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Nope... I sold on the CRL news, it'll be a while before they resubmit their NDA, so from this point, it's more of a longer term hold, IMO.
So... do we see .70s today?
.67 ask up...
Power hour should be awesome.
Three @ .48
Glad I picked up some shares last week... New HOY @ $2.584
GLTA.
Maybe looking at a new HOY today?
1 left @ .45
.44 x .45
ABIO issued a PR today... Today they're up over 200%
ARCA biopharma Announces Patent Issued for Treating Heart Failure Patients with Bucindolol Based on Genetic Testing
Revised Request for FDA Special Protocol Assessment for GencaroTM Development in Genotype-defined Heart Failure Population Submitted
BROOMFIELD, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq: ABIO - News), a biopharmaceutical company developing genetically targeted therapies for heart failure and other cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods of treating heart failure patients with bucindolol based on genetic testing. The patent (USP# 7,678,824) entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting,” provides protection in the United States for this novel approach to treating patients with heart failure, one of the largest health care problems in the United States and the rest of the world. ARCA had previously announced the notice of allowance of this patent. Industry sources estimate that approximately 5.7 million Americans have heart failure and nearly 670,000 new patients are diagnosed annually. In addition, heart failure is the underlying reason for approximately 12 to 15 million annual visits to physicians, 6.5 million annual hospital days and over $37 billion in direct and indirect healthcare costs in the United States.
“We are obviously pleased with the USPTO’s issuance of this patent which we believe will extend our pharmacogenetic intellectual property protection around bucindolol and, if approved for marketing, provide Gencaro market exclusivity into 2025,” said Michael R. Bristow, President and Chief Executive Officer of ARCA. “Chronic heart failure continues to be a major health care problem, and among the challenges to improving care is the uncertainty of patient responses to drug treatment. We believe that a new heart failure therapy that includes a simple test to identify a substantial subpopulation of patients more likely to benefit has the potential to help alleviate some of the problems encountered with the current standard of practice.”
On March 25, 2010, ARCA submitted a revised clinical study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. An SPA is an agreement with the FDA that the proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to support regulatory approval. Any proposed trial protocol must be reviewed and agreed upon with the FDA and the final trial protocol may be significantly different from the Company’s SPA submission. If ARCA obtains sufficient funding and FDA approval of the SPA, ARCA currently expects it could begin the proposed clinical trial approximately one year after such funding and approval. The FDA has previously designated as a Fast Track development program the investigation of Gencaro for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.
About GencaroTM
GencaroTM (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator being developed for the treatment of chronic heart failure (HF). Gencaro is an oral tablet formulation, dosed twice daily. Gencaro is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro is well-tolerated in patients with advanced HF.
About ARCA biopharma
ARCA biopharma is dedicated to developing genetically-targeted therapies for heart failure and other cardiovascular diseases. The Company's lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for heart failure. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted heart failure treatment. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro. For more information please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.arcabiopharma.com&esheet=6228727&lan=en_US&anchor=www.arcabiopharma.com&index=1&md5=d32001ccd8aec6a2c6b59a2011b69a9b.
Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the issuance of, and protection provided by, U.S. Patent 7,678,824 entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting” and statements regarding the timing and outcome of the Company’s SPA submission; regulatory review and potential approval of the Company’s New Drug Application for Gencaro; the prospects for ARCA’s providing sufficient information in a timely manner as requested in the FDA’s Complete Response Letter; and the Company’s ability to fund future operations. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2009 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.
BNVI is getting cheap here, might be a good time to add, or open a position if you haven't already, IMO.
GLTA.
Picked up some ISCO.OB (International Stem Cell Corp.). Lots of potential with this one, IMO.
GLTA.
.445 ask up...
GLTA.
I hope we'll get it around 4-430... But from the past few months, the company likes to issue PRs around 6AM ET...
GL.
6 on bid @ .45
GLTA.
The set date is today (3/18/2010)... IMO, we should be hearing of the FDA decision either after-hours today, or pre-market tomorrow.
GLTA.
Lets knock out those .45s!
GLTA.
6 on bid now!
Got your PM... Everything is going pretty well, what about you?
I bought back in today. IMO, we should get approval, and for both indications (acute AND delayed-onset CINV)...
jmo.
GL.
Nice close... CDIV is really strong, I love this stock!
GLTA.
Picked up some APPA @ $1.56, PDUFA date is 3/18...
.42 x .43
Picked up 12k @ .104
GLTA.
0.029x0.03
Nabi Biopharmaceuticals Announces Fourth Quarter and Full-Year 2009 Financial Results
ROCKVILLE, Md., March 10, 2010 (GLOBE NEWSWIRE) -- Nabi Biopharmaceuticals (Nasdaq:NABI - News) today announced fourth quarter and year-end financial results for the three and twelve month periods ended December 26, 2009.
For the full year ended December 26, 2009, the Company's net loss from continuing operations was $18.7 million, or $0.37 per share, compared to a net loss of $23.0 million, or $0.44 per share, for the year ended December 27, 2008. Including results from discontinued operations, Nabi had a net loss of $18.7 million, or $0.37 per share for the current period, compared with a net loss of 18.7 million, or $0.36 per share, in 2008.
For the quarter ended December 26, 2009, the Company recorded a net income from continuing operations of $1.1 million, or $0.02 per share, compared to a net loss of $5.1 million, or $0.10 per share, for the prior year period. Including results from discontinued operations, Nabi had net income of $1.1 million, or $0.02 per share, compared to a net loss of $4.7 million, or $0.09 per share, in the fourth quarter of 2008.
Revenue of $10.5 million in 2009 reflects payments recognized from the sale of PentaStaph to GlaxoSmithKline Biologicals S.A. (GSK). This includes $3.1 million from the initial $21.5 million payment received from GSK which is being recognized as revenue ratably over the term of the transition services agreement (currently expected to be 14 months), a $5 million payment for the successful achievement of a PentaStaph performance milestone and $2.4 million related to our services provided under the transition services agreement.
General and Administrative expenses for 2009 were $10.0 million compared to $12.4 million in 2008. The decrease is a result of our continued efforts to reduce overall infrastructure costs as well as a reduction in share-based compensation expense, offset in part by higher legal fees associated with the strategic alternatives process. Research and Development expenses were $16.5 million in 2009 compared to $12.6 million in 2008. This increase is primarily due to increased activities associated with the initiation of the first of two NicVAX Phase III clinical trials. General and Administrative expenses for 2010 are expected to approximate 2009 levels while Research and Development expenses are expected to increase as Nabi initiates the second NicVAX Phase III clinical trial, continues activities of the first NicVAX Phase III trial and prepares for commercial manufacture and testing of NicVAX.
The Company repurchased $10.4 million, par value, of its 2.875% convertible senior notes for $10.1 million during 2009, leaving a balance of $6.1 million, par value, at December 26, 2009. Nabi also repurchased 2 million shares of its common stock during 2009 at an average price of $3.94 per share, including 1 million shares in the fourth quarter. During the first quarter of 2010, the Company repurchased an additional 1.8 million shares of common stock for $9.2 million. Since the inception of the repurchase plan in December 2007, a total of 13.9 million shares have been repurchased for a total of $54.1 million, leaving a balance of $10.9 million in the repurchase plan at March 10, 2010.
Net cash provided by operating activities was $6.2 million for the full year 2009 compared to a net use of $18.9 million in 2008. Excluding discontinued operations, cash used in operating activities was $3.6 million for 2009 compared to $22.8 million in 2008, a reduction of 84%. Cash, cash equivalents and marketable securities totaled $119.0 million at the end of 2009 compared to $130.3 million at the end of 2008. The decrease in the balance of cash, cash equivalents and marketable securities is largely due to $7.9 million for stock repurchases and $10.1 million to repurchase debt, offset in part by net cash provided by operating activities.
Fourth Quarter 2009 Accomplishments
•Executed an exclusive worldwide option and license agreement with GSK for NicVAX for a total potential consideration of more than $500 million, including a $40 million non-refundable upfront payment payable in March 2010. The agreement also provides significant royalty opportunities for Nabi.
•Initiated the first of two Phase III clinical trials for NicVAX, the results of which are anticipated in the second half of 2011
•Received a $10 million grant from the National Institute on Drug Abuse to partially offset the cost of the Phase III trials.
•Completed the sale of PentaStaph to GSK and received $26.5 million of the total $46 million consideration in 2009.
Significant Recent and Upcoming Events
•Successfully completed an additional PentaStaph milestone in 2010 and received an $8 million payment, leaving the opportunity to receive an additional $13 Million for the remaining two milestones.
•Received favorable shareholder vote supporting the NicVAX agreement, completed other closing requirements and closed the NicVAX agreement which entitles us to receive the $40 million upfront payment.
•Anticipate initiating the second NicVAX Phase III clinical trial and completing recruitment for the first Phase III trial in the coming months.
"I am very proud and pleased with our accomplishments in 2009. We have successfully executed two important agreements for PentaStaph and NicVAX, closing the PentaStaph agreement in 2009 and recently closing the NicVAX agreement, thereby achieving our major objectives of the strategic alternatives process," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "The NicVAX option and license agreement and the sale of PentaStaph mark two very significant events that have enhanced the value of Nabi Biopharmaceuticals for its shareholders. I am particularly pleased with the partnership with GSK as they have unique strength in the development and marketing of vaccines as well as strength and experience in the smoking cessation therapy arena. Few companies have this unique blend of capabilities."
Financial Results Conference Call and Webcast Information
The Company will host a live webcast at 4:30 p.m. EST today to discuss these results.
The webcast can be accessed at: http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=100445&eventID=2790161
(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your browser. Remove the space if one exists.) or via the Nabi Biopharmaceuticals website at http://www.nabi.com.
If you do not have Internet access, the U.S./Canada call-in number is 800-659-1942 and the international call-in number is 617-614-2710. The passcode is 75516930. An audio replay will be available for U.S./Canada callers at 888-286-2010 and for international callers at 617-801-6888. The replay passcode is 42817627. An audio replay of this call will be available through March 17, 2010. The press release and an archived version of the webcast will be available on the company's website at http://www.nabi.com .
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(R) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse, and StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine), a vaccine designed to prevent the most dangerous and prevalent strains of S. aureus bacterial infections. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit our Web site:http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to conduct and obtain successful results from our two Phase III clinical trials for NicVAX; GSK's failure to exercise its option for and successfully commercialize NicVAX; GSK's failure to successfully develop and commercialize any future generation candidate nicotine vaccine; our ability to commercialize NicVAX if GSK does not exercise its option for NicVAX; our ability to raise sufficient new capital resources to fully develop and commercialize NicVAX if GSK does not exercise the NicVAX option; our ability to attract, retain and motivate key employees; our ability to collect any further milestones and royalty payments under the PhosLo and PentaStaph agreements; the ability to obtain regulatory approval for NicVAX and any future generation candidate nicotine vaccine in the U.S. or other markets; our ability to successfully contract with contract manufacturing organizations for the manufacture and supply of NicVAX; our ability to comply with reporting and payment obligations under government rebate and pricing programs; and loss of full use of our net operating loss carry forwards. These factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 26, 2009 to be filed with the Securities and Exchange Commission.
Nabi Biopharmaceuticals
CONSOLIDATED BALANCE SHEETS
In thousands
December 26,
2009
December 27,
2008
(as adjusted)
ASSETS
Current assets:
Cash and cash equivalents
$ 59,510
$ 106,438
Marketable securities
59,489
23,900
Receivables
6,690
--
Prepaid expenses and other current assets
4,004
1,430
Assets of discontinued operations
--
10,409
Total current assets
129,693
142,177
Property and equipment, net
855
1,315
Other assets
769
729
Total assets
$ 131,317
$ 144,221
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$ 1,735
$ 1,226
Accrued expenses and other current liabilities
4,961
3,030
Deferred revenue
18,447
--
2.875% convertible senior notes, net
5,951
--
Liabilities of discontinued operations
2,816
3,381
Total current liabilities
33,910
7,637
2.875% convertible senior notes, net
--
15,202
Total liabilities
33,910
22,839
Stockholders' equity:
Convertible preferred stock
--
--
Common stock
6,278
6,239
Capital in excess of par value
365,841
363,003
Treasury stock
(50,267)
(42,187)
Other comprehensive income
(20)
60
Accumulated deficit
(224,425)
(205,733)
Total stockholders' equity
97,407
121,382
Total liabilities and stockholders' equity
$ 131,317
$ 144,221
Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Months Ended
For the Twelve Months Ended
In thousands, except share and per share data
December 26,
2009 December 27,
2008
(as adjusted)
December 26,
2009 December 27,
2008
(as adjusted)
Revenues:
Service revenue
$ 10,489 $ --
$ 10,489 $ --
Operating expenses:
Cost of service
1,988 --
1,988 --
General and administrative expenses
2,191 2,269
9,987 12,415
Research and development expenses
4,633 2,651
16,490 12,556
Operating loss
1,677 (4,920)
(17,976) (24,971)
Interest income
48 493
368 4,579
Interest expense
(435) (400)
(1,071) (3,902)
Other income (expense), net
(180) (549)
(48) (1,454)
Loss from continuing operations before income taxes
1,110 (5,376)
(18,727) (25,748)
Benefit from income taxes
-- 247
-- 2,765
Income (loss) from continuing operations
1,110 (5,129)
(18,727) (22,983)
Discontinued operations:
Income from discontinued operations, net of tax provision -- 380
-- 4,245
Income from discontinued operations
-- 380
-- 4,245
Net income (loss)
$ 1,110 $ (4,749)
$ (18,727) $ (18,738)
Basic and diluted (loss) income per share:
Continuing operations
$ 0.02 $ (0.10)
$ (0.37) $ (0.44)
Discontinued operations
0.00 0.01
0.00 0.08
Basic and diluted (loss) income per share
$ 0.02 $ (0.09)
$ (0.37) $ (0.36)
Basic and diluted weighted average shares outstanding
50,339 51,380
50,633 51,866
Nabi Biopharmaceuticals
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended
In thousands
December 26, 2009
December 27, 2008
(as adjusted)
Cash flow from operating activities:
Loss from continuing operations
$ (18,727)
$ (22,983)
Adjustments to reconcile loss from continuing operations to net cash used in operating activities from continuing operations:
Depreciation and amortization
502
574
Non-cash intra-period tax allocation
--
(2,765)
Accretion of discount on convertible senior notes
483
2,304
Share-based compensation
2,463
2,733
Loss (gain) on repurchase of convertible senior notes
302
1,553
Other
4
48
Changes in assets and liabilities:
Receivables
(6,685)
--
Prepaid expenses and other assets
(2,713)
753
Accounts payable, accrued expenses and other
2,298
(4,982)
Deferred revenue
18,447
--
Total adjustments
15,101
218
Net cash used in operating activities from continuing operations
(3,626)
(22,765)
Net cash provided by operating activities from discontinued operations
9,843
3,864
Net cash provided by (used in) operating activities
6,217
(18,901)
Cash flow from investing activities:
Purchases of marketable securities
(91,471)
1,600
Proceeds from sales and maturities of marketable securities
55,833
(23,871)
Capital expenditures
(4)
(53)
Other
--
112
Net cash provided by (used in) investing activities from continuing operations
(35,642)
(22,212)
Net cash provided by investing activities from discontinued operations
--
1,567
Net cash provided by (used in) investing activities
(35,642)
(20,645)
Cash flow from financing activities:
Proceeds from issuance of common stock for employee benefit plans
528
128
Purchase of common stock for treasury
(7,940)
(20,010)
Repurchase of convertible senior notes
(10,091)
(51,634)
Other financing activities
--
(83)
Net cash used in financing activities from continuing operations
(17,503)
(71,599)
Net cash used in financing activities from discontinued operations
--
(23)
Net cash used in financing activities
(17,503)
(71,622)
Net decrease in cash and cash equivalents
(46,928)
(111,168)
Cash and cash equivalents at beginning of period
106,438
217,606
Cash and cash equivalents at end of period
$ 59,510
$ 106,438
.0235 x .024
GLTA.
If you want the link to the filing on pinksheets, here it is:
http://www.otcmarkets.com/otciq/ajax/showFinancialReportById.pdf?id=28251
Here's a link to the report on pinksheets:
http://www.otcmarkets.com/otciq/ajax/showFinancialReportById.pdf?id=28251
Lets hit .03+ by EOD. Slap that ask!
Had some spare change from another purchase I made earlier today, threw it in some PFNO!
GO PFNO!
GLTA
Freed up some funds and picked some up @ .40 on the drop to .39...
GLTA.
Heck.. why would anyone sell here??
I already resigned as mod.
I was reading some earlier posts on this board, and a poster had some good advice for NVLT shareholders: "If you buy something and it doesn't work, why buy another?"
I have never owned Novelos, nor will I ever own Novelos. I hoped that it would have positive phase 3 results for the many NSCLC patients out there, but, sadly it didn't. It's not a scam just because the trial didn't work out, it's a scam b/c the company got BMR to pump this stock up to $3, and they're trying to get the price up now by claiming the lawsuit is w/o merit. The company has no drugs that will ever amount to anything, IMO. The HCV drug was just put in the P3 results PR b/c Novelos didn't want this to go down to <.10.
Nov-002 failed a pivotal trial in NSCLC, how can you think that the trial in breast cancer will be any different?
Also, if you bring up the russian trial results, almost every drug that has succesful results in a russian trial fails. Medivation was the latest victim.
The Novelos drug is just an anti-oxidant. If it works so well, then why isn't green tea a blockbuster?
LOL. Looks like Novelos is desperate to get their share price up -- Novelos is a scam, plain and simple...
It's sad so many were holding this through trial results.
.51s up
Wish I had some free funds... CDIV is a bargain here, IMO.
GL.
Great day all! Let's break .50 tomorrow!
Thanks! I'm out of powder now too.
Congrats on your profits so far... IMO there are a lot more to come