Curis Reports Third Quarter Fiscal 2000 Results.Attention Business and Science Editors CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Nov. 14, 2000 Curis, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CRIS) today reported the results of its operations for the three- and nine-month periods ended September 30, 2000. These results include combined results of the three companies merged into Curis as described below. On July 31, 2000, Creative BioMolecules This page aims to list articles on Wikipedia that describe particular biomolecules or types of biomolecules. This list is not necessarily complete or up to date - if you see an article that should be here but isn't (or one that shouldn't be here but is), please update the page , Inc. (formerly Nasdaq:CBMI CBMI Christian Blind Mission International (Australia) CBMI Content Based Multimedia Indexing CBMI Commercial Building Mold Inspector ), Ontogeny ontogeny: see biogenetic law. Ontogeny The developmental history of an organism from its origin to maturity. It starts with fertilization and ends with the attainment of an adult state, usually expressed in terms of both maximal body , Inc., and Reprogenesis, Inc., merged with and into Curis, Inc. On that date, Curis, as the surviving company surviving company The company that emerges in control following a business combination. The surviving company is generally one of the firms entering the combination but may be a new company formed by the combination. of the merger, assumed the rights and obligations of Creative, Ontogeny and Reprogenesis. Immediately after the merger, Curis was owned approximately 43 percent by the former stockholders of Creative, 38 percent by the former stockholders of Ontogeny and 19 percent by the former stockholders of Reprogenesis. Consequently, for accounting purposes, Curis is deemed to be the successor to Creative, and the historical financial statements of Creative have become the historical financial statements of Curis. Excluding one-time costs and expenses, amortization of intangibles and stock-based compensation, total net loss for the three months ended September 30, 2000 would have been $7,675,000, or $.36 per share. Financial results for the three-month period ended September 30, 2000 included a number of significant, non-recurring, non-cash charges and other merger-related cash expenses incurred in connection with the merger and the formation of Curis on July 31, 2000. These include costs and expenses as follows: a one-time non-cash charge of $294,800,000 resulting from the allocated portion of the purchase price of Ontogeny and Reprogenesis identified under the accounting rules as in-process research and development; stock-based compensation of $9,356,000; amortization of intangible assets of $8,529,000; severance paid to former executive officers and former employees of $1,955,000; and a loss on the disposition of assets of $554,000. Operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the third quarter of 2000 include all costs incurred by Curis for the period from August 1, 2000 to September 30, 2000 and all costs incurred by Creative BioMolecules for the month of July, 2000. Excluding the one-time costs and expenses, amortization of intangibles and stock-based compensation, total operating expenses for the three months ended September 30, 2000 would have been $8,142,000. Curis' cash and investment balance on September 30, 2000 was $44,169,000, which included restricted securities of $4,989,000. The Company had 26,015,824 shares outstanding on September 30, 2000. Primarily as a result of merger-related expenses, Curis reported a net loss of $322,869,000 or $15.19 per share, for the three-month period ended September 30, 2000, compared with a net loss of $2,995,000, or $0.28 per share, for the three-month period ended September 30, 1999. Per share amounts are on both a basic and diluted basis. Total revenues for the three-month period ended September 30, 2000 were $66,000 as compared to $824,000 for the same period in 1999. The decrease in revenues was primarily the result of the termination of a research agreement with Biogen, Inc. in 1999, which was partially offset by revenues earned under a National Institute of Standards and Technology National Institute of Standards and Technology, governmental agency within the U.S. Dept. of Commerce with the mission of "working with industry to develop and apply technology, measurements, and standards" in the national interest. (NIST (National Institute of Standards & Technology, Washington, DC, www.nist.gov) The standards-defining agency of the U.S. government, formerly the National Bureau of Standards. It is one of three agencies that fall under the Technology Administration (www.technology. ) grant received in November 1999. Total operating expenses for the three-month period ended September 30, 2000 were $323,336,000, as compared to $4,138,000 for the same period in 1999.. "The fiscal quarter ended September 30, 2000 was the first for Curis following shareholder approval of the merger of Creative BioMolecules, Ontogeny, and Reprogenesis," said Doros Platika, M.D., president and chief executive officer of Curis. "It has been a busy and exciting start to a new company that is building a leadership presence in regenerative medicine. "The quarter was marked by several research findings based upon the core developmental biology Developmental biology A large field of investigation that includes the study of all changes associated with an organism as it progresses through the life cycle. The life cycles of all multicellular organisms exhibit many similarities. and functional genomics Noun 1. functional genomics - the branch of genomics that determines the biological function of the genes and their products genomics - the branch of genetics that studies organisms in terms of their genomes (their full DNA sequences) technologies driving the discovery of innovative therapies at Curis," said Dr. Platika. "These included a demonstration that treatment with the Sonic Hedgehog For the video game character, see . Sonic hedgehog homolog (SHH) is one of three proteins in the mammalian hedgehog family, the others being desert hedgehog (DHH) and Indian hedgehog (IHH). SHH is the best studied ligand of the hedgehog signaling pathway. protein restored nerve function to normal in pre-clinical models of diabetic neuropathy Diabetic Neuropathy Definition Diabetic neuropathy is a nerve disorder caused by diabetes mellitus. Diabetic neuropathy may be diffuse, affecting several parts of the body, or focal, affecting a specific nerve and part of the body. . Additional findings showed that the Hedgehog pathway is activated following injury to peripheral nerves Peripheral nerves Nerves throughout the body that carry information to and from the spinal cord. Mentioned in: Amyloidosis, Charcot Marie Tooth Disease in pre-clinical models and plays a key role in the nerve recovery process. These studies represent critical components in our program leading up to the introduction of a Hedgehog-based therapy into clinical testing. "Earlier in the quarter, research published in Nature (Vol. 406, 31 August 2000) demonstrated that Curis' approach to treating basal cell carcinoma basal cell carcinoma n. A slow-growing, locally invasive, but rarely metastasizing neoplasm of the skin derived from basal cells of the epidermis or hair follicles. Also called basal cell epithelioma. is based on fundamental genetic differences between cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping. See also: Cancer and normal cells," said Dr. Platika. "Our compound, CUR-61414, inhibits the biological process that leads to the uncontrolled growth seen in basal cell basal cell n. A type of cell found in the deepest layer of the epithelium. and certain other cancers. We expect to file an Investigational New Drug (IND) application to begin human clinical testing with this compound next year. "On the clinical front, enrollment in our Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with Chondrogel was completed in September," said Dr. Platika. "Data from this trial in children with vesicoureteral reflux Vesicoureteral Reflux Definition Vesicoureteral reflux (VUR) refers to a condition in which urine flows from the bladder, back up the ureter, and back into the kidneys. is expected in late 2001. Pending evaluation of this data, we expect to submit a Biologics License Application (BLA BLA abbr. Bachelor of Liberal Arts ) to the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in the first half of 2002, and we plan to market this product ourselves. "In October, Curis received a second $2,000,000 grant from the National Institute of Standards and Technology (NIST) to support the development of a new class of biomaterials designed to enable minimally invasive surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. ," said Dr. Platika. "Such procedures would significantly reduce postoperative pain and decrease the length of hospital stays, recovery time and healthcare costs. Initial applications targeted by NIST under this grant include gastroesophogeal reflux disease and stress urinary incontinence stress urinary incontinence n. See stress incontinence. ." Curis, Inc. is developing products based on technologies in the emerging field of regenerative medicine. Curis is combining insights gained through the study of developmental biology with high-throughput screening capabilities, proteins, cells and biocompatible materials to facilitate the development of new regenerative medicine therapies. For more information, please visit the Curis web site at http://www.curis.com. The statements in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, regulatory approval and commercialization, the impact of competitive products, patents, patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , product liability, third party reimbursement, and other risks and uncertainties associated with the biotechnology industry. For additional factors that could cause actual results to differ materially, please refer to the risk factors section of the Curis joint proxy statement/prospectus filed with the Securities and Exchange Commission on June 19, 2000.
CURIS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three months ended Nine months ended
September 30, September 30,
2000 1999 2000 1999
Revenues $ 65,955 $ 823,573 $ 743,813 $ 2,405,760
Operating expenses:
Research and
development 6,056,255 2,708,005 10,072,461 8,072,342
General and
administrative 4,040,568 1,317,051 6,604,422 4,078,187
Stock-based
compensation 9,356,112 -- 12,495,590 64,000
Amortization
of intangible
assets 8,529,302 112,725 8,647,473 325,705
Loss on
disposition
of fixed assets 553,912 -- 248,516 --
In-process
research &
development 294,800,000 -- 294,800,000 --
Total
operating
expenses 323,336,149 4,137,781 332,868,462 12,540,234
Net loss from
operations (323,270,194) (3,314,208) (332,124,649) (10,134,474)
Interest and
other income 580,706 366,177 1,164,252 1,617,577
Interest expense (179,747) (46,528) (265,362) (114,780)
Total other
income 400,959 319,649 898,890 1,502,797
Net loss $(322,869,235)$ (2,994,559)$(331,225,759)$ (8,631,677)
Accretion and
repurchase
costs on Series
1998/A
Preferred Stock -- -- -- (2,395,559)
Net loss
applicable
to common
stockholders $(322,869,235)$ (2,994,559)$(331,225,759)$ (11,027,236)
Basic and
diluted net
loss per
common share $ (15.19)$ (0.28)$ (22.59)$ (1.04)
Weighted
average common
shares for
basic and
diluted
net loss
computation 21,250,137 10,798,008 14,662,960 10,618,696
CURIS, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
September 30, December 31,
2000 1999
ASSETS
Cash, cash equivalents and
marketable securities $ 44,168,748 $ 21,370,585
Property and equipment, net 7,437,337 2,130,158
Intangible assets 113,737,522 5,075,914
Other assets 1,386,988 315,634
Total assets $166,730,595 $ 28,892,291
LIABILITIES AND STOCKHOLDERS'
EQUITY
Accounts payable and
accrued expenses $ 8,061,659 $ 4,113,994
Debt and capital
lease obligations 5,537,264 1,356,711
Total liabilities 13,598,923 5,470,705
Total stockholders' equity 153,131,672 23,421,586
Total liabilities and
stockholders' equity $166,730,595 $ 28,892,291
|
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion