Neoprobe Provides Third Quarter Results & Development Update; Conference Call Scheduled.DUBLIN, Ohio Dublin is a city in Delaware, Franklin, and Union counties in the U.S. state of Ohio. The population was 31,392 at the 2000 census. In 2006, the population was estimated to be 36,565, and Dublin continues to be one of the fastest-growing suburbs of Columbus. -- Neoprobe Corporation (OTCBB OTCBB
See OTC Bulletin Board (OTCBB). :NEOP NEOP Neoprobe Corporation (stock symbol)
NEOP Near Earth Object Program
NEOP New England Order of Protection
NEOP Nuclear Explosive Operating Procedure ), a diversified developer of innovative oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors.
n. and cardiovascular surgical and diagnostic products, today announced consolidated operating results for the third quarter of 2005. Third quarter results included net device sales of $1.3 million compared to $1.5 million for the third quarter of 2004. Year-to-date net device sales for the first three quarters of 2005 were $4.5 million compared to $4.1 million for the same period in 2004. In addition, Neoprobe reported a net loss of $1.3 million or $0.02 per share compared to a loss of $239,000 or $0.00 per share for the comparable period in 2004. Neoprobe reported a year-to-date net loss of $3.6 million for the first three quarters of 2005 compared to $1.3 million for the same period in 2004. The year-to-date net loss for the three quarters of 2005 included $1.1 million in non-cash charges Non-Cash Charge
A charge off, made by a company against earnings, that does not require an initial outlay of cash.
Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. (consisting primarily of amortization of intangible assets Intangible Asset
An asset that is not physical in nature.
Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. and amortization of warrant and debt-issuance charges related to the financing that was completed in December 2004) compared to total non-cash charges of $575,000 through the first three quarters of 2004.
Brent Larson, Neoprobe's Vice President, Finance and CFO See Chief Financial Officer. , said, "Our year-to-date device sales demonstrate continued strong performance from our gamma device business. Continued growth in the out-of-warranty service and extended service contract aspects of our gamma device business are helping offset the effect of quarterly fluctuations in purchases from our primary device marketing partner. Sales of our blood flow devices continued to provide only a minor contribution to the increase in sales for the quarter. We are continuing to train distributors and are starting to see increases in the number of device evaluations in hospitals which we hope will translate into revenue as the capital sales cycle is completed over the coming months. We believe the next six months will be critical in evaluating the results from recent distributor retraining re·train
tr. & intr.v. re·trained, re·train·ing, re·trains
To train or undergo training again.
re·train and re-invigoration of the sales process A sales process is a systematic approach for performing product or service sales. The reasons for having a sales process include seller and buyer risk management, achieving standardized customer interaction in sales and scalable revenue generation. for our Quantix/OR(TM) device."
David Bupp, Neoprobe's President 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. , said, "The increase in 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. during the quarter over the prior year was primarily due to the costs of non-clinical testing and drug manufacturing validation and production activities associated with Lymphoseek(TM). Our development efforts continue to move Lymphoseek forward, albeit not as rapidly as we had originally anticipated. However, we believe that proactively following the guidance of FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. will ultimately help us to avoid some of the recent regulatory disappointments experienced in our industry and may expedite the review process for the drug. We continue to expect our overall out-of-pocket development costs for Lymphoseek will total approximately $5 million and that the contribution from our device businesses will continue to cover the majority of our corporate overhead to enable us to devote our resources to the development of recurring re·cur
intr.v. re·curred, re·cur·ring, re·curs
1. To happen, come up, or show up again or repeatedly.
2. To return to one's attention or memory.
3. To return in thought or discourse. revenue products."
Neoprobe also provided the following update to its drug and therapeutic development initiatives.
Lymphoseek Development Update
Neoprobe continues to have an active dialogue with FDA regarding Lymphoseek and believes the process is continuing to move forward in a positive manner. In late September, Neoprobe received a letter confirming feedback from recent discussions with FDA regarding the amendment to our Investigational New Drug (IND) application. In its feedback, FDA formalized for·mal·ize
tr.v. for·mal·ized, for·mal·iz·ing, for·mal·iz·es
1. To give a definite form or shape to.
a. To make formal.
b. a very stringent non-clinical template for drug safety involving a total of seven tests. The original Lymphoseek development timeline did not include plans for two repeat dose studies that are being required as a part of the seven tests. We did not expect to have to complete such extensive repeat dose testing due to our assessment that the likelihood of any patient ever receiving two administrations of Lymphoseek would be very low. However, all seven non-clinical tests, including the repeat dose studies, have now been completed. Based on a review of the preliminary reports from these tests, we are not aware of any drug-related adverse findings. The completion of these non-clinical tests has taken longer than our original estimates due to the availability of resources at the testing labs and the extended timelines for completing the testing process as a result of having to use radioactive compounds in the two repeat dose tests to detect the presence of the drug.
FDA's September letter also confirmed that we will be required to use the final commercial drug, produced under Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. (GMP GMP (guanosine monophosphate): see guanine. ) conditions, in the conduct of the Phase II trial. Our original developmental timeline for Lymphoseek had anticipated using drug produced by the University of California, San Diego UCSD is consistently ranked among the top ten public universities for undergraduate education in the United States by U.S. News & World Report. It is a Public Ivy.  For graduate studies, most of UCSD's Ph.D. (UCSD UCSD University of California, San Diego (La Jolla, California)
UCSD User Centered System Design
UCSD Urbana-Champaign Sanitary District (Illinois)
UCSD Ultra Cool Sexy Dudes ) rather than commercially produced material. Our original assessment was based on historical precedents from other similar drug products. However, after evaluating the impact of FDA's requirement for us to use the final commercial drug for the Phase II trial, we believe that while delaying the start of the Phase II in order to answer FDA's chemistry, manufacturing and controls (CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled.
1. ) questions surrounding Lymphoseek will focus FDA's review of the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) on efficacy from the pivotal trial and ultimately put us in a much stronger regulatory position once the NDA is filed.
It is now our plan to file the non-clinical study reports with FDA in December. At roughly the same time, our drug manufacturing partners, Reliable Biopharmaceuticals and Cardinal Health <includeonly></includeonly>
Cardinal Health (NYSE: CAH) is a premier, global healthcare company dedicated to making healthcare safer and more productive. Overview
Headquartered in Dublin, Ohio, Cardinal Health, Inc. , will have completed their development and validation work and have provided responses to the CMC questions raised by FDA. The anticipated review cycle for the non-clinical and CMC information should permit the current clinical hold to be released by FDA at roughly the same time as commercial drug is available in the middle of the first quarter of 2006.
The effects of these changes have required that we adjust our timelines and expectations for Lymphoseek. Prior to the most recent delays in completing the battery of non-clinical safety studies and the requirement to use final commercial material, we had hoped to start the Phase II in the fourth quarter of 2005 followed shortly thereafter by the pivotal trial. We now believe that enrollment of patients in the Phase II trial will not completed until sometime during the first half of 2006 with the pivotal (i.e., 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 ) trial starting in the second half of 2006. Our goal of filing the NDA by mid-year 2006 has now been revised to the end of 2006; however, we believe that strenuously following the guidance we are receiving from FDA will ultimately pay dividends in the review process for the NDA as we remain highly confident in the clinical benefit and market potential of Lymphoseek. We continue to believe that Lymphoseek can be commercialized in the later part of 2007 and that the drug, if approved, should provide a significant positive financial contribution to Neoprobe in 2008.
RIGScan(R) CR Development Update
Neoprobe recently filed a request to establish a corporate IND application for a modified chimeric chi·mer·ic
1. Relating to a chimera.
2. Composed of parts of different origin. (i.e., humanized) version of RIGScan CR. With the establishment of a corporate IND, responsibility for the clinical and commercial development of this humanized version of RIGScan CR will be officially transferred from a physician-sponsored IND to Neoprobe.
David C. Bupp, Neoprobe's President and CEO, said, "We believe moving forward with a humanized version of RIGScan CR will address a number of concerns raised by FDA and will ultimately result in a more producible, reliable and effective drug. The potential partners we are in active discussions with, along with our regulatory advisors and representatives from various regulatory agencies regulatory agency
Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. , have all indicated a strong preference for using a humanized antibody humanized antibody Molecular medicine A recombinant DNA product which ↓ non-human monoclonal antibody immunogenicity, by transferring the hypervariable genes of rodent antibodies–which encode peptide segments capable of recognizing the desired epitope, in further RIGScan CR development activities."
Neoprobe's contract statisticians Statisticians or people who made notable contributions to the theories of statistics, or related aspects of probability, or machine learning: A to E
1. assisting or aiding.
2. a substance that aids another, such as an auxiliary remedy.
3. post-operative chemotherapies for colorectal cancer colorectal cancer
Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. , that it will be necessary to increase the number of patients in a proposed pivotal trial for RIGScan CR to approximately 2,200 in order to show a statistically valid differential in time to recurrence recurrence /re·cur·rence/ (-ker´ens) the return of symptoms after a remission.recur´rent
1. between patients treated using RIGScan CR versus other more traditional methods. Bupp continued "We expect the increase in patients will cause an increase in the development cost; however, we expect that the effect on the development timeline, once a partner is secured and development commences, will be less than six months. We continue to have active dialogue with multiple potential development partners for RIGScan CR. We would characterize the tone of the discussions with the various parties to be active and positive and we are working to conclude a transaction. We have made each of the parties aware of the change in trial size as a part of our ongoing discussions and will continue to update the shareholders as events warrant."
Cira Biosciences Update
Cira Biosciences, Inc. fundraising efforts thus far have been unsuccessful. Bupp commented, "The current state of the capital markets following recent biotech bi·o·tech
short for biotechnology
Noun 1. failures has made it difficult to secure the resources we were originally seeking. We are in the process of re-evaluating our capital needs and investigating alternative, venture-based sources of funding."
Neoprobe's President and CEO, David Bupp, and Vice President and CFO, Brent Larson, will provide a business update and discuss the company's third quarter 2005 results via a conference call scheduled for 11:00 AM EST EST electroshock therapy.
electroshock therapy today, Thursday, November 3, 2005.
The conference call can be accessed live as follows:
--U.S. Toll Free Dial-In number: 1-877-407-8033
--International Dial-In number 1-201-689-8033
A replay of the conference call will be available for 7 days following the call. The replay dial-in number for the U.S. is 1-877-660-6853 and the dial-in number for international callers is 1-201-612-7415. To access the call, enter the Account number (286) and the Conference ID (176135).
Neoprobe is a biomedical bi·o·med·i·cal
1. Of or relating to biomedicine.
2. Of, relating to, or involving biological, medical, and physical sciences. company focused on enhancing patient care and improving patient outcome. Neoprobe currently markets the neo2000(R) line of gamma detection systems that are widely used by cancer surgeons and is commercializing the Quantix(R) line of blood flow measurement products. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical radiopharmaceutical /ra·dio·phar·ma·ceu·ti·cal/ (-fahr?mah-soo´ti-k'l) a radioactive pharmaceutical, nuclide, or other chemical used for diagnostic or therapeutic purposes. agents including Lymphoseek(TM) and RIGScan(R) CR. Neoprobe's recently formed subsidiary, CIRA Biosciences, Inc., is also advancing a patient-specific cellular therapy technology platform called ACT. Neoprobe's strategy is to deliver superior growth and shareholder return by maximizing its strong position in gamma detection technologies and diversifying into new, synergistic synergistic /syn·er·gis·tic/ (sin?er-jis´tik)
1. acting together.
2. enhancing the effect of another force or agent.
1. biomedical markets through continued investment and selective acquisitions. www.neoprobe.com
Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company's plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company's products 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. The words "believe," "expect," "anticipate," "estimate," "project," and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company's continuing operating losses operating loss
The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. , uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company's most recent Annual Report on Form 10-KSB and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
NEOPROBE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS September 30, December 31, 2005 2004 (unaudited) ------------- ------------ Assets: Cash and cash equivalents $3,560,771 $9,842,658 Available-for-sale securities 3,470,758 - Other current assets 1,856,622 1,594,286 Intangible assets, net 2,212,195 2,519,109 Other non-current assets 1,178,747 1,409,842 ------------- ------------ Total assets $12,279,093 $15,365,895 ============= ============ Liabilities and stockholders' equity: Current liabilities $1,020,957 $1,009,936 Notes payable, net of discounts 5,844,236 5,491,494 Warrant liability - 2,560,307 Other liabilities 104,611 140,328 Stockholders' equity 5,309,289 6,163,830 ------------- ------------ Total liabilities and stockholders' equity $12,279,093 $15,365,895 ============= ============ CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended Nine Months Ended September 30, September 30, September 30, September 30, 2005 2004 2005 2004 (unaudited) (unaudited) (unaudited) (unaudited) ------------- ------------- ------------- ------------- Revenues: Net sales $1,333,536 $1,525,134 $4,500,301 $4,098,679 License revenue and other - 200,000 - 600,000 ------------- ------------- ------------- ------------- Total revenues 1,333,536 1,725,134 4,500,301 4,698,679 ------------- ------------- ------------- ------------- Cost of goods sold 532,601 643,303 1,738,157 1,692,084 ------------- ------------- ------------- ------------- Gross profit 800,935 1,081,831 2,762,144 3,006,595 ------------- ------------- ------------- ------------- Operating expenses: Research and development 1,106,242 588,435 3,048,056 1,766,265 Selling, general and adminis- trative 689,030 695,399 2,352,977 2,361,941 ------------- ------------- ------------- ------------- Total operating expenses 1,795,272 1,283,834 5,401,033 4,128,206 ------------- ------------- ------------- ------------- Loss from operations (994,337) (202,003) (2,638,889) (1,121,611) ------------- ------------- ------------- ------------- Interest expense (340,366) (42,494) (1,001,844) (158,647) Increase in warrant liability - - (142,427) - Other income, net 50,236 5,739 151,511 23,050 ------------- ------------- ------------- ------------- Net loss $(1,284,467) $(238,758) $(3,631,649) $(1,257,208) ============= ============= ============= ============= Loss per common share: Basic $(0.02) $(0.00) $(0.06) $(0.02) Diluted $(0.02) $(0.00) $(0.06) $(0.02) Weighted average shares outstanding: Basic 58,469,103 58,076,622 58,414,293 56,290,885 Diluted 58,469,103 58,076,622 58,414,293 56,290,885