any other statements relating to product
candidates, product development programs, the FDA or clinical trial
process including the commencement, process or completion of clinical
trials or the regulatory process. Such statements may include, without
limitation, statements with respect to the Company's plans,
objectives, expectations and intentions and other statements
identified by words such as "may," "could," "would," "should,"
"believes," "expects," "anticipates," "estimates," "intends," "plans"
or similar expressions. 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; competition from other pharmaceutical or biotechnology
companies; and the additional risks discussed in filings with the
Securities and Exchange Commission. All forward-looking statements are
qualified in their entirety by this cautionary statement, and
Molecular Insight undertakes no obligation to revise or update this
news release to reflect events or circumstances after the date hereof.

Results Report for the Fourth Quarter of Fiscal 2007

-0-
*T
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

Three Months Ended
December 31,
-----------------------------
2006 2007
-------------- --------------
(Unaudited) (Unaudited)
Revenue - Research and development
grants $ 118,609 $ 151,777

Operating expenses:
Research and development 4,939,093 13,360,047
General and administrative 2,793,669 6,196,975
Total operating expenses 7,732,762 19,557,022
-------------- --------------

Loss from operations (7,614,153) (19,405,245)

Other (expense) income:
Interest income 158,265 943,970
Interest expense (825,152) (3,193,044)
Total other (expense) income, net (666,887) (2,249,072)
-------------- --------------

-------------- --------------
Net loss (8,281,040) (21,654,317)
-------------- --------------

Redeemable convertible preferred stock
dividends and accretion of issuance
costs (2,072,371) -
-------------- --------------
Net loss attributable to common
stockholders ($10,353,411) ($21,654,317)
============== ==============

Net loss per share attributable to
common stockholders:
Basic and diluted net loss per share
attributable to common stockholders ($2.27) ($0.94)
============== ==============
Weighted average shares used to compute
basic and diluted loss per share
attributable to common stockholders 4,569,605 24,930,728
============== ==============

Twelve Months Ended
December 31,
-----------------------------
2006 2007
-------------- --------------
(Unaudited) (Unaudited)
Revenue - Research and development
grants $ 325,068 $ 730,672

Operating expenses:
Research and development 16,635,206 40,490,409
General and administrative 10,211,164 17,914,868
Total operating expenses 26,846,370 58,405,277
-------------- --------------

Loss from operations (26,521,302) (57,674,605)

Other (expense) income:
Interest income 468,882 2,572,103
Interest expense (1,213,798) (4,722,679)
Total other (expense) income, net (744,916) (2,150,576)
-------------- --------------

-------------- --------------
Net loss (27,266,218) (59,825,181)
-------------- --------------

Redeemable convertible preferred stock
dividends and accretion of issuance
costs (4,957,900) (1,368,037)
-------------- --------------
Net loss attributable to common
stockholders ($32,224,118) ($61,193,218)
============== ==============

Net loss per share attributable to
common stockholders:
Basic and diluted net loss per share
attributable to common stockholders ($7.18) ($2.65)
============== ==============
Weighted average shares used to compute
basic and diluted loss per share
attributable to common stockholders 4,489,661 23,053,719
============== ==============
*T

-0-
*T
CONSOLIDATED BALANCE SHEETS

December 31, December 31,
2006 2007
------------- ------------
(Unaudited) (Unaudited)
Current assets:
Cash and cash equivalents $ 8,915,857 $ 62,115,257
Short-Term Investments - 57,087,609
Accounts receivable--research and
development grants 127,924 324,328
Prepaid expenses and other current assets 1,563,314 1,481,561
------------- ------------
Total current assets 10,607,095 121,008,755
Property and equipment--net 886,783 4,732,689
Debt issuance costs - net - 7,167,701
Deferred stock offering costs and other 1,440,297 -
Investments in treasury bills and other - 43,792,728
------------- ------------
Total assets $ 12,934,175 $176,701,873
============= ============

Current liabilities:
Notes payable, current portion $ 1,734,672 -
Accounts payable 1,499,830 2,701,988
Accrued expenses 5,812,055 11,027,078
Accounts payable and accrued expenses -
related parties 684,243 1,284,055
Success fee liability 278,000 -
------------- ------------
Total current liabilities 10,008,800 15,013,121
------------- ------------

Bonds payable - net of discount - 133,132,390
Notes payable - less current portion 1,832,384 -
Convertible note payable including interest 14,844,286 -
Deferred rent 22,568 -
Redeemable convertible preferred stock 48,089,941 -
------------- ------------
Total stockholders' equity
(deficit) (61,863,804) 28,556,362
------------- ------------
Total liabilities, redeemable convertible
preferred stock and stockholders' equity
(deficit) $ 12,934,175 $176,701,873
============= ============
*T

Molecular Insight Pharmaceuticals, Inc.:
Priscilla Harlan, 617-492-5554
Vice President, Corporate Communications
& Investor Relations

Copyright Business Wire 2008