Cyberkinetics Announces Second Quarter Results.FOXBOROUGH, Mass. -- Cyberkinetics Neurotechnology Systems, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). - CYKN) today announced financial results for the second quarter ended June 30, 2005, and provided an update on its key development programs. Product revenues for the three months ended June 30, 2005 were $127,000 as compared to $133,000 for the three months ended June 30, 2004. Grant income for the three months ended June 30, 2005 was $39,000 as compared to $255,000 for the three months ended June 30, 2004. The decrease in grant income was anticipated and resulted from the company's strategy to transition from Small Business Innovation Research (SBIR SBIR Small Business Innovation Research (program/grant) SBIR Space Based Infra-Red SBIR Speaker-Boundary Interference SBIR Site Backsurface-referenced Ideal Plane/Range (silicon wafers) ) grant contracts to larger contracts that may be available from various federal granting agencies. The net loss applicable to common stockholders for the three months ended June 30, 2005 was $2,414,000, or $0.15 per share, based on 15,718,000 weighted-average common shares outstanding, as compared to $1,741,000, or $0.42 per share, for the three months ended June 30, 2004, based on 4,160,000 weighted-average common shares outstanding. Weighted-average common shares outstanding increased primarily as a result of the conversion of 9,419,000 shares of Series A Redeemable Convertible Preferred Stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". in connection with the October 2004 reverse merger, as well as the issuance of 2,000,000 shares of common stock in connection with a private placement in November 2004. On May 4, 2005, the Company drew down $3,000,000 on its line of credit. At June 30, 2005, the Company had cash and cash equivalents of $4,464,000. "In the second quarter of 2005 Cyberkinetics made important regulatory and clinical advances," stated Timothy R. Surgenor, Cyberkinetics' President and Chief Executive Officer. We received 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. clearance to market our NeuroPort(TM) System, which will be our first clinical product. "NeuroPort is our entry point to the large and growing market for invasive brain monitoring technology. Our plans for the 2006 launch of NeuroPort are on track. The upgrades to our Salt Lake manufacturing facility are almost complete, and we have initiated contact with a number of leading neurologists and neurosurgeons. "We also made significant progress in the clinical testing and development of our BrainGate(TM) System during the quarter," added Surgenor. "I am very pleased to report that we have recently received FDA and IRB IRB See: Industrial Revenue Bond approvals to expand the current patient eligibility criteria in the BrainGate clinical trial protocol 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 include non-speaking participants, as well as individuals with less severe paralysis. Importantly, our thanks go to Matthew Nagle, the first BrainGate trial participant. He recently completed the one year of clinical testing specified by our protocol. As a result of Matthew's pioneering contributions, we are now advancing from early-stage clinical research to the development of specific applications for BrainGate to benefit the disabled." Second Quarter Operational Highlights NeuroPort(TM) System - Neural Monitoring System for Acute Applications --On April 4, 2005, Cyberkinetics obtained 510(k) clearances of its NeuroPort(TM) Cortical cor·ti·cal adj. 1. Of, relating to, derived from, or consisting of cortex. 2. Of, relating to, associated with, or depending on the cerebral cortex. Microelectrode mi·cro·e·lec·trode n. A very small electrode, often used to study electrical characteristics of living cells and tissues. microelectrode, n Array (NeuroPort(TM) Array) and NeuroPort(TM) Neural Signal Processor (NeuroPort(TM) NSP (1) (Network Service Provider) An organization that provides a high-speed Internet backbone to ISPs and other service providers. Sprint, MCI and UUNET are examples of NSPs. See Internet backbones. ). Taken together, the NeuroPort(TM) Array and NeuroPort(TM) NSP comprise a neural monitoring system (the NeuroPort(TM) System) designed for acute inpatient applications, and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. --The NeuroPort(TM) System is Cyberkinetics' first commercial clinical product - an important first step in the Company's strategy to develop a broad family of products to diagnose, monitor and treat neurological diseases Noun 1. neurological disease - a disorder of the nervous system nervous disorder, neurological disorder disorder, upset - a physical condition in which there is a disturbance of normal functioning; "the doctor prescribed some medicine for the disorder"; and injuries, including epilepsy, stroke and brain trauma. --Also during the second quarter 2005, Cyberkinetics began significant improvements to its Salt Lake City manufacturing facility and quality systems. These improvements to the Company's manufacturing infrastructure are aimed at meeting or exceeding FDA standards for clinical-grade products. The facility-improvement program remains on schedule to support sales of the NeuroPort(TM) System in 2006. --Through its initial NeuroPort(TM) marketing activities during the quarter, the Company introduced the capabilities of the NeuroPort(TM) System to a number of leading neurosurgeons and neurologists. The Company is currently selecting leading centers to participate in the initial launch of the product in 2006. BrainGate(TM) System - Direct Brain-Computer Interface A brain-computer interface (BCI), sometimes called a direct neural interface or a brain-machine interface, is a direct communication pathway between a human or animal brain (or brain cell culture) and an external device. for Communication and Control of Other Devices --In July 2005, Cyberkinetics received approvals from the FDA (Food and Drug Administration and IRBs (Institutional Review Boards) at all three participating clinical sites to expand the patient eligibility criteria in trial protocol to include non-speaking, or "locked-in," participants, as well as individuals with less severe paralysis in the upper body. "Locked-in" syndrome is characterized by complete paralysis of voluntary muscles in all parts of the body except for those that control eye movement. The condition may result from traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain , disease or from other causes. Individuals with locked-in syndrome locked-in syndrome Neurology Flaccid tetraplegia with facial paresis and complete incapacity of expression–ie, anarthric and aphonic; LIS is due to damage or dysfunction of descending motor pathways or peripheral nerves, 2º to bilateral destruction are conscious, can think and reason, though they are unable to speak or move. Communication may be possible with blinking eye movements. With the FDA and IRB approvals, the Company expects to be able to recruit from a larger potential pool of patients for the ongoing trial. --To date, two participants have enrolled in the BrainGate(TM) System pilot trial. The first participant successfully completed the one-year testing period according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. trial protocol and will have his implant removed later this year. The Company expects to utilize the valuable data collected from the retrieved implant to improve engineering of future products used in the Company's clinical trials of the BrainGate(TM) System. --There have been no reported adverse events from either participant to date. The Company expects to report data from the second patient, as well as from subsequent participants, at appropriate, peer-reviewed scientific forums. --At the Annual Meeting of the American Spinal Injury Association (ASIA Asia (ā`zhə), the world's largest continent, 17,139,000 sq mi (44,390,000 sq km), with about 3.3 billion people, nearly three fifths of the world's total population. ) in May 2005, Dr. Steven Williams, presented six-month data related to the first participant in Cyberkinetics' pilot trial of the BrainGate(TM) System. Dr. Williams also presented a description of the BrainGate M*Power(TM) Controller, an interface under development, that is designed to allow a BrainGate System participant to control, by thought alone, a standard wireless computer device to perform a wide variety of tasks, including access to the internet. The new interface is also intended to enable participants to access the BrainGate System on a routine basis without reliance on a technician. --In June, the Company reported seven-month results related to the first participant in the BrainGate(TM) pilot trial at the 9th International Conference on Rehabilitation rehabilitation: see physical therapy. Robotics (ICORR ICorr Institute of Corrosion (UK) ICORR Iowa Coalition of Off-Road Riders ). The poster presentation included data on the use of newly developed software to automatically sort neuronal neu·ro·nal adj. Relating to a neuron. neuronal pertaining to or emanating from a neuron. neuronal abiotrophy see hereditary neuronal abiotrophy of Swedish Lapland dogs. signals in approximately two minutes, a significant reduction over the 30-minute time span previously required for technicians to manually sort neuronal signals. This automated process appeared to extract data from more neurons Neurons Nerve cells in the brain, brain stem, and spinal cord that connect the nervous system and the muscles. Mentioned in: Speech Disorders than were previously extracted manually. The automated software element is a critical building block for the Company's M*Power(TM) Controller System (M*Power(TM) Controller). --During the quarter, Cyberkinetics initiated active discussions with potential corporate and academic partners for limb-movement applications of BrainGate technology. The goal of these collaborations is to obtain grant contract funding to support further development of the BrainGate System. One of the most important applications of the BrainGate System is currently directed toward the development of limb-movement capability with feedback control. The applications of limb-movement technology could be used for those with spinal cord injuries Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. , amputations or for rehabilitation. Research Business - Neural Monitoring and Recording for Neuroscience neu·ro·sci·ence n. Any of the sciences, such as neuroanatomy and neurobiology, that deal with the nervous system. neuroscience the embryology, anatomy, physiology, biochemistry and pharmacology of the nervous system. Research --On June 1, 2005, Cyberkinetics announced that the Company had contracted with Alpha Omega Engineering Ltd. (Alpha Omega) to serve as a non-exclusive distributor for the company's line of neuroscience research products. Alpha Omega is a leading supplier of neuroscience systems to the research community both in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and in Europe, with product offerings that are complementary to Cyberkinetics' research products. The supply and distribution agreement supports Cyberkinetics goal of increasing near-term revenues and will provide Cyberkinetics with access to a wide group of neuroscientists Many famous neuroscientists are from the 20th and 21st century, as neuroscience is a fairly new science. However many anatomists, physiologist, and physicians are considered to be neuroscientists as well. in the United States and Europe through an established, reliable and trusted channel. About Cyberkinetics Neurotechnology Systems, Inc. Cyberkinetics Neurotechnology Systems, a leader in brain interface technology, is developing products to treat nervous system diseases and disorders by bringing together advances in neuroscience, computer science and engineering. Cyberkinetics' products are based on over ten years of technology development and cutting-edge neuroscience research at leading academic institutions such as Brown University, the Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Emory University Emory University (ĕm`ərē), near Atlanta, Ga.; coeducational; United Methodist; chartered as Emory College 1836, opened 1837 at Oxford. It became Emory Univ. in 1915 and in 1919 moved to Atlanta. , and the University of Utah The University of Utah (also The U or the U of U or the UU), located in Salt Lake City, is the flagship public research university in the state of Utah, and one of 10 institutions that make up the Utah System of Higher Education. . Cyberkinetics has received FDA clearance to market the NeuroPort(TM) System, a neural monitor designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity. The NeuroPort(TM) System can contribute to the diagnosis and treatment of neurological conditions Neurological conditions A condition that has its origin in some part of the patient's nervous system. Mentioned in: Pervasive Developmental Disorders in patients who have undergone craniotomy Craniotomy Definition Surgical removal of part of the skull to expose the brain. Purpose A craniotomy is the most commonly performed surgery for brain tumor removal. by providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity. Cyberkinetics' BrainGate(TM) System is being designed to give severely paralyzed par·a·lyze tr.v. par·a·lyzed, par·a·lyz·ing, par·a·lyz·es 1. To affect with paralysis; cause to be paralytic. 2. To make unable to move or act: paralyzed by fear. individuals, as well as individuals with motor impairment from a variety of causes, a long-term, direct brain-computer interface for the purpose of communication and control of a computer, assistive devices assistive device Public health Any device designed or adapted to help people with physical or emotional disorders to perform actions, tasks, and activities. See Americans with Disabilities Act, Architectural barriers, Assistive technology. , and, ultimately, limb movement. Patients are currently being enrolled into a pilot clinical trial to test the BrainGate(TM) System's safety and feasibility. Visit Cyberkinetics' website for additional information at www.cyberkineticsinc.com. Forward Looking Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement This announcement contains 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. , including statements about Cyberkinetics' product development plans and progress, financial status and commercial prospects. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, and can be identified by the use of forward-looking terminology such as "may," "will," "believe," "expect," "anticipate" or other comparable terminology. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected in forward-looking statements and reported results shall not be considered an indication of our future performance. Factors that might cause or contribute to such differences include our limited operating history; our lack of profits from operations; our ability to successfully develop and commercialize our proposed products; a lengthy approval process and the uncertainty of FDA and other governmental regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. ; clinical trials may fail to demonstrate the safety and effectiveness of our products; the degree and nature of our competition; our ability to employ and retain qualified employees; compliance with recent legislation regarding corporate governance Corporate Governance The relationship between all the stakeholders in a company. This includes the shareholders, directors, and management of a company, as defined by the corporate charter, bylaws, formal policy, and rule of law. , including the Sarbanes-Oxley Act See SOX. of 2002; as well as those risks more fully discussed in our public filings with the Securities and Exchange Commission, all of which are difficult to predict and some of which are beyond our control. Financial results for the quarter ended June 30, 2005 are summarized in the table below.
Cyberkinetics Neurotechnology Systems, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------- -------------------------
2005 2004 2005 2004
------------ ------------ ------------ ------------
Revenues:
Product sales $127,175 $132,710 $376,667 $261,392
Grant income 39,125 255,434 210,923 444,597
------------ ------------ ------------ ------------
Total revenues 166,300 388,144 587,590 705,989
Operating
expenses:
Cost of product
sales 32,013 50,895 76,669 133,125
Research and
development 1,383,982 742,961 2,837,605 1,372,791
Sales and
marketing 85,691 72,661 168,183 143,768
General and
administrative 989,740 1,050,657 2,076,770 1,693,229
------------ ------------ ------------ ------------
Total operating
expenses 2,491,426 1,917,174 5,159,227 3,342,913
------------ ------------ ------------ ------------
Operating loss (2,325,126) (1,529,030) (4,571,637) (2,636,924)
Other income
(expense):
Interest income 17,950 8,940 33,281 21,985
Interest expense (106,877) (12,740) (123,070) (19,387)
------------ ------------ ------------ ------------
Other (expense)
income, net (88,927) (3,800) (89,789) 2,598
Net loss $(2,414,053) $(1,532,830) $(4,661,426) $(2,634,326)
Dividends and
accretion to
redemption value
of redeemable
convertible
preferred stock - (208,383) - (416,766)
------------ ------------ ------------ ------------
Net loss
attributable to
common
stockholders $(2,414,053) $(1,741,213) $(4,661,426) $(3,051,092)
============ ============ ============ ============
Basic and diluted
net loss
attributable to
common
stockholders per
common share $(0.15) $(0.42) $(0.30) $(0.74)
============ ============ ============ ============
Shares used in
computing basic
and diluted net
loss attributable
to common
stockholders per
common share 15,718,368 4,159,588 15,694,064 4,102,951
============ ============ ============ ============
Condensed Consolidated Balance Sheets
(Unaudited)
As of
June 30, December 31,
2005 2004
------------ ------------
Assets
Current Assets
Cash and cash equivalents $4,463,931 $5,232,641
Other current assets 468,501 726,664
Net property and equipment 676,962 549,927
Other assets 250,112 246,871
------------ ------------
Total assets $5,859,506 $6,756,103
============ ============
Liabilities and stockholders' equity
Current liabilities 4,154,959 1,308,245
Long-term liabilities 264,372 365,528
Stockholders' equity:
Common stock, $0.001 par value 17,078 16,939
Additional paid-in-capital 19,797,134 17,835,622
Common stock held in escrow (13,000) (13,000)
Deferred stock-based compensation (1,027,825) (85,445)
Accumulated deficit (17,333,212) (12,671,786)
------------ ------------
Total stockholders' equity 1,440,175 5,082,330
------------ ------------
Total liabilities and stockholders' equity $5,859,506 $6,756,103
============ ============
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