Archive for February, 2017
$AGN to #Acquire $ZLTQ, All Cash Transaction
– Immediately Accretive All Cash Transaction Expected to Close in the Second Half of 2017 – – Brings Together Allergan’s Best-in-Class Facial Aesthetics, Plastic Surgery & Regenerative Medicine Businesses with Best-in-Class Body Contouring Business – – Body Contouring to Become 3rd Pillar of Allergan’s Global Aesthetic Portfolio – – Three Distinct, Complementary Businesses Converge to Create Optimal Customer Experience – – Body Contouring Represents $4 Billion Global Market Opportunity – – Allergan to Host Investor Conference Call Today at 9:00 a.m. ET –
DUBLIN and PLEASANTON, Calif., Feb. 13, 2017 — Allergan plc (NYSE:AGN), a leading global biopharmaceutical company, and ZELTIQ® Aesthetics, Inc. (NASDAQ:ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire ZELTIQ for $56.50 per share, or $2.475 billion, subject to customary adjustments.
The acquisition of ZELTIQ is immediately accretive and enhances Allergan’s global medical aesthetics portfolio with the addition of ZELTIQ’s flagship CoolSculpting® System, the sales leader in the fast-growing cash pay body contouring segment of medical aesthetics. The CoolSculpting System is FDA-cleared to affect appearance through lipolysis or reduction of unwanted fat using a patented cooling technology. CoolSculpting works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue. Body contouring is a $4 billion market opportunity worldwide and growing.
“The acquisition of ZELTIQ is highly complementary and strategic to Allergan. By adding the best-in-class body contouring CoolSculpting System to our best-in-class facial aesthetics, plastic surgery and regenerative medicine offerings we are creating a world-class aesthetics business,” said Brent Saunders, Chairman and CEO of Allergan. “With CoolSculpting, our offerings to plastic surgeons, dermatologists and aesthetic practitioners will now extend to three of the largest and fastest-growing segments of their practices, putting Allergan in a unique position to provide expanded customer service, and help meet the needs of patients.”
“Allergan’s world-class medical aesthetics products, global footprint, history and commitment to developing best-in-class aesthetic treatments makes the Company ideally suited to realize the maximum commercial potential of the ZELTIQ controlled-cooling technology platform,” said Mark Foley, Chief Executive Officer of ZELTIQ. “I appreciate the unwavering commitment and dedication of the ZELTIQ team in building a world-class Company and technology platform with CoolSculpting. We look forward to working with Allergan to ensure successful completion of this transaction, and supporting the ongoing success of the CoolSculpting technology in the U.S. and around the world.”
Allergan’s acquisition of ZELTIQ is subject to approval by the shareholders of ZELTIQ, expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and fulfillment of certain other customary conditions to closing. Assuming typical regulatory and shareholder approval timeframes, Allergan currently anticipates closing the transaction in the second half of 2017.
Moelis & Company is acting as financial advisor to Allergan, and Debevoise & Plimpton LLP is acting as lead legal counsel. Guggenheim Securities is acting as financial advisor to ZELTIQ, and Cooley LLP is serving as legal counsel.
Conference Call and Webcast
Allergan will host a brief conference call and webcast today at 9:00 a.m. ET to discuss the transaction. The conference call can be accessed from within the U.S. by dialing (877) 251-7980, conference ID 71941558. From international locations, the conference call can be accessed at (716) 803-8252 using the same conference ID. To access the webcast and slides go to Allergan’s Investor Relations Web site at ir.allergan.com or through the following URL: http://edge.media-server.com/m/p/bf98fk5y. A replay of the conference call will also be available by dialing (855) 859-2056 in the U.S. or (404) 537-3406 outside of the U.S., conference ID 71941558.
About the CoolSculpting® Procedure
CoolSculpting® is a non-surgical, clinically proven procedure that selectively reduces unwanted fat using a patented cooling technology. CoolSculpting works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue. Millions of CoolSculpting treatments have been performed by more than 5,700 CoolSculpting systems in over 80 countries. Market research indicates up to a 95 percent customer satisfaction rate with the CoolSculpting procedure. CoolSculpting is available through a network of dermatologists, plastic surgeons and leading aesthetic specialists that offer the procedure. More information can be found at http://www.coolsculpting.com.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company’s R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company’s success is powered by our more than 16,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan’s website at www.Allergan.com.
About ZELTIQ®
ZELTIQ® is a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform. ZELTIQ’s first commercial product, the CoolSculpting® System, is designed to reduce unwanted fat. CoolSculpting is based on the scientific principle that fat cells are more sensitive to cold than the overlying skin and surrounding tissues. It utilizes patented technology of precisely controlled cooling to reduce the temperature of fat cells in the treated area, which is intended to cause fat cell elimination through a natural biological process known as apoptosis. ZELTIQ developed CoolSculpting to safely, noticeably, and measurably reduce the fat layer, to affect appearance.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts, including with respect to Allergan’s acquisition of ZELTIQ are forward-looking statements that reflect Allergan’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting future clinical results based on prior clinical results; the timing or outcome of FDA approvals or actions, if any; successful integration of the ZELTIQ acquisition and the ability to realize the anticipate synergies and benefits of the ZELTIQ acquisition; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s and ZELTIQ’s products; difficulties or delays in manufacturing; the ability of Allergan to complete the acquisition of ZELTIQ; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
Additional Information and Where to Find It.
In connection with the proposed transaction, ZELTIQ Aesthetics, Inc. will be filing documents with the SEC, including preliminary and definitive proxy statements relating to the proposed transaction. The definitive proxy statement will be mailed to ZELTIQ stockholders in connection with the proposed transaction. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORTED BY REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at www.sec.gov, on ZELTIQ’s website at www.zeltiq.com or by contacting ZELTIQ Investor Relations at (925) 474-2500.
ZELTIQ, Allergan plc and their respective directors and executive officers may be deemed participants in the solicitation of proxies from the stockholders of ZELTIQ in connection with the proposed transaction. Information regarding the special interests of ZELTIQ’s directors and executive officers in the proposed transaction will be included in the proxy statement described above. These documents are available free of charge at the SEC’s web site at www.sec.gov and from ZELTIQ Investor Relations as described above. Information about Allergan’s directors and executive officers can be found in Allergan’s definitive proxy statement filed with the SEC on March 25, 2016. You can obtain a free copy of this document at the SEC’s website at www.sec.gov or by accessing Allergan’s website at www.allergan.com and clicking on the “Investors” link and then clicking on the “SEC Filings” link.
CONTACTS:
Allergan:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
ZELTIQ:
Investors:
Nick Laudico
The Ruth Group
(646) 536-7030
$XOMA Announces Pricing of $25 Million #RegisteredOffering
BERKELEY, Calif., Feb. 13, 2017 — XOMA Corporation (Nasdaq:XOMA) announced today that it has agreed to sell 1,200,000 shares of its common stock and 5,003 shares of convertible preferred stock directly to Biotechnology Value Fund, L.P. and certain of its affiliates (“BVF”) in a registered direct offering. XOMA anticipates its aggregate gross proceeds from the offering will be approximately $25.0 million.
BVF agreed to purchase the shares of common stock from the Company pursuant to a subscription agreement at a price of $4.03 per share (the closing price of XOMA’s common stock on February 10, 2017, as reported on the NASDAQ Global Market).
Each share of Series X Preferred Stock will have a stated value of $4,030 per share and will be convertible into 1,000 shares of registered common stock based on a conversion price of $4.03 per share of common stock. The total number of shares of common stock issued upon conversion of all issued Series X Preferred Stock will be 5,003,000 shares. Each share will be convertible at the option of the holder at any time, provided that the holder will be prohibited from converting into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares above a conversion blocker, which is initially set at 19.99% of the total common stock then issued and outstanding immediately following the conversion of such shares.
The offering is expected to close on or about February 15, 2017, subject to customary closing conditions.
The securities described above are being offered by XOMA pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the “SEC”), which the SEC declared effective on February 13, 2015 (File No. 333-201882). A prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Alternatively, XOMA will arrange to send you the prospectus supplement and the accompanying prospectus upon request by calling XOMA at (510) 204-7200.
This press release does not constitute an offer to sell or a solicitation of an offer to buy 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. This press release is being issued pursuant to and in accordance with Rule 134 under the Securities Act of 1933, as amended. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement.
About XOMA
XOMA discovers and develops innovative antibody therapeutics. XOMA has an extensive portfolio of products, programs, and technologies that are the subject of licenses we have in place with other biotech and pharmaceutical companies. There are over 25 such programs that are funded by other companies and could produce milestone payments and royalty payments in the future.
Forward-Looking Statements
Certain statements contained in this press release, including, but not limited to, statements related to the anticipated closing of the offering are forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “estimate,” “anticipate,” “intend,” “expect,” “potential” and similar expressions are intended to identify forward-looking statements. These statements are based on assumptions that may not prove accurate. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to whether the offering will close when anticipated or at all, XOMA’s business strategy, its clinical programs, ability to receive potential milestones and royalty payments, and other risks, including those related to current economic and financial market conditions, that are described in more detail in “Risk Factors” included in the prospectus supplement and accompanying prospectus and the additional risk factors contained in XOMA’s most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. XOMA undertakes no obligation to publicly update any forward-looking statements, regardless of any new information, future events or other occurrences. You are advised, however, to consult any additional disclosures made by XOMA in its reports to the SEC on Forms 10-K, 10-Q and 8-K.
CONTACTS: Investor contact: Luke Heagle Pure Communications +1 910-726-1372 lheagle@purecommunications.com Media contact: Colin Sanford Pure Communications +1 415-946-1094 csanford@purecommunications.com
$GIG to be #Acquired by #IDT for $3.08 per Share
– Projected to add approximately $16M of quarterly revenue at 70% non-GAAP gross margin – Immediately accretive to earnings in first full quarter following close – Creates New Industry Franchise in High Performance Optical Interconnect – Extends IDT Leadership in Communications & Cloud Data Center Products – Conference call to be held on Tuesday, February 14, 2017 at 5am PT / 8am ET
SAN JOSE, CALIFORNIA–(Feb. 13, 2017) – Integrated Device Technology, Inc. (IDT®) (NASDAQ:IDTI) and GigPeak, Inc. (NYSE MKT:GIG) today announced that they have signed a definitive agreement for IDT to acquire GigPeak, Inc., for total cash consideration of $3.08 per share, or approximately $250 million in cash. This per share consideration would represent a premium of approximately 22% to GigPeak’s closing share price on February 10, 2017.
The acquisition of GigPeak provides IDT with a highly regarded optical interconnect product and technology business that is complementary to IDT’s leadership position in real-time interconnect products.
GigPeak’s optical interface products are already broadly used by leading companies in the Communications, Cloud Data Center, and Military/Aviation markets. IDT will now provide seamless ultra-high speed data connectivity products using electrical, RF, and optical technologies.
“GigPeak is a recognized leader in high performance Optical, RF, and Video Transport technology, and is a perfect fit for IDT. The products, technology, and culture of GigPeak all complement and represent an acceleration of our current strategy,” said Gregory Waters, IDT President & CEO. “We gain an exceptional group of talented people and valuable intellectual property with the GigPeak team, and welcome them into one of the most innovative companies in the semiconductor industry.”
“IDT’s acquisition of GigPeak will be a meaningful milestone for all of our stakeholders — stockholders, employees, customers and partners,” said Dr. Avi Katz, Founder, Chairman and CEO of GigPeak, Inc. “We find an exceptional culture, customers, business and technology compatibility with IDT, and we are delighted to join this fine team. Upon the consummation of this acquisition, our leading product suite, which currently addresses the need for greater bandwidth across the network, will now have the advantage of leveraging the scale of resources and broad distribution channels of IDT.”
Offer Recommended by GigPeak Board of Directors
Under the terms of the merger agreement, IDT will commence a tender offer to acquire all of the issued and outstanding common stock of GigPeak for $3.08 per share. The implied fully-diluted equity value of the offer amounts to approximately $250 million.
The Boards of Directors of both GigPeak and IDT have unanimously approved the terms of the merger agreement, and the Board of Directors of GigPeak has resolved to recommend that stockholders accept the offer, once it is commenced.
The acquisition is structured as an all-cash tender offer for all outstanding issued common stock of GigPeak followed by a merger in which remaining shares of GigPeak would be converted into the same dollar per share consideration as in the tender offer. The transaction is not subject to a financing condition, and completion is anticipated during the second calendar quarter of 2017.
The transaction is subject to customary conditions, including the tender of the majority of the outstanding GigPeak shares and the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The transaction is expected to close during the second calendar quarter of 2017. GigPeak is expected to be delisted from the NYSE MKT and integrated into IDT thereafter.
Cowen and Company, LLC and Needham & Company, LLC acted as financial advisers and Crowell & Moring LLP acted as legal adviser to GigPeak. J.P. Morgan Securities LLC acted as exclusive financial adviser to IDT and provided financing commitment for the transaction, and Latham & Watkins LLP acted as legal adviser to IDT.
Conference Call
IDT management will host a conference call on Tuesday, February 14, 2017 to discuss the transaction at 5:00 a.m. PT / 8:00 a.m. ET. This call will replace GigPeak’s previously scheduled earnings call which has been canceled. The call can be accessed by dialing 877-852-6583 (toll free) using passcode 1358127. The call will also be webcast live on the IDT website at www.idt.com and on the GigPeak website at www.gigpeak.com. A replay of the webcast will be made available on the IDT and GigPeak websites beginning at 9:00 a.m. ET tomorrow.
About IDT
Integrated Device Technology, Inc. develops system-level solutions that optimize its customers’ applications. IDT’s market-leading products in RF, real-time interconnect, wireless power, and SmartSensors are among the company’s broad array of complete mixed-signal solutions for the communications, computing, consumer, automotive and industrial segments. Headquartered in San Jose, Calif., IDT has design, manufacturing, sales facilities and distribution partners throughout the world. IDT stock is traded on the NASDAQ Global Select Stock Market® under the symbol “IDTI.” Additional information about IDT can be found at www.IDT.com. Follow IDT on Facebook, LinkedIn, Twitter, YouTube and Google+
About GigPeak
GigPeak, Inc. (NYSE MKT:GIG) is a leading innovator of semiconductor ICs and software solutions for high-speed connectivity and high-quality video compression over the network and the cloud. The focus of the company is to develop and deliver products that enable lower power consumption and faster data connectivity, more efficient use of network infrastructure, broader connectivity to the cloud, and reduce the total cost of ownership of existing network pipes from the core to the end user. GigPeak addresses both the speed of data transmission and the amount of bandwidth the data consumes within the network, and provides solutions that increase the efficiency of the Internet of Things, leveraging its strength in high-speed connectivity and high-quality video compression. The extended product portfolio provides more flexibility to support changing market requirements from ICs and MMICs through full software programmability and cost-efficient custom ASICs.
Additional Information and Where to Find It
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. The tender offer for the outstanding shares of GigPeak’s common stock described in this press release has not commenced. At the time the tender offer is commenced, IDT will file or cause to be filed a Tender Offer Statement on Schedule TO with the SEC and GigPeak will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC related to the tender offer. The Tender Offer Statement (including an Offer to Purchase, a related Letter of Transmittal and other tender offer documents) and the Solicitation/Recommendation Statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Those materials will be made available to GigPeak’s stockholders at no expense to them by the information agent to the tender offer, which will be announced. In addition, all of those materials (and any other documents filed with the SEC) will be available at no charge on the SEC’s website at www.sec.gov.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated consummation of the acquisition of GigPeak and the timing, benefits and financing thereof, IDT’s strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product portfolio, development programs, patent terms and other statements that are not historical facts. These forward-looking statements are based on IDT’s current expectations and inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to IDT’s ability to complete the transaction on the proposed terms and schedule; whether IDT or GigPeak will be able to satisfy their respective closing conditions related to the transaction; whether sufficient stockholders of GigPeak tender their shares of GigPeak common stock in the transaction; whether IDT will obtain financing for the transaction on the expected timeline and terms; the outcome of legal proceedings that may be instituted against GigPeak and/or others relating to the transaction; the possibility that competing offers will be made; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; risks related to future opportunities and plans for the acquired company and its products, including uncertainty of the expected financial performance of the acquired company and its products; disruption from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the calculations of, and factors that may impact the calculations of, the acquisition price in connection with the proposed merger and the allocation of such acquisition price to the net assets acquired in accordance with applicable accounting rules and methodologies; and the possibility that if the acquired company does not achieve the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of IDT’s shares could decline, as well as other risks related to IDT’s and GigPeak’s businesses detailed from time-to-time under the caption “Risk Factors” and elsewhere in IDT’s and the GigPeak’s respective SEC filings and reports, including the Annual Report of GigPeak on Form 10-K for the year ended December 31, 2015 and the Annual Report of IDT on Form 10-K for the year ended April 3, 2016. IDT undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
Financial Contact:
Suzanne Schmidt
IDT Investor Relations
(415) 217-4962
suzanne@blueshirtgroup.com
Press Contact:
Daniel Aitken
IDT Senior Director of Corporate
Marketing and Communications
(408) 574-6480
daniel.aitken@idt.com
Financial Contact for GigPeak, Inc.:
Jim Fanucchi
Darrow Associates
(408) 404-5400
jim@darrowir.com
$ZSAN Announces 3.8mg Dose of #M207 for #Migraine
41.5% of patients experienced freedom from pain at 2 hours vs. 14.3% for placebo (p < 0.0001)
68.3% of patients experienced freedom from most bothersome symptom at 2 hours vs. 42.9% for placebo (p < 0.0009)
26.8% of patients experienced freedom from pain at 1 hour vs. 10.4% for placebo (p < 0.0084)
FREMONT, Calif., Feb. 13, 2017 — Zosano Pharma Corporation (NASDAQ:ZSAN) announces that its lead product candidate, M207, achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in the recently completed ZOTRIP trial. The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, to placebo for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the US. The 3.8mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour and showed durability of effect on pain freedom at 24 and 48 hours. Additionally, M207 was not associated with any Serious Adverse Events (SAEs).
The 3.8mg dose of M207 achieved statistical significance for both co-primary endpoints at two hours:
Primary endpoint | Placebo | 3.8mg M207 | p–value | ||
Pain freedom | 14.3 | % | 41.5 | % | 0.0001 |
Most bothersome symptom free | 42.9 | % | 68.3 | % | 0.0009 |
Furthermore, secondary endpoints measuring pain freedom at additional time points for the 3.8mg dose of M207 showed M207 superior to placebo with a nominal p-value less than 0.05:
Pain Freedom | Placebo | 3.8mg M207 | p–value* | ||
Pain freedom at 45 minutes | 5.2 | % | 17.1 | % | 0.0175 |
Pain freedom at 60 minutes | 10.4 | % | 26.8 | % | 0.0084 |
Pain freedom at 24 hours | 39.0 | % | 69.5 | % | 0.0001 |
Pain freedom at 48 hours | 39.0 | % | 64.6 | % | 0.0013 |
M207 was well-tolerated with no SAEs
- Overall, 13 subjects (3.9%) reported pain at the application site; application site pain was reported as mild in all but 3 subjects;
- The most frequently reported adverse event was redness at the application site (18.3% of subjects). All cases of redness resolved;
- Additionally, 5 (1.5%) patients across M207-treated groups reported dizziness vs 0% on placebo.
Stewart Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Clinic commented, “The ZOTRIP study was successful from the dual perspectives of meeting the co-primary endpoints and no serious adverse events. The study demonstrated a statistically significant 2-hour pain freedom response rate with a low placebo rate for the primary endpoint. The data also indicate a durability of effect at 24 and 48 hours, and meaningful pain freedom rate at 1 hour. If approved by the FDA, M207 has the potential to become an important treatment option for those suffering from migraine.”
A PDF accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/45722c3f-e41a-4c21-826c-4721615c30cd
Overall, higher pain freedom rates were achieved on all doses after 60 minutes over placebo. While the 1.0mg and 1.9mg doses of M207 produced p-values less than 0.05 in pain freedom at two hours, they did not produce a p-value below 0.05 for the co-primary endpoint of freedom from most bothersome symptom at two hours.
“ZOTRIP was designed to be a dose-ranging study, as well as a registration study. We are very pleased by the results for the 3.8mg dose, and look forward to continuing the development of M207 towards filing an NDA and working to bring this novel therapy to patients suffering from the incapacitating effects of migraines,” said Konstantinos Alataris PhD, President and Chief Executive Officer of Zosano.
The ZOTRIP Phase 3 Trial Design:
The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Subjects were enrolled in the ZOTRIP trial at 36 centers across the United States. Those recruited into the trial had a history of at least one year of migraine episodes with or without aura. Upon recruitment, the subjects entered a run-in period that ensured they met the key eligibility criteria of 2-8 migraine attacks per month, which was documented using an electronic diary or an app on their cell phone. Subjects also identified their most bothersome symptom and indicated the presence or absence of nausea, phonophobia or photophobia, during the episodes in the run-in period. Successfully screened subjects were then randomized into the treatment/dosing period in which they had 8 weeks to confirm and receive blinded treatment for a single migraine attack, termed “qualifying migraine.” In which the most bothersome symptom had to be present.
During a qualifying migraine, subjects scored the severity of pain on a 4-point scale, and the presence or absence of migraine associated symptoms (photophobia, phonophobia or nausea), starting pre-dose and then at several intervals over 48 hours post-dose.
Five hundred and eighty nine subjects were enrolled in this study, of which 365 were randomized. Of those randomized, 333 subjects treated and are included in the safety analysis, and 321 qualified for the modified intent-to-treat (mITT) population. 51% of the subjects randomized were found to have severe migraine pain pre-treatment. Also at the time of treatment, 70% reported nausea, 37% aura, and 51% waking up with their migraine (morning migraine). With the multiple doses and multiple endpoints in the trial, a sequential testing procedure was used beginning with the highest dose and the co-primary endpoints. Since statistical significance was not achieved for most bothersome symptom in the 1.9 mg group, p-values for secondary endpoints should be considered nominal p-values.
About Migraine
Migraine is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. An estimated 36 million American adults suffer from migraine. Migraine can be extremely disabling and costly, accounting for more than an estimated $20 billion in direct (e.g., doctor visits, medications) and indirect (e.g., missed work, lost productivity) expenses each year in the United States.
About M207
M207 is Zosano’s proprietary zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan during a migraine attack. In a phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society.
About Zosano Pharma
Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications. The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the timing of expected clinical development milestones, the likelihood that M207 is approved by the FDA and, if approved, the potential of M207 as a treatment for migraine and other future events and expectations. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading “Risk Factors” in our 2015 Annual Report on Form 10-K, as filed with the Securities Exchange Commission on March 29, 2016. In addition, the results of the M207 pivotal trial are not necessarily predictive of results in future trials. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.
Zosano Contact: Georgia Erbez Chief Business Officer, Interim CFO 510-745-1200 Investor Contact: Jamien Jones Blueprint Life Science Group 415-375-3340 x 5 jjones@bplifescience.com
$BIOL #FDA Clearance, Worldwide Launch of New #WaterlaseExpress
The Smallest, Easiest to Use Waterlase at Nearly Half the U.S. Retail Price
BIOLASE, Inc., (NASDAQ: BIOL) the global leader in dental lasers, announced today that its new, fifth-generation Waterlase Express™ all-tissue laser system, having received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA), is available for immediate sale to dentists in the U.S. as well as select international markets in Europe, the Middle East and Asia.
BIOLASE Waterlase Express™ all-tissue laser system – The Smallest, Easiest to Use Waterlase at Nearly Half the U.S. Retail Price (Photo: Business Wire)
Waterlase Express represents the newest addition to the Company’s best-selling Waterlase® portfolio of Er,Cr:YSGG all-tissue lasers, and is the fifth generation of the world’s most widely used all-tissue dental laser wavelength. Waterlase Express will first be exhibited at the upcoming Chicago Dental Society’s Mid-Winter meeting on February 23-25, and then be unveiled internationally in Cologne, Germany at the International Dental Show (IDS), which is the world’s leading trade show for the dental industry.
With extensive qualitative and quantitative research from a team of dentists around the world guiding the design of the system, Waterlase Express represents the new foundation of the Company’s strategy to greatly expand all-tissue laser use in dentistry.
“We are excited to launch the Waterlase Express, our next-generation Waterlase system designed for easy and intuitive operation, integrated learning, and portability. We believe the Express user interface is to legacy laser user interfaces what the Apple iPhone was to the flip phone,” said Harold C. Flynn, Jr. President and CEO of BIOLASE, Inc. “Express will enable significantly higher penetration and adoption of all-tissue laser dentistry worldwide. With all the value of Waterlase technology at nearly one-quarter the size, one-third the weight, and nearly half the U.S. retail price of our market-leading Waterlase iPlus system, we believe Express is the dental laser that is finally ready for the vast majority of dentists around the world, many of whom have waited to integrate our all-tissue laser solutions into their practices.
“These clinicians can now join our current customers who report improved patient-reported outcomes after integrating the laser into their treatment plans, including greatly simplifying perio disease management with REPAIR Perio™, implant management with REPAIR Implant™, pediatric and restorative procedures.”
BIOLASE Chief Technology Officer Dmitri Boutoussov, PhD, said, “When we began this project, our goal was to create a new version of Waterlase that would be a much smaller, simpler, more reliable and cost-effective system, while still carrying all the benefits of powerful Waterlase laser technology. We designed Express so that every dentist, whether completely new to lasers, or a pro, can easily learn Waterlase Express and start using it, with integrated support by BIOLASE and its network of educators and peer practitioners.”
Waterlase Express offers several breakthroughs to help dentists new to all-tissue lasers integrate powerful Waterlase technology with simple, elegant user controls and learning tools. Key features to support ease of learning and ownership for new dentists include:
Game Changing Features and Technology
Easy to learn and use:
- Familiar tablet-based interface makes it easy for new laser dentists to learn quickly
- HD quality clinical animations for every procedure on-board guiding proper laser techniques
- Easy to use procedure presets, with a simple, one-slider cutting adjustment control
- Simplified and intuitive clinical workflows for expansive library of over 80 clinical procedures
- Step-by-step protocols for guiding laser perio and implant procedures
- Full suite of pediatric and deciduous tooth procedures
Easy to own and get support:
- One-touch access to BIOLASE Customer Care™ from the laser control screen when a customer needs assistance (available to U.S. customers only at launch; international availability to follow)
- BIOLASE Connect™ system to link Express owners to a network of support resources
- Resource Center with Patient marketing support resources to enhance integration
- Video tutorials for easy maintenance and care
- Multiple financing options to enable positive cash flow and a great return on investment
Technology advancements:
- System uses compact, miniaturized version of patented Waterlase Er,Cr:YSGG laser engine, with more than 11,500 lasers installed worldwide and used to perform more than an estimated 20 million procedures
- Patented comfortable, contra-angle handpiece design for improved clinical intraoral access
- Cloud-based software, learning, and support content delivery and remote diagnostics
- New side-firing tips to follow soon for implant thread debridement
Dr. Samuel Low, Chief Dental Officer and Vice President of Dental Affairs, was a member of a team of 11 laser dentists from around the world who collaborated with BIOLASE R&D to develop the Waterlase Express experience. “Every setting, every frame of every animation was meticulously crafted by this team of clinical advisors and very talented artists to create a very high-quality learning tool for new laser dentists,” said Dr. Low. “With learning styles more variable than ever, the Waterlase Express offers an appropriate level of simplicity and access to deeper knowledge when needed,” he added.
To learn more about the Waterlase Express system, and other innovations designed to simplify laser dentistry, visit www.biolase.com/waterlaseexpress.
About BIOLASE, Inc.
BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine and also markets, sells, and distributes dental imaging equipment, including digital x-rays and CAD/CAM scanners. BIOLASE’s products are focused on technologies that advance the practice of dentistry to both dentists and their patients. BIOLASE’s proprietary laser products incorporate approximately 255 patented and 90 patent-pending technologies designed to provide biologically clinically superior performance with less pain and faster recovery times. Its innovative products provide cutting-edge technology at competitive prices to deliver the best results for dentists and patients. BIOLASE’s principal products are revolutionary dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications, and a full line of dental imaging equipment. BIOLASE has sold approximately 32,800 laser systems to date in over 90 countries around the world. Laser products under development address BIOLASE’s core dental market and other adjacent medical and consumer markets.
For updates and information on Waterlase® iPlus™ and laser dentistry, find BIOLASE online at www.biolase.com, Facebook at www.facebook.com/biolase, Twitter at www.twitter.com/biolaseinc, LinkedIn at www.linkedin.com/company/biolase, Instagram at www.instagram.com/biolaseinc, and YouTube at www.youtube.com/biolasevideos.
BIOLASE® and Waterlase® are registered trademarks of BIOLASE, Inc.
Apple is a trademark of Apple.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
Statements contained in this press release that refer to BIOLASE’s estimated or anticipated future results or other non-historical facts are forward-looking statements, as are any statements in this press release concerning prospects related to BIOLASE’s strategic initiatives and anticipated financial performance. Forward-looking statements can also be identified through the use of words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “may,” “will,” and variations of these words or similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect BIOLASE’s current expectations regarding existing trends, and its strategic initiatives, and speak only as of the date of this release. Actual results may differ materially from BIOLASE’s current expectations depending upon a number of factors affecting BIOLASE’s business. These factors include, among others, adverse changes in general economic and market conditions, competitive factors including but not limited to pricing pressures and new product introductions, uncertainty of customer acceptance of new product offerings and market changes, risks associated with managing the growth of the business, and those other risks and uncertainties that may be detailed, from time-to-time, in BIOLASE’s reports filed with the SEC. BIOLASE does not undertake any responsibility to revise or update any forward-looking statements contained herein.
BIOLASE
Michael Roux
Vice President of Marketing
949-226-8112
mroux@biolase.com
or
DresnerAllenCaron
Michael Mason (Investors)
212-691-8087
mmason@dresnerallencaron.com
or
Rene Caron (Investors)
rcaron@dresnerallencaron.com
or
Len Hall (Media)
949-474-4300
lhall@dresnerallencaron.com
$ITUS xtends Ownership Period and Changes Record Date for Stock Rights Offering
LOS ANGELES, CA –(February 10, 2017) – ITUS Corporation (“ITUS“) (NASDAQ: ITUS), a company using the power of the immune system for early cancer detection, is changing the Record Date for its current stock rights offering. The new Record Date will be Wednesday, March 1, 2017. For new shareholders to be eligible for the rights offering, shareholders will need to purchase ITUS common stock by Friday, February 24, 2017.
Robert Berman, ITUS’ President and CEO stated, “We are changing the Record Date due to the recent increased level of interest in ITUS and because we are presenting at 3 major investor conferences over the next two weeks in the United States and Europe.”
ITUS’ board of directors has approved a rights offering for ITUS shareholders of up to $12,000,000. The rights offering will include the non-transferable right to purchase one (1) share of ITUS common stock, at a discount, for each share of ITUS common stock owned by shareholders on the ownership day of Friday, February 24, 2017. The discounted price will be the lesser of (i) twenty-five percent (25%) discount to the volume weighted average price for ITUS common stock for the five (5) trading day period through and including Wednesday, March 1, 2017 (the “Record Date”), subject to ITUS board approval and (ii) fifteen percent (15%) discount to the volume weighted average price for ITUS common stock for the five (5) trading day period through and including Friday, March 24, 2017. ITUS shareholders may elect to participate in the rights offering during the subscription period, which will begin on March 3, 2017, and is scheduled to end on March 24, 2017. The final discounted price will be announced on March 24, 2017 after market close and will be available on our website at www.ITUScorp.com.
Proceeds from the rights offering will be used for general working capital purposes, including the continued development of Cchek™, and to further strengthen the company’s balance sheet by reducing the company’s debt. Because the rights are not transferable, the rights cannot be sold, borrowed, assigned, or traded, and the only way to obtain the rights is to be a shareholder of record as of February 24, 2017.
The new calendar for the 2017 rights offering is as follows:
Friday, February 24 | Ownership Day – last day to purchase ITUS common stock to receive rights (must purchase by 4:00 P.M. Eastern Time to become a shareholder on the Record Date). |
Wednesday, March 1 | Record Date (must own ITUS common stock to be eligible to receive rights); Maximum Price for rights offering is set. |
Friday, March 3 | Subscription Period begins. |
Friday, March 24 | Subscription Period ends at 5:00 P.M. Eastern Time (subject to extension of up to thirty (30) days at the discretion of the Company). |
The company will announce any additional changes to the above schedule, and the company reserves the right to cancel the rights offering at any time prior to the closing of the rights offering. ITUS recommends that current ITUS shareholders consider notifying their broker or financial advisor about the upcoming rights offering to ensure they will maximize their ability to participate in the rights offering.
The rights offering will include an over subscription privilege, which will entitle each rights holder that exercises its basic subscription privilege the right to purchase additional shares of ITUS common stock that remain unsubscribed at the expiration of the rights offering. Both the basic and over-subscription privileges are subject to proration.
Volume Weighted average pricing, commonly referred to as “VWAP”, is the average share price of a stock weighted against its trading volume within a particular time frame, which in this instance will be a trading day. VWAP will be calculated as the number of shares bought during a given day multiplied by the share price of each purchase, the product of which is divided by the total shares bought. For the convenience of our shareholders, ITUS will calculate and make available the applicable VWAP pricing referred to in the opening paragraph above.
The Company has hired MacKenzie Partners, Inc. as its information agent to assist shareholders with the transaction. Prior to the mailing of the prospectus, general information about rights offerings and answers to frequently asked questions will be made available on the Investor section ITUS website, as well as at 1(800)322-2885. Live operator telephone support to assist shareholders will also be available from 8 am to 9 pm Eastern standard time on weekdays and from 10 am to 6 pm on Saturdays.
Advisory Group Equity Services, Ltd, which is doing business as RHK Capital, will act as dealer manager for the rights offering. RHK Capital and Advisor Group Equity Services invite any broker dealers interested in participating in the rights offering to contact the syndicate department at itus@rhk.capital.
The information herein is not complete and is subject to change. This press release is not an offer to sell these securities and is not soliciting an offer to buy these securities. The offering can be made only by a final prospectus, including a prospectus supplement. Investors should consider investment objectives, risks, charges and expenses carefully before investing. The base prospectus included in the registration statement contains additional information about ITUS, and the prospectus supplement will contain additional information about the rights offering, and rights holders should read both carefully before exercising their rights and investing.
ITUS Corporation
ITUS funds, develops, acquires, and licenses emerging technologies in areas such as biotechnology. The Company is developing a platform called Cchek™, a series of non-invasive, blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2016 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Contact:
Dean Krouch
310-484-5184
dkrouch@ITUScorp.com
$ATVI @CallofDuty World® League Hits #Atlanta $SNE @PlayStation #PS4
The Call of Duty World® League Presented by PlayStation®4 (CWL) continues the 2017 season as the Call of Duty competition heads to Atlanta for a share of a $200,000 prize pool, and one more important step toward the CWL Championship. Starting today, the world’s best, including talented European teams, will face off at the CWL Atlanta Open, hosted by MLG, February 10-12 at Georgia World Congress Center in Atlanta, GA.
Today will feature the beginning of competition and more than 160 expected teams in the open bracket, one of the largest Call of Duty open brackets ever. The additional 16 teams in Championship pool play will feature the top teams from North America and Europe based on CWL Pro Points. The event will allow the top open bracket teams to move on toward Championship Pool play. On Sunday, the final teams will compete for the coveted title of CWL Atlanta Open Champion and their share of the $200,000 prize pool.
Championship pool play will feature major teams from around the world battling for the top prize. Rise Nation, winners of the CWL Open at MLG Vegas in December will be the overall favorites against Orbit, recent winners of CWL London, and Team EnVyUs, winners of the 2016 CWL Championship at Call of Duty XP.
For those interested in attending, General Admission (GA), tickets are only $49.99 for all three days of competition. The tickets will be offered on a first-come, first-served basis at the Georgia World Congress Center.
The CWL Atlanta Open marks the second North American LAN event for this season of the CWL. In addition to competing for the event prize pool, teams will also compete for coveted CWL Pro Points. These points will determine who takes part in the inaugural CWL Global Pro League taking place live at the MLG Arena in Columbus, Ohio, beginning in April, with an eye toward eventually qualifying for the CWL Championship later this year.
Call of Duty World League Presented by PlayStation®4 is proud to partner with Major League Gaming as North American tournament operator and broadcast partner for the upcoming season. Through MLG’s proven live streaming capabilities and technology, MLG.tv will help to deliver the CWL Atlanta event across a number of platforms including in-game via Infinite Warfare PS4 through the in game video player, mlg.tv/callofduty, twitch.tv/mlg, youtube.com/mlg and facebook.com/mlgpro.
For a taste of the captivating, non-stop action that can be expected during this weekend’s competition, check out the following trailer: https://www.youtube.com/watch?v=c9YjayV_t4o
For the latest intel on the Call of Duty World League Presented by PlayStation®4 and for live broadcasts check out: http://www.callofduty.com/cwl, tv.majorleaguegaming.com/channel/cwl, www.youtube.com/majorleaguegaming, or follow @CODWorldLeague on Twitter, Instagram and Facebook.
About Activision Publishing, Inc.
Headquartered in Santa Monica, California, Activision Publishing, Inc. is a leading global producer and publisher of interactive entertainment. Activision maintains operations throughout the world and is a division of Activision Blizzard, Inc. (NASDAQ: ATVI), an S&P 500 company. More information about Activision and its products can be found on the company’s website, www.activision.com or by following @Activision.
Cautionary Note Regarding Forward-looking Statements: Information in this press release that involves Activision Publishing’s expectations, plans, intentions or strategies regarding the future, including statements about the dates and expected events of the CWL Atlanta Open, the CWL Global Pro League and the Call of Duty World League are forward-looking statements, that are not facts and involve a number of risks and uncertainties. Factors that could cause Activision Publishing’s actual future results to differ materially from those expressed in the forward-looking statements set forth in this release include unanticipated product delays and other factors identified in the risk factors sections of Activision Blizzard’s most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. The forward-looking statements in this release are based upon information available to Activision Publishing and Activision Blizzard as of the date of this release, and neither Activision Publishing nor Activision Blizzard assumes any obligation to update any such forward-looking statements. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of Activision Publishing or Activision Blizzard and are subject to risks, uncertainties and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations.
ACTIVISION and CALL OF DUTY are trademarks of Activision Publishing, Inc. All other trademarks and trade names are the properties of their respective owners.
MAJOR LEAGUE GAMING is a registered trademark of Major League Gaming Corp.
Activision Publishing, Inc.
Robert Taylor, 310-496-5206
PR Manager
Robert.Taylor@activision.com
$IMMU #Exclusive #Global #LicensingAgreement w/ $SGEN on Solid Tumor Therapy
Immunomedics to Receive $250 Million in Upfront Cash Payment; Plus Among Other Milestone Payments, an Additional $50 Million or Negotiated Economic Splits Relating to Rights Outside US, Canada and EU Agreement Provides for Seattle Genetics to Develop, Manufacture and Commercialize IMMU-132 in Multiple Indications; Immunomedics Retains Rights to Co-Promote in the United States Seattle Genetics to Make up to $57 Million Equity Investment for up to 9.9% Stake in Immunomedics Via an Immediate Purchase of Common Stock and a Three-Year Warrant, Each Priced at a 10% Premium to the Company’s 15-Day VWAP Agreement Follows Months-Long Robust, Strategic Process Led by Independent Transaction Committee of the Board and Outside Financial Advisor, Greenhill & Co. IMMU-132 Represents Potential for First-Ever Approved Therapy Specifically for Advanced Metastatic Triple-Negative Breast Cancer (TNBC) Company to Host Conference Call at 8:00 AM Eastern Time to Discuss Transaction
MORRIS PLAINS, N.J., Feb. 10, 2017 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics”) today announced that it has entered into an exclusive global licensing agreement with Seattle Genetics, Inc. (NASDAQ: SGEN), an innovative global biotechnology company that develops and commercializes novel antibody-drug conjugates (ADCs) for the treatment of cancer. Under the agreement, Seattle Genetics will develop, fund, manufacture and commercialize IMMU-132, Immunomedics’ proprietary solid tumor therapy candidate.
The agreement also provides that Seattle Genetics will be responsible for initiating the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval. The agreement includes the development of additional indications for IMMU-132, including urothelial cancer (UC), small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), which are currently in Phase 2 clinical studies, along with other solid tumor indications being studied in ongoing clinical trials.
Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, said, “We are pleased to enter into this exclusive worldwide licensing agreement with Seattle Genetics to further advance IMMU-132 on behalf of patients with late-stage cancers, who have limited therapeutic options, while delivering significant and compelling near- and long-term value to stockholders. Since its founding, Immunomedics has been dedicated to creating and advancing novel therapies in challenging diseases with unmet therapeutic needs. Seattle Genetics’ reputation, development portfolio and track record make them an ideal partner to advance IMMU-132. Additionally, this agreement validates the dedication and effort by our entire internal teams in research and development, manufacturing, clinical, regulatory and general administration. In just over three years, we have brought IMMU-132 through clinical developments in multiple indications, and have advanced the TNBC indication to a potential accelerated approval and launch by late 2017 or early 2018, which could make IMMU-132 available to patients dealing with a highly malignant form of breast cancer. We are proud to have achieved this critical milestone and thank our entire team for their hard work. Immunomedics looks forward to appropriately supporting Seattle Genetics as it seeks to bring IMMU-132 to commercialization.”
Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics, said, “As the global leader in ADCs, we are excited to enter into this licensing agreement with Immunomedics for sacituzumab govitecan. This program would complement our rich pipeline of late- and early-stage programs, potentially allowing us to bring a new therapy for triple-negative breast cancer to patients in need. We have successfully demonstrated our expertise in the development, manufacturing and commercialization of ADCs in oncology, and we look forward to working with Immunomedics to advance this program.”
Dr. David M. Goldenberg, Chairman and Chief Scientific Officer of Immunomedics, commented, “After extensive preclinical research conducted by our scientists, and about three years of clinical development by our clinicians and our collaborating external investigators studying over 400 patients, we have decided that this is the right time to out-license IMMU-132. Although we have had partnerships in the past, I am extremely enthusiastic about entering into this collaboration with Seattle Genetics, a company that has achieved a leadership role in antibody-drug conjugates. Both companies are committed to bringing important products to cancer patients. This common goal is sincere and will be the basis of making IMMU-132 fulfill its full potential.”
Dr. Goldenberg further remarked, “After a long period of interactions with many interested partnering candidates, and a considerable period of discussion with Seattle Genetics, we concluded that working with this group of successful business and marketing executives, clinicians and scientists would allow us to contribute our own scientific and clinical knowledge to them as they further develop IMMU-132 and bring it to commercialization. We are particularly pleased with their enthusiasm, and that this arrangement allows us to continue our ongoing Phase 2 studies in a number of additional cancer types while we transition this product candidate to them.”
Terms of the Agreement
The agreement provides for potential payments of approximately $2 billion across multiple indications, plus double-digit tiered royalties on global net sales. Under the terms of the agreement, Immunomedics will receive $250 million in upfront cash payment, plus, among other milestone payments, an additional $50 million (or negotiated economic splits) relating to rights outside the U.S., Canada and the EU. The remainder of the consideration comprises approximately $1.7 billion that is contingent upon achieving certain clinical, development, regulatory and sales milestones, including an anticipated near-term milestone for acceptance of the Biologics License Application (BLA) by the U.S. Food and Drug Administration for TNBC, additional milestones based on regulatory approval of IMMU-132 for TNBC in the U.S. and other territories, and future development and regulatory milestones for additional indications beyond TNBC. Future royalty payments are tiered double-digit royalties based on global net sales. In addition, Immunomedics will retain the right to elect to co-promote IMMU-132 in the United States by participating in 50% of the sales effort, subject to certain parameters set forth in the agreement.
Joint Steering Committee
Upon completion of the transaction, Immunomedics and Seattle Genetics will each appoint representatives to serve on a Joint Steering Committee (JSC) that will be chaired by a Seattle Genetics representative. The JSC will be responsible for, among other things, determining the overall development, commercialization, manufacturing and intellectual property strategy for IMMU-132.
Timing and Approvals
The companies expect the transaction to close in the first quarter of 2017, subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as well as other customary closing conditions.
Modified Go-Shop Period
Under the terms of the agreement, for a limited period, through February 19, 2017, Immunomedics has the right to continue negotiating with a select number of parties still in the strategic process, and accept a superior proposal. Seattle Genetics has the right to match any superior proposal and if it decides not to match, Immunomedics has the right to accept the superior proposal and terminate the proposed development and license agreement upon payment of a termination fee to Seattle Genetics.
Equity Investment
Concurrent with the transaction, Seattle Genetics is purchasing 3,000,000 shares of common stock, representing an approximately 2.8% stake in Immunomedics, at a per share price of $4.90, which represents a 10% premium to Immunomedics’ 15-day trading volume weighted average stock price of $4.45 for the period ending at the close of trading February 9, 2017, the last trading day prior to entering into the global licensing agreement. Seattle Genetics will also be issued a three-year warrant to purchase 8,655,804 shares of common stock at the same price, which shall be exercisable when the Company has sufficient authorized shares of common stock to enable the exercise of the warrant. Seattle Genetics will not be eligible to vote its stake at the upcoming 2016 Annual Meeting of Stockholders.
“We are delighted to welcome Seattle Genetics to our stockholder base and appreciate their commitment to Immunomedics. Our promising clinical results and this partnership validating the promise of our novel antibody-drug conjugation technology stimulates us to advance our other product candidates using this platform technology,” added Ms. Sullivan.
Strategic Process
The agreement with Seattle Genetics follows a 13 months-long competitive strategic process led over the past several months by outside financial advisor, Greenhill & Co. (“Greenhill”), which was retained for their global capabilities and their significant experience in biopharma M&A and licensing transactions. Greenhill & Co. reports directly to the Transaction Committee of the Board, composed exclusively of the Company’s five independent directors.
Jason Aryeh, independent Vice Chairman of the Immunomedics Board, stated, “We are pleased to offer Immunomedics stockholders the compelling and significant value provided by this agreement with Seattle Genetics. This agreement is the culmination of a robust strategic process, led by Greenhill and the Transaction Committee. Greenhill’s outreach was to more than 45 parties and involved more than half of those parties entering into confidentiality agreements and participating in diligence. In addition to the highly competitive financial terms of the transaction, we believe that Seattle Genetics is the ideal partner for IMMU-132.”
Future Financial Plans
Upon closing of the transaction, the Immunomedics Board and management will evaluate and prioritize the Company’s remaining clinical programs, long- and short-term funding requirements and tax-efficient ways to return capital to stockholders, including share buybacks. The Company will announce the outcome of this review once a decision has been reached.
Immunomedics expects that the transaction will fulfill its liquidity needs such that the Company can fund itself without additional equity raises for the foreseeable future.
Advisors
Greenhill & Co., LLC, is serving as financial advisor to Immunomedics and DLA Piper LLP (US) is serving as legal advisor on the transaction.
Conference Call to Discuss Transaction and Second Quarter 2017 Financial Results
Immunomedics will host a conference call and live audio webcast today at 8:00 AM Eastern Time to discuss this announcement and will also discuss the Company’s second quarter 2017 financial results announced separately yesterday, February 9, 2017. The Company will post a presentation for analysts and investors to its website, www.immunomedics.com, at least 15 minutes prior to the beginning of the conference call.
To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 58226264. The conference call will be also webcast via the Investors page on Immunomedics’ website at www.immunomedics.com.
Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for 30 days through March 11, 2017.
About Immunomedics
Immunomedics (the “Company”) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of eight clinical-stage product candidates. Immunomedics’ portfolio of investigational products includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. IMMU-132 has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 301 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release.
Important Additional Information
Immunomedics, Inc. (the “Company”), its directors and certain of its executive officers will be deemed to be participants in the solicitation of proxies from Company stockholders in connection with the matters to be considered at the Company’s 2016 Annual Meeting. The Company has filed a definitive proxy statement and form of WHITE proxy card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with any such solicitation of proxies from Company stockholders. COMPANY STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS), THE ACCOMPANYING WHITE PROXY CARD AND ANY OTHER RELEVANT DOCUMENTS THAT THE COMPANY FILES WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Information regarding the identity of participants, and their direct or indirect interests, by security holdings or otherwise, is set forth in the proxy statement and other materials filed by the Company with the SEC. Stockholders will be able to obtain the proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC for no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at www.immunomedics.com, by writing to Immunomedics, Inc. at 300 The American Road, Morris Plains, New Jersey 07950, or by calling the Company’s proxy solicitor, or by calling Dr. Chau Cheng, Senior Director, Investor Relations & Corporate Secretary, (973) 605-8200, extension 123.
Forward-Looking Statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, out-licensing arrangements (including the timing and amount of contingent payments under the license and development agreement with Seattle Genetics), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com
Media
Dan Katcher / Ed Trissel / Nick Lamplough
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449
Investors
Dan Burch/Bob Marese
MacKenzie Partners, Inc.
(212) 929-5500
$SHLD Outlines Next Phase Of Its Strategic Transformation
Preliminary fourth quarter 2016 operating results represent significant year-over-year improvement Launches comprehensive restructuring to streamline operations, targeting at least $1.0 billion in annualized cost savings in 2017 Right-sizes asset-based credit facility, creating an incremental $140[1] million in liquidity Plans to reduce outstanding debt and pension obligations by at least $1.5 billion, utilizing proceeds from recent transactions and operational improvements
HOFFMAN ESTATES, Ill., Feb. 10, 2017 — Sears Holdings Corporation (“Holdings,” “we,” “us,” “our,” or the “Company”) (NASDAQ: SHLD) today announced that it delivered meaningful improvement in operating performance for the fourth quarter of 2016, and outlined important actions to drive profitability. These include steps to enhance the Company’s liquidity and financial flexibility, as well as a strategic restructuring program intended to streamline operations, further improve operating performance and target cost reductions of at least $1.0 billion on an annualized basis.
Edward S. Lampert, Chairman and Chief Executive Officer of Sears Holdings, said, “We significantly improved our operating performance and made progress toward profitability in the fourth quarter of 2016. In the first several weeks of 2017, we undertook a series of transactions to optimize our capital structure and unlock value across our wide range of assets. We also reached an agreement to amend our asset-based credit facility which further enhances our liquidity and financial flexibility. Furthermore, we intend to use net proceeds from our announced Craftsman and real estate transactions, as well as from improvements in the operating performance of the Company, to meaningfully reduce our outstanding obligations and their associated expenses.
“To build on our positive momentum, today we are initiating a fundamental restructuring of our operations that targets at least $1.0 billion in cost savings on annualized basis, as well as improves our operating performance. To capture these savings, we plan to reduce our corporate overhead, more closely integrate our Sears and Kmart operations and improve our merchandising, supply chain and inventory management.
“We believe the actions outlined today will reduce our overall cash funding requirements and ensure that Sears Holdings becomes a more agile and competitive retailer with a clear path toward profitability. In addition, we believe these actions will enable us to focus our investments to drive our strategic transformation and the evolution of our Shop Your Way ecosystem through value enhancing partnerships, compelling offerings and a seamless online and in-store shopping experience for our members,” Mr. Lampert concluded.
Next Phase of Our Transformation
Sears Holdings has initiated a restructuring program targeted to deliver at least $1.0 billion in annualized cost savings in 2017. These savings include cost reductions from the previously announced closure of 108 Kmart and 42 Sears stores.
Under the restructuring program, we intend to:
- Simplify Sears Holdings’ organizational structure, including greater consolidation of the Sears and Kmart corporate and support functions, as well as improve accountability for profitability at our store and online channels;
- Implement an integrated model to drive efficiencies in pricing, sourcing, supply chain and inventory management;
- Optimize product assortment at Sears and Kmart stores, using data analytics to better align with preferences of our Best Members focusing on profitable, high-return Best Categories; and
- Actively manage our real estate portfolio to identify additional opportunities for reconfiguration and reduction of capital obligations.
Profitability
In addition to the cost reduction target announced today, we continue to assess our overall operating model and capital structure to become a more agile, asset-light and innovative retailer focused on member experience. To help drive our profitability, we intend to:
- Capitalize on valuable real estate through potential in-store partnerships, sub-divisions, and reformatting to support our Integrated Retail model; and
- Continue to evaluate strategic options for our Kenmore® and DieHard® brands and our Sears Home Services and Sears Auto Centers business through partnerships, joint ventures or other means.
We expect these actions will enable us to focus our investments on driving our strategic transformation and enhancing the value of our Shop Your Way program for our millions of members and the strategic partners that we attract to the program. Our Shop Your Way platform rewards members for buying the products and services they want every day. Through our extensive network of thousands of top brands and millions of products, members can earn points to use on future purchases. Members also have access to special pricing, sales and digital coupons, as well as personalized services and advice.
Transformation Progress to Date
Today’s announcements build on the path we have taken since the beginning of 2017 to improve operational performance and liquidity. Since the calendar year started, we have taken the following strategic actions to strengthen our financial position:
- Obtaining an additional $179 million of loan proceeds, which fully utilizes the $500 million Senior Secured Loan Facility entered into on January 4, 2017;
- Closing a $72.5 million real estate sale on January 26, 2017 for five Sears Full-line stores and two Sears Auto Centers;
- Initiating the closing process of the 150 stores announced during our fourth quarter 2016 with the expectation to complete the closures of all 150 stores during the first quarter of 2017;
- Engaging Eastdil Secured to market and sell at least $1.0 billion of certain real estate properties under the direction of a committee of the Board of Directors; and
- Announcing the Craftsman® transaction for $775 million in cash plus participation in the externalization of the Craftsman® brand by Stanley Black & Decker.
Additional Financial Flexibility
On February 10, 2017, the Company entered into an agreement to amend our existing asset-based credit facility. The amendment provides a $140 million increase to available borrowing capacity under our revolver as compared to availability reported at the end of the third quarter of 2016. Sears Holdings concluded the fourth quarter of 2016 with no borrowings and $464 million of letters of credit outstanding, against its asset-based credit facility. The amendment provides immediate additional liquidity and financial flexibility to the Company.
On a pro forma basis, giving effect to the amendment of our credit facility, our total liquidity and liquid assets would have been over $4.0 billion at the end of third quarter of 2016. The amendment will reduce the aggregate revolver commitments from $1.971 billion to $1.5 billion, but will implement other modifications to covenants and reserves against the credit facility borrowing base that improve net liquidity. The amended credit facility is smaller in size, reflecting the Company’s reduced needs consistent with lower inventory levels associated with our transforming business model, which has fewer physical stores and a greater online presence. The amendment also provides additional flexibility in the form of a $250 million increase in the general debt basket from $750 million to $1.0 billion.
We are targeting a reduction in our outstanding debt and pension obligations of $1.5 billion for fiscal 2017 through improving profitability, asset sales, and working capital management. Sears Holdings has contributed almost $4.0 billion to our pension plan since 2005, driven largely by the prolonged low interest rate environment.
Fourth Quarter Update
As previously indicated in our January 2017 update, sales declined in the fourth quarter of 2016 compared to the prior year fourth quarter due to a combination of the competitive retail environment and fewer operating stores, as we emphasized improving profitability. Accordingly, we have continued to manage inventory and costs closely resulting in a notable improvement in our short-term operating performance and progress toward our profitability goals.
We expect total revenues of $6.1 billion and $22.1 billion for the fourth quarter and full-year of 2016, respectively. Total comparable store sales for the fourth quarter have declined 10.3%, comprised of a decrease of 8.0% at Kmart and a decrease of 12.3% at Sears Domestic. We expect that our fourth quarter 2016 net loss attributable to Sears Holdings’ shareholders will range between $635 million and $535 million, which is inclusive of a non-cash impairment charge related to the Sears trade name of between $350 million and $400 million. This compares to a net loss attributable to Sears Holdings’ shareholders of $580 million in the fourth quarter of 2015, which was inclusive of a non-cash impairment charge related to the Sears trade name of $180 million.
In addition, our preliminary fourth quarter 2016 Adjusted EBITDA was $(61) million, compared to Adjusted EBITDA of $(137) million in the fourth quarter of 2015. This significant improvement in Adjusted EBITDA has been driven by tighter expense control and inventory management.
We have provided below a reconciliation of Adjusted EBITDA, a non-GAAP financial measure, to net loss attributable to Sears Holdings’ shareholders.
Adjusted EBITDA Reconciliation
In addition to our net loss attributable to Sears Holdings’ shareholders determined in accordance with Generally Accepted Accounting Principles (“GAAP”), for purposes of evaluating operating performance, we use Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (“Adjusted EBITDA”), which is a non-GAAP measure. The table set forth below provides a reconciliation of as-adjusted amounts to net loss attributable to Sears Holdings’ shareholders, the most directly comparable GAAP financial measure. We believe that our use of Adjusted EBITDA provides an appropriate measure for investors to use in assessing our performance across periods, given that these measures provide adjustments for certain significant items, which may vary significantly from period to period, improving the comparability of year-to-year results and is therefore representative of our ongoing performance. Therefore, we have adjusted our results to make our statements more useful and comparable. However, we do not, and do not recommend that investors solely use adjusted amounts to assess our financial performance.
millions | Q4 2016 Range | ||||||
• Expected net loss attributable to Sears Holdings’ shareholders | $ | (635) | $ | (535) | |||
• Plus domestic pension expense(1) and significant items not included in Adjusted EBITDA(2) | 665 | 590 | |||||
• Plus income statement line items not included in EBITDA consisting of income taxes, interest expense, interest and investment loss, other income, depreciation and amortization expense and gain on sales of assets | (115) | (90) | |||||
Adjusted EBITDA | $ | (85) | $ | (35) | |||
(1) | The annual pension expense included in our statement of operations related to our legacy domestic pension plans is comprised of interest cost, expected return on plan assets and amortization of experience losses. Gains and losses occur when actual experience differs from the estimates used to allocate the change in value of pension plans to expense throughout the year or when assumptions change, as they may each year. Significant factors that can contribute to the recognition of actuarial gains and losses include changes in discount rates used to remeasure pension obligations on an annual basis or, upon a qualifying remeasurement, differences between actual and expected returns on plan assets and other changes in actuarial assumptions. Management believes these actuarial gains and losses are primarily financing activities that are more reflective of changes in current conditions in global financial markets (and in particular interest rates) that are not directly related to the underlying business and that do not have an immediate, corresponding impact on the benefits provided to eligible retirees. This adjustment eliminates the entire pension expense from the statement of operations to improve comparability. | |||||
(2) | Significant items not included in Adjusted EBITDA include impairment charges related to fixed assets and intangible assets, closed store and severance charges, one-time credits from vendors, expenses associated with legal matters, transaction costs associated with strategic initiatives and other expenses. |
Forward-Looking Statements
This press release contains forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about our strategic restructuring, our transformation through our integrated retail strategy, our plans to redeploy and reconfigure our assets, our plans to market and sell a portion of our existing real estate assets, our expectation of closing the sale of our Craftsman brand as previously announced, our liquidity, our ability to exercise financial flexibility as we meet our obligations and pursue possible strategic transactions, and other statements that describe the Company’s plans. Whenever used, words such as “will,” “expect,” and other terms of similar meaning are intended to identify such forward-looking statements. Forward-looking statements, including these, are based on the current beliefs and expectations of our management and are subject to significant risks, assumptions and uncertainties, many of which are beyond the Company’s control, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Detailed descriptions of other risks relating to Sears Holdings are discussed in our most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. While we believe that our forecasts and assumptions are reasonable, we caution that actual results may differ materially. We intend the forward-looking statements to speak only as of the time made and do not undertake to update or revise them as more information becomes available, except as required by law. Results presented herein are unaudited. The unaudited and estimated financial results for the fourth quarter of 2016 contained in this press release reflect a number of complex and subjective judgments and estimates about the appropriateness of certain reported amounts and disclosures. Our financial statements for the 2016 fiscal year are not finalized. We are required to consider all available information through the finalization of our financial statements and their possible impact on our financial conditions and results of operations for the period, including the impact of such information on the complex judgments and estimates referred to above. As a result, subsequent information or events may lead to material differences between the information about the results of operations described herein and the results of operations described in our subsequent annual report. You should consider this possibility in reviewing the financial information for the period described above.
About Sears Holdings Corporation
Sears Holdings Corporation (NASDAQ: SHLD) is a leading integrated retailer focused on seamlessly connecting the digital and physical shopping experiences to serve our members – wherever, whenever and however they want to shop. Sears Holdings is home to Shop Your Way®, a social shopping platform offering members rewards for shopping at Sears and Kmart as well as with other retail partners across categories important to them. The Company operates through its subsidiaries, including Sears, Roebuck and Co. and Kmart Corporation, with full-line and specialty retail stores across the United States. For more information, visit www.searsholdings.com
[1] Based on the assumption that the extension is applied to the credit facility availability as of October 29, 2016.
NEWS MEDIA CONTACT:
Sears Holdings Public Relations
(847) 286-8371
$PLUG to Host #FY16 #Growth #ConferenceCall on February 24
LATHAM, N.Y., Feb. 10, 2017 — Plug Power Inc. (NASDAQ:PLUG), a leader in providing clean, reliable energy solutions, today announced the Company will host a business update conference call on February 24, 2017. On this call, CEO, Andy Marsh, will discuss preliminary results for the full year of 2016.
Additionally, Marsh will discuss expansion and growth plans for 2017. This will include continued momentum within the material handling business as well as the promising electric vehicle market in China. “The Plug Power team is making substantial contributions, every day, not just with leadership in fuel cell power for industrial electric vehicles, but also with hydrogen fueling station and service solutions, which are accelerating mass adoption,” said Andy Marsh. “I’m looking forward to providing an update on Plug Power’s important footprint in building this industry and the hydrogen economy, as the world embraces electric drive trains.”
Join the call:
Date: Friday, February 24, 2017
Time: 10:00 am ET
Toll-free: 877-407-9221
International: 201-689-8597
Direct webcast: https://event.webcasts.com/starthere.jsp?ei=1135898
The webcast can also be accessed directly from the Plug Power homepage (www.plugpower.com). A playback of the call will be available online for a period of time following the call.
About Plug Power Inc.
The architects of modern hydrogen and fuel cell technology, Plug Power has revolutionized the industry with its simple GenKey solution, elements of which are designed to increase productivity, lower operating costs and reduce carbon footprints in a reliable, cost-effective way. Plug Power’s GenKey solution couples together all the necessary elements to power, fuel and service a customer. Plug Power is the partner that customers trust to take their businesses into the future. For more information about Plug Power, visit www.plugpower.com.
Safe Harbor Statement
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties about Plug Power Inc. (“PLUG”), including but not limited to statements about PLUG’s 2016 objectives, including goals relating to revenue, sales, booking, gross margin and GenKey and GenFuel installations You are cautioned that such statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by which, such performance or results will have been achieved. Such statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in these statements. In particular, the risks and uncertainties include, among other things, the risk that we continue to incur losses and might never achieve or maintain profitability; the risk that we will need to raise additional capital to fund our operations and such capital may not be available to us; the risk that our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue, in whole or in part; the risk that pending orders may not convert to purchase orders, in whole or in part; the risk that a loss of one or more of our major customers could result in a material adverse effect on our financial condition; the risk that a sale of a significant number of shares of stock could depress the market price of our common stock; the risk that negative publicity related to our business or stock could result in a negative impact on our stock value and profitability; the risk of potential losses related to any product liability claims or contract disputes; the risk of loss related to an inability to maintain an effective system of internal controls or key personnel; the risks related to use of flammable fuels in our products; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the risk that our actual net cash used for operating expenses may exceed the projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our products, including GenDrive, GenSure and GenKey systems; the volatility of our stock price; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to successfully expand internationally; our ability to improve system reliability for our GenDrive, ReliOn and GenKey systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; risks associated with potential future acquisitions; and other risks and uncertainties referenced in our public filings with the Securities and Exchange Commission. For additional disclosure regarding these and other risks faced by PLUG, see disclosures contained in PLUG’s public filings with the Securities and Exchange Commission (the “SEC”) including, the “Risk Factors” section of PLUG’s Annual Report on Form 10-K for the year ended December 31, 2015. You should consider these factors in evaluating the forward-looking statements included in this presentation and not place undue reliance on such statements. The forward-looking statements are made as of the date hereof, and PLUG undertakes no obligation to update such statements as a result of new information.
Plug Power Media Contact Teal Vivacqua 518.738.0269 media@plugpower.com
$ZGNX to Participate in the #LeerinkPartners 6th Annual GHC
EMERYVILLE, Calif., Feb. 08, 2017 — Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, today announced that Stephen J. Farr, Ph.D., President and CEO, will present a corporate update at the Leerink Partners 6th Annual Global Healthcare Conference in New York on February 15, 2017.
Leerink Partners 6th Annual Global Healthcare Conference — Zogenix Presentation Details
Date: Wednesday, February 15, 2017
Time: 9:30 am Eastern Time / 6:30 am Pacific Time
Location: New York, NY – Lotte New York Palace Hotel
The presentation will be webcast live and archived for 30 days on Zogenix’s Investor Relations website at ir.zogenix.com.
About Zogenix
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing CNS therapies that address specific clinical needs for people living with orphan and other CNS disorders who need innovative treatment alternatives to improve their daily functioning.
For more information, visit www.zogenix.com.
Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding the potential commercialization of ZX008; the timing of top-line results from the Phase 3 clinical trial of ZX008 in Dravet syndrome and other 2017 milestones; and the timing of any submission of a new drug application to the U.S. Food and Drug Administration or comparable market authorization filing in Europe. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies may not be predictive of future results; Zogenix’s reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of its drug products, if approved; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix’s ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities; Fast Track designation may not result in an expedited regulatory review process; the potential for distraction of management related to the transition of management responsibilities; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACT: Investors: Andrew McDonald Founding Partner, LifeSci Advisors LLC 646-597-6987 | Andrew@lifesciadvisors.com
$RESN Announces First Shipments Using #ISN Designs
Over One Million Units Successfully Shipped to Four Separate Handset OEM’s
Management to Host a Conference Call Tomorrow at 8:00 a.m. PT/11:00 a.m. ET
Resonant Inc. (NASDAQ: RESN), a designer of filters for radio frequency, or RF, front-ends that specializes in delivering designs for difficult bands and complex requirements, today announced that one of its licensee customers has successfully shipped over one million pre-production parts to four separate handset Original Equipment Manufacturers. These are the first shipments by the customer under the initial licensing agreement the parties executed in May 2016, which covers three frequency bands. These high volume bands encompass three Surface Acoustic Wave (SAW) duplexers, which were designed utilizing Resonant’s proprietary design automation platform, ISN®.
“Shipping these pre-production parts represents one of the last steps before commercial acceptance of our designs as we transition from a development-stage company into a product-focused licensor with recurring royalty revenue,” said George B. Holmes, CEO of Resonant. “Throughout the past year, we’ve remained intently focused on engaging with the right players for specific designs that we believe could generate revenue in the shortest amount of time. We believe these initial shipments will represent modest revenue in mass production later this year, they none the less validate our capabilities to convert ‘ISN Ready’ designs into production within 9-12 months of signing a license agreement. We look forward to our continued collaboration with this customer, including the work we have commenced on additional frequency bands. We believe this collaboration ultimately will showcase the value that our tools, technology and team bring to the RF front-end industry.”
Conference Call and Webcast
Management will host an investor conference call tomorrow at 8:00 a.m. Pacific time (11:00 a.m. Eastern time) to provide a corporate update and discuss the first volume shipments, followed by a question and answer session. To participate, please use the following information:
Date: Thursday, February 9, 2017
Time: 8:00 a.m. Pacific time (11:00 a.m. Eastern time)
U.S. Dial-in: 1-877-407-3982
International Dial-in: 1-201-493-6780
Conference ID: 13655087
Webcast: http://public.viavid.com/index.php?id=122939
Please dial in at least 10 minutes before the start of the call to ensure timely participation.
A playback of the call will be available through March 9, 2017. To listen, call 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally. Please use the replay pin number 13655087. A webcast will also be available for 30 days on the IR section of the Resonant website or by clicking here: RESONANT CORPORATE UPDATE CALL.
About Resonant Inc.
Resonant is creating software tools and IP & licensable blocks that enable the development of innovative filter designs for the RF front-end, or RFFE, for the mobile device industry. The RFFE is the circuitry in a mobile device responsible for the radio frequency signal processing and is located between the device’s antenna and its digital baseband. Filters are a critical component of the RFFE that selects the desired radio frequency signals and rejects unwanted signals and noise. For more information, please visit www.resonant.com.
About Resonant’s ISN® Technology
Resonant can create designs for hard bands and complex requirements that we believe have the potential to be manufactured for half the cost and developed in half the time of traditional approaches. The Company’s large suite of proprietary mathematical methods, software design tools and network synthesis techniques enable it to explore a much bigger set of possible solutions and quickly derive the better ones. These improved filters still use existing manufacturing methods (i.e. SAW) and can perform as well as those using higher cost methods (i.e. BAW). While most of the industry designs surface acoustic wave filters using a coupling-of-modes model, Resonant uses circuit models and physical models. Circuit models are computationally much faster, and physical models are highly accurate models based entirely on fundamental material properties and dimensions. Resonant’s method delivers excellent predictability, enabling achievement of the desired product performance in roughly half as many turns through the fab. In addition, because Resonant’s models are fundamental, integration with its foundry and fab customers is eased because its models speak the “fab language” of basic material properties and dimensions.
Safe Harbor / Forward-Looking Statements
This press release contains forward-looking statements, which include the following subjects, among others: the transition from a development-stage company to a licensing company, the timing and amount of future royalty streams, and the timing to bring designs into production. Forward-looking statements are made as of the date of this document and are inherently subject to risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, including, without limitation, the following: our limited operating history; our ability to complete designs that meet customer specifications; the ability of our customers (or their manufacturers) to fabricate our designs in commercial quantities; the ability of our designs to significantly lower costs compared to other designs and solutions; the risk that the intense competition and rapid technological change in our industry renders our designs less useful or obsolete; our ability to find, recruit and retain the highly skilled personnel required for our design process in sufficient numbers to support our growth; our ability to manage growth; and general market, economic and business conditions. Additional factors that could cause actual results to differ materially from those anticipated by our forward-looking statements are under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our most recent Annual Report (Form 10-K) or Quarterly Report (Form 10-Q) filed with the Securities and Exchange Commission. Forward-looking statements are made as of the date of this release, and we expressly disclaim any obligation or undertaking to update forward-looking statements.
MZ North America
Greg Falesnik, 1-949-385-6449
Greg.Falesnik@mzgroup.us
$ONCS to Present New #Phase2 Clinical Data @ ASCO-SITC #ImmunoSym
SAN DIEGO, Feb. 8, 2017 — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will present new clinical data on ImmunoPulse® IL-12, its lead program focused on oncology, at the upcoming 2017 American Association for Cancer Research & Society for Immunotherapy of Cancer (ASCO-SITC) Clinical Immuno-Oncology Symposium. In addition, Punit Dhillon, President & CEO, will present a corporate overview at two investment conferences in February, including: the 19th Annual BIO CEO & Investor Conference and Source Capital Group’s 2017 Disruptive Growth & Healthcare Conference.
2017 ASCO-SITC Clinical Immuno-Oncology Symposium
Dr. Alain Algazi, Associate Clinical Instructor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, will present an oral and poster presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium to be held on February 23-24, 2017, in Orlando, FL.
Details of the presentation are as follows:
Abstract Title: Immune monitoring outcomes of patients with stage III/IV melanoma treated with a combination of pembrolizumab and intratumoral plasmid interleukin 12 (pIL-12) (Abstract ID #78)
Session Title: Activating the Immune System-New Clinical Approaches
Date and Time: February 23, 2017 at 11:30 a.m. – 1:00 p.m. (poster) & 3:30 p.m. – 5:00 p.m. EST (oral)
Location: Hyatt Regency Orlando
Further details on this ASCO-SITC oral and poster presentation will be provided in upcoming Company communications. For more information about this symposium, please visit: http://immunosym.org/
The 19th Annual BIO CEO & Investor Conference
Mr. Dhillon will present a corporate overview at The 19th Annual BIO CEO & Investor Conference on February 14 at 3:00 p.m. EST at The Waldorf Astoria in New York City.
To view to the live webcast, please access the following link at the time of the presentation: http://www.veracast.com/webcasts/bio/ceoinvestor2017/98226117037.cfm. An archived version of the webcast will be available for 90 days on OncoSec’s website: http://www.oncosec.com.
For more information about this conference, please visit: https://www.bio.org/events/bio-ceo-investor-conference
Source Capital Group’s 2017 Disruptive Growth & Healthcare Conference
Mr. Dhillon will present a corporate overview at Source Capital Group’s 2017 Disruptive Growth & Healthcare Conference on February 15 at 3:00 p.m. EST at Convene in New York City.
For more information about this conference, please visit: www.DisruptNYC.com.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse® is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as a systemic immune response. OncoSec’s lead program, ImmunoPulse® IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse® platform. For more information, please visit www.oncosec.com.
CONTACT:
Punit Dhillon
President & Chief Executive Officer
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
Media:
Laura Radocaj
Dian Griesel Int’l.
212-825-3210
$VTNR Announces Entry into $30 Million Credit Facility
Vertex Energy, Inc. (NASDAQ:VTNR), a refiner and marketer of high-quality specialty hydrocarbon products, announced today that it has entered into funding agreements with Encina Business Credit, LLC (EBC) providing for up to $30 million of senior secured debt. The financing, which is comprised of a revolving line of credit, a funded term loan and a delayed draw term loan, will be used to refinance certain of the company’s existing indebtedness and to provide working capital for growth.
Vertex’s Chief Executive Officer, Benjamin P. Cowart, said, “The refinance of the company’s prior credit facility reflects our belief in the future growth of the company. We believe that this step was necessary in ensuring that we clean up our balance sheet, which includes paying off both of our prior lenders, consolidating our debt into one facility and strengthening our cash position.”
Mr. Cowart added, “With the financing completed, we were able to close on the acquisition of the assets of a small collection company in Louisiana. With approximately 90 million gallons of processing capacity, we believe that our collections vertical is key to our growth. Our self-collected gallons today are approximately 20% of our overall production. We anticipate increasing this to 25% in 2017, while we expand our overall production volumes.”
Mr. Cowart concluded, “We believe that we are well-positioned to grow our business in 2017. Our goal for growth involves expanding collections, increasing production volumes and moving to higher margin products, all of which are underway.”
For further information about the transactions, please see our 8-K filing with the SEC today.
ABOUT VERTEX ENERGY, INC.
Vertex Energy, Inc. (VTNR) is a refiner and marketer of high-quality specialty hydrocarbon products. With headquarters in Houston, Texas, Vertex Energy processing facilities are located in Houston (TX), Marrero (LA) and Columbus (OH). For more information on Vertex Energy, please contact Porter, LeVay & Rose, investor relations representative Marlon Nurse, at 212-564-4700 or visit our website at www.vertexenergy.com.
ABOUT ENCINA BUSINESS CREDIT, LLC
Launched in March 2016, EBC is an independent asset-based lending platform targeting middle-market borrowers in the U.S. and Canada that cannot obtain required financing from traditional banks. The firm provides revolving lines of credit and term loans ranging in size from $5–$50 million and secured by accounts receivable, inventory, machinery & equipment and real estate. The platform lends to both privately-owned (sponsor and non-sponsor) and publicly-traded companies across a wide range of industries, including manufacturing, retail, automotive, oil & gas, services, distribution and consumer products. Borrowers use loan proceeds to fund working capital, acquisitions, refinancings, growth, restructurings/turnarounds, debtor-in-possession (DIP)/exit financings and other special situations. Positive cash flow is not a requirement.
Forward-Looking Statements
This press release may contain forward-looking statements, including information about management’s view of Vertex Energy’s future expectations, plans and prospects, within the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 (the “Act”). In particular, when used in the preceding discussion, the words “believes,” “hopes,” “expects,” “intends,” “plans,” “anticipates,” or “may,” and similar conditional expressions are intended to identify forward-looking statements within the meaning of the Act, and are subject to the safe harbor created by the Act. Any statements made in this news release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of Vertex Energy, its divisions and concepts to be materially different than those expressed or implied in such statements. These risk factors and others are included from time to time in documents Vertex Energy files with the Securities and Exchange Commission, including but not limited to, its Form 10-Ks, Form 10-Qs and Form 8-Ks. Other unknown or unpredictable factors also could have material adverse effects on Vertex Energy’s future results. The forward-looking statements included in this press release are made only as of the date hereof. Vertex Energy cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, Vertex Energy undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by Vertex Energy.
Vertex Energy, Inc.
Marlon Nurse, DM, 212-564-4700
Senior VP – Investor Relations
$APOP First #Cancer Patient Treated In PhaseI/II Trial of #ApoGraft
Management expects additional positive upcoming results from its trial in healthy volunteers
TEL AVIV, Israel, Feb. 08, 2017 – Cellect Biotechnology Ltd. (Nasdaq:APOP) (TASE:APOP), a developer of stem cells selection technology, today announces that it has treated the first blood cancer patient in the recently initiated Phase I/II trial of its stem cell technology ApoGraft™.
The trial is intended to assess the Cellect ApoGraft™ process which is designed to prevent Graft-versus-Host Disease (GvHD), a common complication associated with stem cell transplant in which the transplanted immune cells attack the recipient’s body cells and organs. GvHD is a life-threatening condition occurring in up to 50% of stem cell transplants. In this trial, the company will be testing stem cells transplanted from a matched donor related to the patient.
Referring to the trial on healthy volunteers, the company plans to release definitive and complete results of this trial before the end of Q1 this year.
Cellect CEO, Shai Yarkoni commented, “Enrolling our first cancer patient to be treated using our groundbreaking method is a critical milestone for millions of patients worldwide. ApoGraft™ has been proven to be effective in assisting successful stem cells transplants and preventing GvHD during our animal studies. I am excited with prospects of Cellect becoming a key contributor to the fast-growing market for stem cells based products enabling 21st century regenerative medicine.”
The study is being conducted at the Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, Haifa, Israel. The primary objective of the trial is to assess the safety and tolerability of ApoGraft™ administered to patients with hematological malignancies undergoing allogeneic stem cell transplantation from a matched related donor.
About GvHD
Despite improved prophylactic regimens, acute GvHD disease still occurs in 25% to 50% of recipients of allogeneic stem cells transplantation. The incidence of GvHD in recipients of allogeneic stem cells transplantation is increasing due to the increased number of allogeneic transplantations survivors, older recipient age, use of alternative donor grafts, and use of peripheral blood stem cells. GvHD accounts for 15% of deaths after allogeneic stem cells transplantation and is considered the leading cause of non-relapse mortality after allogeneic stem cells transplantation.
About ApoGraft01 study
Study ApoGraft01 (Clinicaltrials.gov identifier: NCT02828878), is an open label, Staggered Four-Cohort, Phase I/II, safety and proof-of-concept study of ApoGraft process in the prevention of acute Graft-versus-Host Disease (GvHD). The study which will enroll 12 patients, aims to evaluate the safety, tolerability and efficacy of the ApoGraft process in patients suffering from hematological malignancies undergoing allogeneic stem cells transplantation from a matched related donor.
About Cellect Biotechnology Ltd.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (NASDAQ:APOPW) (TASE:APOP). The Company has developed a breakthrough technology for the selection of stem cells from any given tissue for any clinical indication; a technology that aims to enable a variety of stem cells applications.
The Company’s technology is expected to provide pharma companies, medical research and hospitals with the tools to rapidly produce stem cells in quantity and quality that will enable commercialization of all stems cell based treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine while this specific clinical trials is aimed at the cancer treatment by bone marrow transplantations.
Forward Looking Statements
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss the upcoming results from the 12 months’ trial in healthy volunteers and timing of announcement thereof, our becoming a key contributor to stem cell based products and the potential of our technology and its proposed uses. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; and inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.’s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
Contact Cellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officer www.cellectbio.com + 972-9-974-1444 LifeSci Advisors Bob Yedid, Managing Director 646-597-6989 bob@lifesciadvisors.com
$AEHR Big Order for #FOXXP™ Test System, Burn-in Products
FREMONT, Calif., Feb. 08, 2017 — Aehr Test Systems (NASDAQ:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced that it has received an order from a subcontractor to its lead customer for its FOX-XP test and burn-in system products as the first step towards a high-volume production application.
As Aehr Test has disclosed previously, this lead customer and its subcontractors have indicated that they anticipate the need for a significant number of production burn-in/test systems to meet their device volume shipments in the upcoming summer of 2017. Aehr Test has taken several steps to shorten lead times and ensure it has the capacity to meet their range of capacity needs and forecasts.
Gayn Erickson, President and CEO of Aehr Test Systems, commented, “We remain very actively engaged with this lead customer and are excited to receive this order to support the quality and reliability testing of their devices. We believe our high power and high capacity FOX-XP test and burn-in system is a perfect fit for this application and represents a significant new opportunity as the customer’s devices move into high volume manufacturing burn-in.
“We recently had a very successful showcasing of our solutions for both wafer level and module level burn-in and test of optical devices at the SPIE Photonics West conference, and we believe the sensor and photonics markets will be significant for Aehr Test. A key driver is the growing market for integrated optical devices in mobile devices, high-performance servers and data centers, where the use of optical devices for sensing and communications is increasing with every new product generation.
“Another key market is the rapidly growing automotive market for sensors and advanced driver assistance systems (ADAS), which have substantially higher requirements for initial quality and long-term reliability.
“These are extremely exciting fields that we believe are going to drive an entirely new level of quality and reliability expectation of hardware systems and pose a very interesting long-term opportunity for Aehr Test.”
About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic, optical and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test products in package and wafer level test. Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX families of test and burn-in systems and the DiePak® carrier. The ABTS system is used in production and qualification testing of packaged parts for both lower-power and higher-power logic as well as all common types of memory devices. The FOX system is a full wafer contact test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers, systems-on-a-chip and integrated optical devices. The DiePak carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of bare die. For more information, please visit the Company’s website at www.aehr.com.
Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding Aehr Test’s expectations, beliefs, intentions or strategies regarding the FOX products, including statements regarding future market opportunities and conditions, expected product shipment dates and customer orders or commitments. These risks and uncertainties include, without limitation, acceptance by customers of the FOX and WaferPak contactor technologies, acceptance by customers of the FOX-XP system, WaferPak Aligner and WaferPak contactors shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described, as well as general market conditions, customer demand and acceptance of Aehr Test’s products and Aehr Test’s ability to execute on its business strategy. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing Aehr Test’s business. Aehr Test disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.
Aehr Test Systems Carl Buck Vice President of Marketing (510) 623-9400 x381 Investor Relations Contact: Todd Kehrli or Jim Byers MKR Group, Inc. (323) 468-2300 aehr@mkr-group.com
$VKTX to Present at 2017 BIO CEO & Investor Conference
SAN DIEGO, Feb. 7, 2017 — Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that its chief executive officer, Brian Lian, Ph.D., will deliver a corporate presentation at the 2017 BIO CEO & Investor Conference, being held February 13-14, 2017 at the Waldorf Astoria Hotel in New York.
Details for this presentation are as follows:
- 2017 BIO CEO & Investor Conference – webcast available
Time/Date: 8:30 a.m. ET on Tuesday, February 14, 2017
Location: Waldorf Astoria Hotel, New York
Presentation Room: Park South
To access the live webcast of Viking’s presentation, please visit “Webcasts & Presentations” within the News & Events section of Viking’s Investors page at www.vikingtherapeutics.com. Additionally, a replay of the webcast will be available on the Viking website following the conference.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Viking is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.
Follow Viking on Twitter @Viking_VKTX.
$MCHP Declares Quarterly #Cash #Dividend of 36.1 Cents Per Share
CHANDLER, Ariz., Feb. 07, 2017 — Microchip Technology Incorporated (NASDAQ:MCHP), a leading provider of microcontroller, mixed-signal, analog and Flash-IP solutions, today announced that its Board of Directors has declared a quarterly cash dividend on its common stock of 36.1 cents per share. The dividend is payable on March 7, 2017 to stockholders of record on February 21, 2017. Microchip initiated quarterly cash dividend payments in the third quarter of fiscal year 2003 and has increased its dividend 51 times since its inception.
“Microchip’s financial results in the December 2016 quarter were outstanding with cash flow from operations being at record levels,” said Steve Sanghi, Chief Executive Officer. “Our Board of Directors is pleased to declare an increase in our quarterly cash dividend to a record 36.1 cents per share, which continues to reflect our ongoing commitment to returning value to our stockholders.”
Cautionary Statement:
The statement contained in this release relating to our ongoing commitment to returning value to our stockholders is a forward-looking statement made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. This statement involves risks and uncertainties that could cause actual results to differ materially, including, but not limited to: actual cash flows generated from and used in the operation of our business; actual or projected levels of capital expenditures; our balance of cash and investments and whether such cash and investments are in the U.S. or foreign accounts; the tax impact of distributing accumulated earnings and profits held by our foreign subsidiaries to the U.S.; changes in the tax rates that our stockholders pay on our dividends; our available borrowings under our credit agreement; the impact of any significant acquisitions we may make; our ability to realize the expected benefits of our acquisitions (including our acquisition of Atmel), changes in demand or market acceptance of our products and the products of our customers; the mix of inventory we hold and our ability to satisfy short-term orders from our inventory; changes in utilization of our manufacturing capacity and our ability to effectively manage our production levels; our ability to control the level of operating expenses relative to our level of revenues; competitive developments including pricing pressures; the level of orders that are received and can be shipped in a quarter; the level of sell-through of our products through distribution; changes or fluctuations in customer order patterns and seasonality; costs and outcome of any current or future tax audit or any litigation or other matters involving intellectual property, customers or other issues; disruptions in our business or the businesses of our customers or suppliers due to natural disasters (including any floods in Thailand), terrorist activity, armed conflict, war, worldwide oil prices and supply, public health concerns or disruptions in the transportation system; and general economic, industry or political conditions in the United States or internationally.
For a detailed discussion of these and other risk factors, please refer to Microchip’s filings on Forms 10-K and 10-Q. You can obtain copies of Forms 10-K and 10-Q and other relevant documents for free at Microchip’s website (www.microchip.com) or the SEC’s website (www.sec.gov) or from commercial document retrieval services.
Stockholders of Microchip are cautioned not to place undue reliance on our forward-looking statements, which speak only as of the date such statements are made. Microchip does not undertake any obligation to publicly update any forward-looking statements to reflect events, circumstances or new information after this February 7, 2017 press release, or to reflect the occurrence of unanticipated events.
About Microchip:
Microchip Technology Incorporated is a leading provider of microcontroller, mixed-signal, analog and Flash-IP solutions, providing low-risk product development, lower total system cost and faster time to market for thousands of diverse customer applications worldwide. Headquartered in Chandler, Arizona, Microchip offers outstanding technical support along with dependable delivery and quality. For more information, visit the Microchip website at www.microchip.com.
The Microchip logo and name are registered trademarks of Microchip Technology Incorporated.
INVESTOR RELATIONS CONTACT: J. Eric Bjornholt – CFO (480) 792-7804
$WPRT & #Volvo Expand #V90 #BiFuel into #Belgium and #Luxembourg
Significant market opportunity with planned expansion in Europe~
VANCOUVER, Feb. 7, 2017 – Westport AB (“Westport“), a Westport Fuel Systems Inc. (“Westport Fuel Systems“) (TSX:WPRT / Nasdaq:WPRT) company, today announced that Volvo Car will expand the Bi-Fuel version of its new V90 station wagon in Belgium and Luxembourg. Unveiled at the 95th European Motor Show in Brussels on January 14th, 2017, the Volvo V90 Bi-Fuel is now available for order at participating Volvo dealers and deliveries are scheduled for May 2017.
Based on Volvo Car’s four-cylinder T5 petrol engine— delivering 254 hp and 350 Nm of torque—and equipped with an 8-speed automatic transmission, the V90 Bi-Fuel configuration provides premium performance and environmental benefits while running on compressed natural gas (CNG)/biomethane.
“Belgium currently has 5,400 natural gas vehicles on the road and a developed infrastructure network that includes 73 CNG stations,” said Didier Hendrickx of Natural Gas Vehicle Association (NGVA) Belgium. “Through tax incentives from the authorities and gas network operators, the Belgium market has the opportunity to grow its natural gas vehicle population to 10,000 vehicles and 100 stations by the end of 2017.”
“The combination of Volvo Car’s exemplary automotive engineering and Westport’s advanced natural gas technology provide European customers a premier fuel choice and vehicle experience,” said Westport Fuel Systems Chief Operating Officer, Automotive & Industrial Group, Andrea Alghisi. “Growth opportunities such as Belgium and Luxembourg make ideal initial markets for Westport Fuel Systems’ planned expansion in the European market.”
The Volvo V90 Bi-Fuel is produced at the Volvo Car factory in Gothenburg, Sweden. Final installations are done at a Westport facility located at the Volvo Car assembly plant in Gothenburg.
About Westport
Westport, a division of Westport Fuel Systems Inc., engineers the world’s most advanced natural gas engines and vehicles. We work with original equipment manufacturers worldwide from design through to production, creating products to meet the growing demand for vehicle technology that will reduce both emissions and fuel costs. To learn more about our business, visit www.westport.com, subscribe to our RSS feed, or follow us on Twitter @WestportDotCom.
About Westport Fuel Systems
At Westport Fuel Systems, we are driving innovation to power a cleaner tomorrow. We are inventors, engineers, manufacturers and suppliers of advanced clean-burning fuel systems and components that can change the way the world moves. Our technology delivers performance, fuel efficiency and environmental benefits to address the challenges of global climate change and urban air quality. Headquartered in Vancouver, Canada, we serve our customers in more than 70 countries with leading global transportation and industrial application brands. At Westport Fuel Systems, we think ahead. For more information, visit www.wfsinc.com.
SOURCE Westport Fuel Systems Inc.
$UNXL Prepares for #FlexibleDisplay Market
UniPixel touch sensors pass 200,000 cycle fold test
SANTA CLARA, Calif., Feb. 7, 2017 — UniPixel, Inc. (NASDAQ: UNXL), a provider of high performance metal mesh capacitive touch sensors to the touchscreen and flexible display markets, announced today positive results from in-house testing conducted on its XTouch touch screen sensors for use in future flexible/foldable display devices such as smartphones, tablets, and wearable devices.
UniPixel conducted tests in which its XTouch sensors were folded and opened more than 200,000 times at a 2-millimeter radius at the fold. During the tests, as well as at the conclusion of those tests, there was no damage to the XTouch sensors and no degradation to their performance capabilities. Flexible displays will also need to have a thin and pliable cover lens that will bend consistently without damage. UniPixel’s Diamond Guard scratch resistant cover lens technology is an excellent complement to XTouch sensors as it is applied in a very thin layer and will bend and seamlessly fold as it protects the underlying touch sensor metal mesh from abrasion damage.
Jalil Shaikh, chief operating officer of UniPixel, commented, “The results of our in-house testing were very positive. As flexible displays require thin and pliable touch sensors and cover lenses, our proprietary XTouch sensors and Diamond Guard are ideally suited for flexible display applications. We have already demonstrated to a major original equipment manufacturer (“OEM”) that our XTouch sensors deliver optimal performance with a lens coating as minute as five microns. As far as we are aware our XTouch sensors are the only sensors available that operate effectively with such a thin cover lens coating.
“We believe that as flexible technologies make their way to the market, our proprietary XTouch and Diamond Guard technologies can become staple components in a broad array of products. While foldable displays are in early consideration by OEMs, our products now meet the early specifications OEMs have targeted to create devices that work effectively with the necessary durability for broad market acceptance.”
About UniPixel
UniPixel, Inc. (NASDAQ: UNXL) develops and markets high performance metal mesh capacitive touch sensors to the touchscreen and flexible display markets. The Company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For additional information, visit www.unipixel.com.
Forward-looking Statements
All statements in this news release that are not based on historical fact are “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, including the statement regarding market acceptance. Such statements contain words such as “will,” and “expect,” or the negative thereof or comparable terminology. These statements are based on management’s current expectations. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. These risks, uncertainties, and other factors include, but are not limited to, risks related to the ability to extend product offerings into new areas or products, the ability to compete in our currents markets, the ability to commercialize licensed technology, unexpected occurrences that deter the “bring to market” plan for products, trends and fluctuations in the industry, changes in demand and purchasing volume of customers, our ability to attract and retain qualified personnel, our ability to raise additional capital, the ability to move product sales to production levels, the success of product sales in new markets or of recently produced product offerings, the ability to enforce our intellectual property rights and those set forth under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 and other current and periodic reports filed or furnished from time to time with the SEC. All forward-looking statements in this press release are made as of the date hereof, based on information available to UniPixel as of the date hereof, and UniPixel assumes no obligation to update any forward-looking statement.
Trademarks in this release are the property of their respective owners.
Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com
$GALT #Galectin3 Inhibitor Combination Immunotherapy Solid Results #Cancer
First-in-human data presented at GTCBio 9th Immunotherapeutics & Immunomonitoring Conference
NORCROSS, Ga., Feb. 07, 2017 — Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, and the Providence Cancer Center today announced the presentation of preclinical and early clinical data from two investigator-initiated Phase 1 clinical trials of GR-MD-02 used in combination with approved cancer immunotherapies. Data presented today at the 9th GTCBio Immunotherapeutics & Immunomonitoring Conference in San Diego, CA by Dr. William L. Redmond, Providence Cancer Center, has been posted.
“Preclinical results in mouse models of multiple types of cancers showed important anti-tumor and increased survival effects of combining GR-MD-02 with different types of immune modulators, providing a compelling case for progressing studies into human patients with cancer,” said William L. Redmond, Ph.D., Associate Member, Laboratory of Cancer Immunotherapy, and Director, Immune Monitoring Laboratory, Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR. “We are pleased that our translational medicine team is conducting two phase 1 clinical trials which were initiated under the direction of principal investigator Brendan D. Curti, M.D., Director of the Providence Biotherapy Program at Providence Cancer Center.”
GR-MD-02 was combined with pembrolizumab (KEYTRUDA®) in patients with advanced melanoma, and this study has been expanded to patients with oral/head and neck cancer (OHN) and non small cell lung cancer (NSCLC) (https://clinicaltrials.gov/ct2/show/NCT02575404?term=GR-MD-02&rank=1). Six subjects with advanced melanoma have been enrolled in the lowest dose cohort (2 mg/kg) with no safety concerns related to GR-MD-02. To date, one partial response and one mixed response has been observed. Below is a chest CT scan of the patient with a partial response showing a marked reduction in tumor size at week 12 of therapy, after 3 doses of combined GR-MD-02 and pembrolizumab.
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/4f1c423b-c711-467b-83f6-8d90f0cfc191
GR-MD-02 was also combined with ipilimumab (Yervoy®) in patients with advanced melanoma (https://clinicaltrials.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=6). Seven subjects treated with the lowest two dose cohorts of GR-MD-02 (1 and 2 mg/kg) have been completed with no safety signals identified due to GR-MD-02. In these low dose initial cohorts, there were no notable changes in the peripheral immune signature. Due to changes in the standard of care for metastatic melanoma (i.e., approval of KEYTRUDA®), recruitment has been slowed significantly.
“We are encouraged by these early safety results and look forward to further data on the safety and efficacy of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA®) in patients with metastatic melanoma, OHN, or NSCLC,” said Dr. Curti. “While we cannot conclude from the one partial response in the pembrolizumab study that the response was related to GR-MD-02, it provides us with a clinically relevant signal to follow as GR-MD-02 doses are escalated. We hope to report additional data in early 2018 when we anticipate a decision on progressing to phase 2. This decision will be based on the response rate of the combination of pembrolizumab with GR-MD-02 as compared to historical response rates to pembrolizumab alone.”
About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease, skin disease and cancer based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
About Robert W. Franz Cancer Research Center, Earle A. Chiles Research Institute (EACRI), Providence Cancer Center, Providence Portland Medical Center, Portland Oregon
Providence Cancer Center, a part of Providence Health & Services, offers the latest in cancer services, including diagnostic, treatment, prevention, education, support and internationally renowned research. The Robert W. Franz Cancer Research Center in the Earle A. Chiles Research Institute is a world-class research facility located within Providence Cancer Center. The Institute’s main area of investigation is cancer immunotherapy, a specialized field of study focused on triggering the immune system to fight cancer. Visit www.chilesresearch.org.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events, and use words such as “may,” “estimate,” “could,” “expect” and others. They are based on current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for GR-MD-02 will lead to a therapy for the treatment of fibrotic liver disease and/or an additional therapy for the treatment of cancer when used in combination with pembrolizumab. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, that Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of GR-MD-02 or any of its other drugs in development. Current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies. Regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to complete its current trials or further develop and/or fund further studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Galectin Therapeutics Contact: Jessica Stanek GregoryFCA jessicas@gregoryfca.com 215-297-3606 Providence Cancer Center, Providence Portland Medical Center Contact: Jean Powell Marks 503-215-6433 jean.marks@providence.org
$DSS #AuthentiGuard Selected For Global #AntiCounterfeiting Deployment
ROCHESTER, NY–(Feb 7, 2017) – Document Security Systems, Inc. (NYSE MKT: DSS), (DSS), a leader in anti-counterfeiting and authentication solutions, today announced its AuthentiGuard anti-counterfeit solution has been selected for worldwide deployment by a U.S. based Fortune Global 500 company. The roll out will begin in North America in early 2017 and expand over the multi-year term of the contract to include additional regions.
AuthentiGuard combines a secure mark printed on product packaging with a smartphone application so investigators, supply chain personnel, or consumers can validate the authenticity of products. The results of scans performed in the field are saved in a database which the brand then uses to analyze and identify how counterfeit product is compromising the supply chain. With fraud threatening the safety of consumers worldwide, AuthentiGuard allows brands to protect consumers with product authentication while simultaneously building a more comprehensive view of threats to the supply chain so they can deploy resources to remediate problems.
“Every day we see more and more counterfeit goods on the market which pose a significant threat to consumers,” said Jeff Ronaldi, CEO of DSS. “Brand owners are getting serious about fighting the threat and AuthentiGuard is one of the most innovative solutions on the market. Winning a global deployment for one of the largest Global 500 companies is the latest validation for the AuthentiGuard technology as well as an indication that the market is adopting aggressive anti-counterfeiting measures.”
The addition of this latest client extends the Company’s success in its brand protection portfolio. The Company recently announced an important reseller relationship with SunChemical focused on AuthentiGuard and also announced the closing of a non-dilutive round of financing for an intellectual property transaction.
“We are seeing strong interest in our anti-counterfeiting solutions,” according to Mike Roy, President of DSS Digital, whose group has responsibility for AuthentiGuard. “Brands are focused on understanding and remediating their counterfeit problem and AuthentiGuard is one of the only solutions on the market which enables them to detect and deter counterfeits in real-time utilizing smartphones. We expect to see more customer wins in 2017 as brands aggressively fight the threat.”
Terms of the agreement will not be disclosed. Revenues are expected to commence in the first quarter of 2017.
About Document Security Systems, Inc.
Document Security Systems, Inc.’s (NYSE MKT: DSS) products and solutions are used by governments, corporations and financial institutions to defeat fraud and to protect brands and digital information from the expanding world-wide counterfeiting problem. DSS technologies help ensure the authenticity of both digital and physical financial instruments, identification documents, sensitive publications, brand packaging and websites.
DSS continually invests in research and development to meet the ever-changing security needs of its clients and offers licensing of its patented technologies. For more information on the AuthentiGuard Suite, please visit www.authentiguard.com. For more information on DSS and its subsidiaries, please visit www.dsssecure.com.
Forward-Looking Statements
Forward-looking statements that may be contained in this press release, including, without limitation, statements related to the Company’s plans, strategies, objectives, expectations, potential value, intentions and adequacy of resources, are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act and contain words such as “believes,” “anticipates,” “expects,” “plans,” “intends” and similar words and phrases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the results projected in any forward-looking statement. In addition to the factors specifically noted in the forward-looking statements, other important factors, risks and uncertainties that could result in those differences include, but are not limited to, the outcomes of any of the Company’s litigation, its ability to raise capital, and those risks and uncertainties disclosed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission. Forward-looking statements that may be contained in this press release are being made as of the date of its release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements.
For More Information
Investor Relations
Document Security Systems, Inc.
(585) 325-3610
Email: ir@documentsecurity.com
$CETX #SaagarGovil, Named to Stony Brook University’s Top 40 Under 40
Farmingdale, NY, Feb. 06, 2017 — Cemtrex (Nasdaq: CETX), a world leading industrial and manufacturing leader, announced today that its Chairman and CEO was recently selected by Stony Brook University as one of its “Top 40 Under 40” for 2017. The list honors forty of the most innovative and entrepreneurial spirited Stony Brook University alumni age forty or younger who are making significant contributions to their professions and communities.
This year’s honorees were recognized for their achievements in medicine, the arts, public service, business, and academia, among other fields. “Stony Brook University graduates are ambitious and creative. They’re passionately engaged in issues that matter and are pushing the boundaries of knowledge and expectations in their fields,” said Stony Brook University President Samuel L. Stanley Jr., M.D. “This year’s 40 Under Forty honorees represent some of Stony Brook’s most influential and focused young alumni.”
Cemtrex’s CEO, Saagar Govil, commented, “I am truly honored and humbled to be recognized by Stony Brook University. Cemtrex has been one of the fast growing industrial companies over the last several years in terms of revenue. Our goal is to continue that trend upward and keep delivering exceptional value for our shareholders.”
About Cemtrex
Cemtrex, Inc. (NASDAQ:CETX) is a world leading diversified industrial and manufacturing company that provides a wide array of solutions to meet today’s technology challenges. Cemtrex provides manufacturing services of advanced custom engineered electronics, industrial services, monitoring instruments for industrial processes and environmental compliance, and systems for controlling particulates, hazardous gases, emissions of Greenhouse gases, and other regulated pollutants used in emissions trading globally.
Safe Harbor Statement
This press release contains forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date.
Investor Relations Cemtrex, Inc. Phone: 631-756-9116 investors@cemtrex.com
$EARS Expands Clinical Development Pipeline w/ Intranasal #Betahistine
– Pipeline strengthens with addition of AM-125 as third clinical-stage program
– Acquisition of assets related to innovative betahistine product for intranasal delivery
– Betahistine is one of the most widely used treatments for vestibular disorders
– Conference call and webcast scheduled for today at 8 am Eastern Time
ZUG, Switzerland, Feb. 3, 2017 — Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that it has added a third clinical-stage development program to its pipeline and is expanding into the field of vestibular disorders. Under the product code AM-125, the Company will develop betahistine dihydrochloride in a spray formulation for the intranasal treatment of Meniere’s disease and vestibular vertigo.
“We are excited to add AM-125 to our development pipeline as it addresses important unmet medical needs in vestibular disorders and serves as a strategic fit with our existing projects,” commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer. “While oral betahistine has been a mainstay treatment for Meniere’s disease and vestibular vertigo for many years and in many countries around the world, we expect the novel approach of intranasal delivery to offer significant additional benefits in terms of efficacy and tolerability.”
Auris Medical has entered into an agreement with Otifex Therapeutics Pty. Ltd. to purchase various assets related to intranasal betahistine, including preclinical and clinical data as well as certain intellectual property rights. In a Phase 1 trial conducted by Otifex, intranasal betahistine showed good tolerance and a significantly higher bioavailability than reported for oral betahistine administration. Auris Medical plans to initiate a second Phase 1 trial in 2017.
“As our treatment options for vestibular disorders are currently very limited in the United States, I am pleased to see that betahistine will be developed as a treatment for patients here who are suffering from Meniere’s disease or vestibular vertigo,” commented Lawrence R. Lustig, MD, Chair, Department of Otolaryngology at Columbia University Medical Center. “The compound has an established track record for safety, and the clinical experience suggests that it may help control or ease vertigo attacks in Meniere’s disease. It will be exciting to have a new treatment for this disabling condition.”
Betahistine is a small molecule drug that acts as a partial histamine H1-receptor agonist and a H3-receptor antagonist. The compound has demonstrated increased cochlear, vestibular and cerebral blood flow, vestibular compensation and the ability to inhibit neuronal firing in the vestibular nuclei. Oral betahistine is approved for the treatment of Meniere’s disease and vestibular vertigo and marketed in more than 80 countries worldwide. Since its launch, more than 130 million patients have been prescribed betahistine. However, betahistine has not been approved for marketing in the United States for the past few decades.
Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to discuss the AM-125 program today, February 3, 2017, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial 1-877-280-3488 (USA) or +1-646-254-3374 (International), and enter passcode 5782790. A live webcast of the conference call will be available in the Investor Relations section of the Auris Medical website at www.aurismedical.com and a replay of the conference call will be available following the live call.
About Meniere’s Disease and Vestibular Vertigo
Meniere’s disease is a chronic disorder of the inner ear characterized by episodes of vertigo (sensation of feeling off balance), ringing in the ears (tinnitus), hearing loss, and fullness in the ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 American adults currently diagnosed with Meniere’s disease and no therapies currently approved by the U.S. Food and Drug Administration. Vestibular vertigo refers to symptoms resulting from dysfunction within the body’s system of balance, including the misperception of movement or dizziness. Data from the U.S. National Health and Nutrition Examination Survey suggest that as many as 69 million American adults have experienced some form of vestibular disorder.[1]
About Auris Medical
Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing oral betahistine for Meniere’s disease and vestibular vertigo (AM-125) and early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol “EARS.”
Forward-looking Statements
This press release may contain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, the timing and conduct of clinical trials of Auris Medical’s product candidates, the clinical utility of Auris Medical’s product candidates, including the likelihood that the TACTT3 trial may not meet its endpoints, the timing or likelihood of regulatory filings and approvals, Auris Medical’s intellectual property position and Auris Medical’s financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical’s capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption “Risk Factors” in Auris Medical’s Annual Report on Form 20-F, in Auris Medical’s Report on Form 6-K filed on November 10, 2016 and in future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.
Company contact: Cindy McGee, Head of Investor Relations and Corporate Communications,
+41 61 201 13 50, investors@aurismedical.com
Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.com
[1] Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults. Arch Intern Med. 2009;169(10):938-944.
$OPTT and #HAITechnologies Joint Application Development, Marketing Agreement
PENNINGTON, N.J., Feb. 06, 2017 — Ocean Power Technologies, Inc. (NASDAQ:OPTT) (“OPT” or “the Company”) and HAI Technologies Corp. announced today a strategic alliance to pursue mutual opportunities through a joint applications development and marketing agreement with an initial focus on offshore oil and gas subsea chemical injection systems where persistent power and real-time data communications are critical.
Dan Krohn, HAI Technologies General Manager stated, “HAI has tremendous experience in a variety of technologies and applications in the offshore oil and gas industry including subsea chemical systems. Chemical injection techniques are used to mitigate the diminishing effects of buildup in piping and pumping systems used in subsea oil production operations. HAI has developed an innovative, compact and modular approach which moves the chemical injection system closer to the production field. We believe HAI Technologies’ advanced chemical injection solutions, combined with OPT’s PB3 PowerBuoy®, creates a unique opportunity to pair two distinctive offshore technologies creating new methods to deal with long distance and remote offshore field developments. We believe combining subsea chemical injection components with a local surface power system such as the PB3, is a new subsea architecture reducing field development cost, and potentially making an impractical field now practical.”
George Kirby, OPT Chief Executive Officer stated: “We are excited to join efforts with such an innovative company as HAI Technologies. Chemical injection systems require persistent and reliable power, and we believe OPT’s PB3 PowerBuoy® can provide prime and augmented power and real-time system control communications which may enable the cost reduction and simplification of transporting chemicals over long distances. Our PowerBuoy compliments HAI’s modular approach to chemical injection systems by providing cost-effective and persistent power and communications. We are seeing a demand for innovative, cost saving technologies in the offshore oil and gas industry, and we believe that HAI Technologies’ innovative chemical injection capabilities, in combination with OPT’s PowerBuoy, will enable our customers to overcome technical hurdles and to deliver significant savings to their operations.”
OPT’s PB3 PowerBuoy® is a reliable and persistent power and communication platform for remote offshore applications such as advanced multi-functional sensors, modular chemical injection systems for subsea oil production operations, and docking stations for subsea drones. End-users can apply the PB3 to a suite of mission critical payloads while extending their range of operation, lowering their operational costs, and enabling real-time data transfer and decision making.
About Ocean Power Technologies, Inc.
Headquartered in Pennington, New Jersey, Ocean Power Technologies (NASDAQ:OPTT) is a leader in ocean wave energy conversion. OPT’s proprietary PowerBuoy® technology is based on a scalable and modular design. OPT specializes in cost-effective and environmentally sound ocean wave based power generation and management technology.
About HAI Technologies Corporation
HAI Technologies, is headquartered in Houston, TX and also operates out of Rochester NY. HAI Technologies specializes in innovative products both for high power long wave acoustics, and products for Oil and Gas subsea field development.
Forward-Looking Statements
This release may contain “forward-looking statements” that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue”, and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.
Company Contact: Matthew T. Shafer, Chief Financial Officer and Treasurer Phone: 609-730-0400 Investor Relations Contact: Andrew Barwicki Barwicki Investor Relations Inc Phone: 516-662-9461
$CNAT to Present at BIO CEO & Investor Conference
SAN DIEGO, Feb. 06, 2017 — Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) today announced its scheduled presentation to provide an overview of the company’s programs and outlook at the Biotechnology Industry Organization (BIO) CEO & Investor Conference in New York at 2:30 p.m. ET on Monday, February 13, 2017. An audio webcast and copy of the presentation will be available in the Investors section of the company’s website at www.conatuspharma.com.
About Conatus Pharmaceuticals Inc.
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.
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. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding emricasan’s potential to interrupt the disease progression across the spectrum of liver disease. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those risks described in the company’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
MEDIA: David Schull Russo Partners, LLC (858) 717-2310 David.Schull@RussoPartnersLLC.com INVESTORS: Alan Engbring Conatus Pharmaceuticals Inc. (858) 376-2637 aengbring@conatuspharma.com
$DTRM Sets a New Industry Standard for #Cloud Platforms
CARMEL, IN–(Feb 6, 2017) – Determine, Inc. (NASDAQ: DTRM), the pioneering leader in global Source-to-Pay and Enterprise Contract Lifecycle Management (ECLM) Cloud Platform solutions, redefines the entire concept of “cloud platform” with Platformance.
“Platformance isn’t just about technology, but what success looks like,” states Determine President and CEO Patrick Stakenas in a new blog. “It’s what people and companies can achieve when they’re empowered at all levels with the ability to solve challenging business problems more efficiently and more easily.”
The Determine Cloud Platform was introduced less than a year ago, but already it’s making an impact on the way their customers achieve business results. As the only modular-based solution structure, companies can start with just one or two best-of-breed solutions and still get all the benefits of the platform’s core – including powerful business process management and a single source of data truth for managing complex and global and industry requirements.
“The concept of Platformance really came out of our customers’ experiences,” adds Mr. Stakenas. “We needed a word to describe the benefits and accelerated performance they were achieving uniquely from our cloud platform. It’s more than just delivering cutting new edge technology — it’s about empowerment and delivering results for the individual and the business entity.”
Unfortunately, the word “platform” is commonly interchanged with the word ‘suite’ across source-to-pay and contract management. This has resulted in confusion and misinformation in the marketplace.
“Platforms are everywhere these days, but platforms are not created equal,” said Jeffrey Grosman, Determine Chief Operating Officer. “Educating businesses about the facts is a big part of what we do. We built our cloud platform to enable people, processes and data to work together in perfect harmony to achieve individual and enterprise success. Calling it Platformance was natural.”
Supporting Resources
Determine blog
Determine on LinkedIn
Determine on Twitter
Determine Resources
About Determine, Inc.
Determine, Inc. (NASDAQ: DTRM) is a leading global provider of SaaS Source to Pay and Enterprise Contract Lifecycle Management (ECLM) solutions. Our visionary technologies allow our customers to effectively manage the full scope of Source to Pay and ECLM using our Determine Cloud Platform. Our Source to Pay software suite includes strategic sourcing, supplier management, contract management and procure-to-pay applications.
The Determine Cloud Platform gives procurement, finance and legal professionals the ability to deliver profound insights through analysis of their supplier relationships and contractual requirements. Our customers leverage the Determine Cloud Platform to discover previously unseen supplier and spend data; make more informed and smarter business decisions; drive new revenue; control costs; improve workflow efficiencies; and mitigate risk.
Our customers benefit from the Determine Cloud Platform’s robust suite of integrated applications. Whether they start with a full-suite implementation or choose to implement just one application and build over time, each additional application allows for the automatic sharing of data already in place on the Determine Cloud Platform.
For more information, please visit: www.determine.com.
Contact
Media Relations:
Rose Lee
Determine Inc.
+1.650.532.1590
pr@determine.com
$DRYS Announces Date of 2017 Annual General Meeting of Shareholders
ATHENS, GREECE–(Feb 6, 2017) – DryShips Inc. (NASDAQ: DRYS) (the “Company” or “DryShips”), a diversified owner of ocean going cargo vessels, announced today that the Company’s 2017 Annual General Meeting of Shareholders (the “Annual Meeting”) will be held at the Company’s offices located at 109 Kifisias Avenue & Sina Street, GR 151 24, Marousi, Athens, Greece on Tuesday, May 2, 2017 at 4:00 p.m., local time.
The Company’s board of directors has fixed the close of business on Wednesday, March 15, 2017 as the record date for the determination of the shareholders entitled to receive notice and to vote at the Annual Meeting or any adjournments or postponements thereof.
Formal notice of the Annual Meeting and the Company’s proxy statement are expected to be sent to shareholders on or about Monday, April 3, 2017.
About DryShips
The Company is a diversified owner of ocean going cargo vessels that operate worldwide. The Company owns a fleet of 13 Panamax drybulk carriers with a combined deadweight tonnage of approximately 1.0 million tons, 1 Very Large Gas Carrier newbuilding and 6 offshore supply vessels, comprising 2 platform supply and 4 oil spill recovery vessels.
DryShips’ common stock is listed on the NASDAQ Capital Market where it trades under the symbol “DRYS.”
Visit the Company’s website at www.dryships.com. The information contained on the Company’s website does not constitute a part of this press release.
Forward-Looking Statements
Matters discussed in this press release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with such safe harbor legislation.
Forward-looking statements reflect our current views with respect to future events and financial performance and may include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.
The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, management’s examination of historical operating trends, data contained in the Company’s records and other data available from third parties. Although the Company believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, the Company cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.
Important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include the factors related to the strength of world economies and currencies, general market conditions, including changes in charter rates and vessel values, failure of a seller or shipyard to deliver one or more vessels, failure of a buyer to accept delivery of a vessel, our inability to procure acquisition financing, default by one or more charterers of our ships, changes in demand for drybulk or LPG commodities, changes in demand that may affect attitudes of time charterers, scheduled and unscheduled drydocking, changes in our voyage and operating expenses, including bunker prices, dry-docking and insurance costs, changes in governmental rules and regulations, changes in our relationships with the lenders under our debt agreements, potential liability from pending or future litigation, domestic and international political conditions, potential disruption of shipping routes due to accidents, international hostilities and political events or acts by terrorists.
Risks and uncertainties are further described in reports filed by DryShips Inc. with the Securities and Exchange Commission, including the Company’s most recently filed Annual Report on Form 20-F.
Investor Relations / Media:
Nicolas Bornozis
Capital Link, Inc. (New York)
Tel. 212-661-7566
E-mail: dryships@capitallink.com
$SRAX @Social_Reality Strengthens #BoardOfDirectors with Appointment of #DerekFerguson
LOS ANGELES, Feb. 3, 2017 — Social Reality, Inc. (NASDAQ: SRAX), an Internet advertising and platform technology company that provides tools to automate the digital advertising market, today announced the appointment of experienced alternative credit and private equity investor Mr. Derek J. Ferguson to its board of directors, effective January 19, 2017. Mr. Ferguson has also been appointed as a member of the company’s Audit Committee.
Mr. Ferguson brings over 13 years of experience as a principal investor in private credit and equity investments together with corporate advisory experience serving middle-market companies across a wide variety of niche industries, including tech-enabled services, consumer, manufacturing and industrials, transportation and logistics, and business services. From February 2012 through July 2016, Mr. Ferguson was a principal with Victory Park Capital Advisors, LLC, an investment firm with a focus on alternative credit and equity solutions for small- and middle-market companies and, before that, was a vice president with Maxim Partners, an independent private equity firm. Mr. Ferguson began his career as an investment banking analyst at J.P. Morgan Securities and thereafter was an associate with Thoma Cressey Equity Partners and a senior associate with Wynnchurch Capital. Mr. Ferguson received a B.S. in finance from the University of Illinois at Urbana-Champaign and an M.B.A. from the Kellogg School of Management at Northwestern University.
“We welcome Derek to our board of directors,” said Social Reality’s Chief Executive Officer Christopher Miglino. “While at Victory Park Capital Advisors, he was primarily responsible for managing our relationship, and so we are excited to add another independent board member who knows our company well and can also add significant value given his broad knowledge of middle-market investing. We look forward to working even more closely with him to drive our business forward.”
“Today’s ecosystem of advertising and marketing participants, including brands, agencies and publishers, has an ever-increasing reliance on insightful analytics and technological innovation to link digital and social media and maximize consumer engagement throughout the value-chain. Social Reality continues to innovate and provide its customers with an expanded set of tools to successfully target, reach and monetize their audiences,” said Mr. Ferguson. “I am honored and excited to serve on Social Reality’s board of directors.”
About Social Reality
Social Reality, Inc. is an Internet advertising company that provides tools to automate the digital advertising market. The company’s Social Reality Ad Exchange (SRAX) is a real-time bidding (RTB) management platform for brands and publishers that allows brands to launch, distribute, track and optimize social and digital media and consumer engagement campaigns. SRAXmd is a health care-focused programmatic RTB exchange that allows pharma brands and publishers of medical content to create custom exchanges that invite specific advertisers to bid on inventory on their sites. The SRAX Social tool is a social media platform and complete management tool that allows brands to launch, distribute, track and optimize social and digital media and consumer engagement campaigns. SRAX APP is a recently launched platform that allows publishers and content owners to launch native mobile applications through our SRAX platform. For more information, please visit www.socialreality.com.
Forward-Looking Statements
This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words or expressions such as “anticipate,” “plan,” “will,” “intend,” “believe” or “expect'” or variations of such words and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including, without limitation, statements made with respect to expectations of our ability to grow our revenues, increase our margins, and report profitable operations, and other risks and uncertainties, all as set forth in our Annual Report on Form 10-K for the year ended December 31, 2015, our most recent Form 10-Q and our subsequent filings with the Securities and Exchange Commission. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of Social Reality and are difficult to predict. Social Reality undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Social Reality, Inc.
$RIGL #Closing #PublicOffering #CommonStock, Full Exercise Additional Purchase Option
SOUTH SAN FRANCISCO, Calif., Feb. 3, 2017 — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced the closing of its previously announced underwritten public offering of 23,000,000 shares of its common stock at a price to the public of $2.00 per share, which includes 3,000,000 additional shares of common stock issued upon the exercise in full of the underwriters’ option to purchase additional shares. The gross proceeds to Rigel from this offering are $46,000,000, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Rigel. All of the shares in the offering were sold by Rigel.
Jefferies LLC, Piper Jaffray & Co. and BMO Capital Markets Corp. acted as joint book-running managers for the offering. H.C. Wainwright & Co., LLC acted as lead manager for the offering.
A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the “SEC”) and is effective. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement may also be obtained from the offices of Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com, from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, Minneapolis, MN 55402, or by telephone at (800) 747-3924, or by email at prospectus@pjc.com, or from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, or by telephone at (800) 414-3627 or by email at bmoprospectus@bmo.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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 Rigel Pharmaceuticals, Inc.
Rigel Pharmaceuticals, Inc. is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel’s pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company’s current clinical programs include clinical trials of fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor in a number of indications. The company completed and reported results from two Phase 3 clinical studies of fostamatinib in chronic immune thrombocytopenia (ITP) in August and October 2016. Rigel is also conducting a Phase 2 clinical trial with fostamatinib in autoimmune hemolytic anemia (AIHA) and a Phase 2 clinical trial for IgA nephropathy (IgAN). In addition, Rigel has two oncology product candidates in Phase 1 development with partners BerGenBio AS and Daiichi Sankyo.
Investor Relations Contact:
Ryan Maynard
Phone: 650.624.1284
Email: invrel@rigel.com
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