BETHESDA, Md., March 12 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced that it is regaining from its partner MedImmune the rights in North America to its most advanced BiTE antibody candidate, blinatumomab, also known as MT103. In Europe, Micromet is conducting a phase 2 clinical trial with blinatumomab for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical trial for the treatment of patients with non-Hodgkin's lymphoma. In addition, the two companies plan to initiate a research program for the development of a new BiTE antibody for the treatment of hematological cancers. Micromet also announced its financial results for the fourth quarter and full year ended December 31, 2008.
"We had a successful 2008 and are excited about the prospects for 2009. Our lead BiTE antibody program blinatumomab reported encouraging clinical data from phase 1 and phase 2 clinical trials last year, which form the basis for advancing the program towards its first pivotal clinical trial. We are pleased to regain North American rights to blinatumomab from our partner and are looking forward to taking control of the worldwide development of the program," stated Christian Itin, President and Chief Executive Officer of Micromet. "With our successful financing and partnering activities last year and early this year, we are well positioned to move our programs to the next value step."
Recent Developments relating to Blinatumomab and Micromet's Collaboration with MedImmune:
In March 2009, MedImmune elected to return its license rights to blinatumomab to Micromet. Micromet will assume responsibility for the worldwide clinical development and commercialization of blinatumomab. MedImmune will complete the development of the commercial scale manufacturing process for blinatumomab at its cost. Upon the first marketing approval of blinatumomab in the United States, MedImmune will have a one-time option to reacquire the commercialization rights in North America at pre-defined terms.
Micromet's clinical development activities with blinatumomab in Europe will continue unchanged. With the return of control over the development of blinatumomab in North America, Micromet will be in a position to align the European and US development activities. Micromet will provide an update later this year on its plans for the development of blinatumomab in the United States.
The companies plan to initiate a research program for the development of a new BiTE antibody for the treatment of hematological cancers. MedImmune has an exclusive license to develop and commercialize the new BiTE antibody in North America, while Micromet owns all rights to the new BiTE antibody outside of North America. MedImmune will reimburse Micromet for its expenses in the performance of certain research and preclinical development activities to be conducted by Micromet. In addition, MedImmune will be required to make milestone payments upon the achievement of certain development milestones, and, if it receives marketing approval, to pay a royalty on net sales of the new BiTE antibody in North America.
Summary of Key Clinical Data Presented in 2008:
Financings and related Events in 2008:
Program Updates in 2009:
Consistent with its January 5, 2009, press release titled "Micromet Key Events for 2009," Micromet intends to provide an update on its research and development programs at the following events:
Additional expected Milestones in 2009:
Quarter Ended December 31, 2008
For the three months ended December 31, 2008, Micromet recognized total revenues of $5.9 million, compared to $7.0 million for the same period in 2007. Total operating expenses were $12.4 million for the three months ended December 31, 2008, compared to $13.1 million for the same period in 2007.
Loss from operations for the three months ended December 31, 2008 was $6.5 million, compared to a loss from operations of $6.1 million for the same period in 2007.
For the three months ended December 31, 2008, Micromet reported a net loss of $5.9 million, or $0.12 per basic and diluted common share, compared to a net loss of $3.8 million, or $0.09 per basic and diluted common share, for the same period in 2007.
Year Ended December 31, 2008
For the year ended December 31, 2008, Micromet recognized total revenues of $27.3 million, compared to $18.4 million for 2007. Total operating expenses were $53.4 million for the year ended December 31, 2008, compared to $43.6 million for 2007.
Loss from operations for the year ended December 31, 2008 was $26.1 million, compared to the $25.2 million loss from operations in 2007.
For the year ended December 31, 2008, Micromet reported a net loss of $33.2 million, or $0.77 per basic and diluted common share, compared to a net loss of $20.1 million, or $0.55 per basic and diluted common share, for 2007. The net loss for the year ended December 31, 2008 includes a non-cash charge of $8.1 million, reflecting an increase during the year in the fair value of warrants that we issued in a 2007 private placement transaction, compared to a $1.8 million non-cash gain for this item in 2007. The fair value of the warrants is calculated based on the Black-Scholes model. Increases in our stock price during a reporting period result in a non-cash expense, while decreases in our stock price during a reporting period result in non-cash income.
Net cash used in operating activities was $15.7 million for the year ended December 31, 2008 compared to $14.3 million used in operating activities for 2007. Micromet's cash and cash equivalents were $46.2 million as of December 31, 2008.
Conference Call and Audio Webcast Today, March 12, 2009, at 9:00 am U.S. Eastern Time.
To participate in this conference call, dial 800-659-1966 (U.S.) or 617-614-2711 (international), passcode: 20334467. The audio webcast can be accessed at: www.micromet-inc.com in the investor relations section of the website. A replay of the call will be available from 12:00 pm Eastern Time on March 12, 2009 (6:00 pm Central European Time) through Thursday, March 19, 2009. The replay number is 888-286-8010 (U.S.) or 617-801-6888 (international), passcode: 99301894.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company with offices in Bethesda, MD and Munich, Germany. The Company is focused on developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. The Company's novel antibody technology is based on its proprietary BiTE(R) antibody platform, representing a new class of antibodies that specifically activate T cells from the patient's own immune system to eliminate cancer cells or other disease related cells. Four of the Company's antibodies are currently in clinical trials, with the remainder of its product pipeline in preclinical development. The Company's lead program is a BiTE antibody known as blinatumomab, or MT103. It is in a phase 2 clinical trial for the treatment of patients with acute lymphoblastic leukemia and a phase 1 clinical trial for the treatment of patients with non-Hodgkin's lymphoma. Micromet's second BiTE antibody in clinical development is MT110, which targets the epithelial cell adhesion molecule (EpCAM). The Company owns all rights to MT110, which is currently in a phase 1 clinical trial for the treatment of patients with solid tumors. The Company's third clinical stage antibody is adecatumumab, also known as MT201, a traditional 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. Micromet licensed a fourth clinical stage antibody, MT293, to TRACON Pharmaceuticals, Inc. MT293 is being developed in a phase 1 clinical trial for the treatment of patients with cancer. The Company's preclinical programs include MT203 being developed in collaboration with Nycomed. MT203 is a traditional human antibody neutralizing the activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which has potential applications in the treatment of inflammatory and autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple sclerosis. Micromet has granted an exclusive option to Bayer Schering Pharma AG to license a BiTE antibody against an undisclosed solid tumor target. Additional BiTE antibodies, targeting CEA, CD33, Her2, EGFR and MCSP, respectively, are in different stages of preclinical development.
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 return of development and commercialization rights to blinatumomab, the future development of blinatumomab and a new BiTE antibody binding to CD19, the conduct, timing and results of future clinical trials, expectations of the future expansion of our product pipeline and collaborations, our plans regarding future presentations of clinical data, our expectations of timing for the publication of results from our research and development programs, our ability to draw down on the Committed Equity Financing Facility with Kingsbridge, and our plans regarding collaborations and other partnering activities. 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 quarter ended September 30, 2008, filed with the SEC on November 6, 2008, as well as other filings by the company with the SEC.
Micromet, Inc. Condensed Consolidated Balance Sheets (In thousands, except par value) December 31, December 31, 2008 2007 Assets Current assets: Cash and cash equivalents $46,168 $27,066 Accounts receivable 3,424 4,689 Prepaid expenses and other current assets 1,950 2,579 Total current assets 51,542 34,334 Property and equipment, net 3,322 4,390 Goodwill 6,462 6,462 Patents, net 5,250 7,680 Deposits and other assets 959 196 Restricted cash 3,140 3,190 Total assets $70,675 $56,252 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $710 $2,335 Accrued expenses 6,492 5,285 Warrant liabilities 12,294 5,218 Current portion of long-term debt obligations - 2,401 Current portion of deferred revenue 4,054 3,360 Total current liabilities 23,550 18,599 Deferred revenue, net of current portion 7,555 8,366 Other non-current liabilities 2,025 2,055 Long-term debt obligations, net of current portion 2,157 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; 50,913 and 40,778 shares issued and outstanding at December 31, 2008 and December 31, 2007, respectively 2 2 Additional paid-in capital 227,806 184,014 Accumulated other comprehensive income 5,749 5,895 Accumulated deficit (198,169) (164,933) Total stockholders´ equity 35,388 24,978 Total liabilities and stockholders' equity $70,675 $56,252
Micromet, Inc. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) Three Months Ended Year Ended December 31, December 31, 2008 2007 2008 2007 Revenues Collaboration agreements $5,212 $6,751 $25,870 $17,366 License fees and other 660 234 1,416 1,018 Total revenues 5,872 6,985 27,286 18,384 Operating expenses Research and development 8,534 9,471 39,189 29,191 General and administrative 3,817 3,590 14,163 14,430 Total operating expenses 12,351 13,061 53,352 43,621 Loss from operations (6,479) (6,076) (26,066) (25,237) Other income (expense) Interest expense (33) (71) (222) (509) Interest income 91 348 740 938 Change in fair value of warrants 439 41 (8,064) 1,750 Other income 131 1,817 377 2,932 Net loss $(5,851) $(3,799) $(33,235) $(20,126) Basic and diluted net loss per common share $(0.12) $(0.09) $(0.77) $(0.55) Weighted average shares used to compute basic and diluted net loss per share 50,534 40,757 43,309 36,362
|SOURCE Micromet, Inc.|
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