mlkrborn
15 years ago
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prnewswire
Neurobiological Technologies Announces Stockholder Approval of Plan of Liquidation and Dissolution
Board of Directors Declares Extraordinary Dividend of $0.75 per share
* Press Release
* Source: Neurobiological Technologies, Inc.
* On 9:00 am EDT, Wednesday October 28, 2009
o Neurobiological Technologies Inc.
EMERYVILLE, Calif., Oct. 28 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (Nasdaq: NTII - News; "NTI") announced today that its stockholders have voted in favor of the company's dissolution pursuant to a plan of liquidation and dissolution at a special meeting of stockholders held on October 27, 2009. In connection with the dissolution, the company also announced that its board of directors has declared an extraordinary dividend of $0.75 per share of common stock, which will be paid to stockholders of record as of November 10, 2009.
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NTII 0.2244 -0.7056
Stockholders overwhelmingly approved the dissolution of the company pursuant to the plan of liquidation and dissolution, with the proposal receiving an affirmative vote from approximately 99% of the votes cast. Detailed results will be published in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, which is expected to be filed with the SEC on or before November 16, 2009.
In connection with the dissolution of the company, NTI plans to file a Form 25 with the Securities and Exchange Commission to effect the voluntary delisting of its common stock from NASDAQ after the extraordinary dividend is paid to stockholders.
Redemption of Series A Preferred Stock
At the special meeting, the stockholders also approved the amendment of the company's certificate of incorporation to authorize the redemption of the outstanding shares of the company's Series A Preferred Stock. The board of directors has voted to redeem the Series A Preferred Stock for $0.50 per share on or about October 30, 2009.
Resignation of Directors; Election of Matthew Loar as Director
On October 27, 2009, directors Abraham E. Cohen, Theodore L. Eliot, Jr., F. Van Kasper and Abraham D. Sofaer submitted their resignations effective upon the filing of the certificate of dissolution with the Secretary of State of the State of Delaware, which is expected to occur on or before November 30, 2009. Also, on October 27, 2009, the board of directors voted to decrease the size of board to three members, effective as of the filing of the certificate of dissolution with the Secretary of State of the State of Delaware, and approved the appointed Matthew M. Loar as a director effective as of such date, to serve along with continuing directors William A Fletcher and John B. ("Jack') Stuppin and to constitute the board of directors after the company's filing the certificate of dissolution.
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc. is a biopharmaceutical company historically focused on developing investigational drugs for central nervous system conditions.
surf1944
16 years ago
Neurobiological Technologies, Inc. Presents Dosing Rationale for Viprinex(TM) (ancrod) at the European Stroke Conference
Wednesday May 14, 8:15 am ET
NICE, France, May 14 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News) reported for the first time at the European Stroke Conference detailed analyses supporting the dosing regimen in NTI's two ongoing Phase 3 studies of Viprinex(TM) (ancrod) for ischemic stroke. The company also provided information as to why it believes these studies are more likely to be successful in treating ischemic stroke than previous Phase 3 clinical trials conducted by others using the same snake venom-derived agent.
David E. Levy, M.D., Vice President, Clinical Development at NTI, presented his retrospective analysis of data from the prior North American and European Phase 3 stroke trials of Viprinex involving more than 1,700 patients. Viprinex has been shown to rapidly reduce blood levels of fibrinogen, an important agent involved in blood clotting and blood viscosity. Elevated fibrinogen levels are a risk factor for stroke and may be associated with greater stroke disability. Prior studies with Viprinex that target fibrinogen have shown a benefit from this approach.
"The prior studies of Viprinex showed improved efficacy, but used a dosing regimen that infused the drug over five to seven days, which kept fibrinogen levels low for too long, compromising safety," said Dr. Levy, the key presenter. "NTI has changed the treatment paradigm to a single, three-hour intravenous dose designed to reduce fibrinogen levels quickly, while avoiding the prolonged low fibrinogen levels that were tried previously. Stopping the infusion after three hours permits fibrinogen to return to normal levels much faster than when the drug is given over five to seven days."
Dosing in the successful North American Phase 3 trial was compared to dosing in the unsuccessful European Phase 3 trial. The analyses showed that European patients initially infused with Viprinex at the most rapid rate had statistically significant efficacy with Viprinex versus placebo. The analysis also showed that patients across both studies whose mean fibrinogen levels were kept above a certain threshold over the entire five to seven day treatment period had a rate of symptomatic intracranial hemorrhage that was substantially lower than in those with lower mean fibrinogen levels over the same five to seven day period. These data suggest that rapid initial lowering of fibrinogen is associated with better efficacy, but for safety purposes fibrinogen should be allowed to return back up to its higher level after treatment.
"Viprinex, a novel Fibrinogen Reducing Agent, is an enzyme that reduces levels of fibrinogen, the primary protein involved in blood clotting," said Warren W. Wasiewski, M.D., Vice President and Chief Medical Officer of Neurobiological Technologies, Inc. and a second author of the retrospective analysis. "Reducing fibrinogen in the blood lowers blood viscosity, which may improve blood flow. Additionally, as the fibrinogen is broken down, natural mechanisms are activated to dissolve blood clots that have already formed. Since Viprinex acts in the blood for a longer period of time than existing therapies for treatment of stroke, the effect of Viprinex on brain blood flow should be sustained longer. We believe that a single infusion of Viprinex would be better than a prolonged infusion for treating ischemic stroke."
Previous studies have shown that Viprinex can be effective when administered up to six hours after the onset of stroke symptoms, which could significantly expand the number of people who can be treated. The only currently approved drug therapy for ischemic stroke is limited to a three-hour window.
With more than 700,000 patients experiencing stroke each year in the United States, and existing therapies limited to the first three hours after onset of stroke symptoms, there is a substantial unmet medical need to increase treatment options that are safe and effective to more stroke patients.
The Ancrod Stroke Program I and II studies are Phase 3 clinical trials currently underway at sites in the United States, various European countries, Russia, Australia, New Zealand, South Africa, Israel and Taiwan.
surf1944
16 years ago
Neurobiological Technologies Reports Third Quarter Financial Results
Monday May 12, 7:00 am ET
- Conference Call at 10:30 a.m. ET, May 13 -
EMERYVILLE, Calif., May 12 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News) today announced financial results for its fiscal third quarter and the nine months ended March 31, 2008.
Revenues for the three months ended March 31, 2008 were $3.7 million compared to $4.9 million for the same three months last year.
Research and development expenses were $5.9 million for the third quarter of 2008 compared to $7.7 million for the same quarter last year. General and administrative expenses were $1.8 million for the three months ended March 31, 2008 compared to $1.7 million in the same period last year.
The net loss for the third quarter of fiscal 2008 was $5.1 million, or $0.19 per share, compared with a net loss of $4.4 million, or $1.04 per share, for the third quarter of 2007.
Revenues for the first nine months of fiscal 2008 were $11.2 million compared to $13.7 million in the same period of 2007. Research and development expenses were $18.8 million for the nine months ended March 31, 2008 compared to $19.2 million for the same period of 2007. General and administrative expenses were $5.3 million for the nine months ended March 31 compared to expenses of $4.7 million for the same period in 2007. The net loss for the nine months ended March 31, 2008 was $12.9 million, or $0.76 per share, compared to a net loss of $9.9 million, or $2.35 per share, for the nine months ended March 31, 2007.
Cash, cash equivalents and short-term investments were $34.6 million at March 31, 2008, and long-term investments were $11.7 million, totaling $46.3 million. During the three months ended March 31, 2008, NTI wrote-down the value of its auction rate securities, which are now classified as long-term investments, by approximately $1.8 million based on uncertainties in the credit markets.
"We are very pleased to have recently and successfully passed our fifth Data Safety Monitoring Board assessment of the Viprinex(TM) phase 3 clinical trials that are currently underway," stated Paul E. Freiman, president and chief executive officer of NTI. "In addition, during the quarter we signed an agreement with the Buck Institute for Age Research that provides us development rights to an exciting compound in early development for the potential treatment of Alzheimer's disease. We also amended our agreement with Merz Pharmaceuticals and Children's Medical Center Corporation, effectively lengthening the term for which they are committed to pay us royalties on the sales of memantine, although at a lower rate than we received previously."
"Looking forward, we are excited about the prospects for our key asset, Viprinex, which has the potential to be the first new drug approved for the treatment of stroke in over ten years," continued Mr. Freiman. "Our main focus as a company is the development of this drug candidate, and the development of this asset is where substantially all of our operating funds are being spent. We believe Viprinex has the potential to double the treatment window over the current approved drug, while at the same time reducing the major side effect of symptomatic intracranial hemorrhage."
Conference Call Information
NTI will webcast its quarterly financial results and host a conference call on Tuesday, May 13, 2008 at 10:30 a.m. (ET), 7:30 a.m. (PT). Dial-in number (877) 591-4953 (U.S. and Canada) and 719-325-4851 (International). The live webcast can be accessed by going to http://investor.shareholder.com/ntii/events.cfm . A playback of the conference call will be available from 1:30 p.m. (ET) on May 13, 2008 through midnight on May 17, 2008. Replay number: (888) 203-1112 (U.S. and Canada) / (719) 457-0820 (international). Replay access code: 3838724.
surf1944
17 years ago
Neurobiological Technologies Reports Receipt of $2.0 Million Royalty Payment for Quarterly Sales of Memantine
Wednesday April 30, 7:00 am ET
EMERYVILLE, Calif., April 30 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News), today announced it has received approximately $2.0 million from Merz Pharmaceuticals GmbH (Merz) for sales by Merz and its marketing partners of Memantine for the treatment of moderate-to-severe Alzheimer's disease during the quarter ended December 31, 2007. Under an exclusive marketing agreement, NTI currently receives quarterly royalty payments on certain sales of Memantine by Merz and its marketing partners.
About Neurobiological Technologies, Inc.
Neurobiological Technologies, Inc, (Nasdaq: NTII - News) is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs. The Company's most advanced product candidate, Viprinex(TM) (ancrod), is in phase 3 clinical testing as a novel investigational drug for treating acute ischemic stroke. Viprinex has multiple mechanisms of action and is specifically designed to double the time period that patients can be treated after the onset of a stroke. Acute ischemic stroke is one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. NTI's pipeline also includes a phase 3 investigational drug for brain swelling and other drug candidates in early-stage development for Alzheimer's and Huntington's diseases.
surf1944
17 years ago
Fifth DSMB Meeting Supports Neurobiological Technologies' Continuation of Phase 3 Stroke Trials With Viprinex(TM) (ancrod)
Wednesday April 16, 6:45 am ET
EMERYVILLE, Calif., April 16 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News), today announced that after a scheduled review, an independent data safety monitoring board (DSMB) has recommended continuation of the company's two Phase 3 clinical trials to determine whether a brief intravenous infusion of Viprinex(TM) (ancrod) started within 6 hours of stroke onset improves functional outcome at 3 months. This is the fifth DSMB meeting for the Ancrod Stroke Program (ASP). The two trials are:
-- ASP-I, the Study of Acute Viprinex for Emergency Stroke: A Randomized,
Double-Blind, Placebo-Controlled Study of Ancrod in Subjects Beginning
Treatment Within 6 Hours of the Onset of Acute, Ischemic Stroke.
-- ASP-II- A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod
in Subjects Beginning Treatment within 6 Hours of the Onset of Acute,
Ischemic Stroke.
About Neurobiological Technologies:
Neurobiological Technologies, Inc, (Nasdaq: NTII - News) is a biopharmaceutical company focused on developing novel, first-in-class agents for central nervous system conditions and other serious unmet medical needs. The Company's most advanced product candidate in phase 3 clinical testing is Viprinex(TM) (ancrod), a novel agent with multiple mechanisms that is specifically designed to expand the treatment window for treating acute ischemic stroke, one of the most prevalent, debilitating and costly diseases in the world for which there are few acceptable treatment options. Its pipeline includes other drug candidates in early-stage development, including a first-of-its-kind drug for the treatment of Alzheimer's disease.
surf1944
17 years ago
Neurobiological Technologies Sets Date for Research and Development Day
Thursday February 14, 1:07 pm ET
EMERYVILLE, Calif., Feb. 14 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News) today announced the date of its first annual Research & Development Day to be held on Tuesday, March 4, 2008. The event will take place from 8:00 to 9:30 a.m. at the Mandarin Oriental Hotel, 80 Columbus Circle, 36th Floor, South Salon, in New York City.
The focus of the meeting will be Viprinex(TM) (ancrod), NTI's compound for the treatment of acute ischemic stroke, currently in two Phase 3 clinical trials.
Questions about the R&D Development Day can be directed to Walter Kass, NTI Investor Counsel, 212-300-4708.
About Neurobiological Technologies, Inc.
NTI is a biopharmaceutical company focused on developing novel agents for central nervous system conditions. The Company's most advanced product candidate is Viprinex (ancrod), a novel multi-targeted agent currently undergoing pivotal Phase 3 clinical testing for the potential treatment of acute ischemic stroke.
Source: Neurobiological Technologies, Inc.
surf1944
17 years ago
Dutton Associates Announces Investment Opinion: Neurobiological Technologies Strong Speculative Buy Rating Maintained in Updated Coverage by Dutton Associates
Wednesday December 12, 11:00 am ET
pink sheet pumper firm
EL DORADO HILLS, Calif.--(BUSINESS WIRE)--Dutton Associates updates its coverage of Neurobiological Technologies (Nasdaq: NTII - News) maintaining a Strong Speculative Buy rating and a 12 month target price of $6. The 12-page report by Dutton senior analyst Denise T. Resnik, M.S. is available at www.jmdutton.com as well as from First Call, Bloomberg, Zacks, Reuters, Knobias, and other leading financial portals.
http://biz.yahoo.com/bw/071212/20071212005643.html?.v=1
surf1944
17 years ago
Celtic Pharma Provides Update on XERECEPT(R) Clinical Program
Wednesday December 5, 7:45 am ET
EMERYVILLE, Calif., Dec. 5 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (Nasdaq: NTII - News; NTI®) today announced that Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") presented interim results for XERECEPT® at the Annual Meeting for the Society of Neuro-Oncology.
Paul Freiman, President and Chief Executive Officer of NTI, stated, "We are pleased with our continuing involvement in the development of XERECEPT and the prospects for this drug, which is so urgently needed."
On December 4, 2007, Celtic Pharma, which acquired the rights and assets related to XERECEPT from NTI in November 2005, issued the following press release:
"New York, London and Bermuda, December 4, 2007 - Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today reported interim study results for XERECEPT® (human corticotropin-releasing factor (hCRF)), which were presented at the 12th Annual Meeting of the Society for Neuro-Oncology ("SNO"), and provided an update on the XERECEPT® clinical development program.
"In a poster presentation at the SNO annual meeting, which took place in Dallas, Texas on November 15-18, 2007, Celtic Pharma disclosed interim results of an on-going, open-label extension trial, which is evaluating the long-term safety and efficacy of XERECEPT® as a new potential treatment for Peritumoral Brain Edema ("PBE"), or tumor-related brain swelling. The data presented at SNO demonstrated that 20 of the first 32 patients enrolled received XERECEPT® daily for at least 20 weeks. XERECEPT® was well- tolerated. Nine of the 20 patients discontinued dexamethasone altogether, and steroid side effects were resolved or improved in the majority of patients who received a reduced dexamethasone dose. The trial is currently enrolling eligible patients with primary or secondary (metastatic) brain tumors who have already completed one of two Phase III randomized, double-blind trials of XERECEPT® currently underway at 27 centers in the U.S., Canada, Australia and New Zealand.
""Side effects of high-dose corticosteroid treatment have a devastating effect on quality-of-life and potentially on life expectancy, and any option that significantly reduces the use of dexamethasone would be a major benefit to patients," said Dr. Patrick O'Connor, Head of Clinical Development at Celtic Pharma. "The interim data presented at SNO are promising and we remain optimistic about the prospects for XERECEPT®."
"Celtic Pharma also announced plans to initiate an imaging study, CPDS 0701, to assess more directly the effects of XERECEPT® on PBE. Sequential brain scans from some glioblastoma patients being treated with XERECEPT® suggest reduction of edema. The imaging study will aim to establish whether this observation can be substantiated over a larger patient population. The multicenter, open-label, randomized study will investigate the efficacy and safety of XERECEPT® for the reduction of PBE in patients with primary or metastatic brain tumors. The study is targeted to begin enrolling patients in early 2008 at investigational sites in the United States and Canada.
"Separately, Celtic Pharma announced the discontinuation of enrollment in study NTI 0302, a Phase III randomized, double-blind study comparing XERECEPT® to dexamethasone in first line treatment of symptoms associated with PBE in patients newly diagnosed with primary malignant glioma. The decision to discontinue enrollment for this trial was due to slower than anticipated recruitment and Celtic Pharma's conclusion that the new CPDS 0701 imaging study would be a more important contributor to the overall robustness of the XERECEPT® development program. No safety issues prompted this decision. The decision is unrelated to the on-going NTI 0303 Phase III study, which is now close to completing recruitment and is expected to reach final data analysis and conclusions in 2008.
"XERECEPT® is an investigational new drug that may present a steroid- sparing alternative to dexamethasone. Dexamethasone is the only treatment currently available for PBE, but this corticosteroid is associated with debilitating side effects, including vision problems, muscle and bone loss, irritability, impaired wound healing and opportunistic infections."
NTI sold the worldwide rights and assets related to XERECEPT to Celtic Pharma in November 2005. NTI is entitled to receive milestone payments upon the achievement of certain regulatory objectives and, if XERECEPT, is approved for commercial sale, NTI is entitled to receive profit-sharing payments on sales in the United States and royalties on sales elsewhere in the world.
surf1944
17 years ago
Buck Institute and Neurobiological Technologies, Inc. Partner to Develop Treatment for Huntington's Disease
Monday December 3, 7:30 am ET
Protein shows multiple treatment benefits in model systems
EMERYVILLE, Calif., and NOVATO, Calif., Dec. 3 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News) and the Buck Institute for Age Research (Buck) today announced they have formed a partnership to develop a drug to treat Huntington's disease (HD), a fatal hereditary brain disorder that affects approximately 30,000 Americans. The research involves fibroblast growth factor-2 (FGF-2), a naturally occurring protein that has been studied extensively for its neuroprotective properties.
Scientists at the Buck have used FGF-2, in both cell-based and animal models of HD. After being treated with FGF-2, mice with HD showed a 150 percent increase in new nerve cells, compared to a 30 percent increase in non-HD mice. Treatment with FGF-2 extended the lifespan of the affected mice by 20 percent; the animals also exhibited improved motor performance, decreased cell death and a reduction in the amount of toxic aggregates that typically form in the brains of those affected by HD. Buck scientists will now seek to create a form of FGF-2 that can be moved into human clinical trials.
"We are proud to be working with Buck on this project," said Paul E. Freiman, President and CEO of NTI. "We look forward to applying our expertise in drug development to this partnership and working to bring this important research from the lab to the patient."
"The fact that FGF-2 has such dramatic effects specifically in HD models and is able to cross the blood-brain barrier shows exciting promise as potential new therapy for HD," said Remy Gross, Buck Institute Director of Business Development. "We are very pleased that NTI has recognized the unmet need among those facing HD; we look forward to working with them in this partnership."
There is currently no effective treatment or cure for HD, which is typically characterized by involuntary movements and dementia. The disease slowly diminishes a person's ability to move, think and communicate. Those affected eventually become totally dependent on others for their care and usually die from complications such as choking, heart failure or infection. The disease is hereditary; each child of a person with HD has a 50/50 chance of inheriting the fatal gene. Approximately 200,000 Americans are believed to be at risk of developing HD, a disease that affects as many people as hemophilia, cystic fibrosis or muscular dystrophy. The symptoms of HD typically begin to appear in mid-life, although the progression of the disease varies among individuals and within the same family.
About the Buck Institute:
The Buck Institute is an independent non-profit organization dedicated to extending the healthspan, the healthy years of each individual's life. The National Institute of Aging designated the Buck a Nathan Shock Center of Excellence in the Biology of Aging, one of just five centers in the country. Buck Institute scientists work in an innovative, interdisciplinary setting to understand the mechanisms of aging and to discover new ways of detecting, preventing and treating age-related diseases such as Alzheimer's and Parkinson's disease, cancer, stroke, and arthritis. Collaborative research at the Institute is supported by genomics, proteomics and bioinformatics technology. For more information: http://www.buckinstitute.org.
surf1944
17 years ago
Neurobiological Technologies Announces Compliance With Nasdaq Listing Standards
EMERYVILLE, Calif., Nov. 20 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. ('NTI') (Nasdaq: NTII) today announced that it was notified on November 19, 2007 by The NASDAQ Stock Market that it has regained compliance with applicable NASDAQ Capital Market continued listing standards. Previously, the NASDAQ Listing Qualifications Department had notified NTI that it was not in compliance with the $35 million market value of listed securities continued listing requirement. NTI regained compliance following the closing on November 2, 2007 of its underwritten stock offering, in which it raised gross proceeds of $60 million and net proceeds of approximately $55 million through the offering and sale of 21,818,181 shares of common stock.
About Neurobiological Technologies, Inc.
NTI is a specialty biopharmaceutical company with expertise in identifying and acquiring promising drug candidates and in designing and managing late-stage clinical trials for central nervous system conditions. The company is currently developing Viprinex(TM) (ancrod), a novel reperfusion agent that is in pivotal Phase 3 trials for the treatment of acute ischemic stroke.
SOURCE Neurobiological Technologies, Inc.
surf1944
17 years ago
Press Release Source: Neurobiological Technologies, Inc.
Neurobiological Technologies Closes $60 Million Common Stock Offering
Monday November 5, 6:30 am ET
EMERYVILLE, Calif., Nov. 5 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI®) (Nasdaq: NTII - News), today announced that it had closed a $60 million underwritten offering of 21,818,181 shares of common stock. Amongst the larger investors in the offering were Biotechnology Value Fund, LP, Great Point Partners, LLC, and Millennium Technology Value Partners, L.P. The Company received approximately $55 million of net offering proceeds after underwriting discounts and commissions.
Paul E. Freiman, President and CEO stated, "Our goal was to raise sufficient capital to fund our lead compound, Viprinex(TM), through the completion of two existing phase 3 trials. Viprinex is being developed as an agent for the treatment of acute ischemic stroke. Based on our forecasts, we anticipate that we have accomplished this goal through both increased positions taken by existing investors, and the addition of significant new investors. The basic premise behind our vision is to enhance the limited treatment options available to victims of this terrible condition."
Mr. Freiman continued, "If we succeed in our ongoing clinical trials of Viprinex for acute ischemic stroke, we expect that we will effectively double the available treatment window for the current approved therapy. We are pleased with the proceeds from this offering, which we expect will end the need for serial fund raises during that time. Merriman Curhan Ford & Co. played a key role in bringing this offering to completion and we were quite pleased with their performance."
Merriman Curhan Ford & Co. (Amex: MEM - News) acted as the sole book-running manager in this offering, and Dawson James Securities, Inc. acted as co-manager.
http://biz.yahoo.com/prnews/071105/aqm069a.html?.v=1
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