Hopkinton, Massachusetts, May 14, 1997--Creative BioMolecules, Inc. (Nasdaq:CBMI) today announced financial results for the first quarter of fiscal 1997, ended March 31, 1997. During this quarter, the Company recorded revenues of $3,647,000 and expenses of $7,395,000 resulting in a net loss of $3,749,000 or $0.11 per share. During the first quarter of 1996, revenues were $2,040,000 and expenses were $5,481,000, resulting in a net loss of $3,441,000 or $0.12 per share. The increased revenues and expenses during the first quarter of 1997 compared with the first quarter of 1996 result primarily from increased research and manufacturing activities in support of the Company’s orthopaedic products partnership with Stryker Corporation, the renal therapy partnership with Biogen, Inc., and other research programs. The Company ended the quarter with over $46 million of cash, cash equivalents and marketable securities.
The Company and Stryker are collaborating to develop orthopaedic reconstruction products, the first of which is a bone graft substitute incorporating OP-1. In the first quarter of 1997, Stryker completed a pivotal trial comparing this bone graft substitute to autograft, the current gold standard in orthopaedic surgery. The objective of the complete trial is to demonstrate that the OP-1 device is comparable to autograft in repairing certain severe bone fractures. Unlike the autograft procedure, the OP-1 based device would eliminate the need for a second surgery to harvest bone for the graft. In February, initial data on approximately 15% of the pivotal trial participants, presented and interpreted by one principal investigator in the trial, indicated bone repair in the patients treated with the OP-1 device was comparable to those treated with autograft. Full analysis of the results, including blinded radiographic analysis by an independent panel, the primary endpoint in the study, is currently underway.
In the renal therapy program, the Company and Biogen established a partnership in December 1996 to develop acute and chronic renal disease therapies based on the Company’s technology. In connection with this partnership, Biogen is funding research at the Company and is conducting its own research intended to support an application for permission to begin clinical trials of a new form of therapy for kidney failure. Preclinical studies with the Company’s therapy indicate that OP-1 can improve renal function and reduce death in animals suffering from either acute or chronic renal failure. The Company is also conducting research into other applications of its morphogenic proteins.
The Company is working closely with Stryker in moving toward the commercialization of this and future orthopaedic reconstruction devices. In the renal disease program, Biogen and Creative are rapidly expanding the research and development effort at both companies.
Creative BioMolecules is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Company’s therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in cell and tissue formation.
Creative BioMolecules, Inc. and Subsidiary |
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Consolidated Statements of Operations |
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1997 |
1996 |
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| REVENUE: | ||||
| Research and development contracts | $2,751,473 |
$1,055,704 |
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| Manufacturing contracts | 232,239 |
612,065 |
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| License fees and royalties | 101,584 |
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| Interest and other | 663,225 |
270,441 |
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| Total revenues | 3,646,937 |
2,039,794 |
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| COSTS AND EXPENSES: | ||||
| Research and development | 5,579,053 |
3,832,752 |
||
| Cost of manufacturing contracts | 161,038 |
477,533 |
||
| General and administrative | 1,602,916 |
1,115,563 |
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| Interest | 52,472 |
54,802 |
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| Total costs and expenses | 7,395,479 |
5,480,650 |
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| NET LOSS | ($3,748,542 |
) | ($3,440,856 |
) |
| NET LOSS PER COMMON SHARE | ($0.11 |
) | ($0.12 |
) |
| WEIGHTED AVERAGE NUMBER OF COMMON AND COMMON EQUIVALENT SHARES OUTSTANDING |
32,853,617 |
29,027,234 |
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Balance Sheet Data |
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| Cash, Cash Equivalents and Marketable Securities | $46,147,109 |
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| Total Assets | $70,459,949 |
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| Total Stockholders' Equity | $64,066,190 |
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The statements in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from Company expectations include, without limitation, varying results from clinical sites within the pivotal trial, different conclusions drawn by evaluators in accordance with pivotal protocols, the impact of competitive products, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products and the other risks and uncertainties detailed from time to time in the Company’s periodic reports.
NOTE: Creative BioMolecules’ latest press releases are available on the Internet at http://www.prnewswire.com (Company News on Call) or they may be requested by fax by calling 800-758-5804, extension 212213.
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