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Quarterly Report (10-Q)
Edgar (US Regulatory) • Mon Aug 9,2010 5:05 PM
http://ih.advfn.com/p.php?pid=nmona&article=43941581&symbol=A%5ECXM
As of August 6, 2010 77,852,154 shares of the registrant’s common stock were outstanding.
NexMed, Inc. Q2/2010 Earnings Call Transcript
August 13, 2010
http://seekingalpha.com/article/220473-nexmed-inc-q2-2010-earnings-call-transcript?source=feed
Quarterly Report (10-Q)
Edgar (US Regulatory) • Thu Aug 12,2010 5:10 PM
http://ih.advfn.com/p.php?pid=nmona&article=43991576&symbol=N%5ENEXM
as of August 10, 2010, 12,824,692 shares of Common Stock, par value $0.001 per share, were outstanding.
Ready Mix, Inc. (RMX) - Special Cash Dividend
Friday August 6, 2010, 6:31 pm EDT
http://finance.yahoo.com/news/RMX-Holdings-Inc-Announces-bw-4057498572.html?x=0&.v=1
RMX Holdings, Inc. Announces Special Cash Dividend
Shares Outstanding: 3.81M
Float: 1.16M
http://finance.yahoo.com/q/ks?s=RMX+Key+Statistics
PHOENIX--(BUSINESS WIRE)--RMX HOLDINGS, INC. (NYSE Amex: RMX) announced today that the Board of Directors of RMX Holdings, Inc. (the “Company”) has declared a special cash dividend of $1.32 per share of common stock payable on August 23, 2010, to shareholders of record on August 16, 2010.
About RMX Holdings, Inc.
The Company formerly provided ready-mix concrete products to the construction industry since 1997, but has no active business operations at this time. On April 1, 2010, the Company completed an asset sale for substantially all of its assets.
Forward-Looking Statements
Statements regarding the evaluation of strategic options, any transaction, including the timing or effects thereof, change in or continuation of current business plan, increase in stockholder value, as well as any other statements that are not historical facts in this press release are forward-looking statements. Such forward-looking statements are based on current expectations and actual results or future events may differ materially. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results of the Company or future events to differ materially from those expressed in or underlying such forward-looking statements, including without limitation: results of the Board's evaluation of strategic alternatives; the ability to obtain Board and stockholder approvals of any proposed transaction; customary conditions to the closing of any proposed transaction; national and local economic, business, real estate and other market conditions; the competitive environment in which the Company operates; the execution of the Company's business plan; financing risks; acquisition and location development risks; potential environmental and other liabilities; and other factors affecting the construction industry generally. For further discussion of certain factors that could affect outcomes, please refer to the "Risk Factors" section of the Company's annual report on Form 10-K for the year ended December 31, 2009, and other subsequent filings by the Company with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. Except as otherwise stated in this press release, the Company does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or otherwise.
Xoma partnership could send shares over $2
http://www.theflyonthewall.com/permalinks/entry.php/XOMAid1162031
Wedbush believes a partnership for XOMA-052 is the next major catalyst for Xoma shares and that such news could send the stock to or above its $2 fair value estimate. The firm sees significant upside in the stock from 2010 catalysts and maintains an Outperform rating.
Keryx Biopharmaceuticals, Inc. To Host Conference Call on Second Quarter 2010 Financial Results
Date : 08/05/2010 @ 4:30PM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=43902587&symbol=N^KERX
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease, today announced that a conference call will be held on Monday, August 9, 2010 at 8:30 a.m. EDT to discuss results for the second quarter ended June 30, 2010 and a business outlook for the remainder of 2010. Ron Bentsur, Chief Executive Officer of Keryx, will host the call.
In order to participate in the conference call, please call 1-877-869-3847 (U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The audio recording of the conference call will be available for replay at http://www.keryx.com, for a period of 15 days after the call.
Keryx will announce its financial results for this period in a press release to be issued prior to the call.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex™ (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Antisoma to present at Canaccord Global Growth Conference
Date : 08/06/2010 @ 7:00AM
Source : UK
Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=43910278&symbol=L^ASM
6 August 2010, London, UK, and Cambridge, MA: Antisoma plc (LSE: ASM; USOTC:
ATSMY) announces that senior executive Dr Michael Boss will present at the 30th
Annual Canaccord Global Growth Conference in Boston on Wednesday August 11 at
1pm local time (6pm BST).
A webcast of the presentation will be available on Antisoma's website
athttp://www.antisoma.com/asm/media/webcast/
For live viewing of the webcast, it is recommended that viewers log on 15
minutes early in order to register and download any necessary software.
Enquiries:
Alison Saville
Senior Marketing and Communications Executive
Antisoma plc
+44 (0)20 3249 2100
Background on Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical company that
develops novel products for the treatment of cancer. The Company has operations
in the UK and the US. Please visitwww.antisoma.com for further information about
Antisoma.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
All reproduction for further distribution is prohibited.
Source: Antisoma plc via Thomson Reuters ONE
Sunrise Senior Living, Inc Q2/2010 Earnings Conference Call Transcript
August 05, 2010
http://seekingalpha.com/article/218857-sunrise-senior-living-inc-q2-2010-earnings-conference-call-transcript
Quarterly Report (10-Q)
...For the Quarterly Period Ended June 30, 2010
Date : 08/05/2010 @ 6:13AM
Source : Edgar (US Regulatory)
Stock : (SRZ)
http://ih.advfn.com/p.php?pid=nmona&article=43890658&symbol=SRZ
Leading Global Pharmaceutical Company Selects NewCardio's QTinno for Phase 1 QT Studies
Date : 08/05/2010 @ 8:00AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43892832&symbol=NWCI
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that QTinno™, NewCardio's automated cardiac safety software solution, has been licensed for use in connection with the first, of what is anticipated to be multiple Phase 1 studies, by the U.S. subsidiary of a large global pharmaceutical company.
The total revenue to NewCardio from this initial study, including the license and related professional services, will be approximately $225,000-$275,000, with most of the revenue expected to be recognized during the current quarter ending September 30, 2010.
Vincent Renz, NewCardio's President and Chief Executive Officer, commented, "We are excited to participate in this study. It is significant that the methodology for this study was selected by the pharmaceutical company, who specifically identified QTinno for part of the ECG analysis. We have already implemented and validated QTinno in preparation for processing the ECGs from the study which has already commenced."
NewCardio's innovative 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead ECG. NewCardio's lead product, QTinno, is a software suite that provides automated, comprehensive cardiac safety analysis as defined in the ICH E14 Guidance for Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The Company believes that QTinno, based on NewCardio's technology and approach, is the industry's most advanced, validated software solution for performing high quality, cost effective automated cardiac safety analysis in drug development.
"This award is further evidence of the increasing market adoption of QTinno, our automated cardiac safety solution, not only as a validated methodology, but also as a clear leader in delivering advanced technology solutions to address the issues that the drug development industry has been struggling with in the effective implementation of the E14 Guidance," Mr. Renz continued. "We have worked closely with the leading clinical trial service providers, sponsors, regulators and key industry knowledge leaders in the development and validation of QTinno, which does not simply automate the current manual or semi-auto methodologies, but takes a new approach in accessing the full potential of data available from the ECG. The excitement generated has not only been about QTinno's ability to deliver high quality results in a cost effective manner today, but also the potential for it to advance the current state of cardiac safety analysis. In addition, our business model as a technology developer, not an ECG core lab, enables us to work effectively with any and all of our potential customers and/or partners, as we are not looking to compete with them but rather to equip them with solutions which enable them to deliver enhanced clinical trial products and services. We are pleased that industry leaders are embracing both NewCardio and QTinno, and thereby validating the quality of our technology and organization. As such, we look forward to an accelerating adoption cycle with excellent market penetration to follow."
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact:
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
SOURCE NewCardio, Inc.
CEL-SCI Successfully Produces and Fills Multikine in New Manufacturing Facility
Date : 08/04/2010 @ 9:45AM
Source : Business Wire
Stock : CEL-SCI Corporation (CVM)
http://ih.advfn.com/p.php?pid=nmona&article=43875805&symbol=A^CVM
CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has successfully produced and filled its first lot of Multikine® in preparation for the upcoming pivotal Phase III trial targeting advanced primary head and neck cancer.
The drug was filled in CEL-SCI’s state-of-the-art "Cold-Fill" manufacturing facility. The Company completed this test in order to ensure that it is able to produce significant quantities of Multikine to support the 880 patient clinical trial which is expected to commence prior to the end of the year. CEL-SCI's manufacturing facility, located outside of Baltimore, has been designed to fill biologics such as Multikine in true cold conditions (4 degrees Centigrade) which prevents/minimizes the loss of biological activity.
"Over the past few months, we have been highly focused on staffing and testing the facility in order to ensure that we have the equipment, resources and personnel to deliver Multikine to patients in the Phase III trial," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We recognize that in a trial of this scale involving a biologic there are many precautions that we need to take, and we have made excellent progress in completing these tasks so we can begin the trial later this year. With a strong balance sheet, the new manufacturing facility, a global CRO in place and having Phase III partners Teva Pharmaceuticals and Orient Europharma, we are well positioned to take Multikine through this pivotal trial. We believe that Multikine represents a paradigm shift in the way cancer patients are treated."
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to eliminate the tumors in 12% of the patients after only three weeks of treatment. Follow-up showed an improvement in the survival rate of those patients treated with Multikine of 33% at a median of three and a half years following surgery. Results of the trial also showed that the treatment regimen killed, on average, about half of the cancer cells before the start of standard therapy like surgery, radiation and chemotherapy. The U.S. Food and Drug Administration gave the go-ahead for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
CEL-SCI is also engaged in multiple other activities related to the start its Phase III clinical trial in 9 countries around the world. The trial is expected to be the largest head and neck cancer clinical study ever conducted, and is the first Phase III study in the world in which immunotherapy is given to patients first, prior to receiving any treatment for cancer, including surgery, radiation and/or chemotherapy. This should be the optimal time to stimulate an immune response against the tumor as the immune system has not yet been weakened by the conventional cancer therapies.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery. A pivotal Phase III clinical trial with Multikine in head and neck cancer is expected to start in the second half of 2010.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
When used in this report, the words "intends," "believes," "anticipated" and "expects" and similar expressions are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties which could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI Corporation's SEC filings, including but not limited to its report on Form 10- K for the year ended September 30, 2009. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
NewCardio Completes First Revenue-Generating Study Using QTinno
Date : 08/04/2010 @ 8:18AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43873655&symbol=NWCI
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that, in collaboration with a leading global biopharmaceutical services provider that signed a Master Services Agreement (MSA) for the use of NewCardio's QTinno™ software solution earlier this year, the first revenue generating study has been completed.
NewCardio successfully installed QTinno at one of their Phase 1 units, enabling the sponsor to complete a small initial study. The data will provide an initial cardiac safety profile which can then be used to determine the next steps for the compound which could include further QT analysis or potential out-licensing of the compound. NewCardio expects to recognize the modest revenue from this study during the third quarter.
"The successful completion of this study, which satisfied all NewCardio's expectations for accuracy and timeliness, will facilitate the ongoing transition to more automated studies in the future," said Vincent Renz, NewCardio's President and Chief Operating Officer. "QTinno was implemented to help perform a small Phase 1 study rapidly and at low cost for their sponsor, providing useful data indicating the cardiac safety profile of the drug. We are excited to have achieved this milestone, and look forward to this leading to additional business with the biopharmaceutical services provider as well as this sponsor in the future."
NewCardio's innovative 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead ECG. NewCardio's lead product, QTinno, is a software suite that provides automated, comprehensive cardiac safety analysis as defined in the ICH E14 Guidance for Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The Company believes that QTinno, based on NewCardio's technology and approach, is the industry's most advanced, validated solution for performing high quality, cost effective automated cardiac safety analysis in drug development.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact:
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
SOURCE NewCardio, Inc.
Discovery Labs Provides Business Update and Reports Second Quarter 2010 Financial Results
Date : 08/04/2010 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=43872051&symbol=DSCO
Discovery Laboratories, Inc. (Nasdaq:DSCO), a biotechnology company developing its novel, synthetic, peptide-containing surfactant and related aerosolization technologies as first in class therapies for severe respiratory diseases, today provides an update on key pipeline and business initiatives and reports financial results for the second quarter ended June 30, 2010. The Company will host a conference call this morning at 8:45 AM EDT. The call-in number is 866-332-5218.
Highlights and upcoming milestones, discussed further below, include:
* Surfaxin® – Discovery Labs continues to advance its program to gain regulatory approval for Surfaxin for the prevention of respiratory distress syndrome (RDS) in premature infants. Discovery has taken into account recently-received guidance from the U.S. FDA in the conduct of its ongoing comprehensive preclinical program, continues to interact with the FDA, and believes it remains on track for the potential filing of a complete response in the first quarter of 2011.
* Surfaxin LS™ (next-generation, lyophilized formulation of Surfaxin) – Discovery Labs is preparing the Surfaxin LS program for planned clinical activities. Fourth quarter 2010 milestones include establishing a commercial-scale Surfaxin LS manufacturing capability at a cGMP-compliant contract manufacturer with expertise in lyophilized formulations; producing necessary process validation batches. Additionally, Discovery Labs is intending to seek regulatory and scientific guidance with respect to its planned Surfaxin LS development program, first with the FDA in the fourth quarter of 2010 and then with the European Medicines Agency (EMA) in the first quarter of 2011.
* Aerosurf® (drug/device combination for noninvasive administration of aerosolized KL4 surfactant to address neonatal RDS) – Discovery Labs and industry-leading engineers are optimizing the design of the novel capillary aerosolization device to potentially reduce development risk and satisfy the regulatory and clinical requirements for Aerosurf. First half 2011 milestones include finalizing Aerosurf clinical device design, producing a sufficient number of devices to conduct design verification testing, and seeking regulatory guidance from the FDA and EMA for the planned Aerosurf development program.
* Phase 2a trial assessing safety and tolerability of aerosolized KL4 surfactant for cystic fibrosis – Top-line results anticipated to be available in the third quarter of 2010.
* Discovery Labs ended the second quarter of 2010 with $23.3 million in cash and marketable securities and a new Committed Equity Financing Facility which, subject to certain conditions, could allow the Company to raise up to $35 million in additional capital. Second quarter 2010 cash burn from operations (before financings and debt service) was $5.3 million. For the second half of 2010, Discovery Labs is providing guidance of projected cash burn from operations (before financings and debt service) of $12.0 million which includes investments to advance the Surfaxin, Surfaxin LS and Aerosurf programs.
W. Thomas Amick, Chairman and interim Chief Executive Officer of Discovery Labs, commented, "Discovery's ongoing program to gain potential Surfaxin approval in 2011 continues to benefit from the FDA's direction and willingness to continue to interact with our team. While remaining focused on Surfaxin, we are advancing our Surfaxin LS and Aerosurf programs in a resource-effective way intended to reduce development risk for these promising, high-value programs.
Discovery Labs has made progress in securing additional capital while exploring potential strategic alliances to adequately support our promising pipeline programs. On the financial front, we have streamlined our operating plans, significantly reduced debt and secured additional financial resources intended to advance Surfaxin to approval and move Surfaxin LS and Aerosurf towards clinical trials. Additionally, we are continuing discussions with several potential strategic alliance partners that clearly recognize the medical and commercial opportunity that Surfaxin, Surfaxin LS and Aerosurf may represent as a valuable RDS franchise. We believe that success in entering into meaningful strategic alliances will likely parallel success in advancing Surfaxin towards a complete response and positioning Surfaxin LS and Aerosurf for initiation of clinical trials."
Although a key priority for Discovery Labs is to secure strategic partners to support ongoing research and development activities and future progress, there can be no assurances that any strategic alliance will be successfully identified or concluded.
Selected Updates on KL4 Surfactant Pipeline Development
Surfaxin® for neonatal RDS: The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a large, multinational Phase 3 clinical program. Discovery Labs believes that the last remaining step necessary to potentially gain FDA marketing approval for Surfaxin for the prevention of RDS is to satisfy the FDA as to the final validation of an important quality control release and stability test for Surfaxin, the fetal rabbit biological activity test (BAT). Discovery Labs is currently conducting a comprehensive preclinical program that is intended to satisfy the FDA in this respect. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.
The ongoing comprehensive preclinical program has involved the optimization and revalidation of the BAT which is now being employed in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of RDS. In June 2010, Discovery Labs received written guidance from the FDA regarding the comprehensive preclinical program that is consistent with its ongoing program. Also in June 2010, Discovery Labs submitted data and analysis from its program to optimize and revalidate the BAT.
In July 2010, Discovery Labs took the opportunity to further interact with the FDA via a conference call regarding several important aspects of the ongoing comprehensive preclinical program. The FDA's comments support the activities undertaken by Discovery Labs to optimize and revalidate the BAT. Also during the meeting, the FDA requested that Discovery Labs provide additional data and analysis regarding the revalidation of the BAT intended to aid the FDA in its final determination of whether the BAT is appropriately validated for use as an ongoing quality control release and stability test for Surfaxin, if approved. Discovery Labs also obtained further FDA guidance regarding certain aspects of the ongoing side-by-side preclinical studies involving the BAT and preterm lamb model of RDS.
Discovery Labs has taken into account the FDA's guidance into ongoing activities, including the planned submission of the additional BAT-related data and analysis requested by the FDA. During the July teleconference, the FDA reiterated its willingness to provide continued guidance on plans to gain Surfaxin approval. Since then, Discovery Labs has continued interactions with the FDA intended to ensure that the comprehensive preclinical program satisfies the FDA as to the final validation of the BAT and its ultimate appropriateness as a release and stability test for Surfaxin, upon potential approval. However, future interactions with the FDA could affect the ultimate timing, conduct and outcomes of remaining steps necessary to gain Surfaxin approval, including the potential filing of the complete response. Discovery Labs believes it can provide the data and analysis requested by the FDA and remain on track to submit a complete response to the FDA in the first quarter of 2011, potentially leading to Surfaxin approval that year.
Surfaxin LS™ for neonatal RDS: Discovery Labs' development strategy for Surfaxin LS is to build upon the Surfaxin clinical experience to create a best-in-class surfactant therapy with improved preparation and administration flexibility and the potential to further improve clinical performance. Data presented at the May 2010 Pediatric Academic Societies Meeting indicate that Surfaxin LS, when compared to currently marketed, animal-derived surfactant products, favorably improved lung function and oxygenation while attenuating lung inflammation in an animal model of RDS.
To support plans for finalizing the intended development pathway for Surfaxin LS, the Company is currently conducting a series of key chemistry, manufacturing and control (CMC) activities. The Company has determined that clinical and commercial manufacturing requirements for Surfaxin LS would be most efficiently met by collaborating with a world-class contract manufacturing organization (CMO) with a successful, multi-national regulatory track record and established expertise in current good manufacturing practices (cGMP) and lyophilized formulations. In that regard, Discovery Labs has contracted with a leading pharmaceutical CMO to establish a cGMP-compliant clinical and commercial Surfaxin LS manufacturing capability. The production of required process validation batches is anticipated to be initiated in the fourth quarter of 2010.
Additionally, the Company intends to seek regulatory and scientific guidance with respect to its planned development program, first with the FDA in the fourth quarter of 2010 and then with the EMA in the first quarter of 2011.
Aerosurf® for neonatal RDS: Aerosurf is a novel drug/device combination therapy incorporating Discovery Labs' synthetic surfactant and unique capillary aerosolization technology to allow early administration of aerosolized surfactant to prevent neonatal RDS. Aerosurf holds the promise to significantly expand the use of surfactant therapy by providing neonatologists with a less-invasive means of delivering KL4 surfactant without the current requirement of invasive endotracheal intubation and mechanical ventilation.
Through the conduct of the Aerosurf program, the Company's aerosol engineers and scientists have meaningfully improved the design of the capillary aerosolization device and patient interface for neonatal application, employing a flexible design strategy to support potential downstream applications of aerosolized KL4surfactant in other respiratory disorders. The Company has recently engaged a leading global technology company with expertise in biomedical devices to assist in incorporating design improvements into the capillary aerosolization device. The design of the capillary aerosolization device is being optimized to potentially reduce development risk and satisfy regulatory and clinical requirements for Aerosurf. The Company anticipates finalizing the clinical Aerosurf device design and producing a sufficient number of Aerosurf devices to complete required design verification testing in the first half of 2011.
Additionally, the Company is preparing to engage the FDA and EMA in the first half of 2011 for regulatory and scientific guidance with respect to the planned Aerosurf clinical development program. In preparation, the Company is currently conducting important CMC activities for Aerosurf, including dose-ranging experiments conducted in a well-established animal model of RDS and comprehensive aerosol characterization studies.
Phase 2a trial for cystic fibrosis: Aerosolized KL4 surfactant is being evaluated in an investigator-initiated Phase 2a clinical trial as a single center, pilot study to evaluate the effects of aerosolized KL4 surfactant in patients with mild to moderate cystic fibrosis (CF). The study is designed to assess the safety, tolerability and potential effect on mucociliary clearance from short term administration of aerosolized KL4 surfactant. Enrollment has been completed and top-line results are expected to be available in the third quarter of 2010.
Surfaxin, Surfaxin LS and Aerosurf are investigational products and are not approved by the FDA or any other world health regulatory authority for use in humans.
Selected Financial Results for the Quarter Ended June 30, 2010
For the quarter ended June 30, 2010, the Company reported a net loss of $6.3 million (or $0.04 per share) on 160.4 million weighted average common shares outstanding compared to a net loss of $7.9 million (or $0.07 per share) on 112.7 million weighted average common shares outstanding for the same period in 2009. As of June 30, 2010, the Company had 194.1 million common shares outstanding.
As of June 30, 2010, the Company had cash and marketable securities of $23.3 million. Additionally in June, the Company secured a new Committed Equity Financing Facility (CEFF) with Kingsbridge Capital Limited, a private investment group, in which Kingsbridge has committed to provide up to $35 million of capital over a three-year period through the purchase of up to approximately 31.6 million newly-issued shares of Discovery Labs' common stock. Under the terms of the CEFF agreement, Discovery Labs will be able determine the exact timing and amount of any financings, subject to certain conditions and limitations (including price and share limitations). In connection with the CEFF, Discovery Labs issued a five-year warrant to Kingsbridge to purchase up to 1,250,000 shares of common stock at an exercise price of $0.4459 per share.
On June 22, 2010, the Company completed a public offering of common stock and warrants resulting in gross proceeds of $10.0 million from the issuance of 35.7 million shares of common stock, 17.9 million five-year warrants and 17.9 million short-term (9-month) warrants. The shares and warrants were priced at $0.28 per unit. The five-year warrants have an exercise price of $0.40 per share and the short-term warrants have an exercise price of $0.28 per share. Net proceeds from the offering, after underwriting discounts and commissions and other fees and expenses, were $9.1 million. The Company could realize up to an additional $5.0 million in proceeds by March 22, 2011, from the potential exercise of the short-term warrants.
Net cash burn from ongoing operating activities (before financing and debt service activities) for the second quarter of 2010 was $5.3 million. The Company anticipates that its net cash burn for operating activities (before any financing and debt service activities) for the second half of 2010 will be approximately $12.0 million.
In April 2010, the Company restructured its $10.6 million loan with PharmaBio Development Inc. (PharmaBio), the former strategic investment subsidiary of Quintiles Transnational Corp. (Quintiles). The Company satisfied $6.6 million of the loan in cash. As of June 30, 2010, $4.0 million remained as the short-term outstanding balance of the loan. On July 30, 2010, $2.0 of the loan was paid and the remaining balance of $2.0 million is due on September 30, 2010. Additionally, contemporaneously with the restructuring, PharmaBio purchased Discovery Labs common stock and warrants resulting in net proceeds of $2.1 million to Discovery Labs. Quintiles, PharmaBio and the Company have also agreed to explore a long-term strategic collaboration for the development of Surfaxin LS and Aerosurf, however, there can be no assurance that any such arrangements will be achieved.
The descriptions of the transactions referred to herein with respect to Kingsbridge, the recently completed public offering and the PharmaBio loan restructuring and the PharmaBio investment in Discovery Labs' common stock are entirely qualified by reference to the transaction documents, which are attached as exhibits to each related Form 8-K filed by the Company with the Securities and Exchange Commission ("SEC"). Readers are referred to, and encouraged to read in their entirety, the Forms 8-K, including the exhibits attached thereto, and the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 to be filed with the SEC, which includes further detail on the Company's business plans and operations, financial condition and results of operations.
Conference Call Details
Discovery Labs will hold a conference call on Wednesday, August 4, 2010 at 8:45 AM EDT to further discuss the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. This audio webcast will be available through a live broadcast on the Internet at http://intercallus.stream57.com/DiscoveryLaboratories_080410 and www.discoverylabs.com. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 89526041.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (c) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Capital Market listing requirements prior to the expiration of the additional grace period currently in effect, which could cause the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to health care reform; and other risks and uncertainties described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
Sunesis Pharmaceuticals Appoints Steering Committee and Clinical Partners for Vosaroxin Pivotal Phase 3 Trial in AML
Date : 08/04/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=43872471&symbol=N^SNSS
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced the Steering Committee and other clinical trial partners for its pivotal Phase 3 trial of vosaroxin in acute myeloid leukemia (AML). Sunesis also announced that it requested, and that the United States Adopted Names (USAN) Council has accepted the new nonproprietary name "vosaroxin" for its lead drug candidate (formerly known as voreloxin). The USAN Council aims for global standardization and unification of drug nomenclature and related rules to ensure that drug information is communicated accurately and unambiguously.
The Phase 3 trial, known as VALOR (Vosaroxin and Ara-C combination evaLuating Overall survival in Relapsed/refractory AML), is a multinational, randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin in combination with cytarabine in 450 patients with first relapsed or primary refractory AML. It is expected to begin enrollment later this year.
"We have made important progress toward ensuring that our pivotal Phase 3 AML trial is a well-executed study, and continue to work diligently toward ensuring its timely launch," said Daniel Swisher, Sunesis' Chief Executive Officer. "Our internal clinical leadership, which includes individuals with extensive late-stage development experience, is now supplemented by clinical partners and a Steering Committee with significant, international hematology experience. We are in the process of compiling and finalizing the documentation needed for local regulatory authority and ethics committee submissions, and we remain on track to initiate the VALOR trial later this year."
"Refractory and relapsed AML are disease settings for which there is an enduring unmet medical need. Currently no Phase 3 trial is enrolling both first relapsed or primary refractory AML patients," said Eric Feldman, MD, Chair of the VALOR Steering Committee and Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College. "The VALOR trial is a rigorously designed study which will provide randomized data assessing the potential incremental contribution of vosaroxin to underlying cytarabine therapy in relapsed or refractory AML, with overall survival serving as the primary endpoint. I look forward to the initiation of this trial and to serving as a member of its Steering Committee."
The Steering Committee will provide scientific oversight for the VALOR trial as well as communicate its recommendations regarding trial conduct with the trial's Data Safety Monitoring Board and Sunesis. Steering Committee members are:
* Eric Feldman, MD, Chair of Steering Committee, Professor of Medicine and Director of the Leukemia Program and Hematological Malignancies at Weill Cornell Medical College
* Harry Erba, MD, PhD, Associate Professor, Department of Internal Medicine at the University of Michigan and Executive Officer of the Southwest Oncology Group
* Gary Schiller, MD, Professor of Medicine, Director of the Hemapherisis Unit and Chairman of the Medical Specialties College of the David Geffen School of Medicine at the University of California, Los Angeles
* Robert Stuart, MD, founding director of the Aplastic Anemia & Myelodysplastic Syndrome Foundation, Director of the clinical component of the Hollings Cancer Center's Hematological Malignancies Program and Medical Director of the Clinical Trials Office at the University of South Carolina
* Norbert Vey, MD, Professor of Medicine, Leukemia and MDS Unit, Department of Hematology at the Institut Paoli-Calmettes, Marseille, France
Among the clinical trial partners appointed by Sunesis are (i) ICON, a contract research organization with global capabilities, hematology expertise and extensive Phase 3 experience; (ii) Catalent Pharma Solutions, a leading global provider of advanced technologies, and development, clinical, manufacturing and packaging services, including global comparator procurement, secondary packaging and logistics; and (iii) Cytel, a highly regarded statistical services provider. Sunesis has also retained the Clinical Development Group, LLC to augment Sunesis' Phase 3 strategic development support for the VALOR trial, including clinical site management and patient recruitment. Key individuals from the Clinical Development Group have recent, multinational Phase 3 AML trial experience, including Ann Cahill, formerly the Vice President of Clinical Development at Vion Pharmaceuticals.
About Vosaroxin (formerly voreloxin)
Vosaroxin, formerly known as voreloxin, is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Sunesis plans to initiate the VALOR trial, a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in combination with cytarabine in a relapsed/refractory AML patient population, in the second half of this year.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including without limitation statements related to the planned commencement and timing of the VALOR trial, a pivotal Phase 3 clinical trial of vosaroxin (formerly voreloxin). Words such as "expected," "remain on track," "will," "plans" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include without limitation, risks related to Sunesis' need for additional funding to fully finance the planned vosaroxin pivotal trial, the risk that Sunesis' development activities for vosaroxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of vosaroxin, and the risk that Sunesis' proprietary rights may not adequately protect vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Registration Statement on Form S-3 (File No. 333-168191) and its periodic and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
YRC Worldwide Q2 2010 Earnings Call Transcript
August 03, 2010
http://seekingalpha.com/article/218337-yrc-worldwide-q2-2010-earnings-call-transcript?source=feed
Sunesis Pharmaceuticals to Present at BMO Capital Markets 10th Annual Focus on Healthcare Investor Conference
Date : 08/03/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals, Inc. (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=43852456&symbol=SNSS
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers, today announced that Eric Bjerkholt, Senior Vice President, Corporate Development and Finance, will be presenting at the BMO Capital Markets 10th Annual Focus on Healthcare Investor Conference on Thursday, August 5, 2010 at 11:15 A.M. Eastern Time at the Sheraton New York Hotel & Towers in New York City.
A live webcast of this presentation will be available on the Sunesis website at http://ir.sunesis.com. A replay of the webcast will be archived on the "Calendar of Events" page in the Investors and Media section of the Sunesis website for two weeks.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
LifeSci Advisors Initiates Coverage on Keryx Biopharmaceuticals
Date : 08/02/2010 @ 12:44PM
Source : Business Wire
Stock : LifeSci Advisors, LLC (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=43840847&symbol=KERX
LifeSci Advisors, LLC., a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage on Keryx Biopharmaceuticals (Nasdaq: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease.
“Keryx has multiple robust late-stage programs underway and our analysis indicates that perifosine, the company’s lead candidate, has blockbuster potential as an anti-cancer agent,” commented Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “Additionally, we believe Zerenex, the company’s therapeutic in development for the treatment of patients with end-stage renal disease, may have significant safety, efficacy and dosing advantages over currently marketed therapies in its class. Given these attributes, we believe that positive results from the ongoing Phase III trial of Zerenex could position the drug to capture significant market share.”
LifeSci Advisors’ 56-page Initiation Report contains a detailed discussion of Keryx Biopharmaceuticals pipeline products, including perifosine for relapsed/refractory multiple myeloma and advanced colorectal cancer and Zerenex for hyperphosphatemia associated with end-stage renal disease. The report outlines competitive positioning and growth opportunities for these products, which are now in Phase III clinical trials under Special Protocol Assessment (SPA) with the FDA. The report highlights recent clinical achievements, short-term and long-term expected milestones, relevant market dynamics, and risks.
Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on Keryx Biopharmaceuticals as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About Keryx Biopharmaceuticals:
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing perifosine, a novel, potentially first-in-class, oral anti-cancer agent that inhibits key signal transduction pathways, which are associated with programmed cell death, cell growth, cell differentiation and cell survival. Perifosine is currently in Phase III clinical development for both refractory advanced colorectal cancer and multiple myeloma. Each of the Phase III programs is being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase III clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Please visit www.keryx.com for more information.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company’s website, www.lifesciadvisors.com.
Important Disclosures:
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
Forward-looking statements:
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.
LifeSci Advisors Initiates Coverage on Keryx Biopharmaceuticals
Date : 08/02/2010 @ 12:44PM
Source : Business Wire
Stock : LifeSci Advisors, LLC (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=43840847&symbol=KERX
LifeSci Advisors, LLC., a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage on Keryx Biopharmaceuticals (Nasdaq: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease.
“Keryx has multiple robust late-stage programs underway and our analysis indicates that perifosine, the company’s lead candidate, has blockbuster potential as an anti-cancer agent,” commented Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. “Additionally, we believe Zerenex, the company’s therapeutic in development for the treatment of patients with end-stage renal disease, may have significant safety, efficacy and dosing advantages over currently marketed therapies in its class. Given these attributes, we believe that positive results from the ongoing Phase III trial of Zerenex could position the drug to capture significant market share.”
LifeSci Advisors’ 56-page Initiation Report contains a detailed discussion of Keryx Biopharmaceuticals pipeline products, including perifosine for relapsed/refractory multiple myeloma and advanced colorectal cancer and Zerenex for hyperphosphatemia associated with end-stage renal disease. The report outlines competitive positioning and growth opportunities for these products, which are now in Phase III clinical trials under Special Protocol Assessment (SPA) with the FDA. The report highlights recent clinical achievements, short-term and long-term expected milestones, relevant market dynamics, and risks.
Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on Keryx Biopharmaceuticals as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About Keryx Biopharmaceuticals:
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing perifosine, a novel, potentially first-in-class, oral anti-cancer agent that inhibits key signal transduction pathways, which are associated with programmed cell death, cell growth, cell differentiation and cell survival. Perifosine is currently in Phase III clinical development for both refractory advanced colorectal cancer and multiple myeloma. Each of the Phase III programs is being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase III clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Please visit www.keryx.com for more information.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company’s website, www.lifesciadvisors.com.
Important Disclosures:
The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.
Forward-looking statements:
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.
you are in (again) ??
...take this:
http://world-of-stocks.com/rt_data/yrcw
YRC Worldwide CEO: Reverse Stock Split May Not Happen In 2Q
http://ih.advfn.com/p.php?pid=nmona&article=43220579&symbol=YRCW
Notice of Delisting or Failure to Satisfy a Continued Listing Standard
http://ih.advfn.com/p.php?pid=nmona&article=41857395&symbol=NASDAQ%3AYRCW
Vitaros® - final approval decision expected November 2010
NEXMED RECEIVES SCREENING ACCEPTANCE LETTER FROM HEALTH CANADA FOR VITAROS®
150-day Review Cycle Triggered for Final Approvability of Product in Canada
http://www.nexmed.com/press_06232010.html
San Diego--(BUSINESS WIRE)-- NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of product candidates based on the NexACT® technology, today announced that Health Canada has confirmed acceptance of the Company’s CMC (Chemistry, Manufacturing and Controls) response for review. The Screening Acceptance Letter (the “Acceptance Letter”) from Health Canada was issued in connection with its New Drug Submission (“NDS”) for Vitaros®, the Company’s topical treatment for erectile dysfunction. The Acceptance Letter confirms that the CMC response filed by NexMed is acceptable for the final, 150-day review cycle, during which regulatory reviewers will determine the final approvability of the product for marketing in Canada. Based on the date of acceptance, a final approval decision is expected by the end of November 2010.
Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, “Receipt of the Acceptance Letter marks another important milestone in the development history of Vitaros and we remain positive about the possibility for eventual product approval. As such, we anticipate utilizing our Canadian application as the basis for filing new marketing applications in other international markets.”
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT® drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites : http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company. For example, and without limitation, there can be no assurance that Health Canada or any other foreign regulatory authority will approve Vitaros for marketing approval.
Contacts:
NexMed, Inc.
Edward Cox, V.P.
Investor Relations & Corporate Development NexMed, Inc.
(858) 926-5811
ecox@nexmed.com
NexMed Investor Relations
Paula Schwartz
NexMed, Inc. Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Antisoma's preliminary results for the year ended 30 June 2010
Date : 07/29/2010 @ 2:01AM
Source : UK Regulatory (RNS & others)
Stock : Antisoma (ASM)
http://ih.advfn.com/p.php?pid=nmona&article=43787366&symbol=L^ASM
London, UK, and Cambridge, MA: 29 July 2010 Antisoma plc (LSE: ASM; USOTC:
ATSMY) today announces its preliminary results for the year ended 30 June 2010.
These results have been prepared under International Financial Reporting
Standards ('IFRS') as adopted for use by the European Union.
Key events of 2009/2010
AS1413
* Positive final data reported from secondary AML phase II trial
* Secondary AML phase III trial over 75% enrolled
* FDA Fast Track status awarded
* Phase III data expected H1 2011
AS1411
* Positive long-term follow-up data from phase II AML trial
* Renal cancer phase II trial shows further evidence of activity
* New non-clinical data indicate potential in major cancer types
* Orphan drug status for AML obtained in US and EU
* Phase IIb trial in AML ongoing; headline data expected H1 2011
ASA404
* Front-line lung cancer phase III trial discontinued for futility
Financial highlights
* Cash at 30 June 2010 of GBP 32.1 million (30 June 2009: GBP 67.0 million)
* Cash life extends well beyond key phase III results
* Revenues of GBP 20.3 million (2009: GBP 25.2 million)
* Reflects half of the USD 60 million up-front payment from sanofi-aventis
(GBP 19.7 million) for the divestment of oral fludarabine
* Full year loss of GBP 18.7 million (2009: loss of GBP 16.4 million)
Commenting on the results, Glyn Edwards, CEO of Antisoma, said: "We have two
promising cancer drugs, AS1413 and AS1411, both of which we expect to report key
trial data by mid-2011, and cash resources to take us well past these data."
A webcast and conference call will be held today at 10.30 am BST. The webcast
can be accessed via Antisoma's website at
http://www.antisoma.com/asm/media/webcast/ and the call by dialling +44 (0)
207 806 1964 (US toll-free +1 718 354 1390) and using the Confirmation Code:
9656482. A recording of the webcast will also be available afterwards on the
Antisoma website.
Enquiries:
Antisoma plc +44 (0)7909 915 068
Glyn Edwards, Chief Executive Officer
Eric Dodd, Chief Financial Officer
Daniel Elger, VP, Marketing & Communications
Buchanan Communications +44 (0)20 7466 5000
Mark Court, Lisa Baderoon, Catherine Breen
Except for the historical information presented, certain matters described in
this announcement are forward looking statements that are subject to a number
of risks and uncertainties that could cause actual results to differ materially
from results, performance or achievements expressed or implied by such
statements. These risks and uncertainties may be associated with product
discovery and development, including statements regarding the Group's clinical
development programmes, the expected timing of clinical trials and regulatory
filings. Such statements are based on management's current expectations, but
actual results may differ materially.
Joint Chief Executive and Chairman's statement
Overview
We have had a challenging year, including a disappointment in March, when a
phase III trial evaluating ASA404 as a first-line treatment for lung cancer was
discontinued for futility. We recognise that ASA404 was considered the Company's
most significant asset, but we are fortunate in having another late-stage cancer
drug, AS1413, with substantial market potential. Addressing an indication in
acute leukaemia where there is high unmet need, poor satisfaction with currently
available generic therapies and clear potential for post-launch growth, AS1413
could readily achieve peak sales comparable in scale to the royalties that we
might have obtained through our alliance on ASA404. We expect data from the
phase III pivotal study of this compound in the first half of 2011.
AS1413 phase III trial nears enrolment target
AS1413 is a novel chemotherapy that we are testing in a large randomised phase
III trial in patients with secondary acute myeloid leukaemia (secondary AML).
The trial, known as ACCEDE, is approaching its enrolment target, which is to
screen 450 patients in order to provide 420 evaluable patients. Enrolment should
be completed in the third quarter of 2010 and we expect to announce results in
the first half of 2011.
During the year, we have presented new findings supporting AS1413 at major
scientific and medical meetings. In December, we reported positive final data
from a phase II trial of AS1413 in secondary AML at the American Society of
Hematology (ASH) Annual Meeting. We saw an encouraging number of longer-term
responders, with 30% of patients who achieved remission after treatment with
AS1413 still alive after 2 years. A presentation at the American Association of
Cancer Research (AACR) Annual Meeting in April reinforced the differentiation of
AS1413 from currently available leukaemia treatments and its potential to
provide unique benefits for patients. Presentations at the American Society of
Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association
(EHA) Annual Meeting in June highlighted the importance of multi-drug resistance
as a barrier to successful treatment of AML. A key feature of AS1413 is its
ability to evade multi-drug resistance mechanisms.
In June we announced that the U.S. Food and Drug Administration (FDA) had
granted Fast Track designation to AS1413 for the treatment of secondary AML.
Fast-track designated drugs usually qualify for Priority Review, an expedited
review process available to drugs that offer major advances in treatment or
provide a treatment where no adequate therapy exists.
There is interest from potential partners in licensing AS1413. We have decided
to take a pragmatic stance to realising the value of the drug, and have
therefore widened our partnering discussions to include US rights, which we had
previously planned to retain. However, as we have the resources ourselves to
complete development of AS1413, we will only strike a deal ahead of the phase
III data if terms are sufficiently favourable.
We believe that AS1413 could ultimately find application in a number of blood
cancer settings, with potential sales running to hundreds of millions of dollars
annually.
AS1411 phase IIb trial ongoing
AS1411 is the most advanced aptamer in trials for cancer. In March we initiated
a 90-patient phase IIb study in patients with AML. This trial follows an earlier
60-patient randomised phase II trial in AML, in which use of AS1411 in
combination with cytarabine produced a higher remission rate than cytarabine
alone, without imposing any significant additional side-effects. At this year's
ASCO meeting, we presented long-term follow up data from the earlier study,
showing that five of the eight patients who responded to an AS1411-based
regimen, all of whom had advanced disease on entry to the study, had substantial
survival durations (from 12 to over 20 months). Headline data from the phase IIb
study are expected in the first half of 2011.
We continue to accumulate evidence that AS1411 has potential in a variety of
different cancers. Non-clinical data presented at AACR in April showed activity
in a model of colorectal cancer and positive findings when AS1411 was combined
with various approved treatments for blood cancers. At the ASCO meeting in June
we presented data from a 35-patient phase II study of AS1411 in advanced renal
cancer, which provided further evidence of activity in this setting.
In October we announced that AS1411 had been granted orphan drug status in the
US and the EU for the treatment of AML. These grants will provide seven years of
market exclusivity in the US and ten years of exclusivity in the EU if AS1411 is
approved as a treatment for AML.
DCAM auto-immune programme progressing towards partnering
We have an important pre-clinical programme in auto-immune diseases. This
comprises a series of molecules collectively known as DCAMs (dendritic cell
auto-immune modulators). They are highly specific, small-molecule inhibitors of
wild-type Flt3, and are designed for oral treatment of various auto-immune
conditions. Positive results have already been achieved in animal models of
inflammatory bowel disease and rheumatoid arthritis, and we are now working
towards establishing a licensing partnership for further development of the
programme.
Other pipeline developments
During the period, we discontinued development of a phase II product, AS1402,
divested a phase I product, P2045, to Bryan Oncor, and put on hold further
development of AS1409. We have also discontinued a number of preclinical
programmes as we focus our resources on development of our late-stage products,
AS1413 and AS1411.
Cash conservation measures enacted
We are no longer anticipating further revenues from the ASA404 programme, and
have therefore taken steps to reduce our cash utilisation and ensure that our
funds take us comfortably past key clinical data on AS1413 and AS1411, which are
expected during the first half of 2011. We finished the period with cash and
short-term deposits of GBP 32.1 million (2009: GBP 67.0 million).
Total revenues for the year ended 30 June 2010 were GBP 20.3 million, compared
with GBP 25.2 million last year. This year's revenues reflect half of the USD
60.0 million up-front payment from sanofi-aventis (GBP 19.7 million) for oral
fludarabine, which was deferred from the previous financial year, and the first
of five annual contingent payments due under the agreement.
Total operating expenses have increased from GBP 40.8 million last year to GBP
43.4 million this year, mainly reflecting an increase in general and
administrative costs, which were GBP 7.9 million (2009: GBP 4.9 million),
reflecting impairments made to intangible assets and lower foreign exchange
gains during the year. Research and development (R&D) costs were GBP 35.5
million (2009: GBP 35.9 million).
We have recorded a full-year loss of GBP 18.7 million (2009: GBP 16.4 million).
At this stage in our development, profits and losses reflect the balance between
recognition of deferred revenues and our ongoing operating expenses.
Board and management changes
Regrettably, we have had to restructure the business and make headcount
reductions as part of our effort to conserve cash resources. As part of the
restructuring, our former Chief Operating Officer, Dr Ursula Ney, left the
Company and the Antisoma Board in April. Ursula made a very significant
contribution to the development of Antisoma, and we wish her well with future
ventures. In June we closed our laboratories at BioPark in Hertfordshire,
leaving our operations concentrated at our headquarters in London and at our
Cambridge, MA, site and reducing our total headcount to around sixty.
Outlook
We believe we have the product assets, people and financial resources to build
value for the future. We look forward to a number of important clinical
milestones in the near term, notably phase III data on AS1413 and phase IIb data
on AS1411, both of which we expect in the first half of 2011.
Glyn Edwards
Chief Executive Officer
Barry Price
Chairman
IBOX updated!
NMT Medical, Inc. - Q2/2010 Earnings Call Transcript
July 30, 2010
http://seekingalpha.com/article/217735-nmt-medical-inc-q2-2010-earnings-call-transcript?source=feed
NMT Medical Announces Second-Quarter 2010 Financial Results
Date : 07/29/2010 @ 7:30AM
Source : Business Wire
Stock : NMT Medical, Inc. (NMTI)
http://ih.advfn.com/p.php?pid=nmona&article=43794356&symbol=NMTI
NMT Medical, Inc. (NASDAQ: NMTI), an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures, today announced financial results for the quarter ended June 30, 2010.
Second-Quarter Results
Second-quarter 2010 total revenues were approximately $2.6 million compared with approximately $3.2 million for the quarter ended June 30, 2009.
Cardiac septal repair implant sales in North America for the second quarter of 2010 were approximately $1.9 million compared with approximately $2.4 million in the second quarter of 2009. Implant sales outside of North America were approximately $700,000 in the second quarter of 2010 compared with $800,000 in the corresponding period of 2009.
For the second quarter of 2010, NMT reported net income of approximately $2.6 million, or $0.16 per diluted share, compared with a net loss of approximately $3.8 million, or $0.29 per share, for the corresponding period in 2009. Net income for the second quarter of 2010 includes a non-cash, pre-tax gain of $6.4 million related to the change in fair value of the warrants issued in February 2010 as part of the Company’s $5.8 million financing. For the second-quarter of 2010, NMT reported a loss from operations of approximately $4.0 million compared with a loss of approximately $3.9 million in the same period of 2009.
Management Comments
“During the second quarter, we believe the medical community was eagerly anticipating the results of CLOSURE I, our pivotal patent foramen ovale (PFO)/stroke and transient ischemic attack (TIA) trial, which may have slowed the referral pattern and the number of procedures performed during the second quarter in the U.S.,” said President and Chief Executive Officer Frank Martin. “In addition, our revenues outside of North America reflect a shortfall in our larger Western European markets.”
“We commenced data analysis for CLOSURE I early in the quarter and announced preliminary results in mid-June, which indicated that the trial did not meet its primary endpoint,” Martin said. “However, the preliminary results of CLOSURE I did confirm several positive attributes of our technology. While the trial did not demonstrate that treatment by device closure with the STARFlex® implant is superior, the results indicate that closure with STARFlex® provided a small, but not statistically significant, benefit over current best medical therapy. The primary endpoint included the incidence of a recurrent stroke/TIA confirmed by MRI imaging. In addition to a very low rate of thrombus formation, for the first time in any prospective, randomized and independent core lab adjudicated PFO related trial, the results indicate that the safety profile of the STARFlex® device had a low rate of complications, similar to that of current best medical therapy. Closure rates in the trial were 86.5%, which is consistent with NMT’s previously reported results for the STARFlex® implant. We are currently in discussions with the U.S. Food and Drug Administration to evaluate our possible next steps relating to the stroke/TIA indication. We plan to provide an update, once an appropriate course of action has been determined. We currently anticipate that full trial data results will be discussed at the American Heart Association meeting in November 2010.”
Chief Operating Officer, Richard E. Davis, said, “As of June 30, 2010, cash, cash equivalents and marketable securities were approximately $6.5 million. Going forward, we will continue to tightly manage expenses, preserve cash, evaluate financing alternatives and adjust our operating plan accordingly in order to support our ongoing clinical trials and development programs. We currently expect third-quarter 2010 revenues to be approximately $2.5 million.”
Conference Call Reminder
Management will conduct a conference call at 9:30 a.m. ET today to review the Company’s financial results and provide a business update. Individuals who are interested in listening to the live webcast should log on to the “Investors” section of NMT Medical’s website at www.nmtmedical.com. The conference call also may be accessed by dialing (877) 407-5790 or (201) 689-8328. For interested individuals unable to join the live conference call, a replay will be archived for one year via webcast on the Company’s website.
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right-to-left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right-to-left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 33,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
For more information about NMT Medical, please visit www.nmtmedical.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements – including statements regarding the timing, cost, clinical status, and outcome of the Company’s CLOSURE I trial, its ongoing clinical trials and development programs, the Company’s revenue expectations for the third quarter of 2010, the Company’s expected savings from cost reductions, the success of its new distribution partnerships, expansion of the Company’s cardiovascular business and market opportunities, including stroke, TIA and any other new applications for the Company’s technology or products, regulatory approvals for the Company’s products in the United States and abroad and the Company’s investment in product development – involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may cause such a difference include, but are not limited to, the Company’s ability to develop and commercialize new products, a potential delay in the regulatory process with the U.S. Food and Drug Administration and foreign regulatory agencies, as well as risk factors discussed under the heading “Risk Factors” included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2009, Form 10-Q for the quarter ended March 31, 2010 and subsequent filings with the U.S. Securities and Exchange Commission.
NewCardio Announces New $1.5 Million Line of Credit with Existing Shareholders
Date : 07/29/2010 @ 12:15PM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43801301&symbol=NWCI
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, today announced that it has entered into a new line of credit with three of its existing shareholders, one of which is represented on the Board of Directors, to strengthen its financial position. This will allow the company further time to fully commercialize its lead solution, QTinno™.
In conjunction with signing this credit line, the company withdrew the S-1 registration statement, previously filed with the Securities and Exchange Commission (SEC) as it does not currently intend to pursue the public offering. Management believes that the company has sufficient operating capital to sustain its operations and fund its business plan at this time.
The credit facility is part of a series of steps designed to improve the company's ability to identify and attract potential strategic relationships and/or investors, which is intended to enable the company to maximize the value to be derived through continued development of its 3D platform technology.
Vincent W. Renz Jr., President and Chief Executive Officer of NewCardio, commented, "We appreciate the confidence shown by our original investors in NewCardio, and we believe this line of credit is preferable to equity offerings we had been considering under the now-withdrawn S-1 Registration Statement. In the last 60 days, we have re-organized our senior management team to focus on commercializing our technology and expanding our presence with pharmaceutical companies, clinical organizations and regulators. We have also taken steps to strengthen our financial position by reducing cash usage over the next six months. Now with this line of credit, we are confident we have sufficient resources to execute our strategy for QTinno as well as improve our position as we explore a number of strategic opportunities which will enable the accelerated development of our 3D platform technology. We look forward to updating our shareholders in more detail in a conference call in the coming weeks."
Management anticipates conducting a conference call in mid-August to coincide with the release of its second quarter financial results for the period ended June 30, 2010. Management will schedule and announce a conference call prior to that date.
The new $1.5 million line of credit is being provided by existing investors that participated in the July 2009 credit line. The conditions to advances, and rights of the lenders, are set forth in the credit line documents that are exhibits to NewCardio's current report on Form 8-K, filed with the SEC contemporaneously with this press release.
In addition, as of this date, all previous commitments to fund the Company under prior credit lines have been met in full.
Mr. Renz continued, "We believe that the commitment of our original investors to provide an additional $1.5 million credit line, as well as fully fund all amounts on the existing current credit line, reinforces their confidence with the company, our management team and the recent changes we implemented. Their support enables us to focus on our key commercialization and strategic initiatives."
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact:
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
SOURCE NewCardio, Inc.
NewCardio to Conduct Corporate Update Conference Call on August 12, 2010
Date : 07/29/2010 @ 8:00AM
Source : PR Newswire
Stock : Newcardio (BB) (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=43795205&symbol=NWCI
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, today announced that the Company expects to file its Form 10-Q for the second quarter ended June 30, 2010 on August 12, 2010 and management will conduct a conference call to provide a corporate update and discuss progress as follows:
What: NewCardio Corporate Update Conference Call
When: 1:30 p.m. PT/ 4:30 p.m. ET, Thursday, August 12, 2010
Where: Please dial 1-888-846-5003 (domestic) or 1-480-629-9856 (International) five to 10 minutes before the call. Investors will also have the opportunity to listen to the conference call and the replay on the News and Events section of the NewCardio website at: http://www.newcardio.com.
Questions: Select questions for the conference call will also be taken via email at nwci@haydenir.com and can be sent any time prior to the conference call's starting time.
Replay: A replay of the call will be available by dialing 1-877-870-5176 (domestic) or 1-858-384-5517 (international) and referencing passcode 4339629.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead ECG. NewCardio's 3D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact:
Hayden IR
Jeff Stanlis, Partner
(602) 476-1821
jeff@haydenir.com
SOURCE NewCardio, Inc.
IBOX-update (part1 - done!) ...Ticker change inquired
Zoom Technologies' LEIMONE Brand Continues to Drive Appeal to China Telecom's Young User
Date : 07/28/2010 @ 9:00AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=43776437&symbol=ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and related products, today unveiled the LEIMONE E33, its third in a series of 3G "LEIMONE" brand multimedia phones. The E33 phone will be sold through China Telecom, one of China's major mobile phone operators.
Mr. Leo Gu, Chief Executive Officer of Zoom Technologies, said, "This is another milestone in developing our LEIMONE brand into a leading consumer recognized name. The launch of our third 3G LEIMONE phone reflects Zoom's outstanding 3G capabilities and continues to solidify our already strong relationship with China Telecom. This is a very exciting time for Zoom as our LEIMONE brand phones, which carry a higher profit margin than our contract engineering & manufacturing service (EMS) phones, are growing in use and popularity. Zoom believes it is positioned to benefit from the outstanding growth expected in the design and production of advanced mobile phones for China's 3G network. The design and features of our newest E33 phone caters to young users who are price sensitive and yet demand rich multimedia features in their handsets. We are confident that the E33 mobile phone will appeal to China's burgeoning young customer base."
The LEIMONE E33 3G mobile phone is coming to market in September and is targeted for China's younger customers with its fashionable design, sleek interface, and middle to low-end price point. The E33 features a 2.4 inch 65K TFT 320Hx240W aspect ratio back-lit LED screen, a high resolution camera, flash memory expansion slot, FM radio, Bluetooth 2.1 and GPS navigation capabilities, 220 minutes talk time and 120 hours on standby mode, and is fully compatible with China Telecom's 3G applications.
For more information on the LEIMONE E33 and other LEIMONE phones, please visit Zoom Technologies' website at www.zoomleimone.com.
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its Own Brand Manufacturing (OBM) under the Leimone brand name. The company's products are both exported and sold domestically.
Forward-Looking Statements
Certain statements in this press release may constitute "forward looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1318454
Contacts:
Cynthia Hiponia
The Blueshirt Group
+1 415-217-4966
Zoom Technologies' Leimone Brand Enjoys High Acceptance by Mobile Phone Customers in China
Date : 07/21/2010 @ 12:00PM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=43688829&symbol=N^ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and related products, today announced that 128,000 Leimone brand mobile phones were sold within the first half of 2010, including 16,000 units of the latest 3G design. These phones are sold through one of China's major mobile phone operators, China Telecom, and also through various retail channels. The Leimone brand phones carry a higher profit margin than the Company's contract engineering & manufacturing service (EMS) business activities.
Zoom Technologies began to manufacture and sell its Leimone brand mobile phones in the second quarter of 2009. With the successful launches of several Leimone models so far in 2010, the Company anticipates selling more than 600,000 Leimone units by the end of this year.
Mr. Leo Gu, Chairman and CEO of Zoom Technologies, commented, "Our Leimone phones are extremely popular for their ease of use and attractive price points, a great fit for the growing number of young people in China seeking mid-priced phones with sleek designs. We will continue to focus our manufacturing activities on our core business and explore potential ancillary revenue streams made available by the increasing use of China's 3G networks. We are only beginning to take advantage of the growth in China's mobile phone market for the foreseeable future. With 14 production lines, we have the capacity to manufacture up to 10 million units for our EMS customers and at the same time, produce 12 models of our own feature-rich handsets equipped with the latest technologies, including four models for the 3G networks, two of which we have already introduced this year."
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its Own Brand Manufacturing (OBM) under the brand name of Leimone. The company's products are both exported and sold domestically.
Forward-Looking Statements
Certain statements in this press release may constitute "forward looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
Marc S. Firestone Joins Unilife Corporation's Board of Directors
Date : 07/28/2010 @ 8:00AM
Source : PR Newswire
Stock : Unilife (MM) (UNIS)
http://ih.advfn.com/p.php?pid=nmona&article=43774909&symbol=UNIS
Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that Marc S. Firestone, Executive Vice President and General Counsel for Kraft Foods (NYSE: KFT), has joined Unilife's Board of Directors as a new independent director. Mr. Firestone will chair the Unilife Board's Nominating and Corporate Governance Committees and serve as a member of the Strategic Partnerships Committee.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "Adding Mr. Firestone to our Board reflects our dedication to growing Unilife and building upon our successes. We believe his far-reaching knowledge and vast legal and government relations experience with two Fortune 100 companies will provide us with exceptional guidance as we focus on our international business development initiatives. Additionally, his capabilities complement those of our existing team of experienced and talented board members. We expect to utilize his exceptional leadership skills and experience to their fullest as we move forward with our plans."
Mr. Firestone said, "The development of a unique and truly innovative range of safety syringes by Unilife represents a wonderful business opportunity to enhance the delivery of safe healthcare to people across the world. Having partnered with a number of nongovernment organizations, I understand how important it is for corporations not only to be profitable, but ideally to address societal needs at the same time. Unsafe injection practices represent a significant global challenge. I believe that Unilife and its pharmaceutical partners can make a genuine difference, and it's a privilege for me to be part of that effort. I'm excited by my appointment to the Unilife Board and look forward to making a valuable contribution to the continued success of the Company on the world stage."
Mr. Firestone, 50, leads the department that is responsible for legal, corporate affairs, government affairs, compliance, and corporate governance for Kraft Foods Inc., a Fortune 100 company and the largest food company in the United States with annual, worldwide sales of approximately $48 billion. In his current position, Mr. Firestone oversees 450 people around the world. He worked in Europe for seven years, and more recently has represented Kraft Foods before the U.S. Senate, UK Parliament, European Commission, and in meetings with public interest groups, community organizations and the media. He has also handled various matters for Kraft Foods before major U.S. regulatory agencies. Additionally, Mr. Firestone advised the Kraft Foods Board and executive management team on the legal, governance and communications aspects of numerous multibillion dollar transactions and acquisitions, including the recent acquisition of Cadbury plc for approximately $19 billion.
Prior to his position at Kraft Foods, Mr. Firestone held senior executive positions for Philip Morris Companies and its subsidiaries, including as Senior Vice President and General Counsel, Philip Morris International, and Senior Vice President of Regulatory Affairs, Phillip Morris Companies.
Mr. Firestone is a frequent public speaker on international competition law, diversity and in-house practice, and has received several awards, including the Distinguished General Counsel Award. He holds a juris doctorate from Tulane University School of Law in New Orleans, and a bachelor's degree from Washington & Lee University in Virginia. In addition to English, he is proficient in French and Italian.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.
General: UNIS-G
Investor Contacts (US):
Todd Fromer / Garth Russell
Stuart Fine
KCSA Strategic Communications
Carpe DM Inc
Phone + 1 212-682-6300
Phone + 1 908 469 1788
Investor Contacts (Australia)
Jeff Carter
Unilife Corporation
Phone + 61 2 8346 6500
SOURCE Unilife Corporation
Zoom Technologies' LEIMONE Brand Continues to Drive Appeal to China Telecom's Young User
Date : 07/28/2010 @ 9:00AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=43776437&symbol=ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and related products, today unveiled the LEIMONE E33, its third in a series of 3G "LEIMONE" brand multimedia phones. The E33 phone will be sold through China Telecom, one of China's major mobile phone operators.
Mr. Leo Gu, Chief Executive Officer of Zoom Technologies, said, "This is another milestone in developing our LEIMONE brand into a leading consumer recognized name. The launch of our third 3G LEIMONE phone reflects Zoom's outstanding 3G capabilities and continues to solidify our already strong relationship with China Telecom. This is a very exciting time for Zoom as our LEIMONE brand phones, which carry a higher profit margin than our contract engineering & manufacturing service (EMS) phones, are growing in use and popularity. Zoom believes it is positioned to benefit from the outstanding growth expected in the design and production of advanced mobile phones for China's 3G network. The design and features of our newest E33 phone caters to young users who are price sensitive and yet demand rich multimedia features in their handsets. We are confident that the E33 mobile phone will appeal to China's burgeoning young customer base."
The LEIMONE E33 3G mobile phone is coming to market in September and is targeted for China's younger customers with its fashionable design, sleek interface, and middle to low-end price point. The E33 features a 2.4 inch 65K TFT 320Hx240W aspect ratio back-lit LED screen, a high resolution camera, flash memory expansion slot, FM radio, Bluetooth 2.1 and GPS navigation capabilities, 220 minutes talk time and 120 hours on standby mode, and is fully compatible with China Telecom's 3G applications.
For more information on the LEIMONE E33 and other LEIMONE phones, please visit Zoom Technologies' website at www.zoomleimone.com.
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its Own Brand Manufacturing (OBM) under the Leimone brand name. The company's products are both exported and sold domestically.
Forward-Looking Statements
Certain statements in this press release may constitute "forward looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
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Contacts:
Cynthia Hiponia
The Blueshirt Group
+1 415-217-4966
YMB Rumor: FINANCIAL ENGINEERING will create short squeeze
rumor: FINANCIAL ENGINEERING will create short squeeze at the next 45 days !!
14-Jul-10 @ nyse_trader
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_Y/threadview?m=tm&bn=27297&tid=163206&mid=163206&tof=1&frt=2
Friend of mine is working on the street...he confirm that the big money are planning short squeeze .they are going to use financial engineering over the next few weeks to squeeze all those shorts bellow 0.80 !! watch and learn....he said that there is too much milk to be squeeze here...!
YRCW short have to be afraid...according to me after his statement...!
##################################################
25-Jul-10 @ nyse_trader
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_Y/threadview?m=tm&bn=27297&tid=163206&mid=178707&tof=1&rt=1&frt=2&off=1
I talked with this friend of mine today and he said....that short will feel the real pain during the next 2 weeks !!! he added that the drop of share price is part of the financial engineering ,the big boys have accumulated as much as they can YRCW shares and the real short squeeze will begin when the official news is released ! that means august 3rd !
according to him the plan is from 3 up to august 6..the short squeeze will push the price over 3 usd !!! i do not believe about that...3 usd is too much i said...but he said that short must to cover 70 000 000 shares...and the retails longs does not hold so much shares !
the big boys are not agree to sell their shares bellow 3 usd per share !!
think about that again !!
so far he is right !
second quarter results will be announced on 08/03,2010
...until this date: up! (one week to go)
http://investors.yrcw.com/releasedetail.cfm?ReleaseID=486835
Trailer Trends: Recession Doesn't Stop Advances in Trailer Technology
7/23/2010
By Tom Berg, Senior Editor
http://truckinginfo.com/trucks-trailers/news-detail.asp?news_id=71094&news_category_id=67
Even through the Great Recession, many trailer and body makers spent time and money developing advanced products that promise to improve operating efficiencies and save money for their customers. They're betting their investments will pay off soon, as trailer orders are picking up in response to increased amounts of freight being shipped. Many orders will be for new, improved equipment.
For instance, Wabash National has begun building ArcticLite refrigerated trailers for Prime Inc. The 53-by-102 vans have DuraPlate AeroSkirts, low rolling resistance tires, SolarGuard roofs and a specific insulation package. The builder's plant in Lafayette, Ind., started on a first group of 725 trailers in April. Prime's order calls for 4,000 ArcticLites over 34 months.
Other companies that have recently placed large orders for trailers include Xtralease and Swift.
Some manufacturers displayed their latest designs at truck shows earlier this year, including the Mid-America Trucking Show in Louisville, Ky., and The Work Truck Show in St. Louis. Some companies held press conferences to call attention to their new products, while others bought booth space and waited to be discovered. Still others issued announcements by e-mail. Here are some we've found in recent months - and this doesn't even include advancements from suppliers in areas such as suspensions, tires and lighting.
High-Tech Plastic
Plastic and aluminum are combined in the design of two lightweight end-dump semitrailers displayed by Wink Trailer, a new manufacturer that set up a booth at the Louisville show. The "Innovator" half-round and "Revolutionizer" flat-side models use aluminum frames with polyethylene plastic sheeting to reduce weight and cost compared to all-aluminum vehicles. The plastic is of ultra high-molecular-weight (UHMW) composition commonly used in dump liners to reduce freezing and sticking of loads. A typical 39-foot half-round trailer weighs about 10,000 pounds, which is 1,000 pounds less than an aluminum dump trailer, according to Jimmy Wink, a proponent of the half-round concept and founder of the recently formed company in Rockport, Ind. The square-profile Revolutionizer trailer uses UHMW plastic in its sides and bottom.
Hybrid Dump 'Trailer'
East Manufacturing has designed an aluminum dump trailer with flat sides and a half-round bottom, and the builder displayed a prototype at the Louisville show. The bottom of the yet-to-be-named model sits about 7 inches lower than a standard half-round vehicle for a lower center of gravity and greater stability during dumping and while under way, representatives said at the show. The flat sides are formed of welded aluminum box sections from East's Genesis design to add strength and rigidity.
The flat/half-round profile yields 2 cubic yards more volume than with a straight half-round trailer of the same length, and weighs 9,500 to 10,000 pounds. The company is testing the design to ensure high strength and plans to begin production this summer.
Steerable Axles
Powered steerable axles are employed on chip trailers produced by Western Trailers for use on twisting trails in the woods of Washington's Olympic Peninsula. Ridewell supplies the "Force Steer" axles, which allow long box trailers to go where more maneuverable log racks can be pulled on the rough dirt trails. The chip trailers take on brush and other wood waste left from timber cutting and carry it to co-generation plants to produce electricity.
More Stable Dumps
Mac Trailer is promoting "full-stance" tandems on end-dump trailers. All wheels of the tandem stay on the ground while the trailer rises because its body pivots on the tandem's subframe. This makes the trailer more stable during tipping than frameless vehicles whose forward axles rise with the body, the company says. The rest of the body is frameless, so the complete vehicle weighs up to 2,000 pounds less than a full-frame trailer.
Auto Lift Axle
A sensor-activated lift axle was mounted at the forward position of a Merritt spread-tandem aluminum livestock trailer, which also featured easy-sloping moveable racks and other items to reduce stress for hogs it'll haul. The "Pork Pot" model's lift axle automatically raises or deploys when the trailer's light to reduce tire scuffing and needless miles.
AG, Windmill Models
Trail King displayed three interesting models in Louisville. An aluminum Super Hi-Lite live-bottom hauler of agricultural feeds and fertilizers features "rolled" sides that help save 600 to 1,000 pounds over more conventional construction. An external-ring aluminum dry-bulk tanker, also for ag supplies, weighs only 10,000 pounds. A 128-foot-long extendable windmill "blade" trailer has self-steering rear axles automatically triggered by an electro-mechanical fifth-wheel sensor.
Weight-Tranfer
Talbert Manufacturing recently announced the Equalizer, a nitrogen-assisted weight-transfer system for spread axle trailers. It hydraulically transfers loads and dampens road shock to smooth the ride. The suspension system oscillates around a central self-tracking pivot point to provide proportionate weight distribution in each axle grouping, regardless of varying road conditions. Operators can make easy and quick adjustments, and maintain those settings to maximize loads safely and efficiently.
The system has a dual 2-speed landing gear to ease connections to trailers, and can be easily lifted out of the way for backing. It allows a 14-foot, 1-inch spread with 54-inch axle spacing; and a 14-foot, 7-inch spread with 60-inch axle spacing. It is powered by a Honda gas engine power pack. The Equalizer is available for use with Talbert 55SA (55-ton) and 60SA (60-ton) 3+1 spread axle series trailers and axle attachments.
Revolution Platforms
Fontaine Trailer's third in its Revolution line of platform trailers is a 48-foot-by-102-inch dropdeck trailer that weighs only 9,300 pounds. The Revolution Hybrid Dropdeck features steel main beams with an extruded aluminum floor. The patented design is lighter and stronger and boasts a concentrated load capacity of 54,000 pounds in just 5 feet.
The Fontaine Revolution Hybrid features a sleek unitized design, made possible by technology borrowed from the aerospace industry. This maintains the integrity of the trailer geometry under load and under centrifugal force, says the company.
Tough Side Skirts
Utility Trailer Manufacturing has designed belly skirts that save 4 to 5 percent in fuel and resist collision damage from high-center obstructions.
Called Utility Side Skirt (USS) 120 and -160, the aerodynamic enhancers use galvanized steel supports and UV-protected fiberglass-reinforced plastic panels. Both materials are corrosion resistant and flexible, and extensive structural testing at Utility's facility in southern California show that the supports spring back into shape after being bent as much as 70 degrees either way by impacts with loading dock aprons and the like. The USS-120 and USS-160 are CARB-compliant for California operations (though users should further verify this with CARB), and are certified for the federal EPA's voluntary SmartWay program.
Fuel Saving Skirts
Silver Eagle Manufacturing now offers Aero Saber trailer side skirts that showed 5.7 percent fuel savings at highway speeds in TMC-SAE Type 2 testing. The skirts have aluminum skins and steel braces; there's 18 inches of bottom clearance, including 16 inches of flexible rubber, so the skirts pass undamaged over roadway obstructions like snow piles and railroad crossings.
Silver Eagle continues to offer Solus-designed Mid Length fiberglass skirts that got 4 percent fuel savings in the same type of tests.
Flexible Skirts
Carrier Transicold has begun selling AeroFlex fiberglass trailer side skirts through its North American dealer network. Developed by Freight Wing, the fairings have demonstrated up to a 7.5 percent improved fuel economy at highway speeds, Carrier says.
Available for dry freight and refrigerated trailers, patent-pending AeroFlex fairings are made of impact-resistant, flexible TPO (thermoplastic olefin) plastic that is UV stabilized to maintain a good appearance. The material's flexibility and a 180-degree top hinge allows the low-clearance fairings to flex and withstand side and bottom impacts. They weigh 160 pounds and are SmartWay verified, so they meet California requirements for trailer fairings.
Carrier Transicold continues to offer Freight Wing's original aluminum gap and side fairings.
Drag-Reducing Device
SmartTruck, a venture launched by the former head of EPA's SmartWay program, has released its first product into the marketplace, a trailer UnderTray system. The new product, dubbed UT-6, is meant to minimize the drag associated with trailer underside components. It features wheel and suspension fairings, a rear fairing and aero rain gutters.
The device works by compressing and accelerating incoming air flow and injecting high energy air into trailer wake. It pulls high-energy, attached air flow from the top of the trailer down into the trailer wake.
Using the device can produce a 12 percent reduction in drag. The system has also been tested to provide a 6.78 percent improvement in fuel mileage on the whole truck, during normal, long-haul operations.
Lightweight Walls
Supreme Corp. announced a lightweight wall material called FiberPanel, consisting of a polypropylene-and-fiberglass core sandwiched by skins of resin and gelcoat. It measures 4 to 6 millimeters (0.157 to 0.236 inch) in width, so allows high-cube capacity for van bodies. It is continuously extruded, so can be cut to any needed length, but normally up to 26 feet.
For truck bodies up to 12 feet long, it's stiff enough to stand alone; beyond that it's supported by low-profile posts. For now it's used in Supreme's Signature and Intercity van bodies.
From the July 2010 issue of Heavy Duty Trucking.