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(SNCR) to Present at the Stifel Technology, Internet & Media Conference
Synchronoss Technologies, Inc. (NASDAQ: SNCR), the mobile innovation leader that provides cloud solutions and software-based activation for connected devices globally, today announced that its Chief Financial Officer, Executive Vice President & Treasurer, Larry Irving; and its Executive Vice President & Chief Corporate Strategy Officer, Biju Nair, will present at the Stifel Technology, Internet & Media Conference at the Fairmont Hotel in San Francisco on Wednesday, February 12, 2014 at 8:35 a.m. Pacific Time.
A live webcast of the presentation, as well as the replay, will be available on the “Investor Relations” page of the company’s Web site: www.synchronoss.com.
About Synchronoss Technologies, Inc.
Synchronoss Technologies, Inc. (NASDAQ:SNCR), is a mobile innovation leader that provides cloud solutions and software-based activation for connected devices across the globe. The company’s proven and scalable technology solutions allow customers to connect, synchronize and activate connected devices and services that empower enterprises and consumers to live in a connected world. For more information visit us at:
(AKAM) to Participate in the Goldman Sachs Technology and Internet Conference
CAMBRIDGE, Mass., Feb. 6, 2014 /PRNewswire/ — Akamai Technologies, Inc. (NASDAQ: AKAM), the leading provider of cloud services for delivering, optimizing and securing online content and business applications, announced today that it will be participating in the Goldman Sachs Technology and Internet Conference in San Francisco, CA. CEO Tom Leighton will present an update on Akamai’s service offerings.
When: | Tuesday, February 11, 2014 2:40 p.m. (PT) / 5:40 p.m. (ET) |
Where: | Palace Hotel 2 New Montgomery Street San Francisco |
What: | Presentation: Fireside chat with Goldman Sachs Analyst Heather Bellini |
A live audio webcast of the presentation and a replay will be available on Akamai’s website at http://www.akamai.com/html/investor/index.html. Please go to the “News & Events” section of the Akamai Investor Relations Web page to access the presentation.
About Akamai
Akamai® is the leading provider of cloud services for delivering, optimizing and securing online content and business applications. At the core of the Company’s solutions is the Akamai Intelligent Platform™ providing extensive reach, coupled with unmatched reliability, security, visibility and expertise. Akamai removes the complexities of connecting the increasingly mobile world, supporting 24/7 consumer demand, and enabling enterprises to securely leverage the cloud. To learn more about how Akamai is accelerating the pace of innovation in a hyperconnected world, please visit www.akamai.com or blogs.akamai.com, and follow @Akamai on Twitter.
Contacts: | ||
Jeff Young Media Relations 617-444-3913 jyoung@akamai.com |
–or– | Tom Barth Investor Relations 617-274-7130tbarth@akamai.com |
(IDRA) Announces Pricing of Public Offering of Common Stock
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) (“Idera” or the “Company”) today announced the pricing of an underwritten public offering of 6,841,250 shares of common stock for a public offering price of $4.00 per share, and pre-funded warrants to purchase up to an aggregate of 2,158,750 shares of common stock at the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant. The gross proceeds to Idera from this offering are expected to be approximately $36 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Idera and excluding the proceeds, if any, from the exercise of the pre-funded warrants. The Company has granted to the underwriters participating in the offering a 30-day option to purchase up to an additional 1,026,188 shares of common stock to cover over-allotments, if any. The offering is expected to close on or about February 10, 2014, subject to customary closing conditions.
Idera anticipates using the net proceeds from the offering to advance the clinical development of its Toll-like Receptor (TLRs) antagonists in its autoimmune disease and genetically defined B-cell lymphoma programs, to advance the development of its gene silencing oligonucleotides (GSOs) in its GSO program and for working capital and other general corporate purposes.
Piper Jaffray & Co. and Cowen and Company, LLC are acting as joint bookrunning managers for the offering.
The securities described above are being offered by the Company pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on September 18, 2013. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered has been filed with the SEC and is available on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, via telephone at 800-747-3924 or email at prospectus@pjc.com; or from Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at (631) 274-2806 or fax at (631) 254-7140.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Idera Pharmaceuticals, Inc.
Idera’s proprietary technology involves creating novel nucleic acid therapeutics designed to inhibit over-activation of TLRs. Idera is developing these therapeutics for the treatment of genetically defined forms of B-cell lymphoma and for autoimmune diseases with orphan indications. In addition to its TLR programs, Idera is developing GSOs that it has created using its proprietary technology, to inhibit the production of disease-associated proteins by targeting RNA.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company’s strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. There are a number of important factors that could cause Idera’s actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether results obtained in early research, preclinical studies and clinical trials will be indicative of the results that will be generated in future clinical studies; whether products based on Idera’s technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company’s products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and the Current Report on Form 8-K that was filed on February 5, 2014. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
(DRNA) Panel on RNAi Therapeutics At 16th Annual BIO CEO and Investor Conference
Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA), a leader in the development of RNAi-based therapeutics, today announced its participation in a panel discussion on RNAi therapeutics at the 16th Annual BIO CEO & Investor Conference. Douglas M. Fambrough, PhD, the company’s President and CEO, is scheduled to take part in a Therapeutic Workshop entitled: “Delivering the [RNAi] Goods” to be held on Monday, February 10th, at 10:30 a.m. Eastern Standard Time.
About Dicerna Pharmaceuticals, Inc.
Dicerna is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare inherited diseases involving the liver and for cancers that are genetically defined. Dicerna is using its proprietary RNA interference (RNAi) technology platform to build a broad pipeline in these therapeutic areas and intends to discover, develop and commercialize novel therapeutics either on its own or in collaboration with pharmaceutical partners.
(MYGN) to Acquire Crescendo Bioscience
Diversifies Myriad’s Product Portfolio Into High Growth Autoimmune Market
SALT LAKE CITY, Feb. 4, 2014 — Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that it has entered into a definitive agreement to acquire Crescendo Bioscience, Inc., a global leader in autoimmune diagnostics, for $270 million in cash which will be reduced by $25 million for the repayment of a loan made to Crescendo and customary adjustments in accordance with the acquisition agreement.
The transaction is expected to close before the end of Myriad’s fiscal year 2014, pending satisfactory completion of customary closing items and regulatory approval. A discussion of the acquisition will be provided during Myriad’s second fiscal quarter earnings call later today at 4:30 pm EST.
“Crescendo Bioscience fits well into our diagnostic portfolio that is focused on saving lives and improving the quality of life of patients across major diseases,” said Peter D. Meldrum, president and CEO of Myriad Genetics. “Crescendo has pioneered protein-based diagnostics for monitoring disease activity in patients with rheumatoid arthritis and this acquisition diversifies our business into a new high growth, multibillion dollar market opportunity. We are pleased to welcome the 130 employees of Crescendo to the Myriad team and look forward to the impact of this innovative and dedicated group on our organization.”
“Crescendo has built a strong and growing position in the rheumatoid arthritis diagnostic market, and I believe Myriad will enable us to move to the next level in terms of scale and growth,” said William Hagstrom, president and CEO of Crescendo Bioscience. “We envision multiple opportunities over the next several years where, as a combined company, we can expand our presence into international markets and provide new innovative products that help improve the lives of patients suffering from autoimmune diseases.”
Crescendo was founded in July 2002 and is a leading molecular diagnostic laboratory in the area of inflammatory and autoimmune diseases. Their core product, Vectra® DA, is a quantitative, protein-based test to routinely assess rheumatoid arthritis disease activity and provide rheumatologists with expanded clinical insights to more effectively treat their patients. In the United States, more than 1.5 million individuals suffer from rheumatoid arthritis (RA) resulting in over $11 billion in healthcare costs. Crescendo is also building a comprehensive understanding of the biology of other autoimmune diseases and has a pipeline of products under development for a wide range of diseases and conditions managed by rheumatologists. Crescendo additionally has created novel software products for physicians, including VectraView™ which allows a comprehensive overview of all RA patients’ level of disease activity and trends and MyRA® which is a patient tracking and communications tool.
In 2013, Crescendo was ranked the 2nd fastest growing healthcare company in North America on Deloitte’s 2013 Technology Fast 500 list. During the quarter ended December 31, 2013, Crescendo tested 27,000 RA patient samples, an increase of 23 percent over the prior quarter ended September 30, 2013. Crescendo Bioscience, Inc. will retain its name and operate as a wholly owned subsidiary of Myriad Genetics, Inc. based in South San Francisco.
Benefits of the Transaction
- Facilitates Myriad’s Entry into the High Growth Autoimmune Market: Myriad sees a major growth opportunity for molecular diagnostics to aid patients in the autoimmune market. Beyond rheumatoid arthritis there are several other areas in rheumatology as well as the broader autoimmune market where molecular diagnostics could play a major role in patient risk assessment, diagnosis, prognostic outlook and therapy selection. This complements Myriad’s current disease focus which includes products in oncology, women’s health, urology, and dermatology.
- Diversifies Myriad’s Product Revenues: A core strategic initiative for Myriad is to continue to diversify its revenue stream into new attractive markets. Vectra DA represents a $3.0 billion global market opportunity, and Myriad believes Crescendo will be a major growth driver for the Company looking forward.
- Enhances Myriad’s Strength in Protein-Based Diagnostics: Myriad, a world leader in molecular diagnostics, believes that it will further strengthen its leadership position in protein diagnostics with the acquisition of Crescendo. The three major sources of novel biomarkers are DNA, RNA, and proteins and Myriad believes that Crescendo will contribute significantly to Myriad’s industry leading diagnostic product pipeline and complement the protein expertise at Myriad RBM.
- Creates Opportunities to Leverage Myriad’s Commercial Infrastructure: As one of the largest molecular diagnostic laboratories in the United States, Myriad expects to leverage its operational expertise in customer service, sales and marketing, managed care, and product development to further expand Crescendo’s domestic business. Additionally, Myriad’s expects that its international presence will open up new market opportunities for Crescendo’s products outside of the United States.
- Offers Long-Term Financial Benefits: Myriad expects Crescendo to generate significant operating profits in the future and to be accretive to earnings beginning in fiscal year 2016. In April 2013, Vectra DA received national coverage for reimbursement by the Centers for Medicare and Medicaid Services (CMS) and is in the process of obtaining private insurance coverage. The typical RA patient may be monitored with a Vectra DA test at least twice per year.
Financing and Approvals
Myriad intends to fund the transaction entirely through cash on hand and anticipates having sufficient cash following the transaction to continue its current $300 million share repurchase program. The transaction is expected to be completed before the end of fiscal year 2014 and is subject to the satisfaction of customary closing conditions and regulatory approvals.
Advisors
JP Morgan Securities LLC is acting as financial advisor to Myriad Genetics and Mintz Levin Cohn Ferris Glovsky and Popeo PC is serving as legal counsel.
Conference Call
The Company will discuss the proposed acquisition during its second fiscal quarter earnings call on Tuesday, February 4, 2014 at 4:30 pm EST. Participating on the call will be Peter Meldrum, president and CEO; William Hagstrom, president of Crescendo Bioscience; Mark Capone, president of Myriad Genetic Laboratories; and James Evans, CFO. The dial-in number for domestic callers is (800) 891-8357. International callers may dial (212) 231-2921. All callers will be asked to enter the reservation number 21703449. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the above reservation number. The conference call also will be available through a live webcast at www.myriad.com.
About Crescendo Biosciences
Crescendo Bioscience, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, CA. Crescendo Bioscience develops quantitative, objective, blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases. For more information, please visit the company’s website at http://www.CrescendoBio.com.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad’s molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual’s decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, Melaris, Myriad myPath, Myriad myPlan, Myriad myRisk, TheraGuide, Prezeon, Panexia, and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the timing of the closing of the proposed acquisition; the fit of Crescendo into the Company’s diagnostic portfolio and diversification of the Company’s business as a result of this acquisition; the expected addition of Crescendo employees to the Myriad team; Crescendo’s position in the rheumatoid arthritis diagnostic market and its ability to move to the next level in terms of scale and growth with the Company’s assistance; Crescendo’s vision of multiple opportunities over the next several years; the anticipated benefits of the acquisition of Crescendo set forth under the caption “Benefits of the Transaction;” the Company’s intent to fund the transaction entirely through cash and marketable securities on hand and the Company’s expectation of having sufficient cash following the transaction to continue its current $300 million share repurchase program; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
(PTX) Attracts $65 Million Institutional Investment
Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) (“Pernix” or the “Company”), a specialty pharmaceutical company, today announced that it has hired industry veteran Doug Drysdale as Chief Executive Officer. Mr. Drysdale has also been appointed to the Company’s Board of Directors and shall serve as Chairman. Mr. Drysdale’s appointment is supported by a group of institutional investors led by Athyrium Capital Management, who have agreed to purchase $65 million aggregate principal amount of 8.00% Convertible Senior Notes due 2019 (the “Notes”) from Pernix, providing the company with expansion capital for the acquisition of accretive specialty products to be added to the Company’s portfolio, as well as for working capital and general corporate purposes.
Appointment of Doug Drysdale as Chief Executive Officer
Mr. Drysdale most recently served as Chief Executive Officer of Alvogen, Inc., from 2008 to 2013, building the company from inception to become a global leader in pharmaceuticals. Alvogen now operates in thirty countries and has a portfolio of over 200 projects in development and registration. Prior to Alvogen, Mr. Drysdale helped build the multinational pharmaceutical giant Actavis, as head of mergers and acquisitions and a member of the executive board, spearheading specialty acquisitions such as Sindan (oncology) and Abrika (CR formulations). Recognized in 2012 as an Ernst & Young Entrepreneur of the Year, Mr. Drysdale brings a track record of accomplishment earned over the course of a twenty-five year career in the healthcare industry. Prior industry leadership positions also include Vice President of Global Business Development with Alpharma, Inc.; Global Licensing with Forest Laboratories, Inc.; Executive Vice President and Co-Founder of Alkensa, Inc.; and Director Business Development with Elan Corp, plc.
“Doug is a proven value creator for shareholders,” said Mike Pearce, board member and former chief executive officer of Pernix. “Fortified with expansion capital and a stable platform free of legacy issues, I believe he will lead Pernix to unprecedented heights.”
Commenting on his appointment, Mr. Drysdale said, “I am excited to be leading Pernix toward a brighter future. Armed with a strong war chest and with the support of the Pernix board, the Company is well-positioned to acquire specialty pharmaceutical products to add to its portfolio. By focusing less on primary care and more on specialty audiences, Pernix can better leverage its sales and marketing expertise, create cross-selling opportunities, and provide a more cohesive continuum of care to patients and physicians.” Mr. Drysdale added, “I want to thank Mike for doing a great job of steadying the ship during a period of restructuring for Pernix. I look forward to working with Mike and the other members of our board of directors.”
Mike Pearce, who has resigned as chief executive officer, has agreed to remain with the company through a transition period. Further changes to the Company’s board of directors will be announced in due course as the Company looks to add additional industry talent to its board.
Pricing of $65 Million of 8.00% Convertible Senior Notes
The Notes, which mature in 2019 unless earlier converted, carry a coupon of 8% and are convertible into shares of Pernix common stock at an initial conversion price of $3.60 per share, representing a conversion premium of more than 70% over the last reported sale price of Pernix’s common stock on the NASDAQ Global Market on February 4, 2014.
The purchase of the Notes is expected to close as soon as practicable, subject to the satisfaction of customary closing conditions. The Notes will be issued at a price equal to 100% of the principal amount thereof.
The offering of the Notes was limited to institutional accredited investors and qualified institutional buyers pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Neither the Notes nor any shares of Pernix’s common stock issuable upon conversion of the Notes have been registered under the Securities Act or under any state securities laws and, unless so registered, may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.
Settlement of Legal Liabilities
Pernix today also announced favorable resolution of pending legal matters.
On January 29, 2014, a Stipulation of Dismissal was filed with the United States District Court for the Southern District of Texas in connection with the settlement of all claims brought against Pernix by the former shareholders of Cypress Pharmaceuticals, Inc. (“Cypress”) and all claims brought against the former shareholders of Cypress by Pernix in connection with the purchase of Cypress by Pernix pursuant to the Securities Purchase Agreement by and among Pernix and the former Cypress shareholders (the “Purchase Agreement”). As part of the settlement, Pernix has agreed to pay $1,330,000 to the former Cypress shareholders on or before February 7, 2014, which Pernix accrued at the time of the Cypress acquisition as a contingent consideration in the Company’s financial statements. In exchange for this payment, both parties released all claims against the other parties, which includes the former Cypress shareholders waiving any rights to the put obligation of Pernix included in the Purchase Agreement. Additionally, the payment repays in full all currently existing obligations by Pernix to fund the escrow account or to pay the holdback amount under the Purchase Agreement. The settlement also modified the language relating to a prospective product milestone payment to the former Cypress shareholders pursuant to the Purchase Agreement with an aim toward greater product development flexibility, but still reflects a one-time payment of $5,000,000, payable in cash or stock, upon the achievement of an NDA acceptance by the FDA of any one of the four pipeline products transferred in the acquisition of Cypress.
In resolution of a separate and unrelated matter, Pernix also reports that it has reached an agreement with the Attorney General of the State of Texas to settle all claims arising from certain actions by Cypress prior to its acquisition by Pernix under the Texas Medicaid Fraud Protection Act in conjunction with a Civil Investigative Demand made on Cypress and referencing a $42 million preliminary claim. In settlement, Pernix has agreed to pay $12,000,000 to the State of Texas, which the Company accrued and charged to expense in the Company’s financial statements at December 31, 2013. An initial payment of $2,000,000, which has already been paid to the Company’s counsel, is due and payable within ten business days of the effective date of the final settlement agreement. Thereafter, Pernix shall make subsequent payments of $2,000,000 on each of the first five anniversaries of the effective date of the settlement agreement.
Conference Call
Management will host a conference call on Wednesday, February 5, 2014 at 4:30 p.m. to discuss these developments. The conference call will feature remarks from Michael Pearce, outgoing Chairman and Chief Executive Officer, and Doug Drysdale, incoming Chairman and Chief Executive Officer. To participate in the live conference call, please dial (877) 312-8783 (domestic) or (408) 940-3874 (international), and provide conference ID code 59083028. A live webcast of the call will also be available on the investor relations section of the Company website, www.pernixtx.com. Please allow extra time prior to the webcast to register and download and install any necessary audio software.
A replay of the call will be available through February 12, 2014. To access the replay, please dial (855) 859-2056 (domestic) and (404) 537-3406 (international), and provide conference ID code 59083028. An online archive of the webcast will be available on the Company’s website for 30 days following the call.
About Athyrium Capital Management
Athyrium Capital Management, LLC is an asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium invests across all healthcare verticals including biopharma, medical devices and products, and healthcare services and partners with management teams to implement creative financing solutions to companies’ capital needs. The Athyrium team has substantial investment experience in the healthcare sector across a wide range of asset classes, including public equity, private equity, fixed income, royalties, and other structured securities. Athyrium has over $600 million under management as of September 30, 2013. The firm’s investors include public and corporate pension funds, charitable endowments, insurance companies, funds-of-funds, family offices, and university endowments. For more information, please visit www.athyrium.com.
About Pernix Therapeutics Holdings, Inc.
Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, manufacturing and development of branded pharmaceutical products. The Company markets a portfolio of branded products, including: CEDAX®, an antibiotic for middle ear infections; NATROBA™, a topical treatment for head lice; ZUTRIPRO®, for the treatment of cough and cold; OMECLAMOX-PAK®, a 10-day treatment for H. pylori infection and duodenal ulcer disease; and REZYST™, a dietary pro-biotic. The Company also markets SILENOR, a non-narcotic product for the treatment of insomnia. The Company promotes its branded products to physicians through its Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Cypress Pharmaceuticals and Macoven Pharmaceuticals. The Company’s wholly owned subsidiary, Pernix Manufacturing, manufactures and packages products for the pharmaceutical industry in a wide range of dosage forms. Founded in 1996, the Company is based in Houston, TX.
Additional information about Pernix is available on the Company’s website located at www.pernixtx.com.
Cautionary Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. Because these statements reflect the Company’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption “Risk Factors” in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in the Company’s Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
(CYTR) Announces Closing of Public Offering of Common Stock
CytRx Announces Closing of Public Offering of Common Stock, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the closing of its previously announced underwritten public offering. The gross proceeds to CytRx from its sale of 13,225,000 shares of common stock at a price to the public of $6.50 per share, which include the proceeds from the exercise of the underwriters’ option to purchase an additional 1,725,000 shares, were approximately $86.0 million, prior to deducting underwriting discounts and commissions and other offering expenses payable by CytRx.
CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures.
Jefferies LLC acted as the sole book-running manager for the offering. Oppenheimer & Co. Inc., Aegis Capital Corp. and H.C. Wainwright & Co., LLC acted as co-lead managers for the offering.
The shares described above were sold pursuant to a shelf registration statement on Form S-3, including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC). The final prospectus supplement related to the offering also has been filed with the SEC. Copies of the final prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, by email at Prospectus_Department@Jefferies.com or by phone at 877-547-6340 or by accessing the SEC’s website at http://www.sec.gov.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin.
Forward-Looking Statements
This press release contains statements relating to the offering that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(ATNM) to Present at the 16th Annual BIO CEO & Investor Conference
Company Looks Forward to Communicating its Exciting Prospects and Meeting with Conference Attendees
Actinium Pharmaceuticals, Inc. (OTCQB:ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that Dr. Kaushik J. Dave, President and CEO, will present at the 16th Annual BIO CEO & Investor Conference from February 10th to 11th, 2014. Dr. Dave will present an overview of the company on Tuesday, February 11, 2014 at 1:30 pm ET.
Presentation Information: | ||||
Date: | Tuesday, February 11, 2014 | |||
Time: | 1:30 pm ET | |||
Location: | The Waldorf-Astoria Hotel: Conrad Room, New York, NY | |||
Webcast: | http://www.veracast.com/webcasts/bio/ceoinvestor2014/68234189.cfm | |||
About Actinium Pharmaceuticals
Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.
For more information:
Visit our web site www.actiniumpharmaceuticals.com
Forward-Looking Statement for Actinium Pharmaceuticals, Inc.
This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
(OHRP) to Present at the 16th Annual BIO CEO & Investor Conference
NEW YORK, NYvia eTeligisOhr Pharmaceutical (NASDAQ: OHRP), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced that Irach Taraporewala, Ph.D., Chief Executive Officer, will present a corporate overview and business update at the 16th Annual BIO CEO & Investor Conference, being held at The Waldorf Astoria in New York City on February 10-11, 2014.
Details of the presentation are as follows:
Date: Tuesday, February 11, 2014
Time: 9:00am Eastern Time
Webcast: http://www.veracast.com/webcasts/bio/ceoinvestor2014/66223481077.cfm
Location: Waldorf Astoria, Basildon Room
About Ohr Pharmaceutical Inc.
Ohr Pharmaceutical Inc. (OHRP) is a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets. The Company is focused on advancing its pipeline products currently in phase II clinical development: Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia. Additional information on the company can be found at www.ohrpharmaceutical.com.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA or Health Canada will approve final testing or marketing of any pharmaceutical product. Ohr’s most recent Annual Report and subsequent Quarterly Reports discuss some of the important risk factors that may affect our business, results of operations and financial condition. We disclaim any intent to revise or update publicly any forward-looking statements for any reason.
Contact:
Ohr Pharmaceutical Inc.
Investor Relations
(877) 215-4813
ir@ohrpharmaceutical.com
LifeSci Advisors, LLC
Michael Rice
646-597-6987
mrice@lifesciadvisors.com
(OVAS) Appoints Fertility Pioneer Jamie Grifo M.D., Ph.D., to Clinical Advisory Board
OvaScienceSM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of female fertility treatments, announced today the appointment of Jamie Grifo, M.D., Ph.D., of the New York University (NYU) Fertility Center and the Division of Reproductive Endocrinology at the NYU School of Medicine, to its Clinical Advisory Board.
“Throughout his career, Dr. Grifo has been at the forefront of bringing the latest innovations in fertility to patients, such as pre-implantation genetic diagnosis,” said Michelle Dipp, Chief Executive Officer, OvaScience. “His research continues to drive major advances in the field and we look forward to his contributions to OvaScience.”
“As more women delay childbearing, which can result in decreased egg quality, there are a growing number of patients seeking fertility treatments that could benefit from new innovations in the field,” said Dr. Grifo. “OvaScience’s EggPCSM technology is unique in that it has the potential to improve egg quality and offer new possibilities for helping women build their own families.”
Dr. Grifo is renowned in reproductive medicine for his technical innovation and leadership. His team pioneered the first successful use of pre-implantation genetic diagnosis (PGD) in the U.S., a technique which has been used in the assisted reproduction of thousands of children worldwide. Dr. Grifo’s research also produced the NYU Vitrification Method, a standard of care at NYU Fertility Center since 2004. Additional research focuses on egg freezing and stem cells.
Dr. Grifo is the Program Director of the New York University (NYU) Fertility Center. Since 1995 he has been the Director of the Division of Reproductive Endocrinology at the NYU School of Medicine where he also holds the faculty appointment of Professor of Obstetrics and Gynecology. He received his M.D. and Ph.D. degrees at Case Western Reserve School of Medicine. A member of the American Society for Reproductive Medicine since 1989, Dr. Grifo has served on the Ethics Committee and is past president of the Society for Assisted Reproductive Technologies.
About OvaScience
OvaScience (NASDAQ: OVAS) is a life sciences company focused on the discovery, development and commercialization of new fertility treatments. The Company’s patented technology is based on the discovery of egg precursor cells (EggPCSM), which are found in the ovaries. By applying proprietary technology to identify and purify EggPCs, OvaScience is developing potential next generation in vitro fertilization (IVF) treatments. The Company currently has three fertility treatments in development: AUGMENTSM, which aims to improve egg quality and increase the success of IVF; OvaPrimeSM, designed to boost a woman’s egg reserve using her own EggPCs; and OvaTureSM, which seeks to create mature fertilizable eggs from a woman’s own EggPCs without the need for hormone injections. OvaScience’s team of scientists, physicians and advisers includes recognized leaders in the field of reproductive medicine. For more information, please visit www.ovascience.com and connect with us on Twitter and Facebook.
Forward-Looking Statements
This press release includes forward-looking statements about the prospects for the Company’s technology in addressing female infertility, the Company’s strategy, future plans and prospects, and the development and commercialization of the Company’s product candidates. Any statements in this release about our strategy, plans, prospects and future expectations, financial position and operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” ”aim,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: our expectations regarding the regulatory approvals required for AUGMENT outside of the United States and our expectation that AUGMENT meets the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we plan to introduce AUGMENT in ACE clinics; the science underlying our product candidates (including AUGMENT, OvaPrime and OvaTure), which is unproven; our ability to obtain, maintain and protect intellectual property utilized by our products; our ability to obtain additional funding to support our activities; our dependence on third parties, including our dependence on Intrexon Corporation; the successful development of, and ability to obtain regulatory approval for, our product candidates; our ability to develop our product candidates, including AUGMENT, OvaPrime and OvaTure, on the timelines we expect, if at all; our ability to commercialize our product candidates, including AUGMENT and OvaPrime, on the timelines we expect, if at all; competition from others; and our short operating history; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.
(ATMI) Entegris to Acquire ATMI
Transaction Combines Two Preeminent Suppliers of Critical Technology to the Semiconductor Industry
ATMI Shareholders to Receive $34.00 per Share in Cash
Expected to be Immediately Accretive to non-GAAP EPS
BILLERICA, Mass. and DANBURY, Conn., Feb. 4, 2014 — Entegris, Inc. (Nasdaq:ENTG) and ATMI (Nasdaq:ATMI) today announced that the Boards of Directors of both companies have unanimously approved a definitive merger agreement under which Entegris will acquire ATMI for a total equity value of approximately $1.15 billion on a fully-diluted basis, or approximately $850 million net of cash acquired, including the net cash proceeds from the sale of ATMI’s LifeSciences business of $170 million.
Under the terms of the merger agreement, ATMI shareholders will receive $34.00 in cash, without interest or dividends, for each share of ATMI common stock they hold at the time of closing. The companies anticipate closing the transaction in the second quarter of 2014. The price represents a premium of 26.3 percent to ATMI’s closing price of $26.93 on February 3, 2014. The transaction is expected to yield approximately $30 million in annualized cost synergies. Entegris expects to fund the all-cash transaction with a combination of existing cash balances and additional committed debt financing, and expects it to be immediately accretive to non-GAAP earnings per share (EPS).
The combination brings together two key suppliers in the semiconductor industry to create a technology leader in advanced process materials, contamination control and wafer handling. By leveraging ATMI’s market-leading critical products, global infrastructure and expertise in key processes, Entegris will have an even stronger platform to serve the demanding technology needs of the world’s largest semiconductor makers and other electronics companies. The transaction will also provide a broader set of growth opportunities, and the company will sustain its investments in R&D, infrastructure and metrology to support that growth.
Bertrand Loy, President and Chief Executive Officer of Entegris said, “ATMI’s microelectronics business is an excellent fit with Entegris and provides us with a premium portfolio of products that will enable us to create enhanced value. ATMI and Entegris share a long and successful history of solving some of the most difficult yield challenges facing the industry. Together, we will be uniquely positioned with innovative yield-enhancing solutions to address the increasing complexity and cost of new semiconductor processes. Upon closing, approximately 80% of our product sales will be unit-driven and focused on the most rapidly growing and critical areas of the semiconductor fab. We are excited about the opportunities ahead and look forward to quickly realizing the significant benefits of this transaction for our shareholders, customers and employees.”
Doug Neugold, President and Chief Executive Officer of ATMI, said, “Throughout this process, our goal has been to enter into a transaction that not only maximizes shareholder value, but also places our business with the right partner for our valued customers and employees. We are pleased to merge our microelectronics business into Entegris. Entegris’ global platform and complementary products represents a great opportunity for ATMI stakeholders, including our shareholders, who will receive an immediate premium for their investment.”
Financial Benefits
The combination is expected to generate annualized cost synergies of approximately $30 million, achieved through identified operational efficiencies and overhead consolidation. The combined company will have an efficient balance sheet, benefitting from the deployment of excess cash and the addition of attractive debt financing. The transaction is expected to be immediately accretive to non-GAAP EPS with the potential for significant earnings leverage as the combined company’s cash flow generation enables the repayment of debt.
Closing Conditions
The transaction is subject to regulatory approvals of both U.S. and international regulators, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act, as well as other customary closing conditions. The transaction is also subject to approval by ATMI shareholders.
The transaction is also conditioned on the closing of ATMI’s previously announced sale of its LifeSciences business, which is expected in the first quarter of 2014.
Entegris and ATMI Fourth Quarter 2013 Earnings Results
In separate press releases issued today, both Entegris and ATMI announced their financial results for the fourth quarter and full year 2013.
Advisors
Goldman, Sachs & Co. is serving as the exclusive financial advisor and Ropes & Gray LLP is serving as legal counsel to Entegris. Barclays Capital is serving as the financial advisor and Weil, Gotshal & Manges LLP is serving as legal counsel to ATMI. Goldman Sachs Bank USA has been appointed to act as the lead arranger and bookrunner for the committed financing that has been obtained by Entegris in connection with the merger and the related transactions.
Conference Call and Webcast Details
Entegris and ATMI will host a joint conference call and online webcast today, February 4, 2014, at 8:30 a.m. Eastern Time to discuss the transaction announcement. It will be streamed live over Entegris’ website at http://investor.entegris.com/events.cfm and over ATMI’s website at http://www.atmi.com/. Interested participants can access the call by dialing toll-free (866) 610-1072 or (973) 935-2840 for international callers and referencing confirmation code #59322873. Participants are asked to dial in 5 to 10 minutes prior to the start of the call. A replay of the call will be available starting February 4, 2013 at 11:30 a.m. Eastern Time and can be accessed telephonically by dialing (800) 585-8367 or (404) 537-3406 and using the passcode #59322873, or by accessing http://investor.entegris.com/events.cfm.
About Entegris
Entegris provides a wide range of products for purifying, protecting and transporting critical materials used in processing and manufacturing in semiconductor and other high-tech industries. Entegris is ISO 9001 certified and has manufacturing, customer service or research facilities in the United States, China, France, Germany, Israel, Japan, Malaysia, Singapore, South Korea and Taiwan. Additional information can be found at www.entegris.com.
About ATMI
ATMI, Inc. is a global provider of specialty semiconductor materials, and safe, high-purity materials handling and delivery solutions designed to increase process efficiencies for the microelectronics, life sciences, and other industries. For more information, please visit http://www.atmi.com.
Important Notice and Additional Information
This communication may be deemed to be solicitation material in respect of the proposed acquisition of ATMI by ENTEGRIS. In connection with the proposed transaction, ATMI intends to file a proxy statement and other related documents with the Securities and Exchange Commission (the “SEC”). INVESTORS AND STOCKHOLDERS OF ATMI ARE ADVISED TO READ THE PROXY STATEMENT AND THESE OTHER MATERIALS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ATMI AND THE PROPOSED TRANSACTION. Investors and stockholders may obtain a free copy of the proxy statement (when available) and other documents filed by ATMI with the SEC at the SEC web site at www.sec.gov. Copies of the proxy statement (when available) and other filings made by ATMI with the SEC can also be obtained, free of charge, by directing a request to Troy Dewar, VP investor Relations and Corporate Communications, ATMI, Inc., 7 Commerce Drive, Danbury, CT 06810. The proxy statement (when available) and such other documents are also available for free on ATMI’s web site at www.atmi.com as soon as reasonably practicable after ATMI electronically files such material with, or furnish it to, the SEC.
Participants in the Solicitation
ATMI and its directors and officers and other persons may be deemed to be participants in the solicitation of proxies from ATMI’s stockholders in connection with the proposed acquisition transaction. Information regarding the directors and executive officers of ATMI is set forth in the proxy statement for ATMI’s 2013 Annual Meeting of Stockholders, which was filed with the SEC on April 11, 2013, and in ATMI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, which was filed with the SEC on February 22, 2013. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available. Investors should read the proxy statement carefully when it becomes available before making any voting or investment decisions.
Cautionary Statement Regarding Forward-Looking Statements
Statements about the expected timing, completion and effects of the proposed merger, and all other statements made in this news release that are not historical facts are forward-looking statements and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, these forward-looking statements may be identified by the use of words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe” or “project,” or the negative of those words or other comparable words. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to Entegris and ATMI as of the date hereof, and, subject to any applicable law to the contrary, Entegris and ATMI undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Such forward-looking statements are subject to a number of risks, assumptions and uncertainties that could cause actual results to differ materially from those projected in such forward-looking statements. Such risks and uncertainties include: any conditions imposed on the parties in connection with consummation of the transaction described herein; approval of the merger by ATMI’s stockholders; the ability to obtain regulatory approvals of the transactions contemplated by the merger agreement on the proposed terms and schedule; the failure of ATMI’s stockholders to approve the transactions contemplated by the merger agreement; ATMI’s ability to maintain relationships with customers, employees or suppliers following the announcement of the merger agreement; the ability of third parties to fulfill their obligations relating to the proposed transactions, including providing financing under current financial market conditions; the ability of the parties to satisfy the conditions to closing of the transactions contemplated by the merger agreement; the risk that the transactions contemplated by the merger agreement may not be completed in the time frame expected by the parties or at all; and the risks that are described from time to time in Entegris and ATMI’S reports filed with the SEC, including Entegris’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, filed with the SEC on February 22, 2013, ATMI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2012, filed with the SEC on February 22, 2013, and in other of Entegris and ATMI’s filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Entegris and ATMI caution investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Entegris and ATMI do not undertake and expressly disclaim any obligation to update or revise them except as otherwise required by law.
CONTACT: Steven Cantor VP of Corporate Relations T +1 978 436 6750 irelations@entegris.com
(FURX) Positive Top-Line Results Pivotal Phase III In IBS-d
Studies Meet FDA and EMA Primary Endpoints Conference Call and Webcast Scheduled for 8:30 a.m. ET Today
Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced top-line results indicating the company’s two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. These endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome.
“I am very pleased with the strength of the data, and proud of our team for its hard work and excellent development of eluxadoline,” said Fred Eshelman, founding chairman of Furiex. “In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials. Additionally, we have completed all toxicology studies and believe we are on schedule, including chemistry and manufacturing work, for an NDA submission by the end of the second quarter of 2014.”
The studies, known as 3001 and 3002, were randomized, double-blind, placebo-controlled studies in which patients received eluxadoline, 75 mg twice-daily (BID), eluxadoline 100 mg BID or placebo BID. A total of 2,428 subjects were enrolled across the two studies. The primary efficacy endpoint was a composite response evaluated over the initial 12 weeks of double-blind treatment for FDA evaluation, and over the 26 weeks of double-blind treatment for EMA evaluation. Response rates were compared based on patients who met the daily composite response criteria (improvement in pain and stool consistency) for at least 50% of the days from weeks 1 to 12 and weeks 1 to 26. A patient must have met both of the following criteria on any given day to be a daily responder:
- Daily stool consistency response: Bristol stool score <5, or the absence of a bowel movement; and
- Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of week prior to randomization).
“We are pleased with these top-line results, which put us one step closer to filling an unmet medical need in men and women with IBS-d,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “In addition to showing both rapid onset and durable efficacy of the primary endpoints, both pivotal studies demonstrated robust efficacy for the secondary endpoint of adequate relief of IBS symptoms. We look forward to further analyzing the data and plan to present details at an upcoming medical conference.”
Eluxadoline has been granted Fast Track status by the FDA, a process designed to facilitate development and expedite the review of drugs to treat diseases with significant unmet medical need.
Key Findings from Study 3002 (intention-to-treat analysis):
Patients receiving eluxadoline demonstrated statistically significantly higher responder rates for the following composite primary endpoints:
- For the FDA composite endpoint (response over weeks 1-12), the responder rates were 29.5% for eluxadoline 100 mg, 28.9% for eluxadoline 75 mg and 16.2% for placebo (p <0.001 both doses); and
- For the EMA composite endpoint (response over weeks 1-26), the responder rates were 32.6% for 100 mg, 30.4% for 75 mg and 20.2% for placebo (p ≤0.001 both doses).
With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher rates of stool consistency response over weeks 1-12, namely 100 mg=35.5%, 75 mg=37.0% and placebo=20.9% (p <0.001 both doses), and numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=50.9% vs. placebo=45.3%, p =0.12).
Key Findings from Study 3001 (intention-to-treat analysis)
Patients receiving eluxadoline demonstrated statistically significantly higher response rates for the following primary composite endpoints:
- For the FDA composite endpoint (response over weeks 1-12), the responder rates were 25.1% for eluxadoline 100 mg (p =0.004), 23.9% for eluxadoline 75 mg (p =0.014) and 17.1% for placebo; and
- For the EMA composite endpoint (response over weeks 1-26), the responder rates were 29.3% for 100 mg (p <0.001), 23.4% for 75 mg (p =0.11) and 19.0% for placebo.
With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher response rates of stool consistency over weeks 1-12, namely 100 mg=34.3%, 75 mg=30.0% and placebo=22.0% (p <0.009 both doses) and, numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=43.2% vs. placebo=39.6%, p =0.28).
Data pooled from studies 3001 and 3002 for the composite endpoint from the two studies demonstrated a differential effect between active and placebo. For the FDA endpoint, the differential effects were 9.5% and 10.3% for 75 and 100 mg respectively. Similarly, for the EMA 26 week endpoint, the differential effects were 7.2% and 11.5% for the 75 and 100 mg respectively. All p values were <0.001.
Eluxadoline had a favorable tolerability and safety profile in the trials. The most commonly reported side effects across the two studies were constipation (8.3% for 100 mg eluxadoline, 7.4% for 75 mg eluxadoline vs. 2.4% for placebo) and nausea (7.3% for 100 mg eluxadoline, 7.8% for 75 mg eluxadoline vs. 4.8% placebo). Sporadic elevations of liver enzymes (>3XULN) were seen in both the active and placebo arms, with a difference between active and placebo <0.5%, all of which resolved. There were infrequent adjudicated events of mild pancreatitis involving five patients who received eluxadoline (0.3% of those treated with the compound). Three of these subjects reported heavy alcohol consumption, one patient was noted to have biliary sludge, a known risk factor for pancreatitis, and one subject experienced transient sphincter of Oddi spasm, which is a known opiate class effect associated with pancreatitis.
About the Eluxadoline Clinical Trial Program
More than 2,500 subjects have received eluxadoline across the Phase I, II and III programs.
Furiex’s Phase III program of eluxadoline consisted of two similar studies – 3001 and 3002. Both were randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of eluxadoline in the treatment of patients with diarrhea-predominant irritable bowel syndrome. The studies involved a pre-treatment phase (consisting of a pre-screening period of up to one week, and a screening period of up to three weeks), and double-blind treatment periods of 52 weeks for study 3001 and 26 weeks for study 3002. Additionally, study 3001 had a two-week post-treatment follow-up period while study 3002 had a four-week, single-blind placebo withdrawal period.
Efficacy assessments for the determination of clinical response were conducted through the first 26 weeks for study 3001, and through 30 weeks for study 3002. The continuation of double-blind treatment through Week 52 for study 3001 allowed for continued observation of the long-term safety of eluxadoline. There were 1,282 and 1,146 patients enrolled into studies 3001 and 3002, respectively; randomization was 1:1:1 eluxadoline 75 mg, eluxadoline 100 mg or placebo.
Company to Host Conference Call
Furiex will conduct a live conference call and webcast Tuesday, February 4, 2014 at 8:30 a.m. ET to discuss the top-line results. A Q&A session will follow. All interested parties can access the webcast through the Presentations and Events link in the Investors section of the Furiex website at www.furiex.com. The webcast will be archived shortly after the call for on-demand replay. The conference call will be broadcast live over the Internet and will also be available using the following direct dial numbers:
Participant dial-in: | + 1 877 677 9122 (U.S./Canada) | |
+ 1 708 290 1401 (International) | ||
Conference ID: | 59157670 |
About IBS-d
IBS-d is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 28 million patients in the U.S. and the major markets in Europe. Although the exact cause of IBS-d is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact. IBS-d can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-d is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.
About Eluxadoline
Eluxadoline is a novel, orally active investigational agent with combined mu opioid receptor agonist and delta opioid receptor antagonist activity which acts locally in the gut and has very low oral bioavailability. This dual opioid activity is designed to treat diarrhea and pain symptoms of IBS-d, without causing the constipating side effects that can occur with unopposed mu opioid agonists. Eluxadoline has been granted Fast Track status by the FDA, a process designed to facilitate development and expedite the review of drugs to treat diseases with significant unmet medical need.
About Furiex
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The Company collaborates with pharmaceutical and biotechnology companies and has a diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, and four products on the market. The Company’s mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: progress of compounds in clinical trials and regulatory approvals; potential changes to regulatory guidance by regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency; the risk of finding a collaborator for our late-stage compounds, or risks involved in our attempting to commercialize compounds ourselves; continuing losses and our potential need for additional financing; the risks and expense of continuing the research and development activities of our existing compounds; inability of collaborators to effectively market approved products for which we receive royalty and sales-based milestone payments; changes in the safety and efficacy profile of our existing compounds as they progress through research and development; new collaborative agreements that we might enter into in the future; the costs of defending any patent opposition or litigation necessary to protect our proprietary technologies; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.
(IPCI) Receives $3.1 Million From Par Pharmaceuticals, Inc.
– First Profit-Share Payment on 15 and 30 mg Generic Focalin XR® Sales
TORONTO, Feb. 3, 2014 — Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced the receipt of approximately $3.1 million as its first payment relating to commercial sales of dexmethylphenidate hydrochloride extended-release capsules by its licensee Par Pharmaceutical, Inc. (“Par”). This represents the Company’s share of profits for the 15 and 30 mg strengths of the drug product for the period commencing with the first commercial sales of those strengths on November 19, 2013 and ending December 31, 2013 under its License and Commercialization Agreement with Par. Future profit-share payments are expected on a quarterly basis, although the amounts of any such payments cannot now be determined and may vary significantly from time-to-time. All dollar amounts referenced herein are in United States dollars unless otherwise noted.
As the first-filer for the drug product in the 15 mg strength, the Company currently has 180 days of exclusivity of generic sales for that strength from the November 19, 2013 date of launch in the United States by Par. In addition, Intellipharmaceutics has the potential to receive its share of the profits on the 5, 10, 20 and 40 mg strengths which were also tentatively approved by the United States Food and Drug Administration (“FDA”), subject to the right of another party or parties to 180 days of generic exclusivity from the date of first launch of such strengths of the drug product by such parties. The Company currently believes Par intends to launch these strengths immediately upon the expiry of those exclusivity periods and upon the anticipated final approvals from the FDA at those times, but there can be no assurance as to if or when any such approvals or launches will occur.
At the present time, publicly available records of the FDA show that only four entities, including the Company, have received approvals or tentative approvals to market one or more generic strengths of this drug product. Further, the Company believes that only three of those entities, including the Company, have commenced sales of one or more generic strengths of the drug product. Dr. Isa Odidi, CEO and co-founder of the Company, stated, “We believe that the number of competitors tentatively approved or in the market at this time is an indication that our drug delivery technologies and competence are robust and well-adapted to the formulation of difficult-to-replicate generic drug products.”
Intellipharmaceutics disclaims any intention and has no obligation or responsibility, except as required by law, to make, update or revise any statements regarding any future profit-share payments under its agreement with Par.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company’s patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and has recently been granted final FDA approval for its dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths. In addition, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including Abbreviated New Drug Applications (“ANDAs”) filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexista™ oxycodone, an abuse-deterrent oxycodone, based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and Regabatin™ XR pregabalin extended-release capsules.
Certain statements in this document constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or “forward-looking information” under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” “intends,” “could,” or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies and products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing, the timing and success of product launches, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA and other governmental regulations applicable to the Company and its third party manufacturers’ facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, as amended, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S. The forward-looking statements are made as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Company Contact: Intellipharmaceutics International Inc. Shameze Rampertab Vice President Finance & CFO 416-798-3001 investors@intellipharmaceutics.com Investor Contact: ProActive Capital Kirin Smith 646-863-6519 ksmith@proactivecapital.com
(IFON) Broadens Product Line with Launch of the verykool® T742 KolorPad™ Tablet
SAN DIEGO, Feb. 3, 2014 — InfoSonics Corporation (NASDAQ: IFON) today announced the launch of its new verykool® T742 tablet with Wi-Fi and 3G capabilities.
The T742, nicknamed the KolorPadTM, is a 7-inch tablet powered by a 1.3 GHz dual core processor and the Android 4.2 operating system. This full-featured tablet is being offered at a suggested retail price of $149.
“We are thrilled to release our T742 KolorPadTM tablet, which will unlock a multitude of possibilities for users at an incredibly affordable price,” said Joseph Ram, the company’s president and chief executive officer. “The T742 is a compact tablet featuring a 7-inch capacitive LCD touchscreen, up to 32 GBs of external storage, USB tethering and Bluetooth 4.0. Whether you primarily use your tablet for reading eBooks and browsing the internet, or playing games and checking e-mail, the T742 has the capacity to accommodate most every need. The tablet also supports HID (Human Interface Device) of the Bluetooth profile, so it can connect to a keyboard, mouse and even game joysticks through a USB on-the-go interface. As an added value, each tablet is packaged with a stereo headset, data cable, travel adapter, USB on-the-go cable and case.”
Additional details on the T742 are as follows:
- 3G HSDPA (21Mbps, HSUPA 5.76Mbps) Dual band (850/1900) and 2G GSM Quad band (850/900/1800/1900)
- WAP, SMS and MMS e-mail (POP3, IMAP), plus push e-mail
- GPS, gravity sensor, and turn by turn navigation
- 3 megapixel rear camera plus front facing VGA camera
- Built-in FM radio and MP3 music player
- 2,500 mAh Li-ion battery
- USB port, 3.5mm audio jack, and loudspeaker
The verykool® T742 KolorPadTM Tablet is available now. To learn more about the device, visit our verykool® website at http://www.verykool.net/Products/T742
About InfoSonics Corporation
InfoSonics is a San Diego-based designer, manufacturer and provider of wireless handsets and related products to OEMs, carriers, distributors and consumers in the United States, Latin America, Europe, Africa and Asia Pacific. The company is committed to delivering quality products with innovative industrial designs that appeal to consumers and offer exceptional value. InfoSonics sells and supports its own line of products under the verykool®and other private label brands. Additional information can be found on our corporate website at www.infosonics.com and www.verykool.net.
Except for the factual statements made herein, the information contained in this news release consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not guarantees of performance and our actual results could differ materially from those contained in such statements. Factors that could cause or contribute to such differences include, without limitation: (1) customer acceptance of the new T742 tablet; (2) our ability to continue to differentiate our products, including the T742, from the competition; (3) significant changes in supplier terms and relationships or shortages in component or product supply; (4) extended general economic downturn in world markets; (5) inability to secure adequate supply of competitive products on a timely basis and on commercially reasonable terms; (6) inability to attract new sources of profitable business from expansion of products or services or risks associated with entry into new markets, including geographies, products and services; and (7) rapid product improvement and technological changes leading to changes in consumer demand for multimedia wireless handset products and features. Reference is also made to other factors detailed from time to time in our periodic reports filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this release and we undertake no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date of this release.
Note: All trademarks and copyrights other than InfoSonics and verykool are property of their respective owners.
(GIG) Offers Its Custom Structured ASIC Solutions for Rapid Productization of Cryptocurrency
GigOptix, Inc. (NYSE MKT: GIG), a leading supplier of advanced high speed semiconductor components and Structured ASIC chips for use in various areas such as Cloud connectivity, data centers, consumer electronics links and interactive applications, through optical and wireless communications networks, today announced that its Custom Structured ASIC applications are establishing GigOptix as one the foremost providers of ASICs for the fast growing cryptocurrency bit mining market.
Based on recent product releases, the combination of GigOptix’s leading Structured ASIC and Standard Cell technology have proven the customizable CMOS platform to be a cost effective, high-performance structured ASIC solution with a dramatically reduced product turnaround time compared to traditional ASIC sources. This makes it an excellent offering to address the recently emerging computationally intensive cryptocurrency applications like Bitcoin (BTC), Litecoin (LTC), Dogecoin (DOGE), Ripple (XRP), Peercoin (PPC), Mastercoin (MSC), and Namecoin (NMC).
“GigOptix Structured ASICs provide a quickly deployed, low cost alternative in high-speed systems where FPGAs have been traditionally employed. We are pleased to see a strong interest in cryptocurrency applications where high speed is paramount and low power is becoming more important,” said Anil Chaudhry, Vice President and General Manager of the ASIC Product Line at GigOptix. “Many cryptocurrencies have increasing computational complexity with rapid design cycles, which GigOptix Structured ASICs know-how and Intellectual Property (IP) address efficiently through advanced CMOS processes and fast turnaround times. We take care of the productized silicon so that our customers – from recreational hobbyists to the most advanced commercial digital drilling operations – can focus on their algorithms and system interaction.”
GigOptix’s Custom Structured ASIC technology requires customization of only the metal interconnect layers, making the development cost a fraction of the upfront Non-Recurring Engineering (NRE) investment normally required by other suppliers for a fully custom Standard Cell ASIC. GigOptix technology enables the bit mining system developers to access the necessary technology for building ASICs at an affordable upfront cost instead of using high powered, high cost FPGA’s or high NRE fully custom Standard Cell ASICs. The reduced manufacturing turnaround times associated with GigOptix Custom Structured ASICs are a further advantage to the bit mining community, where fast time to market is critical to the successful deployment of new systems.
GigOptix is actively engaged as a partner for silicon manufacturing for the bit mining community’s newest ASIC designs, with a wide range of applications from the smallest silicon geometries to larger process nodes. This enables a variety of project scales and related budgets, thus minimizing the upfront development costs normally associated with this type of ASIC development. By leveraging robust customization, developers will benefit from lower development costs while delivering a faster time to market.
GigOptix ASIC Applications
For ASIC applications, GigOptix provides the broadest offering of value-added ASIC solutions, including Standard Cell, Structured ASIC and Custom Structured ASIC technologies. GigOptix has completed more than 2000 ASIC designs over its history. A rich portfolio of analog and digital IP’s particularly for optical applications and complimentary technical skills in analog and digital design, enables GigOptix to develop new products and expand its offering for various applications for established and emerging technologies.
About GigOptix, Inc.
GigOptix is a leading fabless supplier of high speed semiconductor components that enable end-to-end information streaming over optical and wireless networks. The products address long haul and metro telecom applications as well as emerging high-growth opportunities for Cloud and data centers connectivity, and interactive applications for consumer electronics. GigOptix offers a unique broad portfolio of Drivers and TIAs for 40Gbps, 100Gbps and 400Gbps fiber-optic telecommunications and data-communications networks, and high performance MMIC solutions that enable next generation wireless microwave systems up to 90GHz. GigOptix also offers a wide range of digital and mixed-signal ASIC solutions and enables product lifetime extension through its GigOptix Sunset Rescue Program.
(BEAT) Announces Significant Patent Litigation Victory
MALVERN, Pa., Feb. 3, 2014 — BioTelemetry, Inc. (Nasdaq:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, announced today a significant victory in the patent infringement case against Mednet Healthcare Technologies, Inc. and its subsidiaries, Heart-Care Corporation of America, Universal Medical Inc., and Universal Medical Laboratory, Inc. (“Mednet”), as well as other named defendants. Mednet entered into a consent judgment, declaring that the Mednet entities infringed on five patents owned by BioTelemetry and its subsidiary, Braemar Manufacturing, and that all five patents are valid.
The lawsuit, which was filed in the U.S. District Court for the Eastern District of Pennsylvania in May 2012, centered on patented technology used in BioTelemetry’s Mobile Cardiac Outpatient Telemetry (MCOTTM). A litigation team from Ropes & Gray represented BioTelemetry in the case.
Following the entry of the consent judgment, BioTelemetry acquired all outstanding shares of Mednet for an aggregate purchase price of approximately $16.0 million, consisting of $5.5 million of cash, $0.8 million of BioTelemetry common stock and the assumption of $9.7 million of debt. Mednet’s core competencies include outpatient cardiac monitoring and contract manufacturing of cardiac monitoring devices.
Joseph H. Capper, President and Chief Executive Officer of BioTelemetry, commented, “I believe the acquisition of Mednet is the best possible outcome for all involved. While an unorthodox path to such a combination, the company will benefit from Mednet’s more than $25 million in annual revenue and its reputation for world class customer service. We expect the acquisition to be accretive, adding $4.0 to $5.0 million of EBITDA post-integration. We are pleased to add the Mednet employees to the BioTelemetry team and look forward to continuing to provide superior service to their many loyal customers.”
Christopher Keane, President of Mednet, commented, “This merger is the perfect fit for the Mednet family. It will allow Mednet to continue to provide unparalleled service while allowing us to offer Biotelemetry’s industry leading technology to our customers.”
About BioTelemetry
BioTelemetry, Inc., formerly known as CardioNet, Inc., is the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care. The Company currently provides cardiac monitoring services, original equipment manufacturing with a primary focus on cardiac monitoring devices and centralized cardiac core laboratory services. More information can be found at www.biotelinc.com.
Cautionary Statement Regarding Forward-Looking Statements
This document includes certain forward-looking statements within the meaning of the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the impact of the Mednet acquisition on our operations and our ability to successfully integrate their operations, the prospects for our products and our confidence in the Company’s future, as well as our expectations regarding the effect the United contract will have on the company’s operating results. These statements may be identified by words such as “expect,” “anticipate,” “estimate,” “intend,” “plan,” “believe,” “promises” and other words and terms of similar meaning. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including important factors that could delay, divert, or change any of these expectations, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, effects of changes in health care legislation, effectiveness of our cost savings initiatives, relationships with our government and commercial payors, changes to insurance coverage and reimbursement levels for our products, the success of our sales and marketing initiatives, our ability to attract and retain talented executive management and sales personnel, our ability to identify acquisition candidates, acquire them on attractive terms and integrate their operations into our business, the commercialization of new products, market factors, internal research and development initiatives, partnered research and development initiatives, competitive product development, changes in governmental regulations and legislation, the continued consolidation of payors, acceptance of our new products and services, patent protection, adverse regulatory action, and litigation success, our ability to successfully create a new holding company structure and to anticipate the benefits of such structure. For further details and a discussion of these and other risks and uncertainties, please see our public filings with the Securities and Exchange Commission, including our latest periodic reports on Form 10-K and 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
CONTACT: BioTelemetry, Inc. Heather C. Getz Investor Relations 800-908-7103 investorrelations@cardionet.com
(HOTR) Completes Acquisition of Hooters Pacific Northwest Franchise
Company Also Completes Acquisition of Spoon Bar & Kitchen
CHARLOTTE, NC–(February 03, 2014) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (Chanticleer Holdings or the “Company”), a minority holder in the privately held parent company of the Hooters® brand Hooters Of America, and a franchisee of international Hooters restaurants, has announced that it has completed the acquisition of Hooters’ U.S. Pacific Northwest franchise rights and two existing restaurants in Oregon and Washington.
Chanticleer has acquired 100% of the shares of Tacoma Wings, LLC and Hooters of Oregon Partners, LLC, owners and operators of the two locations in Portland, OR and Tacoma, WA. All leasehold and current franchise rights to the Hooters locations in Oregon and Washington have been transferred to the Company and Management is evaluating locations around the Portland and Seattle areas for future restaurant openings.
In addition, Chanticleer also completed its acquisition of Chef John Tesar’s fine dining seafood restaurant, Spoon Bar & Kitchen, located in Dallas, TX, acquiring 100% of the shares of Dallas Spoon, LLC and Dallas Spoon Beverage, LLC. The Company intends to expand the Spoon brand taking its healthier seafood menu into a new, fast-casual dining concept.
Mike Pruitt, Chairman and Chief Executive Officer, commented, “We are starting off the new year successfully completing both of these acquisitions and more importantly adding three operating restaurants to our portfolio. The Pacific Northwest provides strategic opportunities to expand the footprint of our brands.”
For more information on the transactions, please refer to Chanticleer Holdings’ filings at www.sec.gov.
About Chanticleer Holdings, Inc
Headquartered in a Charlotte, NC, Chanticleer Holdings (HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including England, South Africa, Hungary, and Brazil and has joint ventured with the current Hooters franchisee in Australia and domestically in Oregon and Washington. Chanticleer is evaluating several additional international opportunities. The Company also owns and operates American Roadside Burgers and owns a majority interest in Just Fresh restaurants in the U.S.
For further information, please visit www.chanticleerholdings.com
Facebook: www.Facebook.com/ChanticleerHOTR
Twitter: http://Twitter.com/ChanticleerHOTR
Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts
Forward-Looking Statements:
Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Press Information:
Chanticleer Holdings, Inc.
Investor Relations
Phone: 704.366.5122
ir@chanticleerholdings.com
(CYTR) to Present at the 16th Annual BIO CEO & Investor Conference on Feb 10
CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that President and CEO Steven A. Kriegsman and Vice President of Business Development David Haen will present at the 16th Annual BIO CEO & Investor Conference on Monday, February 10, 2014, at 2:30 p.m. Eastern time (11:30 a.m. Pacific time). The conference is being held February 10-11 at the Waldorf Astoria Hotel in New York City.
A live and archived webcast of the presentation will be available on the Company’s website at www.cytrx.com/investors/presentations.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in patients with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy, and recently announced that it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in that clinical trial. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in patients with late-stage glioblastoma (brain cancer), and a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.
About the BIO CEO & Investor Conference
Now in its sixteenth year, the BIO CEO & Investor Conference is the largest investor conference focused on established and emerging publicly traded and select private biotech companies. Each year the BIO CEO & Investor Conference provides a neutral forum where institutional investors, industry analysts, and senior biotechnology executives have the opportunity to shape the future investment landscape of the biotechnology industry. The conference features issue-oriented plenary sessions, educational sessions focused on hot therapeutic areas and key business issues, company presentations, one-on-one meetings, and networking opportunities.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(ENTA) Results from Four All-Oral, Interferon-Free, Phase 3 Hep-C Studies
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) today announced results from the PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II studies. These studies are the remaining four phase 3 studies of the six phase 3 registrational studies being conducted by AbbVie for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection using a regimen containing Enanta’s lead protease inhibitor ABT-450. ABT-450 is part of AbbVie’s investigational three direct-acting antiviral regimen consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. These studies were conducted with and without ribavirin. The combination of the three different mechanisms of action in this regimen interrupts the HCV replication process with the goal of optimizing SVR rates across different patient populations.
Results from these studies demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in these GT1 patients and low rates of discontinuation due to adverse events.
A summary of AbbVie’s Phase 3 clinical trial results for the 3D regimen consisting of ABT-450/ritonavir, ABT-267 and ABT-333 follows:
Study | Patient Type (number) | Treatment Regimen | Treatment Duration |
SVR12 | ||||||||
PEARL-II | GT1b treatment-experienced (n=179) |
|
12 week | 100% | ||||||||
|
12 weeks | 97% | ||||||||||
PEARL-III | GT1b, treatment-naïve (n=419) |
|
12 weeks | 99% | ||||||||
|
12 weeks | 99% | ||||||||||
PEARL-IV | GT1a, treatment-naïve (n=305) |
|
12 weeks | 90% | ||||||||
|
12 weeks | 97% | ||||||||||
TURQUOISE-II | GT1 treatment-naïve and treatment- experienced with compensated cirrhosis (n=380) |
|
12 weeks | 92% | ||||||||
|
24 weeks | 96% | ||||||||||
SAPPHIRE-I | GT1 treatment-naïve (n=631) |
|
12 weeks | 96% | ||||||||
SAPPHIRE-II | GT1 treatment-experienced (n=394) |
|
12 weeks | 96% | ||||||||
Overall, across the four studies, the three direct-acting antiviral regimen was well tolerated with few adverse event-related discontinuations. The most commonly reported adverse events in PEARL-II and PEARL-III were fatigue and headache. In PEARL-IV and TURQUOISE-II, the most commonly reported adverse events were fatigue, headache and nausea.
“We are pleased that SVR rates continue to be high in both treatment-naive and treatment-experienced GT1 HCV patients with and without ribavirin, as well as in the difficult-to-treat compensated cirrhotic patients. In addition, these trials demonstrate the exceptional tolerability of the regimen, with less than one percent (0.8%) of patients discontinuing therapy due to adverse events,” said Jay R. Luly, Ph.D. President and CEO. “We are also pleased that AbbVie has announced it is on track to begin major regulatory submissions early in the second quarter of 2014.”
These six phase 3 trials included 2,308 patients from more than 25 countries around the world. This is the only registrational program to include a dedicated study of an all-oral regimen in patients with compensated cirrhosis. In May 2013, AbbVie’s three direct-acting antiviral regimen with and without ribavirin for GT1 HCV was designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). AbbVie has stated that it intends to disclose detailed study results at future scientific congresses and in publications.
About Study M13-389 (PEARL-II)
PEARL-II is a global, multi-center, randomized, open-label, controlled study to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-experienced adult patients.
The study population consisted of 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis: 91 patients were randomized to the regimen without ribavirin for 12 weeks, and 88 patients were randomized to the regimen plus ribavirin for 12 weeks. In the ribavirin-free arm, 100 percent (n=91/91) of patients achieved SVR12, while 97 percent (n=85/88) achieved SVR12 in the ribavirin-containing arm.
The most commonly reported adverse events were fatigue and headache. Discontinuations due to adverse events were reported in none of the patients in the ribavirin-free arm and two (2 percent) patients in the ribavirin-containing arm. There were no patients in either arm of the study that experienced virologic relapse or breakthrough.
About Study M13-961 (PEARL-III)
PEARL-III is a global, multi-center, randomized, double-blind, controlled study to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-naïve adult patients.
The study population consisted of 419 GT1b treatment-naïve patients with no evidence of liver cirrhosis; 209 patients were randomized to the regimen without ribavirin for 12 weeks, and 210 patients were randomized to the regimen plus ribavirin for 12 weeks. Following 12 weeks of treatment, 99 percent receiving the regimen without ribavirin (n=207/209) and 99 percent receiving the regimen plus ribavirin (n=209/210) achieved SVR12.
The most commonly reported adverse events were fatigue and headache. No patient discontinued study drug due to adverse events. Virologic relapse or breakthrough was noted in none of the patients receiving the regimen without ribavirin and 0.5 percent of patients receiving the regimen plus ribavirin.
About Study M14-002 (PEARL-IV)
PEARL-IV is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with and without ribavirin in non-cirrhotic, GT1a HCV-infected, treatment-naïve adult patients.
The study population consisted of 305 GT1a treatment-naïve patients with no evidence of liver cirrhosis; 205 patients were randomized to the regimen without ribavirin for 12 weeks, and 100 patients were randomized to the regimen with ribavirin for 12 weeks. Following 12 weeks of treatment, 90 percent of patients receiving the regimen without ribavirin (n=185/205) and 97 percent receiving the regimen plus ribavirin (n=97/100) achieved SVR12.
The most commonly reported adverse events were fatigue, headache and nausea. Discontinuations due to adverse events were reported in two (1 percent) patients receiving the regimen without ribavirin and no patients in the ribavirin-containing arm. Virologic relapse or breakthrough was noted in 8 percent of patients receiving the regimen without ribavirin and 2 percent of patients receiving the regimen with ribavirin.
About Study M13-099 (TURQUOISE-II)
TURQUOISE-II is the first phase III study completed exclusively in GT1 cirrhotic patients investigating an all-oral interferon-free regimen. It is a global, multi-center, randomized, open-label study evaluating the efficacy and safety of 12 or 24 weeks of treatment with the three direct-acting antiviral regimen with ribavirin in cirrhotic, GT1a and GT1b HCV-infected, treatment-naïve and treatment-experienced adult patients.
The study population consisted of 380 GT1a and GT1b, treatment-naïve and treatment-experienced patients with compensated cirrhosis; 208 patients were randomized to the regimen plus ribavirin for 12 weeks, and 172 patients were randomized to the regimen plus ribavirin for 24 weeks. Following 12 weeks of treatment, 92 percent of patients (n=191/208) achieved SVR12. Following 24 weeks of treatment, 96 percent of patients (n=165/172) achieved SVR12.
The most commonly reported adverse events were fatigue, headache and nausea. Discontinuations due to adverse events were reported in four (2 percent) patients receiving the regimen with ribavirin for 12 weeks and four (2 percent) patients in the 24-week arm. Virologic relapse or breakthrough was noted in 6 percent of patients in the 12-week arm and 2 percent in the 24-week arm.
Additional information about AbbVie’s phase 3 studies can be found on www.clinicaltrials.gov.
Protease Inhibitor Collaboration with AbbVie (formerly the research-based pharmaceutical business of Abbott Laboratories)
In December 2006, Enanta and Abbott announced a worldwide agreement to collaborate on the discovery, development and commercialization of HCV NS3 and NS3/4A protease inhibitors and HCV protease inhibitor-containing drug combinations. ABT-450 is a protease inhibitor identified as a lead compound through the collaboration. Under the agreement, AbbVie is responsible for all development and commercialization activities for ABT-450. Enanta received $57 million in connection with signing the collaboration agreement, has received $55 million in subsequent clinical milestone payments, and is eligible to receive an additional $195 million in payments for regulatory milestones, as well as double-digit royalties worldwide on any revenue allocable to the collaboration’s protease inhibitors. Also, for any additional collaborative HCV protease inhibitor product candidate developed under the agreement, Enanta holds an option to modify the U.S. portion of it rights to receive milestone payments and worldwide royalties. With this option, Enanta can fund 40 percent of U.S. development costs and U.S. commercialization efforts (sales and promotion costs) for the additional protease inhibitor in exchange for 40 percent of any U.S. profits ultimately achieved after regulatory approval, instead of receiving payments for U.S. commercial regulatory approval milestones and royalties on U.S. sales of that protease inhibitor.
About Hepatitis C Virus (HCV)
Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is typically spread through direct contact with the blood of an infected person. Hepatitis C increases a person’s risk of developing chronic liver disease, cirrhosis, liver cancer and death. Patients with compensated cirrhosis have a liver that is heavily scarred but that can still perform many important bodily functions with few or no symptoms. There is an acute need for new HCV therapies that are safer and more effective for many variants of the virus.
About Enanta
Enanta Pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. Enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes – protease (partnered with AbbVie), NS5A (partnered with Novartis) and nucleotide polymerase – as well as a host-targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Additionally, Enanta has created a new class of antibiotics, called Bicyclolides, for the treatment of multi-drug resistant bacteria, with a focus on developing an intravenous and oral treatment for hospital and community MRSA (methicillin-resistant Staphylococcus aureus) infections.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with respect to the clinical data and the planned regulatory submissions for the three direct-acting antiviral HCV treatment regimen containing ABT-450. Statements that are not historical facts are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors that may affect actual results include final results of ongoing clinical trials of the three direct-acting antiviral ABT-450-containing regimen, the development, regulatory and marketing efforts of AbbVie (our collaborator on ABT-450), clinical development of competitive product candidates, regulatory submissions by AbbVie and its competitors in HCV and regulatory actions affecting the three direct-acting antiviral ABT-450-containing regimen and competitive regimens. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
(CYTR) Announces Pricing of Approximately $75 Million Public Offering of Common Stock
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced the pricing of its previously announced underwritten public offering. CytRx is offering 11.5 million shares of common stock at a public offering price of $6.50 per share for gross proceeds of approximately $75 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by CytRx.
CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. CytRx has granted the underwriters a 30-day option to purchase up to an additional 1.725 million shares of common stock. The offering is expected to close on or about February 5, 2014, subject to satisfaction of customary closing conditions.
Jefferies LLC is the sole book-running manager for the offering. Oppenheimer & Co. Inc., Aegis Capital Corp. and H.C. Wainwright & Co., LLC are acting as co-lead managers for the offering.
CytRx is offering the shares described above pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and has been declared effective by the Securities and Exchange Commission (SEC). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement related to the offering was filed with the SEC on January 30, 2014 and a final prospectus supplement related to the offering will be filed with the SEC today. Copies of the final prospectus supplement and the accompanying prospectus, when available, may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, by email at Prospectus_Department@Jefferies.com or by phone at 877-547-6340 or by accessing the SEC’s website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of CytRx Corporation, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin.
Forward-Looking Statements
This press release contains statements relating to the proposed offering that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties, such as market risks and the risk that the conditions to the closing of the offering will not be satisfied and other risks detailed in CytRx’s filings with the SEC. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(LIQT) Announces Milestone Order for Flat Sheet Membranes
BALLERUP, Denmark, Jan. 30, 2014 — LiqTech International, Inc. (NYSE: LIQT) (“LiqTech”) is pleased to announce that after extensive and successful testing LiqTech has received a production order for flat sheet silicon carbide membranes from the Middle East.
Finn Helmer, CEO, stated, “This first real production order opens up what we believe will be a significant market opportunity. Tests have shown that the flat sheet silicon carbide membrane is unmatched in the market for cleaning drinking water, waste water and pre-reverse osmosis (“Pre-RO”) desalination. Testing is ongoing in 22 additional sites and we expect that our success in recording this particular order will result in significant additional orders from the other test sites.
Further, our initial results in sea water Pre-RO with our new flat sheet membranes has demonstrated a more energy efficient and reliable technology compared to conventional technologies and this is beginning to be accepted by the market. In due course, we will expand our marketing efforts to cover other large applications that can utilize LiqTech’s flat sheet silicon carbide membranes.”
The initial flat sheet silicon carbide membranes order is for 250 meter2 and is scheduled for delivery in March.
ABOUT LIQTECH INTERNATIONAL, INC.
LiqTech International, Inc., a Nevada corporation, is a clean technology company that for more than a decade has developed and provided state-of-the-art technologies for gas and liquid purification using ceramic silicon carbide filters, particularly highly specialized filters for the control of soot exhaust particles from diesel engines and for liquid filtration. It also manufactures ceramic silicon carbide kiln furniture. Using nanotechnology, LiqTech develops products using proprietary silicon carbide technology. LiqTech’s products are based on unique silicon carbide membranes which facilitate new applications and improve existing technologies. For more information, please visit www.liqtech.com.
Forward-Looking Statements
This press release contains “forward-looking statements.” Although the forward-looking statements in this release reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged to carefully review and consider the various disclosures made by us in the our reports filed with the Securities and Exchange Commission, including the risk factors that attempt to advise interested parties of the risks that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. We assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
(MEIL) Announces Affiliation With Ontario Biodiesel Association
LAS VEGAS, NV–(Jan 30, 2014) – Methes Energies International Ltd. (NASDAQ: MEIL), a renewable energy company that offers an array of products and services to biodiesel fuel producers, is pleased to announce that Methes Energies Canada Inc. has joined, as a Founding Member, the Ontario Biodiesel Association (OBA) which promotes the production and use of biodiesel in the Province of Ontario, Canada.
OBA members have invested over $80 million in plant and equipment to produce biodiesel in the province. Beside environmental benefits, the biodiesel industry provides a direct and indirect positive economic impact on the province and its agricultural sector. In May 2013, the Honorable Charles Sousa, Ontario Minister of Finance, announced and committed through the government’s budget, a consultation process to develop a Biodiesel policy in Ontario. That process began in July 2013 and the creation of the Ontario Biodiesel Association demonstrates the industry’s commitment to the collective interests and concerns of the industry.
Paul Grenier, Executive Director for the Ontario Biodiesel Association said, “OBA’s strength is the unity of biodiesel producers, supporting Provincial policy development, to improve Ontario’s air quality by promoting increased use of Biodiesel. The OBA is working with the Ontario government, feedstock suppliers and other key stakeholders to the industry to reach this goal.”
Methes President Nicholas Ng said, “We are proud to be a founding member of the OBA and look forward to work together with other producers in the province. The timing of a mandate in Ontario could not be better and we are hoping for an early implementation as early as April 2014. Other provinces in Canada have strong mandates already in place including production incentives for biodiesel producers. Ontario is moving in the right direction and we are excited to be part of the process in helping the government drafting policies that will have a positive impact for all stakeholders.”
About Methes Energies International Ltd.
Methes Energies International Ltd. is a renewable energy company that offers a variety of products and services to biodiesel fuel producers. Methes also offers biodiesel processors that are unique, truly compact, fully automated state-of-the-art and continuous flow that can run on a wide variety of feedstocks. Methes markets and sells biodiesel fuel produced at its showcase production facility in Mississauga, Ontario, Canada and at its 13 MGY facility in Sombra, Ontario, to customers in the U.S. and Canada, as well as providing multiple biodiesel fuel solutions to its clientele. Among its services are selling commodities to its network of biodiesel producers, selling their biodiesel production and providing clients with proprietary software to operate and control their processors. Methes also remotely monitors the quality and characteristics of its clients’ production, upgrades and repairs their processors and advises clients on adjusting their processes to use varying feedstock to improve the quality of their biodiesel. For more information, please visit www.methes.com.
This press release contains forward-looking statements regarding future events and financial performance. In some cases, you can identify these statements by words such as “may,” “might,” “will,” “should,” “except,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” the negative of these terms and other comparable terminology. These statements involve a number of risks and uncertainties and are based on numerous assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. There are or may be important factors that could cause our actual results to materially differ from our historical results or from any future results expressed or implied by such forward looking statements. These factors include, but are not limited to, those discussed under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended November 30, 2012, filed on February 25, 2013, as amended, which is available at the U.S. Securities and Exchange Commission website at www.sec.gov. The forward-looking statements in this press release are based upon management’s reasonable belief as of the date hereof. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Contacts:
Methes Energies International Ltd.
Michel G. Laporte
Chairman and CEO
702-932-9964
(MEEC) Announces Major Commercial Commitment for Mercury Emissions Control
WORTHINGTON, OH–(Jan 30, 2014) – Midwest Energy Emissions Corporation (OTCQB: MEEC) (“ME2C”) today announced that it has received firm commitments from a major U.S. power producer for multi-year, mercury pollution control for MATS compliance. The commitments are for a fleet of 9 generating units. ME2C estimates that revenues for this relationship will grow to roughly $30 million per year by 2016, the final MATS compliance year, with initial revenues beginning in 2014.
The U.S. Environmental Protection Agency’s (EPA) Mercury and Air Toxic Standards (MATS) rule requires that all coal- and oil-fired power plants in the U.S., larger than 25 mega-watts, must remove roughly 90% of mercury from their emissions beginning April 16, 2015. Some plants have been given extensions into 2016. ME2C employs patented technology that has been shown to achieve mercury removal levels compliant with MATS at a significantly lower cost and with less operational impact than currently used methods
CEO Alan Kelley stated, “This very significant win for our Company is the direct result of over 20 years of dedicated research and technology development in advanced mercury control solutions. We believe that our proprietary technology is truly the best in class, and this business commitment serves as validation of our belief.”
Kelley continued, “This is a significant milestone achievement for our team and shareholders, with anticipated annual revenues of over $30 million per year when the full fleet of this single power provider is under MATS compliance. We further believe that this is just the beginning of the adoption of our technology by others and expect to be making additional commercial announcements soon.”
About Midwest Energy Emissions Corp. (ME2C) Midwest Energy Emissions Corp. delivers cost effective mercury capture technologies to power plants and other large industrial coal-burning units in the United States and Canada. The Company’s proprietary technology allows customers to meet the new, highly restrictive standards the U.S. EPA has set for mercury emissions, in an effective and economical manner with the least disruption to their current equipment and on-going operations. For more information, please refer to the Company’s website at www.midwestemissions.com.
Safe Harbor Statement: With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. Matters that may cause actual results to differ materially from those in the forward-looking statements include, among other factors, the gain or loss of a major customer, change in environmental regulations, disruption in supply of materials, a significant change in general economic conditions in any of the regions where our customer utilities might experience significant changes in electric demand, a significant disruption in the supply of coal to our customer units, the loss of key management personnel, failure to obtain adequate working capital to execute the business plan and any major litigation regarding the Company. In addition, this release contains time-sensitive information that reflects management’s best analysis only as of the date of this release. The Company does not undertake any obligation to publicly update or revise any forward-looking statements to reflect future events, information or circumstances that arise after the date of this release. Further information concerning issues that could materially affect financial performance related to forward-looking statements contained in this release can be found in the Company’s periodic filings with the Securities and Exchange Commission.
CONTACT INFORMATION
Keith R. McGee
Director of Investor Relations
Midwest Energy Emissions Corp.
614-505-6115
kmcgee@midwestemissions.com
(CYTR) Announces Proposed Public Offering of Common Stock
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced its intention, subject to market and other conditions, to commence an underwritten public offering of its common stock. CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Jefferies LLC is the sole book-running manager for the offering.
CytRx is offering the shares described above pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and has been declared effective by the Securities and Exchange Commission (SEC). The securities may be offered only by means of a prospectus. A preliminary prospectus supplement relating to the proposed offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, by email at Prospectus_Department@Jefferies.com or by phone at 877-547-6340 or by accessing the SEC’s website at http://www.sec.gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of CytRx Corporation, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin.
Forward-Looking Statements
This press release contains statements relating to the proposed offering that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including with respect to the completion, timing and size of its proposed offering. Such statements involve risks and uncertainties, such as market risks and the risk that the conditions to the closing of the offering will not be satisfied and other risks detailed in CytRx’s filings with the SEC. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
(ATNM) MissionIR Exclusive Audio Interview With CEO Dr. Kaushik J. Dave
ATLANTA, GA–(Jan 30, 2014) – MissionIR today announces the online availability of its interview with Actinium Pharmaceuticals, Inc. (OTCQB: ATNM) president and Chief Executive Officer Dr. Kaushik J. Dave, a 25-year veteran with extensive biotech and pharmaceutical experience. The full audio interview is available at the following link: http://ATNM.MissionIR.com/interview.html.
Actinium is a biotech company leveraging modern science and its proprietary platform to develop and commercialize groundbreaking therapies for treatment in different types of cancer that currently do not have any approved treatment.
Iomab-B is the company’s lead program for bone marrow conditioning in patients with acute myeloid leukemia (AML) who do not have any curative treatment options. Iomab-B is poised to start a pivotal phase 3 study, backed by significant data from five completed phase 1 and phase 2 clinical trials.
“This program has the potential to disrupt the field of bone marrow transplant, and as a consequence, has attracted a significant amount of interest from the medical community,” Dr. Dave stated in the interview.
Actinium’s pipeline also includes Actimab-A, currently in phase 1/phase 2 clinical studies as a primary induction treatment of AML. The company’s business model is to leverage its expertise and strong partnerships with leading cancer institutions to further the development of these drug candidates.
Dr. Dave detailed his education and extensive background in the pharmaceutical industry and drug development, noting that his interest in joining Actinium stemmed from recognizing the company’s “significant unrealized potential for growth.” Dr. Dave also briefly touched on the blended expertise of the rest of Actinium’s leadership and board of directors.
“These folks, all of them, bring complementary skills… all of which make our team well-equipped to face challenges of a rapidly ascending biotech company,” he stated.
In 2013, Actinium achieved several important milestones, as explained by Dr. Dave in the interview, which have positioned the company to reach several key objectives in 2014, including:
- Iomab-B poised to start phase 3
- Interim phase 2 results for Actimab-A
- Uplist to Nasdaq or NYSE exchange
- Obtaining additional analyst coverage
- Establish strategic collaborations
Wrapping up the interview, Dr. Dave explained Actinium position in the biotech industry, how it is raising awareness in the investment community, and the company’s recent private placement of approximately $6.6 million in gross proceeds, which is allocated toward achieving the company goals for the year.
About Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.
For additional information, please visit the Company’s corporate Website: www.ActiniumPharmaceuticals.com
This press release may contain “forward-looking statements.” Expressions of future goals and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements may include, without limitation, statements about our market opportunity, strategies, competition, expected activities and expenditures as we pursue our business plan. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot predict the effect that market conditions, customer acceptance of products, regulatory issues, competitive factors, or other business circumstances and factors described in our filings with the Securities and Exchange Commission may have on our results. The company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this press release.
Actinium Pharmaceuticals
New York, NY
www.ActiniumPharmaceuticals.com
646-459-4201
CSohmer@ActiniumPharmaceuticals.com
Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(DSCI) Closes $86 Million Underwritten Public Offering of Common Stock
Derma Sciences, Inc. (the “Company”) (Nasdaq: DSCI), a tissue regeneration company focused on advanced wound care, today announced the closing of an underwritten public offering of 7,500,000 shares of common stock at a price to the public of $11.50 per share, which includes the exercise of the underwriters’ option to purchase 978,261 shares of common stock to cover over-allotments. Piper Jaffray & Co. and Canaccord Genuity Inc. were joint bookrunning managers for the offering. Oppenheimer & Co. Inc. and Roth Capital Partners were financial advisors to the Company.
Total net proceeds to the Company were approximately $80.7 million after deducting the underwriting discount and estimated offering expenses. The Company expects to use the proceeds from the offering for the continued development of DSC127, for sales force expansion and for general corporate purposes.
“The proceeds from this offering bring us closer to achieving our goal to be the leading company in advanced wound care,” said Edward J. Quilty, chairman and chief executive officer of Derma Sciences. “With more than $100 million in cash on our balance sheet now, we will expand our sales organization to sell our portfolio of cutting-edge products including AmnioMatrix®, our novel human placental-derived tissue products, and continue our DSC127 Phase 3 trials for diabetic foot ulcer healing. In addition, these funds allow us the flexibility to bring in other advanced wound care products and companies, should we identify additional suitable candidates,” Mr. Quilty added.
The offering was made pursuant to a shelf registration statement that was previously filed with and declared effective by the Securities and Exchange Commission (SEC) and a registration statement filed with and declared effective by the SEC pursuant to Rule 462(b) promulgated under the Securities Act of 1933, as amended.
A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC on January 27, 2014. Electronic copies of the prospectus supplement and accompanying prospectus can be obtained through the website of the SEC at www.sec.gov. When available, copies of the prospectus supplement and accompanying prospectus relating to the offering can also be obtained by contacting Piper Jaffray & Co., by mail at 800 Nicollet Mall, Suite 800, Minneapolis, MN 55402, or by telephone at (800) 747-3924 or by contacting the Syndicate Department of Canaccord Genuity Inc., by mail at 99 High Street, 12th Floor, Boston, MA 02110, or by telephone at (800) 225-6201.
This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This offering may be made only by means of a prospectus supplement and accompanying base prospectus.
About Derma Sciences, Inc.
Derma Sciences is a medical technology company focused on three segments of the wound care marketplace: pharmaceutical wound care products; advanced wound care dressings to address chronic wounds including diabetic ulcers; and traditional dressings. The Company has begun its Phase 3 clinical trials in diabetic foot ulcer healing with DSC127, based on excellent Phase 2 data. During the third quarter of 2014 Derma Sciences expects to begin marketing AmnioMatrix®, a portfolio of two novel human placental-derived tissue products for wound healing. Its MEDIHONEY® product is the leading brand of honey-based dressings for the management of wounds and burns. The product has been shown in clinical studies to be effective in a variety of indications. TCC-EZ® is its gold-standard total contact casting system for diabetic foot ulcers. Other novel products introduced into the $14 billion global wound care market include XTRASORB® for better management of wound exudate, and BIOGUARD® for barrier protection against microbes and other contaminants.
For more information please visit www.dermasciences.com.
Forward-Looking Statements
Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release or that are otherwise made by or on behalf of the Company. Factors that may affect the Company’s results include, but are not limited to, product demand, market acceptance, impact of competitive products and prices, product development, completion of an acquisition, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks. Additional factors that could cause or contribute to differences between the Company’s actual results and forward-looking statements include but are not limited to, those discussed in the Company’s filings with the U.S. Securities and Exchange Commission.
(CGIX) Launches Webinar Series On DNA-Based Cervical Cancer Diagnostic Test
RUTHERFORD, N.J., Jan. 29, 2014 — Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or the “Company”), an emerging leader in DNA-based diagnostics, is launching a webinar series to inform clinicians and pathologists of the value of its proprietary DNA-based test for cervical cancer, FHACT™, which is processed in the Company’s CLIA certified, clinical laboratory. The webinar series will begin on Friday, January 31, at 9:30 a.m. ET and will be available again on Thursday, February 6, at 9:30 a.m. ET.
CGI’s webinar series, “An introduction to FHACT™: the FISH-based HPV-Associated Cancer Test,” was designed by Jane Houldsworth, PhD, Vice President of R&D at CGI, to better inform clinicians and pathologists about the value of using FHACT™ to help in triaging women with low grade cytological abnormalities prior to colposcopy.
Dr. Houldsworth led the research study of FHACT™ at CGI in collaboration with the National Cancer Institute (NCI). Data from the study was published in the July 2013 issue of Gynecologic Oncology (http://dx.doi.org/10.1016/j.ygyno.2013.06.005) where the genetic regions assessed in FHACT™ were found to be associated with severity of cervical lesions.
“About 2 million women are referred each year in the U.S. to undergo colposcopy, based on abnormal cytology and HPV testing, and of these significantly less than half require additional medical follow-up for diagnosed precancerous and cancerous lesions. Thus, there is a need to identify with greater efficiency women who are at risk to have such medically actionable lesions prior to referral for colposcopy. FHACT™ has the potential to reduce the health-care burden associated with cervical cancer and requires no further sample from the patient,” commented Dr. Houldsworth. “The potential of FHACT™ to provide more accurate and earlier detection of HPV-associated cancers and pre-cancers can save valuable time in the testing process, while creating substantial cost savings for the healthcare system.”
Although approximately 90% of HPV infections will be cleared within 2 years, a minority of precancerous lesions will progress to a higher-grade lesion. Women diagnosed with LSIL (low-grade squamous intraepithelial lesions) have a marginally higher risk of progression, and current high-risk HPV testing does not provide additional benefit in risk assessment for cancer. It is in these clinical settings where the integration of additional genetic biomarkers in the triage process is needed to limit unnecessary colposcopies and excisional procedures and to identify those women with lesions that are at risk of progressing to a higher grade cervical cancer.
CGI’s non-invasive FHACT™ test provides genomic information directly from leftover liquid cytology and does not require additional office visits. By using a unique combination of four genetic biomarkers, the FHACT™ test increases the sensitivity of detection of cells that show genomic abnormalities.
To register for the webinar series, please visit: http://www.cgifhact.com/webinar/.
The webinar series will be hosted by CGI’s Associate Product Manager, Alexandra Arndt, BS, CG (ASCP). Registered attendees of the live webinars can participate in Q&A sessions with Ms. Arndt. For those unable to attend the live events, the webinar series will be available for on demand viewing.
About Cancer Genetics:
Cancer Genetics, Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference lab is focused entirely on maintaining clinical excellence and is both CLIA certified and CAP accredited and has licensure from several states including New York State. We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute. For further information, please see www.cancergenetics.com.
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Company’s Form 10-Q for the quarter ended September 30, 2013 and other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics disclaims any obligation to update these forward-looking statements.
CONTACT: Investor Relations RedChip Companies, Inc. Jon Cunningham, 800-733-2447, ext. 107 jon@redchip.com
(LIVE) Announced Forward Stock Split Leaves Short Positions Nervous
NEW YORK, NY–(Jan 29, 2014) – LiveDeal (NASDAQ: LIVE) recently announced it will be initiating a 3-for-1 forward stock split in early February, but ahead of the split, investors with short positions will be looking to cover before their position also splits into one 3 times larger than currently held. Late in Tuesday’s session, we may have seen the first shot at trying to create doubt in the minds of long investors at LiveDeal. Shares of the company’s stock began to pull back after an article written by someone disclosing he does, in fact, have a short position in the stock, appeared on the financial website Seeking Alpha.
Like most Seeking Alpha articles written by those short a particular stock, their concerns are never aired when the stock is priced lower; instead, investors are treated to a laundry list of negative topics after the writer has built a short position at much higher prices. And, then in an attempt to look like the savior, the article is published and the writer hopes to profit exponentially after the seed of doubt is planted.
This phenomenon serves two purposes when the company is about to conduct a forward stock split. It helps the writer enjoy a nice payday as the price pulls back on fear, and it allows the author to cover their position before having to do so with 3 times as many shares after the stock splits and potentially moves to higher prices again. Keep in mind a $1 increase after the split is equivalent to a $3 increase before the split, so the stakes are high for anyone short.
Stockholders will receive three shares of Common Stock for every one share of Common Stock owned on the record date of February 3, 2014. Those additional shares will be distributed at the close of business on February 11th, and the stock split will go into effect on NASDAQ when trading begins on February 12th.
LiveDeal was due a pull back, and there are likely many investors on the sidelines who are cheering for a much lower split price than the $20-25 range it was trading at prior to Tuesday. Any pull back before the split means the stock will have a more attractive entry price after the split, thus ensuring more investors can afford the lower price, and grow with LiveDeal as its innovative new “instant-deal” platform takes off in more cities and in more industries outside of the dining industry.
About Stock Market Media Group
SMMG is a full service IR firm specializing in Research and Content Development. It offers a platform for corporate stories to unfold through the media with Reports, Interviews and Articles. For more information and to read disclaimers and disclosures: www.stockmarketmediagroup.com.
This article is the opinion of SMMG and was written based upon publicly available information. LiveDeal hasn’t endorsed or compensated SMMG for this article.
Contact:
Stock Market Media Group
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(BSFT) Selected By Sprint BroadSoft to Deliver Next-Generation IMS and Voice Over LTE Services
BroadWorks to Power Sprint’s 3G IMS Network Transformation Vision and Migration to 4G Voice Over LTE
GAITHERSBURG, MD–(Jan 29, 2014) – BroadSoft, Inc. (NASDAQ: BSFT) today announced that Sprint (NYSE: S) has selected BroadSoft’s BroadWorks® platform to enhance VoIP services made available by Sprint to both its consumer and business customers.
BroadWorks, which is IR.92 and IR.94 compliant, is architected to easily integrate with 2G, 3G, and 4G IP Multimedia Subsystem (IMS)-based networks. BroadWorks’ Service Centralization and Continuity application server enables mobile network operators to deliver next-generation, Unified Communications (UC) services over their existing legacy GSM and/or CDMA networks. And with BroadWorks’ Voice Call Continuity, these UC services transition effortlessly from legacy networks as an operator migrates to VoLTE.
BroadSoft has extensive industry experience and superior capabilities, including:
- Industry leadership with IMS networks, with over 70 deployments worldwide, and proven scalability to support millions of subscribers
- A single architecture to serve both the consumer and business market segments, at a lower total cost of ownership through software-based media resource functions
- Platform flexibility and support for industry standards, enabling the seamless integration of third-party technologies and applications
- Virtualized and elastic software defined network architecture that integrates with other network components
- Ability to deliver high-definition, Quality of Service mean opinion scores (MOS) required by mobile consumer subscribers
“We were seeking a single voice and video application server platform to support our IMS network transformation in order to provide the communication services both our consumer and enterprise customers are demanding today,” said Iyad Tarazi, Vice President of Network Development, Sprint.
Michael Tessler, president and chief executive officer, BroadSoft, said, “We are committed to providing superior technical capabilities that enable our service provider customers to offer the highest quality communications experience and look forward to helping Sprint achieve these objectives through our BroadWorks platform.”
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by their use of terms and phrases such as “enable” and other similar terms and phrases and include, among others, statements regarding the benefits to Sprint and its customers of using BroadSoft’s products and services. The outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated by these forward-looking statements, including, but not limited to, the financial and other benefits to BroadSoft resulting from the deployment of BroadSoft’s products and services by Sprint, as well as those factors contained in the “Risk Factors” sections of the Company’s Form 10-K for the year ended December 31, 2012, filed with the Securities and Exchange Commission, or SEC, on February 27, 2013, and in BroadSoft’s other filings with the SEC. All information in this release is as of January 29, 2014. Except as required by law, BroadSoft undertakes no obligation to update publicly any forward-looking statement made herein for any reason to conform the statement to actual results or changes in its expectations.
About BroadSoft
BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Company’s core communications platform enables the delivery of a range of enterprise and consumer calling, messaging and collaboration communication services, including private branch exchanges, video calling, text messaging and converged mobile and fixed-line services.
(ONVO) Announces First Delivery of 3D Liver Tissue to Key Opinion Leader
SAN DIEGO, Jan. 29, 2014 — Organovo Holdings, Inc. (NYSE MKT: ONVO) (“Organovo”), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, today announced that it has performed its first 3D Liver tissue delivery.
The achievement marks the delivery of Organovo’s 3D Liver tissue to a laboratory outside of the company to a key opinion leader (KOL) for experimentation, and marks the achievement of a milestone along the pathway to commercial launch of its 3D liver tissue product. Organovo achieved the milestone ahead of its April 2014 target date. Key opinion leaders are generally experts, in this case top research scientists, in a particular field whose opinions and publications will influence practice. Organovo expects KOLs to make recommendations on improvements to the tissue before launch and to influence peers through their reporting of their research results at conferences and through peer reviewed publications.
“This is an important milestone for Organovo R&D,” said Organovo Chief Technology Officer and Executive Vice President of Research and Development Dr. Sharon Presnell. “In developing these tissues, we have gone through a careful set of research studies involving many individual tissues, and greatly increased our ability to produce them. By the end of January, we expect to have bioprinted nearly four hundred 3D Liver tissues during the month.”
Organovo also introduced updated guidance on the timing of its product launch. Organovo had planned to launch its 3D Liver tissue product by the end of December 2014. It now expects to commence the commercial launch and start generating revenue through a services model prior to December 2014. “As pharmaceutical and biotechnology companies move to continue to outsource their R&D efforts,” explained Keith Murphy, Organovo’s chief executive officer, “our ability to deliver a service offering in addition to products will be critical to meet their needs and to enter the $7B preclinical research services market.” The company anticipates that preclinical toxicology testing services can command prices in the high tens of thousands of dollars per compound for standard screening for liver alone.
Organovo’s 3D Liver tissues exhibit several key features that remain stable over time:
- Tissue-like cellular density;
- Multi-layered architecture with multiple cell types positioned relative to one another, reaching up to 500 microns thickness, with tissues comprised of up to 20 cell layers;
- Albumin production 5-9 times greater than matched 2D controls, suggesting superior functionality;
- Stable albumin production for over 40 days, fibrinogen and transferrin production, and inducible cytochrome P450 enzymatic activities, including CYP 1A2 and CYP 3A4;
- Cholesterol biosynthesis, which has been demonstrated for the first time in a multi-cellular 3D human liver system in vitro;
- Evidence of the formation of tight junctions in the liver tissues, demonstrated by cadherin and claudin staining by day 3 of tissue formation; and
- Demonstration of appropriate response to hepatotoxic insults from acetaminophen, acetaminophen in combination with ethanol, and diclofenac.
Organovo plans to release additional data in 2014 on its 3D Kidney tissues and breast cancer tissues now in development. In December, Organovo demonstrated that its NovoGen bioprinted breast cancer tissues retain compartmentalized structures with interaction between stromal and cancer cells, along with formation of endothelial networks and differentiation of adipocytes. NovoGen 3D bioprinted constructs were demonstrated to be less susceptible to tamoxifen-induced toxicity than isolated 2D cancer cells when treated with the same dose of tamoxifen for the same duration, highlighting the potential utility of this model in identifying superior drugs with greater toxicity against complex, multicellular 3D tumor models.
Organovo also reminded investors of the continued availability of Organovo’s December 5, 2013 online presentation. Organovo’s Chairman and Chief Executive Officer, Keith Murphy, presented in a live interactive online forum that was a recorded event. The online content that can be accessed consists of a 30 min presentation as well as the text of a Q&A session that followed.
LINK: www.retailinvestorconferences.com > click on red “register / watch event now” button
The Company also reminded investors of its guidance to investors regarding “Short and Distort” articles.
About Organovo Holdings, Inc.
Organovo designs and creates functional, three-dimensional human tissues for medical research and therapeutic applications. The Company is collaborating with pharmaceutical and academic partners to develop human biological disease models in three dimensions. These 3D human tissues have the potential to accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost. In addition to numerous scientific publications, the Company’s technology has been featured in The Wall Street Journal, Time Magazine, and The Economist. Organovo is changing the shape of medical research and practice. Learn more at www.organovo.com.
Safe Harbor State
Any statements contained in this press release 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. Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the Company’s products and technology; the timing of commercial launch and the market acceptance and potential for the Company’s products, and the risks related to the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in our filings with the SEC, including the prospectus supplement that we filed with the SEC on November 27, 2013 and the transition report on Form 10-KT for the period ended March 31, 2013 that we filed with the SEC on May 24, 2013 and our other filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events.
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