Large Scale Biology Corporation -- LSBC -- Reports Financial Results for Third Quarter 2002.Business Editors/Health & Medical Writers VACAVILLE, Calif.--(BUSINESS WIRE)--Oct. 23, 2002 Will Explore Partnering Alternatives for Revised Clinical Trials Strategy to Complete Promising Plant-Produced NHL NHL Non-Hodgkin's lymphoma, see there Cancer Vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. Development Large Scale Biology Corporation (Nasdaq:LSBC LSBC Law Society of British Columbia LSBC Large Scale Biology Corporation LSBC Lone Star Bulldog Club LSBC Lasalle & Bureau County Railroad Company LSBC Lifesaver for Babies and Children (St John Ambulance, UK) LSBC Lone Star Bit Company ) today reported results for the third quarter ended September 30, 2002. LSBC's net loss for the third quarter of 2002 was $6.8 million, or $0.27 per share, compared to a net loss of $9.6 million, or $0.38 per share for the second quarter of 2002 and $4.8 million, or $0.20 per share for the third quarter of 2001. Revenues for the quarter ended September 30, 2002 were $0.7 million, sequentially higher than the second quarter of 2002 and a decrease from $5.1 million in the same period last year, reflecting the end of all funding from the research collaboration phase of the Company's agreement with The Dow Chemical Company The Dow Chemical Company (NYSE: DOW TYO: 4850 ) is an American multinational corporation headquartered in Midland, Michigan. Overview The Dow Chemical Company is currently the second largest chemical manufacturer in the World (after BASF)[1]. and Dow AgroSciences Dow AgroSciences LLC is a wholly owned subsidiary of the Dow Chemical Company specializing in not only agricultural chemicals such as pesticides, but also seeds and biotechnology solutions. The company is based in Indianapolis, Indiana, in the United States. LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , the Company's primary source of revenue for the quarter ended September 30, 2001. Total operating costs operating costs npl → gastos mpl operacionales and expenses for the third quarter 2002 were $7.6 million, a decrease of approximately $2.6 million from the second quarter of 2002 and $3.0 million from the third quarter of 2001. Included in the second quarter of 2002 was an expense of approximately $900,000 for severance The act of dividing, or the state of being divided. The term severance has unique meanings in different branches of the law. Courts use the term in both civil and criminal litigation in two ways: first, when dividing a lawsuit into two or more parts, and second, when benefits related to the Company's reorganization in June 2002. Large Scale Biology Corporation ended the quarter with approximately $27.3 million in cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has . "In another quarter of economic turbulence turbulence, state of violent or agitated behavior in a fluid. Turbulent behavior is characteristic of systems of large numbers of particles, and its unpredictability and randomness has long thwarted attempts to fully understand it, even with such powerful tools as , LSBC management has succeeded in advancing revenue-generating objectives with new deals, restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). to operate more efficiently and preserve cash, repositioning repositioning Laparoscopic surgery The changing of a Pt's position during a procedure to improve access or visualization of the operative field, which may be linked to complications, as it changes anatomic planes of operation. Cf Laparoscopic surgery. business units to accelerate commercialization opportunities and recasting re·cast tr.v. re·cast, re·cast·ing, re·casts 1. To mold again: recast a bell. 2. strategy for the development of our most promising pipeline products," said John D. Fowler, President. "We have continued to make hard choices in funding our product priorities during a quarter of strong scientific news and weak market conditions. Significantly, we are today announcing a multi-pronged strategy to further the clinical development of our plant-produced vaccines for non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma (NHL). Recent clinical results announced on August 6, 2002 encouraged our clinical team to spend the past 2 1/2 months devising a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , multi-site Phase II/III pivotal clinical trial of the NHL vaccine, which we will discuss with the 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. this fall. This approach differs from our previously announced plan to begin only Phase II trials of the NHL vaccine this month, but we believe this new compressed approach is scientifically justified and likely to reach the final stages of FDA approval more quickly and less expensively than under traditionally separate Phase II and Phase III Noun 1. phase III - 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 FDA protocols. At the same time, given the significant funding required to move the NHL product to commercialization, we will explore alternative funding opportunities for this program, including potentially seeking a partner with which to co-develop our NHL vaccine." Robert L. Erwin, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of LSBC, said, "We believe we have made the necessary progress in our NHL vaccine development program to justify moving forward more rapidly and on a more aggressive timeline. Given the present biotechnology market-financing environment, we believe it prudent to explore partnering alternatives prior to commencing our proposed pivotal Phase II/III trials. We also have developed other potential clinical trial protocols A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial. The protocol usually also gives the background and reason the trial is being conducted, but these could be provided in to treat sub-populations of NHL patients, such as those with indolent lymphoma Indolent lymphoma (also called low-grade) Cancerous growths of lymphoid tissue that progress slowly to more aggressive forms of cancer. Mentioned in: MALT Lymphoma who have not been previously treated with chemotherapy chemotherapy (kē'mōthĕr`əpē), treatment of disease with chemicals or drugs. One chemotherapeutic approach is the development of selectively toxic substances, i.e. , and may also move forward with these trials, which may allow even faster assessment of the clinical efficacy of our vaccine. Additionally, we have made significant progress with our potential alpha-Galactosidase product for the treatment of Fabry's disease Fa·bry's disease n. A sex-linked disorder of glycolipid metabolism characterized by a variety of progressive symptoms including fevers, hypertension, and purple skin lesions, with death resulting from renal, cardiac, or cerebrovascular complications. . We filed an orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the application in September for this indication and expect to file an IND later this winter. We may seek a partner for this proprietary product as well." Third-quarter and recent Company highlights include: -- Announcement of a $12.3 million, five-year proteomics contract with the National Institute of Environmental Health Sciences to analyze samples and create a public database relating environmental exposure to disease. This prestigious collaboration provides significant near-term revenues and validates LSBC/Proteomics' proprietary technologies. -- Announcement of a new collaboration with the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (South Africa) to develop and manufacture vaccines intended to protect against infectious diseases, including cervical cancer and AIDS/HIV. After joint work on promising vaccines is completed, we anticipate that the most promising vaccine candidates will be produced at LSBC/Biomanufacturing in Kentucky for clinical trials. -- Announcement of a $2 million, three-year award from the National Institute of Standards and Technology to develop a new vaccine discovery and production platform that will generate strong and lasting immunological responses. The award, which begins funding in November 2002, will hasten improvements to LSBC's proprietary GENEWARE(R) system/technology capabilities for multiple public health and commercial benefits. -- Announcement that Agilent Technologies, Inc. has licensed Large Scale Biology Corporation's proteomics sample preparation and immunosubtraction technology for the research market. -- Announcement of promising results from the Phase I clinical trials conducted by Ronald Levy, MD, Chief of Oncology at Stanford University School of Medicine, for LSBC's personalized vaccines for non-Hodgkin's lymphoma patients. The vaccines were well tolerated in all 16 patients with no reported serious adverse events. The clinical results indicate a positive immune response to the vaccine that calls for proceeding to next phases of trial in the approval process. An analysis of the Phase I results will be presented formally at the Meeting of the American Society of Hematology in December 2002. -- Announcement of the filing for Orphan Drug Status on plant-produced Human alpha-Galactosidase A used for the treatment of Fabry's disease. LSBC has manufactured clinical-grade quantities of alpha-Galactosidase A at LSBC/Biomanufacturing in Kentucky. -- Announcement of the creation of Biopharmaceutical Development, Biomanufacturing and Proteomics business units to support commercial opportunities. Directed by separate chains of command, the freestanding business units are a further refinement of a corporate reorganization undertaken earlier in the year designed to focus business development and more rapidly achieve commercial end points. -- Appointment of Charles D. Nash to the board of directors of Large Scale Biology Corporation. Mr. Nash is a corporate financial strategist and principal of Nash Equity Capital, Inc. of Atlanta, Georgia. Conference Call Large Scale Biology Corporation will host a conference call discussing third quarter financial results and 2002 outlook on Wednesday, October 23, 2002 at 5:00 P.M. (EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT ). A live webcast of the call may be accessed on Large Scale Biology Corporation's website at www.lsbc.com. If you are unable to participate during the live webcast, the call will be archived on the LSBC web site through close of business on November 1, 2002. An audio replay of the call will be available until midnight, October 25, 2002, two hours after the call. For replay in the U.S., dial (800) 642-1687, or outside of the U.S., dial (706) 645-9291. Please enter the conference identification number 6069283. About Large Scale Biology Corporation Large Scale Biology Corporation uses its 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) , proteomics pro·te·o·mics n. The analysis of the expression, localization, functions, and interactions of the proteins produced by the genes of an organism. and biomanufacturing technologies to develop and manufacture personalized per·son·al·ize tr.v. per·son·al·ized, per·son·al·iz·ing, per·son·al·iz·es 1. To take (a general remark or characterization) in a personal manner. 2. To attribute human or personal qualities to; personify. drugs, vaccines and diagnostics for rapid identification and effective treatment of disease. Corporate offices and the Genomics Division are headquartered in Vacaville, California Vacaville, California is located in Solano County, California, United States, between Sacramento and San Francisco. As of the 2000 census, the city had a total population of 88,625. ; the Company's Proteomics Division is located in Germantown, Maryland; and the Company's Biomanufacturing Division is located in Owensboro, Kentucky Owensboro is the third largest city in Kentucky and the county seat of Daviess County.GR6 It is located on U.S. Highway 60 about 32 miles southeast of Evansville, Indiana and is the principal city of the Owensboro, Kentucky Metropolitan Statistical Area. . For more information about Large Scale Biology Corporation, visit the Company's website at www.lsbc.com. In this release, any statements, which refer to expectations, projections or other characterizations of future events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or , are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . Forward-looking statements involve risks, uncertainties and situations that may cause our actual results or performance to be materially different from any future results or performance expressed or implied by these statements, including our dependence upon and our ability to enter into and maintain successful relationships with collaboration partners, creation of demand for products incorporating or made using our technologies, our ability to improve and keep our technologies competitive, delays or issues which may arise in securing FDA approval for certain products we develop, the actual clinical efficacy of such products, our ability to manage costs in ways that preserve our product pipeline and technology base and the requirement for substantial funding to conduct research and development and to expand commercialization activities. We cannot guarantee future results, levels of activity, performance or achievements. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this release. For a further list and description of such risks and uncertainties, see LSBC's reports filed with the Securities and Exchange Commission, including Forms 10-K and 10-Q. Except as required by law, we do not undertake to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. LSBC(TM) is a trademark of Large Scale Biology Corporation. GENEWARE(R) is a registered trademark of Large Scale Biology Corporation.
Large Scale Biology Corporation
Condensed Consolidated Statements of Operations
Unaudited
(In thousands, except per share amounts)
Three months ended Nine months ended
Sept. 30, Sept. 30,
-------------------- --------------------
2002 2001 2002 2001
-------- -------- -------- --------
Revenues $ 710 $ 5,129 $ 1,625 $ 17,053
-------- -------- -------- --------
Costs and expenses:
Development
agreements 579 681 867 3,216
Research and
development 4,525 5,794 16,758 16,376
General,
administrative
and marketing 2,370 3,781 9,983 10,266
Amortization of
purchased
intangibles 156 325 468 975
-------- -------- -------- --------
Total costs
and expenses 7,630 10,581 28,076 30,833
-------- -------- -------- --------
Loss from operations (6,920) (5,452) (26,451) (13,780)
Interest income, net 156 651 587 2,710
-------- -------- -------- --------
Net loss $ (6,764) $ (4,801) $(25,864) $(11,070)
======== ======== ======== ========
Net loss per share
- basic and diluted $ (0.27) $ (0.20) $ (1.04) $ (0.45)
======== ======== ======== ========
Weighted average
shares outstanding
- basic and diluted 24,993 24,573 24,962 24,537
======== ======== ======== ========
Large Scale Biology Corporation
Condensed Consolidated Balance Sheets
Unaudited
(In thousands)
Sept. 30, Dec. 31,
2002 2001
------- -------
Assets
Current assets:
Cash and marketable securities $27,251 $48,779
Other current assets 1,397 1,217
------- -------
Total current assets 28,648 49,996
Property, plant, and equipment, net 16,457 18,882
Intangible and other assets, net 6,936 8,034
------- -------
$52,041 $76,912
======= =======
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued expenses $ 2,062 $ 2,921
Current portion of long-term debt 104 107
Deferred revenue and customer advances 400 278
------- -------
Total current liabilities 2,566 3,306
Long-term debt 217 249
Long-term deferred revenue -- 320
------- -------
Total liabilities 2,783 3,875
Stockholders' equity 49,258 73,037
------- -------
$52,041 $76,912
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