Uncategorized
$ARLP & $AHGP Declare #Q4 Unitholder Distribution
Alliance Resource Partners, L.P. (NASDAQ: ARLP) and Alliance Holdings GP, L.P. (NASDAQ: AHGP) today announced that the Board of Directors of ARLP’s managing general partner and AHGP’s general partner approved a cash distribution to their respective unitholders for the quarter ended December 31, 2016 (the “2016 Quarter”).
ARLP unitholders will receive a cash distribution for the 2016 Quarter of $0.4375 per unit (an annualized rate of $1.75 per unit), payable on February 14, 2017 to all unitholders of record as of the close of trading on February 7, 2017. The announced distribution is equal to the distribution declared for the quarter ended September 30, 2016 (the “Sequential Quarter”) and compares to the quarterly unitholder distribution of $0.675 per unit for the quarter ended December 31, 2015 (the “2015 Quarter”).
AHGP unitholders will receive a cash distribution for the 2016 Quarter of $0.55 per unit (an annualized rate of $2.20 per unit), payable on February 17, 2017 to all unitholders of record as of the close of trading on February 10, 2017. The announced distribution is equal to the distribution declared for the Sequential Quarter and compares to the quarterly unitholder distribution of $0.96 per unit for the 2015 Quarter.
As previously announced, ARLP and AHGP will report financial results for the 2016 Quarter and full year before the market opens on Monday, January 30, 2017 and Alliance management will discuss these results during a conference call beginning at 10:00 a.m. Eastern that same day.
To participate in the conference call, dial (855) 793-3259 and provide conference number 48863667. International callers should dial (631) 485-4928 and provide the same conference number. Investors may also listen to the call via the “investor information” section of ARLP’s website at http://www.arlp.com or AHGP’s website at http://www.ahgp.com.
An audio replay of the conference call will be available for approximately one week. To access the audio replay, dial (855) 859-2056 and provide conference number 48863667. International callers should dial (404) 537-3406 and provide the same conference number.
This announcement is intended to be a qualified notice under Treasury Regulation Section 1.1446-4(b), with 100% of the partnership’s distributions to foreign investors attributable to gross income, gain or loss that is effectively connected with a United States trade or business. Accordingly, ARLP’s distributions to foreign investors are subject to federal income tax withholding at the highest applicable tax rate.
About Alliance Resource Partners, L.P.
ARLP is a diversified producer and marketer of coal to major United States utilities and industrial users. ARLP, the nation’s first publicly traded master limited partnership involved in the production and marketing of coal, is currently the second largest coal producer in the eastern United States with mining operations in the Illinois Basin and Appalachian coal producing regions.
ARLP currently operates eight mining complexes in Illinois, Indiana, Kentucky, Maryland and West Virginia. ARLP also operates a coal loading terminal on the Ohio River at Mount Vernon, Indiana.
News, unit prices and additional information about ARLP, including filings with the Securities and Exchange Commission, are available at http://www.arlp.com. For more information, contact the investor relations department of Alliance Resource Partners, L.P. at (918) 295-7674 or via e-mail at investorrelations@arlp.com.
About Alliance Holdings GP, L.P.
AHGP is a limited partnership formed to own and control Alliance Resource Management GP, LLC, the managing general partner of Alliance Resource Partners, L.P. (NASDAQ: ARLP), through which it holds a 1.98% general partner interest and the incentive distribution rights in ARLP. In addition, AHGP owns 31,088,338 common units of ARLP.
News, unit prices and additional information about AHGP including filings with the Securities and Exchange Commission, are available at http://www.ahgp.com. For more information, contact the investor relations department of Alliance Holdings GP, L.P. at (918) 295-1415 or via e-mail at investorrelations@ahgp.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170127005537/en/
Alliance Holdings GP, L.P.
Alliance Resource Partners, L.P.
Brian L. Cantrell, 918-295-7673
$AUPH Worldwide #ClinicalTrials as its #CRO for #Phase3 #Lupus Nephritis Trial
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced that it has selected Worldwide Clinical Trials (“Worldwide”) as its Clinical Research Organization (CRO) for the AURORA Phase 3 study of volcosporin for the treatment of active lupus nephritis (LN).
“Selecting a CRO for AURORA is a key milestone for Aurinia following our successful end-of-Phase 2 meeting with the U.S. Food & Drug Administration (FDA) Division of Pulmonary, Allergy and Rheumatology Products. We are thrilled to partner with Worldwide to support the AURORA Phase 3 clinical trial,” said Charles Rowland, Chief Executive Officer of Aurinia. “We are rapidly moving forward with our plans to bring this important therapy to market for patients living with this devastating disease, and Worldwide’s deep expertise and capabilities in managing pivotal trials will be a tremendous asset to us. We are on track to commence the AURORA trial in the second quarter of 2017, and we expect the results from this study will support a New Drug Application (NDA) submission to the FDA.”
With support from Worldwide, Aurinia will proceed with conducting a randomized, placebo-controlled, double-blind global 52-week trial in approximately 320 patients. The primary endpoint as in the Phase 2b AURA trial is renal response (complete remission), at 24 weeks. In addition to the assessment of renal response, a key marker of clinical benefit in this population is the duration of proteinuria improvement. Therefore, secondary endpoints will include the duration of renal response at 52 weeks (48 weeks in AURA), an efficacy measure which delineates durability of renal response (remission), an important parameter in evaluating long-term outcomes for the treatment of LN.
“Our entire Worldwide team is delighted to have been selected as Aurinia’s CRO partner to advance voclosporin, which has the potential to become the first FDA-approved treatment for LN,” said Peter Benton, President and Chief Operating Officer at Worldwide Clinical Trials. “We’re truly honored that an innovator like Aurinia recognizes what Worldwide brings to the table: medical and scientific expertise, proactive insight, dogged determination, rigorous processes and a commitment to getting it right. We’re looking forward to working closely with Aurinia’s clinical development team on this new therapy, which could significantly improve the lives and long-term outcomes of patients suffering from LN.”
About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,000 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.
About Lupus Nephritis (LN)
Lupus Nephritis (LN) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (SLE) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.
About AURORA
The AURORA study is a 52-week global double-blind placebo controlled Phase III study that will compare the efficacy of one dose of voclosporin (23.7mg BID) or placebo added to current standard of care of mycophenolate mofetil (MMF, also known as CellCept®) in achieving renal response (formerly referred to as complete remission) in patients with active LN. Both arms will also receive low doses of corticosteroids as part of background therapy after a stringent taper. Aurinia believes this Phase III clinical trial whose design is consistent with the ongoing AURA study, will support a New Drug Application (NDA) submission.
About Aurinia
Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of lupus nephritis (LN). The company is headquartered in Victoria, BC and focuses its development efforts globally. www.auriniapharma.com.
About Worldwide Clinical Trials
Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia and Asia. One of the world’s leading, full-service contract research organizations (CROs), we partner with sponsors in the pharmaceutical and biotechnology industries to deliver fully integrated clinical development and bioanalytical services, extending from first-in-human through phase IV studies. Grounded in medicine and science, we help sponsors move from discovery into clinical development and commercialization across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID), and rare diseases. For more information, visit www.Worldwide.com.
Forward Looking Statements
This press release contains forward-looking statements, including statements related to Aurinia’s clinical and regulatory strategy, future clinical development plans, Aurinia’s analysis, assessment and conclusions of the results of the AURA-LV clinical study. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “plans,” “intends,” “may,” “will,” “believe,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Aurinia’s current expectations. Forward-looking statements involve risks and uncertainties. Aurinia’s 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, the risk that Aurinia’s analyses, assessment and conclusions of the results of the AURA-LV clinical study set forth in this release may change based on further analyses of such data, and the risk that Aurinia’s clinical studies for voclosporin may not lead to regulatory approval. These and other risk factors are discussed under “Risk Factors” and elsewhere in Aurinia’s Annual Information Form for the year ended December 31, 2015 filed with Canadian securities authorities and available at www.sedar.com and on Form 40-F with the U.S. Securities Exchange Commission and available at www.sec.gov, each as updated by subsequent filings, including filings on Form 6-K. Aurinia expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Aurinia’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Aurinia Pharmaceuticals Inc.
Investor & Media Contact:
Celia Economides
Head of IR & Communications
ceconomides@auriniapharma.com
or
Worldwide Clinical Trials Media Contact:
LuJean Smith, +1.610.329.2056
Vice President, Global Marketing Communications
lujean.smith@worldwide.com
$HBMD Prices #Upsized #PublicOffering of #CommonStock
Howard Bancorp, Inc. (Nasdaq:HBMD) (the “Company”), the parent company of Howard Bank, today announced the pricing of an upsized underwritten public offering of 2,400,000 shares of its common stock at a public offering price of $15.00 per share, raising approximately $36.0 million in gross proceeds. The Company has granted the underwriters a 30-day option to purchase up to an additional 360,000 shares of its common stock at the public offering price, less the underwriting discount, to cover over-allotments, if any.
The Company intends to use the net proceeds from the offering for general corporate purposes, including contributing to the capital of Howard Bank to support its lending and investing activities, repayment of debt and to support or fund acquisitions of other institutions or branches as and if opportunities for such transactions become available.
Raymond James & Associates, Inc. is serving as bookrunning manager and Stephens Inc. is serving as lead manager. The closing of the transaction is subject to customary closing conditions. The shares are expected to be delivered on February 1, 2017.
A registration statement relating to these securities has been declared effective by the Securities and Exchange Commission. The offering will be made only by means of a prospectus and prospectus supplement. Copies of the prospectus and, when available, prospectus supplement for the offering may be obtained by visiting the SEC website at www.sec.gov or by contacting: Raymond James & Associates, Inc., 880 Carillon Parkway, St. Petersburg, Florida 33716, (800)-248-8863 or by email at prospectus@raymondjames.com.
About Howard Bancorp, Inc.
Howard Bancorp, Inc. is the parent company of Howard Bank, is a Maryland-chartered trust company operating as a commercial bank. Headquartered in Ellicott City, Maryland, Howard Bank operates a general commercial banking business through its 13 branches located throughout the Greater Baltimore Metropolitan Area. It had consolidated assets of approximately $1.0 billion at December 31, 2016. Additional information about Howard Bancorp, Inc. and Howard Bank are available on its Web site at www.howardbank.com.
Howard Bancorp, Inc.
George C. Coffman, 410-750-0020
Chief Financial Officer
$PULM $CARA #Biotech #MergersAndAcquisitions Activity to Rise in 2017
NEW YORK, NY / January 27, 2017 / The Biotech Industry witnessed a drop in mergers and acquisitions (M&A) activity amidst a slump in 2016. The Nasdaq Biotech Index declined roughly 22 percent in 2016. M&A activity within the Biotech Industry totaled 326 deals worth approximately $91 billion in 2016, compared to $118 billion the year prior, according to Bloomberg. Also the number of M&A deals in the sector in 2016 was the lowest total in six years. Research & development productivity of 12 of the biggest biopharma companies, which was measured by annual projected R&D returns, hit a 7 year low in 2016, according to a recent study completed by Deloitte. With many large firms having more cash available, giving them plenty of firepower for larger number of in M & A activities in 2017.
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“With a large gap remaining between large BioPharma’s actual and desired revenues, and historically high amounts of cash on hand, look for an uptick of larger acquisition targets,” says David Risinger, an analyst for Morgan Stanley who covers big pharma. “This is particularly true of the U.S. BioPharma industry, where the amount of cash on hand is greater and intentions more focused.”
Pulmatrix Inc. (NASDAQ: PULM)
Get Your Up-To-Date Pulmatrix Research Report Click Here
Pulmatrix’s shares surged 35.37 percent to close at $2.22 a share Thursday. The stock traded between $1.42 and $2.59 on volume of 20.32 million shares traded. On January 17th, the company announced PUR1900, a drug candidate for the treatment of fungal infections in the lungs of CF patients, received the “Qualified Infectious Disease Product” (QIDP) designation from the U.S. Food & Drug Administration.
“The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic fibrosis (CF) patients suffering from fungal lung infections,” said Pulmatrix CEO Robert Clarke, PhD. “It will give us the benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market exclusivity.”
Cara Therapeutics Inc. (NASDAQ: CARA)
Get Your Up-To-Date Cara Therapeutics Research Report Click Here
Cara Therapeutics’ shares jumped 6.26 percent to close at $13.74 a share Thursday. The stock traded between $12.93 and $13.98 on volume of 2.29 million shares traded. Cara’s most advanced patented compound, CR845, is currently undergoing clinical testing for acute pain and pruritus. This compound possesses analgesic, anti-inflammatory and anti-pruritic activities appropriate for multiple therapeutic applications. On November 29th, the company announced the completion of patient enrollment for the multi-dose phase of its adaptive Phase 2/3 trial of I.V. CR845 in dialysis patients suffering from moderate-to-severe uremic pruritus (UP).
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$WASH #CommercialFinancing Development of Property in #Dedham, #MA
WESTERLY, R.I., Jan. 26, 2017 — Washington Trust’s Commercial Real Estate Group recently provided commercial financing to Dedham Retail Realty Ventures for the development of a two-parcel property directly across from Legacy Place, a 600,000 square-foot open air shopping, dining and entertainment destination in Dedham, MA.
The new property includes two retail buildings, totaling approximately 11,500 square feet of space. Tenants include Sprint, Select Comfort, Starbucks and Red Wing shoes. Demand for the properties is strong due to its great visibility and location on a highly trafficked retail corridor.
“This property has a superb location that was instrumental in its leasing momentum,” said Julia Anne M. Slom, Senior Vice President & Team Leader of Washington Trust’s Commercial Real Estate Group. “The plaza serves as a great compliment to surrounding retail development.”
Washington Trust’s Commercial Real Estate Group provides commercial real estate mortgages for the construction, refinancing, or purchasing of investment real estate projects. Financing ranges in size from several hundred thousand dollars up to multi-million dollar projects. For more information, contact Bethany Lyons, Vice President, Commercial Real Estate Group, at 401-401-1538 or 1-800-475-2265 ext. 1538.
ABOUT WASHINGTON TRUST®
Founded in 1800, Washington Trust is the oldest community bank in the nation and one of the Northeast’s premier financial services companies. Washington Trust offers a full range of financial services, including commercial banking, mortgage banking, personal banking and wealth management and trust services through its offices located in Rhode Island, Connecticut and Massachusetts. The Washington Trust Company is a subsidiary of Washington Trust Bancorp, Inc., (NASDAQ:WASH). Additional information on Washington Trust and its subsidiaries can be found at https://www.washtrust.com/.
MEDIA CONTACT: Tony Nunes Public Relations 401.348.1657 ajnunes@washtrust.com
$GWGH #BrianChen to Lead Development of #Epigenetic #MortalityPrediction Technology
MINNEAPOLIS, Jan. 26, 2017 — GWG Holdings, Inc. (Nasdaq:GWGH), a financial services company applying epigenetic technology to transform the life insurance industry, announced it has hired Dr. Brian Chen to lead its new initiative to measure and predict human lifespan.
As Vice President of Research and Analytics, Dr. Chen will be responsible for developing and implementing GWG’s new life insurance underwriting process using “DNA Methylation-Based Predictor of Mortality” technology optioned from the University of California, Los Angeles (UCLA). The technology developed by Dr. Steve Horvath at UCLA will be used by GWG to more accurately assess the life expectancies of policy owners. GWG is in the process of integrating this technology into its actuarial underwriting method to enhance its current secondary market business, as well as explore even greater opportunities in the life insurance industry.
“Brian will play a key role in bringing to market our proprietary approach that uses epigenetic technology to determine estimates of an individual’s lifespan,” said GWG CEO Jon Sabes. “His experience working with Dr. Steve Horvath and the technology we have optioned from UCLA will accelerate our development of new procedures and products. Our goal is to rewrite the century-old ways of life insurance underwriting and reinvent the industry in doing so. This is an exciting opportunity for us as we push forward into the insurtech space where insurance and technology meet.”
Dr. Chen worked closely with Dr. Horvath at UCLA as an epidemiologist who studied the biological underpinnings of aging and age-related diseases. Dr. Chen was first author of the study on DNA methylation and mortality prediction building on Dr. Horvath’s work that was published in the journal Aging in September 2016. Most recently, Dr. Chen worked at the National Institute on Aging (NIA) as a postdoctoral researcher. Prior to coming to the NIA, Dr. Chen worked at the National Heart, Lung, and Blood Institute’s Framingham Heart Study that provided important blood samples for the UCLA team’s work. Dr. Chen received his Ph.D. in epidemiology from UCLA and Master’s in Public Health from the University of California at Berkeley.
About GWG Holdings, Inc.
GWG Holdings, Inc. (Nasdaq:GWGH) is a financial services company committed to applying advanced epigenetic mortality prediction technology to the life insurance and related industries. Already a recognized disruptor in the life insurance secondary market, GWG seeks to further transform the industry by continuing to create innovative products and services. As of September 30, 2016, GWG’s growing portfolio consisted of $1.27 billion in face value of policy benefits and paid consumers $357 million for their life insurance.
For more information about GWG Holdings, Inc. email info@gwglife.com or visit www.gwgh.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “would,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about our estimates regarding future revenue and financial performance. We may not actually achieve the expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the expectations disclosed in the forward-looking statements we make. More information about potential factors that could affect our business and financial results is contained in our filings with the Securities and Exchange Commission. Additional information will also be set forth in our future quarterly reports on Form 10-Q, annual reports on Form 10-K and other filings that we make with the Securities and Exchange Commission. We do not intend, and undertake no duty, to release publicly any updates or revisions to any forward-looking statements contained herein.
Media contacts: Dan Callahan GWG Holdings, Inc. (612) 746-1935 dcallahan@gwglife.com Matt Ehlers G&S Business Communications (919) 870-5718, x3221 mehlers@gscommunications.com
$MEOH Notice of #Cash #Dividend
VANCOUVER, BRITISH COLUMBIA–(Jan. 26, 2017) – Methanex Corporation (TSX:MX)(NASDAQ:MEOH) announced today that its Board of Directors has declared a quarterly dividend of US$0.275 per share that will be payable on March 31, 2017 to holders of common shares of record on March 17, 2017.
Methanex is a Vancouver-based, publicly traded company and is the world’s largest producer and supplier of methanol to major international markets. Methanex shares are listed for trading on the Toronto Stock Exchange in Canada under the trading symbol “MX” and on the NASDAQ Global Market in the United States under the trading symbol “MEOH”. Methanex can be visited online at www.methanex.com.
Sandra Daycock
Director, Investor Relations
Methanex Corporation
604-661-2600 or Toll Free: 1 800 661 8851
www.methanex.com
$ORPN to Host Key Opinion Leader Lunch, Focus on #Orphan #NeurologicalDisease
Investor Lunch and Live Webcast at 12 Noon Eastern Time on February 2
TEL AVIV, Israel, Jan. 26, 2017 — Bioblast Pharma Ltd. (Nasdaq:ORPN), a clinical-stage, orphan disease-focused biotechnology company, will host a KOL lunch on the subject of orphan neurological diseases and treatments at 12pm on Thursday, February 2, 2017 in New York City.
Bioblast management will provide an overview of the Company’s ongoing clinical development work with trehalose 90 mg/mL IV solution, a proprietary first-in-class therapeutic. Trehalose is currently in Phase 2 development for the treatment of oculopharyngeal muscular dystrophy (OPMD) and spinocerebellar ataxia, type 3 (SCA3). The keynote presentation will be made by Bernard Brais, MD, a leading neurologist and Professor of Neurology and Human Genetics at McGill University. He is Co-Director of the Rare Neurological Diseases Group of the Montreal Neurological Institute, one of the leading institutions specializing in the treatment of OPMD. Dr. Brais will discuss OPMD while Warren Wasiewski, MD, Bioblast’s Chief Medical Officer and Head of R&D, will cover the preclinical and clinical results for trehalose in both OPMD and SCA3.
Dr. Brais specializes in the clinical care and genetic basis of muscular dystrophies and other rare neurogenetic disorders. Over the last two decades, he has been recognized as an international leader on OPMD. In 1998, he published a paper on the first PABPN1 mutations responsible for OPMD in Nature Genetics. He also helped to first document the presence of mutated PABPN1 in the intranuclear inclusions underlying the pathology of OPMD, later showing that many RNA binding proteins were also aggregated in the inclusions.
Dr. Brais has followed the largest global cohort of OPMD cases since the early 1990s. Since 1998, he has overseen a cohort of more than 1,400 OPMD cases.
The lunch event is intended for institutional investors and analysts only. Please RSVP in advance if you plan to attend, as space is limited. To reserve a spot, please reply to this email or contact LifeSci Advisors, LLC at mac@lifesciadvisors.com.
A live webcast of the event, with slides, will be available at http://lifesci.rampard.com/20170202/reg.jsp and within the Investors section of the Company’s website at www.bioblastpharma.com.
Trehalose proprietary position
Bioblast has received a U.S. patent for administration of trehalose to treat SCA3 (and OPMD) that is expected to expire in 2033. In addition, the Company has secured Orphan Drug Designation for SCA3 and OPMD in the U.S. and in the EU.
Trehalose is a protein stabilizer that also activates autophagy and crosses the blood-brain barrier
Trehalose is a low molecular weight disaccharide (.342 kDa) that protects against pathological processes in cells. It has been shown to penetrate muscle and cross the blood-brain barrier. In animal models of several diseases associated with abnormal cellular-protein aggregation, it has been shown to reduce pathological aggregation of misfolded proteins as well as to activate autophagy pathways through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. Activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material.
About Oculopharyngeal Muscular Dystrophy (OPMD)
OPMD is an inherited myopathy characterized by dysphagia (difficulty in swallowing), eyelid drooping (ptosis) and the loss of muscle strength in multiple muscles of the limbs. Symptoms generally appear in mid-life and get worse over time. As the dysphagia becomes more severe, patients may become malnourished, may lose significant weight, and may suffer from repeated incidents of aspiration pneumonia. The disease is caused by a genetic mutation responsible for the creation of a mutant protein (PABPN1) with an expanded polyalanine domain that aggregates within patient muscle cells. There is no approved pharmacologic treatment for OPMD.
About Spinocerebellar Ataxia Type 3 (SCA3; Machado-Joseph Disease)
SCA3, also known as Machado-Joseph disease, is the most common form of hereditary cerebellar ataxias, which are a group of genetic diseases characterized by ataxia, spasticity, difficulty with speech and swallowing, weakness in arms and memory deficits. Symptoms can begin in early adolescence and get worse over time. Eventually SCA3 leads to paralysis, and severe cases can lead to an early death in the fourth decade of life. SCA3 is currently considered incurable, and there is no approved pharmacologic treatment for SCA3.
About Bioblast Pharma Ltd.
Bioblast Pharma is a clinical-stage biotechnology company committed to developing clinically meaningful therapies for patients with rare and ultra-rare genetic diseases. Bioblast is traded on the NASDAQ under the symbol “ORPN”. For more information, please visit our website: www.BioblastPharma.com, the content of which is not incorporated herein by reference.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss future clinical studies and imply that our product candidate may successfully treat certain medical conditions. In addition, historic results of scientific research and clinical and preclinical studies do not guarantee that the conclusions of future research or studies will suggest identical or even similar conclusions or that historic results referred to in this press release would not be interpreted differently, in light of additional research and clinical and preclinical study results. Because such statements deal with future events and are based on Bioblast Pharma Ltd.’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Bioblast Pharma could differ materially from those described in or implied by the statements in this press release, including those discussed under the heading “Risk Factors” in Bioblast Pharma’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 29, 2016, and in any subsequent filings with the SEC. Except as otherwise required by law, Bioblast Pharma disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
INVESTOR CONTACT Matthew P. Duffy Managing Director LifeSci Advisors LLC Phone: 212-915-0685
$FFHL Material Increase in #PolyesterFilm for #PCB
BEIJING, Jan. 26, 2017 — Fuwei Films (Holdings) Co., Ltd. (Nasdaq: FFHL) (“Fuwei Films” or the “Company”), a manufacturer and distributor of high-quality BOPET plastic films in China, today announced that the Company has signed an annual sales contract for 2017 with Eternal Electronic Material (Guangzhou) Co., Ltd. (“Eternal Electronic”), one of the Company’s top five customers during the year ended December 31, 2015 that purchases polyester film for PCB from Fuwei Films. Polyester film for PCB is a base film for dry film. Eternal Electronic is a well-known manufacturer of dry films globally, which is mainly used in Printed Circuit Boards (“PCB”). Based on the new contract, Fuwei expects that the total polyester film for PCB sales in the first quarter of 2017 will approximately increase by 34.5% compared to the same period of 2016. Fuwei Films continues to improve its product quality and has been supplying Eternal Electronic with advantageous prices and sound services for the past few years.
“We believe that the increase of orders from Eternal Electronic demonstrates that our product quality of polyester film for PCB is recognized by our customers,” commented Mr. Zengyong Wang, Chairman of Fuwei Films, “Our Company will continue to execute a portfolio of products that optimizes a higher margin strategy. We intend to continue to leverage our R&D capabilities and develop new, high-quality products with strong profit margins and maintain our excellent customer service in order to maintain a competitive advantage over our competitors.”
About Fuwei Films
Fuwei Films conducts its business through its wholly owned subsidiary, Fuwei Films (Shandong) Co., Ltd. (“Fuwei Shandong”). Fuwei Shandong develops, manufactures and distributes high-quality plastic films using the biaxial oriented stretch technique, otherwise known as BOPET film (biaxially oriented polyethylene terephthalate). Fuwei’s BOPET film is widely used to package food, medicine, cosmetics, tobacco, and alcohol, as well as in the imaging, electronics, and magnetic products industries.
Safe Harbor
This press release contains information that constitutes forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are subject to risks. Risk factors that could contribute to such differences include those matters more fully disclosed in the Company’s reports filed with the U.S. Securities and Exchange Commission which, among other things, include both the possible delisting of the Company’s ordinary shares from the NASDAQ Global Market; significant competition in the BOPET film industry, especially the significant oversupply of BOPET films resulting from the rapid growth of the Chinese BOPET industry capacity, changes in the international market and trade barriers, especially the adverse impact of the antidumping investigation and imposition of an anti-dumping duty on imports of the BOPET films originating from the People’s Republic of China (“China”) conducted by certain main importing countries; and the effect of the recent US presidential election on trade policy, fluctuations of RMB exchange rate, the reduce in demand for the Company’s products or the loss of main customers which may result in the decrease of sales, and negatively influencing the Company’s financial performance, uncertainty as to the future profitability, uncertainty as to the Company’s ability to successfully obtain additional funds to meet the working capital needs of the new BOPET production line, uncertainty as to the Company’s ability to continuously develop new BOPET film products to be produced by the third production line and keep up with changes in BOPET film technology, risks associated with possible defects and errors in its products including complaints and claims from clients, uncertainty as to its ability to protect and enforce its intellectual property rights, uncertainty as to its ability to attract and retain qualified executives and personnel, and uncertainty in acquiring raw materials on time and on acceptable terms, particularly in light of the volatility in the prices of petroleum products in recent years, instability of power and energy supply, and the uncertainty regarding the future operation of the Company in connection with the changes in the labor law in China, the measures taken by the Chinese government to save energy and reduce emissions, and the complaints from nearby residents and local government about the noise caused by our production as well as the uncertainty of the impact of major shareholder transfer that have substantial influence over the Company and the Company’s business operation including possible overlap of our BOPET products, customers and market orientation with an BOPET film manufacturer, which is controlled by the same individual who has control over the shares of our major shareholder. The forward-looking information provided herein represents the Company’s estimates as of the date of the press release, and subsequent events and developments may cause the Company’s estimates to change. The Company specifically disclaims any obligation to update the forward-looking information in the future. Therefore, this forward-looking information should not be relied upon as representing the Company’s estimates of its future financial performance as of any date subsequent to the date of this press release. Actual results of our operations may differ materially from information contained in the forward-looking statements as a result of the risk factors.
For more information, please contact:
In China:
Ms. Xiaoli Yu
Investor Relations Manager
Phone: +86-133-615-59266
Email: fuweiIR@fuweifilms.com
In the U.S.:
Vivian Chen
Investor Relations
Grayling
Phone: +1-646-284-9427
Email: vivian.chen@grayling.com
$RGSE Announces #PublicOffering of Common Stock and Warrants
LOUISVILLE, Colo., Jan. 26, 2017 — RGS Energy (NASDAQ:RGSE) today announced that it commenced a public offering of (A) units each consisting of one share of Class A common stock, par value $0.0001, or “Common Stock,” and a Series K Warrant to purchase Common Stock, and (B) units each consisting of one prepaid Series L Warrant to purchase one share of Common Stock and a Series K Warrant to purchase Common Stock. Roth Capital Partners is serving as exclusive placement agent in the offering on a “best efforts” basis.
The offering is being conducted pursuant to a prospectus supplement and an accompanying prospectus filed as part of an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (“SEC”). Prospective investors should read the prospectus supplement and the accompanying prospectus and the other documents that RGS Energy has filed with the SEC for more complete information about RGS Energy and the offering. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering are available free of charge on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained from the offices of Roth Capital Partners at 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660.
This announcement shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer or sale of any securities, in any state or jurisdiction in which the offer, solicitation, or sale of securities would be unlawful. Any offers, solicitations of offers to buy, or sales of securities will only be made pursuant to the registration statement filed with the SEC, including the related prospectus.
About RGS Energy
RGS Energy (NASDAQ:RGSE) is a residential and small commercial solar company since 1978, which has installed more than 25,000 solar power systems. RGS Energy makes it very convenient for customers to save on their energy bill by providing turnkey solar solutions – from system design, construction planning, customer financing assistance, installation, to interconnection and warranty.
RGS Energy is the company’s registered trade name. The company files periodic and other reports with the SEC under its official name “Real Goods Solar, Inc.”
Media and Investor Relations Contact for RGS Energy: Ron Both Managing Partner, CMA Tel 1-949-432-7566 RGSE@cma.team
$NVIV #INSPIRE Study of #NeuroSpinalScaffold, Promising Sixth Patient Conversion
-Patient Converts from Complete Paralysis to Partial Paralysis-
InVivo Therapeutics Holdings Corp. (NVIV) today announced that the patient enrolled in December in the INSPIRE study of the Neuro-Spinal Scaffold has improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury in the time between discharge and the one-month evaluation. This is the sixth out of the eleven patients (54.5% conversion rate) in follow-up to have had an AIS grade improvement. Two patients who have not yet converted are early in follow-up, with conversion possible before the six-month endpoint. The INSPIRE conversion rate is considerably higher than rates observed in a range of SCI natural history databases.
Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, said: “I have been encouraged by the data generated to date in the INSPIRE study, including the two conversions in patients that I have implanted with the Neuro-Spinal Scaffold.” Dr. Coric, Chief of Neurosurgery at the Carolinas Medical Center and a member of the INSPIRE Study Steering Committee performed the implantation with his partner at Carolina Neurosurgery and Spine Associates, Samuel Chewning, M.D.
“The AIS conversion rate observed thus far in the INSPIRE study has exceeded expectations,” CEO and Chairman Mark Perrin said. “We look forward to following this patient’s progress, and we’re hopeful that we will continue to observe positive INSPIRE results as we work towards completing enrollment.”
About The INSPIRE Study
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of a HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.
About the Neuro-Spinal Scaffold™ Implant
Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in the INSPIRE pivotal probable benefit study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.
About InVivo Therapeutics
InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.
Safe Harbor Statement
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold, the timing of additional enrollments, and the expectation for application for an HDE. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.
InVivo Therapeutics
Brian Luque, 617-863-5535
Investor Relations
bluque@invivotherapeutics.com
$BOBE Restaurant Sales, #PinelandFarms #Acquisition Mark Beginning of New Era
- Bob Evans Farms, Inc. announces definitive agreements for the sale of Bob Evans Restaurants and the purchase of Pineland Farms Potato Company, enabling the Company to focus on driving growth of BEF Foods
- Golden Gate Capital to acquire Bob Evans Restaurants for $565 million plus assumption of certain net working capital liabilities. Net proceeds of $475 to $485 million expected
- Net proceeds of Bob Evans Restaurants transaction expected to be used for repayment of outstanding indebtedness and payment of a special dividend of approximately $150 million ($7.50 per share) within approximately 60 days following closing
- BEF Foods acquiring Pineland Farms Potato Company for $115 million using new borrowings. Purchase price may be increased if certain financial metrics are achieved during a 24-month period after closing
- Both transactions expected to close by the end of fiscal 2017 (April 28, 2017)
- Company reaffirms fiscal year 2017 non-GAAP(1) adjusted diluted EPS guidance range of $2.15 to $2.30 assuming April 28, 2017, closings. Company also announces preliminary fiscal year 2018 Bob Evans Farms, Inc. revenue and EBITDA(1) targets of $470 million, and $105 million, respectively, assuming closing of both transactions on April 28, 2017
- Mike Townsley, President, BEF Foods, will assume the role of President and Chief Executive Officer of Bob Evans Farms, Inc. following the closing of the Bob Evans Restaurants transaction
NEW ALBANY, Ohio, Jan. 24, 2017 — Bob Evans Farms, Inc. (NASDAQ:BOBE) today announced two transformational transactions resulting from the board of directors’ strategic review of the Company’s alternatives for creating shareholder value.
The sale of Bob Evans Restaurants and the acquisition of Pineland Farms Potato Company (“PFPC”) marks the beginning of a new era at Bob Evans Farms (“Bob Evans”) in which the Company will focus exclusively on realizing the full potential of its BEF Foods business. BEF Foods is the national market share leader in refrigerated dinner side dishes, and is also the market share leader in sausage products in its core Midwest markets. The new Bob Evans, further strengthened by the manufacturing and intellectual capital of PFPC, is positioned to be a higher profit and higher growth company that is expected to provide better returns to shareholders and an enhanced product line for customers.
The Company has entered into a definitive agreement for the sale of Bob Evans Restaurants to an affiliate of Golden Gate Capital for $565 million plus assumption of certain net working capital liabilities at the time of closing estimated to be $40 to $50 million. The Company estimates that cash proceeds net of taxes and transaction-related costs will be $475 to $485 million. As discussed below, net cash proceeds are expected to be used to repay current indebtedness and payment of a special dividend. Additionally, the Company entered into a definitive agreement for the purchase of PFPC for $115 million. The purchase price may be increased by up to $25 million if certain financial metrics are achieved during a 24-month period after closing.
President and Chief Executive Officer Saed Mohseni said, “Today we announced two transactions that are a major step in our strategic transformation that we believe will continue Bob Evans’ history of success. The sale of Bob Evans Restaurants enables us to concentrate exclusively on BEF Foods, our fastest growing and most profitable segment. We believe this focus will result in higher returns for our shareholders and, as a more focused private business, Bob Evans Restaurants will be better able to deliver on its brand promise of providing quality food and hospitality to every guest at every meal. Bob Evans Restaurants has made tremendous progress over the last few years as our teams have strived to upgrade every aspect of the guest experience. We believe our talented restaurant teams, combined with Golden Gate Capital’s industry expertise and significant resources, positions Bob Evans Restaurants well for realizing its full potential.
“I am also pleased that we have signed an agreement to purchase PFPC. We believe this transaction will better enable BEF Foods to continue growing and innovating. The acquisition of PFPC not only increases our side-dish production capacity, it provides capability to produce and sell diced and shredded potato products in both the retail and foodservice channels. The acquisition also diversifies our production capability by adding a second state-of-the-art potato processing facility with 180 million pounds of capacity, 50 million pounds of which are expected to come online in April 2017. Furthermore, PFPC comes with a 900 acre potato farm and is surrounded by an additional 55,000+ acres of annual potato production. Its close proximity to tens of thousands of acres of potato production is particularly attractive as it greatly reduces transportation costs. BEF Food’s side-dish product mix is expected to reach 66% of sales volume by 2020, and the PFPC acquisition mitigates the need for near term capital spending for additional capacity to meet our growth targets. Following the completion of these transactions, Bob Evans will be focused exclusively on sales and profit growth of BEF Foods.”
Executive Chairman Doug Benham said, “The board of directors has consistently evaluated all options for creating shareholder value. From the outset, our philosophy has been to engage in a robust and deliberate process in an effort to make what we believe are the best decisions for shareholders. We believe these transactions are the best options for creating shareholder value and providing for the future success of these two great businesses.
“Following the closing of the Bob Evans Restaurants transaction, Mike Townsley, President, BEF Foods, will assume the role of President and Chief Executive Officer of Bob Evans. Mike joined Bob Evans as president and chief operating officer of Owens Foods, Inc. in June 2003. Mike was appointed president of BEF Foods in June 2008. He also served as co-chief executive officer from December 2014 to September 2015. Mike has been the driving force behind the transformation of BEF Foods and we look forward to continued strong leadership from him and his team, including Chief Administrative and Chief Financial Officer Mark Hood who will remain in his role. The board appreciates the extraordinary talent, energy, and vision that Saed Mohseni has brought to Bob Evans and is excited that he has agreed to continue leading Bob Evans Restaurants following the transaction.”
Josh Cohen, Managing Director at Golden Gate Capital, said, “Bob Evans Restaurants is an exceptional brand, uniquely differentiated by its deep-rooted heritage of farm-fresh food and heartfelt hospitality. As an independent company partnered with Golden Gate Capital, Bob Evans Restaurants will be well-positioned to sharpen its focus on enhancing the business, with increased flexibility and resources to grow the company for the long-term. We look forward to working with Saed Mohseni and the talented management team to support Bob Evans Restaurants as it enters this exciting new chapter.”
Chief Administrative and Chief Financial Officer Mark Hood said, “The Company expects to provide an updated GAAP EPS guidance range and recast Bob Evans Restaurants’ results as discontinued operations when it reports third quarter fiscal 2017 results. We are reaffirming our full-year fiscal 2017 non-GAAP diluted EPS guidance range of $2.15 to $2.30, assuming a closing date of April 28, 2017, on the aforementioned transactions. Furthermore, it is our expectation that our board of directors will declare a special dividend of approximately $150 million ($7.50 per share) representing net cash proceeds from the sale of Bob Evans Restaurants after repayment of debt within 60 days following the transaction. Additionally, the board of directors increased the Company’s existing share repurchase authorization to $100 million through calendar year 2017. We also anticipate continuation of our quarterly dividend payments, currently at $0.34 per share.
“We are also providing fiscal year 2018 preliminary revenue and EBITDA targets of $470 million, and $105 million, respectively. We expect to establish a $300 million credit facility at the time of the transaction closings and expect that our targeted leverage range will be 1.0-2.0x which provides considerable flexibility to continue to grow and invest in BEF Foods.”
CONFERENCE CALL DETAILS:
The Company will host a conference call to discuss this announcement at 8:30 a.m. (ET) on Wednesday, January 25, 2017. The dial-in number for the conference call is (855) 468-0551, access code 54342985. A replay will be available at (800) 585-8367, access code 54342985.
A simultaneous webcast will be available at http://investors.bobevans.com/events.cfm. The archived webcast will also be available on the Web site.
The closings of the transactions are each subject to expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary closing conditions. The sale of the Bob Evans Restaurants business to Golden Gate Capital is not subject to a financing condition. Under the terms of the definitive agreement for the sale of the Bob Evans Restaurants business, the Company will provide certain transactional support services to the buyer for a period of 18 to 24 months following the closing.
Under the terms of the definitive agreement for the sale of the Bob Evans Restaurant business, the Company may solicit superior proposals from third parties through February 28, 2017. It is not anticipated that any developments will be disclosed with regard to this process unless the Company’s Board of Directors makes a decision with respect to a potential superior proposal. There are no guarantees that this process will result in a superior proposal.
J.P. Morgan Securities LLC served as financial advisor to the Company on the sale of Bob Evans Restaurants. UBS Investment Bank served as financial advisor to Golden Gate Capital.
Information concerning this event was filed by the Company today with the Securities and Exchange Commission and can be obtained at www.sec.gov.
(1)Non-GAAP Financial Measures
We have included in this release a forecast of adjusted diluted EPS and EBITDA for future periods. These forward-looking financial measures are not presented in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP).
Our non-GAAP measures are used by analysts, investors and other interested parties to compare our performance with the performance of other companies that report similar non-GAAP measures. We believe these non-GAAP measures provide meaningful supplemental information regarding financial performance by excluding certain expenses and benefits that may not be indicative of core business operating results. We believe the non-GAAP measures, when viewed in conjunction with U.S. GAAP results and the accompanying reconciliations, enhance the comparability of results against prior periods and allow for greater transparency of financial results and business outlook. In addition, we use non-GAAP data internally to assess performance and facilitate management’s internal comparison of our financial performance to that of prior periods, as well as trend analysis for budgeting and planning purposes. The presentation of our non-GAAP measures is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with U.S. GAAP. Furthermore, our non-GAAP measures may not be comparable to similarly titled measures reported by other companies and may have limitations as an analytical tool. We define EBITDA as GAAP net income plus interest expense, provision for income taxes, depreciation, and amortization.
Reconciliations of the Company’s projected adjusted diluted EPS for fiscal year 2017 and EBITDA for fiscal year 2018 to the most directly comparable GAAP financial measures are omitted from this release because the Company is unable to provide such reconciliations without unreasonable effort. In particular, in light of the transactions being announced in this release, management is not able to calculate certain amounts necessary to provide corresponding forecasted financial measures calculated in accordance with GAAP and related reconciliations at this time as a result of the complexity of recasting historical information to reflect the Company’s Bob Evans Restaurants segment as a discontinued operation, the complexity in completion of purchase accounting related to the PFPC acquired assets and operations on a pro forma basis, and the inherent difficulty in forecasting generally and in quantifying certain projected amounts that are necessary for such calculations and reconciliations.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
Certain statements in this news release that are not historical facts are forward-looking statements. Forward-looking statements involve various important assumptions, risks and uncertainties. Actual results may differ materially from those predicted by the forward-looking statements because of various factors and possible events. The risks and uncertainties in connection with such forward-looking statements related to the proposed transactions include, but are not limited to, the occurrence of any event, change or other circumstances that could delay the closing of either of the proposed transactions; the possibility of non-consummation of the proposed transactions and the termination of the respective transaction agreements; the failure to satisfy any of the conditions to the respective transaction agreements; adverse effects on the Company’s common stock because of the failure to complete either of the proposed transactions; the Company’s businesses experiencing disruptions due to transaction-related uncertainty or other factors making it more difficult to maintain relationships with employees and business partners; significant transaction costs related to the proposed transactions; and the dependence on the proposed special dividend of the consummation of the sale of the Bob Evans Restaurants Business. Additional information about the factors and events that could cause actual results to differ materially from those predicted by the forward looking statements, along with certain other risks, uncertainties and assumptions related to the Company and its business, may be found in our Annual Report on Form 10-K for the fiscal year ended April 29, 2016, and in our other filings with the Securities and Exchange Commission. We note these factors for investors as contemplated by the Private Securities Litigation Reform Act of 1995. Predicting or identifying all such risk factors is impossible. Consequently, investors should not consider any such list to be a complete set of all potential risks and uncertainties. Forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to update any forward-looking statement to reflect circumstances or events that occur after the date of the statement to reflect unanticipated events. All subsequent written and oral forward-looking statements attributable to us or any person acting on behalf of the Company are qualified by the cautionary statements in this section.
About Bob Evans Farms, Inc.
Bob Evans Farms, Inc. owns and operates full-service restaurants under the Bob Evans Restaurants brand name. At the end of the second fiscal quarter (October 28, 2016), Bob Evans Restaurants owned and operated 522 family restaurants in 18 states, primarily in the Midwest, mid-Atlantic and Southeast regions of the United States. Bob Evans Farms, Inc., through its BEF Foods segment, is also a leading producer and distributor of refrigerated side dishes, pork sausage, and a variety of refrigerated and frozen convenience food items under the Bob Evans and Owens brand names. For more information about Bob Evans Farms, Inc., visit www.bobevans.com.
About Pineland Farms Potato Company
Nearly twenty years ago a group of fourth generation Maine potato farmers had a vision that would create jobs, business opportunities, and a brighter future for the young people of northern Maine. In 1997, they built a state-of-the-art potato processing facility that transformed the thousands of acres of potatoes grown in the region from a commodity to a refrigerated ready-to-cook product. In addition to contracting processing potatoes from many family-owned farms, the company purchased its own farming operation in 2012 and became a vertically integrated business. The company’s key products include a wide variety of cut and mashed potato products serving retail and foodservice customers.
About Golden Gate Capital
Golden Gate Capital is a San Francisco-based private equity investment firm with over $15 billion of capital under management. The principals of Golden Gate Capital have a long and successful history of investing across a wide range of industries and transaction types, including going-privates, corporate divestitures, and recapitalizations, as well as debt and public equity investments. Representative restaurant/retail investments sponsored by Golden Gate Capital include Red Lobster, California Pizza Kitchen, On The Border Mexican Grill & Cantina, Eddie Bauer, Express, Pacific Sunwear, Payless ShoeSource and Zales.
BOBE-G
Contacts: Bob Evans Farms, Inc. Scott C. Taggart Vice President, Investor Relations (614) 492-4954 Golden Gate Capital Jenny Gore/Alyssa Linn (312) 895-4700/(310) 201-2040
$CLRB Additional #US #Patent #CLR131 & #CLR125 in Broad Spectrum of #SolidTumors
MADISON, Wis., Jan. 24, 2017 — Cellectar Biosciences, Inc. (Nasdaq:CLRB), an oncology-focused clinical stage biotechnology company, today announces that the United States Patent and Trademark Office (“USPTO”) has granted patent number 9,550,002, which covers method of use for the company’s lead compound, CLR 131, as well as CLR 125, for the treatment of cancer. The granting of this patent follows the company’s previous announcement of patent allowances for the use of the company’s phospholipid drug conjugate (PDC) delivery platform in these tumor types.
“This patent strengthens our radiotherapeutic intellectual property portfolio and further demonstrates Cellectar’s commitment to optimizing our PDC technology platform,” said Jim Caruso, president and CEO of Cellectar. “While we are currently focused on developing CLR 131 for hematologic malignancies such as multiple myeloma, the claims granted provide additional development optionality for Cellectar or a potential partner.”
The granted patent covers the use of CLR 131 for the potential treatment of a broad range of malignant solid tumors, which include adrenal, lung, ovarian or cervical, prostate, liver, breast and colon, as well as melanoma or subcutaneous cancers.
About CLR 131
CLR 131 is an investigational compound under development for a range of hematologic malignancies. It is currently being evaluated in a Phase I clinical trial in patients with relapsed or refractory multiple myeloma. The company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. Based upon pre-clinical and interim Phase I study data, treatment with CLR 131 provides a novel approach to treating hematological diseases and may provide patients with therapeutic benefits, including overall response rate (ORR), an improvement in progression-free survival (PFS) and overall quality of life. CLR 131 utilizes the company’s patented PDC tumor targeting delivery platform to deliver a cytotoxic radioisotope, iodine-131 directly to tumor cells. The FDA has granted Cellectar an orphan drug designation for CLR 131 in the treatment of multiple myeloma.
About CLR 125
CLR 125 is a broad-spectrum, cancer-targeting, radiotherapeutic, which may be uniquely suited to treat micro-metastatic disease. CLR 125 uses the radioisotope iodine-125 conjugated to the company’s proprietary phospholipid drug conjugate (PDC) delivery platform. Similar to CLR 131, the selective uptake and retention of CLR 125 has been observed in malignant tissues during pre-clinical studies. Funded by a recent NCI SBIR award, the company evaluated the feasibility and safety of CLR 125 for the treatment of triple-negative breast cancer (TNBC) in the (neo) adjuvant setting. This program has successfully completed and demonstrated appropriate biodistribution, tolerability, and dose response.
About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The company deliberately designed its phospholipid ether (PLE) carrier platform to be coupled with a variety of payloads to facilitate both therapeutic and diagnostic applications. The basis for selective tumor targeting of our PDC compounds lies in the differences between the plasma membranes of cancer cells compared to those of normal cells. Cancer cell membranes are highly enriched in lipid rafts, which are glycolipoprotein microdomains of the plasma membrane of cells that contain high concentrations of cholesterol and sphingolipids, and serve to organize cell surface and intracellular signaling molecules. PDCs have been tested in more than 80 different xenograft models of cancer.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC platform is based on the company’s proprietary phospholipid ether analogs. These novel small-molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I clinical study in patients with relapsed or refractory multiple myeloma. In addition, the company plans to initiate a Phase II clinical study to assess efficacy in a range of B-cell malignancies in the first quarter of 2017. The company is also developing PDCs for targeted delivery of chemotherapeutics such as paclitaxel (CLR 1603-PTX), a preclinical stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information please visit www.cellectar.com.
This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K/A for the year ended December 31, 2015. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
CONTACT: Jules Abraham JQA Partners, Inc. 917-885-7378 jabraham@jqapartners.com
$CDTI #Partners with #DENSO #NorthAmerica #HeavyDuty #Automotive Market
Reflects CDTi’s growing success as a leading provider of enabling emission control technology
OXNARD, Calif., Jan. 24, 2017 — Clean Diesel Technologies, Inc. (Nasdaq:CDTI) (“CDTi” or “the Company”), a leader in advanced emission control technology, has partnered with DENSO Products and Services Americas Inc., an affiliate of leading global automotive supplier DENSO Corp., to supply CDTi’s enabling technologies to the North American heavy-duty market. Under the scope of the partnership the two companies will launch PowerEdge diesel after-treatment, which will be distributed by DENSO and manufactured by CDTi featuring CDTi’s Diesel Particulate Filter (DPF) and Diesel Oxidation Catalyst (DOC) technologies.
“This partnership reflects our continued success in positioning CDTi as a provider of emissions solutions to the global automotive market,” stated Matthew Beale, CDTi’s CEO. “DENSO’s choice of CDTi provides further evidence of our growing technology leadership in the world’s largest heavy-duty markets. We are excited to add DENSO to our growing customer base of global manufacturing and distribution partners.”
“DENSO strives to provide our customers with innovative products that contribute to the productivity of their businesses,” stated Frank Jenkins, senior manager of DENSO’s Heavy Duty Marketing Group, DENSO Products and Services Americas, Inc. “CDTi shares our commitment to product reliability and durability, rigorous safety and performance standards, innovation, customer service and environmental stewardship.”
“Partnering with DENSO supports our continued commercial momentum in the large, fast-growing opportunity for OE-quality after-treatment solutions in North America,” stated Jason P. Soika, CDTi’s Vice President, Sales & Marketing. “This agreement significantly expands our reach into the multi-million-dollar market for replacement DPFs and DOCs. In addition, being selected as a supplier for DENSO further validates the quality of our OEM replacement products.”
Collaborating with CDTI enables DENSO to offer customers an extended range of application coverage by consolidating more than 260 original equipment (OE) part numbers to less than 80. The all-makes strategy provides inventory efficiency by managing fewer SKUs while providing customers with optimal application coverage. Additionally, CDTi is continually introducing OE replacements for emerging applications and monitoring product lifecycle to ensure the portfolio aligns with newly introduced and outgoing technologies.
Diesel Particulate Filter (DPF)
A diesel particulate filter, or DPF, is a system that filters exhaust gas flow to capture solid particulate matter (PM) — created as a byproduct of the internal combustion process. DPFs have been used as pollution control devices for both on- and off-road vehicles and equipment since the 1980s. Designed and manufactured in North America, CDTi’s DPFs are exact-fit OEM replacements that meet or exceed OEM emissions requirements and are backed by an industry-leading 2-year, unlimited mileage warranty.
Diesel Oxidation Catalyst (DOC)
A diesel oxidation catalyst, or DOC, is a device that utilizes complex chemical processes to transform hazardous pollutants from diesel engines, turning them into less harmful exhaust, similar to an automobile’s catalytic converter. DOCs are normally honeycombs coated with an active catalyst formulation, engineered in combination with a DPF, to dramatically reduce particulate matter (PM) by 90% along with reducing other dangerous gaseous emissions by 50% to 70%.
About CDTi
CDTi develops advanced materials technology for the emissions control market. CDTi’s proprietary technologies provide high-value sustainable solutions to reduce hazardous emissions, increase energy efficiency and lower the carbon intensity of on- and off-road combustion engine systems. With a continuing focus on innovation-driven commercialization and global expansion, CDTi’s breakthrough Powder-to-Coat (P2C™) technology exploits the Company’s high-performance, advanced low-platinum group metal (PGM) emission reduction catalysts. Key technology platforms include Mixed Phase Catalyst (MPC®), Base Metal Activated Rhodium Support (BMARS™), Synergized PGM (SPGM™), Zero PGM (ZPGM™) and Spinel™. For more information, please visit www.cdti.com.
About DENSO Corporation
DENSO Corp., headquartered in Kariya, Aichi prefecture, Japan, is a leading global automotive supplier of advanced technology, systems and components in the areas of thermal, powertrain control, electronics, information and safety. Its customers include all the world’s major carmakers. Worldwide, the company has more than 200 subsidiaries and affiliates in 38 countries and regions (including Japan) and employs more than 150,000 people. Consolidated global sales for the fiscal year ending March 31, 2016, totaled US$40.2 billion. Last fiscal year, DENSO spent 8.8 percent of its global consolidated sales on research and development. DENSO common stock is traded on the Tokyo and Nagoya stock exchanges. For more information, go to www.globaldenso.com or visit our media website at http://www.globaldenso.com/en/newsreleases/media-center/.
Forward-Looking Statements
Certain information contained in this press release constitutes forward-looking statements, including any statements that are not statements of historical fact. You can identify these forward-looking statements by the use of the words “believes”, “expects”, “anticipates”, “plans”, “may”, “will”, “would”, “intends”, “estimates”, and other similar expressions, whether in the negative or affirmative. Forward-looking statements are based on a series of expectations, assumptions, estimates and projections, which involve substantial uncertainty and risk. In this document, the Company includes forward-looking statements regarding the acceleration of the Company’s business transformation into an advanced materials company, the conversion of outstanding indebtedness into common stock, global trends in the automotive and heavy duty diesel markets, the Company’s future financial performance, and the performance of the Company’s technology, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. In general, actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including, but not limited, to (i) that the Company may not be able to (a) successfully implement, or implement at all, its strategic priorities; (b) streamline its operations or align its organization and infrastructure with the anticipated business; (c) meet expectations or projections; (d) decrease costs; (e) increase sales; (f) obtain adequate funding; (g) retain or secure customers; (h) increase its customer base; (i) protect its intellectual property; (j) successfully evolve into an advanced materials supplier or, even if successful, increase profitability; (k) successfully market new products; (l) obtain product verifications or approvals; (m) attract or retain key personnel; (n) validate, optimize and scale our powder-to-coat capability; or (o) realize benefits from investments; (ii) funding for and enforcement and tightening of emissions controls, standards and regulations; (iii) prices of PGM and rare earth metals; (iv) royalty and other restrictions on sales in certain Asian countries; (v) supply disruptions or failures; (vi) regulatory, marketing and competitive factors; (vii) environmental harm or damages; and (viii) other risks and uncertainties discussed or referenced in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. In addition, any forward-looking statements represent the Company’s estimates only as of the date of such statements and should not be relied upon as representing the Company’s estimates as of any subsequent date. The Company specifically disclaims any obligation to update forward-looking statements. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Contact Information:
Becky Herrick or Cathy Mattison
LHA (IR Agency)
+1 415 433 3777
bherrick@lhai.com / cmattison@lhai.com
$ASYS Announces Large Orders, #PECVD Systems and #Bifacial #Ntype Tech
TEMPE, Ariz., Jan. 24, 2017 — Amtech Systems, Inc. (NASDAQ: ASYS), a global supplier of production equipment and related supplies for the solar, semiconductor, and LED markets, today announced fiscal year 2017 year-to-date order bookings through January 20, 2017 are approximately $84 million. This includes solar orders of $60 million. The solar bookings include major wins for the Company’s high productivity PECVD platform with top tier customers in China, Malaysia, and Taiwan and an n-type bi-facial turnkey order from a new customer in China. The majority of the orders are expected to ship within the next six to nine months.
Fokko Pentinga, CEO and President of Amtech, commented, “These competitive wins are a direct result of our ongoing investment program and a clear testament to the Company’s ability to meet the market’s expectations as they selectively invest in next-generation technology solutions. Our newly introduced PECVD platform is recognized as a compelling solution to increase the efficiency in solar cell manufacturing while lowering the cost of ownership. The continuing development of our advanced n-type technology led to this turnkey order from a customer who will use the technology for Bi-Facial glass-glass module design in the first of a multi-phase 1GW cell and module expansion. We believe that Amtech has the right mix of n-type and PERC cell technologies for this expanding global solar market where success is driven by the best next-gen technology solutions. Recently, we have experienced increased customer interest in our n-type technology. As the solar market looks to the future, we believe n-type cell technology has the best roadmap to higher efficiency.”
About Amtech Systems, Inc.
Amtech Systems, Inc. is a global supplier of advanced thermal processing equipment to the solar, semiconductor / electronics, and LED manufacturing markets. Amtech’s equipment includes diffusion, ALD and PECVD systems and solder reflow systems. Amtech also supplies wafer handling automation and polishing equipment and related consumable products. The Company’s wafer handling, thermal processing and consumable products currently address the diffusion, oxidation, and deposition steps used in the fabrication of solar cells, LEDs, semiconductors, MEMS, printed circuit boards, semiconductor packaging, and the polishing of newly sliced sapphire and silicon wafers. Amtech’s products are recognized under the leading brand names Tempress SystemsTM, Bruce TechnologiesTM, PR HoffmanTM, R2D AutomationTM, SoLayTec, and BTU International.
Cautionary Note Regarding Forward-Looking Statements
Certain information contained in this press release is forward-looking in nature. All statements in this press release, or made by management of Amtech Systems, Inc. and its subsidiaries (“Amtech”), other than statements of historical fact, are hereby identified as “forward-looking statements” (as such term is defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended). In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “would,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology and are intended to identify such forward-looking statements. Examples of forward-looking statements include statements regarding Amtech’s future financial results, operating results, business strategies, projected costs, products under development, competitive positions, and plans and objectives of Amtech and its management for future operations. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. The Form 10-K that Amtech filed with the Securities and Exchange Commission (the “SEC”) for the year-ended September 30, 2016, listed various important factors that could affect the company’s future operating results and financial condition and could cause actual results to differ materially from historical results and expectations based on forward-looking statements made in this document or elsewhere by Amtech or on its behalf. These factors can be found under the heading “Risk Factors” in the Form 10-Ks and investors should refer to them. Because it is not possible to predict or identify all such factors, any such list cannot be considered a complete set of all potential risks or uncertainties. Except as required by law, we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events, or otherwise.
| Contacts: | |
| Amtech Systems, Inc.Robert T. Hass
Chief Financial Officer (480) 967-5146
|
ChristensenInvestor Relations
Patty Bruner (480) 201-6075 |
$XON to #Acquire $GNVC Huge Expansion of #GeneDelivery Platform #AdenoVerse
GenVec’s AdenoVerse™ to be Integrated into Intrexon’s Proprietary Synthetic Biology Platform
GERMANTOWN, Md., and GAITHERSBURG, Md., Jan. 24, 2017 — Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, today announced that it has entered into a definitive agreement to acquire GenVec, Inc. (NASDAQ: GNVC), a clinical-stage company and pioneer in the development of AdenoVerse™ gene delivery technology.
Intrexon intends to integrate and expand upon GenVec’s expertise in adenoviral vectors and cGMP drug product manufacturing to enhance its broad gene transfer capabilities that encompass multiple viral and non-viral platforms. Notably, the combined technologies have the potential to yield the next generation of adenoviral (AdV) delivery through the creation of a scalable manufacturing platform utilizing helper-dependent adenovirus with significantly higher payload capacity of >30kb, as compared to current viral delivery methods ranging from 4.5kb – 9kb.
Thomas D. Reed, Ph.D., Intrexon’s chief science officer commented, “Our acquisition of GenVec will mark our continuing commitment to add gene delivery platforms that complement our multigenic control systems. Intrexon’s proficiency in using various viral as well as non-viral transfer techniques to integrate our gene programs affords us the capability to pursue an array of in vivo and ex vivo gene and cell therapy approaches, and the addition of a helper-dependent adenoviral system with a substantial payload capacity dramatically expands the types of in vivo therapeutic programs we can pursue.”
“GenVec has contributed significantly to advancements in gene therapy through its AdenoVerse technology, and over 3,000 clinical trial subjects have received their therapeutics and vaccines across the globe. We are enthusiastic to begin working alongside their highly accomplished research and drug development team,” added Dr. Reed.
“After a detailed and careful evaluation, our board of directors believes that this is the best alternative to maximize value for GenVec’s shareholders,” said Douglas Swirsky, GenVec’s president and CEO. “We expect that the strong scientific synergies, coupled with Intrexon’s extensive resources, will help unlock the true potential of the AdenoVerse platform.”
Through an AdV-based vector, Intrexon has already delivered the first clinically validated transcriptional gene switch utilizing the RheoSwitch Therapeutic System® to regulate the expression and concentration of a powerful cytokine, interleukin-12, to treat cancer. Intrexon’s gene control systems combined with the array of GenVec’s AdV-based technology is projected to accelerate its ability to develop cutting-edge gene therapies that regulate in vivo expression of multiple therapeutic effectors.
Additionally, GenVec’s selection of vector origins and serotypes as well as know-how in specifying cellular and tissue targets is expected to expedite the design and production of vectors that complement Intrexon’s multigene programming and focus on safety with limited off-target effect.
Douglas E. Brough, Ph.D., GenVec’s chief scientific officer stated, “We are excited to be joining the talented team at Intrexon. Utilization of their advanced synthetic biology tools and expertise is expected to enable the development of a manufacturing approach that will greatly increase the capacity of our expression cassettes to over 30kb. This next-generation delivery platform is anticipated to vastly exceed other viral delivery methods and accommodate Intrexon’s advanced gene programming to target complex multi-gene disorders.”
Transaction Terms and Timing
Pursuant to the definitive agreement, upon the closing of the transaction GenVec stockholders will receive 0.297 of a share of Intrexon Common Stock in exchange for each share of GenVec common stock. This exchange ratio represents $7.00 per share of GenVec’s common stock based on Intrexon’s 5-day volume weighted average price as of January 23, 2017. GenVec stockholders will also receive a right to contingent consideration equal to 50% of any milestone or royalty payments received within 36 months after the closing of the transaction under GenVec’s Research Collaboration and License Agreement with Novartis. Consummation of the acquisition is subject to customary closing conditions, including GenVec stockholder approval, and is expected to occur in the second quarter of 2017.
Roth Capital Partners provided advisory services to the Board of Directors of GenVec in connection with the transaction, and Hogan Lovells is serving as legal counsel to GenVec. Thompson Hine is serving as legal counsel to Intrexon.
About Intrexon Corporation
Intrexon Corporation (NYSE:XON) is Powering the Bioindustrial Revolution with Better DNA™ to create biologically-based products that improve the quality of life and the health of the planet. The Company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA®, and we invite you to discover more at www.dna.com or follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.
About GenVec
GenVec is a clinical-stage gene delivery company focused on developing a pipeline of cutting-edge therapeutics and vaccines using its proprietary AdenoVerse platform. The company is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVec’s lead product candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, the company is also focused on opportunities to license its proprietary technology platform, including vectors and production cell lines, for the development and manufacture of therapeutics and vaccines to the biopharmaceutical industry. Additional information about GenVec is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.
Trademarks
Intrexon, Powering the Bioindustrial Revolution with Better DNA, and Better DNA are trademarks of Intrexon and/or its affiliates. AdenoVerse™ is a trademark of GenVec, Inc. Other names may be trademarks of their respective owners.
Safe Harbor Statement
This communication contains “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These statements, as they relate to Intrexon Corporation (“Intrexon”) or GenVec, Inc (“GenVec”), the management of either such company, the proposed transaction between Intrexon and GenVec, or the future development of gene delivery technology and gene therapies as a result of the transaction, involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. These statements are based on current plans, estimates and projections, and therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Intrexon and GenVec undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions and projections about the business and future financial results of the biotechnology industry, and other legal, regulatory and economic developments. We use words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe harbor provisions of the PSLRA. Actual results could differ materially from the results contemplated by these forward-looking statements due to a number of factors, including, but not limited to, those described in the documents Intrexon and GenVec have filed with the U.S. Securities and Exchange Commission (the “SEC”), risks related to the development of gene delivery technology and gene therapies, as well as the possibility that (1) Intrexon and GenVec may be unable to obtain stockholder or regulatory approvals required for the proposed transaction or may be required to accept conditions that could reduce the anticipated benefits of the merger as a condition to obtaining regulatory approvals; (2) the length of time necessary to consummate the proposed transaction may be longer than anticipated; (3) problems may arise in successfully integrating the business and technologies of Intrexon and GenVec; (4) the proposed transaction may involve unexpected costs; (5) the businesses may suffer as a result of uncertainty surrounding the proposed transaction, including difficulties in maintaining relationships with third parties or retaining key employees; (6) the parties may be unable to meet expectations regarding the timing, completion and accounting and tax treatments of the transaction; or (7) the industry may be subject to future risks that are described in the “Risk Factors” section of the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC by Intrexon and GenVec. Neither Intrexon nor GenVec gives any assurance that either Intrexon or GenVec will achieve its expectations.
The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that affect the businesses of Intrexon and GenVec described in the “Risk Factors” section of their respective Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by either of them from time to time with the SEC. All forward-looking statements included in this document are based upon information available to Intrexon and GenVec on the date hereof, and neither Intrexon nor GenVec assumes any obligation to update or revise any such forward-looking statements.
Additional Information and Where to Find It
This document relates to a proposed transaction between GenVec and Intrexon, which will become the subject of a registration statement and joint proxy statement/prospectus forming a part thereof to be filed with the SEC by Intrexon. This document is not a substitute for the registration statement and joint proxy statement/prospectus that Intrexon will file with the SEC or any other documents that GenVec or Intrexon may file with the SEC or send to stockholders in connection with the proposed transaction. Before making any voting decision, investors and security holders are urged to read the registration statement, joint proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction and related matters.
Investors and security holders will be able to obtain free copies of the registration statement, joint proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by GenVec or Intrexon through the website maintained by the SEC at www.sec.gov.
In addition, investors and security holders will be able to obtain free copies of the joint proxy statement/prospectus, once it is filed, from GenVec by accessing GenVec’s website at ir.genvec.com/all-sec-filings or upon written request to ir@genvec.com.
Participants in Solicitation
Intrexon, GenVec and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from GenVec’s stockholders in connection with the proposed transaction. Information regarding GenVec’s directors and executive officers is contained in the proxy statement for GenVec’s 2016 Annual Meeting of Stockholders, which was filed with the SEC on September 12, 2016. You can obtain a free copy of this document at the SEC’s website at www.sec.gov or by accessing GenVec’s website at ir.genvec.com/all-sec-filings. Information regarding Intrexon’s executive officers and directors is contained in the proxy statement for Intrexon’s 2016 Annual Meeting of Stockholders filed with the SEC on April 29, 2016. You can obtain a free copy of this document at the SEC’s website at www.sec.gov or by accessing Intrexon’s website at www.dna.com. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the joint proxy statement/prospectus regarding the proposed transaction when it becomes available. You may obtain free copies of this document as described in the preceding paragraph.
For more information regarding Intrexon Corporation, contact:
Investor Contact
Christopher Basta
Vice President, Investor Relations
Tel: +1 (561) 410-7052
investors@intrexon.com
Corporate Contact
Marie Rossi, Ph.D.
Senior Manager, Technical Communications
Tel: +1 (301) 556-9850
publicrelations@intrexon.com
For more information regarding GenVec, contact:
Rena Cohen
Senior Manager, Communications and Administration
Tel: +1 (240) 632-5501
ir@genvec.com
$ADMA to #Acquire Certain Assets from #Biotest; #Plasma
ADMA to secure:
- Ownership and control of U.S. based Immune Globulin manufacturing facility
- FDA licensed products portfolio with immediate and on-going commercial sales
- $40M in Equity/Debt Financing from Biotest AG; ADMA’s cash runway presently expected to be extended to 2H 2018
RAMSEY, N.J., Jan. 23, 2017 — ADMA Biologics, Inc. (NASDAQ:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases, today announced it signed a definitive agreement to acquire certain manufacturing and therapy-related assets from Biotest Pharmaceuticals Corporation (BPC), a wholly-owned subsidiary of Biotest AG. The transaction, subject to customary closing conditions, including shareholder approval, is expected to close during the first half of 2017.
ADMA’s lead product candidate, RI-002, is manufactured at BPC’s facility in Boca Raton, Florida. ADMA has been working closely with BPC on resolving certain issues at this facility in connection with deficiencies identified by the U.S. Food and Drug Administration (FDA) in ADMA’s Complete Response Letter (CRL) for RI-002 (July 2016). RI-002 is a specialty plasma-derived, polyclonal, intravenous immune globulin (IGIV). ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with Primary Immune Deficiency Disease (PIDD).
“Upon the completion of this transaction, ADMA believes it will be uniquely positioned to offer a fully vertically integrated plasma products and immune globulin platform in the U.S. This transaction will allow ADMA to work directly with the FDA in efforts to obtain U.S. regulatory approval for RI-002 and remediate the outstanding Warning Letter at the manufacturing facility,” stated Adam Grossman, President and Chief Executive Officer, Director and Founder of ADMA Biologics.
“Through this transformative transaction, we believe that combining these acquired assets with our innovative immune globulin intellectual property will afford ADMA an expedited and less costly pathway for exploring additional hyperimmune globulin product candidates, as well as other potential plasma derived products. We believe the plasma industry and market are poised for growth in the coming years, as such, ADMA believes that it has secured a prime place for it and its stockholders to reap the rewards associated with marketing novel plasma derived therapies. Additionally, as evidenced by recent transactional activity in the plasma products industry, this transaction should enhance our Company’s competitive positioning and will accelerate ADMA’s growth and ultimately benefit its stockholders,” Mr. Grossman concluded.
Dr. James Mond, Chief Medical and Scientific Officer of ADMA Biologics, stated, “Since the receipt of the CRL for RI-002 this past July, ADMA has been working to find a solution to the issues which would result in the most expeditious way to obtain FDA regulatory approval for RI-002. With the experience of our management team and Board of Directors in the plasma products industry, BPC and Biotest AG have conveyed their belief that ADMA is the ideal company to lead the efforts for the resolution of the Warning Letter at the plant as well as harnessing the potential of the assets and championing the BPC product portfolio.”
“With operational control and the ability to employ ADMA’s strict fiscal management policies and oversight to the operations of these acquired assets, we believe ADMA will generate a positive impact on future gross margins for the company as well as for RI-002, once it’s approved by the FDA,” stated Mr. Brian Lenz, Chief Financial Officer of ADMA Biologics.
“Biotest AG, BPC and ADMA look forward to the closing of this promising and transformative transaction, which is anticipated to occur during the first half of 2017,” said Dr. Bernhard Ehmer, Chief Executive Officer and Chairman of the Board of Management of Biotest AG. “We believe that ADMA’s management team and Board are equipped with the operational expertise required to effectively leverage the acquired manufacturing facilities, and ultimately achieve FDA licensure of RI-002. We are confident that ADMA is ideally suited to maximize the commercial potential of the acquired assets,” Mr. Ehmer concluded.
The core assets ADMA will be acquiring upon consummation of the proposed transaction include:
- Property, facilities, laboratories, equipment and certain employees located at 5800 and 5900 Park of Commerce Blvd, Boca Raton, FL, which properties are comprised of two commercial buildings totaling ~126,000 square feet on ~15 acres of land. The buildings house a fully equipped plasma fractionation and purification plant of FDA licensed biologics, testing laboratories, office space, ambient and cold storage warehouses, as well as a commercial scale monoclonal antibody production facility.
- FDA licensed products including Nabi-HB™ (Hepatitis B Immune Globulin, Human) and BIVIGAM™ (Immune Globulin Intravenous, Human).
- Contract manufacturing and services agreement for a third party’s licensed hyperimmune globulin product.
- Biotest will provide ADMA with cash consideration totaling up to $40 million, consisting of a $12.5 million in cash upon closing, a $15 million unsecured subordinated loan at a six (6%) percent per annum interest rate, and interest only through the life of the loan and final principal payment due in full at the end of the five year loan period, along with a firm equity commitment to invest an additional $12.5 million in future equity financings of ADMA. Although there can be no assurances, it is presently anticipated that with ADMA’s cash on hand forecasted at the time of the anticipated closing, plus the contractual capital commitments from Biotest AG, ADMA is expected to have sufficient cash for operations into the second half of 2018, if not longer.
The consideration for the above listed assets, cash and financing commitments to be given by ADMA upon the closing of the proposed transaction includes the following:
- Fifty percent of ADMA’s capital stock, less one share (calculated as of immediately following the closing and on a post-closing issuance basis), consisting of (a) voting common stock equal to 25% of the issued and outstanding common stock of ADMA, and (b) non-voting common stock representing the balance of such 50% equity interest, less one share.
- The right for BPC to designate one director and one observer to ADMA’s Board of Directors.
- ADMA will transfer ownership to BPC of its two wholly-owned plasma centers in Norcross, Georgia and Marietta, Georgia, effective January 1, 2019.
- Biotest AG to maintain its existing distribution rights granted for RI-002 in Europe, Near and Middle East and selected other territories and a right of first offer to BPC for the distribution of potential future ADMA developed plasma based products in the territories.
BPC will be entering into a standstill with ADMA, which will limit BPC’s ability to control the company. BPC will also agree to a six (6) month lock up of the sale of ADMA securities.
The proposed transaction will be further described in more detail in a current report on Form 8-K and also in a proxy statement on Schedule 14A to be filed by ADMA with the United States Securities and Exchange Commission.
Conference Call/Webcast
ADMA will be conducting an investor conference call today at 8:30am ET to discuss this transaction.
| Toll Free: | 800-378-6592 | |||
| International: | 719-457-2695 | |||
| Conference ID: | 4027526 | |||
| Webcast: | http://public.viavid.com/index.php?id=122695 |
Replays, available through January 27:
| Domestic: | 844-512-2921 | |||
| International: | 412-317-6671 | |||
| Replay PIN: | 4027526 |
Advisors
Raymond James & Associates, Inc. has delivered a fairness opinion to ADMA and PJT Partners is serving as strategic and financial advisor to ADMA. Credit Suisse is serving as financial advisor to Biotest AG. Legal counsel for ADMA is Paul, Weiss, Rifkind, Wharton & Garrison LLP and for Biotest AG is Greenberg Traurig, LLP.
About ADMA Biologics, Inc. (ADMA)
ADMA is a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the proposed treatment of Immune Deficiencies and the prevention and treatment of certain infectious diseases. ADMA’s mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. ADMA has received U.S. Patent 9,107,906 relating to certain aspects of its product candidate. For more information, please visit www.admabiologics.com.
About RI-002
ADMA’s lead product candidate, RI-002, is a specialty plasma-derived, polyclonal, intravenous immune globulin (IGIV) derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus (CMV), measles, tetanus, etc.) as well as plasma from donors tested to have high levels of neutralizing antibodies to respiratory syncytial virus (RSV). ADMA is pursuing an indication for the use of this specialty intravenous immune globulin (IGIV) product for treatment of patients diagnosed with PIDD. Polyclonal antibodies are the primary active component of IGIV products. Polyclonal antibodies are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses. Data review indicates that the polyclonal antibodies present in RI-002 support its ability to prevent infections in immune-compromised patients.
About Biotest Pharmaceuticals Corporation
Biotest Pharmaceuticals Corporation is a wholly-owned subsidiary of Biotest AG, a German global provider of plasma products. The company researches, develops and manufactures biotherapeutic plasma protein products, with a specialization in immunology and hematology and is a leader in the collection of source plasma. Biotest Pharmaceuticals owns and manages plasmapheresis centers across the United States and operates a state-of-the-art manufacturing facility in Boca Raton, Florida. Biotest Pharmaceuticals is committed to serving the thousands of patients worldwide who rely on plasma-based therapies. Biotest Pharmaceuticals’ team of over 1,000 employees is part of Biotest AG’s global workforce of more than 2,500 associates worldwide. To learn more about Biotest Pharmaceuticals, its Plasma Centers, and the difference they make in the lives of patients and the healthcare community, please visit them at www.biotestpharma.com and www.biotestplasma.com.
About Biotest AG
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 2,500 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Additional Information and Where to Find It
This document is for informational purposes only and is neither an offer to purchase or sell nor a solicitation of a proxy with respect to any common shares of ADMA or any other securities. A proxy statement on Schedule 14A, including related documents, will be filed with the United States Securities and Exchange Commission (the “SEC”) by ADMA. THE PROXY STATEMENT ON SCHEDULE 14A AND RELATED MATERALS FILED WITH THE SEC WILL CONTAIN IMPORTANT INFORMATION. SHAREHOLDERS OF ADMA ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT SUCH HOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING THE TRANSACTION DESCRIBED HEREIN. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the ADMA representative that will be named in the proxy statement on Schedule 14A.
Participants in the Solicitation
ADMA Biologics, Inc. and its directors and certain executive officers; ADMA BioManufacturing, LLC; Aisling Capital II, LP; Biomark Capital Management Co. LLC; Maggro, LLC; The Genesis Foundation; Hariden, LLC; Biotest AG; Biotest Pharmaceuticals Corporation; and Biotest US Corporation may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction described herein. Information regarding persons who may be deemed to be participants (including descriptions of their interests, by security holdings or otherwise) is contained in: ADMA Biologics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 23, 2016 (SEC File No. 001-36728); ADMA Biologics, Inc.’s 2016 annual meeting definitive proxy statement on Schedule 14A, filed with the SEC on April 29, 2016; and subsequent SEC filings made by such persons, including more complete descriptions that will be available for review in a proxy statement on Schedule 14A which ADMA Biologics, Inc. plans to file with the SEC and provide to its stockholders in connection with the proposed transaction.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate,” “intend,” “target,” “will,” “is likely,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements concerning our ability to develop, manufacture, and commercialize specialty plasma-based biologics for the proposed treatment of immune deficiencies and the prevention of certain infectious diseases, the success of our work with our third party vendors and the U.S. Food and Drug Administration in furtherance of and progress towards an approval of our Biologics License Application for specialty plasma-based biologics and the ability of such third parties to respond adequately or in a timely manner to the issues raised by the FDA, our ability to successfully pursue commercialization and prelaunch activities, the timeframe within which we may receive approval from the FDA for specialty plasma-based biologics, if at all, the potential of our specialty plasma-based biologics to provide meaningful clinical improvement for patients living with PIDD or other indications and our ability to realize increased prices for plasma growth in the plasma collection industry. These forward-looking statements also involve risks and uncertainties concerning our ability to complete and close the proposed transaction described herein, the expected closing date of such transaction, the anticipated benefits and synergies of such transaction, anticipated future combined businesses, operations, products and services, and liquidity, debt repayment and capital return expectations. Actual events or results may differ materially from those described in this document due to a number of important factors. These factors include, among others, the outcome of regulatory reviews of the proposed transaction; the ability of the parties to complete the transaction; the ability of ADMA to successfully integrate the therapy business of BPC, operations (including manufacturing and supply operations), sales and distribution channels, business and financial systems and infrastructures, research and development, technologies, products, services and employees; the ability of the parties to retain their customers and suppliers; the ability of the parties to minimize the diversion of their managements’ attention from ongoing business matters; ADMA’s ability to manage the increased scale, complexity and globalization of its business, operations and employee base post-closing; and other risks detailed in ADMA’s filings with the SEC, including those discussed in ADMA’s most recent Annual Report on Form 10-K and in any subsequent periodic reports on Form 10-Q and Form 8-K, and any amendments thereto, each of which is on file with the SEC and available at the SEC’s website at www.sec.gov. SEC filings for ADMA are also available in the Investor Relations section of ADMA’s website at www.admabiologics.com. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by ADMA or any other person that the objectives and plans of ADMA will be achieved in any specified time frame, if at all. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.
COMPANY CONTACT: Brian Lenz Vice President and Chief Financial Officer |201-478-5552 | www.admabiologics.com INVESTOR RELATIONS CONTACT: Matthew Duffy Managing Director, LifeSci Advisors, LLC | 212-915-0685 |
$BIOL #FDA Clearance, Worldwide Launch #EpicPro™ #Diode #Laser System
New Premium Diode Laser Offers Technological Advances in Laser Dentistry
BIOLASE, Inc., (NASDAQ: BIOL) the global leader in dental lasers, announced today its Epic Pro™ laser system, a new, innovative dental diode laser system that offers higher laser power than most diode lasers in dentistry, has received 510(k) clearance for commercial distribution from the U.S. Food and Drug Administration (FDA). The Epic Pro laser system, which received marketing authorization in select international markets late last year, can now be sold in the U.S.
The newest addition to the Company’s Epic portfolio of soft-tissue diode lasers, Epic Pro offers important advancements in cutting speed, control, precision and improvements in consistency and predictability.
The Epic Pro is the first commercially available laser system resulting from BIOLASE’s strategic development agreement with IPG Medical Corporation, a subsidiary of IPG Photonics Corporation, reached in 2015.
“The collaboration between IPG Medical and BIOLASE has been exciting,” said IPG Medical President Gregory Altshuler, Ph.D. “The Epic Pro with IPG Medical’s super pulse diode laser offers all new computer-controlled thermal super pulsing capability with real-time tip temperature monitoring and automatic power control designed to assist dentists in performing procedures quickly and with great precision. This new feature is a very significant innovation that we believe will provide the technological basis for other clinical modalities.”
BIOLASE President and CEO Harold C. Flynn, Jr. noted that the Company’s worldwide launch is now underway with systems available for delivery in the U.S. and select international markets.
“We are proud to expand the BIOLASE product portfolio by introducing the Epic Pro as our premium diode laser solution. There is nothing else like it on the market,” Flynn said. “The high end capabilities of this new laser, such as its cutting speed, power and control, allow us to access market segments we have not been able to before, such as the oral and maxillofacial surgeon markets, which previously had not been interested in diode lasers. This advanced new laser system also provides us a platform for the future expansion of our capabilities and indications. Epic Pro represents our ongoing commitment to elevating the standard of care in dentistry, and achieving better patient reported outcomes while enabling clinicians to realize better business returns.”
To learn more about Epic Pro visit www.biolase.com
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 and Epic Pro™ is a trademark of BIOLASE, Inc.
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
Lou Beltran
Product Manager
949-226-8116
lbeltran@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
$GLBL Exclusivity Agreement with #BrookfieldAssetManagement
BETHESDA, Md., Jan. 23, 2017 — TerraForm Global, Inc. (Nasdaq:GLBL) (“TerraForm Global” or the “Company”), a global owner and operator of clean energy power plants, today announced that the Company has entered into an exclusivity agreement with Brookfield Asset Management (“Brookfield”) in connection with its previously disclosed strategic alternatives process to maximize shareholder value. Under the exclusivity agreement, the Company has agreed to negotiate exclusively with Brookfield in connection with a potential business combination between the Company and Brookfield until the earlier of the execution of a definitive agreement for such transaction or 11:59 p.m. New York City time on March 6, 2017.
TerraForm Global also noted that, prior to entering into the exclusivity agreement, the Company received a revised bid letter from Brookfield. In its letter, Brookfield proposed four possible transactions, none of which is subject to any financing condition. Under the terms of the consideration, Brookfield would either acquire 100% of the Company for as much as $4.35 per share or replace SunEdison as the Company’s sponsor and purchase 50.1% of the Company’s outstanding shares for as much as $4.25 per share. However, any aggregate amounts payable to the Company’s shareholders will reflect the terms of a final settlement agreement, if any, between the Company and SunEdison as described below. The terms of any such final settlement agreement may cause any amounts payable in a transaction for all or part of the Company to differ materially from those described above.
Brookfield’s proposals are subject to certain conditions, including the satisfactory completion of confirmatory due diligence and the negotiation of mutually acceptable definitive transaction documentation, which addresses, among other things, the treatment of potential liabilities previously disclosed by the Company, a voting and support agreement with SunEdison and the negotiation of a comprehensive settlement agreement between the Company and SunEdison that is acceptable to Brookfield.
There is no assurance that the Company and Brookfield will enter into a definitive agreement for a potential transaction and there is no assurance as to the form, terms or timing of any transaction even if an agreement is reached between the parties. The final form and terms of any such transaction, including any consideration ultimately received by the Company’s shareholders in such transaction, and any conditions to closing, may be materially different from the terms under Brookfield’s proposals described above.
Settlement Discussions with SunEdison, Inc.
As previously disclosed, TerraForm Global has been engaged in settlement discussions with SunEdison, Inc. (“SunEdison”) as part of its ongoing strategic alternatives process, and announced today that it has entered into a memorandum of understanding (the “MOU”) with SunEdison. The MOU outlines potential separate settlements of claims between SunEdison and the Company and SunEdison and TerraForm Power, Inc. (Nasdaq:TERP) (“TerraForm Power”) in connection with the Chapter 11 bankruptcy case of SunEdison (the “SunEdison Bankruptcy”). The Company’s Board of Directors approved the MOU upon the recommendation of its independent members who do not also serve on the Board of Directors of TerraForm Power. The settlements of the intercompany claims are subject to the approval of the U.S bankruptcy court overseeing the SunEdison Chapter 11 cases.
The MOU contains certain non-binding proposed settlement terms to resolve the complex legal relationship between the Company and SunEdison, including, among other things, an allocation of the total consideration paid in connection with a transaction for all or part of TerraForm Global and, with certain exceptions, the full mutual release of all claims of SunEdison and its affiliated debtors and non-debtors. Under the proposed settlement terms, SunEdison would receive consideration equal to 25% of the total consideration paid to all of the Company’s shareholders, reflecting the settlement of intercompany claims, cancelation of incentive distribution rights and other factors considered by the Company’s Board of Directors. The remaining consideration would be distributed to holders of shares of the Class A common stock of the Company.
In addition, under the MOU, TerraForm Global and SunEdison will work toward the terms of an agreement for a sale of all or part of the Company, provided that the final settlement agreement is reached on or before January 27, 2017. Any transaction will be jointly approved by both TerraForm Global and SunEdison.
The proposed terms are not legally binding on any party to the MOU and are subject to a number of conditions and contingencies, including TerraForm Global entering into a transaction jointly approved by the Company and SunEdison, TerraForm Power entering into a transaction jointly approved by TerraForm Power and SunEdison and approval by the Bankruptcy Court by April 1, 2017 of the settlement agreements involving SunEdison and each of the Company and TerraForm Power.
Additional information about the agreements described herein can be found in the Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission on January 23, 2017. A copy of the filing is available on the Investors page of TerraForm Global’s website at http://www.terraformglobal.com.
TerraForm Global has engaged Centerview Partners, Greentech Capital Advisors and AlixPartners as financial advisors and Sullivan & Cromwell LLP as its legal advisor.
About TerraForm Global
TerraForm Global is a renewable energy company that is changing how energy is generated, distributed and owned. TerraForm Global creates value for its investors by owning and operating clean energy power plants in high-growth emerging markets. For more information about TerraForm Global, please visit: www.terraformglobal.com.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information in this press release, this press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. These statements involve estimates, expectations, projections, goals, assumptions, known and unknown risks, and uncertainties and typically include words or variations of words such as “expect,” “anticipate,” “believe,” “intend,” “plan,” “seek,” “estimate,” “predict,” “project,” “goal,” “guidance,” “outlook,” “objective,” “forecast,” “target,” “potential,” “continue,” “would,” “will,” “should,” “could,” or “may” or other comparable terms and phrases.
They include, without limitation, statements relating to TerraForm Global, TerraForm Power and SunEdison entering into settlement agreements; TerraForm Power, TerraForm Global and SunEdison documenting or entering into an agreement for the sale of all or part of the Company or TerraForm Power; the proposed terms and timing of any settlement agreement (including the proposed allocation of the total consideration paid in connection with a transaction for all or part of the Company or TerraForm Power and the mutual release of claims of SunEdison, TerraForm Power and TerraForm Global); the contingencies relating to approval of any settlement of claims between TerraForm Power, TerraForm Global and SunEdison, including approval by the bankruptcy court in the SunEdison Bankruptcy; proposals for a sale of the Company to Brookfield; and the form, terms and timing of a transaction, if any, between the Company (or the Company and TerraForm Power) and Brookfield, including the proposed consideration to be received from such transaction. These forward-looking statements are based on current expectations as of the date of this press release and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including but not limited to: whether and when TerraForm Power, TerraForm Global and SunEdison are able to reach definitive settlement agreements, the terms of any such settlement agreements, whether the bankruptcy court in the SunEdison Bankruptcy would approve the terms of any such settlement agreement, whether any interested party in the SunEdison Bankruptcy would contest the terms of any such settlement agreement, whether and when the Company (or the Company and TerraForm Power) and Brookfield are able to reach an agreement for a sale of the Company (or the Company and TerraForm Power); the terms of any such agreement; whether any such agreement would be approved by the necessary parties, as well as additional factors we have described in other filings with the Securities and Exchange Commission.
The risks included above are not exhaustive. Other factors that could adversely affect our business and prospects are described in the filings made by us with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.
Contacts: Investors: Brett Prior TerraForm Global investors@terraform.com Media: Meaghan Repko / Joseph Sala / Nicholas Leasure Joele Frank, Wilkinson Brimmer Katcher media@terraform.com (212) 355-4449
$HMNY Names Chairman #TheodoreFarnsworth as #CEO
Former CEO, Pat Krishnan, to lead all technology operations as Chief Innovation Officer
MIAMI and NEW YORK, Jan. 23, 2017 — Helios and Matheson Analytics Inc. (NASDAQ: HMNY) today announced that Theodore Farnsworth, HMNY’s Chairman of the Board, has been appointed as HMNY’s Chief Executive Officer. Farnsworth, founder of HMNY’s subsidiary, Zone Technologies, Inc., and creator of the RedZone Map smartphone app, is assuming the chief executive role of HMNY from Pat Krishnan, who is moving into the newly created position of Chief Innovation Officer.
“The integration of HMNY and RedZone is continuing at a rapid pace. I am thrilled to take on the chief executive role at HMNY, allowing Pat to focus on being our technology visionary while I focus on growing the company and RedZone’s reach,” said Farnsworth. “It’s important to make these changes now in order to fulfill the company’s overall vision, as well as its current and future technology needs,” continued Farnsworth.
As both Chairman and Chief Executive Officer, Farnsworth will lead the company’s strategic direction and all day-to-day operations. Mr. Krishnan will drive many technology-related functions of the company, including initiatives related to artificial intelligence and social listening. As Chief Innovation Officer, Mr. Krishnan will be assuming management of RedZone’s worldwide technology functions in the United States (Miami, New York and Silicon Valley), India and Israel.
“Being able to dedicate my full time and attention to the company’s technology innovation and development will put us on the fast track,” said Krishnan. “I believe doing so will enable us to accelerate our proprietary technology output and pursue the further incorporation of predictive analytics, computer learning and artificial intelligence into our RedZone Map application.”
About Helios and Matheson
Helios and Matheson Analytics Inc. (NASDAQ: HMNY) provides information technology consulting, training services, software products and an enhanced suite of services of predictive analytics. With its client roster including Fortune 500 corporations, HMNY focuses mainly on the BFSI and Technology verticals. HMNY’s solutions cover the entire spectrum of IT needs, including applications, data, and infrastructure. HMNY is headquartered in New York, NY and listed on the NASDAQ Capital Market under the symbol HMNY. For more information, visit us www.hmny.com.
About RedZone Map
RedZone (Zone Technologies, Inc.) is a state-of-the-art mapping and spatial analysis company with operations in the U.S. and Israel. Its eye-opening safety map app enhances mobile GPS navigation by providing advanced proprietary technology to guide travelers to their destinations while avoiding risky areas deemed “red zones,” due to high groupings of crime data, with safer routes generally 15% longer. More than that, the app incorporates a social media component allowing for real-time “It’s happening now” crime reporting coupled with real time data from over 1,400 local, state, national and global sources. Currently available to iOS and Android users. More information is available on the RedZone Map website.
Cautionary Statement on Forward-looking Information
Certain statements in this communication contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this communication are forward-looking statements.
Such forward-looking statements are based on a number of assumptions. Although HMNY’s management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Risk factors and other material information concerning HMNY are described in its Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2015, its registration statement on Form S-3 declared effective on January 13, 2017 and other filings, including subsequent current and periodic reports and registration statements, filed with the U.S. Securities and Exchange Commission. You are cautioned to review such reports and other filings at www.sec.gov.
Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on HMNY’s current expectations and HMNY does not undertake an obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.
Media Contact:
Ashley Boarman
Landis Communications
(415) 359-2312
redzone@landispr.com
$MRNS Positive Preliminary Data From Children With #CDKL5 Genetic Disorder
Plans to Apply for Orphan Drug Designation
RADNOR, Pa., Jan. 23, 2017 — Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), today announced positive preliminary data from the initial CDKL5 patients enrolled in its ongoing Phase 2 open-label study evaluating its CNS-selective GABAA modulator, ganaxolone, as a treatment for orphan, genetic disorders. CDKL5 is a severe, rare genetic disorder that results in early-onset, difficult-to-control seizures, and neuro-developmental impairment. Enrollment is continuing in the study with top-line data expected in mid-2017.
Four patients have been enrolled in this cohort of the study and received up to 1800 mg/kg of ganaxolone per day for an average treatment duration of five-months. Three of the four patients experienced a notable reduction in seizure frequency compared to baseline ranging from 52% to 88%. All responders continue to receive treatment, two of whom have completed six-months of treatment and have elected to participate in the study extension. One patient discontinued the study after four-months of treatment due to lack of efficacy. Safety data to date are consistent with earlier studies where ganaxolone has shown to be generally safe and well-tolerated.
“We are encouraged by the results in these difficult-to-treat pediatric patients,” commented Dr. Jaakko Lappalainen, Vice President of Clinical Development of Marinus Pharmaceuticals. “Concurrent with completing this study, we will be evaluating the potential for breakthrough therapy and applying for orphan drug designation with the United States Food and Drug Administration. CDKL5 pediatric epilepsy may prove to be an attractive and efficient path for ganaxolone and we look forward to evaluating results from the final patients enrolled in this cohort of the study.”
Michael G. Chez, MD, Director of Pediatric Neurology Research and Pediatric Epilepsy, Sutter Neuroscience Institute in Sacramento, CA commented, “I am impressed with the responder rate and magnitude of seizure control seen with ganaxolone in the initial CDKL5 patients. The CGIs (clinical global impression scales) are consistent with seizure control, with responders showing ‘much improved’ under this scale. I look forward to further evaluating these children and seeing the final results.”
At the annual meeting of the American Epilepsy Society, Dr. Chez presented EEG data from one CDKL5 and two PCDH19 patients that he treated with ganaxolone in the on-going Phase 2 open-label study. The patients received up to 1800 mg/day of ganaxolone. EEG measurements were taken at baseline and followed-up at 8-12 weeks of treatment.
The CDKL5 patient showed a >67% seizure reduction and EEG changes consistent with clinical improvement (50% reduction in awake slow-spike wave discharges). The two patients with PCDH19 showed an 80% and 75% reduction in seizure frequency, respectively, and EEG improvement in slow-spike and wave frequency of >90% and 80% on awake and asleep EEG.
This Phase 2 open-label trial is currently accepting patients at five sites in the United States and one in Italy. The multi-cohort study is designed to enroll up to 10 patients with each of CDKL5 disorder, Lennox Gastaut Syndrome (LGS) and PCDH19 pediatric epilepsy. The study is actively recruiting CDKL5 and LGS patients. The PCDH19 cohort of the study is currently closed for enrollment, however, there are still children receiving ganaxolone in the study extension. For more information about the study visit clinicaltrials.gov.
About CDKL5 Disorder
CDKL5 is a serious and rare genetic disorder that is caused by a mutation of the cyclin-dependent kinase-like 5 (CDKL5) gene, located on the X chromosome. It predominantly affects girls and is characterized by early-onset, difficult-to-control seizures and severe neuro‑developmental impairment. The CDKL5 gene encodes proteins essential for normal brain function. Most children affected by CDKL5 cannot walk, talk, or care for themselves. Many also suffer from scoliosis, visual impairment, gastrointestinal difficulties, and sleeping disorders. Currently, there are no approved therapies for CDKL5 disorder. No previous formal clinical trials have been conducted in this population.
About Ganaxolone
Ganaxolone is a CNS-selective GABAA modulator being developed in three different dose forms (IV, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone acts on a well-characterized synaptic and extrasynaptic GABAA target known for its anti-seizure and anti-anxiety activity. Ganaxolone has been studied in more than 1,400 subjects, both pediatric and adult, at therapeutically relevant dose levels and treatment regimens for up to two years. In these studies, ganaxolone was generally safe and well tolerated, with the most commonly reported adverse events of somnolence, dizziness and fatigue.
About Marinus Pharmaceuticals
Marinus Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development of ganaxolone, which offers a new mechanism of action, demonstrated efficacy and safety and convenient dosing, to improve the lives of patients suffering from epilepsy and neuropsychiatric disorders. Ganaxolone is a CNS-selective GABAA modulator that acts on a well-characterized target in the brain known to have both anti-seizure and anti-anxiety effects. Ganaxolone is being developed in three different dose forms (IV, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. Marinus is currently evaluating ganaxolone in orphan pediatric indications for the treatment of genetic seizure and behavior disorders, and preparing to initiate Phase 2 studies in status epilepticus, an orphan indication, and postpartum depression. For more information visit www.marinuspharma.com.
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Marinus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “expect”, “anticipate”, “estimate”, “intend”, “believe”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding our interpretation of clinical and preclinical studies, assessment of positive nature and notability of preliminary data, development plans for our product candidate, including the development of dose forms, the clinical trial testing schedule and milestones, the ability to complete enrollment in our clinical trials, interpretation of scientific basis for ganaxolone use, timing for availability and release of data, the safety, potential efficacy and therapeutic potential of our product candidate and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical trials, the timing of the clinical trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters, including the development of formulations of ganaxolone, that could affect the availability or commercial potential of our drug candidates. Marinus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see filings Marinus has made with the Securities and Exchange Commission.
CONTACT: Company: Lisa M. Caperelli Senior Director, Investor Relations & Corporate Communications Marinus Pharmaceuticals, Inc. 484-801-4674 lcaperelli@marinuspharma.com
$CIIX Covered in New Report from WallStreet Research™
Before the opening bell, top-ranked independent research firm WallStreet Research™ (WSR) announced the release of a Corporate Profile Analyst Report covering ChineseInvestors.com, Inc. (OTCQB: CIIX). In addition to highlighting CIIX’s ongoing operations, including both its efforts to provide a range of financial information to the global Chinese population via www.Chinesefn.com and its preparations to capitalize on the thriving market for cannabidiol-based products through its www.ChineseCBDoil.com website, the WSR report gives prospective investors some additional insight into the tremendous growth opportunities presented by the company’s evolving strategy.
“The Company’s recent announcements regarding expansion into the medical marijuana and CBD oil industry has driven great interest in CIIX shares,” Alan Stone, managing director of WSR, stated in this morning’s news release. “As a result, the shares have significantly increased in both market value and trading volume, potentially positioning the company for a listing either on the NASDAQ or the NYSE Markets sometime later in 2017.”
In recent weeks, CIIX has made considerable progress toward the impending launch of its operations in the emerging global cannabis industry. Last month, the company announced a new partnership with a well-known cannabidiol (CBD) health brand that will enable CIIX to retail nutritional supplements containing CBD to the Asian market through both online and in-store distribution channels. Shortly after that announcement, CIIX unveiled plans to launch the world’s first CBD health products online store available in the Chinese language by the end of January 2017. The headquarters for this operation will be located in Shanghai, and the company has already outlined plans to create a wholly-owned subsidiary within the Shanghai Free Trade Zone with the sole focus of supplying CBD-based health products to the expansive worldwide Chinese population.
This morning’s release of a research report from WSR came just days after the release of a similar update from Traders News Source (TNS), an equity research firm specializing in small and micro-cap securities. The TNS report also placed a great deal of focus on CIIX’s recent entry into the cannabis industry through www.ChineseCBDoil.com. The firm notes that, while marijuana use is currently illegal in the People’s Republic of China, cannabis-based oils are legal, providing a potential market for CIIX that includes well over one billion people in China alone.
For more information, visit www.ChineseInvestors.com
$CNCE #FDA #OrphanDrug Designation for #CTP656 in #CysticFibrosis
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for CTP-656, Concert’s next generation CFTR potentiator being developed for the treatment of cystic fibrosis. In December 2016, Concert initiated a Phase 2 trial in the U.S. evaluating CTP-656 in cystic fibrosis patients with gating mutations. Topline results from the Phase 2 trial are expected by year-end 2017.
“Receiving orphan drug designation is an important regulatory milestone, and we are pleased that CTP-656 for cystic fibrosis has been granted this status,” said Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We are developing CTP-656 to potentially offer advantages over standard of care, and our team is committed to advancing the clinical development program to address the unmet needs of individuals with cystic fibrosis.”
The Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people in the United States. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval.
About CTP-656 and Cystic Fibrosis
CTP-656 is a novel CFTR potentiator that may offer next generation, once-daily dosing and was developed by Concert’s novel application of deuterium chemistry to modify ivacaftor. Ivacaftor is marketed by Vertex Pharmaceuticals under the brand name Kalydeco. Concert is initially developing CTP-656 as a potential monotherapy treatment for cystic fibrosis due to gating mutations of the gene that encodes for cystic fibrosis transmembrane conductance regulator (CFTR), a protein, which regulates components of sweat, mucus clearance and digestion. The Company also intends to enable potentially more effective combinations to treat other mutations, including homozygous F508del, by partnering with other potentially complementary CFTR modulators.
Cystic fibrosis is a life-threatening, hereditary genetic disease that has systemic effects and can cause significantly reduced lung and digestive system function. According to the Cystic Fibrosis Foundation, an estimated 70,000 people worldwide have cystic fibrosis.
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical company focused on applying its DCE Platform® (deuterated chemical entity platform) to create novel medicines designed to address unmet patient needs. The Company’s approach starts with approved drugs in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy. Concert has a broad pipeline of innovative medicines targeting pulmonary diseases, including cystic fibrosis, central nervous systems (CNS) disorders, as well as autoimmune and inflammatory diseases. For more information please visit www.concertpharma.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements about clinical development of CTP-656 and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, whether orphan drug status will be granted and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and in other filings that we make with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.
Concert Pharmaceuticals, Inc.
Justine E. Koenigsberg (Investors), 781-674-5284
ir@concertpharma.com
or
The Yates Network
Kathryn Morris (Media), 845-635-9828
$CCLP Announces Quarterly Distribution, #Q4 Results Schedule
MIDLAND, Texas, Jan. 20, 2017 — CSI Compressco LP (“CSI Compressco”) (NASDAQ: CCLP) today announced that the board of directors of its general partner has declared a cash distribution attributable to the quarter ended December 31, 2016 of $0.3775 per outstanding common unit, which is equal to the previous quarterly distribution, or $1.51 per outstanding common unit on an annualized basis. This cash distribution will be paid on February 14, 2017 to all common unitholders of record as of the close of business on February 1, 2017.
CSI Compressco expects to release its fourth quarter 2016 earnings results on Tuesday, February 28, 2017 and will host a conference call at 10:30 a.m. Eastern Time on that day to discuss the earnings results. The phone number for the call is 1-866-374-8397. The conference will also be available by live audio webcast and may be accessed through CSI Compressco’s website at www.csicompressco.com. The earnings press release will be available on CSI Compressco’s website prior to the conference call. A replay of the call will be available at 1-877-344-7529, conference number 10100208, for one week following the conference, and the archived webcast will be available through CSI Compressco’s website for thirty days following the conference.
About CSI Compressco
CSI Compressco is a provider of compression services and equipment for natural gas and oil production, gathering, transportation, processing, and storage. CSI Compressco’s compression and related services business includes a fleet of approximately 6,000 compressor packages and in excess of 1.1 million in aggregate horsepower, utilizing a full spectrum of low-, medium-, and high-horsepower engines. CSI Compressco also provides well monitoring and automated sand separation services in conjunction with compression services in Mexico. CSI Compressco’s equipment sales business includes the fabrication and sale of standard compressor packages, custom-designed compressor packages, and oilfield fluid pump systems designed and fabricated primarily at our facility in Midland, Texas. CSI Compressco’s aftermarket business provides compressor package reconfiguration and maintenance services as well as the sale of compressor package parts and components manufactured by third-party suppliers. CSI Compressco’s customers comprise a broad base of natural gas and oil exploration and production, mid-stream, transmission, and storage companies operating throughout many of the onshore producing regions of the United States as well as in a number of foreign countries, including Mexico, Canada, and Argentina. CSI Compressco is managed by CSI Compressco GP Inc., which is an indirect, wholly owned subsidiary of TETRA Technologies, Inc.(NYSE: TTI).
$LSXMB Prices #PrivateOffering, $400M of 1% Cash Convertible Senior Notes due 2023
Liberty Media Corporation (“Liberty”) (Nasdaq: LSXMA, LSXMB, LSXMK, BATRA, BATRK, LMCA, LMCK) announced today that it has priced and agreed to sell to initial purchasers in a private offering $400,000,000 aggregate principal amount of its 1.0% cash convertible senior notes due 2023 (the “notes”).
Liberty has granted to the initial purchasers an option to purchase additional notes with an aggregate principal amount of up to $50,000,000. The notes will mature on January 30, 2023 and will be convertible, under certain circumstances, into cash based on the trading prices of the underlying shares of Series C Liberty Media common stock (“LMCK”). The initial conversion rate for the notes will be 27.1091 shares of LMCK per $1,000 principal amount of notes, equivalent to an initial conversion price of approximately $36.89 per share of LMCK. All conversions of notes will be settled in cash, and not through the delivery of any securities.
The offering is expected to close on January 23, 2017, subject to the satisfaction of customary closing conditions.
Liberty expects to use the net proceeds of the offering to fund an increase to the cash consideration payable to the selling shareholders (the “Selling Shareholders”) of Formula 1 (“F1”) by $400 million and retain in treasury the approximately 19 million shares that would otherwise have been issuable to the Selling Shareholders based on the per share purchase price of $21.26. These LMCK shares will be reserved by Liberty for issuance to the F1 teams at a per share purchase price of $21.26. The aggregate number of LMCK shares to be issued at the F1 closing will not change as a result of this transaction. Only the allocation of the 138 million shares will change as follows: approximately 57 million to the Selling Shareholders, approximately 62 million to the third party investors and approximately 19 million into treasury. To the extent such shares are not issued to the F1 teams within six months following the closing of the acquisition, which is expected to occur this month, the shares will be retired. If the initial purchasers exercise their option to purchase additional notes, net proceeds raised from the issuance of such additional notes will be attributed to the Liberty Media Group balance sheet as cash. If the acquisition of F1 is not completed, Liberty will use the net proceeds from this offering for general corporate purposes, which may include capital expenditures, acquisitions, working capital, repayment of debt and repurchases of common stock. Pending the completion of the F1 acquisition or other such uses, Liberty intends to invest the net proceeds in cash equivalents or short-term investments.
Following the completion of the F1 acquisition and the financing described above, approximate ownership of the equity of the Liberty Media Group (to be renamed the Formula One Group) will be comprised of (1): 33% owned by the Selling Shareholders, 28% owned by the third party investors pursuant to an agreement with Liberty announced on December 14, 2016 and 38% owned by existing Liberty Media Group shareholders.
The notes, as well as the associated cash proceeds, will be attributed to the Liberty Media Group. Pro forma for this financing and the closing of the F1 acquisition, total debt attributed to the Liberty Media Group will include the proposed $450 million cash convertible senior notes due 2023 (assuming the exercise in full of the initial purchasers’ option to purchase additional notes), $1 billion 1.375% convertible notes due 2023, $445 million Time Warner Inc. exchangeable debentures due 2046, $350 million drawn under a Live Nation margin loan, $36 million of other corporate level debt as of September 30, 2016 and approximately $4.1 billion of existing F1 debt as of July 31, 2016.
The notes have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. The notes are being offered by means of an offering memorandum solely to “Qualified Institutional Buyers” pursuant to, and as that term is defined in, Rule 144A of the Securities Act.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the notes nor shall there be any sale of notes in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.
Forward-Looking Statements
This press release includes certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the intended launch of a private offering of notes and the use of proceeds therefrom. These forward-looking statements involve many risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including, without limitation, general market conditions. These forward-looking statements speak only as of the date of this press release, and Liberty expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in Liberty’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. Please refer to the publicly filed documents of Liberty, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, for risks and uncertainties related to Liberty’s business which may affect the statements made in this press release.
About Liberty Media Corporation
Liberty Media Corporation operates and owns interests in a broad range of media, communications and entertainment businesses. Those businesses are attributed to three tracking stock groups: the Liberty SiriusXM Group, the Braves Group and the Liberty Media Group. The businesses and assets attributed to the Liberty SiriusXM Group (Nasdaq: LSXMA, LSXMB, LSXMK) include our interest in SiriusXM. The businesses and assets attributed to the Braves Group (Nasdaq: BATRA, BATRK) include our subsidiary Braves Holdings, LLC. The businesses and assets attributed to the Liberty Media Group (Nasdaq: LMCA, LMCK) consist of all of Liberty Media Corporation’s businesses and assets other than those attributed to the Liberty SiriusXM Group and the Braves Group, including its interests in Live Nation Entertainment and Formula 1, and minority equity investments in Time Warner Inc. and Viacom.
(1) Ownership percentages (i) are calculated based on the undiluted share count as of 10/31/2016, (ii) include the dilutive impact of the $351 million Exchangeable Notes to be issued in connection with the proposed F1 acquisition and (iii) exclude the approximately 19 million LMCK shares to be held in Treasury and not outstanding as of the closing of the F1 acquisition. Percentages do not sum to 100 due to rounding.
Liberty Media Corporation
Courtnee Chun, 720-875-5420
$NAME #Rightside Sale of #eNom to #Tucows $TCX
KIRKLAND, Wash., Jan. 20, 2017 — Rightside Group, Ltd. (Nasdaq:NAME), a leading provider of domain name services that advance the way businesses and consumers define and present themselves online, today announced that it has signed a definitive agreement for the sale of eNom to Tucows Inc. (Nasdaq:TCX) for $83.5 million, less a net working capital adjustment of $6.8 million, resulting in net cash at closing of $76.7 million. The eNom business is a leading wholesale registrar that provides domain services to a network of over 28,000 resellers. The agreement sharpens Rightside’s focus on its Registry and retail Registrar businesses, and provides additional capital to drive growth and enhance shareholder value. The transaction is expected to close later today.
Rightside recently conducted an extensive strategic review and concluded that while it is in a strong position to leverage the global trends in the domain industry, it would further benefit from divesting eNom in order to place a greater focus on its higher growth and higher margin Registry and retail Registrar businesses. The divestiture is consistent with Rightside’s strategy to position its portfolio of new generic Top Level Domains (new gTLDs) for long-term growth by leveraging the end-to-end domain services offered by Rightside through the vertical integration of its flagship retail registrar, Name.com, and its Registry business. The divestiture also enhances Rightside’s ability to make additional investments in the Registry business as the market for new domains continues to develop.
“The divestiture of eNom creates a stronger alignment between Rightside’s vision, strategy and financial profile and we believe this is the best way to increase shareholder value,” said Chief Executive Officer Taryn Naidu. “The market for new gTLDs is rapidly developing and the divestiture enables us to more intensely focus on our higher growth and higher margin businesses, where our Registry and Name.com businesses are leading the way with the new domains.”
“We would like to thank our eNom colleagues for their hard work in building such a well-respected business and for their dedication to Rightside. We look forward to seeing their continued success and continuing to work with eNom as a valuable distribution partner as part of Tucows,” added Naidu.
“eNom is one of the great and long-lived brands in the domain industry, with an outstanding reputation among its large network of resellers,” said Elliot Noss, President and Chief Executive Officer of Tucows. “We welcome eNom’s talented team into the Tucows family as they continue to deliver innovative products and excellent service to resellers and end-customers.”
eNom has approximately 14.5 million domains under management and generated approximately $116.5 million in revenue through Q3 2016, primarily from its wholesale registrar business. As part of Tucows, eNom will continue to be a distribution partner for Rightside’s new gTLDs.
Rightside will receive $76.7 million of net cash proceeds from the transaction, net of working capital adjustments. Concurrent with close, Rightside will pay approximately $4 million of transaction related expenses and will repay all of the debt outstanding under its credit facility. Following the transaction, Rightside will be in a strong financial position with approximately $90 million in cash on its balance sheet.
Rightside has hired Barclays Capital Inc. as its financial advisor and Wilson Sonsini Goodrich & Rosati, P.C. as its legal advisor on this transaction. Following this transaction, Rightside will continue to evaluate strategic options, including the potential use of proceeds from this divestiture.
Conference Call and Webcast
Rightside will host a conference call and audio webcast with investors and analysts Monday, January 23, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time):
- Live conference call: (844) 413-1777 (domestic) or (716) 247-5761 (international)
- Conference call replay available through January 28, 2017: (855) 859-2056 (domestic) or (404) 537-3406 (international)
- Conference ID: 57050879
- Live and archived webcast: http://www.rightside.market
About Rightside
Rightside® inspires and delivers new possibilities for consumers and businesses to define and present themselves online. The company, with its affiliates, is a leading provider of domain name services, offering one of the industry’s most comprehensive platforms for the discovery, registration, usage, and monetization of domain names. Headquartered in Kirkland, WA, Rightside has offices in North America, Europe, and Australia. For more information please visit www.rightside.co.
About Tucows
Tucows is a provider of network access, domain names and other Internet services. Ting (https://ting.com) delivers mobile phone service and fixed Internet access with outstanding customer support. OpenSRS (http://opensrs.com) manages nearly 15 million domain names and millions of value-added services through a global reseller network of over 13,000 web hosts and ISPs. Hover (http://hover.com) makes it easy for individuals and small businesses to manage their domain names and email addresses. More information can be found on Tucows’ corporate website (http://tucows.com).
Cautionary Information Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including, among others, statements regarding expected net cash proceeds from the divestiture of eNom, Rightside’s anticipated use of such cash proceeds, expected benefits from the divestiture, expectations about plans and objectives for future operations after the divestiture, future results of operations and financial position, and the market for gTLDs. Statements containing words such as may, believe, anticipate, expect, intend, plan, project, and estimate or similar expressions constitute forward-looking statements. Statements regarding Rightside’s future performance are based on current expectations, estimates and projections about our industry, financial condition, operating performance and results of operations, including certain assumptions related thereto. Actual results may differ materially from the results predicted, and reported results should not be considered an indication of future performance. Forward-looking statements involve risks, uncertainties and assumptions, including, among others, the risks that are described under the heading “Risk Factors” in Rightside’s periodic reports filed with the Securities and Exchange Commission. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Rightside does not intend to revise or update the information set forth in this press release, except as required by law, and may not provide this type of information in the future.
Investor Contacts The Blueshirt Group Allise Furlani, 212-331-8433, allise@blueshirtgroup.rocks Brinlea Johnson, 212-331-8424, brinlea@blueshirtgroup.rocks
$INFI Presents #Preclinical Data, #Phase1 on #IPI549 at #PI3K Keystone; #Opdivo
– Inhibition of PI3K-Gamma by IPI-549 Can Overcome Tumor Resistance to Checkpoint Inhibitors in Preclinical Models –
CAMBRIDGE, Mass., Jan. 20, 2017 — Today, during a plenary session at the Keystone Symposia Conference, “PI3K Pathways in Immunology, Growth Disorders and Cancer,” Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) presented preclinical data for IPI-549, an oral immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase-gamma (PI3K-gamma). Preclinical data showed that IPI-549 is able to help overcome resistance to checkpoint inhibition by remodeling the immune-suppressive tumor microenvironment primarily through its effects on myeloid cells, a type of cell considered to be involved in suppressing immune response against tumors. Initial Phase 1 monotherapy data from nine patients with advanced solid tumors were also summarized and showed that the safety, pharmacokinetics and pharmacodynamics of IPI-549 monotherapy treatment appeared favorable. IPI-549 is believed to be the only PI3K-gamma inhibitor in clinical development.
These preclinical data provide a compelling rationale for Infinity’s ongoing Phase 1 clinical study designed to evaluate IPI-549 as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors. The combination portion of the Phase 1 study will include patients with non-small cell lung cancer (NSCLC), melanoma, and squamous cell carcinoma of the head and neck (SCCHN) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint therapy. There is a great need for additional treatment options for the growing number of patients living with these cancers, which account for more than 17 percent of all new cancer cases in the U.S.1,2
“While new immunotherapies, such as T cell checkpoint inhibitors, are showing great promise in the treatment of various cancers, there are multiple mechanisms of immune tolerance in tumors. Additional treatment options are needed for patients who relapse or do not respond to currently available therapies,” stated Jeffery Kutok, M.D., Ph.D., vice president of biology and translational science at Infinity Pharmaceuticals and a plenary speaker at the conference. “The data presented suggest that targeting PI3K-gamma by IPI-549 within immune-suppressive myeloid cells in the tumor microenvironment could offer a unique way to both enhance the activity of checkpoint inhibition in sensitive tumors, as well as to overcome tumor resistance to checkpoint inhibition. Infinity is excited to be at the forefront of developing a potentially transformative approach within immuno-oncology, and we look forward to reporting additional data from our Phase 1 study of IPI-549 later this year.”
The tumor microenvironment, or TME, refers to the non-cancerous cells present in the tumor. Cells within the TME, including immune-suppressive myeloid cells, can provide growth signals to tumor cells, as well as signals that inhibit an anti-tumor immune response. The presence of the supportive TME is believed to be one reason why some cancer therapies do not provide durable or effective results. Targeting the immune-suppressive myeloid cells represents an emerging approach within the field of cancer immunotherapy, and inhibition of PI3K-gamma represents a novel approach to targeting the immune-suppressive microenvironment.
Summary of Today’s Presentation
In a presentation entitled “The PI3K-gamma inhibitor, IPI-549, increases antitumor immunity by targeting tumor-associated myeloid cells and overcomes immune checkpoint blockade resistance in preclinical models,” Dr. Kutok reviewed data previously published in two Nature articles3,4 and presented at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference.5,6
Preclinical data showed that macrophage PI3K-gamma signaling promotes immune suppression by inhibiting activation of anti-tumor T cells. Blocking PI3K-gamma activated the immune response and significantly suppressed growth of tumors in preclinical models. These data demonstrate that PI3K-gamma plays a key role in cancer growth and also help to further elucidate the mechanism of action for IPI-549.
Preclinical data also demonstrated that resistance to immune checkpoint blockade is directly mediated by the suppressive activity of tumor-infiltrating myeloid cells in a number of preclinical tumor models and confirmed that immune-suppressive myeloid cells play a critical role in resistance to checkpoint inhibitors. Furthermore, the data showed that inhibition of PI3K-gamma by IPI-549 switched the activation of myeloid cells from an immune-suppressive state to a pro-inflammatory state, leading to enhanced anti-tumor cytotoxic T cell activity, particularly when combined with checkpoint inhibitors. Thus, in preclinical models, IPI-549 treatment is able to overcome resistance to checkpoint inhibition. These findings provide further rationale for the ongoing Phase 1 study of IPI-549 in combination with checkpoint inhibitors.
Phase 1 clinical data from nine patients treated with IPI-549 administered as a monotherapy at doses ranging from 10 mg once daily (QD) to 20 mg QD were also summarized during the presentation. As of the September 2016 data cutoff, no dose limiting toxicities and no serious adverse events were observed. Pharmacokinetic and pharmacodynamic data supported once daily dosing of IPI-549 based on the observed half-life and inhibition of the PI3K-gamma pathway.
About the IPI-549 Phase 1 Study
The ongoing Phase 1 clinical study of IPI-549 is designed to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo® in patients with advanced solid tumors. The study includes monotherapy and combination dose-escalation phases, in addition to expansion cohorts, and is expected to enroll approximately 175 patients.
The IPI-549 monotherapy dose-escalation phase is expected to be completed in the first half of 2017, and the monotherapy expansion phase in patients with advanced solid tumors is anticipated to begin in the second half of the year. Once the dose-escalation phase evaluating IPI-549 plus Opdivo is completed, an expansion phase is planned to evaluate the combination in patients with select solid tumors, including non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). Patients enrolled in expansion cohorts evaluating IPI-549 plus Opdivo represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study.
About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 increases antitumor immunity by targeting tumor-associated myeloid cells and overcomes immune checkpoint blockade resistance in preclinical tumor models. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors. A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing.7
IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Infinity
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is developing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study in patients with advanced solid tumors is ongoing. For more information on Infinity, please refer to Infinity’s website at www.infi.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 including those regarding the company’s expectations about the timing and type of data presentations, the therapeutic potential of PI3K-gamma inhibition and of IPI-549, alone or in combination with other agents, clinical trial plans regarding IPI-549. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations, including, for example, that there is no guarantee that IPI-549 will successfully complete necessary preclinical and clinical development phases, or gain regulatory approval, and other risks described in greater detail under the caption “Risk Factors” included in Infinity’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 2016, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
OPDIVO® is a registered trademark of Bristol-Myers Squibb.
Contact:
Jaren Irene Madden, Senior Director, Investor Relations and Corporate Communications
617-453-1336 or Jaren.Madden@infi.com
1 American Cancer Society, Cancer Facts and Statistics 2016, http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index and http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics, Last Accessed September 29, 2016.
2 Conquer Cancer Foundation, Head and Neck Cancer Statistics, http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics, Last Accessed September 29, 2016.
3 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3Kγ is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437–442.
4 De Henau, O., Rausch, M., Winkler, D., Campesato, L., et al. Overcoming resistance to checkpoint blockade therapy by targeting PI3Kγ in myeloid cells. Nature, 2016 Nov;539:443-447.
5 Tochler, A., Hong D., Sullivan R, et al. IPI-549-01: A Phase 1/1b first-in-human study of IPI-549, a PI3K-gamma inhibitor, as monotherapy and in combination with an anti-PD1 antibody in subjects with advanced solid tumors. Presented at Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival (Poster B070), 2016.
6 Rausch, M., Tchaicha, Tibbitts, T. et al. The PI3K-gamma inhibitor, IPI-549, increases antitumor immunity by targeting tumor-associated myeloid cells and remodeling the immune-suppressive tumor microenvironment. Presented at Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival (Poster B032), 2016.
7 www.clinicaltrials.gov, NCT02637531.
$CRTN Continued Growth in #NetworkTransformation
Company experiences strong demand across its Network Transformation services in both North America and EMEA markets
OVERLAND PARK, Kan., Jan. 20, 2017 — Cartesian™ (NASDAQ:CRTN), a leading provider of consulting services and managed solutions to the global telecom, media and technology industries, has reported that demand for its network transformation services has been experiencing consistently strong growth in both North America and Europe, the Middle East, and Africa (EMEA).
Leveraging the company’s 25-year history in the communications industry, Cartesian’s network transformation expertise and experience accelerates the service provider-led transformation initiatives, specifically in the areas of network fiber expansion and upgrades, customer migration, access cost optimization, expansion opportunity identification and next-generation technology adoption such as NFV and SDN.
Network transformation services has developed into a more central focus for the company, where it has been experiencing strong growth resulting from major M&A and technology shifts in the industry that have challenged the way network operators do business.
“We see new challenges arise every day for network operators, who are spending billions of dollars each year to prevent customer churn and circumvent competitive technologies and providers,” said Peter Woodward, CEO of Cartesian. “At their core, our engagements have helped operators maximize their capital spend and successfully accelerate the transformation of their networks. We believe there is an increasingly large market opportunity in front of us, and have been capitalizing on it in recent years because of our specialized industry and domain knowledge, leading analytics capabilities, and high-touch customer service approach.”
Starting with an overall assessment of the network inventory, the company assists operators in identifying opportunities for network upgrades and expansion, as well as methods to implement these changes in a cost-effective and return-generating basis. The company also uses proprietary data and technology, including network visualization tools, to give operators not only a better insight into their own networks, but also that of their competitors, helping them consider the full spectrum of industry information before executing highly complex and costly network transformation initiatives.
Woodward added: “Every communications infrastructure has a lifespan, and helping to restructure and migrate aging networks is an integral part of what we do. We are pleased by how successful this rapidly growing area of our business has been, but realize there are countless opportunities for us to pursue in this evolving landscape, especially as regulators and government organizations place greater pressure on these operators to enhance their networks. As a result, we will continue to penetrate those markets where demand is at its highest and where we can optimize our utilization to profitably grow this practice.”
About Cartesian, Inc.
Cartesian, Inc. (NASDAQ:CRTN) is a specialist provider of consulting services and managed solutions to leaders in the global communications, technology and digital media industries. Cartesian provides strategic advice, management consulting, and managed solutions to clients worldwide. The company has offices in Boston, Kansas City, London, New York, Philadelphia and Washington. For more information, visit www.cartesian.com.
Investor Contact: Matt Glover or Najim Mostamand Liolios Group, Inc. 949-574-3860 CRTN@liolios.com
$HRTX Announces Pricing of Underwritten #PublicOffering of Common Stock
Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on developing novel best-in-class treatment solutions to address some of the biggest unmet patient needs, today announced the pricing of an underwritten public offering of $150 million of shares of its common stock, offered at a price of $12.20 per share. Heron Therapeutics, Inc. has granted the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of common stock. The offering is expected to close on or about January 24, 2017, subject to customary closing conditions. BofA Merrill Lynch, Cowen and Company, LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and JMP Securities LLC are acting as lead managers and Noble Capital Markets, LifeSci Capital, Aegis Capital Corp and Lake Street Capital Markets are acting as co-managers for the offering.
The gross offering size will be approximately $150 million before deducting customary underwriting discounts and commissions and offering expenses. Heron Therapeutics, Inc. intends to use the net proceeds from the underwritten offering primarily for general corporate purposes, which include, but are not limited to, the continued commercialization and marketing of SUSTOL®, the commercial launch of CINVANTI™, if approved by the U.S. Food and Drug Administration, funding the company’s ongoing and future clinical trials, including further Phase 2 studies and Phase 3 studies of HTX-011, preclinical development work, for general and administrative expenses, repayment of a portion of its outstanding debt, or other product development activities.
The securities described above are being offered pursuant to a shelf registration statement (File No. 333-212784), which became effective automatically on July 29, 2016. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. 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. The offering can be made only by means of a prospectus, copies of which may be obtained at the United States Securities and Exchange Commission’s website at www.sec.gov, or by request at BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department or by email at dg.prospectus_requests@baml.com; Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (631) 274-2806 or by fax at (631) 254-7140; and Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6142 or by email at syndicate@leerink.com.
Investor Relations Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior Vice President, General Counsel & Corporate Secretary
dszekeres@herontx.com
and
Corporate Contact:
Heron Therapeutics, Inc.
David Szekeres, 858-251-4447
Senior Vice President, General Counsel & Corporate Secretary
dszekeres@herontx.com
$RTNB Awarded 5-Year Training Subcontract Supporting #DoD
COLORADO SPRINGS, Colo., Jan. 19, 2017 — root9B, a root9B Holdings Inc. (NASDAQ: RTNB) company, and leading provider of advanced cybersecurity services and training for commercial and government clients, announced today that it is part of a team with Chiron Technology Services, Inc. that was awarded a Department of Defense (DoD) training contract. This contract is an indefinite-delivery/indefinite-quantity (IDIQ) contract, and has a period of performance of 5 years, with a ceiling value of $50 million.
The competitively awarded contract will partner root9B’s Subject Matter Expertise and instruction in Advanced Cyber operations. root9B will provide relevant and operationally focused training in Cyber Operations, Incident Response, Threat Emulation, and Network Defense.
The effort will draw on root9B’s real-world operational experiences to deliver state-of-the-art cyber training focused on developing the operational skills needed to protect against the evolving capabilities of cyber adversaries and elevate the skills of future cybersecurity teams. As a Mission Qualification Training (MQT) provider to multiple DoD cyber units, root9B understands that developing relevant, practical knowledge, insight, and technical skills is central to establishing a cadre of cybersecurity teams who are mission-ready.
“This contract enables the nation’s most-focused Cybersecurity teams to receive operationally relevant advanced training from a strong cadre of teammates,” said Mike Morris, root9B’s Chief Technology Officer. “We are honored to provide this customer with an advanced cyber training solution that serves the customer’s end-to-end training mission requirements.”
About root9B
Ranked as the #1 Cybersecurity company for 2016 by Cybersecurity Ventures, root9B stands in defiance of the unwanted human presence within our clients’ networks by attacking the root of the problem—the adversary’s ability to gain entry and remain undetected. root9B’s application of advanced technology developed through cutting-edge R&D and engineering and refined through relevant, hands-on training is revolutionary. root9B combines next generation technology, tactics development, specialty tools, and deep mission experience. root9B personnel leverage their extensive backgrounds in the U.S. Intelligence Community to conduct advanced vulnerability analysis, penetration testing, digital forensics, incident response, Industrial Control System (ICS) security, and HUNT (Active Adversary Pursuit) engagements on networks worldwide. For more information, visit www.root9B.com.
About root9B Holdings, Inc.
root9B Holdings is a leading provider of Cybersecurity and Regulatory Risk Mitigation Services. Through its wholly owned subsidiaries root9B and IPSA International, the Company delivers results that improve productivity, mitigate risk and maximize profits. Its clients range in size from Fortune 100 companies to mid-sized and owner-managed businesses across a broad range of industries including local, state and government agencies. For more information, visit www.root9bholdings.com
Forward Looking Statements
Certain statements contained in this press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the Company’s current expectations or beliefs and are subject to uncertainty and changes in circumstances. Actual results may vary materially from those expressed or implied by the statements herein due to changes in economic, business, competitive and/or regulatory factors, and other risks and uncertainties affecting the operation of the Company’s business. These risks, uncertainties and contingencies are indicated from time to time in the Company’s filings with the Securities and Exchange Commission. The information set forth herein should be read in light of such risks. Further, investors should keep in mind that the Company’s financial results in any particular period may not be indicative of future results. The Company is under no obligation to, and expressly disclaims any obligation to, update or alter its forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.
| Media Contact: | Investors: |
| Andrew Hoffman | Devin Sullivan |
| Zito Partners | The Equity Group Inc. |
| 908-546-7447 | 212-836-9608 |
| andrew@zitopartners.com | dsullivan@equityny.com |
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