Counting my change
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CRXX..I would wait,I think there are better plays.
BIEL..I still feel BIEL is a good long term play. I know it has been frustrating but they are a transparent company with great products.Remember,BIEL has had nothing but good news and good reviews of it products.I may add at these levels.
I usually break out when I complain about SNSS LOL. SNSS is a great stock and will head north as soon as we get out of the over-all down DOW.
TLCR -Talecris Added to NASDAQ Biotechnology Index
Monday, 17 May 2010 03:32
RESEARCH TRIANGLE PARK, N.C., May 17 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics Holdings Corp. (Nasdaq: TLCR) announced today that the company has been added to the NASDAQ Biotechnology Index® ( NBI). Talecris is among nine securities added to the index by the NASDAQ OMX Group, Inc. ( NDAQ). The semi-annual re-ranking of the index will become effective prior to market open on Monday, May 24, 2010.
The Index is designed to track the performance of a set of NASDAQ listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is re-ranked semi-annually in May and November.
"We are pleased to be included in the biotechnology index following our IPO last year," said Lawrence D. Stern, chairman and CEO of Talecris.
The NASDAQ Biotechnology Index is the basis for the iShares Nasdaq Biotechnology Index(SM) Fund (Nasdaq: IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the NASDAQ Biotechnology Index and the iShares Nasdaq Biotechnology Index Fund trade on various exchanges.
For more information about the NASDAQ Biotechnology Index, including detailed eligibility criteria, visit https://indexes.nasdaqomx.com/.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology and hemostasis. For more information, please visit: www.talecris.com.
SOURCETalecris Biotherapeutics, Inc.
ADDED Shares of SPPI...Way under valued,Strong Pipeline,good long play
NEOP..Neoprobe Device Featured in Breast Cancer Localization Procedure
Radioactive Seeds Used to Identify Non-Palpable Breast Lesions
businesswire
Press Release Source: Neoprobe Corporation On Monday May 17, 2010, 9:00 am EDT
DUBLIN, Ohio--(BUSINESS WIRE)--Neoprobe Corporation (OTCBB: NEOP - News), a diversified developer of innovative biomedical surgical oncology products, today announced that its gamma radiation detection system product line, which includes the neo2000® and neoprobe® GDS systems, was featured in a peer reviewed publication characterizing the emergence of the use of radioactive “seeds” to assist in the surgical excision of non-palpable breast lesions. The procedure, termed radioactive seed localization (RSL), was indicated by the researchers to be a promising alternative to the standard wire-localized breast biopsy procedure. The research, published in the American Journal of Surgery, was conducted by research teams at the Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; and the University of South Florida, Tampa, FL.
“The RSL research activity is a demonstration of the flexibility of the Neoprobe gamma detection platform,” said Dr. Richard Orahood, Neoprobe’s Medical Director. “The goal of Neoprobe is to work with researchers and clinicians to improve the treatment of the thousands of patients who are diagnosed with breast cancer annually. Neoprobe was at the forefront of the development of the intraoperative lymphatic mapping procedure for the staging of breast cancer. The development and implementation of innovative procedures like RSL may help improve the diagnosis and treatment of patients diagnosed with breast cancer.”
About Neoprobe
Neoprobe is a biomedical company focused on enhancing patient care and improving patient outcome by meeting the critical intraoperative diagnostic information needs of physicians and therapeutic treatment needs of patients. Neoprobe currently markets the neoprobe® GDS line of gamma detection systems that are widely used by cancer surgeons. In addition, Neoprobe holds significant interests in the development of related biomedical systems and radiopharmaceutical agents including Lymphoseek® and RIGScan™ CR. Neoprobe’s 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 biomedical markets through continued investment and selective acquisitions. www.neoprobe.com.
Contact:
Neoprobe Corporation
Brent Larson, 614-822-2330
Vice President / CFO
or
The Shoreham Group
Tim Ryan, 212-242-7777
PSID - on Watch
PositiveID Corporation Completes Initial Prototype of its iGlucose Product for Real-Time Diabetes Management
Delivery of the prototype is ahead of schedule; Company accelerates launch plans
businesswire
The iGlucose system consists of a small cradle that connects to any data-capable glucose meter to automatically communicate a diabetic's blood sugar readings to the iGlucose online database. (Photo: Business Wire). View Multimedia Gallery
The iGlucose system consists of a small cradle that connects to any data-capable glucose meter to automatically communicate a diabetic's blood sugar readings to the iGlucose online database. (Photo: Business Wire).
View Multimedia Gallery
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PSID 1.12 -0.05
Chart for PositiveID Corporation
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Press Release Source: PositiveID Corporation On Monday May 17, 2010, 9:00 am EDT
DELRAY BEACH, Fla.--(BUSINESS WIRE)--PositiveID Corporation (“PositiveID” or the “Company”) (NASDAQ: PSID - News) announced today that it has completed development of the initial prototype of its iGlucose system, creating a small cradle that connects to any data-capable glucose meter to automatically communicate a diabetic’s blood sugar readings to the iGlucose online database. As a result of the early completion of the prototype, the Company is highly focused on commercialization efforts and is accelerating its launch plans. iGlucose provides next generation, real-time data to improve diabetes management and help ensure patient compliance, data accuracy and insurance reimbursement.
The iGlucose system is a stand-alone, self-contained unit that automatically queries a diabetic user’s data-capable glucometer for blood glucose data and sends that data via encrypted SMS text messaging to an online database. The iGlucose system functions without the use of a cell phone, wireless network, telephone line or personal computer. At the patient’s discretion, blood glucose data can also be forwarded to physicians and caregivers at predetermined intervals.
According to a November 2009 study by researchers at the University of Chicago published in the journal Diabetes Care, the number of diabetics in the U.S., which currently stands at 23.7 million, may almost double in 25 years, and the annual cost of treating them may triple to $336 billion.
Scott R. Silverman, Chairman and CEO of PositiveID, said, “We are pleased to complete the initial prototype of the iGlucose system ahead of schedule and we are intently focused on bringing this product to market. We believe iGlucose can play an important role in diabetic care, helping patients to take a proactive role in managing their disease on a macro level, which could not only improve the condition of their disease but also reduce costs to the healthcare system and insurers.”
About PositiveID Corporation
PositiveID Corporation develops and markets healthcare and information management products through its RFID-based diagnostic devices and identification technologies, and its proprietary disease management tools. PositiveID operates in two main divisions: HealthID and ID Security. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID’s future expectations, including the likelihood that the Company can successfully bring the iGlucose system to market, the functionality of the iGlucose system and online database, the Company’s ability to accelerate its launch plans, the likelihood that the number of diabetics may almost double in 25 years and the annual cost of treating them may triple of $336 billion, the ability of the iGlucose system to play an important role in diabetic care, helping patients to take a proactive role in managing their disease to not only improve the condition of their disease but also reduce costs to the healthcare system and insurers, and all other statements in this press release other than historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID’s actual results could differ materially from expected results. These risks and uncertainties include the Company’s ability to successfully develop, fund and commercialize the iGlucose system, as well as certain other risks. Additional information about these and other factors that could affect the Company’s business is set forth in the Company’s various filings with the Securities and Exchange Commission, including those set forth in the Company’s 10-K filed on March 19, 2010, and the Company’s 10-Q filed on May 6, 2010, under the caption “Risk Factors.” The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
National Minority Quality Forum CEO Urges Senator Grassley to Focus New Legislation on Removal of Unapproved Drugs
Monday, 17 May 2010 02:30
WASHINGTON--(BUSINESS WIRE)--National Minority Quality Forum (The Forum) President and CEO, Dr. Gary Puckrein, expressed appreciation for Senator Grassleys (R-IA) interest in pursuing legislation to help the Food and Drug Administration (FDA) increase their oversight of unapproved drugs in the United States marketplace.
“We are encouraged to see that protecting patients from the potential dangers posed by unapproved drugs is still a top priority for Sen. Grassley”
We are encouraged to see that protecting patients from the potential dangers posed by unapproved drugs is still a top priority for Sen. Grassley, said Dr. Puckrein.We agree that it is important for the FDA to create an inventory of the unapproved drugs in the U.S., but it is as important to recognize that there is much the agency can do today without this legislation. This includes enforcing their own unapproved drugs initiative by removing all known unapproved drugs once an approved version has been made available.
The Forum, which is currently facilitating an educational campaign on unapproved drugs called the Did You Know Project, hopes to work with Senator Grassley to rid the market of these potentially harmful products. The project is meant to educate patients and key stakeholders on the dangers associated with unapproved drug use.
According to a report in FDA Weekly, the Senator plans to work towards legislation meant to better protect patients from unapproved drugs. The Senator most recently worked to include a provision in the Patient Protection and Affordable Care Act requiring the FDA to create a comprehensive list of all unapproved drugs available in the marketplace. The provision, which would have forbidden Medicaid from providing reimbursements to patients for unapproved products, was not included in the final bill that was passed into law.
Currently, there are thousands of unapproved drugs available for purchase in the United States and physicians write millions of prescriptions for these potentially dangerous products every year. Due to adverse side effects and drug-to-drug interactions, unapproved drugs can be dangerous to patients.
In March, The Forum sent a letter to the FDA showing support for the FDAs Unapproved Drugs Initiative, a risk-based enforcement program announced in 2006 that calls for the removal of unapproved drugs from the marketplace.
About the National Minority Quality Forum
The National Minority Quality Forum is a non-profit organization that was founded in 1998 by Dr. Gary Puckrein in order to address the critical need for strengthening national and local efforts to use evidence-based, data-driven initiatives to guide programs to eliminate the disproportionate burden of premature death and preventable illness for racial and ethnic minorities and other under-served populations.
HEB:Hemispherx Biopharma Prepares Application to Initiate Phase II Clinical Trials in China With Ampligen(R)
Proposed Trial to Address Seriously Ill Patients With Influenza
globenewswire
Press Release Source: Hemispherx Biopharma, Inc. On Monday May 17, 2010, 6:00 am EDT
PHILADELPHIA, May 17, 2010 (GLOBE NEWSWIRE) -- As part of its expanding international program Hemispherx Biopharma, Inc. (NYSE Amex:HEB), (the "Company"), announced an agreement with Fountain Medical Development Ltd., a leading Chinese clinical research organization (CRO) to prepare, file and gain approval from the authorities in China to conduct a study of Ampligen, an investigational therapeutic. Ampligen(R) is a member of a new class of antivirals/ immuno-potentiators with broad spectrum therapeutic properties. Hemispherx plans to investigate the experimental therapeutic for potential treatment of seriously ill hospitalized flu patients, many with underlying respiratory conditions. The proposed study will determine the extent to which their clinical parameters return to normal more rapidly with potential shortening of their hospital stay relative to patients treated only with placebo plus the existing "standards of care". Hemispherx has engaged Fountain with a plan to initiate this study during next year's flu season in various parts of China.
Influenza is a serious world wide health threat producing significant debilitation and death rates in individuals with compromised pulmonary functions and/ or immuno-compromised conditions.
According to a recent Tufts University New Release (April 15, 2010) reporting on U.S. flu activity across the nation, 10.5% of the 9.7 million hospitalizations in elderly patients that occur annually were due to pneumonia and influenza. The researchers studied intensity of flu by extracting information from 248,889 Medicare and Medicaid hospitalization records from 1991 through 2004.
This agreement with Fountain Medical Group follows last month's entering a definitive contract with Max Neeman, a major India-based CRO, to conduct similar trials in India using Alferon N in severely ill patient populations.
About Fountain Medical
Fountain Medical Development Ltd. is a contract research organization (CRO) which provides a full range of ICH GCP compliant clinical research services for multinational clients conducting clinical research in China. Fountain's management team has decades of combined experience working with the world's leading CRO's and drug developers and is capable of handling regulatory affairs, clinical operations, safety, project management, data management and statistical analysis, as well as global standard clinical trial protocol design. Fountain has hands-on clinical trial experience in multiple therapeutic areas in the U.S. and China, delivering data to support submissions in the U.S., EU and Japan. Fountain has Phase I-IV clinical testing capabilities and central laboratory in China, which are co-localized in a leading hospital. For more information, please visit http://www.fountain-med.com.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon LDO. Ampligen(R) represents experimental nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net .
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R) and Alferon(R) LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications. Further, the commencement of clinical trials in June, 2010 by Max Neeman in India is a target date but cannot be guaranteed due to a variety of risk factors outside of the parties' control and should be regarded only as a forward looking estimate. Similarly, the initiation or timing of clinical trials in China with Ampligen(R) cannot be guaranteed due to a variety of risk factors outside the Company's control.
Contact:
Hemispherx Biopharma, Inc.
Dianne Will
518-398-6222
ir@hemispherx.net
Spittingfire....Great info,Thanks!!
EBS...Emergent BioSolutions Recognized as Biotechnology Firm of the Year by Tech Council of Maryland
ROCKVILLE, Md.--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has been named Biotechnology Firm of the Year at the Tech Council of Maryland's (TCM) Annual Tech Awards. This award acknowledges the company that best exemplifies the spirit of Maryland's biotechnology community as well as its presence and leadership within the state.
“It also acknowledges the role that businesses play in contributing to the State's economic and job growth. Emergent is proud to be amongst the technology and life sciences companies that have chosen Maryland as its home.”
It is an honor to represent Emergent BioSolutions, a company composed of talented and hardworking individuals committed to the corporate mission of protecting life, said Fuad El-Hibri, chairman and chief executive officer, who received the award on behalf of the company.
For 22 years, TCM has recognized companies that have helped establish Maryland's thriving technology community. This years theme Building Something Great Together focuses on the tremendous growth and future outlook for the technology community.
The theme, ˜Building Something Great Together,is meaningful because Emergence success is built on teamwork and collaboration, Mr. El-Hibri continued.It also acknowledges the role that businesses play in contributing to the States economic and job growth. Emergent is proud to be amongst the technology and life sciences companies that have chosen Maryland as its home.
The criteria for the Biotechnology Firm of the Year Award include: achieving significant and measurable success, contributing to the advancement of bio-sciences through cutting-edge research and development, crisply executing a growth strategy, and helping foster a vibrant biotech community.
TCM is the largest technology trade group serving the advanced technology and biotechnology communities of Maryland. TCMs mission is to advocate for the interests of the technology community, further the role of technology in the Maryland economy, and nurture an environment where technology companies can collaborate, grow and succeed.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapeutics that assist the bodys immune system to prevent or treat disease. Emergents marketed product, BioThrax (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax disease. Emergents product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
I agree 100%
We should here something official on production (May 18,19) and the new internet ordering system soon.
POSC: Damned if you do and damned if you don't
Written by Peter DePalma
Friday, 14 May 2010 05:47
After alerting members to Positron Corporation (OTC:POSC), the stock roared from $.06 to a fifty-two week high of $.30. Shortly after that, we advised our readers and subscribers that they should consider selling their positions in POSC before the scheduled press conference, fearing that the event could become a "buy on rumor sell on news" event.
We've come back from vacation to an email box full of both love and hate mail, thus the title of today's article.
Apparently, our advice to "sell" prior to the press event did not go over well with many of the longs who felt that we were sending mixed messages about the stock, but after carefully considering what many day traders do with these "forward looking" types of stock plays, my editors felt strongly that we should advise our readers despite the potential for back lash.
As it turned out, things got even uglier than any of us expected when the company decided not to announce their highly anticipated partnership details to an audience of reporters in attendance at New York's Nasdaq Marketsite. Most of the reporters covering the event didn't even blink, but the tens of thousands of investors who were following the conference via webcast immediately responded by dumping their shares. What resulted was a wave of attacks and false accusations about BMR promoting and/or pumping and dumping the stock. Those who followed the advice and erred on the side of caution won while those who decided to gamble more speculatively paid a price.
At the end of the day, the facts still remain: POSC is a solid company that has been around for over 27 years. The CEO may need more media relations training given his very rough delivery at the podium, but reporters at the event (none of whom even asked about the partnership details that investors were craving) seemed to take the most interest in management's announcement that POSC anticipates generating over $200 million in revenue within 18 months and over a billion in revenue within 4 to 5 years. This is a stock that many of us have jumped back in on and is still available for mere pennies per share.
Even though they fully intended to when the news conference was scheduled, POSC could not announce the name of the key partnership they wanted to reveal at the press conference for a number of reasons. As we understand it, there are at least one contractual and several strategic partnerships in the works or even already in place. As many disappointed and angry investors called and cried for full disclosure under threats of lawsuits, the company followed up with a cryptic press release about the matter in the days following the conference. Although no one at the company can go on record publicly for the same reasons we mentioned, we have confirmed to the best of our abilities and based on candid interviews with multiple sources, that Positron has partnered with Covidien (NYSE:COV). In addition, our sources tell us that they are also in the process of aligning with other big board companies for some very important strategic partnerships on the pharmaceutical side of the business. Furthermore, it's worth considering that any one of these strategic partners may choose to take a position in or even outright buy the company; especially once the new network of automated imaging drug dispensing machines is set up.
BMR was told that at one point, one of Positron's newest allies had apparently gone so far as to "threaten them" before deciding that joining forces might be a better way to respond to their innovative nuclear medicine's dispensing and distribution technology. The bonding experience with that company is still shaky, but much more friendly now according to those familiar with the situation and it definitely played into why the company decided against the public revelations.
If one looks at POSC and it's FDA approved PET Scan imaging technologies, the back orders for systems, and the shift not only in the marketplace, but also the reimbursement as well as medical and technical needs of the cardio and oncology imaging space, it's clear to see that the company is not only undervalued, but vastly undervalued. Look up IMGG and you'll find a company that traded at close to $2 per share this year based on only "half the promise" that POSC offers today. That company has submitted for FDA approvals several times and still have no clearance, yet they still trade today at nearly fifty cents per share.
Is the company trading higher than it was when we first covered it? Absolutely, and it is difficult to argue that the share price will not continue to rise as future revenues, orders and developments are announced. Do we continue to see it as a multi-bagger? Of course we do. Especially given the fact that the entire space they deal in is changing and that they are positioned without a single competitor as the leading company within that space.
Disclosure: Long POSC
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
HNAB..Hana Biosciences Reports First Quarter 2010 Financial Results
globenewswire
Press Release Source: Hana Biosciences, Inc. On Friday May 14, 2010, 8:30 am
SOUTH SAN FRANCISCO, Calif., May 14, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.
"During the first quarter of 2010, we continued our focus on the clinical and manufacturing development for Marqibo(R) in relapsed/refractory adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We continue to move forward with our submission plans following input received from the Food and Drug Administration during our April pre-New Drug Application meeting. We are confident that the complete rALLy data from the entire 65 patient population, which will be reported in an oral presentation at the 2010 Meeting of the American Society of Clinical Oncology, will provide additional evidence of Marqibo's efficacy."
Recent Clinical and Corporate Highlights
* In April 2010, Hana completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo(R) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission. Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
* In April 2010, Hana also announced that complete data from its pivotal study of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative ALL, had been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois. The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
* In March 2010, Hana announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy. The U.S. Patent Application Number 11/886,803 is entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" and extends intellectual property protection around menadione into 2026.
First Quarter 2010 Financial Results
The Company reported a net loss of $5.5 million, or $0.07 per share, for the quarter ended March 31, 2010 compared with a net loss of $5.6 million, or $0.17 per share, for the quarter ended March 31, 2009.
Total operating expenses for the quarter ended March 31, 2010, were $4.4 million compared with $5.6 million for the quarter ended March 31, 2009.
Research and development expenses were $3.3 million for the quarter ended March 31, 2010, compared with $4.2 million for the quarter ended March 31, 2009.
General and administrative expenses were $1.1 million for the quarter ended March 31, 2010, compared with $1.4 million for the quarter ended March 31, 2009.
As of March 31, 2010, the Company had cash, cash equivalents and available-for-sale securities of $4.2 million. Cash used in operations was $5.5 million for the quarter. The Company has implemented cost controls to conserve its cash and continues to evaluate both traditional and non-dilutive financing options. With a lower cash burn rate, the Company's current cash resources are sufficient to fund operations through June 2010.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding the extent of the Company's intellectual property rights and protections relating to menadione; and statements relating to the period of time for which its existing cash resources are sufficient to fund operations and whether the Company's cost control measures will be sufficient to preserve its cash resources until additional capital is obtained. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.
HANA BIOSCIENCES, INC.
BALANCE SHEETS
March 31,
2010 December 31,
2009
ASSETS (Unaudited)
Current assets:
Cash and cash equivalents $ 4,096,056 $9,570,453
Available-for-sale securities 76,000 68,000
Prepaid expenses and other current assets 104,414 114,067
Total current assets 4,276,470 9,752,520
Property and equipment, net 217,492 252,455
Restricted cash 125,000 125,000
Debt issuance costs 1,018,755 1,193,594
Total assets $5,637,717 $11,323,569
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable and accrued liabilities $3,416,775 $4,027,075
Other short-term liabilities 27,382 43,586
Total current liabilities 3,444,157 4,070,661
Notes payable, net of discount 22,836,344 22,597,050
Other long-term liabilities 6,224 6,540
Warrant liabilities 2,104,666 2,145,511
Total long term liabilities 24,947,234 24,749,101
Total liabilities 28,391,391 28,819,762
Stockholders' deficit:
Common stock; $0.001 par value:
200,000,000 shares authorized, 79,788,264 and 79,649,976 shares issued and outstanding at March 31, 2010 and December 31, 2009, respectively 79,788 79,650
Additional paid-in capital 117,779,666 117,572,373
Accumulated other comprehensive income (16,000) (24,000)
Accumulated deficit (140,597,128) (135,124,216)
Total stockholders' deficit (22,753,674) (17,496,193)
Total liabilities and stockholders' deficit $5,637,717 $11,323,569
HANA BIOSCIENCES, INC.
STATEMENT OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended
March 31,
2010 2009
Operating expenses:
General and administrative $1,170,895 $1,377,600
Research and development 3,258,545 4,192,483
Total operating expenses 4,429,440 5,570,083
Loss from operations (4,429,440) (5,570,083)
Other income (expense):
Interest income 267 11,582
Interest expense (1,084,584) (727,007)
Other expense, net -- (4,907)
Change in fair market value of warrant liabilities 40,845 664,060
Total other expense (1,043,472) (56,272)
Net loss $ (5,472,912) $ (5,626,355)
Net loss per share, basic and diluted $ (0.07) $ (0.17)
Weighted average shares used in computing net loss per share, basic and diluted 79,782,118 32,449,739
Comprehensive loss:
Net loss $ (5,472,912) $ (5,626,355)
Unrealized holding gains (losses) arising during the period 8,000 (32,000)
Comprehensive loss $ (5,464,912) $ (5,658,355)
Contact:
Hana Biosciences, Inc.
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com
Burns McClellan
Rebecca Birbach
(212) 213-0006
rbirbach@burnsmc.com
HNAB..Hana Biosciences Reports First Quarter 2010 Financial Results
globenewswire
Press Release Source: Hana Biosciences, Inc. On Friday May 14, 2010, 8:30 am
SOUTH SAN FRANCISCO, Calif., May 14, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.
"During the first quarter of 2010, we continued our focus on the clinical and manufacturing development for Marqibo(R) in relapsed/refractory adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We continue to move forward with our submission plans following input received from the Food and Drug Administration during our April pre-New Drug Application meeting. We are confident that the complete rALLy data from the entire 65 patient population, which will be reported in an oral presentation at the 2010 Meeting of the American Society of Clinical Oncology, will provide additional evidence of Marqibo's efficacy."
Recent Clinical and Corporate Highlights
* In April 2010, Hana completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo(R) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission. Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
* In April 2010, Hana also announced that complete data from its pivotal study of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative ALL, had been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois. The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
* In March 2010, Hana announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy. The U.S. Patent Application Number 11/886,803 is entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" and extends intellectual property protection around menadione into 2026.
First Quarter 2010 Financial Results
The Company reported a net loss of $5.5 million, or $0.07 per share, for the quarter ended March 31, 2010 compared with a net loss of $5.6 million, or $0.17 per share, for the quarter ended March 31, 2009.
Total operating expenses for the quarter ended March 31, 2010, were $4.4 million compared with $5.6 million for the quarter ended March 31, 2009.
Research and development expenses were $3.3 million for the quarter ended March 31, 2010, compared with $4.2 million for the quarter ended March 31, 2009.
General and administrative expenses were $1.1 million for the quarter ended March 31, 2010, compared with $1.4 million for the quarter ended March 31, 2009.
As of March 31, 2010, the Company had cash, cash equivalents and available-for-sale securities of $4.2 million. Cash used in operations was $5.5 million for the quarter. The Company has implemented cost controls to conserve its cash and continues to evaluate both traditional and non-dilutive financing options. With a lower cash burn rate, the Company's current cash resources are sufficient to fund operations through June 2010.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding the extent of the Company's intellectual property rights and protections relating to menadione; and statements relating to the period of time for which its existing cash resources are sufficient to fund operations and whether the Company's cost control measures will be sufficient to preserve its cash resources until additional capital is obtained. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.
HANA BIOSCIENCES, INC.
BALANCE SHEETS
March 31,
2010 December 31,
2009
ASSETS (Unaudited)
Current assets:
Cash and cash equivalents $ 4,096,056 $9,570,453
Available-for-sale securities 76,000 68,000
Prepaid expenses and other current assets 104,414 114,067
Total current assets 4,276,470 9,752,520
Property and equipment, net 217,492 252,455
Restricted cash 125,000 125,000
Debt issuance costs 1,018,755 1,193,594
Total assets $5,637,717 $11,323,569
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable and accrued liabilities $3,416,775 $4,027,075
Other short-term liabilities 27,382 43,586
Total current liabilities 3,444,157 4,070,661
Notes payable, net of discount 22,836,344 22,597,050
Other long-term liabilities 6,224 6,540
Warrant liabilities 2,104,666 2,145,511
Total long term liabilities 24,947,234 24,749,101
Total liabilities 28,391,391 28,819,762
Stockholders' deficit:
Common stock; $0.001 par value:
200,000,000 shares authorized, 79,788,264 and 79,649,976 shares issued and outstanding at March 31, 2010 and December 31, 2009, respectively 79,788 79,650
Additional paid-in capital 117,779,666 117,572,373
Accumulated other comprehensive income (16,000) (24,000)
Accumulated deficit (140,597,128) (135,124,216)
Total stockholders' deficit (22,753,674) (17,496,193)
Total liabilities and stockholders' deficit $5,637,717 $11,323,569
HANA BIOSCIENCES, INC.
STATEMENT OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended
March 31,
2010 2009
Operating expenses:
General and administrative $1,170,895 $1,377,600
Research and development 3,258,545 4,192,483
Total operating expenses 4,429,440 5,570,083
Loss from operations (4,429,440) (5,570,083)
Other income (expense):
Interest income 267 11,582
Interest expense (1,084,584) (727,007)
Other expense, net -- (4,907)
Change in fair market value of warrant liabilities 40,845 664,060
Total other expense (1,043,472) (56,272)
Net loss $ (5,472,912) $ (5,626,355)
Net loss per share, basic and diluted $ (0.07) $ (0.17)
Weighted average shares used in computing net loss per share, basic and diluted 79,782,118 32,449,739
Comprehensive loss:
Net loss $ (5,472,912) $ (5,626,355)
Unrealized holding gains (losses) arising during the period 8,000 (32,000)
Comprehensive loss $ (5,464,912) $ (5,658,355)
Contact:
Hana Biosciences, Inc.
Investor & Media Contacts:
Investor Relations Team
(650) 588-6641
investor.relations@hanabiosciences.com
Burns McClellan
Rebecca Birbach
(212) 213-0006
rbirbach@burnsmc.com
NEPH, Alive and Kicking...
Nephros Reports 2010 First Quarter Financial Results
prnewswire
Press Release Source: Nephros, Inc. On Thursday May 13, 2010, 3:00 pm
RIVER EDGE, N.J., May 13 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board:NEPH.ob - News) announced today financial results for the three months ended March 31, 2010.
First Quarter Highlights
* Increased revenues by 57% to approximately $989,000 from prior year.
* Reduced loss from operations by approximately $213,000 or 29% from prior year.
* Signed Product development Agreement with STERIS Corp.
* Distribution Agreement signed with Bellco Canada.
"For the remainder of 2010, the company's primary focus is to obtain a formal response to our pending 510(k) submission and complete the approval process," said Paul A. Mieyal, acting CEO of Nephros. "At the same time, we are aggressively evaluating ways to reduce our cost of goods and increase sales of MD filters in Europe. Nephros has an installed base of DSU filters for infection control in several major hospitals. Nephros is seeking additional distributors and plans to hire additional salespeople to expand this market. Our relationship with the U.S. military remains solid. Our goal is to leverage research funding to obtain contracts to supply filtration products to the military. We continue to seek additional funding opportunities to support our business plan."
Financial Performance for the First Quarter Ended March 31, 2010 (Unaudited)
For the quarter ended March 31, 2010, Nephros recognized net product revenues of approximately $989,000 compared with $631,000 in the corresponding period of 2009, an increase of $358,000 or 57%. The increase is primarily attributable to an approximately $120,000 or 36% increase in revenue related to the contract with the Office of Naval Research recognized in the first quarter of 2010 compared to the same period in 2009. Sales of the OLpur™ MD 190 and MD 220 products in Europe increased by approximately $140,000 or 51% in the first quarter of 2010 compared to the same period in 2009. Sales of Dual Stage Ultrafilters (DSUs) in the United States increased by approximately $98,000 or 408% in the first quarter of 2010 compared to the same period in 2009.
Operating expenses for the three months ended March 31, 2010 were approximately $916,000 compared with $919,000 in the corresponding period of 2009. The decrease of approximately $3,000 is primarily related to the reduction in depreciation expense of $36,000 or 50% in the first quarter of 2010 compared to the same period in 2009. Selling, general and administrative expenses were approximately $18,000 or 2% more in the first quarter of 2010 compared to the same period in 2009. Increased spending in severance pay, legal and accounting expenses was partially offset by reduced spending in personnel related and marketing expenses. Research and development expenses increased by approximately $15,000 in the first quarter of 2010 compared to the same period in 2009. Increases were primarily related to personnel costs.
Nephros' net loss was approximately $528,000 or $0.01 per basic and diluted common share for the first quarter of 2010 versus a net loss of approximately $735,000 or $0.02 per basic and diluted common share in the fourth quarter of 2009. Nephros' net loss decreased $207,000 or 28% in the current quarter primarily due to the approximately $213,000 or 29% reduction in loss from operations in the first quarter of 2010 compared to the same period in 2009.
End-Stage Renal Disease (ESRD) Products
Nephros completed the patient treatment phase of the U.S. clinical trial evaluation of the OLpur™ H2H™ module and OLpur™ MD 220 filter during the second quarter of 2008. The Company submitted the clinical data to the FDA with the 510(k) application for U.S. marketing approval of these products in November 2008. Following its review of the application, the FDA requested additional information from us. We replied to the FDA inquiries on March 13, 2009. The FDA has not provided us with any additional requests for information or rendered a decision on our application. We have made inquiries to the FDA about the status of our application and have most recently been informed that as of March 10, 2010 our application is still under their review process. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
Water Ultrafiltration Products
On July 1, 2009, we received FDA approval to market the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros is investigating a range of commercial, industrial and retail opportunities for its DSU technology. On March 23, 2010, Nephros announced a product development agreement with STERIS Corporation.
Military Product Development
Nephros has contracted with the Office of Naval Research to develop an advanced water purification system for military field use. Nephros' proprietary dual stage cold sterilization ultrafilter will form the basis of the portable system. Nephros is continuing the development of its dual stage ultra reliable personal water filtration system under support from its U.S. Department of Defense appropriation and has completed initial concept development. Once work on this initial project was completed in August 2009, we were awarded a new $1.8 million research contract from the Office of Naval Research for continued development of a potable dual-stage military water purifying filter. We have also introduced the DSU to various government agencies as a solution to providing potable water in certain emergency response situations.
About Nephros, Inc.
Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The Nephros hemodiafiltration ("HDF") system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. Nephros ESRD products are sold and distributed throughout Europe and are currently being used in over fifty clinics in Europe.
The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. Nephros's DSUs are being evaluated at several major U.S. medical centers for infection control. The DSU has also been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information about Nephros, please visit our website at http://www.nephros.com
Forward-Looking Statements
Statements in this news release that are not historical facts constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Such statements may be preceded by words such as "may," "plans," "expects," "believes," "hopes," "potential" or similar words. For such statements, Nephros claims the protection of the PSLRA.
Forward-looking statements are not guarantees of future performance, are based on assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond Nephros' control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that Nephros may not be able: (i) to obtain additional funding when needed or on favorable terms; (ii) to continue as a going concern; (iii) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iv) to have its technologies and products accepted in current or future target markets; (v) to demonstrate in pre-clinical or clinical trials the anticipated efficacy, safety or cost savings of products that appeared promising to Nephros in research or clinical trials; or (vi) to secure or enforce adequate legal protection, including patent protection, for its products. More detailed information about Nephros and the risk factors that may affect the realization of forward-looking statements is set forth in Nephros' filings with the SEC. Investors and security holders are encouraged to read these documents on the SEC's website at http://www.sec.gov/. Nephros does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
NEPH, Alive and Kicking...
Nephros Reports 2010 First Quarter Financial Results
prnewswire
Press Release Source: Nephros, Inc. On Thursday May 13, 2010, 3:00 pm
RIVER EDGE, N.J., May 13 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board:NEPH.ob - News) announced today financial results for the three months ended March 31, 2010.
First Quarter Highlights
* Increased revenues by 57% to approximately $989,000 from prior year.
* Reduced loss from operations by approximately $213,000 or 29% from prior year.
* Signed Product development Agreement with STERIS Corp.
* Distribution Agreement signed with Bellco Canada.
"For the remainder of 2010, the company's primary focus is to obtain a formal response to our pending 510(k) submission and complete the approval process," said Paul A. Mieyal, acting CEO of Nephros. "At the same time, we are aggressively evaluating ways to reduce our cost of goods and increase sales of MD filters in Europe. Nephros has an installed base of DSU filters for infection control in several major hospitals. Nephros is seeking additional distributors and plans to hire additional salespeople to expand this market. Our relationship with the U.S. military remains solid. Our goal is to leverage research funding to obtain contracts to supply filtration products to the military. We continue to seek additional funding opportunities to support our business plan."
Financial Performance for the First Quarter Ended March 31, 2010 (Unaudited)
For the quarter ended March 31, 2010, Nephros recognized net product revenues of approximately $989,000 compared with $631,000 in the corresponding period of 2009, an increase of $358,000 or 57%. The increase is primarily attributable to an approximately $120,000 or 36% increase in revenue related to the contract with the Office of Naval Research recognized in the first quarter of 2010 compared to the same period in 2009. Sales of the OLpur™ MD 190 and MD 220 products in Europe increased by approximately $140,000 or 51% in the first quarter of 2010 compared to the same period in 2009. Sales of Dual Stage Ultrafilters (DSUs) in the United States increased by approximately $98,000 or 408% in the first quarter of 2010 compared to the same period in 2009.
Operating expenses for the three months ended March 31, 2010 were approximately $916,000 compared with $919,000 in the corresponding period of 2009. The decrease of approximately $3,000 is primarily related to the reduction in depreciation expense of $36,000 or 50% in the first quarter of 2010 compared to the same period in 2009. Selling, general and administrative expenses were approximately $18,000 or 2% more in the first quarter of 2010 compared to the same period in 2009. Increased spending in severance pay, legal and accounting expenses was partially offset by reduced spending in personnel related and marketing expenses. Research and development expenses increased by approximately $15,000 in the first quarter of 2010 compared to the same period in 2009. Increases were primarily related to personnel costs.
Nephros' net loss was approximately $528,000 or $0.01 per basic and diluted common share for the first quarter of 2010 versus a net loss of approximately $735,000 or $0.02 per basic and diluted common share in the fourth quarter of 2009. Nephros' net loss decreased $207,000 or 28% in the current quarter primarily due to the approximately $213,000 or 29% reduction in loss from operations in the first quarter of 2010 compared to the same period in 2009.
End-Stage Renal Disease (ESRD) Products
Nephros completed the patient treatment phase of the U.S. clinical trial evaluation of the OLpur™ H2H™ module and OLpur™ MD 220 filter during the second quarter of 2008. The Company submitted the clinical data to the FDA with the 510(k) application for U.S. marketing approval of these products in November 2008. Following its review of the application, the FDA requested additional information from us. We replied to the FDA inquiries on March 13, 2009. The FDA has not provided us with any additional requests for information or rendered a decision on our application. We have made inquiries to the FDA about the status of our application and have most recently been informed that as of March 10, 2010 our application is still under their review process. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
Water Ultrafiltration Products
On July 1, 2009, we received FDA approval to market the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. Nephros is investigating a range of commercial, industrial and retail opportunities for its DSU technology. On March 23, 2010, Nephros announced a product development agreement with STERIS Corporation.
Military Product Development
Nephros has contracted with the Office of Naval Research to develop an advanced water purification system for military field use. Nephros' proprietary dual stage cold sterilization ultrafilter will form the basis of the portable system. Nephros is continuing the development of its dual stage ultra reliable personal water filtration system under support from its U.S. Department of Defense appropriation and has completed initial concept development. Once work on this initial project was completed in August 2009, we were awarded a new $1.8 million research contract from the Office of Naval Research for continued development of a potable dual-stage military water purifying filter. We have also introduced the DSU to various government agencies as a solution to providing potable water in certain emergency response situations.
About Nephros, Inc.
Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The Nephros hemodiafiltration ("HDF") system is designed to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient. Nephros ESRD products are sold and distributed throughout Europe and are currently being used in over fifty clinics in Europe.
The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. Nephros's DSUs are being evaluated at several major U.S. medical centers for infection control. The DSU has also been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information about Nephros, please visit our website at http://www.nephros.com
Forward-Looking Statements
Statements in this news release that are not historical facts constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Such statements may be preceded by words such as "may," "plans," "expects," "believes," "hopes," "potential" or similar words. For such statements, Nephros claims the protection of the PSLRA.
Forward-looking statements are not guarantees of future performance, are based on assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond Nephros' control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that Nephros may not be able: (i) to obtain additional funding when needed or on favorable terms; (ii) to continue as a going concern; (iii) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iv) to have its technologies and products accepted in current or future target markets; (v) to demonstrate in pre-clinical or clinical trials the anticipated efficacy, safety or cost savings of products that appeared promising to Nephros in research or clinical trials; or (vi) to secure or enforce adequate legal protection, including patent protection, for its products. More detailed information about Nephros and the risk factors that may affect the realization of forward-looking statements is set forth in Nephros' filings with the SEC. Investors and security holders are encouraged to read these documents on the SEC's website at http://www.sec.gov/. Nephros does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise except as required by law.
Added Shares of SPPI on the dip..Under valued,it is also being accumulated,Large pipeline
I am with you 100% on POZN ..this is a great call. Totally under- valued!
Hemispherx Biopharma to Present at the Rodman Healthcare Conference
globenewswire
Press Release Source: Hemispherx Biopharma, Inc. On Thursday May 13, 2010, 8:00 am
PHILADELPHIA, May 13, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), today announced that the Company will participate in the Rodman & Renshaw 6th Annual Global Healthcare Conference to be held on May 16-18, 2010 at the Grosvenor House Hotel, London, UK. Dr. William A. Carter, Hemispherx's Chairman & CEO, is scheduled to present on Monday, May 17th, at 11:30 AM BST; 6:30 AM EDT.
Programs to launch Alferon(R) N Phase II clinical trials and preparation for new clinical trials of Alferon(R) LDO and Ampligen(R), both experimental therapeutics, will be described at this conference. Dr. Carter will discuss studies and activities planned for Southeast Asia, the Pacific Rim and South America. His presentation will include an update on the clinical trials for hospitalized flu patients in India which the company and Max Neeman are seeking approval to begin in June 2010, the Indian Monsoon season.
Dr. Carter will also provide an interim report on retrospective analyses of patient samples from the completed Phase III trial of Ampligen(R) in potential treatment of Chronic Fatigue Syndrome ("CFS") conducted in collaboration with the Whittemore Peterson Institute; these studies are expected to provide a new perspective on the design of a confirmatory Phase III study in this disorder. The samples are being analyzed for the presence of XMRV, a novel retrovirus, reported to be found in approximately two-thirds of CFS patients.
The presentation will be Webcast live. Listeners can access this broadcast through Hemispherx`s Website at http://www.hemispherx.net. The webcast will be available for 30 days following the presentation.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon LDO. Ampligen(R) represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R) and Alferon(R) LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications. Further, the commencement of clinical trials by Max Neeman in India is its target date but cannot be guaranteed due to a variety of risk factors outside of the parties control and should be regarded only as a forward looking estimate.
Contact:
Hemispherx Biopharma, Inc.
Company/Investor Contact:
518-398-6222
ir@hemispherx.net
Good advise,PIE!
POZN is a solid company and play. It should not be trading at this level. I am still holding my shares.
Added ALXA...5 months till PDUFA date with extremely strong data. Time to accumulate.
ABIGHAMMER,I understand what you are saying ,but they have been up front with most of what they have said.The other stuff may or may not of happened because of numerous reasons.It is not uncommon for a start up company to change strategies or ideas,as they are in the growing stage.My DD and experience is guiding me in believing we have a good company here.
I personally talked to Paul and confirmed with the ordering dept.That that was the production schedule.
Guys ...remember Robert and Paul's shares are restricted,and they have 1.5 million of their own money in the game.They have all the reason to improve the PPS!
ABIGHAMMER, They are set for production on May 18 and 19th.
Stockpicker..What in the world are you taking about? They are working on the entire website to include credit card payments,Plus they got into one of the toughest Whole Foods markets in the country.Would Whole Foods do business with a pump and dump?
All I ask is back up what you are saying with good DD.
From Natures Peak Website...Our new On-Line Store is under construction. To Order Now Call Toll-Free...1-800-628-7325
EVRN just called me on my order they are ready to go. The website consultants are working hard to get credit card orders going this week!!
NRTI..Inergetics to Attend the "Noble Financial Capital Markets ONTRACK 2010 Equity Conference"
12:00p ET May 11, 2010 (GlobeNewswire)
Inergetics, Inc. (OTCBB:NRTI), a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company will be presenting at the Noble Financial Capital Markets ONTRACK 2010 Equity Conference being held on June 7th --8th 2010 in Hollywood, FL.
The Noble Financial Group (www.noblefinancialgroup.com) is a research driven, full-service investment banking boutique focused on small-cap emerging growth companies. Each year, Noble Financial's Capital Markets Group hosts a two-day annual equity conference that brings together the executive teams of public companies and potential institutional investors.
The goal of the conference, which will feature 140 presenting companies that were selected after thorough analysis of close to 1,000 public companies, is to offer investors diversity in terms of market capitalization and industry representation coming from a mix of growth and value names. More information about the conference can be found at Noble Financial Ontrack 2010 Equity Conference.
"Noble Financial's Sixth Annual Equity Conference will provide us with a predominantly institutional audience for which we can demonstrate the Company's strong value proposition by highlighting our recent capital restructuring and business agreements. Additionally, we will provide guidance and visibility of Inergetics' revenue dashboard over the next 6-12 months, which will be positively affected by our recently formed strategic relationships, particularly in the second half of 2010. With a full picture of the Company's achievements over the past year and our forecast for the upcoming 12 months, we are very confident that we'll receive positive interest from the investment professionals in attendance," stated President & CEO Mark Mirken.
For more information about the Company, please visit www.resurgex.com.
About Inergetics, Inc.
Inergetics, Inc. is a leading developer of nutritional supplements for the Clinical Health and Sports Supplement markets. The Company has established a line of Resurgex products consisting of proprietary nutritional formulas that are used by a wide range of clinical patients and consumers. Resurgex(TM) products provide comprehensive nutritional support for actively treated cancer patients as well as those in post-treatment care and elderly members of the assisted living community. Inergetics has also developed Surgex(TM) sports nutrition formula to meet the nutritional needs of professional, Olympic, and amateur elite athletes that experience post-workout symptoms such as fatigue, loss of lean muscle, oxidative stress, and reduced immune function.
Resurgex Essential(TM) and Resurgex Essential Plus(TM) are comprehensive, calorically dense formulas that meet and exceed the nutritional requirements of the assisted living community.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, including, without limitation, those with respect to the objectives, plans and strategies of the Company and SPI set forth herein and those preceded by or that include the words "believes,'' "expects,'' "given,'' "targets,'' "intends,'' "anticipates," "plans,'' "projects,'' "forecasts'' or similar expressions, are "forward-looking statements." Although the Company's management believes that such forward-looking statements are reasonable, it cannot guarantee that such expectations are, or will be, correct. These forward-looking statements involve a number of risks and uncertainties, which could cause the Company's future results to differ materially from those anticipated. The Company assumes no obligation to update any of the information contained or referenced in this press release.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Inergetics, Inc.
CONTACT: Seal Point Consulting, LLC
Investor Contact
267-364-5407
Investors@sealpointconsulting.com
Cytori Therapeutics, Inc. (CYTX) will present and provide a webcast of their corporate presentation at MDB Capital Bright Lights Conference at 5:30 PM (EDT) on Wednesday, May 12, 2010 in San Francisco. The audio webcast may be accessed under "Webcasts" in the Investor Relations section of the Company's website, . The webcast can be accessed live and will be available for replay one hour after the presentation on the Company's website. The webcast will be archived for 90 days.
Cytori Therapeutics, Inc. (CYTX) will present and provide a webcast of their corporate presentation at MDB Capital Bright Lights Conference at 5:30 PM (EDT) on Wednesday, May 12, 2010 in San Francisco. The audio webcast may be accessed under "Webcasts" in the Investor Relations section of the Company's website, . The webcast can be accessed live and will be available for replay one hour after the presentation on the Company's website. The webcast will be archived for 90 days.
Alert..BNVI Bionovo Announces First Quarter 2010 Highlights and Financial Results
prnewswire
Press Release Source: Bionovo, Inc. On Tuesday May 11, 2010, 4:01 pm
EMERYVILLE, Calif., May 11 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq:BNVI - News) today announced first quarter highlights and financial results for the three months ended March 31, 2010.
"The first four months of 2010 were characterized by intense activity within the company, as we prepared data for the regulatory agencies. We, along with our regulatory, scientific and medical advisors, have compiled a body of information on Menerba that should help it move forward in 2010," said Isaac Cohen, O.M.D., Bionovo's Chairman and Chief Executive Officer. "The rest of 2010 is poised to be even more intense for Bionovo, as we expect to be able to initiate the next stage of clinical trials for Menerba, with positive feedback from the regulatory agencies."
"While the company has been strongly focused on progressing Menerba, we have been making good progress in the scientific and clinical community in developing our cancer program. For example, Bezielle, our promising, novel, oral drug for metastatic breast cancer, was selected as one of the 'top 100 investigational drugs' by the prestigious publication R&D Directions," said Mary Tagliaferri, M.D., Bionovo's President and Chief Medical Officer. "Furthermore, the U.S. Patent and Trademark Office has now issued a key patent for Bezielle, as described in our previous press release."
Key Events To Date
* The Company announced that the US Patent and Trademark Office (USPTO) has issued a patent covering a method of using Bionovo's proprietary drug candidate Bezielle® (BZL101) for the treatment of metastatic breast cancer. Bionovo's US Patent covers a method of treating breast cancer using Bezielle. This patent also covers the use of Bionovo's proprietary Bezielle formulation as a monotherapy for the treatment of breast cancer. The patent is expected to provide coverage through at least November 13, 2026.
"Following two positive Phase 1 trials of Bezielle, this is another critical milestone in Bionovo's efforts to develop Bezielle into a valuable treatment option for an indication that needs new, safe treatment options. Furthermore, intellectual property protection is essential for successfully partnering our drug candidates, and further assuring shareholder value creation," said Dr. Cohen.
* The Company held its Annual Meeting of Stockholders on Monday, May 3, 2010. In this meeting, all nominated directors were elected and all proposals were approved by the stockholders.
On behalf of the Board of Directors, Dr. Cohen continued, "We are gratified by the support offered by our stockholders in these challenging times. We are focused on creating long term shareholder value."
* The Company announced the appointment of quality control and botanical authentication expert, Paul Pui-Hay But, Ph.D., to the company's Scientific Advisory Board. Dr. But is the Chief Scientist for the Food and Drug Authentication Laboratory Ltd., Hong Kong, China, and a leading investigator and consultant on botanical authentication and Chinese medicine quality control.
"We are honored to have Dr. Paul But join our Scientific Advisory Board, given his well established expertise in the field of botanical authentication and Chinese medicine quality control. This expertise has proven invaluable to the development of our manufacturing process for our botanical drug candidates," said Dr. Cohen.
First Quarter Results
Total operating expenses for the three months ending March 31, 2010 were $4.7 million compared to $4.6 million for the same period in 2009. Total operating expenses for the first quarter included the purchase of manufacturing supplies and raw materials and testing for the Menerba manufacturing process development. The Company expects operating expenses to decrease in the second quarter.
The Company reported a net loss for the three months ended March 31, 2010 of $4.7 million, or $0.04 per share, compared with a net loss of $4.7 million, or $0.06 per share, for the same period in 2009.
The Company ended the quarter with $11.8 million in cash, cash equivalents and short term investments, and began the quarter with $15.9 million, a difference of $4.1 million. The cash balance at the end of the quarter reflects the cash expenses mentioned above as well as capital expenditures to support the Menerba manufacturing process development.
Conference Call
The Company will conduct a conference call and webcast to review the financial results and the Company's plans for 2010 later today, Tuesday, May 11, 2010 at 5:00 p.m. (Eastern).
Interested parties can access the call by dialing (877) 317-6789 or (412) 317-6789, or can listen via a live internet webcast, which can be found at http://bionovo.com/investors/events. A replay of the call will be available via webcast at http://bionovo.com/investors/events or by playback at (877) 344-7529 or (412) 317-0088, conference code 440464, through May 14, 2010.
About Bionovo, Inc.
Bionovo, Inc. is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". For more information about Bionovo and its programs, visit: http://www.bionovo.com.
Forward Looking Statements
This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Certain of these risks and uncertainties are or will be described in greater detail in our filings with the Securities and Exchange Commission, which are available at http://www.sec.gov. Bionovo, Inc. is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Thank you,Barefootrunner,for clearing this up.
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) today announced the approval of a New Drug Submission (NDS) by Health Canada, the regulatory authority in Canada, for ONSOLIS (fentanyl buccal soluble film) in the management of breakthrough pain in opioid-tolerant adult patients with cancer. ONSOLIS is the first product approved in Canada for this indication.
ONSOLIS will be marketed in Canada by Meda Valeant Pharma Canada Inc., a joint venture between BDSI’s commercial partner, Meda AB, and Valeant Canada Limited, a wholly owned subsidiary of Valeant Pharmaceuticals International (NYSE:VRX). ONSOLIS will be launched in the third quarter of this year.
"The regulatory approval of ONSOLIS in Canada represents the culmination of a great collaborative effort between BDSI, Meda, and Valeant," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "ONSOLIS provides an important new option to manage the potentially debilitating effects of breakthrough pain in opioid-tolerant individuals with cancer. As the first oral transmucosal fentanyl product in Canada, our commercial partners have the opportunity to establish and build an important new market for ONSOLIS."
Poniard Pharmaceuticals, Inc. (Nasdaq:PARD) jumped 22% today after the company reported that it will resume its efforts in seeking regulatory for experimental cancer drug candidate, picoplatin. Ronald A. Martell, chief executive officer of Poniard said: "The data generated to date underscore picoplatin's potential efficacy and safety in a variety of solid tumors, and we are currently developing registration strategies for picoplatin in lung, colorectal, prostate and ovarian cancers. Concurrent with this effort, we are continuing to explore strategic alternatives to support and optimize the value of the picoplatin program for our shareholders."
In a separate release today the company announced that data from the Phase 3 SPEAR trial evaluating the efficacy and safety of picoplatin as a second-line treatment in small cell lung cancer (SCLC) has been accepted for an oral presentation during the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting.
"We believe the SPEAR trial, one of the largest second-line SCLC trials conducted in the world, provides valuable clinical insights that can be used to further the study of treatments for small cell lung cancer," said Ronald A. Martell, chief executive officer of Poniard Pharmaceuticals. "The SPEAR data adds to the growing body of clinical evidence that we believe supports the value proposition of picoplatin as an attractive, late-stage, highly versatile anticancer compound that has demonstrated efficacy and safety in a variety of solid tumor types."
Shares of Poniard jumped 23 cents to close the day at $1.27.
Generex Biotechnology Corporation (Nasdaq:GNBT) today announced that it has achieved enrolled of over 400 subjects in its pivotal global Phase III study of its flagship product, Generex Oral-lyn(TM), a proprietary buccal insulin spray product designed to replace prandial injections of insulin.
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today the appointment of Dr. Afsaneh Motamed-Khorasani as Director of Oncology. Dr. Motamed-Khorasani will be responsible for medical affairs for RPC's Onko-Sure in vitro diagnostic (IVD) cancer test, including product research and development, collaboration with Mayo Clinic to advance development of RPC's next-generation Onko-Sure IVD cancer test, on-going clinical trial work, authorship and publication of scientific white papers, articles, abstracts and peer-reviewed papers related to Onko-Sure and future developed products and representation for RPC at various oncology, medical and financial conferences, tradeshows and events.