BETHESDA, Md., Aug. 6 /PRNewswire-FirstCall/ -- Micromet, Inc.
(NASDAQ: MITI), a biopharmaceutical company developing novel,
proprietary antibodies for the treatment of cancer, inflammation
and autoimmune diseases, today announced its financial results for
the second quarter and six months ended June 30, 2009. In the
second quarter of 2009, Micromet achieved a number of significant
milestones illustrating its continued progress in the clinic and in
corporate development. The milestones included presentations of
preclinical data on EGFR-targeting BiTE antibodies as well as
Micromet's BiTE antibody MT110, which targets EpCAM, at the
American Association of Cancer Research (AACR) conference, the
presentation of a product pipeline update at a research and
development day for investors and analysts, the presentation of
adecatumumab (MT201) phase 1b combination data at the American
Society of Clinical Oncology (ASCO) meeting, the presentation of
blinatumomab phase 2 data in acute lymphoblastic leukemia (ALL) at
the 14th Congress of the European Hematology Association (EHA), the
initiation of the first clinical trial with MT203, and the addition
of Micromet's common stock to the Russell 3000 index. These
developments are further summarized below: -- On April 22, Micromet
presented preclinical data showing activity in vivo and in vitro of
EGFR-targeting BiTE antibodies against KRAS- and BRAF-mutated human
colorectal cancer cells at the AACR meeting. The non-clinical data
indicated that Micromet's BiTE antibodies developed from the
currently marketed EGFR-specific monoclonal antibodies Erbitux
(cetuximab) and Vectibix (panitumumab) appeared to overcome the
resistance of mutated tumor cells to those monoclonal antibodies.
Micromet also presented data at the AACR meeting indicating that
its BiTE antibody MT110 can direct T cells to eliminate
EpCAM-expressing human colorectal cancer stem cells in cell culture
and in animal models. -- On April 24, Micromet held its annual
analyst meeting to present an update to investors and analysts on
its BiTE antibody pipeline and to review key AACR presentations. --
On June 1, Micromet presented an update at ASCO 2009 on a phase 1b
combination study of its human monoclonal antibody adecatumumab
with docetaxel in patients with metastatic breast cancer. The trial
demonstrated that combining adecatumumab with docetaxel was
feasible, with clinically manageable diarrhea being the main side
effect at higher doses. The overall response rate measured
according to the Response Evaluation Criteria In Solid Tumors
(RECIST) standards [version 1.0] was 38% in patients with high
expression of EpCAM (n=8), the target of adecatumumab, compared to
9% in patients with low EpCAM expression (n=11). Patients treated
with higher doses of adecatumumab also appeared to have a longer
time to progression when compared to patients treated at lower
doses (167 days versus 83 days). -- On June 8, The German
Multicenter ALL Study Group (GMALL) presented data at the EHA
meeting in Berlin indicating that blinatumomab had achieved the
primary endpoint in a phase 2 clinical trial in the treatment of
ALL patients. The primary endpoint of the trial was minimal
residual disease (MRD) response, or elimination of ALL cancer cells
in patients with MRD below the limit of detection, within four
cycles of treatment. Achievement of this primary endpoint required
that 5 of the 21 patients enrolled in the trial have a MRD
response. In the data presented, 13 of the 16 patients evaluated to
date, or 81%, demonstrated an MRD response, qualifying the trial as
having met its primary endpoint before its completion. -- On June
18, Micromet announced that a phase 1 clinical trial had been
initiated with its anti-GM-CSF human antibody MT203 by its
collaboration partner Nycomed. -- On June 29 Micromet announced
that it had been added to the Russell 3000 Index as part of the
annual reconstitution of the Russell indexes, which occurred on
June 26, 2009. Russell determines membership for its equity indexes
primarily by objective, market-capitalization rankings and style
attributes. The Russell 3000 also serves as the U.S. component to
the Russell Global Index, which Russell launched in 2007. Russell
indexes are widely used by investment managers and institutional
investors for index funds and as benchmarks for both passive and
active investment strategies. "We made significant clinical
progress on blinatumomab during the second quarter of 2009, and we
look forward to initiating a pivotal trial in acute lymphoblastic
leukemia in 2010," stated Christian Itin, Ph.D., President and CEO
of Micromet. Subsequent Events On August 4, after the completion of
the second quarter, Micromet closed a public offering of its common
stock with gross proceeds of $80.5 million, which included the full
exercise of the underwriters' over-allotment option. The net
proceeds from this offering, after underwriting discount and
offering expenses payable by Micromet, were approximately $75.0
million. The net proceeds of the offering, together with Micromet's
existing cash, cash equivalents and short-term investments, are
expected to fund operations for at least two years. "We are pleased
with the positive reception the financing has received in this
overall challenging economic environment. Our strengthened
financial position will support the development of the BiTE
antibody platform and our lead product candidate blinatumomab,"
commented Dr. Itin. Financial Results: Quarter Ended June 30, 2009
For the three months ended June 30, 2009, Micromet recognized total
revenues of $4.9 million, compared to $8.5 million for the same
period in 2008. Total operating expenses were $12.6 million for the
three months ended June 30, 2009, compared to $14.4 million for the
same period in 2008. Loss from operations for the three months
ended June 30, 2009 was $7.7 million, compared to a loss from
operations of $5.9 million for the same period in 2008. For the
three months ended June 30, 2009, Micromet reported a net loss of
$13.9 million, or a loss of $0.27 per basic and diluted common
share, compared to a net loss of $8.6 million, or $0.21 per basic
and diluted common share, for the same period in 2008. The net loss
for the three months ending June 30, 2009 includes a non-cash
charge of $6.3 million, reflecting an increase during the quarter
in the fair value of warrants issued in connection with a private
placement transaction in 2007. The Company recorded a $3.0 million
non-cash charge for this item in the second quarter of 2008. Six
Months Ended June 30, 2009 For the six months ended June 30, 2009,
Micromet recognized total revenues of $12.4 million, compared to
$14.4 million for the same period in 2008. Total operating expenses
were $25.0 million for the six months ended June 30, 2009, compared
to $27.6 million for the same period in 2008. Loss from operations
for the six months ended June 30, 2009 was $12.6 million, compared
to a loss from operations of $13.3 million for the same period in
2008. For the six months ended June 30, 2009, Micromet reported a
net loss of $14.3 million, or a loss of $0.28 per basic and diluted
common share, compared to a net loss of $14.5 million, or $0.36 per
basic and diluted common share, for the same period in 2008. The
net loss for the six months ending June 30, 2009 includes a
non-cash charge of $1.8 million, reflecting an increase during the
period in the fair value of warrants issued in connection with a
private placement transaction in 2007. The Company recorded a $1.7
million non-cash charge for this item in the first half of 2008.
Net cash used in operating activities was $4.1 million for the six
months ended June 30, 2009 compared to $4.7 million used in
operating activities for the same period in 2008. Net cash used in
investing activities was $15.3 million for the six months ended
June 30, 2009 compared to $0.3 million used in investing activities
for the same period in 2008. Net cash provided by financing
activities was $5.6 million for the six months ended June 30, 2009,
primarily the result of two draw downs from our committed equity
financing facility with Kingsbridge Capital Limited during the
second quarter of 2009. Micromet's cash, cash equivalents and
short-term investments were $49.2 million as of June 30, 2009. The
net proceeds of $75.0 million from the public offering were
received on August 4, 2009 and are not included in the Company's
cash balance as of June 30, 2009. Conference Call and Audio Webcast
Today, August 6, 2009, at 9:00 am Eastern Time. To participate in
this conference call, dial 866-730-5770 (U.S.) or 857-350-1594
(international), passcode: 56008602. The audio webcast can be
accessed at http://www.micromet-inc.com/. A replay of the call will
be available from 12:00 pm Eastern Time on August 6, 2009 (6:00 pm
Central European Time) through Thursday, August 13, 2009. The
replay number is 888-286-8010 (U.S.) or 617-801-6888
(international), passcode: 59290657. About Micromet, Inc. Micromet,
Inc. is a biopharmaceutical company developing novel, proprietary
antibodies for the treatment of cancer, inflammation and autoimmune
diseases. Its product development pipeline includes novel
antibodies generated with its proprietary BiTE antibody platform,
as well as conventional monoclonal antibodies. BiTE antibodies
represent a new class of antibodies that activate the T cells of a
patient's immune system to eliminate cancer cells. Five of
Micromet's antibodies are currently in clinical trials. Its BiTE
antibody blinatumomab (MT103) is in a phase 2 clinical trial for
the treatment of patients with acute lymphoblastic leukemia (ALL),
and in a phase 1 clinical trial for the treatment of patients with
non-Hodgkin's lymphoma (NHL). A second BiTE antibody, MT110, is in
a phase 1 clinical trial for the treatment of patients with solid
tumors. MT110 binds to the epithelial cell adhesion molecule, or
EpCAM, which is overexpressed in many solid tumors. Micromet's
human monoclonal antibody adecatumumab (MT201) also binds to EpCAM
and is being developed under a collaboration with Merck Serono.
Adecatumomab is in a phase 2 clinical trial in colorectal carcinoma
patients after complete resection of liver metastases, and a phase
1b clinical trial evaluating adecatumumab in combination with
docetaxel for the treatment of patients with metastatic breast
cancer. Micromet's monoclonal antibody MT293, also known as TRC093,
is licensed to TRACON Pharmaceuticals, Inc., and is in a phase 1
clinical trial for the treatment of patients with cancer. MT203, a
human antibody neutralizing the activity of granulocyte/macrophage
colony stimulating factor (GM-CSF), which has potential
applications in the treatment of various inflammatory and
autoimmune diseases, such as rheumatoid arthritis, psoriasis, or
multiple sclerosis, is in a phase 1 clinical trial conducted by
Micromet's collaboration partner Nycomed. Micromet's licensee
Morphotek, a wholly-owned subsidiary of Eisai, is also expected to
initiate a first phase 1 clinical trial with Micromet's
glycolipid-binding human antibody MT228 for the treatment of
melanoma. Micromet's preclinical product pipeline includes several
novel BiTE antibodies generated with its proprietary BiTE antibody
platform technology. A BiTE antibody targeting CEA for the
treatment of solid tumors is being developed in collaboration with
MedImmune. In addition, Micromet has entered into an option,
collaboration and license agreement with Bayer Schering Pharma AG
under which Bayer Schering Pharma was granted an exclusive option
to license a specified BiTE antibody against an undisclosed solid
tumor target. Other BiTE antibodies targeting MSCP, CD33, HER2,
EGFR and other targets are in various stages of preclinical
development. Forward-Looking Statements This release contains
certain forward-looking statements that involve risks and
uncertainties that could cause actual results to be materially
different from historical results or from any future results
expressed or implied by such forward-looking statements. These
forward-looking statements include statements regarding our
available cash resources, the efficacy, safety and intended
utilization of our product candidates, the conduct, timing and
results of future clinical trials, and expectations of the future
expansion of our product pipeline and collaborations. You are urged
to consider statements that include the words "ongoing," "may,"
"will," "believes," "potential," "expects," "plans," "anticipates,"
"intends," or the negative of those words or other similar words to
be uncertain and forward-looking. Factors that may cause actual
results to differ materially from any future results expressed or
implied by any forward-looking statements include the risk that
product candidates that appeared promising in early research,
preclinical studies or clinical trials do not demonstrate safety
and/or efficacy in subsequent clinical trials, the risk that
encouraging results from early research, preclinical studies or
clinical trials may not be confirmed upon further analysis of the
detailed results of such research, preclinical study or clinical
trial, the risk that additional information relating to the safety,
efficacy or tolerability of our product candidates may be
discovered upon further analysis of preclinical or clinical trial
data, the risk that we or our collaborators will not obtain
approval to market our product candidates, the risks associated
with reliance on outside financing to meet capital requirements,
and the risks associated with reliance on collaborators, including
MedImmune, Merck Serono, TRACON and Nycomed, for the funding or
conduct of further development and commercialization activities
relating to our product candidates. These factors and others are
more fully discussed in Micromet's Quarterly Report on Form 10-Q
for the fiscal quarter ended March 31, 2009, filed with the SEC on
May 11, 2009, as well as other filings by the company with the SEC.
(Tables Follow) Micromet, Inc. Condensed Consolidated Balance
Sheets (In thousands, except par value) June 30, December 31, 2009
2008 ------------- ------------ (unaudited) Assets Current assets:
Cash, cash equivalents and short-term investments $49,213 $46,168
Accounts receivable 1,838 3,424 Prepaid expenses and other current
assets 1,938 1,950 ------- ------- Total current assets 52,989
51,542 Property and equipment, net 3,098 3,322 Goodwill 6,462 6,462
Patents, net 4,185 5,250 Other long-term assets 3 959 Restricted
cash 3,137 3,140 ------- ------- Total assets $69,874 $70,675
======= ======= Liabilities and Stockholders' Equity Current
liabilities: Accounts payable $1,566 $710 Accrued expenses 5,950
6,492 Common stock warrants liability 14,123 12,294 Current portion
of long-term debt 2,149 - Current portion of deferred revenue 6,802
4,054 ------- ------ Total current liabilities 30,590 23,550
------- ------ Deferred revenue, net of current portion 7,314 7,555
Other non-current liabilities 2,057 2,025 Long-term debt
obligations - 2,157 Commitments - - Stockholders' equity: Preferred
stock, $0.00004 par value; 10,000 shares authorized; no shares
issued and outstanding - - Common stock, $0.00004 par value;
150,000 shares authorized; 52,579 shares issued and outstanding at
June 30, 2009; 50,913 shares issued and outstanding at December 31,
2008 2 2 Additional paid-in capital 234,997 227,806 Accumulated
other comprehensive income 7,360 5,749 Accumulated deficit
(212,446) (198,169) ------- ------- Total stockholders equity
29,913 35,388 ------- ------- Total liabilities and stockholders'
equity $69,874 $70,675 ======= ======= Micromet, Inc. Condensed
Consolidated Statements of Operations (In thousands, except per
share amounts) (Unaudited) Three Months Ended Six Months Ended June
30, June 30, -------------------- ------------------- 2009 2008
2009 2008 ---- ---- ---- ---- Revenues Collaboration agreements
$4,594 $7,900 $11,900 $13,649 License fees and other 336 552 493
727 -------- -------- -------- -------- Total revenues 4,930 8,452
12,393 14,376 Operating expenses Research and 8,950 10,992 17,639
20,712 development General and 3,629 3,383 7,316 6,917
administrative -------- -------- -------- -------- Total operating
expenses 12,579 14,375 24,955 27,629 -------- -------- --------
-------- Loss from operations (7,649) (5,923) (12,562) (13,253)
Other income (expense) Interest expense (94) (32) (170) (144)
Interest income 141 199 280 466 Change in fair value of (6,261)
(2,962) (1,829) (1,709) warrants Other income (expense) (82) 91 4
147 -------- -------- -------- -------- Net loss $(13,945) $(8,627)
$(14,277) $(14,493) ======== ======== ======== ======== Basic and
diluted net loss per common share $(0.27) $(0.21) $(0.28) $(0.36)
======== ======== ======== ======== Weighted average shares used to
compute basic and diluted net loss per share 51,480 40,824 51,198
40,802 ======== ======== ======== ======== DATASOURCE: Micromet,
Inc. CONTACT: US Media, Andrea tenBroek or Chris Stamm,
+1-781-684-0770, , or European Media, Ludger Wess, +49 (40) 8816
5964, , or US Investors, Susan Noonan, +1-212-966-3650, , or
European Investors, Ines-Regina Buth, +49 (30) 2363 2768, Web Site:
http://www.micromet-inc.com/
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