Micromet, Inc. Reports Second Quarter 2008 Financial Results

2008-08-07 06:00:00

Micromet, Inc. Reports Second Quarter 2008 Financial Results

    BETHESDA, Md., Aug. 7 /EMWNews/ -- Micromet, Inc. (Nasdaq:

MITI), a biopharmaceutical company focusing on the development of 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, 2008.



    Summary of Recent Events:



    In June, Micromet and MedImmune presented a clinical update for the

BiTE(R) antibody blinatumomab (MT103/MEDI-538) at the International

Conference on Malignant Lymphoma in Lugano, Switzerland. All seven patients

with relapsed non-Hodgkin's lymphoma treated with blinatumomab at the

highest dose level presented at the conference responded to the treatment

with partial or complete responses. Responses also appeared to be durable.

The most frequent side effects observed so far were lymphopenia, pyrexia

and leukopenia. Less common adverse events included transient neutropenia

and thrombocytopenia, transient increase of liver enzymes and central

nervous system events, all of which were fully reversible. In addition,

Micromet and MedImmune commenced treatment of patients with acute

lymphoblastic leukemia in a phase 2 clinical trial of blinatumomab.



    Also in June, Micromet received a milestone payment of $775,000 from

Nycomed in connection with the initiation of formal preclinical safety

studies for antibody MT203, which has potential applications in the

treatment of inflammatory and autoimmune diseases.



    In April, Micromet announced the initiation of the first phase 1

clinical trial with its BiTE antibody MT110. The study will explore the

safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of MT110

in patients with lung cancer and patients with gastrointestinal cancer.

MT110 targets the epithelial cell adhesion molecule (EpCAM or CD326), which

is highly expressed on colon, lung, breast, prostate, ovarian, gastric and

pancreatic cancer cells and on cancer stem cells of colon, breast, prostate

and pancreas cancers. Cancer stem cells are believed to cause metastases

and recurrence of these cancers.



    Also in April, Micromet presented five posters at the American

Association for Cancer Research (AACR) showing recent progress on the

company's proprietary BiTE antibody platform and new BiTE antibodies:



    -- Anti-cancer antibodies in marketed products Herceptin(R), Erbitux(R)

and Vectibix(R) and the anti-asthma antibody in Xolair(R) were successfully

converted to highly potent BiTE antibodies.



    -- Animal data from two studies indicated feasibility of subcutaneous

administration of BiTE antibodies MT103 and MT110.



    -- Animal data provided proof of concept for a BiTE antibody targeting

CD33 with potential use in the treatment of acute myelogenic leukemia

(AML), and a BiTE antibody targeting MCSP with potential use in the

treatment of melanoma.



    -- Animal data suggested a therapeutic window for a BiTE antibody

targeting EpCAM in a relevant animal species.



    Summarizing the events, Christian Itin, Ph.D., President and Chief

Executive Officer of Micromet said: "We have made significant progress with

the BiTE antibody platform introducing new BiTE antibodies that target a

wide range of tumor indications and converting currently marketed

therapeutic antibodies into potent BiTE antibodies with much increased

activity against tumor cells. We believe that the progress on our

proprietary BiTE antibody platform will allow us to expand our own product

pipeline, while at the same time engaging in new collaborations on selected

BiTE antibody programs."



    Financial Results:



    Quarter Ended June 30, 2008



    For the three months ended June 30, 2008, Micromet recognized total

revenues of $8.5 million, compared to $3.1 million for the same period in

2007. Total operating expenses were $14.4 million for the three months

ended June 30, 2008, compared to $11.1 million for the same period in 2007.

For the three months ended June 30, 2008, Micromet reported a net loss of

$8.6 million, or $0.21 per basic and diluted common share, compared to a

net loss of $6.5 million, or $0.20 per basic and diluted common share, for

the same period in 2007.



    Six Months Ended June 30, 2008



    For the six months ended June 30, 2008, Micromet recognized total

revenues of $14.4 million, compared to $5.8 million for the same period in

2007. Total operating expenses were $27.6 million for the six months ended

June 30, 2008, compared to $21.4 million for the same period in 2007. For

the six months ended June 30, 2008, Micromet reported a net loss of $14.5

million, or $0.36 per basic and diluted common share, compared to a net

loss of $14.1 million, or $0.44 per basic and diluted common share, for the

same period in 2007.



    Micromet's cash and cash equivalents were $22.4 million as of June 30,

2008. Net cash used in operating activities was $4.7 million for the six

months ended June 30, 2008 compared to $7.9 million used in operating

activities for the same period in 2007.



    2008 Outlook:



    -- At the annual meeting of the European Society for Molecular Oncology

(ESMO) in September in Stockholm, Sweden, Micromet will present data from

the ongoing phase 1b clinical trial of patients with metastatic breast

cancer treated with adecatumumab (MT201) in combination with docetaxel.

Further, Micromet plans to initiate a phase 2 clinical trial later in 2008

to evaluate adecatumumab in an adjuvant setting.



    -- At the annual meeting of the American Society for Hematology (ASH)

in December, Micromet expects to provide a further update on the currently

ongoing phase 1 clinical trial of blinatumomab in patients with

non-Hodgkins lymphoma.



    -- Also at ASH, Micromet expects to present initial results on the

currently ongoing phase 2 clinical trial of blinatumomab in patients with

acute lymphoblastic leukemia (ALL).



    -- Finally, Micromet expects that its collaboration partner MedImmune

will begin a phase 1 clinical trial in the United States evaluating

blinatumomab in patients with chronic lymphocytic leukemia by the end of

2008.



    Conference Call and Audio Webcast Today, August 7, 2008, at 9:00 am

Eastern Time



    To participate in this conference call, dial 866-356-4279 (U.S.) or

617-597-5394 (international), passcode: 19440822. The audio webcast can be

accessed at: http://www.micromet-inc.com on the investor relations section of the

website.



    A replay of the call will be available from 11:00 am Eastern Time on

August 7, 2008 (5:00 pm Central European Time) through Thursday, August 14,

2008. The replay number is 888-286-8010 (U.S.) or 617-801-6888

(international), passcode: 13099911.



    About Micromet, Inc.



    Micromet, Inc. (http://www.micromet-inc.com) is a biopharmaceutical company

developing novel, proprietary antibodies for the treatment of cancer,

inflammation and autoimmune diseases. Four of its antibodies are currently

in clinical trials, while the remainder of the product pipeline is in

preclinical development. The BiTE(R) antibody blinatumomab, also known as

MT103, is in a phase 2 clinical trial for the treatment of patients with

acute lymphoblastic leukemia and in a phase 1 clinical trial for the

treatment of patients with non-Hodgkin's lymphoma. BiTE antibodies

represent a new class of antibodies that activate the T cells of a

patient's own immune system to eliminate cancer cells. Micromet is

developing blinatumomab in collaboration with MedImmune, Inc., a subsidiary

of AstraZeneca plc. MT110, a second BiTE antibody being developed by

Micromet that targets the epithelial cell adhesion molecule (EpCAM), is

currently in a phase 1 clinical trial for the treatment of patients with

lung or gastrointestinal cancer. The third clinical stage antibody is

adecatumumab, also known as MT201, a human monoclonal antibody that targets

EpCAM-expressing solid tumors. Micromet is developing adecatumumab in

collaboration with Merck Serono in a phase 1b clinical trial evaluating

adecatumumab in combination with docetaxel for the treatment of patients

with metastatic breast cancer. The fourth clinical stage antibody is MT293,

which is licensed to TRACON Pharmaceuticals, Inc. and is being developed in

a phase 1 clinical trial for the treatment of patients with cancer. Three

additional BiTE antibodies, targeting CD33, CEA and MCSP, respectively, are

in preclinical development. In addition, Micromet has established a

collaboration with Nycomed for the development and commercialization of

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.



    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 the efficacy, safety and intended

utilization of our product candidates, the development of our BiTE antibody

technology, the conduct, timing and results of future clinical trials,

expectations of the future expansion of our product pipeline and

collaborations, and our plans regarding future presentations of clinical

data. 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 Annual Report on Form 10-K for the fiscal year ended December

31, 2007, filed with the SEC on March 14, 2008, as well as other filings by

the company with the SEC.




Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. Micromet undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. (Tables Follow) Micromet, Inc. Condensed Consolidated Balance Sheets (In thousands, except par value) June 30, December 31, 2008 2007 Assets Current assets: Cash and cash equivalents $22,427 $27,066 Accounts receivable 2,483 4,689 Prepaid expenses and other current assets 2,095 2,579 Total current assets 27,005 34,334 Property and equipment, net 4,298 4,390 Goodwill 6,462 6,462 Patents, net 7,061 7,680 Deposits and other assets 216 196 Restricted cash 3,247 3,190 Total assets $48,289 $56,252 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $2,991 $2,335 Accrued expenses 5,195 4,765 Common stock warrant liability 6,928 5,218 Other liabilities 484 520 Current portion of long-term debt obligations 2,586 2,401 Current portion of deferred revenue 4,898 3,360 Total current liabilities 23,082 18,599 Deferred revenue, net of current portion 8,580 8,366 Other non-current liabilities 2,203 2,055 Long-term debt obligations, net of current portion 2,417 2,254 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; 40,829 and 40,778 shares issued and outstanding at June 30, 2008 and December 31, 2007, respectively 2 2 Additional paid-in capital 185,802 184,015 Accumulated other comprehensive income 5,629 5,894 Accumulated deficit (179,426) (164,933) Total stockholders' equity 12,007 24,978 Total liabilities and stockholders' equity $48,289 $56,252 Micromet, Inc. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 2008 2007 2008 2007 Revenues Collaboration agreements $7,900 $2,548 $13,649 $5,093 License fees and other 552 518 727 743 Total revenues 8,452 3,066 14,376 5,836 Operating expenses Research and development 10,992 6,714 20,712 13,424 General and administrative 3,383 4,370 6,917 7,932 Total operating expenses 14,375 11,084 27,629 21,356 Loss from operations (5,923) (8,018) (13,253) (15,520) Other income (expense) Interest expense (32) (178) (144) (434) Interest income 199 99 466 225 Change in fair value of warrants (2,962) 522 (1,709) 522 Other income 91 1,106 147 1,148 Net loss $(8,627) $(6,469) $(14,493) $(14,059) Basic and diluted net loss per common share $(0.21) $(0.20) $(0.36) $(0.44) Weighted average shares used to compute basic and diluted net loss per share 40,824 32,315 40,802 31,909

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