Caution: Transcripts from SeekingAlpha typically have several clerical errors; if a sentence in the transcript makes no sense or is impossible to parse, it’s probably not what was actually said on the CC.
[The cash balance on 3/31/09 was $87.9M, and the cash burn during 1Q09 was $20.6M. (Please see the actual PR for financial tables.) The only other news in this PR is that enrollment is complete in the M118 phase-2a trial in PCI; top-line results from this trial are expected during the current quarter.
On the CC, CEO Craig Wheeler stated that routine interactions continue between NVS/MNTA and the FDA Office of Generic Drugs regarding the Lovenox ANDA, and there are no indications that the FDA will request any data beyond the immunogenicity package that NVA/MNTA furnished in Sep 2008 (#msg-32449872). Further, Wheeler confirmed that the FDA has inspected the plants of all four Chinese suppliers of bulk heparin that NVS employs in its Lovenox supply chain; although the FDA has not yet issued final reports on all four suppliers, Wheeler knows of no reason to anticipate deficiencies or delays in this facet of the Lovenox ANDA.]
CAMBRIDGE, Mass., May 7, 2009 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM: MNTA ), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the quarter ended March 31, 2009.
For the first quarter of 2009, the Company reported a net loss of $17.9 million, compared with a net loss of $13.3 million for the same period last year. At March 31, 2009, the Company had cash, cash equivalents, and marketable securities of $87.9 million, compared with $108.5 million at December 31, 2008.
``Momenta's innovative product pipeline comprises both complex mixture generics and novel drugs,'' said Craig A. Wheeler, President and Chief Executive Officer. ``In the first quarter we made substantial progress in the novel drug development side of our business, advancing both our novel anticoagulant, M118 and our novel oncology product candidate, M402. On the generic side of the business, the reviews of our two ANDAs continue,'' he concluded.
First Quarter 2009 Financial Results
Revenue for the first quarter of 2009 was $4.0 million, approximately equal to the $4.2 million of collaborative revenue for the same period last year. Research and development expenses for the first quarter of 2009 were $15.8 million, compared to $12.9 million for the same period last year. The increase in research and development expenses principally resulted from increased clinical trial costs as the Company approaches the completion of the Phase 2a clinical trial for the M118 program, increased manufacturing, process development and third-party research costs in support of the M356 program and increased stock-based compensation expense.
General and administrative expenses for the first quarter of 2009 totaled $6.3 million, compared with $5.8 million for the same period last year. The increase in general and administrative expenses was primarily due to increased stock-based compensation expense associated with the annual grant of stock options and increased professional fees.
Recent Corporate Developments
In April, the Company presented results from preclinical studies of the Company's novel oncology product candidate, M402, at the American Association of Cancer Research meeting in Denver, CO. One of the key findings was that M402, in combination with chemotherapeutic agents, inhibited spontaneous tumor metastasis in a murine metastatic breast carcinoma model.
In April, the patient accrual portion of the M118 EMINENCE trial was completed. The Phase 2a trial of the novel anticoagulant enrolled approximately 500 patients undergoing percutaneous coronary intervention (PCI). Top line data for the study is expected late in the second quarter of 2009.
Conference Call Information
Management will host a conference call on Thursday, May 7, 2009 at 10:00 am EDT to discuss these results and provide an update on the Company. To access the call, please dial (877) 852-6543 (domestic) or (719) 325-4774 (international) prior to the scheduled conference call time and provide the access code 9924917. A replay of the call will be available approximately two hours after the call and will be accessible through May 20, 2009. To access the replay, please dial (888) 203-1112 (domestic) or (719) 457-0820 (international) and provide the access code 9924917.
A live audio webcast of the call will be available on the ``Investors'' section of the Company's website, http://www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through June 7, 2009.
About Momenta
Momenta Pharmaceuticals is a biotechnology company, headquartered in Cambridge, MA, specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs.‹
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