Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced
today financial results for the quarter ended June 30, 2007 and
provided financial and operational guidance for fiscal year 2007.
�Molecular Insight has had a very productive second quarter in
progressing our robust portfolio of promising and innovative
molecular imaging pharmaceuticals and targeted radiotherapeutics
for cancer,� said David S. Barlow, Chairman and CEO of Molecular
Insight. �Our clinical development programs are all on or ahead of
plan. We have initiated the planned pivotal registration trial for
Zemiva and are actively enrolling patients on schedule. Our Phase 1
of a planned Phase 1/2 trial for AzedraTM has begun dosing the
second patient cohort ahead of schedule, and, in the Onalta�
development program, we completed the technology transfer from
Tyco/Mallinckrodt to two manufacturing sites, ahead of schedule.
Our Solazed� and Trofex development programs remain on track.�
�During the quarter, we signed an important and strategic purchase
and sale agreement for a manufacturing facility in Denton, Texas,
which we believe will eventually allow us to manufacture and
produce many, if not all of our own products. Additionally, we were
recognized for cutting edge research for our Trofex program for the
detection of prostate cancer,� Mr. Barlow added. Recent Corporate
Highlights Initiated a planned pivotal registration Phase 2 trial
with Zemiva, the company�s lead molecular imaging pharmaceutical,
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 will 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. These two trials together could form
the basis of an application with the U.S. Food and Drug
Administration (FDA) for marketing approval of Zemiva. Completed
the Normals reference database trial for Zemiva in 174 subjects.
The database is designed to provide a library of normal cardiac
images and a computer-based algorithm to facilitate more timely and
accurate reading of Zemiva scans. As part of the company�s clinical
development strategy, the Normals database will be applied
throughout the Zemiva development program and during its potential
commercialization. Announced that results of the prospective
analysis of the Zemiva Phase 2b trial and the validation of the
Zemiva Normals reference database will be presented as
late-breaking clinical data at the upcoming American Society of
Nuclear Cardiologists (ASNC) annual meeting. The Society of Nuclear
Medicine recognized Molecular Insight research on the compound
MIP-1072 with the 2007 Berson-Yalow Award for the most original
scientific abstract that made the most significant contribution to
basic or clinical radioassay. The company presented preclinical
data on MIP-1072 at the 54th annual meeting of the Society of
Nuclear Medicine. MIP-1072 is a radiolabeled molecular imaging
pharmaceutical in the company�s Trofex program which is in
development for the detection and staging of prostate cancer.
Preclinical studies suggest that MIP-1072 can identify the presence
of prostate tumors specifically and non-invasively by targeting
prostate-specific membrane antigen (PSMA) expression on prostate
cancer cells. Entered into a $3 million purchase agreement for a
domestic, commercial-scale radiopharmaceutical manufacturing
facility in Denton, Texas with NeoRx Manufacturing Group, Inc., a
wholly owned subsidiary of Poniard Pharmaceuticals, Inc. Financial
Highlights of the Second Quarter 2007 Second quarter 2007 net loss
attributable to common shareholders was ($11.5) million, or ($0.47)
per share, compared to a net loss attributable to common
shareholders of ($6.5) million, or ($1.44) per share, in the second
quarter of 2006. Total revenues for the second quarter of 2007 were
$15,000, compared to total revenues of $82,000 in the second
quarter of 2006. Our revenues to date have consisted of National
Institute of Health grants. Cash and cash equivalents and
short-term investments at June 30, 2007 totaled $49.7 million,
compared to $8.9 million at December 31, 2006. Research and
development (R&D) expenses totaled $7.7 million in the second
quarter of 2007, compared to $3.6 million in the second quarter of
2006. The increase in R&D expenses is primarily due to
increased costs associated with the Phase 2 trials for Azedra and
Zemiva, increased preclinical development costs and
compensation-related expenses associated with an expanded R&D
team. General and administrative (G&A) expenses were $4.4
million for the second quarter of 2007, compared to $2.0 million in
the second quarter of 2006. The major increases in G&A expenses
were the increased compensation expense including stock based
compensation, increased legal fees, increased recruiting and
relocation fees, increased communications, sales and marketing
expenses and increased insurance expenses. These increases were
primarily a result of both additional services and expenses related
to our new public company legal and reporting requirements
following our initial public offering in the first quarter of 2007,
and additional consulting services to support accounting and
finance personnel in the second quarter of 2007. Other (expense)
income net was $555,000 in income, net for the second quarter of
2007 compared to $41,000 expense in the second quarter of 2006.
This increase was primarily due to additional interest income from
the higher cash and investment funds following the initial public
offering and lower interest expense from reduction in notes
payable, from the payoff of debt and the conversion of convertible
debt to common stock as part of the stock offering. Redeemable
convertible preferred stock dividends and accretion of issuance
costs were $0 for the second quarter of 2007, compared to $939,000
for the second quarter of 2006. This decrease was a result of the
company�s preferred stock being converted to common stock following
the initial public offering. Molecular Insight Operational Guidance
Molecular Insight expects to meet the following clinical milestones
over the next 12 to 18 months: Report prospective analysis of the
Zemiva Phase 2b trial and the validation of the Zemiva Normals
reference database at the ASNC annual meeting on September 8, 2007
Complete purchase of domestic, commercial-scale radiopharmaceutical
manufacturing facility in the second half of 2007 Complete the
planned pivotal registration Phase 2 trial that is currently
underway for Zemiva in the first half of 2008 Initiate a
neuroblastoma clinical trial with Azedra in the first half of 2008
Complete Phase 1 Azedra dose-ranging clinical trial in
pheochromocytoma in the first half of 2008 Initiate a Phase 1
dosimetry trial with Solazed, a targeted radiotherapeutic small
molecule for the treatment of malignant melanoma, in the first half
of 2008 Initiate a Phase 1 dosimetry trial with Trofex, a
prostate-specific membrane antigen-targeted molecular imaging
pharmaceutical for the diagnosis of prostate cancer, in the first
half of 2008 Initiate an additional Phase 1 dosimetry trial with
Onalta, a somatostatin receptor-targeted molecular radiotherapeutic
peptide for the treatment of neuroendocrine tumors, in the first
half of 2008 Initiate a planned confirmatory Phase 3 pivotal trial
with Zemiva in the second half of 2008 Initiate a planned Phase 2
pivotal trial with Azedra in the second half of 2008 Complete a
Trofex dosimetry trial in the second half of 2008 Initiate a dose
and image optimization trial for Trofex in the second half of 2008
Conference Call Access Information The company will host a
conference call to discuss financial results on Monday, August 13,
2007, at 10:00 a.m. Eastern Time. The call can be accessed by
dialing (866) 202-0886 or (617) 213-8841 (for international
participants) at least five minutes prior to the start of the call.
The participant pass code is 70088080. 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
96917838. A live audio webcast of the call will also be available
on 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 audio webcast
and the PowerPoint slides 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 and targeted
radiotherapeutics and molecular imaging pharmaceuticals with
initial applications in the areas of oncology and cardiology. Its
lead targeted 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�, Onalta�, Zemiva� and any
other statements relating to product candidates or the applicable
regulatory process, including clinical development programs,
estimated enrollment figures and number of sites for the Phase 2
trial with Zemiva, and projected clinical milestones over the next
12 to 18 months. 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
Second Quarter of Fiscal 2007 CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED) (in thousands, except per share amounts) Three Months
Ended Six Months Ended June 30, June 30, � 2006 � � 2007 � � 2006 �
� 2007 � (Unaudited) (Unaudited) (Unaudited) (Unaudited) Revenue -
Research and development grants $ 82,391 $ 14,686 $ 163,909 $
262,253 � Operating expenses: Research and development 3,619,433
7,683,083 7,687,553 17,368,387 General and adminis-trative
1,970,212 4,430,606 4,873,655 7,505,010 Total operating expenses �
5,589,645 � � 12,113,689 � � 12,561,208 � � 24,873,397 � � Loss
from operations (5,507,254 ) (12,099,003 ) (12,397,299 )
(24,611,144 ) � Other (expense) income: Interest income 89,512
620,412 255,501 1,146,329 Interest expense (130,697 ) (53,865 )
(248,835 ) (1,489,068 ) Other � - � � (11,514 ) � - � � (22,096 )
Total other (expense) income, net � (41,185 ) � 555,033 � � 6,666 �
� (364,835 ) � � � � Net loss � (5,548,439 ) � (11,543,970 ) �
(12,390,633 ) � (24,975,979 ) � Redeemable convertible preferred
stock dividends and accretion of issuance costs � (939,420 ) � - �
� (1,894,034 ) � (1,368,126 ) Net loss attributable to common
stockholders � ($6,487,859 ) � ($11,543,970 ) � ($14,284,667 ) �
($26,344,105 ) � Net loss per share attributable to common
stockholders: Basic and diluted net loss per share attributable to
common stockholders � ($1.44 ) � ($0.47 ) � ($3.23 ) $ (1.24 )
Weighted average shares used to compute basic and diluted loss per
share attributable to common stockholders � 4,500,541 � �
24,782,715 � � 4,426,879 � � 21,208,365 � CONSOLIDATED BALANCE
SHEETS (in thousands) December 31, June 30, � 2006 � 2007
(Unaudited) Current assets: Cash and cash equivalents $ 8,915,857 $
5,601,812 Short-Term Investments - 44,172,728 Accounts
receivable�research and development grants 127,924 344,309 Prepaid
expenses and other current assets � 1,563,314 � 1,049,989 Total
current assets 10,607,095 51,168,838 Property and equipment�net
886,783 2,002,082 Deferred stock offering cost 982,195 - Deposits
7,291 542,588 Other assets � 450,811 � 186,822 Total assets $
12,934,175 $ 53,900,330 � Current liabilities: Notes payable,
current portion $ 1,734,672 $ 1,746,916 Accounts payable 1,499,830
1,395,425 Accrued expenses 5,812,055 6,664,887 Accounts payable and
accrued expenses � related parties 684,243 948,461 Success fee
liability � 278,000 � - Total current liabilities � 10,008,800 �
10,755,689 � Notes payable - less current portion 1,832,384 937,981
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)
� 42,206,660 Total liabilities, redeemable convertible preferred
stock and stockholders� equity (deficit) $ 12,934,175 $ 53,900,330
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