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FONAR Corp. (FONR) Reports Fiscal 2009 Year-End Financial Results
MELVILLE, NY — (Marketwire) — 10/05/09 — FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning(TM), today announced its financial results for the fiscal year ending June 30, 2009. Total net income for the fiscal year ended June 30, 2009 was $1.1 million, as compared to a net loss of $13.5 million for fiscal 2008. The net income per share (basic and diluted) for the fiscal year ended June 30, 2009 was $0.21, as compared to a net loss per share (basic and diluted) of $2.76 during fiscal 2008.
Raymond V. Damadian, Chairman and President of Fonar Corporation, said, “We are very pleased to see the Company return to profitability. We have now made a profit for three quarters straight and are hopeful to continue this trend of profitability. A very sound reason is that the FONAR UPRIGHT® Multi-Position(TM) MRI technology (Dynamic MRI) is the only participant in this unique market. The impact of FONAR’s patented technology on net income growth can be seen in Fig. 1.”
Total revenues increased by 12% to $39.7 million for the fiscal year ended June 30, 2009 as compared to $35.6 million for fiscal 2008.
Total costs and expenses related to operations decreased 23%, from $52.5 million in the fiscal year ended June 30, 2008, to $40.4 million in the fiscal year ended June 30, 2009. The loss from operations decreased 96% from a loss of $16.9 million in the fiscal year ended June 30, 2008, to a loss of $0.7 million in the fiscal year ended June 30, 2009. Dr. Damadian continued, “The Company has done well controlling costs while continuing to produce the FONAR UPRIGHT® Multi-Position(TM) MRI scanner. This is the result of a cost cutting program that we initiated over a year ago.”
Revenues from product sales of the FONAR UPRIGHT® Multi-Position(TM) MRI scanners increased 48% from $11.2 million in the fiscal year ended June 30, 2008 to $16.6 million one year later at fiscal 2009. At June 30, 2009 there were 137 FONAR UPRIGHT® Multi-Position(TM) MRI scanners installed in the United States and around the world. Included in net income for the year ended June 30, 2009 is a pre-tax gain on the sale of a subsidiary of $1.4 million.
At June 30, 2009, total assets were $28.4 million, total current assets were $18.3 million, total current liabilities were $29.1 million, and total long-term liabilities were $2.1 million. The backlog for MRI product was $25.7 million. Total cash and marketable securities were $1.2 million.
Dr. Damadian said, “FONAR’s prospects have much improved since the country’s financial difficulties last year and our customers’ uncertainties regarding the Deficit Reduction Act (DRA) have eased. Over the past few years, the medical evidence continues to grow indicating that the FONAR UPRIGHT® Multi-Position(TM) MRI is the best MRI for diagnosing spine problems. So as pent-up demand for MRI scanners surfaces, we can expect rising sales.”
“Unfortunately, the outcomes of spinal surgery are less than optimal, a fact underscored by the recent book titled ‘The Failed Spine,’ published by Lippincott, Williams & Wilkins, (M. Szpalski and R. Gunzburg, Editors, 2005). The high failure rate has resulted in the acronym, FBSS, which stands for Failed Back Surgery Syndrome. The authors report that the ‘major identifiable causes of FBSS’ include ‘failure to identify the structural source(s) of pain correctly,'” stated Dr. Damadian.
“Sadly, the distinguished Swedish spine surgeon, Alf Nachemson, MD, characterizes these unsatisfactory patient outcomes as the ‘high number of multiply operated surgical cripples,’ (Nachemson, A., The lumbar spine: An orthopaedic challenge. Spine, 1976:1, 59-71.).
“Since the FONAR UPRIGHT® Multi-Position(TM) MRI can place the patient in the exact position that generates his or her symptoms, the MRI picture can be taken in that position. This unique capability assures that the degenerative spinal change responsible for the patient’s pain is correctly identified and operated on, instead of surgery being performed on another spinal change that is not responsible for the patient’s symptoms. Unfortunately, surgery on the wrong spinal segment can generate additional symptoms post-operatively, while the patient continues to suffer with the symptoms not addressed by surgery on the wrong segment,” remarked Dr. Damadian.
“FONAR’s position in medical imaging is immeasurably enhanced by the fact that FONAR is the leader in UPRIGHT® Multi-Position(TM) MRI technology,” concluded Dr. Damadian.
RECENT HIGHLIGHTS AND ACCOMPLISHMENTS
On November 17, 2008, The Company held its annual shareholder meeting for the combined fiscal years ending June 30, 2009 and 2008. All proposals before the shareholders passed.
In February 2009, Dr. Damadian was the recipient of the 2009 AIMBE Honorary Fellow Award (American Institute for Medical and Biological Engineering) for his discovery of MRI. Dr. Damadian is the originator of the concept of magnetic resonance (MR) scanning of the human body (1969). The AIMBE Award was presented at the annual meeting of AIMBE, held February 11-13 in Washington, D.C.
The award says: “In 1970, Raymond Damadian, M.D., made the discovery that is the basis for magnetic resonance (MR) scanning that there is a marked difference in relaxation times between normal and abnormal tissues of the same type, as well as between different types of normal tissues. This seminal discovery, which remains the basis for the making of every MRI image ever produced, is the foundation of the MRI industry. Dr. Damadian published his discovery in his milestone 1971 paper in the journal Science (Science 171:1151, 1971) and filed the pioneer patent for the practical use of his discovery in 1972.” (www.fonar.com/news/022409.htm).
During the past fiscal year, FONAR also expanded its global reach with a sale in Libya, marking the first sale of an UPRIGHT® MRI in Africa and additional sales in the Middle East.
On February 18, 2009 the Company made an earnings announcement titled: FONAR Reports Profit and 2nd Quarter Fiscal 2009 Financial Results; FONAR’s Innovative ‘Made In America’ UPRIGHT MRI Adds Product Revenues. Within the release, Dr. Damadian said, “In this era of jobs being exported to other countries, 82% of the components that create The FONAR UPRIGHT® Multi-Position(TM) MRI are purchased from 26 American States. So FONAR can truly say, ‘Made in America.'”
This past June, Dr. Damadian attended grand openings for three UPRIGHT® Multi-Position(TM) MRI customers who spanned the world. First he attended a grand opening in Kamloops, Canada, for the installation of the first UPRIGHT® Multi-Position(TM) MRI in Canada. Then he participated in a grand opening in South Dakota. Finally, Dr. Damadian attended a grand opening in Munich, Germany. All of these ceremonies featured Dr. Damadian as the inventor of the MRI.
For investor and other information visit: www.fonar.com.
UPRIGHT® and STAND-UP® are registered trademarks and The Inventor of MR Scanning(TM), Full Range of Motion(TM), pMRI(TM), Dynamic(TM), Multi-Position(TM), True Flow(TM), The Proof is in the Picture(TM), Spondylography(TM) Spondylometry(TM) and Upright Radiology(TM) are trademarks of FONAR Corporation.
This release may include forward-looking statements from the company that may or may not materialize. Additional information on factors that could potentially affect the company’s financial results may be found in the company’s filings with the Securities and Exchange Commission.
FONAR CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
ASSETS
June 30,
------------------------
2009 2008
----------- -----------
Current Assets:
Cash and cash equivalents $ 1,225,619 $ 1,325,512
Marketable securities 22,652 1,068,168
Accounts receivable - net of allowances for
doubtful accounts of $2,393,326 and $2,020,208
at June 30, 2009 and 2008, respectively 5,391,822 5,157,594
Medical receivables - net of allowances for
doubtful accounts of $1,343,500 and $769,000
at June 30, 2009 and 2008, respectively 374,225 1,227,858
Management fee receivable - net of allowances for
doubtful accounts of $5,093,345 and $3,958,733
at June 30, 2009 and 2008, respectively 3,273,756 5,040,523
Management fee receivable - related medical
practices - net of allowances for doubtful
accounts of $1,094,818 and $2,413,483 at
June 30, 2009 and 2008, respectively 2,196,580 1,372,261
Costs and estimated earnings in excess of
billings on uncompleted contracts 1,475,706 6,285
Inventories 3,172,397 3,255,915
Current portion of advances and notes to related
medical practices 164,611 155,423
Current portion of note receivable 517,934 2,508,306
Prepaid expenses and other current assets 472,397 869,353
----------- -----------
Total Current Assets 18,287,699 21,987,198
Property and Equipment - Net 2,892,380 3,932,533
Advances and Notes to Related Medical Practices -
net of allowances for doubtful accounts of
$264,791 at June 30, 2009 and at June 30, 2008 89,032 263,363
Notes Receivable - net of allowance for doubtful
accounts of $65,000 at June 30, 2009 and at
June 30, 2008 1,778,626 2,296,560
Other Intangible Assets - Net 4,920,241 4,809,564
Other Assets 391,237 1,936,415
----------- -----------
Total Assets $28,359,215 $35,225,633
=========== ===========
FONAR CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
LIABILITIES
June 30,
-----------------------
2009 2008
---------- -----------
Current Liabilities:
Current portion of long-term debt and capital
Leases $ 277,494 $ 372,722
Current portion of long-term debt - related
party 79,509 -
Accounts payable 3,518,609 4,019,993
Other current liabilities 8,460,042 8,316,263
Unearned revenue on service contracts 5,526,006 5,193,645
Customer advances 9,237,921 14,276,311
Billings in excess of costs and estimated
earnings on uncompleted contracts 2,026,441 5,773,286
----------- -----------
Total Current Liabilities 29,126,022 37,952,220
----------- -----------
Long-Term Liabilities:
Accounts payable 184,168 -
Due to related medical practices 643,135 97,663
Long-term debt and capital leases, less
current portion 759,211 756,976
Long-term debt, less current
portion - related party 160,176 -
Other liabilities 363,550 496,837
----------- -----------
Total Long-Term Liabilities 2,110,240 1,351,476
----------- -----------
Total Liabilities 31,236,262 39,303,696
----------- -----------
Commitments, Contingencies and Other Matters
FONAR CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
STOCKHOLDERS' DEFICIENCY
June 30,
-------------------------
2009 2008
----------- -----------
Minority Interest $ 63,815 $ 166,966
Stockholders' Deficiency:
Class A non-voting preferred stock - $.0001
par value; authorized - 1,600,000 shares;
issued and outstanding - 313,451 shares
at June 30, 2009 and 2008 31 31
Preferred stock - $.001 par value;
authorized - 2,000,000 shares; issued
and outstanding - none - -
Common stock - $.0001 par value; authorized -
30,000,000 shares at
June 30, 2009 and 2008, respectively;
issued - 4,917,918 and 4,915,918 shares
at June 30, 2009 and 2008, respectively;
outstanding - 4,906,275 and 4,904,275
shares at June 30, 2009 and 2008, respectively 491 490
Class B common stock (10 votes per share) -
$.0001 par value; authorized - 800,000
shares; issued and outstanding - 158
shares at June 30, 2009 and 2008 - -
Class C common stock (25 votes per share) -
$.0001 par value; authorized - 2,000,000
shares; issued and outstanding - 382,513
shares at June 30, 2009 and 2008
Paid-in capital in excess of par value
Accumulated other comprehensive loss 38 38
Accumulated deficit 172,280,600 172,276,540
Notes receivable from employee stockholders (20,995) (72,723)
Treasury stock, at cost - 11,643 shares (174,258,607) (175,379,874)
of common stock at June 30, 2009 and 2008 (267,030) (394,141)
Total Stockholders' Deficiency (675,390) (675,390)
------------ ------------
Total Liabilities and Stockholders'
Deficiency (2,940,862) (4,245,029)
------------ ------------
$ 28,359,215 $ 35,225,633
============ ============
FONAR CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended June 30,
----------------------------
2009 2008
Revenues ------------- -------------
Product sales - net $ 17,175,417 $ 11,326,388
Service and repair fees - net 10,345,091 10,930,331
Service and repair fees - related
parties - net 192,500 110,000
Management and other fees 7,342,614 8,337,000
Management and other fees - related
medical practices - net 2,911,318 3,706,636
License fees and royalties 1,755,493 1,158,478
------------ ------------
Total Revenues - Net 39,722,433 35,568,833
------------ ------------
Costs and Expenses
Costs related to product sales 10,758,201 11,143,826
Costs related to service and repair fees 3,992,557 5,107,802
Costs related to service and repair fees
- related parties 74,293 51,404
Costs related to management and other fees 4,507,587 5,548,605
Costs related to management and other fees
- related medical practices 2,790,745 3,041,828
Research and development 3,593,470 5,006,591
Selling, general and administrative, inclusive
of compensatory element of stock issuances of
$4,061 and $360 for the years ended June 30,
2009 and 2008, respectively 13,423,066 20,386,748
Provision for bad debts 1,286,451 2,208,820
------------- -------------
Total Costs and Expenses 40,426,370 52,495,624
------------- -------------
Loss from Operations (703,937) (16,926,791)
Other Income and (Expenses):
Interest expense (333,229) (535,322)
Investment income 325,688 694,910
Interest income - related parties 20,818 33,801
Other income - net 410,657 129,368
Minority interests in income of partnerships (10,995) (219,058)
Gain on sale of investment - 571,161
Gain on sale of consolidated subsidiary 1,448,196 3,394,975
Loss on note receivable - (658,351)
------------- -------------
Income (Loss) Before Provision For
(Benefit From) Income Taxes 1,157,198 (13,515,307)
Provision for (Benefit from) Income Taxes 35,931 (6,940)
------------ -------------
Net Income (Loss) $ 1,121,267 $ (13,508,367)
============ =============
FONAR CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended June 30,
----------------------------
2009 2008
------------- -------------
Net Income (Loss) Available to Common and
Class C Common Stockholders $ 1,053,898 $ (13,508,367)
============= =============
Basic and Diluted Net Income (Loss) Per Common
Share Available to Common Stockholders $ 0.21 $ (2.76)
============= =============
Basic Net Income Per Share - Common C $ 0.06 N/A
============= =============
Oncolytics Biotech(R) Inc. (ONCY) Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
CALGARY, Oct. 2 /PRNewswire-FirstCall/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data, that depending upon outcome, could support a license application submission for REOLYSIN.
“Oncolytics is the first company to reach an agreement with the FDA on a Phase 3 trial design for an intravenously-administered oncolytic virus under the SPA process,” said Dr. Brad Thompson, President and CEO of Oncolytics. “This is an exciting step forward for our clinical program for REOLYSIN, which has become a first-in-class agent. A Phase 3 trial in patients with platinum-refractory head and neck cancers is a logical choice for our first pivotal trial with REOLYSIN. In Phase 1/2 trials, the treatment combination has increased the response rate by several-fold compared to historical outcomes.”
As specified in the SPA, the randomized, two-arm, double-blind, multicentre, two-stage, adaptive Phase 3 trial will assess the intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. All patients will receive treatment every three weeks (21 day cycles) with paclitaxel and carboplatin and will also receive, on a blinded basis, either intravenous placebo or intravenous REOLYSIN. All dosing takes place in the first five days of each cycle with all patients receiving standard intravenous doses of paclitaxel and carboplatin on day one only, and on days one through five, either intravenous placebo or intravenous REOLYSIN at a dose of 3×10(10) TCID(50). Patients may continue to receive the trial combination therapy for up to eight, 21-day cycles and, thereafter, blinded placebo or blinded REOLYSIN until the patient has progressive disease or meets other criteria for removal from the trial.
The primary endpoint for the trial is overall survival (OS); secondary endpoints include progression free survival (PFS), objective response rate (complete response (CR) + partial response (PR)) and duration of response, and safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin. The first stage of the trial is non-adaptive, and is designed to enroll 80 patients. The second stage is adaptive, and is designed to enroll between 100 and 400 patients with the most probable statistical enrolment being 195 patients in this stage. This adaptive trial design allows frequent data evaluation to determine if the probability of reaching a statistically significant endpoint has been achieved.
The decision to pursue a Phase 3 trial in head and neck cancers was predicated on positive results seen in the Company’s U.K. Phase 1 and Phase 2 combination REOLYSIN and paclitaxel/carboplatin clinical trials, as well as significant preclinical work demonstrating synergy in combination with taxane or platinum-based drugs. Interim results of the U.K. Phase 1/2 trial reported in March 2009 demonstrated an overall response rate (PR and CR) of 42% and a total clinical benefit rate (PR + CR + stable disease) of 75%. Enrolment in the Phase 2 portion of the trial was concluded in July 2009, and updated results are expected to be presented in the fourth quarter of 2009.
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a conference call and webcast today, October 2, 2009 at 6:30 a.m. MT (8:30 a.m. ET) to update investors on the Phase 3 program for REOLYSIN. To access the conference call by telephone, dial 1-416-644-3426 or 1-800-732-1073. A live audio webcast will also be available at the following link: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2828320 or through the Company’s website at www.oncolyticsbiotech.com. Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through October 9, 2009. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 4169017 followed by the number sign.
About the Special Protocol Assessment Process
Upon the request of a study sponsor, the FDA will evaluate certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements; this includes clinical protocols for Phase 3 trials whose data will form the primary basis for an efficacy claim that will be part of an original Biologics License Application. For more information about the SPA process, please go to:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
About REOLYSIN
REOLYSIN is a proprietary formulation of the human reovirus that acts primarily as a direct cytotoxic agent. Reovirus is naturally occurring (not genetically engineered) and has been demonstrated to replicate specifically in tumour cells bearing an activated Ras pathway, leaving healthy normal cells intact. At least two thirds of carcinomas and more than 90% of metastatic disease has Ras involvement.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company’s expectations related to the SPA agreement on a Phase 3 combination REOLYSIN and paclitaxel/carboplatin trial for patients with platinum-refractory head and neck cancers, the planned timing and implementation of the Phase 3 trial, and the Company’s belief as to the potential of REOLYSIN as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a controlled test, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.
Arigene Co., Ltd. to Acquire Trimeris, Inc. (TRMS)
Oct. 2, 2009 (Business Wire) — Trimeris, Inc. (“Trimeris”) (NASDAQ:TRMS) today announced that it has entered into a merger agreement with Arigene Co., Ltd., a Korean corporation traded on the Korean Securities Dealers Association Quotation System (“Arigene”) (KOSDAQ: 067850) pursuant to which Arigene has agreed to acquire Trimeris for approximately $81 million through a cash tender offer of $3.60 per share, followed by a merger to acquire all remaining outstanding Trimeris shares at the same price per share paid in the tender offer. The tender offer price represents an approximately 55% premium to Trimeris’ average stock price over the last three month period ending on October 1, 2009 and an approximately 40% premium to the closing price of Trimeris’ common stock on October 1, 2009.
Stockholders of Trimeris representing approximately 36% of shares outstanding have executed voting agreements in support of the transaction. The transaction has been approved by the boards of directors of Trimeris and Arigene. The parties expect the tender offer and merger to be completed in the fourth quarter of 2009.
The tender offer will expire at midnight Eastern Time on the 20th business day following and including the tender offer commencement date, unless extended in accordance with the terms of the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission. Following the tender offer, if successful, RTM Acquisition Company, a wholly owned subsidiary of Arigene, will be merged with and into Trimeris, with Trimeris continuing as the surviving corporation. As a result of the merger, Trimeris will become a wholly-owned subsidiary of Arigene.
The consummation of the tender offer is subject to the satisfaction or waiver of certain conditions, including, among others: (i) a majority of outstanding Trimeris shares having been tendered in response to the offer, (ii) the absence of any injunction or act by any governmental agency prohibiting the transaction, (iii) there not having been a material adverse change with respect to Trimeris, and (iv) other customary conditions. The tender offer is not subject to a financing condition.
Advisors
Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor to Trimeris for this transaction. HCube Advisors, Inc. acted as financial advisor and K&L Gates, LLP is acting as legal advisor to Arigene.
About Trimeris, Inc.
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the commercialization of therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON®, approved in the U.S., Canada and European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. For more information about Trimeris, please visit the Company’s website at http://www.trimeris.com.
About Arigene Co., Ltd.
Arigene Co., Ltd. (KOSDAQ: 067850) is a developer, manufacturer and marketer of Ubiquitous Healthcare Systems (U-Healthcare) and related medical equipment in Korea. With its planned acquisition of Trimeris, Inc., Arigene is expanding its business to the broader biotechnology industry.
Cautionary Note regarding Forward Looking Statements
This document and any attachments may contain forward-looking information about the proposed transaction between Trimeris and Arigene, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company, new product development, including obtaining regulatory approvals, and any other statements about Trimeris’ managements’ future expectations, beliefs, goals, plans or prospects constitute forward looking statements. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward looking statements. These forward looking statements involve known and unknown risks and uncertainties that may cause Trimeris’ actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward looking statements. Important factors that may cause or contribute to such differences include uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Trimeris’ stockholders will tender their stock in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; transaction costs; whether results obtained in clinical studies or in preclinical studies will be indicative of results obtained in future clinical trials; whether Trimeris will be able to obtain regulatory approvals and such other factors as are set forth in the risk factors detailed from time to time in Trimeris’ periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in Trimeris’ Form 10-K filed with the Securities and Exchange Commission on March 13, 2009, which are incorporated herein by reference. The forward looking statements are made only as of the date of publication. Except as otherwise required by law, the Company specifically disclaims any obligation to update any of these forward looking statements.
Additional Information
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Trimeris. Arigene and RTM Acquisition Company, a wholly owned subsidiary of Arigene, have not commenced the tender offer for the shares of Trimeris stock described in this press release. Upon commencement of the tender offer, Arigene and RTM Acquisition Company will file with the SEC a tender offer statement on Schedule TO and related exhibits, including the offer to purchase, letter of transmittal, and other related documents. Following commencement of the tender offer, Trimeris will file with the SEC a tender offer solicitation/recommendation statement on Schedule 14D-9. These documents will contain important information about Arigene, Trimeris, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available. These materials will be sent free of charge to all stockholders of Trimeris. Investors and security holders will also be able to obtain free copies of the tender offer statement, the tender offer solicitation/recommendation statement and other documents filed with the SEC by Arigene and Trimeris through the web site maintained by the SEC at www.sec.gov.
Additional Analysis Confirms Significant Symptomatic Benefit of Droxidopa in Treatment of Neurogenic Orthostatic Hypotension
CHARLOTTE, N.C., Oct. 1, 2009 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that continued analysis of previously reported results from Study 302, the first of two pivotal Phase III trials in Chelsea’s registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), confirm statistically significant benefits across five clinically relevant assessment criteria that reflect symptomatic improvements and corroborate other supportive symptom data. The collective dataset also supports the exceptional safety and tolerability of Droxidopa.
“We are encouraged by the breadth and depth of findings from Study 302 that demonstrate a symptomatic benefit and provide validation of the safety and tolerability of Droxidopa for the treatment of neurogenic orthostatic hypotension — a serious condition with an urgent need for improved treatments,” said Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. “In looking ahead, we believe these results will be evident in the results of Study 301 expected this quarter. Further, we believe the outcome of Study 301 may be enhanced by the washout period included in that study. This belief is supported by open-label data from Study 301 that demonstrate a marked return of symptoms prior to randomization. The increase in average dizziness score from 1.0 following dose titration to 5.4 after a 7-day washout period in Study 301 suggests a reduction in the carry-over effect that appeared to follow sustained drug treatment prior to randomized withdrawal in Study 302.”
Statistically Significant Symptomatic Benefit on Multiple Endpoints
Patients randomized into this double-blind, placebo controlled study were evaluated for functional and symptomatic improvement through multiple secondary endpoints including a clinician-recorded and patient-recorded clinical global impressions-severity (CGI-S) scale and the orthostatic hypotension questionnaire (OHQ), a two part questionnaire consisting of the six-item orthostatic hypotension symptom assessment scale (OHSA) and the four-item orthostatic hypotension daily activities scale (OHDAS).
With the exception of vision, Droxidopa demonstrated a marked improvement over placebo for each of the five other symptoms measured by the OHSA (dizziness, weakness, fatigue, concentration, and head/neck pain) with the overall composite OHSA score supporting the benefit of Droxidopa over placebo. Despite indicating an improvement over placebo, Item 1 on the OHSA (dizziness), the primary endpoint in the study, did not achieve statistical significance.
On the OHDAS, a measure of patient function which asks patients to evaluate the average impact of orthostatic hypotension on their daily lives over the prior week period using an 11-point scale, Droxidopa demonstrated a statistically significant improvement in activities that require standing for a short time (p=0.043), standing for a long time (p=0.023) as well as a statistically significant improvement in the composite OHDAS score (p=0.029) which includes evaluation of standing and walking for both short and long times.
Notably, in addition to symptomatic and functional benefits registered on the OHQ, Droxidopa demonstrated statistically significant improvement on both the clinician-recorded (p=0.045) and patient-recorded (p=0.008) CGI-severity scale, a widely accepted scale that asks clinicians and patients to rate the severity of a patient’s symptoms at the time of assessment.
“No other drug treatment has successfully demonstrated a statistically significant symptomatic and/or functional benefit in treating orthostatic hypotension,” commented Dr. Art Hewitt, Vice President of Drug Development at Chelsea Therapeutics. “By achieving statistical significance on five secondary endpoints that reflect both a functional and symptomatic benefit, three of which were specifically developed for this indication, Droxidopa has clearly demonstrated its unique ability to meaningfully treat symptomatic neurogenic orthostatic hypotension. We look forward to discussing these results with the FDA, as we believe that results from Study 302 provide meaningful data supporting Droxidopa’s efficacy and want to ensure we are taking all appropriate and actionable steps to ensure a successful NDA filing.”
Proven Safety and Tolerability
As previously reported, Droxidopa proved to be safe and well tolerated at all dose levels, with no significant adverse events or treatment related withdrawals in the Droxidopa arm.
Of the 101 patients evaluated in Study 302 (50 Droxidopa/51 Placebo), an equal number of patients on Droxidopa and placebo, 13 (26%), experienced at least one instance of supine systolic blood pressure (SBP) >160 mmHg; six (12%) of Droxidopa patients experienced supine SBP >180 mmHg vs. four (8%) on placebo. No patients treated with Droxidopa experienced supine hypertension >200 mmHg compared to one (2%) patient on placebo. These findings, in light of the inherent prevalence of supine hypertension in patients with primary autonomic failure, demonstrate that treatment with Droxidopa does not meaningfully alter the incidence of supine hypertension in the patient group. In the product labeling for Midodrine, the only approved compound for the treatment of orthostatic hypotension, supine hypertension (> 200 mmHg) is reported at 13.4%.
In addition, treatment with Droxidopa demonstrates a dramatic improvement in the incidence of falls associated with orthostatic hypotension. In Study 302, six (12%) patients on placebo reported falling at least once during the 14-day treatment period compared to one (2%) patient in the Droxidopa arm. This marked reduction in falls, while recorded under adverse events for the study, further supports the significant symptomatic benefit experienced by patients treated with Droxidopa.
NOH Impacts Quality of Life, Increases Health Care Costs
Neurogenic orthostatic hypotension is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope.
An estimated 300,000 patients suffer from chronic symptomatic NOH in the U.S. and the EU. Symptoms of chronic NOH can be incapacitating — not only putting patients at high risk for falls and associated injuries — but also severely impacting the quality of life of patients and their loved ones, and generating significant health care costs. The only current FDA-approved treatment for orthostatic hypotension has not been shown to be effective in alleviating the symptoms of the condition and is limited in its use by a pronounced side-effect profile.
About Droxidopa and the Droxidopa Registration Trial in NOH
Currently available in Japan and with 15 years of safety and efficacy data, Droxidopa is the first drug to demonstrate symptomatic improvement of NOH. As an orally active synthetic precursor of norepinephrine, Droxidopa increases the supply of norepinephrine available for delivery to its receptors, effectively targeting the root cause of NOH to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.
The Droxidopa Phase III registration program in NOH includes two double-blind, placebo-controlled studies: Study 301 and Study 302. Study 301was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA). An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses is acceptable to support regulatory approval. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea’s most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX), currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases including RA.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder.
RAM Energy Resources (RAME) Announces Regained Compliance With Nasdaq Listing Rules
TULSA, Okla., Sept. 30, 2009 (GLOBE NEWSWIRE) — RAM Energy Resources, Inc. (Nasdaq:RAME) reported today that the company had received a letter from The Nasdaq Stock Market advising that RAM had regained compliance with Nasdaq’s minimum bid price listing requirements.
Previously, RAM received a notice of deficiency on September 15, 2009 from Nasdaq notifying the company that for the 30 consecutive business days preceding the date of the letter, the bid price of the company’s common stock had closed below the $1.00 per share minimum bid price required for continued listing on The Nasdaq Capital Market, and that RAM had 180 days to regain compliance by meeting or exceeding the minimum bid price for a period of at least 10 consecutive trading days.
The letter received from Nasdaq today states, because the company’s common stock closed above the $1.00 minimum bid price for at least 10 consecutive trading days following September 15, 2009, the company had regained compliance and the matter is now closed. Shares of RAM common stock closed Tuesday at $1.23 per share.
Forward-Looking Statements
This release includes certain statements that may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release, other than statements of historical facts, that address RAM’s interpretation of Nasdaq Marketplace Rule 5801C (3)(A) as well as potential outcomes evolving from the compliance process, are forward-looking statements. Although RAM believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include oil and gas prices, developmental, exploitation and exploration successes, actions taken and to be taken by governments as a result of political and economic conditions or other factors, inflation rates, continued availability of capital and financing, and general economic, market or business conditions as well as other risk factors described from time to time in the company’s filings with the SEC. The company assumes no obligation to update publicly such forward-looking statements, whether as a result of new information, future events or otherwise.
RAM is an independent energy company engaged in the acquisition, development, exploitation and exploration of oil and gas properties and the marketing of natural gas and crude oil. Company headquarters are in Tulsa, Oklahoma, and its common shares are traded on the Nasdaq Exchange under the symbol RAME. For additional information, visit the company website at www.ramenergy.com.
Sunair Services Corp. (SNR) Announces Proposed Merger With Massey Services
DEERFIELD BEACH, Fla., Sept. 29 /PRNewswire-FirstCall/ — Sunair Services Corporation (AMEX: SNR) today announced that it has entered into a definitive merger agreement with Massey Services, Inc. pursuant to which Massey would acquire all of the outstanding common stock of Sunair in an all-cash transaction valued at $2.75 per share, which represents a premium of approximately 47% over the stock’s closing price on September 25, 2009. Massey’s operations would merge with Middleton Pest Control, Inc., a wholly owned subsidiary of Sunair with headquarters located in Orlando, Florida, which provides pest control and lawn care services to both residential and commercial customers. The transaction is expected to close in November subject to the approval of Sunair’s shareholders, customary regulatory approvals and other closing conditions. Following the closing, Harvey L. Massey will be the Chairman and CEO of the combined companies, which will be privately held.
Massey Services is headquartered in Orlando, Florida and provides residential and commercial pest control services, termite protection and lawn, tree and shrub care services in Florida, Georgia and Louisiana. Massey is a shareholder of Sunair and owns approximately 9.63% of Sunair’s common stock.
Sunair Chairman, Richard C. Rochon commented that “Sunair’s board of directors has concluded a lengthy evaluation of numerous strategic alternatives to enhance shareholder value and has concluded that joining forces with Massey is in the best interests of our shareholders.” Massey Chairman, Harvey L. Massey, said “we believe the new organization created by this merger will build upon the complimentary strengths of both companies to provide superior value for our customers, employees and all stakeholders.”
Hyde Park Capital is acting as Sunair’s financial advisor, Akerman Senterfitt is acting as Sunair’s legal counsel, and Shuffield Lowman is acting as Massey’s legal counsel.
About Sunair
Sunair Services Corporation, a Florida corporation, through its wholly owned subsidiary, Middleton Pest Control, Inc., with headquarters located in Orlando, Florida, provides pest control and lawn care services to both residential and commercial customers. Middleton provides essential pest control services and protection against termites and insects to homes and businesses. In addition, Middleton supplies lawn care services to homes and businesses, which includes fertilization treatments and protection against disease, weeds and insects for lawns and shrubs. For more information about Sunair, please visit http://www.sunairservices.com.
Cautionary Note Regarding Forward-looking Statements
This release contains one or more forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, the expected timing of the closing of the transaction. Forward-looking statements are identified by words such as “will,” “expected,” “believe” and other similar words. Sunair cautions readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. A variety of known and unknown risks and uncertainties could cause actual results to differ materially from the anticipated results which include, but are not limited to: satisfaction of all regulatory and other conditions required for closing, the ability to obtain the approval of Sunair’s shareholders, adverse developments in Sunair’s business, and unanticipated expenses. In addition, other risks and uncertainties not presently known to us or that we consider immaterial could affect the accuracy of any such forward-looking statements. Sunair does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that exist after the date on which they were made. Additional risks and uncertainties include those detailed from time to time in Sunair’s publicly filed documents, including its annual report on Form 10-K for its fiscal year ended September 30, 2008.
Important Merger Information
This communication may be deemed to be solicitation material in respect of the proposed acquisition of Sunair by Massey Services, Inc. In connection with the proposed acquisition, Sunair intends to file a proxy statement on Schedule 14A with the Securities and Exchange Commission, or SEC, and Sunair intends to file other relevant materials with the SEC. Shareholders of Sunair are urged to read all relevant documents filed with the SEC when they become available, including Sunair’s proxy statement, because they will contain important information about the proposed transaction, Sunair and Massey Services, Inc. A definitive proxy statement will be sent to holders of Sunair common stock seeking their approval of the proposed transaction. This communication is not a solicitation of a proxy from any security holder of Sunair.
Investors and security holders will be able to obtain the documents (when available) free of charge at the SEC’s web site, http://www.sec.gov. In addition, Sunair shareholders may obtain free copies of the documents filed with the SEC when available by contacting Edward M. Carriero, Jr., Sunair’s Chief Financial Officer, at (561) 208-7400. Such documents are not currently available. You may also read and copy any reports, statements and other information filed by Sunair with the SEC at the SEC public reference room at 100 F Street, N.E. Room 1580, Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 or visit the SEC’s website for further information on its public reference room.
Sunair and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the holders of Sunair common stock in respect of the proposed transaction. Information about the directors and executive officers of Sunair is set forth in Sunair’s proxy statement which was filed with the SEC on January 28, 2009. Investors may obtain additional information regarding the interest of Sunair and its directors and executive officers in the proposed transaction by reading the proxy statement regarding the acquisition when it becomes available.
Marshall Edwards, Inc.’s NV-128, a Novel mTOR Inhibitor, Demonstrates Good Safety Profile and High Anti-Cancer Activity In Vivo Marshall Edwards, Inc.’s NV-128, a Novel mTOR Inhibitor, Demonstrates Good Safety Profile and High Anti-Cancer Activity In Vivo
SYDNEY, AUSTRALIA and NEW CANAAN, CT — (Marketwire) — 09/29/09 — Marshall Edwards, Inc. (NASDAQ: MSHL), a pharmaceutical company specializing in clinical development of oncology drugs, today released data demonstrating that the efficacy of NV-128 in animal xenograft models is achieved without apparent toxicity.
NV-128 is a novel flavonoid small molecule mTOR inhibitor, capable of inhibiting both mTORC1 and mTORC2 pathways which are central to the aberrant proliferative capacity of both mature cancer cells and cancer stem cells.
The data demonstrated that NV-128 has much greater safety than some other mTOR inhibitors in mice bearing human ovarian cancer xenografts.
Most of the current compounds acting on this pathway are analogs of rapamycin, known as rapalogs. Rapamycin and its analogs are regarded as the archetypal inhibitors of mammalian target of rapamycin or mTOR. In addition to their reported toxicities, rapalogs have been shown to contribute to the development of drug resistant tumors and ultimately reduced effectiveness over time due to their inability to efficiently inhibit mTORC2, a complex of mTOR with “rictor” (rapamycin-insensitive companion of mTOR).
NV-128 administered daily resulted in a reduction in tumor volume of 51 per cent relative to untreated control animals after 15 days, compared to a 50 per cent reduction in mice given rapamycin every other day. However, whereas rapamycin treated mice lost 8 per cent of body weight over this period, NV-128 treated mice gained weight, finishing at 6 per cent above their starting weight after the 15 day period. This is a significant indicator of lack of toxicity for NV-128, whereas the weight loss in the rapamycin-treated mice was judged to be a reflection of the well documented toxicity of rapamycin in both animal and human studies. After 21 days the tumors were removed and weighed. In NV-128 treated mice, tumor mass was reduced by 41 per cent compared to vehicle controls, an effect equivalent to rapamycin treated animals in which tumor mass was reduced by 44 per cent.
In additional data released today by Marshall Edwards Inc., the Company reported that NV-128 was judged to be without cardiac toxicity, further indicating the likely safety of NV-128 in clinical use.
One limitation of many drugs in clinical application, including some mTOR inhibitors, is their interference with heart function causing the interval between heart beats to increase (known as the QTc interval). In carefully controlled studies undertaken by an independent contract laboratory, using guinea pigs attached to recording devices to monitor heart function (electrocardiograms), NV-128 administration was shown to have no impact on the QTc interval and was judged therefore to be devoid of cardiac toxicity.
“The combined findings of high level efficacy and good safety profile, including a lack of interference with heart functioning, is a significant step forward in the search for safe and effective cancer drugs that target mTOR,” said Professor Alan Husband, Group Director of Research for Marshall Edwards, Inc.
“mTOR inhibitors have been given a high priority by many pharmaceutical companies working in the oncology field in recent times but none have been able to produce clinical efficacy in the absence of toxicities. We are encouraged that the novel mTOR inhibitor, NV-128, has great potential in human cancer management and we are moving as rapidly as possible to obtain approvals for human clinical trials to commence,” Professor Husband said.
The Marshall Edwards cancer biology group, headed by Dr. David Brown, is currently also exploring the utility of NV-128 in non-small cell lung cancer (NSCLC) models.
“While broadly acting against most cancer cell lines, of all the cell lines we have tested with NV-128, NSCLC lines appear to be the most sensitive to the anti-cancer effects of the drug,” said Dr. Brown.
“More recently we have also obtained evidence of the anti-cancer effect of NV-128 in vivo in mice bearing human NSCLC xenografts. Since lung cancer is one of the most prevalent forms of human cancer, we are excited at the prospect in due course of taking the compound into the clinic to evaluate it as a treatment option for this priority target indication,” Dr. Brown said.
About NV-128:
Structurally, NV-128 is an analog of triphendiol and phenoxodiol, both of which are investigational drugs that have been licensed by Novogen Limited to Marshall Edwards, Inc. Phenoxodiol is in development for ovarian and prostate cancer and triphendiol has been granted orphan drug status by the FDA for pancreatic and bile duct cancers, and late stage melanoma.
In contrast to phenoxodiol and triphendiol, NV-128 has been shown to induce caspase-independent DNA degradation and cancer cell death. It appears that in conjunction with autophagy induction, NV-128 induces caspase independent cell death via the AKT-mTOR pathway resulting in beclin sequestration of Bcl-2, Bax up-regulation and mitochondrial depolarization. As a consequence, endonuclease G translocates to the nucleus where it initiates DNA degradation and cell death. This offers an opportunity for use as a monotherapy in chemoresistant cancers and enhanced efficacy against cancer targets less susceptible to phenoxodiol. The option for co-administration of combinations of these drugs is also under investigation to extend the potential therapeutic range of this unique class of oncology compounds.
About Marshall Edwards, Inc:
Marshall Edwards, Inc. (NASDAQ: MSHL) is a specialist oncology company focused on the clinical development of novel anti-cancer therapeutics. These derive from a flavonoid technology platform, which has generated a number of novel compounds characterized by broad ranging activity against a range of cancer cell types with few side effects. Marshall Edwards, Inc. has licensed rights from Novogen Limited (ASX: NRT) (NASDAQ: NVGN) to bring four oncology drugs — phenoxodiol, triphendiol, NV-143 and NV-128 — to market globally.
Marshall Edwards, Inc. is majority owned by Novogen Limited, an Australian biotechnology company that is specializing in the development of therapeutics based on a flavonoid technology platform. Novogen is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases. More information on the Novogen group of companies can be found at www.marshalledwardsinc.com and www.novogen.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third arty patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
Astrotech Corp. (ASTC) Reports Financial Results for Fourth Quarter and Fiscal Year 2009
Sep. 28, 2009 (Business Wire) — Astrotech Corporation (NASDAQ:ASTC) today announced financial results for its fourth quarter and fiscal year ended June 30, 2009.
“This reporting period commemorates our return to profitable earnings and the completion of the turnaround for Astrotech that started in January 2007,” said Thomas B. Pickens III, Chairman and CEO. “The Company is now on a firm foundation and I feel very confident about the future of Astrotech and its expected earnings going forward.”
Fourth Quarter Results
The Company posted a fourth quarter fiscal year 2009 net income of $2.6 million, or $0.15 per diluted share on revenue of $10.4 million compared with a fourth quarter fiscal year 2008 net loss of $1.5 million, or $(0.11) per diluted share on revenue of $6.1 million.
Fiscal Year Results
Astrotech’s net income for the fiscal year ended June 30, 2009 was $4.7 million, or $0.28 per diluted share on revenue of $32.0 million compared to a net loss of $36.0 million, or $(4.26) per diluted share on revenue of $25.5 million for the prior fiscal year. These results represent a 25.2% increase in revenue over fiscal year 2008. Additionally, this marks the first time since 2005 that the Company has reported net income for the fiscal year.
Liquidity
As of June 30, 2009, we had cash on hand of $4.7 million and our working capital was approximately $8.4 million. The Company maintains a $6.0 million financing facility with Green Bank, N.A., consisting of a $4.0 million term loan and a $2.0 million revolving credit facility. On June 30, 2009, $3.6 million of the term loan, which expires in February 2011, was outstanding. During third quarter fiscal year 2009, the Company renewed the one-year revolving credit facility through February 2010 on terms substantially similar to the previous facility. At June 30, 2009, the Company had no outstanding liability under the revolving credit facility.
Update of Ongoing Operations
Astrotech’s growth strategy is to build on its industry-leading ground support operations and offer a more comprehensive set of services to government and commercial satellite customers through its wholly owned and largest subsidiary, Astrotech Space Operations (“ASO”). Specifically, the Company has developed and has begun to offer an End-to-End Mission Assurance capability that leverages Astrotech’s core-competency in ground processing services to provide pre-launch mission design and planning services and post-launch command-and-control and data management services. This initiative offers new opportunities to meet what the Company believes is an increasing demand from commercial and government customers for a cost-effective and reliable provider of these services.
The Company has a backlog of $25.4 million as of June 30, 2009. The majority of this backlog is for ASO pre-launch satellite processing services, which include hardware launch preparation; advance planning; use of unique satellite preparation facilities; and, spacecraft checkout, encapsulation, fueling, transport, and remote control through launch.
Strategic Financial and Business Alternatives
Astrotech also announced today that its Board of Directors has engaged investment banking firm Lazard Ltd. to advise the Company in exploring strategic financial and business alternatives to enhance shareholder value. Lazard Middle Market is the midcap focused financial advisory business of Lazard.
The range of alternatives which may be considered could include strategic acquisitions, a sale of some or all of the company’s assets or a variety of other possible transactions. There can be no assurance regarding the timing of or whether the Company will elect to pursue any of the strategic alternatives it may consider, or that any such alternatives will result in changes to the Company’s plans or will be consummated.
About Astrotech Corporation
Astrotech is one of the first space commerce companies and remains a strong entrepreneurial leader in the aerospace industry. The Company serves our government and commercial satellite and spacecraft customers with our pre-launch services from our Astrotech Space Operations (ASO) subsidiary and incubates space technology businesses having formed three companies; the 1st Detect Corporation is developing what we believe is a breakthrough mini-mass spectrometer; Astrogenetix, Inc. expects to produce biotech products in space and has recently developed a vaccine candidate for Salmonella; and AirWard Corporation is drawing on Astrotech’s space heritage of sending cargo to space by selling hazardous material containers for the airline industry.
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, continued government support and funding for key space programs, the ability to expand ASO, product performance and market acceptance of products and services, as well as other risk factors and business considerations described in the Company’s Securities and Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. The Company assumes no obligation to update these forward-looking statements.
Euro Tech Holdings Company Limited (CLWT) Reports on Activities of Subsidiary and Associated Companies
HONG KONG, Sept. 28 /PRNewswire-Asia/ — Euro Tech Holdings Company Limited (Nasdaq: CLWT – News) today announced that its subsidiary company, PACT Environmental Equipment Co., Ltd. (“PACT”) is going to take part in Water Environmental Federation Technical Exhibition and Conference (“WEFTEC”) in Orlando Florida (October 12 – 14, 2009), in order to promote and expand environmental protection business outside China.
WEFTEC is the world’s largest exhibition covering water and wastewater equipment and services. PACT’s main products exhibited in poster form are MBRs, Belt Filter Presses, Rotating Drum Screens, Clarifier Scrapers, Floating Decanters and custom manufacturing.
Zhejiang Tianlan Environmental Technology Co. Ltd., (“Blue Sky”), an associated company of Euro Tech, has recently been awarded two contracts totally US$3.3 million by two companies in China. The contracts cover design, manufacture, supply, and commissioning of desulphurization equipment for various applications. The contracts are for five FGD equipment, (Flue Gas Desulphurization equipment), for boilers of 75 tons/hour of steam for applications in paper and cogeneration (heat and power) plants in Zhejiang. To cope with expansion, Blue Sky has recently moved into its self owned and new factory with area of approximately 20,000 square metres in Hangzhou, Zhejiang.
Zhejiang Jia Huan Electronic co. Ltd. (“Jia Huan”), an associated company of Euro Tech, has recently formed a 80% owned subsidiary company to develop, manufacture and sell energy saving products, such as solar and LED lighting products. To fully utilize the existing resources, Jia Huan wants to diversify into energy saving business.
About PACT:
PACT, based in Shanghai, is a global provider of environmental solutions for industrial and municipal clients, focusing on water and wastewater treatment. PACT’s capabilities cover design, manufacturing, sourcing, installation and servicing of water/wastewater treatment, water desalination plants and equipment.
About Blue Sky
Blue Sky (formerly known as Zhejiang Tianlan Desulfurization and Dust- Removal Co. Ltd.), found in 2000, is a fast growing company which provides a comprehensive service for design, general contract, equipment manufacturing, installation, testing and operation management of the treatment of waste gases emitted from various boilers and industrial furnaces of power plants, steel works and chemical plants.
About Jia Huan
Jia Huan, an established and profitable company, has been in business since 1969. 95% of Jia Huan’s business is related to air pollution control and less than 5% is for water and wastewater treatment. Jia Huan designs and manufactures automatic control systems and electric voltage control equipment for electrostatic precipitators which are major air purification equipment for power plants, cement plants and incinerators to remove and collect dust and pollutants from the exhaust stacks
Certain statements in this news release regarding the Company’s expectations, estimates, present view of circumstances or events, and statements containing words such as estimates, anticipates, intends, or expects, or words of similar import, constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements indicate uncertainty and the Company can give no assurance with regard to actual outcomes. Specific risk factors may include, without limitation, having the Company’s offices and operations situated in Hong Kong and China, doing business in China, competing with Chinese manufactured products, competing with the Company’s own suppliers, dependence on vendors, and lack of long term written agreements with suppliers and customers, development of new products, entering new markets, possible downturns in business conditions, increased competition, loss of significant customers, availability of qualified personnel, negotiating definitive agreements, new marketing efforts and the timely development of resources. See the “Risk Factor” discussions in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 20-F for its fiscal year ended December 31, 2008.
Gander Mountain Company (GMTN) Announces Intent to Go Private
ST. PAUL, Minn., Sept. 28 /PRNewswire-FirstCall/ — Gander Mountain Company (www.GanderMtn.com) (Nasdaq: GMTN), the nation’s largest retail network of stores for hunting, fishing, camping, and marine products and services and outdoor lifestyle apparel and footwear, today announced its intent to cease its public company status.
A special committee of the company’s board of directors, comprised of independent directors, has recommended, and the board of directors has approved, plans to cease the registration of its common stock with the Securities and Exchange Commission under the Securities Exchange Act of 1934. The company expects that, as a result of this deregistration, its shares of common stock will cease to be listed on the Nasdaq Global Market.
Going-Private Transaction
In order to ensure that it will be eligible to deregister its shares of common stock, in accordance with SEC rules and regulations, Gander Mountain will reduce its number of beneficial shareholders to below 300. To accomplish this, the special committee of the board recommended, and the board of directors approved, an amendment to the company’s articles of incorporation to effect a 1-for-30,000 reverse stock split of its common stock. After the reverse stock split, any shareholder holding less than one share will receive a cash payment of $5.15 for each share held prior to the reverse split. Immediately following the reverse stock split, the company will file a second amendment to its articles of incorporation to effect a 30,000-for-1 forward stock split. As a result, shareholders owning 30,000 or more shares of common stock at the time of the reverse split will retain their current numbers of shares of common stock without change and not receive cash in the transaction. The funding for the cash payment for the fractional shares described above will be provided by the company’s two largest shareholders, Gratco LLC and Holiday Stationstores, Inc.
Gander Mountain’s board of directors decided to pursue taking the company private after concluding that the disadvantages of remaining an SEC-reporting company, including the costs associated with ongoing regulatory requirements, outweighed the benefits of public company status to the company and its shareholders. Greene Holcomb & Fisher LLC, independent financial advisor to the special committee, determined that the cash-out price of fractional shares is fair from a financial point of view to those shareholders who would be cashed out in the proposed transaction.
Under Minnesota law, Gander Mountain’s board may amend its articles of incorporation to conduct the stock splits without the approval of the company’s shareholders, therefore it is not seeking the approval of the going-private transaction from our shareholders.
Once Gander Mountain becomes a private company, it intends to continue its efforts to improve operating performance and reduce its outstanding indebtedness. The company’s two largest shareholders have agreed to make an offer to purchase shares held by remaining shareholders following the going private transaction at the same price of $5.15 per share following effectiveness of the stock splits described above.
Prior to consummating the going-private transaction described above, the company must file a preliminary information statement and a transaction statement with the Securities and Exchange Commission. Following review by the SEC, the company intends to distribute a definitive information statement to its shareholders and to effect the going-private transaction as soon as practicable following the date that is 20 days after the distribution of the information statement to shareholders. The company anticipates the transaction will be completed in early 2010. If the transaction is completed, the company would no longer file periodic reports with the SEC. This release is not an offer to acquire or sell any securities.
The special committee and the board of directors each have reserved the right to change the terms of the proposed reverse stock split, including the split ratio, to the extent they believe it is necessary or desirable in order to accomplish the goal of reducing the number of beneficial holders to fewer than 300. The special committee may also abandon the proposed transaction at any time prior to its completion if it believes that the proposed transaction is no longer in the best interests of the company or its shareholders.
About Gander Mountain Company:
Gander Mountain Company (Nasdaq: GMTN), headquartered in Saint Paul, Minnesota, is the nation’s largest retail network of stores for hunting, fishing, camping, marine, and outdoor lifestyle apparel and footwear, products and services. Established in 1960, the Gander Mountain brand has offered an expanding assortment of outdoor equipment, technical apparel and footwear, as well as gunsmith and archery services. The stores feature national, regional and local brands as well as the company’s owned brands. Focused on a “We Live Outdoors” culture, Gander Mountain dedicates itself to creating outdoor memories. There are 116 conveniently located Gander Mountain outdoor lifestyle stores in 23 states and three outlet stores. Customers may also shop at www.GanderMtn.com. For the nearest store location call 800-282-5993 or visit www.GanderMtn.com. Gander Mountain is also the parent company of Overton’s (www.overtons.com), a leading catalog and Internet based retailer of products for boating and other water sports enthusiasts.
Cautionary Note Regarding Forward-Looking Statements
Any statements in this release that are not historical or current facts are forward-looking statements. All forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In addition to the risk the transactions described herein will not be completed, certain of these risks and uncertainties are described in the “Risk Factors” section of the company’s Annual Report on Form 10-K for fiscal 2008 and other required reports, as filed with the SEC, which are available at http://www.GanderMtn.com and at the SEC’s Website at http://www.sec.gov.
Covidien (COV) Announces Definitive Agreement to Acquire Aspect Medical Systems, Inc. (ASPM)
Sep. 28, 2009 (Business Wire) — Covidien (NYSE: COV) and Aspect Medical Systems, Inc. (NASDAQ: ASPM) today announced that Covidien has reached a definitive agreement to acquire Aspect, a global market leader in brain monitoring technology.
The Boards of Directors of both companies have unanimously approved the transaction, pursuant to which a wholly owned subsidiary of Covidien will pay $12.00 in cash per Aspect share for a total of approximately $210 million, net of cash and short-term investments acquired. The transaction, which will take the form of an all cash tender offer followed by a second-step merger, is subject to customary closing conditions, including receipt of certain regulatory approvals, and is expected to be completed by the end of calendar 2009.
Founded in 1987, Aspect is recognized as a pioneer and global market leader in brain monitoring, with 2008 revenues of $99 million. Aspect’s premier product — Bispectral Index™ (BIS™) technology — became the first clinically proven and commercially available direct measure of the effects of anesthetics and sedatives on the brain. Aspect led the way to develop proprietary technologies that directly measure these effects and ultimately improve the quality and cost effectiveness of patient care. BIS technology is designed to allow medical professionals to reliably gauge the precise amount of anesthetic medication required by each patient, resulting in better overall patient care.
“The acquisition of Aspect will allow Covidien to broaden its product offerings and add a market leading brain monitoring technology to its portfolio,” said Pete Wehrly, President, Respiratory & Monitoring Solutions, Covidien. “Aspect will bring us enhanced clinical expertise, a strong research & development organization and expand our presence in the operating room. The acquisition is consistent with our strategy of expanding into adjacent market segments and will help us achieve our mission of enhancing the quality of life for patients and improving outcomes for our customers.”
“Joining Covidien provides Aspect with the scale and resources to accelerate growth of BIS and other Aspect products, to continue to invest in outcomes research, comparative effectiveness and innovation, and to support the strategy of providing products that are designed to improve patient outcomes,” said Nassib Chamoun, President and Chief Executive Officer, Aspect Medical Systems. “Above all, we are pleased to become part of a company that shares our commitment to evidence-based medicine and the development of products that help clinicians cost-effectively deliver better care.”
Assuming a December 31, 2009, closing, Covidien expects this transaction to dilute fiscal 2010 GAAP earnings per share, primarily due to a one-time charge for restructuring. On a non-GAAP basis, excluding the restructuring charge, the transaction is expected to be slightly dilutive to 2010 earnings per share; however, the underlying strength of Covidien’s existing businesses is expected to offset this dilution. As a result, Covidien does not anticipate this transaction will have a material impact on its fiscal 2010 sales or operating margin outlook.
Once the transaction has been completed, Covidien will report the Aspect business as part of its Oximetry and Monitoring product line in the Medical Devices segment.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.
ABOUT ASPECT MEDICAL SYSTEMS, INC.
Aspect Medical Systems, Inc. is a global market leader in brain monitoring technology. To date, the Company’s Bispectral Index (BIS) technology has been used to assess approximately 34 million patients and has been the subject of more than 3,300 published articles and abstracts. BIS technology is installed in approximately 78 percent of hospitals listed in the July 2009 U.S. News and World Report ranking of America’s Best Hospitals and in approximately 74 percent of all U.S. operating rooms. In the last twelve months, BIS technology was used in approximately 19 percent of all U.S. surgical procedures requiring general anesthesia or deep sedation. Aspect Medical Systems has OEM agreements with nine leading manufacturers of patient monitoring systems. For more information, visit Aspect’s Web site at http://www.aspectmedical.com.
FORWARD-LOOKING STATEMENTS
Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. This release contains forward-looking information about Covidien’s proposed acquisition of Aspect Medical Systems, Inc., the timing of the anticipated transaction, the potential benefits of the anticipated transaction, Aspect’s clinical trials, products and product candidates and the potential benefits of such products and product candidates, and expected dilutive effect. Any forward-looking statements contained herein are based on Covidien’s and Aspect’s management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, the satisfaction of conditions to closing the agreement; the ability to successfully integrate Aspect’s operations and programs with Covidien’s and the time and resources required to do so, the uncertainties inherent in commercial, research and development activities, decisions by regulatory authorities regarding whether and when to approve any applications for such product candidates and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments. These and other factors are identified and described in more detail in Covidien’s and Aspect’s filings with the SEC. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. We disclaim any obligation to update these forward-looking statements other than as required by law.
NON-GAAP Financial Information
This release contains a non-GAAP financial measure. This non-GAAP financial measure, which is used a measure of Covidien’s performance, should be considered in addition to, not as a substitute for, or superior to, measures of Covidien’s financial performance prepared in accordance with GAAP. A reconciliation of this non-GAAP financial measure to GAAP is provided in the text of this release. Covidien’s non-GAAP measures may be defined differently than similar terms used by other companies, and accordingly, care should be exercised in understanding how Covidien defines its non-GAAP financial measures.
Specifically, any one-time charge for restructuring is excluded from the projected earnings per share dilution.
Covidien management uses this non-GAAP financial measure to gain an understanding of its comparative operating performance (when comparing such results with previous periods or forecasts) and future prospects. This non-GAAP financial measure is also used by Covidien’s management in their financial and operating decision-making because management believes it reflects the underlying economics of Covidien’s ongoing business in a manner that allows meaningful period-to-period comparisons. Such comparisons may be more meaningful because operating results presented under GAAP may include, from time to time, items that are not necessarily relevant to understand Covidien’s business and may, in some cases, be difficult to forecast accurately for future periods. Covidien’s management believes that this non-GAAP financial measure provides useful information to investors and others in understanding and evaluating Covidien’s current operating performance and future prospects in the same manner as management does if they so choose. Non-GAAP financial measures have limitations, however, because they do not include all items of income and expense that affect Covidien’s operations. Covidien’s management compensates for this and other limitations by also considering Covidien’s financial results as determined in accordance with GAAP.
IMPORTANT INFORMATION ABOUT THE TENDER OFFER
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Aspect. Transformer Delaware Corp. (the “Merger Sub”), an indirect, wholly-owned subsidiary of Covidien, has not commenced the tender offer for the shares of Aspect stock described in this press release.
Upon commencement of the tender offer, the Merger Sub will file with the SEC a tender offer statement on Schedule TO and related exhibits, including the offer to purchase, letter of transmittal, and other related documents. Following commencement of the tender offer, Aspect will file with the SEC a tender offer solicitation/recommendation statement on Schedule 14D-9. These documents will contain important information about Covidien, Aspect, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available.
Investors and security holders will be able to obtain free copies of the tender offer statement, the tender offer solicitation/recommendation statement and other documents filed with the SEC by the Merger Sub and Aspect through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of these documents by contacting:
Baldwin Technology Co., Inc. (BLD) and technotrans End Patent Dispute
SHELTON, Conn.–(BUSINESS WIRE)–Baldwin Technology Company, Inc. (NYSE Amex:BLD), a global leader in process automation technology for the printing industry, announced the settlement of its patent dispute with technotrans.
Baldwin Germany GmbH, Friedberg, as the plaintiff and technotrans AG, Sassenberg, as the defendant, have agreed to an out-of-court settlement to terminate the proceedings that have been continuing for a number of years in connection with the infringement of a patent. Technotrans is to pay an amount of EURO 6.5million (approximately $9.6 million) in compensation to Baldwin. In return, Baldwin undertakes to declare the proceedings before the Dusseldorf district court in respect of the amount as settled.
The Boards of Management of both parties have reached the conclusion that this solution is in the best interests of both companies.
About Baldwin
Baldwin Technology Company, Inc. is a leading international supplier of process automation equipment for the printing and publishing industries. Baldwin offers its customers a broad range of market-leading technologies, products and systems that enhance the quality of printed products and improve the economic and environmental efficiency of printing presses. Headquartered in Shelton, Connecticut, the company has operations strategically located in the major print markets and distributes its products via a global sales and service infrastructure. Baldwin’s technology and products include cleaning systems, fluid management and ink control systems, web press protection systems and drying systems and the related consumables. For more information, visit http://www.baldwintech.com.
Information for investors, including an investment profile about Baldwin is available at www.hawkassociates.com/profile/bld.cfm. Investors may contact Julie Marshall or Frank Hawkins, Hawk Associates, at (305) 451-1888, e-mail: baldwin@hawkassociates.com. An online investor kit including press releases, current price quotes, stock charts and other valuable information for investors are available at http://www.hawkassociates.com.
This release contains certain forward-looking statements that involve known and unknown risks, uncertainties or other factors not under the company’s control, which may cause actual results, performance or achievements of the company to be materially different from the results, performance, or other expectations implied by these forward-looking statements. These factors include, but are not limited to, those detailed in the company’s periodic filings with the Securities and Exchange Commission.
The Finish Line, Inc. (FINL) Reports Second Quarter Results
INDIANAPOLIS, Sept. 24 /PRNewswire-FirstCall/ — The Finish Line, Inc. (Nasdaq: FINL) today reported results for its second fiscal quarter, representing the 13-week period ended August 29, 2009. As previously disclosed, the company exited the Man Alive business effective July 4, 2009. Therefore, all financial results of the Man Alive operations are included in discontinued operations for all periods presented.
Second Quarter Results
Comparable store sales declined 9.9% in the second quarter compared to a 4.9% increase last year. Net sales declined 11.4% to $298.7 million for the period compared to $337.0 million as a result of fewer stores and the comparable store sales decline.
Finish Line reported income from continuing operations of $11.7 million, or $0.21 per diluted share, compared to income from continuing operations of $14.9 million, or $0.27 per diluted share, in the second quarter last year. Diluted weighted average shares outstanding for the second quarter were 54.6 million versus 54.3 million for the same period a year ago.
Consolidated merchandise inventories were reduced 18% to $221.4 million as of August 29, 2009 compared to $269.9 million a year ago. Finish Line inventory declined 13.4% overall and 10.1% on a per-square-foot basis.
At quarter end, the company had no interest-bearing debt and $142.9 million in cash and cash equivalents, up from $65.0 million at the end of the second quarter a year ago.
“In the second quarter, we continued to manage the business conservatively by controlling costs and increasing efficiencies, but we also made and will continue to make appropriate investments in our business to drive sales and profitable growth,” said Finish Line Chief Executive Officer Glenn Lyon. “Our online business and cross-channel strategies are growing, and we are focused on building upon that growth by improving the customer experience wherever and whenever they shop with us. Overall, our focus at Finish Line is to sustain the health of our balance sheet, maintain our premium brand position, and within the realities of what remains a cautious consumer environment, position ourselves for future profit growth.”
Year-to-Date Results
For the 26 weeks ended August 29, 2009, Finish Line reported income from continuing operations of $13.5 million, or $0.24 per diluted share, versus income from continuing operations of $17.3 million, or $0.32 per diluted share for the same period a year ago.
Year-to-date comparable store sales declined 7.2% versus a 3.4% increase last year. Net sales declined 8.6% to $557.8 million, compared to $610.0 million a year ago.
Conference Call
The Company will host a conference call for investors Friday, September 25 at 8:30 a.m. EDT. To participate in the call, dial (660) 422-4970, conference ID#29769719. To listen online, visit www.finishline.com. A replay of the conference call can be accessed at (706) 645-9291, conference ID#29769719. This replay will be available beginning at approximately 9:45 a.m. EDT Friday, September 25, and will remain available through Monday, September 28. In addition, the replay will be available on the Web at www.finishline.com.
Forward Looking Statements
The company has experienced, and expects to continue to experience, significant variability in net sales, net income (loss) and comparable store net sales from quarter to quarter. Therefore, the results of the periods presented herein are not necessarily indicative of the results to be expected for any other future period or year.
Certain statements contained in this press release regard matters that are not historical facts and are forward looking statements (as such term is defined in the rules promulgated pursuant to the Securities Act of 1933, as amended). Because such forward looking statements contain risks and uncertainties, actual results may differ materially from those expressed in or implied by such forward looking statements.
Factors that could cause results of the company to differ materially include, but are not limited to: changing consumer preferences; the company’s inability to successfully market its footwear, apparel, accessories and other merchandise; price, product and other competition from other retailers (including internet and direct manufacturer sales); the unavailability of products; the inability to locate and obtain favorable lease terms for the company’s stores; the loss of key employees; the effect of economic conditions including current conditions in the financial services industry, depressed demand in the housing market and unemployment rates; management of growth, the outcome of litigation, and the other risks detailed in the company’s Securities and Exchange Commission filings.
Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to release publicly the results of any revisions to these forward looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
The Company expects to report Q3 results on Tuesday, December 22, 2009 after the market closes followed by a live conference call on Wednesday, December 23, 2009 at approximately 8:30 a.m. EDT.
About Finish Line
The Finish Line, Inc. is a premium athletic footwear store and one of the nation’s largest mall-based specialty retailers, offering a large selection of performance and sport-style footwear, apparel and accessories for men, women and kids. The Finish Line, Inc. is publicly traded on the NASDAQ Global Select Market under the symbol FINL. The company operates 680 Finish Line stores in 47 states and offers online shopping at www.finishline.com.
Keryx Biopharmaceuticals, Inc. (KERX) Reports Results of Open Label Extension Study Examining Long-Term Use of Zerenex
NEW YORK, Sept. 23 /PRNewswire-FirstCall/ — Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced results of the Open Label Extension (OLE) trial of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. The OLE trial, conducted in Taiwan, enrolled 29 of the 37 Taiwanese patients that had completed the randomized, multi-center, multi-national (United States and Taiwan) dose-ranging Phase 2 study. This OLE represents the first trial to examine the long-term safety and efficacy of Zerenex as a phosphate binder. The treatment period in all previous Zerenex Phase 2 clinical trials did not exceed 28 days.
The OLE trial provided for a daily dose, ranging from 2 to 6 g/day of Zerenex, for a period of up to one year following completion of the 28-day, dose-ranging Phase 2 study. The average duration of the patients’ participation in the OLE trial was 306 +/- 85 days.
Data from the OLE trial indicate that the mean serum phosphorus level throughout the trial was 5.22 +/- 0.18 mg/dL, and the mean product of calcium times phosphate (CaxP) was 49.06 +/- 2.15 mg(2)/dL(2), both within the normal range as recommended by the KDOQI guidelines. In addition, during the OLE trial, the administration of IV iron as a supplement was withheld in 8 patients (27.6%) for periods ranging from 3 to 6 months and the administration of EPO was withheld in 8 patients (27.6%) for short periods because the hemoglobin, hematocrit, and iron parameters were within normal clinical ranges as assessed by the investigator. There were no signs of potential iron overload in the study patients, and there were no Zerenex-related serious adverse events as noted by either the patient or investigator.
Ron Bentsur, CEO of Keryx Biopharmaceuticals, stated, “We are very excited about this long-term data for Zerenex. The study suggests that Zerenex can maintain patients within the normal serum phosphorous range for extended periods of time and that the drug appears to be well-tolerated.” Mr. Bentsur added, “We are also very encouraged by the emerging data suggesting that Zerenex may reduce the need for IV iron or EPO in this dialysis patient population, and should the results be replicated in the upcoming Phase 3 program, this could represent a significant clinical and cost advantage to the patient and the doctor.”
ABOUT HYPERPHOSPHATEMIA
In the United States, according to data from the U.S. Renal Data System, there are approximately 485,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise 60% to approximately 785,000 by 2020. The majority of ESRD patients, over 350,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism (and its related cardiovascular complications), renal osteodystrophy and soft tissue mineralization. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. The need for alternative phosphate-binding agents has long been recognized, especially given the increasing prevalence of ESRD as well as shortcomings with current therapies. Zerenex has the potential to be an effective and safe treatment in lowering and/or maintaining normal serum phosphorus levels in patients with ESRD and hyperphosphatemia.
The market for phosphate binders to treat hyperphosphatemia in ESRD patients in the U.S. exceeded $600 million in 2008, and has grown approximately 25% per annum over the last five years.
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 the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. 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 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and Keryx is in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for Zerenex (ferric citrate), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete clinical trials for Zerenex; our ability to meet anticipated development timelines for Zerenex due to recruitment, clinical trial results, manufacturing capabilities or other factors; our ability to replicate in our planned Phase 3 clinical program the efficacy and safety of Zerenex observed in the previous Phase 2 and the OLE clinical trials, and the effects on IV iron and EPO use observed in the OLE trial; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
New Online Tool Gives YRC Customers Greater Flexibility to Meet Must Arrive By Dates (MABD) and Windows via Service Day Calculator New Online Tool Gives YRC Customers Greater Flexibility to Meet Must Arrive By Dates (MABD) and Windows via Service Day Calculator
OVERLAND PARK, Kan., Sept. 23 /PRNewswire-FirstCall/ — YRC Inc., a subsidiary of YRC Worldwide Inc. (Nasdaq: YRCW), announced today the launch of a new Service Day Calculator that can be accessed through its customer Web site, my.yrc.com . Ideal for retailers – but available to any shipper or consignee – the online tool helps customers determine when goods need to be available for pick up, to have shipments arrive at the destination precisely when needed.
“Our customers’ success drives our success. That’s why we’re committed to providing flexible solutions and tools that help them better manage their inventories and production schedules,” said Greg Reid, executive vice president and chief marketing officer – YRC Worldwide. “The my.yrc.com Service Day Calculator does just that by placing focus on the desired delivery date and time and working backwards from there. This helps improve the consistency and precision of deliveries. For our retail customers it improves their vendor scorecards and mitigates costly charge backs.”
Customers can access the Service Day Calculator by logging into my.yrc.com. New customers simply need to register for a my.yrc.com login if they do not currently have one. Once in the application, service day results are displayed in a matrix that includes transit days and all service options: Standard Ground, Fastest Ground, and Expedited Precision. From the matrix options, customers can easily access links to online Rate Quotes and Bills of Lading to book and ship online.
About YRC Worldwide
YRC Worldwide Inc., a Fortune 500 company and one of the largest transportation service providers in the world, is the holding company for a portfolio of successful brands including YRC, YRC Reimer, YRC Glen Moore, YRC Logistics, New Penn, Holland and Reddaway. YRC Worldwide has the largest, most comprehensive network in North America with local, regional, national and international capabilities. Through its team of experienced service professionals, YRC Worldwide offers industry-leading expertise in heavyweight shipments and flexible supply chain solutions, ensuring customers can ship industrial, commercial and retail goods with confidence. The company is headquartered in Overland Park, Kan.
Web site: www.yrcw.com
Neuralstem, Inc. (CUR) Receives FDA Approval to Commence First ALS Stem Cell Trial
ROCKVILLE, Md., Sept. 21 /PRNewswire-FirstCall/ — Neuralstem, Inc. (NYSE Amex: CUR) today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells.
(Logo: http://www.newscom.com/cgi-bin/prnh/20061221/DCTH007LOGO )
Neuralstem is the first company to commence a stem cell trial to treat ALS. The trial will study the safety of Neuralstem’s cells and the surgical procedures and devices required for multiple injections of Neuralstem’s cells directly into the grey matter of the spinal cord. The FDA’s approval represents a significant step toward delivering regenerative medicine directly to damaged neural cells in humans. ALS affects roughly 30,000 people in the U.S., with about 7,000 new diagnoses per year.
Neuralstem CEO and President, Richard Garr, stated, “The beginning of our clinical trial program is a major step towards achieving Neuralstem’s goal of treating ALS, a fatal neurodegenerative disease for which currently there is no effective treatment or cure. While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process. This trial will be in the extremely capable hands of Dr. Eva L. Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery, and Dr. Jonathan Glass, Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, world-renowned for their study and treatment of ALS patients. We believe that there is no better team to conduct this study for us,” said Garr. Their participation is subject to formal IRB approval by their institutions.
“We are very excited about this clinical trial,” said Dr. Eva L. Feldman, who will direct the Neuralstem clinical trial program for ALS. “This is a major advancement in what still could be a long road to a new and improved treatment for ALS. ALS is a terrible disease that ultimately kills by paralysis,” said Feldman, who also directs the A. Alfred Taubman Medical Research Institute. “In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS,” Dr. Feldman concluded.
About the Trial
The ALS patients will be treated through spinal injections of its patented human neural stem cells.
This first trial, which will primarily evaluate safety of the cells and the surgery procedure, will ultimately consist of 18 ALS patients with varying degrees of the disease. The FDA has approved the first stage of the trial, which consists of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord. The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.
Neuralstem expects to conduct the trial at Emory University with Dr. Jonathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, as site Principal Investigator (PI) and with Dr. Nicholas Boulis, M. D. performing the neurosurgery. The overall PI for the ALS trial program is Dr. Eva Feldman, M.D., Ph.D., Director of the University of Michigan Health System ALS Clinic and the Program for Neurology Research & Discovery.
About Neuralstem, Inc.
Neuralstem’s patented technology enables, for the first time, the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells into mature, physiologically relevant human neurons and glia. The company is targeting major central nervous system diseases including: Ischemic Spastic Paraplegia, Traumatic Spinal Cord Injury, Huntington’s disease and Amyotrophic Lateral Sclerosis (ALS), often referred to as Lou Gehrig’s disease. Neuralstem plans to initiate a Phase I clinical trial to treat ALS with its stem cells. ALS is a progressive fatal neurodegenerative disease that affects nerve cells in the brain, leading to the degeneration and death of the motor neurons in the spinal cord that control muscle movement. Pre-clinical work has shown Neuralstem’s cells to extend the life of rats with ALS (as reported the journal TRANSPLANTATION, October 16, 2006, in collaboration with Johns Hopkins University researchers), and also reversed paralysis in rats with Ischemic Spastic Paraplegia, (as reported in NEUROSCIENCE, June 29, 2007, in collaboration with researchers at University of California San Diego).
Cautionary Statement Regarding Forward Looking Information
This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem’s technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward- looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the annual report on Form 10-K for the year ended December 31, 2008 and the quarterly report on form 10-Q for the period ended June 30, 2009.
YM BioSciences, Inc. (YMI) Reports Nimotuzumab Approved For Marketing in Mexico
MISSISSAUGA, Sept. 17 /PRNewswire-FirstCall/ – YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported that nimotuzumab has been approved for marketing in Mexico. YM BioSciences also announced that it has enrolled the first two patients in its randomized, double-blind trial evaluating nimotuzumab in patients with brain metastases from non-small-cell lung cancer (NSCLC).
“Mexico is the 21st country to have approved nimotuzumab for marketing and, while YM’s license for major market territories for nimotuzumab does not include Mexico, this approval reflects the growing recognition throughout much of the world of the value to patients of our drug and the progress being made in its commercialization,” said David Allan, Chairman and CEO of YM BioSciences. “As part of YM’s registration strategy for nimotuzumab, we were also pleased to report the opening of this second of two randomized, double-blind trials that YM is conducting in Canada and which are both now being expanded internationally.”
Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR), licensed to YM’s majority-owned subsidiary, CIMYM BioSciences Inc., by CIMAB S.A., and developed at the Center of Molecular Immunology in Cuba. Nimotuzumab is approved in two of the countries in YM’s territories. The drug has demonstrated efficacy in clinical trials without producing the numerous and severe toxicities observed with the other marketed EGFR-targeting drugs. Mexican regulatory authorities have approved nimotuzumab for the treatment of squamous cell carcinoma of the head and neck (SCCHN), adult glioma and pediatric glioma. The approval was granted to Laboratorios PiSA in Guadalajara, Mexico and nimotuzumab will be commercialized under the name VECTHIX(R).
First patients enrolled in multinational randomized, double-blind brain metastases trial
YM BioSciences recently enrolled and treated the first two patients in its multinational randomized, double-blind trial evaluating nimotuzumab plus whole-brain radiation therapy (WBRT) to WBRT alone in patients with brain metastases from NSCLC. The trial is designed enroll approximately 88 patients over twelve months followed by a twelve-month follow-up period and will likely include 12 investigational centers in Canada plus additional centers in other countries. The patients were enrolled at the L’Hopital Maisonneuve-Rosemont in Montreal, Canada.
Nimotuzumab (200 mg IV infusions) will be administered weekly during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. Patients will be assessed by laboratory tests, imaging studies, standardized neurologic examination, and neurologic symptoms. The primary efficacy endpoint is intracranial disease progression over six months. The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at six months; time to intracranial disease progression; and time to overall progression.
“This randomized, double-blinded, multicentric trial was based on a randomized pilot open-label trial from which encouraging, preliminary results were presented at the EORTC-NCI-AACR “Molecular Targets and Cancer Therapeutics” meeting held on October 21-24, 2008 in Geneva. YM is preparing to imminently open the first international centers on both this and the ongoing palliative NSCLC randomized trial. In this trial, as with the others being conducted by YM, extensive samples are being collected and stored in anticipation of a comprehensive program of translational analysis,” said Dr. Leonardo Viana Nicacio, YM’s Director of Clinical Affairs.
Nimotuzumab is reported to have been has been administered to more than 5,000 patients worldwide and is currently in 32 trials internationally of which 11 are being conducted by YM and its four licensees. Three of the latter are Phase III trials, including one being conducted by the internationally recognized National Cancer Center of Singapore, which selected nimotuzumab over the alternative antibodies because of its benign side effect profile. Nimotuzumab is also available on a compassionate use basis in the US for children with pediatric glioma and is designated an Orphan Drug for adult and pediatric glioma by the FDA as well as the EMEA for Europe.
About YM BioSciences
YM BioSciences Inc. is a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development. The Company is currently developing two late-stage products: nimotuzumab, an EGFR-targeting Affinity-Optimized Antibody(TM), and AeroLEF(R), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl. YM has proven regulatory and clinical trial expertise and a diversified business model designed to reduce risk while advancing clinical products toward international approval, marketing and commercialization.
This press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; that AeroLEF(R) will continue to generate positive efficacy and safety data in future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Origin Agritech Limited (SEED) Subsidiary Reaches Agreement for Novel Glyphosate-Tolerance Gene
Sep. 17, 2009 (Business Wire) — Origin Biotechnology, a wholly-owned subsidiary of Origin Agritech Limited (NASDAQ:SEED) announced it has reached an comprehensive, worldwide agreement with the Institute of Microbiology of the Chinese Academy of Sciences (CAS) and Sichuan Biotech Engineering, Limited. CAS and Sichuan Biotech jointly own the rights to an internally developed gene which is highly tolerant to glyphosate (herbicide). This glyphosate-tolerance gene, demonstrated to be extremely effective in both laboratory and field environments, is entirely new to the consumer markets in that it has never been commercialized, and is protected by patents granted separately by China and USA separately.
For the entire life of the patent, Origin Biotechnology will receive exclusive rights to sell and develop corn, soybean, rice, cotton and canola products that contain these technology traits worldwide, both in the territory within China and outside of China. Origin Biotechnology will also receive exclusive rights to sub-license to any third parties to sell and develop corn, soybean, rice, cotton and canola products that contain these traits and with application of patent technology worldwide in the territory within China and outside of China. Origin Biotech will also receive the rights to improve and further develop this glyphosate-tolerant gene. Additionally, no change of control in the patent will have impact on the validity of this agreement.
As a result of this landmark agreement for Origin, Chairman Gengchen Han reiterated, “Origin continues to demonstrate that it is the leading, technology-focused crop seed company in China. Our goal remains consistent —- to lead the industry by serving farmers with unique enabling technology and services, producing and protecting higher crop yields. Our focus remains in the production of higher quality seed products, whether proprietary or licensed.”
UPDATE OF ORIGIN GM PROGRAM
Phytase
World’s first transgenic phytase corn is expected to be commercially launched as the first genetically modified corn product in China. Phase 5 passage is expected near term pending a final stage approval from the Ministry of Agriculture (MOA). Currently, phytase corn continues to remain the only biotechnology corn product in Phase 5 of development in China. Phytase is currently used as an additive essential for the growth and development of all animals, and limits the amount of phosphorus waste in the environment. Phytase, as an additive for animal feed, is mandatory in Europe, Southeast Asia, South Korea, Japan, and Taiwan for environmental purposes. The worldwide phytase potential market size is US$500 million dollars, including US$200 million for China alone, according to the China Feed Industry Study. The corn seed market in China is estimated at US$1 billion.
Glyphosate (Herbicide) Tolerance
Glyphosate tolerance has passed the intermediate testing phase (Phase 2) and entered the environmental release testing phase (Phase 3). Worldwide, the largest segment of the transgenic crop market has been herbicide tolerant crops. Specifically, glyphosate tolerant crops have been widely accepted in cotton, corn, and canola in North America. Introduced in the US in 1998, the use of glyphosate tolerant corn grew from 950,000 acres in 1998 to 2.3 million acres in 1999 to 41 million acres in 2007, or at a compounded annual growth rate of 51.9%, according to the US Department of Agriculture. The rapid historical adoption rate indicates farmers find this trait to be extremely valuable. The high level of adoption of these crops by farmers has also caused the reduction in value of the remaining herbicide market.
Since their introduction in 1996, over 75 million acres of genetically engineered glyphosate-tolerant crops have been planted, making up 46% of the corn, 80% of soybean acres, and 70% of cotton acres in the US. These genetically engineered crops have been adopted by farmers because they are perceived to offer significant economic benefits over conventional crop and herbicide programs. The adoption of glyphosate-tolerant crops has reduced costs for US farmers an estimated $1.2 billion. On the basis of recent adoption rates by growers around the world, it appears that glyphosate-tolerant crops will continue to grow in number and in hectares planted.
Pest Resistance (Bt Corn)
Pest resistance (Bt Corn) has passed the intermediate testing phase (Phase 2)and entered the environmental release phase (Phase 3). In these phase 2 and 3 trials, these traits continue to perform as the best performing traits for pest resistance throughout China.
Bt crops produce a protein toxic to specific insects used in areas with high levels of infestations of targeted pests. Bt cotton, which controls varieties of the budworm and bollworm, was planted on 59 percent of U.S. cotton acreage and 75 percent of the Chinese cotton acreage in 2007. Introduced in 1996 in the US, acreage of Bt corn has grown from 3.6 million acres in 1999 to 44 million acres in 2007, or at a compounded annual growth rate of 36.7%, according to the US Department of Agriculture. This Bt corn variety was planted on 49 percent of U.S. corn acreage in 2007.
About Origin
Founded in 1997 and headquartered in Beijing, Origin Agritech Limited (Nasdaq: SEED) is one of China’s leading, vertically-integrated agricultural technology company specializing in hybrid seed research, development and production to supply the growing populations of China and Southeast Asia. Origin develops, grows, processes, and markets hybrid seeds to farmers throughout China and parts of Southeast Asia via a network of approximately 3,200 distributors. The hybrid seed industry is estimated at US$2 billion and that is expected to double by 2010. The animal nutrition market is estimated at US$1.6 billion. The Company currently operates facilities in 30 of China’s 32 provinces as well as Beijing. Since Origin launched its first entirely internally developed seed in 2003, the Company has developed and commercialized a proprietary seed portfolio of ten corn hybrids, six rice hybrids and two canola hybrids. For further information, please log on www.originagritech.com.
Forward Looking Statements
This release contains forward-looking statements. All forward-looking statements included in this release are based on information available to us on the date hereof. These statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results to differ materially from those implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “targets,” “goals,” “projects,” “continue,” or variations of such words, similar expressions, or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Neither we nor any other person can assume responsibility for the accuracy and completeness of forward-looking statements. Important factors that may cause actual results to differ from expectations include, but are not limited to, those risk factors discussed in Origin’s filings with the SEC including its transition report on Form 20-F filed with the SEC on February 15, 2007. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.
Positive Phase IIb Results for GSK1838262 (XP13512) Reported for Neuropathic Pain Associated with Post-Herpetic Neuralgia
Sep. 17, 2009 (Business Wire) — GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) today announced top-line results from a Phase IIb clinical trial evaluating the safety and efficacy of GSK1838262/XP13512 (gabapentin enacarbil) for neuropathic pain associated with post-herpetic neuralgia (PHN) in adults. In this study, subjects were randomized to receive placebo, 1200, 2400 or 3600 mg/day of GSK1838262 dosed twice a day. All doses of GSK1838262 demonstrated statistically significant improvements over placebo on the primary endpoint, which was the change from baseline to the end of maintenance treatment in the 24-hour average pain intensity score.
This 14-week, double-blind, placebo-controlled study enrolled 376 subjects with PHN who had been experiencing pain for at least three months following healing of the herpes zoster skin rash. The pre-specified statistical analysis included adjustment for comparisons of multiple GSK1838262 doses to placebo. The adjusted p-values for comparison of 1200, 2400 and 3600 mg/day doses to placebo were 0.013, 0.029 and 0.002, respectively.
GSK1838262 was generally well tolerated at all doses in this study. The most common adverse events were dizziness (placebo 15%, 1200 mg/day 17%, 2400 mg/day 26% and 3600 mg/day 30%) and somnolence (8%, 10%, 11% and 14%, respectively). Most of these adverse events were mild or moderate in intensity. Withdrawals due to adverse events were 13%, 6%, 15% and 18%, respectively.
“We are encouraged by the positive results in this study of GSK1838262 in treating neuropathic pain associated with PHN, which is a debilitating condition for affected patients. We look forward to sharing the full results at a future medical meeting,” said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicines Development Center. “We are currently evaluating the next steps for the development of this compound for the treatment of neuropathic pain.”
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort said, “We are pleased with the efficacy and tolerability results observed across all doses in this study. These results build upon the positive Phase IIa study in PHN patients we previously conducted with this product candidate. We look forward to continuing to work with GSK to advance the development of this compound in neuropathic pain.”
About PHN
Post-herpetic neuralgia is a neuropathic pain syndrome that primarily affects people over fifty and often results in disability. PHN follows an outbreak of herpes zoster, commonly known as shingles. Approximately one million people in the United States develop shingles each year. Of these, nearly 15 percent develop PHN.
Conference Call and Webcast Information
XenoPort will host a conference call at 9:00 a.m. Eastern Time today. To access the conference call via the Internet, go to www.XenoPort.com. To access the live conference call via phone, dial 1-888-275-3514. International callers may access the live call by dialing 1-706-679-1417.
The replay of the conference call may be accessed after 12:00 p.m. Eastern Time today via the Internet, at www.XenoPort.com, or via phone at 1-800-642-1687 for domestic callers or 1-706-645-9291 for international callers. The reference number to enter the call and the replay of the call is 31158623.
GSK1838262 is a new chemical entity that is designed to provide dose proportional and sustained exposure of gabapentin by taking advantage of high-capacity transport mechanisms in the gastrointestinal tract. A New Drug Application for GSK1838262 for the treatment of moderate-to-severe primary restless legs syndrome (RLS) is being reviewed by the U.S. Food and Drug Administration.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
XenoPort is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. XenoPort is developing its lead product candidate in partnership with Astellas Pharma Inc. and GSK. XenoPort’s product candidates are being studied for the potential treatment of RLS, gastroesophageal reflux disease, migraine headaches, neuropathic pain, spasticity related to spinal cord injury and Parkinson’s disease. To learn more about XenoPort, please visit the Web site at www.XenoPort.com.
Zargis Receives FDA Clearance for Signal X6 Telemedicine Device; OK Allows Delivery to US Army
STAMFORD, Conn., Sept. 17 /PRNewswire-FirstCall/ — Zargis Medical Corp., a spin-off from Siemens Corporate Research (NYSE: SI) and a majority-owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced today it has received U.S. Food and Drug Administration (FDA) clearance to market its new Signal X6(TM) device. Zargis also announced the delivery of seven Signal X6 devices to the U.S. Army for deployment in six Department of Defense medical facilities.
Signal X6 is noninvasive, easy to use and simultaneously records heart and lung sounds from six adhesive sensors. The recordings can be evaluated locally or, for locations where a cardiac specialist is not immediately available for consultation, transmitted through the Internet for remote evaluation. Signal X6 and our recently launched Zargis Cardioscan(TM) device were both designed for user-friendly digital heart sound analysis. The configuration of the Signal X6 provides a unique telemedicine resource in situations where evaluations would benefit from high fidelity multi-channel synchronous recordings.
“As healthcare systems continue to demand improved outcomes with utilization of fewer resources, we believe that Signal X6 will provide cost-effective, high quality cardiac analysis in situations where it’s not practical for a patient to visit a specialist,” said John Kallassy, Zargis’ CEO.
Prototypes for Signal X6 were first developed with funding from the Telemedicine and Advanced Technology Research Center (TATRC) through the AAMTI program. The AAMTI program provides funding to AMEDD personnel to demonstrate technology and document the impact on cost, access and quality of care. TATRC (www.tatrc.org) is an element of the United States Army Medical Research and Materiel Command (USAMRMC).
About Zargis Medical Corp.
Zargis Medical Corp. develops advanced diagnostic decision support products and services for primary care physicians, pediatricians, cardiologists and other healthcare professionals. Zargis was formed in 2001 when Siemens Corporate Research, a division of Siemens AG (NYSE: SI), and Speedus Corp. co-invested to develop and market an advanced acoustic technology designed to detect heart abnormalities identified through analysis of heart sounds.
For additional information about Zargis or Speedus Corp., contact Peter Hodge at 888.773.3669 (ext. 23) or phodge@zargis.com or visit the following Web sites: www.zargis.com and www.speedus.com.
Statements contained herein that are not historical facts, including but not limited to statements about the Company’s product, corporate identity and focus, may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company, including, but not limited to, the continuing development of the Company’s sales, marketing and support efforts.
Adobe to Acquire Omniture, Inc. (OMTR)
Sep. 15, 2009 (Business Wire) — Adobe Systems Incorporated (Nasdaq:ADBE) and Omniture, Inc. (Nasdaq:OMTR) today announced the two companies have entered into a definitive agreement for Adobe to acquire Omniture in a transaction valued at approximately $1.8 billion on a fully diluted equity-value basis. Under the terms of the agreement, Adobe will commence a tender offer to acquire all of the outstanding common stock of Omniture for $21.50 per share in cash.
Adobe’s acquisition of Omniture furthers its mission to revolutionize the way the world engages with ideas and information. By combining Adobe’s content creation tools and ubiquitous clients with Omniture’s Web analytics, measurement and optimization technologies, Adobe will be well positioned to deliver solutions that can transform the future of engaging experiences and e-commerce across all digital content, platforms and devices.
The combination of the two companies will increase the value Adobe delivers to customers. For designers, developers and online marketers, an integrated workflow — with optimization capabilities embedded in the creation tools — will streamline the creation and delivery of relevant content and applications. This optimization will enable advertisers, advertising agencies, publishers and e-tailers to achieve greater ROI from their digital media investments and improve their end users’ experiences.
“Adobe customers are looking to us for solutions to deliver engaging experiences and more effectively monetize their content and applications online,” said Shantanu Narayen, president and chief executive officer of Adobe. “This is a game changer for both Adobe and our customers. We will enable advertisers, media companies and e-tailers to realize the full value of their digital assets.”
“Omniture’s mission has been to enable our customers to optimize every digital interaction,” said Josh James, CEO of Omniture. “By joining forces with Adobe, we will accelerate our ability to deliver on that vision and together bring new innovation to the market that improves content engagement, advertising effectiveness and the overall user experience, which will drive more advertising dollars online.”
Expanded Opportunities for Adobe and Omniture
This acquisition will significantly expand Adobe’s addressable market and growth potential, broadening solutions Adobe provides to the rapidly growing Internet advertising, e-commerce and digital media markets.
The combination will also expand Adobe’s offering of mission-critical solutions to the enterprise customer. Adding the capabilities of Omniture will further enhance Adobe’s offerings and ability to appeal to online marketers, including chief marketing officers.
The acquisition of Omniture will further diversify Adobe’s business, adding a scalable SaaS platform that captures over a trillion transactions per quarter, an expansive partner ecosystem, and a recurring revenue model.
For Omniture, joining Adobe will provide global operational scale and the ability to more quickly penetrate new geographies and markets, thereby accelerating its go-to-market strategy and growth potential.
Integration and Closing Details
As part of the expected integration of the two companies, Omniture will become a new business unit within Adobe. Omniture’s CEO, Josh James, will join Adobe as senior vice president of the new business unit, reporting to Adobe’s president and CEO, Shantanu Narayen.
The completion of the transaction, which is subject to customary government approvals and the satisfaction of other customary conditions, is expected to close in the fourth quarter of Adobe’s 2009 fiscal year.
The proposed offer represents a premium of 45 percent over Omniture’s average closing price for the last 30 trading days through yesterday’s close.
Adobe believes the acquisition will be accretive to Adobe’s non-GAAP earnings in fiscal year 2010.
The companies will make information, including an FAQ and other details about the acquisition, available at http://www.adobe.com/aboutadobe/invrelations/adobeandomniture.html.
Conference Call Scheduled for 2:00 p.m. PDT Today
Adobe will comment on the acquisition of Omniture today during its Q3 FY2009 earnings conference call, which is scheduled to begin at 2:00 p.m. PDT today. Investors, analysts and press can participate in a live Webcast via Adobe Acrobat Connect Pro or access the live conference call using the following access information:
| Webcast: | Go to http://www.adobe.com/ADBE and click on the Q3 FY09 Earnings Conference Call icon | |
| Live Call: | Dial 888-213-3930 and use passcode 3412311 | |
| Questions: | Contact Adobe Investor Relations at 408-536-4416 or ir@adobe.com |
The call and Webcast will last approximately one hour. An archive of the call will be made available in Adobe Acrobat Connect Pro for approximately 45 days. Listening to the live Webcast works best with Adobe Flash Player version 10 or later. Firewalls designed to protect corporate information can prevent listening to the Webcast.
Forward-Looking Statements Disclosure
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risks to both companies that the acquisition of Omniture will not be consummated, as the transaction is subject to certain closing conditions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including statements regarding: the anticipated timing of filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; any projections of earnings, revenues or other financial items; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to Adobe’s ability to successfully integrate the products and employees of Adobe and Omniture, as well as the ability to ensure continued performance or market growth of Omniture’s products. These risks, uncertainties and other factors, and the general risks associated with the respective businesses of Adobe and Omniture described in the reports and other documents filed by each of them with the Securities and Exchange Commission, could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. All forward-looking statements are based on information currently available to Adobe and Omniture and are qualified in their entirety by this cautionary statement. Neither Adobe nor Omniture assumes any obligation to update any such forward-looking statements or other statements included in this press release.
Additional Information and Where to Find It
This press release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Omniture’s common stock will only be made pursuant to a tender offer statement on schedule TO, including an offer to purchase and other related materials that Snowbird Acquisition Corporation, a wholly-owned subsidiary of Adobe Systems Incorporated, intends to file with the Securities and Exchange Commission. In addition, Omniture will file with the Securities and Exchange Commission a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, Omniture stockholders will be able to obtain the tender statement on schedule TO, the offer to purchase, the Solicitation/Recommendation Statement on Schedule 14D-9 and related materials with respect to the offer, free of charge at the website of the Securities and Exchange Commission at www.sec.gov, from the information agent and dealer manager named in the tender offer materials or from Snowbird Acquisition Corporation. Omniture’s stockholders are advised to read these documents, any amendments to these documents and any other documents relating to the tender offer that are filed with the SEC carefully and in their entirety prior to making any decisions with respect to the offer because they contain important information, including the terms and conditions of the offer.
About Omniture
Omniture, Inc. is a leading provider of online business optimization software, enabling customers to manage and enhance online, offline and multi-channel business initiatives. Omniture’s software, which it hosts and delivers to its customers as an on-demand subscription service and on-premise solution, enables customers to capture, store and analyze information generated by their Web sites and other sources and to gain critical business insights into the performance and efficiency of marketing and sales initiatives and other business processes. In addition, Omniture offers a range of professional services that complement its online services, including implementation, best practices, consulting, customer support and user training through Omniture Education. Omniture’s more than 5,000 customers include eBay, AOL, Wal-Mart, Gannett, Microsoft, Neiman Marcus, Oracle, Sony and HP. www.omniture.com
About Adobe Systems Incorporated
Adobe revolutionizes how the world engages with ideas and information – anytime, anywhere and through any medium. For more information, visit www.adobe.com.
© 2009 Adobe Systems Incorporated and Omniture, Inc. All rights reserved. Adobe, Flash, and the Adobe Logo are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries. Omniture and the Omniture logo are either registered trademarks or trademarks of Omniture, Inc. in the United States and/or other countries. All other trademarks are the property of their respective owners.
Keryx Biopharmaceuticals, Inc. (KERX) Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma
NEW YORK, Sept. 16 /PRNewswire/ — Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma. In August, the Company announced that it had reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial in relapsed/refractory multiple myeloma and that the study is expected to start by year-end.
Ron Bentsur, Chief Executive Officer of Keryx, commented, “The Orphan-Drug designation for perifosine in multiple myeloma is a very important milestone for Keryx, as the market exclusivity protection provided by this designation significantly enhances the commercial opportunity of perifosine in this indication.” Mr. Bentsur continued, “Following our exciting announcement last month that we had reached an agreement with the FDA on an SPA for a Phase 3 trial for perifosine in relapsed/refractory multiple myeloma, it is encouraging to further add to the value of the perifosine program with this Orphan-Drug designation. We look forward to commencing the Phase 3 study by year-end.”
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.
About Orphan-Drug Designation
Orphan-drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.
Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui dances/ucm080571.pdf
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cells, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.
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 KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, a key signaling cascade that has been shown to induce cell growth and cell transformation. 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 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has recently completed a Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and Keryx is in the process of finalizing the U.S. Phase 3 program for Zerenex in consultation with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from the Phase 3 study of KRX-0401 (perifosine) will not coincide with the data analyses from the Phase 1 / 2 study previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the FDA website is not incorporated by reference into this press release and is included for reference purposes only.
Hi-Shear Technology Corp. (HSR) Signs Merger Agreement
Sep. 16, 2009 (Business Wire) — Hi-Shear Technology Corporation (NYSE Amex: HSR) today announced that it has entered into a definitive merger agreement with Chemring Group PLC (LSE: CHR), whereby Chemring will acquire Hi-Shear in an all cash transaction valued at approximately $132.0 million.
The board of directors of Hi-Shear approved the transaction with Chemring, based, in part, upon the recommendation of a special committee of the board that was established to consider strategic alternatives. Under the terms of the merger agreement, upon consummation of the transaction, Hi-Shear stockholders will receive an amount in cash equal to $19.18 per share of Hi-Shear’s outstanding common stock, which represents a premium of 61.4% over Hi-Shear’s closing stock price on September 15, 2009. The transaction is subject to customary closing conditions, including approval of the transaction by Hi-Shear’s stockholders and the expiration or termination of applicable waiting periods under the Hart-Scott Rodino Antitrust Improvement Act of 1976, and is expected to be completed in the fourth quarter of 2009.
“We are extremely pleased to join the Chemring Group. This combination of two well-known and respected companies worldwide will provide enhanced and increased capabilities and resources to better serve our loyal customers. The transaction has a strong strategic basis and supports Hi-Shear’s commitment to both our stockholders and our customers,” stated George Trahan, Hi-Shear’s Chairman and CEO.
In connection with the transaction, Lazard served as financial advisor to the Special Committee of the Board of Directors of Hi-Shear and Gibson, Dunn & Crutcher LLP served as its legal counsel.
About Hi-Shear
Hi-Shear Technology Corporation provides pyrotechnic, mechanical, and electronic products to prime aerospace customers for use in aerospace and defense markets where safety, performance and high reliability are essential. It develops and produces advanced systems and products that are primarily used worldwide in space satellites, launch vehicles, national defense, and government programs.
About Chemring
Chemring, with 2008 revenues of £354.2 million, is a global company that specializes in the manufacture of energetic material products and decoy countermeasures. Chemring provides solutions for highly demanding customer requirements in defense, security and safety markets. Chemring is a world-leading defense company involved in critical defense development programs in the UK, US, Europe and Australia. Chemring’s capabilities to provide solutions to customer requirements are based on its core competencies in: (i) energetic materials, (ii) high reliability and safety and (iii) volume manufacturing. Chemring is built on a hundred-year history of innovation and development and currently employs over 3000 people in the UK, US, France, Germany, Italy, Norway, Spain and Australia. Chemring sells to over 80 countries and its end-users include the military services, security forces and commercial marine operators.
This release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those projected in the forward-looking statements as a result of certain risk factors, including but not limited to: (i) adverse changes in general economic or market conditions; (ii) the satisfaction of closing conditions, including the receipt of Hi-Shear’s stockholder approval and regulatory approvals, in connection with the proposed transaction; (iii) fluctuations in Hi-Shear’s operating results and risks associated with trading of Hi-Shear’s stock; (iv) war or acts of terrorism; (v) the ability to attract and retain highly qualified employees; (vi) changes in government laws and regulations; and (vii) other one-time events and other important factors disclosed previously and from time to time in Hi-Shear’s filings with the U.S. Securities and Exchange Commission (the “SEC”). Except as required by law, Hi-Shear disclaims any obligation to update any such forward-looking statements after the date of this release.
IMPORTANT ADDITIONAL INFORMATION WILL BE FILED WITH THE SEC
In connection with the proposed transaction with Chemring, Hi-Shear intends to file a proxy statement and other relevant documents concerning the transaction with the SEC. STOCKHOLDERS OF HI-SHEAR ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TRANSACTION.
Investors and security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by Hi-Shear through the web site maintained by the SEC at www.sec.gov. Free copies of the proxy statement, when available, and Hi-Shear’s other filings with the SEC also may be obtained on Hi-Shear’s website at www.hstc.com or by directing a request to Investor Relations at (310) 784-2100.
Hi-Shear, and its directors and executive officers, may be deemed to be participants in the solicitation of proxies from Hi-Shear’s stockholders at Hi-Shear’s upcoming Special Meeting of Stockholders with respect to the transaction with Chemring. Information regarding Hi-Shear’s directors and executive officers is contained in Hi-Shear’s definitive proxy statement filed with the SEC on September 9, 2009 for its 2009 Annual Meeting of Stockholders. As of September 15, 2009, Hi-Shear’s directors and executive officers beneficially owned (as calculated in accordance with SEC Rule 13d-3) in the aggregate approximately 2,489,140 shares, or 36.4%, of Hi-Shear’s common stock. Additional information regarding the interests of such participants will be included in the proxy statement relating to the upcoming Special Meeting of Stockholders that will be filed with the SEC and available free of charge as indicated above. You can obtain free copies of these documents as set forth above.
Lexicon Pharmaceuticals, Inc. (LXRX) Completes Phase 1 Clinical Trial and Initiates Phase 2 Clinical Trial of LX4211
THE WOODLANDS, Texas, Sept. 15 /PRNewswire-FirstCall/ — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained favorable results from recently completed Phase 1 studies of LX4211 and announced today that it has initiated a Phase 2 clinical trial of the drug candidate in patients with type 2 diabetes mellitus. LX4211 is an orally-delivered, small molecule drug candidate that inhibits the sodium glucose transporter 2 (SGLT2). LX4211 is Lexicon’s fourth drug candidate currently being tested in Phase 2 clinical trials.
“LX4211 offers an opportunity to treat diabetes by increasing urinary glucose excretion through a mechanism of action that is expected to avoid some of the disadvantages of existing diabetes drugs that result in storage of excess glucose,” said Brian P. Zambrowicz, Ph.D., executive vice president and chief scientific officer at Lexicon. “By contrast, LX4211 through inhibition of SGLT2 has the potential to reduce caloric load and thereby enhance overall glucose homeostasis in patients with type 2 diabetes.”
In the recently completed Phase 1 clinical trial in normal healthy volunteers, LX4211 was well tolerated at all dose levels and produced a dose-dependent increase in urinary glucose excretion. LX4211 also demonstrated a favorable pharmacokinetic profile supporting the potential for once daily dosing. Adverse events were generally mild and were distributed across all dose groups, including the placebo group.
Based on the Phase 1 clinical results, Lexicon has initiated a Phase 2 clinical trial to evaluate the safety and tolerability of two dose levels of LX4211 and its effect on diabetes biomarkers including: fasting blood glucose, urinary glucose excretion and response to oral glucose tolerance testing in patients with type 2 diabetes. The four-week, randomized, double-blind, placebo-controlled study will be conducted in the United States and is expected to enroll 36 patients with type 2 diabetes.
In addition to LX4211, Lexicon has three other drug candidates progressing in Phase 2 clinical trials: LX1031 for irritable bowel syndrome, LX1032 for carcinoid syndrome and LX2931 for rheumatoid arthritis. For more information about Lexicon’s clinical development programs, please visit www.lexpharma.com.
About the Target
LX4211 was developed at Lexicon as a potent inhibitor of the sodium glucose transporter 2 (SGLT2), a transporter responsible for the majority of glucose reabsorption by the kidneys. Lexicon found that mouse knockouts engineered to lack the SGLT2 gene are healthy and require less insulin to manage a glucose challenge. Compounds developed by Lexicon that inhibit SGLT2 may potentially treat diabetes by increasing urinary glucose excretion, thereby lowering blood glucose levels as well as caloric load.
About Diabetes
Diabetes mellitus is a common metabolic disorder associated with abnormally high blood sugar levels. Diabetes is classified as either type 1, which is characterized by severely diminished insulin production, or type 2, which is characterized by moderately diminished insulin production in conjunction with insulin resistance (insensitivity of the tissues of the body to insulin). Insulin is a hormone that regulates blood glucose levels. Diabetes can seriously impair overall quality of life and may lead to multiple complications including heart disease, stroke, and kidney failure. According to the International Diabetes Federation, more than 245 million people have diabetes, with type 2 diabetes being the most prevalent.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company’s research team. The company has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX4211 and the potential therapeutic and commercial potential of LX4211. This press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct clinical development of LX4211 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Factors Affecting Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2008, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Hyperdynamics Corp. (HDY) Signs Memorandum of Understanding with Guinea Government
Sep. 14, 2009 (PR Newswire) — SUGAR LAND, Texas, Sept. 14 /PRNewswire-FirstCall/ — Hyperdynamics Corporation (NYSE Amex: HDY) today announced that following a week of negotiations, Ray Leonard, Chief Executive Officer, and Minister of Mines, Energy and Hydraulics of the Republic of Guinea, Mahmoud Thiam, have signed a Memorandum of Understanding (“MOU”). The MOU is a binding agreement reaffirming the validity of Hyperdynamics’ concession.
Leonard stated, “I am pleased that the government supports Hyperdynamics’ continuing program to explore for oil and gas offshore Guinea. This agreement clarifies key points such as the relinquishment dates of portions of our acreage and continuing rights, which allows us to move forward on our planned seismic program in the fourth quarter 2009.”
Key terms of the agreement include the following:
-- The Government of Guinea reaffirms the validity of Hyperdynamics' concession and the Company's right to choose 36%, being 28,800 square kilometers, (11,160 square miles) of the initial acreage and carry it through the exploration period. -- The required relinquishment of 64% of the acreage by the Company, as stated in the 2006 Hydrocarbon Production Sharing Contract, must take place by December 31, 2009. -- The Company must spud its first well no later than calendar year 2011. -- Hyperdynamics has the right of first refusal on any new concessions Guinea offers within the 64% relinquished area, granting Hyperdynamics the right to match the terms offered by another party. -- The contract in its entirety will be reviewed to assure it is in conformity with international standards. If this process has not come to a satisfactory conclusion within six months, any unresolved points will be submitted to international arbitration.
A joint working team of Hyperdynamics Corporation and the Ministry of Mines, Energy and Hydraulics technical experts will begin joint work in October to identify outstanding points in the contract and begin transference of data to Guinea to allow the Ministry to prepare for the handling of the released acreage.
About Hyperdynamics
Hyperdynamics Corporation is committed to providing energy for the future by exploring internationally for new sources of oil and gas. It holds the exploration license for the offshore area of the West African Republic of Guinea. To find out more about Hyperdynamics, visit its website at http://www.hyperdynamics.com.
Forward Looking Statements
This news release and the Company’s website referenced in this news release contain forward looking statements as defined by the U.S. Securities and Exchange Commission regarding Hyperdynamics Corporation’s future plans and expected performance that are based on assumptions the Company believes to be reasonable. A number of risks and uncertainties could cause actual results to differ materially from these statements, including without limitation, funding and exploration efforts, risks associated with operating in a developing country in Africa, political developments in Guinea, fluctuations in oil and gas prices and other risk factors described from time to time in the Company’s reports filed with the SEC. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the issuance of this news release or to reflect any change in the Company’s expectations with respect to these forward-looking statements.
eDiets.com, Inc. (DIET) Announces Additional Investment for Growth Opportunities
FORT LAUDERDALE, Fla., Sept. 11 /PRNewswire-FirstCall/ — eDiets.com, Inc. (Nasdaq: DIET), a leading provider of convenient at-home diet, fitness and healthy lifestyle solutions, today announced that it has entered into a $600,000 Private Placement with certain members of management and the Board of Directors. The investment will immediately convert into common stock at $1.06 per share. The Company will use the proceeds to fund future growth opportunities including the expansion of advertising related to fresh meal delivery relaunch.
Kevin McGrath, President and Chief Executive Officer, commented, “We continue to make meaningful progress on improving our overall operating performance and improving our cash flow. I am confident that our strategic plan and promotional initiatives have positioned our business for long-term profitable growth.”
About eDiets
eDiets.com, Inc. is a leading provider of personalized nutrition, fitness and weight-loss programs. eDiets currently features its award-winning, fresh-prepared diet meal delivery service as one of the more than 20 popular diet plans sold directly to members on its flagship site, www.eDiets.com. The company also provides a broad range of customized wellness and weight management solutions for Fortune 500 clients. eDiets.com’s unique infrastructure offers businesses, as well as individuals, an end-to-end solution strategically tailored to meet its customers’ specific goals of achieving a healthy lifestyle. For more information, please call 310-954-1105 or visit www.eDiets.com.
Safe Harbor Statement
Statements which are not historical in nature are forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements. These risks and uncertainties include, among others, that we will not be able to obtain sufficient and/or acceptable outside financing (when and if required);, changes in general economic and business conditions; changes in product acceptance by consumers; a decline in the effectiveness of sales and marketing efforts; loss of market share and pressure on prices resulting from competition; significant investments in our technology platform, marketing plans, and product development to remain competitive with other online providers of healthy living and weight loss plans, many of which may be found to offer superior and more varied features than our plans and may also be offered for free; volatility in the advertising markets; any delay, disruption, or suspension of our supply of prepared meals from our vendor; changes in consumer preferences and discretionary spending; product liability and other risks from the sale of ingested products; regulatory actions affecting our marketing activities; and the outcome of litigation pending against us. For additional information regarding these and other risks and uncertainties associated with eDiets.com’s business, reference is made to our Annual Report on Form 10-K for the year ended December 31, 2008, and other reports filed from time to time with the Securities and Exchange Commission. All forward-looking statements are current only as of the date on which such statements are made. We do not undertake any obligation to publicly update any forward- looking statements.
Salix Pharmaceuticals, Ltd. (SLXP) Announces Statistically Significant Results for Both the Primary and Key Secondary Analyses Of Rifaximin
Sep. 14, 2009 (Business Wire) — Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful outcome of two Phase 3, randomized, double-blind, placebo-controlled, multicenter trials, TARGET 1 and TARGET 2, designed to evaluate the efficacy and safety of rifaximin 550 mg TID in the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS). In each trial rifaximin versus placebo treated patients demonstrated a statistically significant improvement for the primary endpoint of the adequate relief of IBS symptoms as assessed over one month (weeks 3, 4, 5 and 6) following completion of a 14-day course of therapy (weeks 1 and 2). Consistent with the primary endpoint in each trial, the key secondary endpoint of relief of IBS-related bloating also demonstrated statistical significance of rifaximin versus placebo in each trial. These two large confirmatory trials with 600 patients each were conducted following the previously reported positive results from a Phase 2 trial.
“We are extremely pleased with the outcome of our pivotal Phase 3 trials of rifaximin in the treatment of non-constipation irritable bowel syndrome,” stated Bill Forbes, Pharm.D., Senior Vice President and Chief Development Officer, Salix Pharmaceuticals. “Irritable bowel syndrome, characterized by abdominal pain, bloating and altered bowel habits, is one of the most common chronic medical conditions. Non-constipation IBS comprises the most common forms of IBS by including patients that have either diarrhea-predominant or diarrhea-constipation alternating symptoms. Based on the most current understanding of IBS, TARGET 1 and TARGET 2 were designed to investigate the utility of rifaximin, a broad spectrum, minimally absorbed, gut-selective antibiotic, with minimal side effects, in relieving the symptoms of IBS by altering the bacteria believed to be responsible for creating the symptoms. TARGET 1 and TARGET 2 will serve as the confirmatory trials for the Company’s New Drug Application seeking marketing approval for rifaximin as a treatment option in this condition which is associated with widespread prevalence, incapacitating symptoms and substantial medical costs. The Company is targeting to submit the NDA during the first half of 2010.”
Commenting on the results of TARGET 1 and TARGET 2, Mark Pimentel, MD, FRCP (C), Associate Professor of Medicine, Geffen School of Medicine at UCLA, Director, GI Motility Program, Cedars-Sinai Medical Center, stated: “Over the past decade, scientific discovery has continued to mount evidence for the role of gut bacteria in IBS and the effectiveness of antibiotics in alleviating symptoms of this condition. These two large-scale, multicenter trials affirm the rationale for a gut-selective antibiotic in the treatment of this common, chronic and debilitating condition and may provide pivotal evidence in the effort to deliver a significant therapeutic advancement to these patients.”
About TARGET 1 and TARGET 2
TARGET 1 and TARGET 2 (T-Targeted, non-systemic; A-Antibiotic; R-Rifaximin; G-Gut-selective; E-Evaluation of; T-Treatment for non-C IBS) were designed to assess the clinical efficacy and safety of a 550 mg TID dosing regimen of rifaximin (1650 mg/day) compared with placebo in a broad population comprised of males and females 18 years of age and older who have been diagnosed with non-constipation IBS, e.g., diarrhea-predominant IBS or alternating IBS. The primary efficacy endpoint of TARGET 1 and TARGET 2 is the proportion of subjects who achieve adequate relief of IBS symptoms for at least 2 weeks during the first 4 weeks of the 10-week follow-up phase. The two 600-subject trials were conducted simultaneously in approximately 180 study centers throughout the United States and Canada. Subjects received rifaximin or placebo (1:1 randomization) for 14 days and then were followed for 10 weeks for study duration of 12 weeks.
About Phase 2b Trial
Salix previously announced the successful completion and outcome of its Phase 2b trial to assess the efficacy and safety of rifaximin in the treatment of patients with diarrhea-associated irritable bowel syndrome. As reported in a May 20, 2008 press release, top-line results of the 680-patient study demonstrated that a 14-day course of rifaximin at 550 mg twice-a-day provided a statistically significant improvement in the protocol specified co-primary endpoints for both adequate relief of diarrhea-associated IBS symptoms as well as the adequate relief of IBS related bloating, compared to placebo.
About IBS
Among one of the most common chronic conditions, irritable bowel syndrome (IBS) affects approximately 15% of adults in the United States. IBS includes altered bowel habits with abdominal pain and discomfort. Among other contributors, recent science has shown that alterations in gut flora / bacteria have been identified as a potentially important contributor to the pathophysiology of IBS. Small intestinal bacterial overgrowth, a condition associated with excessive numbers of bacteria in the small intestine, may underlie some of the gastrointestinal symptoms associated with IBS. The Company estimates the U.S. commercial opportunity represented by the non-constipation IBS market to be approximately $2.2 billion.
About XIFAXAN® (rifaximin)
Rifaximin is a gut-selective antibiotic with negligible systemic absorption (<0.4%) and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.
Rifaximin tablets 200 mg, which Salix markets in the United States under the trade name XIFAXAN® (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea caused by non–invasive strains of Escherichia coli. XIFAXAN (rifaximin) is a gut–selective antibiotic with negligible systemic absorption (<0.4%) and broad–spectrum activity in vitro against both gram–positive and gram–negative pathogens. Rifaximin has a similar tolerability profile to that of placebo and has activity against the most common TD pathogens. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24–48 hours and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (versus 19.7%), headache 9.7% (versus 9.2%), abdominal pain 7.2% (versus 10.1 %) and rectal tenesmus 7.2% (versus 8.8%).
Rifaximin has been used in Italy for 24 years and is approved in 33 countries. Salix acquired rights to market rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in Italy under the trade name Normix®.
About Salix Pharmaceuticals
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.
Salix also markets OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended-release capsules 0.375 g., METOZOLVTM ODT (metoclopramide HCl), PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® Azathioprine Tablets, USP, 75/100 mg, ANUSOL-HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam and rifaximin for additional indications are under development.
For full prescribing information on Salix products, please visit www.salix.com.
Salix trades on the NASDAQ Global Select Market under the ticker symbol “SLXP.”
For more information, please visit our Web site at www.salix.com or contact the Company at 919-862-1000. Information on our Web site is not incorporated into our SEC filings.
Please Note: The materials provided herein contain projections and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the unpredictable nature of the duration and results of regulatory review of new drug applications; market acceptance for approved products; generic and other competition; the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our need to return to profitability; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
Zoom Technologies, Inc. (ZOOM) Reports Q2 2009 Financial Results of Recently Approved Acquisition
BOSTON, MA — (Marketwire) — 09/14/09 — Zoom Technologies, Inc. (NASDAQ: ZOOM)
Highlights:
-- Recently approved Zoom acquisition expected to close by end of
September
-- Gold Lion Q2 2009 revenue increased 354% to $53.1 million, versus
$11.7 million in Q2 2008
-- Gold Lion Q2 2009 net income grew to $1.7 million, versus net
loss of $0.1 million in Q2 2008
-- Gold Lion management's full year 2009 net revenue guidance in the
range of $145 million to $155 million, versus $81 million in 2008
-- Gold Lion management's full year 2009 net income guidance in the
range of $5.9 million to $6.1 million, versus $2.8 million in 2008
Zoom Technologies, Inc. (NASDAQ: ZOOM) today announced second quarter financial results of Gold Lion Holdings. Zoom shareholders approved the acquisition of Gold Lion, one of the top ten Chinese mobile phone manufacturers, on Tuesday, September 8, 2009. The acquisition is expected to close this month.
Gold Lion reported Q2 2009 revenues of $53.1 million, up 354% over $11.7 million for Q2 2008, and up 84% sequentially from $28.8 million for Q1 2009. Revenue growth was partially due to a significant order from one of Gold Lion’s existing customers, a major mobile communications original equipment manufacturer.
Gross profit for Q2 2009 rose 147% to $3.2 million, compared to $1.3 million for Q2 2008. Gross profit as a percentage of revenue for the second quarter of 2009 was 5.95%, compared to 10.95% for the same period of the prior year. The decline in gross margins is primarily due to low gross margin for the order mentioned above.
Total operating expenses for Q2 2009 were $0.4 million, compared to $0.6 million in Q2 2008. The decrease in expenses despite a jump in revenues was due primarily to management’s continued emphasis on cost control and production efficiencies.
Net income for Q2 2009 was $1.7 million. This compared to net loss of $0.1 million for the second quarter of 2008 and net income of $0.9 million in the first quarter of 2009.
Mr. Lei Gu, Chairman and Chief Executive Officer of Gold Lion, said, “We are most pleased to report these outstanding quarterly results following the recently announced and shareholder approved transaction with Zoom Technologies. We believe these results reflect the burgeoning mobile telecommunications business in China and our ability to drive revenues and profit in this market. The exceptional quarter includes revenue from an order placed by one of our top customers, which is also the top domestic mobile handset brand.”
Looking ahead, Mr. Gu commented, “For full year 2009, we expect total revenues to be between $145 million and $155 million and net income to be in the range of $5.9 million and $6.1 million.”
Mr. Frank Manning, the President, CEO, and Chairman of Zoom, said: “These results further demonstrate the value of the transaction we expect to close in September. The mobile phone market in China is growing rapidly, and we believe Gold Lion is well-positioned to benefit from this growth.”
About Gold Lion Holding Ltd.
Gold Lion is a holding company with subsidiaries that engage in the manufacturing, research and development, and sales of electronic and telecommunication products for 3rd generation mobile phones, wireless communication circuitry, and related software products. Gold Lion’s 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 and also designs and manufactures its own brand of mobile phones under the “Leimone” brand.
About Zoom Technologies, Inc.
Zoom Technologies, Inc. designs, produces, markets, and supports communication products under the Zoom, Hayes®, and Global Village® brands. Zoom is headquartered in Boston, and its European sales and support center is in the UK. Zoom markets its products in over forty countries, and provides multi-lingual support from its offices in Boston and the UK. For more information about Zoom and its products, please see www.zoom.com.
Forward-Looking Statements
This release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this release regarding Gold Lion, TCB Digital, JS Leimone and Profit Harvest (collectively, “Gold Lion”), the value or likelihood of the merger, or Gold Lion’s future results are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The parties may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements, and readers/investors should not place undue reliance on the forward-looking statements. Important factors that could cause actual results or events to differ materially from the forward-looking statements, include among others: the ability of Zoom and Gold Lion to satisfy the conditions to closing of the proposed acquisition; the ability of Gold Lion to achieve its expected revenues and net income for 2009, which is dependent on a variety of factors; changing principles of generally accepted accounting principles; outcomes of government reviews, inquiries, investigations and related litigation; continued compliance with government regulations; legislation or regulatory environments; requirements or changes adversely affecting the business in which Zoom or Gold Lion is engaged; fluctuations in customer demand; management of rapid growth; intensity of competition; the time to develop and market new products; general economic conditions; geopolitical events and regulatory changes. Further, the forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments made by the combined company. These forward-looking statements inherently involve certain risks and uncertainties, some of which are detailed in Zoom’s proxy statement, its Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Neither Zoom nor Gold Lion assumes any obligation to update any forward-looking statements.
NIVS IntelliMedia (NIV) Granted Mobile Phone License
HUIZHOU, China, Sept. 11 /PRNewswire-Asia-FirstCall/ — NIVS IntelliMedia Technology Group, Inc., (“NIVS” or the “Company”) (NYSE: NIV), a consumer electronics company that designs, manufactures and sells intelligent audio and visual products, today announced that the Company has been granted the license to manufacture mobile phones by the Ministry of Industry and Information Technology. The Company will be allowed to operate its mobile phone business in mainland China under NIVS’s own brand name.
NIVS currently has the R&D capabilities and intellectual property rights to manufacture 3G mobile phones and has already introduced a dual-mode EVDO/GSM 3G handset to the market. The license will allow the Company to speed up the market entry for such handsets under the NIVS brand name.
Mr. Tianfu Li, CEO and Chairman of NIVS, commented, “We are very excited to be entering the huge market of 3G telecommunications in China. The three giant telecom operators, China Mobile, China Telecom and China Unicom, are projected to invest a total of RMB 400 billion (US$58.6 billion) in 3G infrastructure over the next three years, which we believe will create a lot of revenue opportunities for NIVS. Because building strong relationships with network operators is so important in the 3G era, we have been actively working closely with these top three operators in China. On August 24, we were invited to participate in China Telecom’s sales conference for their 3G brand, Tianyi, as well as in their smart phone conference in early September. We are pleased to be working closely with such a big operator and are hopeful to become an OEM supplier for China Telecom. Aside from providing 3G terminal products such as the mobile handset, we also aim to be involved in telecom operators’ operational business so as to enhance our sustainable profitability in the 3G industry.”
About NIVS IntelliMedia Technology Group, Inc.
NIVS IntelliMedia Technology Group is an integrated consumer electronics company that designs, manufactures, markets and sells intelligent audio and video products in China, Greater Asia, Europe, and North America. The NIVS brand has received “Most Popular Brand” distinction in China’s acoustic industry for three consecutive years, among numerous other awards. Ranked 43rd on Forbes’ Top 100 Chinese Research and Development Companies, NIVS has developed leading Chinese speech interactive technology, which forms a foundation for the Company’s intelligent audio and visual systems, including digital audio, LCD televisions, digital video broadcasting (“DVB”) set-top boxes, peripherals and more.
Safe Harbor Statement
This release contains certain “forward-looking statements” relating to the business of the Company and its subsidiary companies. These forward looking statements are often identified by the use of forward-looking terminology such as “believes, expects” or similar expressions. Such forward looking statements involve known and unknown risks and uncertainties, including, but not limited to the Company’s reliance on its major customers for a large portion of its net sales; the Company’s ability to develop and market new products; the Company’s ability to continue to borrow and raise additional capital to fund its operations; the Company’s ability to collect aging trade receivables and the effect of a growing doubtful account allowance; the Company’s ability to accurately forecast amounts of supplies needed to meet customer demand; exposure to market risk through sales in international markets; the market acceptance of the Company’s products; exposure to product liability and defect claims; fluctuations in the availability of raw materials and components needed for the Company’s products; protection of the Company’s intellectual property rights; changes in the laws of the PRC that affect the Company’s operations; development of a public trading market for the Company’s securities; and the cost of complying with current and future governmental regulations and the impact of any changes in the regulations on the Company’s operations. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including the discussed above and in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (www.sec.gov). All forward-looking statements attributable the Company or to persons acting on its behalf are expressly qualified in their entirety by these factors other than as required under the securities laws. The Company does not assume a duty to update these forward-looking statements.
Speedus Corp. (SPDE) Subsidiary Develops Distribution; Signs International Rep Agreement
GERMANTOWN, Md., Sept. 11 /PRNewswire/ — Density Dynamics, a majority owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced today it has signed an International Representation agreement covering India with Graphay, Inc.
“We are excited to establish a sales and distribution channel for the cutting-edge DRAM-based SSD’s built for high speed data enterprise users. My experience at Wachovia in the data center environment led me to witness the Jet.io SSD. Its power and performance capabilities are highly anticipated in the Indian market and together with Graphay’s technologies, will address pressing needs of our Enterprise customers. We look forward to a long and fruitful relationship,” said Ashish Majmundar, CEO and founder of Graphay.
About Density Dynamics
Density Dynamics, a majority owned subsidiary of Speedus Corp., is a pioneer in the solid-state storage and I/O acceleration technology. Its high performance RamFlash solid-state storage and computing devices are designed to reduce I/O bottlenecks while also reducing power, cooling, and rack space requirements. Density Dynamics can be found on the web at www.densitydynamics.com.
About Graphay
Graphay, headquartered in Matthews, NC, is an Enterprise IT Solutions Provider to customers in India & Israel. Graphay offers end-to-end architecture design, desktop and data center virtualization, along with best-in-breed products from its Global technology partners. Graphay can be found on the web at www.graphay.com.
About Speedus Corp.
Additional information on Speedus Corp. may be obtained at www.speedus.com or by contacting Peter Hodge at 888-773-3669 (ext. 23) or phodge@speedus.com.
Statements contained herein that are not historical facts, including but not limited to statements about the Company’s product, corporate identity and focus, may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company, including, but not limited to, the continuing development of the Company’s sales, marketing and support efforts.
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